Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB891 Compare Versions

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Old	New	Differences
1	1	II
2	2	119THCONGRESS
3	3	1
4	4	STSESSION S. 891
5	5	To extend expiring health provisions and improve health care delivery.
6	6	IN THE SENATE OF THE UNITED STATES
7	7	MARCH6, 2025
8	8	Mr. W
9	9	YDEN(for himself and Mr. SANDERS) introduced the following bill;
10	10	which was read twice and referred to the Committee on Finance
11	11	A BILL
12	12	To extend expiring health provisions and improve health care
13	13	delivery.
14	14	Be it enacted by the Senate and House of Representa-1
15	15	tives of the United States of America in Congress assembled, 2
16	16	SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3
17	17	(a) S
18	18	HORTTITLE.—This Act may be cited as the 4
19	19	‘‘Bipartisan Health Care Act’’. 5
20	20	(b) T
21	21	ABLE OFCONTENTS.—The table of contents for 6
22	22	this Act is as follows: 7
23	23	Sec. 1. Short title; table of contents.
24	24	TITLE I—MEDICAID
25	25	Sec. 101. Streamlined enrollment process for eligible out-of-state providers
26	26	under Medicaid and CHIP.
27	27	Sec. 102. Making certain adjustments to coverage of home or community-based
28	28	services under Medicaid.
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32	32	Sec. 103. Removing certain age restrictions on Medicaid eligibility for working
33	33	adults with disabilities.
34	34	Sec. 104. Medicaid State plan requirement for determining residency and cov-
35	35	erage for military families.
36	36	Sec. 105. Ensuring the reliability of address information provided under the
37	37	Medicaid program.
38	38	Sec. 106. Codifying certain Medicaid provider screening requirements related to
39	39	deceased providers.
40	40	Sec. 107. Modifying certain State requirements for ensuring deceased individ-
41	41	uals do not remain enrolled.
42	42	Sec. 108. One-year delay of Medicaid and CHIP requirements for health
43	43	screenings, referrals, and case management services for eligible
44	44	juveniles in public institutions; State interim work plans.
45	45	Sec. 109. State studies and HHS report on costs of providing maternity, labor,
46	46	and delivery services.
47	47	Sec. 110. Modifying certain disproportionate share hospital allotments.
48	48	Sec. 111. Modifying certain limitations on disproportionate share hospital pay-
49	49	ment adjustments under the Medicaid program.
50	50	Sec. 112. Ensuring accurate payments to pharmacies under Medicaid.
51	51	Sec. 113. Preventing the use of abusive spread pricing in Medicaid.
52	52	TITLE II—MEDICARE
53	53	Sec. 201. Extension of increased inpatient hospital payment adjustment for cer-
54	54	tain low-volume hospitals.
55	55	Sec. 202. Extension of the Medicare-dependent hospital (MDH) program.
56	56	Sec. 203. Extension of add-on payments for ambulance services.
57	57	Sec. 204. Extending incentive payments for participation in eligible alternative
58	58	payment models.
59	59	Sec. 205. Temporary payment increase under the Medicare physician fee sched-
60	60	ule to account for exceptional circumstances.
61	61	Sec. 206. Extension of funding for quality measure endorsement, input, and se-
62	62	lection.
63	63	Sec. 207. Extension of funding outreach and assistance for low-income pro-
64	64	grams.
65	65	Sec. 208. Extension of the work geographic index floor.
66	66	Sec. 209. Extension of certain telehealth flexibilities.
67	67	Sec. 210. Requiring modifier for use of telehealth to conduct face-to-face en-
68	68	counter prior to recertification of eligibility for hospice care.
69	69	Sec. 211. Extending acute hospital care at home waiver flexibilities.
70	70	Sec. 212. Enhancing certain program integrity requirements for DME under
71	71	Medicare.
72	72	Sec. 213. Guidance on furnishing services via telehealth to individuals with lim-
73	73	ited English proficiency.
74	74	Sec. 214. In-home cardiopulmonary rehabilitation flexibilities.
75	75	Sec. 215. Inclusion of virtual diabetes prevention program suppliers in MDPP
76	76	Expanded Model.
77	77	Sec. 216. Medication-induced movement disorder outreach and education.
78	78	Sec. 217. Report on wearable medical devices.
79	79	Sec. 218. Extension of temporary inclusion of authorized oral antiviral drugs as
80	80	covered part D drugs.
81	81	Sec. 219. Extension of adjustment to calculation of hospice cap amount.
82	82	Sec. 220. Multiyear contracting authority for MedPAC and MACPAC.
83	83	Sec. 221. Contracting parity for MedPAC and MACPAC.
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87	87	Sec. 222. Adjustments to Medicare part D cost-sharing reductions for low-in-
88	88	come individuals.
89	89	Sec. 223. Requiring Enhanced and Accurate Lists of (REAL) Health Providers
90	90	Act.
91	91	Sec. 224. Medicare coverage of multi-cancer early detection screening tests.
92	92	Sec. 225. Medicare coverage of external infusion pumps and non-self-admin-
93	93	istrable home infusion drugs.
94	94	Sec. 226. Assuring pharmacy access and choice for Medicare beneficiaries.
95	95	Sec. 227. Modernizing and Ensuring PBM Accountability.
96	96	Sec. 228. Requiring a separate identification number and an attestation for
97	97	each off-campus outpatient department of a provider.
98	98	Sec. 229. Medicare sequestration.
99	99	Sec. 230. Medicare improvement fund.
100	100	TITLE III—HUMAN SERVICES
101	101	Sec. 301. Sexual risk avoidance education extension.
102	102	Sec. 302. Personal responsibility education extension.
103	103	Sec. 303. Extension of funding for family-to-family health information centers.
104	104	TITLE IV—PUBLIC HEALTH EXTENDERS
105	105	Subtitle A—Extensions
106	106	Sec. 401. Extension for community health centers, National Health Service
107	107	Corps, and teaching health centers that operate GME pro-
108	108	grams.
109	109	Sec. 402. Extension of special diabetes programs.
110	110	Subtitle B—World Trade Center Health Program
111	111	Sec. 411. 9/11 responder and survivor health funding corrections.
112	112	TITLE V—SUPPORT ACT REAUTHORIZATION
113	113	Sec. 501. Short title.
114	114	Subtitle A—Prevention
115	115	Sec. 511. Prenatal and postnatal health.
116	116	Sec. 512. Monitoring and education regarding infections associated with illicit
117	117	drug use and other risk factors.
118	118	Sec. 513. Preventing overdoses of controlled substances.
119	119	Sec. 514. Support for individuals and families impacted by fetal alcohol spec-
120	120	trum disorder.
121	121	Sec. 515. Promoting State choice in PDMP systems.
122	122	Sec. 516. First responder training program.
123	123	Sec. 517. Donald J. Cohen National Child Traumatic Stress Initiative.
124	124	Sec. 518. Protecting suicide prevention lifeline from cybersecurity incidents.
125	125	Sec. 519. Bruce’s law.
126	126	Sec. 520. Guidance on at-home drug disposal systems.
127	127	Sec. 521. Assessment of opioid drugs and actions.
128	128	Sec. 522. Grant program for State and Tribal response to opioid use disorders.
129	129	Subtitle B—Treatment
130	130	Sec. 531. Residential treatment program for pregnant and postpartum women.
131	131	Sec. 532. Improving access to addiction medicine providers.
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135	135	Sec. 533. Mental and behavioral health education and training grants.
136	136	Sec. 534. Loan repayment program for substance use disorder treatment work-
137	137	force.
138	138	Sec. 535. Development and dissemination of model training programs for sub-
139	139	stance use disorder patient records.
140	140	Sec. 536. Task force on best practices for trauma-informed identification, refer-
141	141	ral, and support.
142	142	Sec. 537. Grants to enhance access to substance use disorder treatment.
143	143	Sec. 538. State guidance related to individuals with serious mental illness and
144	144	children with serious emotional disturbance.
145	145	Sec. 539. Reviewing the scheduling of approved products containing a combina-
146	146	tion of buprenorphine and naloxone.
147	147	Subtitle C—Recovery
148	148	Sec. 541. Building communities of recovery.
149	149	Sec. 542. Peer support technical assistance center.
150	150	Sec. 543. Comprehensive opioid recovery centers.
151	151	Sec. 544. Youth prevention and recovery.
152	152	Sec. 545. CAREER Act.
153	153	Sec. 546. Addressing economic and workforce impacts of the opioid crisis.
154	154	Subtitle D—Miscellaneous Matters
155	155	Sec. 551. Delivery of a controlled substance by a pharmacy to a prescribing
156	156	practitioner.
157	157	Sec. 552. Technical correction on controlled substances dispensing.
158	158	Sec. 553. Required training for prescribers of controlled substances.
159	159	Sec. 554. Extension of temporary order for fentanyl-related substances.
160	160	TITLE VI—PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND
161	161	RESPONSE
162	162	Sec. 601. Short title.
163	163	Subtitle A—State and Local Readiness and Response
164	164	Sec. 611. Temporary reassignment of State and local personnel during a public
165	165	health emergency.
166	166	Sec. 612. Public Health Emergency Preparedness program.
167	167	Sec. 613. Hospital Preparedness Program.
168	168	Sec. 614. Facilities and capacities of the Centers for Disease Control and Pre-
169	169	vention to combat public health security threats.
170	170	Sec. 615. Pilot program to support State medical stockpiles.
171	171	Sec. 616. Enhancing domestic wastewater surveillance for pathogen detection.
172	172	Sec. 617. Reauthorization of Mosquito Abatement for Safety and Health pro-
173	173	gram.
174	174	Subtitle B—Federal Planning and Coordination
175	175	Sec. 621. All-Hazards Emergency Preparedness and Response.
176	176	Sec. 622. National Health Security Strategy.
177	177	Sec. 623. Improving development and distribution of diagnostic tests.
178	178	Sec. 624. Combating antimicrobial resistance.
179	179	Sec. 625. Strategic National Stockpile and material threats.
180	180	Sec. 626. Medical countermeasures for viral threats with pandemic potential.
181	181	Sec. 627. Public Health Emergency Medical Countermeasures Enterprise.
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185	185	Sec. 628. Fellowship and training programs.
186	186	Sec. 629. Regional biocontainment research laboratories.
187	187	Sec. 629A. Limitation related to countries of concern conducting certain re-
188	188	search.
189	189	Subtitle C—Addressing the Needs of All Individuals
190	190	Sec. 631. Improving access to certain programs.
191	191	Sec. 632. Supporting at-risk individuals during emergency responses.
192	192	Sec. 633. National advisory committees.
193	193	Sec. 634. National Academies study on prizes.
194	194	Subtitle D—Additional Reauthorizations
195	195	Sec. 641. Medical countermeasure priority review voucher.
196	196	Sec. 642. Epidemic Intelligence Service.
197	197	Sec. 643. Monitoring and distribution of certain medical countermeasures.
198	198	Sec. 644. Regional health care emergency preparedness and response systems.
199	199	Sec. 645. Emergency system for advance registration of volunteer health pro-
200	200	fessionals.
201	201	Sec. 646. Ensuring collaboration and coordination in medical countermeasure
202	202	development.
203	203	Sec. 647. Military and civilian partnership for trauma readiness.
204	204	Sec. 648. National Disaster Medical System.
205	205	Sec. 649. Volunteer Medical Reserve Corps.
206	206	Sec. 649A. Epidemiology-laboratory capacity.
207	207	TITLE VII—PUBLIC HEALTH PROGRAMS
208	208	Sec. 701. Action for dental health.
209	209	Sec. 702. PREEMIE.
210	210	Sec. 703. Preventing maternal deaths.
211	211	Sec. 704. Sickle cell disease prevention and treatment.
212	212	Sec. 705. Traumatic brain injuries.
213	213	Sec. 706. Lifespan respite care.
214	214	Sec. 707. Dr. Lorna Breen health care provider protection.
215	215	Sec. 708. SCREENS for Cancer.
216	216	Sec. 709. DeOndra Dixon INCLUDE Project.
217	217	Sec. 710. IMPROVE Initiative.
218	218	Sec. 711. Organ Procurement and Transplantation Network.
219	219	Sec. 712. Honor Our Living Donors.
220	220	Sec. 713. Program for pediatric studies of drugs.
221	221	TITLE VIII—FOOD AND DRUG ADMINISTRATION
222	222	Subtitle A—Give Kids a Chance
223	223	Sec. 801. Research into pediatric uses of drugs; additional authorities of Food
224	224	and Drug Administration regarding molecularly targeted can-
225	225	cer drugs.
226	226	Sec. 802. Ensuring completion of pediatric study requirements.
227	227	Sec. 803. FDA report on PREA enforcement.
228	228	Sec. 804. Extension of authority to issue priority review vouchers to encourage
229	229	treatments for rare pediatric diseases.
230	230	Sec. 805. Limitations on exclusive approval or licensure of orphan drugs.
231	231	Subtitle B—United States-Abraham Accords Cooperation and Security
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235	235	Sec. 811. Establishment of Abraham Accords Office within Food and Drug Ad-
236	236	ministration.
237	237	TITLE IX—LOWERING PRESCRIPTION DRUG COSTS
238	238	Sec. 901. Oversight of pharmacy benefit management services.
239	239	Sec. 902. Full rebate pass through to plan; exception for innocent plan fidu-
240	240	ciaries.
241	241	Sec. 903. Increasing transparency in generic drug applications.
242	242	Sec. 904. Title 35 amendments.
243	243	TITLE X—MISCELLANEOUS
244	244	Sec. 1001. Extension of safe harbor for absence of deductible for telehealth.
245	245	TITLE I—MEDICAID 1
246	246	SEC. 101. STREAMLINED ENROLLMENT PROCESS FOR ELI-2
247	247	GIBLE OUT-OF-STATE PROVIDERS UNDER 3
248	248	MEDICAID AND CHIP. 4
249	249	(a) I
250	250	NGENERAL.—Section 1902(kk) of the Social Se-5
251	251	curity Act (42 U.S.C. 1396a(kk)) is amended by adding 6
252	252	at the end the following new paragraph: 7
253	253	‘‘(10) S
254	254	TREAMLINED ENROLLMENT PROCESS 8
255	255	FOR ELIGIBLE OUT-OF-STATE PROVIDERS.— 9
256	256	‘‘(A) I
257	257	N GENERAL.—The State— 10
258	258	‘‘(i) adopts and implements a process 11
259	259	to allow an eligible out-of-State provider to 12
260	260	enroll under the State plan (or a waiver of 13
261	261	such plan) to furnish items and services to, 14
262	262	or order, prescribe, refer, or certify eligi-15
263	263	bility for items and services for, qualifying 16
264	264	individuals without the imposition of 17
265	265	screening or enrollment requirements by 18
266	266	such State that exceed the minimum nec-19
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270	270	essary for such State to provide payment 1
271	271	to an eligible out-of-State provider under 2
272	272	such State plan (or a waiver of such plan), 3
273	273	such as the provider’s name and National 4
274	274	Provider Identifier (and such other infor-5
275	275	mation specified by the Secretary); and 6
276	276	‘‘(ii) provides that an eligible out-of- 7
277	277	State provider that enrolls as a partici-8
278	278	pating provider in the State plan (or a 9
279	279	waiver of such plan) through such process 10
280	280	shall be so enrolled for a 5-year period, un-11
281	281	less the provider is terminated or excluded 12
282	282	from participation during such period. 13
283	283	‘‘(B) D
284	284	EFINITIONS.—In this paragraph: 14
285	285	‘‘(i) E
286	286	LIGIBLE OUT-OF-STATE PRO-15
287	287	VIDER.—The term ‘eligible out-of-State 16
288	288	provider’ means, with respect to a State, a 17
289	289	provider— 18
290	290	‘‘(I) that is located in any other 19
291	291	State; 20
292	292	‘‘(II) that— 21
293	293	‘‘(aa) was determined by the 22
294	294	Secretary to have a limited risk 23
295	295	of fraud, waste, and abuse for 24
296	296	purposes of determining the level 25
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300	300	of screening to be conducted 1
301	301	under section 1866(j)(2), has 2
302	302	been so screened under such sec-3
303	303	tion 1866(j)(2), and is enrolled in 4
304	304	the Medicare program under title 5
305	305	XVIII; or 6
306	306	‘‘(bb) was determined by the 7
307	307	State agency administering or su-8
308	308	pervising the administration of 9
309	309	the State plan (or a waiver of 10
310	310	such plan) of such other State to 11
311	311	have a limited risk of fraud, 12
312	312	waste, and abuse for purposes of 13
313	313	determining the level of screening 14
314	314	to be conducted under paragraph 15
315	315	(1) of this subsection, has been 16
316	316	so screened under such para-17
317	317	graph (1), and is enrolled under 18
318	318	such State plan (or a waiver of 19
319	319	such plan); and 20
320	320	‘‘(III) that has not been— 21
321	321	‘‘(aa) excluded from partici-22
322	322	pation in any Federal health care 23
323	323	program pursuant to section 24
324	324	1128 or 1128A; 25
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328	328	‘‘(bb) excluded from partici-1
329	329	pation in the State plan (or a 2
330	330	waiver of such plan) pursuant to 3
331	331	part 1002 of title 42, Code of 4
332	332	Federal Regulations (or any suc-5
333	333	cessor regulation), or State law; 6
334	334	or 7
335	335	‘‘(cc) terminated from par-8
336	336	ticipating in a Federal health 9
337	337	care program or the State plan 10
338	338	(or a waiver of such plan) for a 11
339	339	reason described in paragraph 12
340	340	(8)(A). 13
341	341	‘‘(ii) Q
342	342	UALIFYING INDIVIDUAL .—The 14
343	343	term ‘qualifying individual’ means an indi-15
344	344	vidual under 21 years of age who is en-16
345	345	rolled under the State plan (or waiver of 17
346	346	such plan). 18
347	347	‘‘(iii) S
348	348	TATE.—The term ‘State’ 19
349	349	means 1 of the 50 States or the District 20
350	350	of Columbia.’’. 21
351	351	(b) C
352	352	ONFORMINGAMENDMENTS.— 22
353	353	(1) Section 1902(a)(77) of the Social Security 23
354	354	Act (42 U.S.C. 1396a(a)(77)) is amended by insert-24
355	355	ing ‘‘enrollment,’’ after ‘‘screening,’’. 25
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359	359	(2) The subsection heading for section 1
360	360	1902(kk) of such Act (42 U.S.C. 1396a(kk)) is 2
361	361	amended by inserting ‘‘enrollment,’’ after ‘‘screen-3
362	362	ing,’’. 4
363	363	(3) Section 2107(e)(1)(G) of such Act (42 5
364	364	U.S.C. 1397gg(e)(1)(G)) is amended by inserting 6
365	365	‘‘enrollment,’’ after ‘‘screening,’’. 7
366	366	(c) E
367	367	FFECTIVEDATE.—The amendments made by 8
368	368	this section shall take effect on the date that is 3 years 9
369	369	after the date of enactment of this Act. 10
370	370	SEC. 102. MAKING CERTAIN ADJUSTMENTS TO COVERAGE 11
371	371	OF HOME OR COMMUNITY-BASED SERVICES 12
372	372	UNDER MEDICAID. 13
373	373	(a) I
374	374	NCREASINGTRANSPARENCY OF HCBS COV-14
375	375	ERAGEUNDERMEDICAID.— 15
376	376	(1) I
377	377	N GENERAL.—Section 1915(c) of the So-16
378	378	cial Security Act (42 U.S.C. 1396n(c)) is amend-17
379	379	ed— 18
380	380	(A) in paragraph (2)— 19
381	381	(i) in subparagraph (E)— 20
382	382	(I) by inserting ‘‘, not less fre-21
383	383	quently than’’ before ‘‘annually’’; and 22
384	384	(II) by inserting ‘‘(including, 23
385	385	with respect to such information pro-24
386	386	vided on or after July 9, 2027, the in-25
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390	390	formation specified in paragraph 1
391	391	(11))’’ before the period at the end; 2
392	392	and 3
393	393	(ii) by adding at the end the following 4
394	394	flush sentence: 5
395	395	‘‘The Secretary shall make all information provided 6
396	396	under subparagraph (E) on or after the date of the 7
397	397	enactment of this sentence publicly available on the 8
398	398	website of the Centers for Medicare & Medicaid 9
399	399	Services.’’; and 10
400	400	(B) by adding at the end the following new 11
401	401	paragraph: 12
402	402	‘‘(11) For purposes of paragraph (2)(E), the 13
403	403	information specified in this paragraph is the fol-14
404	404	lowing: 15
405	405	‘‘(A) In the case of a State that limits the 16
406	406	number of individuals who may be provided 17
407	407	home or community-based services under a 18
408	408	waiver granted under this subsection and main-19
409	409	tains a list of individuals waiting to enroll in 20
410	410	such waiver, a description of how the State 21
411	411	maintains such list, including— 22
412	412	‘‘(i) information on whether the State 23
413	413	screens individuals on such list to deter-24
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417	417	mine whether such individuals are eligible 1
418	418	to receive such services under such waiver; 2
419	419	‘‘(ii) information on whether (and, if 3
420	420	applicable, how often) the State periodi-4
421	421	cally re-screens individuals on such list for 5
422	422	eligibility; 6
423	423	‘‘(iii) the number of people on such 7
424	424	list of individuals waiting to enroll in such 8
425	425	waiver; and 9
426	426	‘‘(iv) the average amount of time that 10
427	427	individuals newly enrolled in such waiver 11
428	428	within the past 12 months were on such 12
429	429	list of individuals waiting to enroll in such 13
430	430	waiver. 14
431	431	‘‘(B) With respect to homemaker services, 15
432	432	home health aide services, personal care serv-16
433	433	ices, and habilitation services furnished under 17
434	434	waivers under this subsection, by each such 18
435	435	service type— 19
436	436	‘‘(i) for individuals newly receiving 20
437	437	such services within the past 12 months, 21
438	438	the average amount of time (which may be 22
439	439	determined using statistically valid random 23
440	440	sampling of such individuals) from when 24
441	441	such services are initially approved for 25
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445	445	such an individual to when such individual 1
446	446	begins receiving such services; and 2
447	447	‘‘(ii) the percentage of authorized 3
448	448	hours (which may be determined using sta-4
449	449	tistically valid random sampling of individ-5
450	450	uals authorized to receive such services) 6
451	451	that are provided within the past 12 7
452	452	months.’’. 8
453	453	(2) C
454	454	ONFORMING AMENDMENTS .—Section 1915 9
455	455	of the Social Security Act (42 U.S.C. 1396n) is 10
456	456	amended— 11
457	457	(A) in subsection (i) by adding at the end 12
458	458	the following new paragraph: 13
459	459	‘‘(8) R
460	460	EPORTING REQUIREMENT .—With respect 14
461	461	to homemaker services, home health aide services, 15
462	462	personal care services, and habilitation services pro-16
463	463	vided under this subsection on or after July 9, 2027, 17
464	464	the State, not less frequently than annually, shall 18
465	465	provide to the Secretary the same information re-19
466	466	garding such services as the State is required to pro-20
467	467	vide under subsection (c)(11)(B).’’; 21
468	468	(B) in subsection (j)(2)(E), by inserting 22
469	469	after the second sentence the following: ‘‘With 23
470	470	respect to any homemaker services, home health 24
471	471	aide services, personal care services, and habili-25
472	472	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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474	474	•S 891 IS
475	475	tation services provided under this subsection 1
476	476	on or after July 9, 2027, the State, not less fre-2
477	477	quently than annually, shall provide to the Sec-3
478	478	retary the same information regarding such 4
479	479	services as the State is required to provide 5
480	480	under subsection (c)(11)(B).’’; and 6
481	481	(C) in subsection (k)(3)(E)— 7
482	482	(i) by striking ‘‘and’’ after ‘‘the cost 8
483	483	of such services and supports,’’; and 9
484	484	(ii) by inserting before the period, the 10
485	485	following: ‘‘, and with respect to home-11
486	486	maker services, home health aide services, 12
487	487	personal care services, and habilitation 13
488	488	services provided under this subsection on 14
489	489	or after July 9, 2027, not less frequently 15
490	490	than annually, the same information re-16
491	491	garding such services as the State is re-17
492	492	quired to provide under subsection 18
493	493	(c)(11)(B)’’. 19
494	494	(b) D
495	495	EMONSTRATION PROGRAMTOEXPANDHCBS 20
496	496	C
497	497	OVERAGEUNDERSECTION1915(C) WAIVERS.—Section 21
498	498	1915(c) of the Social Security Act (42 U.S.C. 1396n(c)), 22
499	499	as amended by subsection (a), is further amended— 23
500	500	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
501	501	TKELLEY on LAP7H3WLY3PROD with BILLS 15
502	502	•S 891 IS
503	503	(1) in paragraph (2)(E), by inserting ‘‘, and the 1
504	504	information specified in paragraph (12)(C)(v), when 2
505	505	applicable’’ after ‘‘paragraph (11)’’; and 3
506	506	(2) by adding at the end the following new 4
507	507	paragraph: 5
508	508	‘‘(12) D
509	509	EMONSTRATION PROGRAM TO EXPAND 6
510	510	COVERAGE FOR HOME OR COMMUNITY -BASED SERV-7
511	511	ICES.— 8
512	512	‘‘(A) I
513	513	N GENERAL.— 9
514	514	‘‘(i) A
515	515	PPROVAL.—Not later than 24 10
516	516	months after the date on which the plan-11
517	517	ning grants under subparagraph (B) are 12
518	518	awarded, notwithstanding paragraph (1), 13
519	519	the Secretary may approve a waiver that is 14
520	520	standalone from any other waiver approved 15
521	521	under this subsection for not more than 5 16
522	522	States, selected in accordance with clause 17
523	523	(ii), to include as medical assistance under 18
524	524	the State plan of such State, for the 3-year 19
525	525	period beginning on the date of such ap-20
526	526	proval, payment for part or all of the cost 21
527	527	of home or community-based services 22
528	528	(other than room and board (as described 23
529	529	in paragraph (1))) approved by the Sec-24
530	530	retary which are provided pursuant to a 25
531	531	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
532	532	TKELLEY on LAP7H3WLY3PROD with BILLS 16
533	533	•S 891 IS
534	534	written plan of care to individuals de-1
535	535	scribed in subparagraph (C)(iii). 2
536	536	‘‘(ii) S
537	537	ELECTION CRITERIA.—In se-3
538	538	lecting States for purposes of clause (i), 4
539	539	the Secretary shall— 5
540	540	‘‘(I) only select States that re-6
541	541	ceived a planning grant under sub-7
542	542	paragraph (B); 8
543	543	‘‘(II) only select States that meet 9
544	544	the requirements specified in subpara-10
545	545	graph (C) and such other require-11
546	546	ments as the Secretary may determine 12
547	547	appropriate; 13
548	548	‘‘(III) select States in a manner 14
549	549	that ensures geographic diversity; 15
550	550	‘‘(IV) give preference to States 16
551	551	with a higher percentage (relative to 17
552	552	other States that apply to be selected 18
553	553	for purposes of clause (i)) of the total 19
554	554	State population residing in rural 20
555	555	areas (as determined by the Sec-21
556	556	retary); 22
557	557	‘‘(V) give preference to States 23
558	558	that have demonstrated more progress 24
559	559	in rebalancing long-term services and 25
560	560	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
561	561	TKELLEY on LAP7H3WLY3PROD with BILLS 17
562	562	•S 891 IS
563	563	supports systems under this title, as 1
564	564	determined based on the relative share 2
565	565	of individuals who use home or com-3
566	566	munity-based services (as defined by 4
567	567	the Secretary) under this title as a 5
568	568	percentage of total individuals who 6
569	569	use long-term services and supports 7
570	570	(as defined by the Secretary) under 8
571	571	this title (in the most recent year for 9
572	572	which such data is available); and 10
573	573	‘‘(VI) give preference to States 11
574	574	that pursue a waiver under this para-12
575	575	graph that incorporates the provision 13
576	576	of mental health services for adults 14
577	577	with serious mental illness, children 15
578	578	with serious emotional disturbances, 16
579	579	or individuals with substance use dis-17
580	580	order. 18
581	581	‘‘(B) P
582	582	LANNING GRANTS.— 19
583	583	‘‘(i) I
584	584	N GENERAL.— 20
585	585	‘‘(I) A
586	586	PPROVAL.—Not later than 21
587	587	18 months after the date of the enact-22
588	588	ment of this paragraph, the Secretary 23
589	589	shall award planning grants of not 24
590	590	more than $5,000,000 each to not 25
591	591	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
592	592	TKELLEY on LAP7H3WLY3PROD with BILLS 18
593	593	•S 891 IS
594	594	more than 10 States for purposes of 1
595	595	preparing to submit a request for a 2
596	596	waiver under this subsection (includ-3
597	597	ing for costs to implement the waiver 4
598	598	or other activities to expand the provi-5
599	599	sion of home or community-based 6
600	600	services under this section) to provide 7
601	601	home or community-based services to 8
602	602	individuals described in subparagraph 9
603	603	(C)(iii). 10
604	604	‘‘(II) S
605	605	ELECTION CRITERIA.—In 11
606	606	awarding planning grants under sub-12
607	607	clause (I), the Secretary shall use the 13
608	608	selection criteria specified in sub-14
609	609	clauses (III) through (VI) of subpara-15
610	610	graph (A)(ii). 16
611	611	‘‘(ii) C
612	612	ONSULTATION.—A State that is 17
613	613	awarded a planning grant under clause (i) 18
614	614	shall, in preparing to submit a request for 19
615	615	a waiver described in such clause, consult 20
616	616	with— 21
617	617	‘‘(I) individuals in need of (and 22
618	618	not receiving) home or community- 23
619	619	based services, individuals receiving 24
620	620	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
621	621	TKELLEY on LAP7H3WLY3PROD with BILLS 19
622	622	•S 891 IS
623	623	home or community-based services, 1
624	624	and the caregivers of such individuals; 2
625	625	‘‘(II) providers furnishing home 3
626	626	or community-based services; and 4
627	627	‘‘(III) such other stakeholders, as 5
628	628	the Secretary may specify. 6
629	629	‘‘(C) S
630	630	TATE REQUIREMENTS .—In addition 7
631	631	to the requirements specified under this sub-8
632	632	section (except for the requirements described 9
633	633	in subparagraphs (C) and (D) of paragraph (2) 10
634	634	and any other requirement the Secretary deter-11
635	635	mines to be inapplicable in the context of a 12
636	636	waiver relation to individuals who do not re-13
637	637	quire the level of care described in paragraph 14
638	638	(1)), the requirements specified in this para-15
639	639	graph are, with respect to a State, the fol-16
640	640	lowing: 17
641	641	‘‘(i) As of the date that such State re-18
642	642	quests a waiver under this subsection to 19
643	643	provide home or community-based services 20
644	644	to individuals described in clause (iii), all 21
645	645	other waivers (if any) granted under this 22
646	646	subsection to such State meet the require-23
647	647	ments of this subsection. 24
648	648	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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650	650	•S 891 IS
651	651	‘‘(ii) The State demonstrates to the 1
652	652	Secretary that approval of a waiver under 2
653	653	this subsection with respect to individuals 3
654	654	described in clause (iii) will not result in a 4
655	655	material increase of the average amount of 5
656	656	time that individuals with respect to whom 6
657	657	a determination described in paragraph (1) 7
658	658	has been made will need to wait to receive 8
659	659	home or community-based services under 9
660	660	any waiver granted under this subsection, 10
661	661	as determined by the Secretary. 11
662	662	‘‘(iii) The State establishes needs- 12
663	663	based criteria, subject to the approval of 13
664	664	the Secretary, to identify individuals for 14
665	665	whom a determination described in para-15
666	666	graph (1) is not applicable, who will be eli-16
667	667	gible for home or community-based serv-17
668	668	ices under a waiver approved under this 18
669	669	paragraph, and specifies the home or com-19
670	670	munity-based services such individuals so 20
671	671	eligible will receive. 21
672	672	‘‘(iv) The State established needs- 22
673	673	based criteria for determining whether an 23
674	674	individual described in clause (iii) requires 24
675	675	the level of care provided in a hospital, 25
676	676	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
677	677	TKELLEY on LAP7H3WLY3PROD with BILLS 21
678	678	•S 891 IS
679	679	nursing facility, or an intermediate care fa-1
680	680	cility for individuals with developmental 2
681	681	disabilities under the State plan or under 3
682	682	any waiver of such plan that are more 4
683	683	stringent than the needs-based criteria es-5
684	684	tablished under clause (iii) for determining 6
685	685	eligibility for home or community-based 7
686	686	services. 8
687	687	‘‘(v) The State attests that the State’s 9
688	688	average per capita expenditure for medical 10
689	689	assistance under the State plan (or waiver 11
690	690	of such plan) provided with respect to such 12
691	691	individuals enrolled in a waiver under this 13
692	692	paragraph will not exceed the State’s aver-14
693	693	age per capita expenditures for medical as-15
694	694	sistance for individuals receiving institu-16
695	695	tional care under the State plan (or waiver 17
696	696	of such plan) for the duration that the 18
697	697	waiver under this paragraph is in effect. 19
698	698	‘‘(vi) The State provides to the Sec-20
699	699	retary data (in such form and manner as 21
700	700	the Secretary may specify) regarding the 22
701	701	number of individuals described in clause 23
702	702	(i) with respect to a State seeking approval 24
703	703	of a waiver under this subsection, to whom 25
704	704	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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706	706	•S 891 IS
707	707	the State will make such services available 1
708	708	under such waiver. 2
709	709	‘‘(vii) The State agrees to provide to 3
710	710	the Secretary, not less frequently than an-4
711	711	nually, data for purposes of paragraph 5
712	712	(2)(E) (in such form and manner as the 6
713	713	Secretary may specify) regarding, with re-7
714	714	spect to each preceding year in which a 8
715	715	waiver under this subsection to provide 9
716	716	home and community-based services to in-10
717	717	dividuals described in clause (iii) was in ef-11
718	718	fect— 12
719	719	‘‘(I) the cost (as such term is de-13
720	720	fined by the Secretary) of such serv-14
721	721	ices furnished to individuals described 15
722	722	in clause (iii), broken down by type of 16
723	723	service; 17
724	724	‘‘(II) with respect to each type of 18
725	725	home and community-based service 19
726	726	provided under the waiver, the length 20
727	727	of time that such individuals have re-21
728	728	ceived such service; 22
729	729	‘‘(III) a comparison between the 23
730	730	data described in subclause (I) and 24
731	731	any comparable data available with 25
732	732	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
733	733	TKELLEY on LAP7H3WLY3PROD with BILLS 23
734	734	•S 891 IS
735	735	respect to individuals with respect to 1
736	736	whom a determination described in 2
737	737	paragraph (1) has been made and 3
738	738	with respect to individuals receiving 4
739	739	institutional care under this title; and 5
740	740	‘‘(IV) the number of individuals 6
741	741	who have received home and commu-7
742	742	nity-based services under the waiver 8
743	743	during the preceding year.’’. 9
744	744	(c) N
745	745	ON-APPLICATION OF THE PAPERWORKREDUC-10
746	746	TIONACT.—Chapter 35 of title 44, United States Code 11
747	747	(commonly referred to as the ‘‘Paperwork Reduction Act 12
748	748	of 1995’’), shall not apply to the implementation of the 13
749	749	amendments made by subsections (a) and (b). 14
750	750	(d) CMS G
751	751	UIDANCE TOSTATES ONINTERIMCOV-15
752	752	ERAGEUNDERSECTION1915 HOME ANDCOMMUNITY- 16
753	753	B
754	754	ASEDSERVICESAUTHORITIES.—Not later than January 17
755	755	1, 2027, the Secretary of Health and Human Services 18
756	756	shall issue guidance to the States to clarify how a State 19
757	757	may provide, with respect to an individual who is eligible 20
758	758	for home and community-based services under section 21
759	759	1915 of the Social Security Act (42 U.S.C. 1396n), cov-22
760	760	erage of such services pursuant to a provisional written 23
761	761	plan of care, pending finalization, with respect to such in-24
762	762	dividual. 25
763	763	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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765	765	•S 891 IS
766	766	(e) FUNDING.— 1
767	767	(1) I
768	768	N GENERAL.—There are appropriated, out 2
769	769	of any funds in the Treasury not otherwise obli-3
770	770	gated, $71,000,000 for fiscal year 2025, to remain 4
771	771	available until expended, to the Secretary of Health 5
772	772	and Human Services for purposes of carrying out 6
773	773	subsection (d) and the amendments made by sub-7
774	774	section (b). 8
775	775	(2) R
776	776	ESERVATION FOR PLANNING GRANTS .—Of 9
777	777	the amount appropriated under paragraph (1), the 10
778	778	Secretary of Health and Human Services shall re-11
779	779	serve $50,000,000 of such amount to award plan-12
780	780	ning grants under the demonstration program estab-13
781	781	lished by the amendments made by subsection (b). 14
782	782	SEC. 103. REMOVING CERTAIN AGE RESTRICTIONS ON MED-15
783	783	ICAID ELIGIBILITY FOR WORKING ADULTS 16
784	784	WITH DISABILITIES. 17
785	785	(a) M
786	786	ODIFICATION OFOPTIONALBUY-INGROUPS.— 18
787	787	(1) I
788	788	N GENERAL .—Section 19
789	789	1902(a)(10)(A)(ii)(XV) of the Social Security Act 20
790	790	(42 U.S.C. 1396a(a)(10)(A)(ii)(XV)) is amended by 21
791	791	striking ‘‘but less than 65,’’. 22
792	792	(2) D
793	793	EFINITION MODIFICATION .—Section 23
794	794	1905(v)(1)(A) of the Social Security Act (42 U.S.C. 24
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796	796	TKELLEY on LAP7H3WLY3PROD with BILLS 25
797	797	•S 891 IS
798	798	1396d(v)(1)(A)) is amended by striking ‘‘, but less 1
799	799	than 65,’’. 2
800	800	(b) A
801	801	PPLICATION TO CERTAINSTATES.—A State 3
802	802	that, as of the date of enactment of this Act, provides for 4
803	803	making medical assistance available to individuals de-5
804	804	scribed in subclause (XV) or (XVI) of section 6
805	805	1902(a)(10)(A)(ii) of the Social Security Act (42 U.S.C. 7
806	806	1396a(a)(10)(A)(ii)) shall not be regarded as failing to 8
807	807	comply with the requirements of either such subclause (as 9
808	808	amended by subsection (a)(1)) or with section 10
809	809	1905(v)(1)(A) of the Social Security Act (42 U.S.C. 11
810	810	1396d(v)(1)(A)) (as amended by subsection (a)(2)) before 12
811	811	January 1, 2027. 13
812	812	SEC. 104. MEDICAID STATE PLAN REQUIREMENT FOR DE-14
813	813	TERMINING RESIDENCY AND COVERAGE FOR 15
814	814	MILITARY FAMILIES. 16
815	815	(a) I
816	816	NGENERAL.—Section 1902 of the Social Secu-17
817	817	rity Act (42 U.S.C. 1396a) is amended— 18
818	818	(1) in subsection (a)— 19
819	819	(A) in paragraph (86), by striking ‘‘and’’ 20
820	820	at the end; 21
821	821	(B) in paragraph (87), by striking the pe-22
822	822	riod at the end and inserting ‘‘; and’’; and 23
823	823	(C) by inserting after paragraph (87), the 24
824	824	following new paragraph: 25
825	825	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
826	826	TKELLEY on LAP7H3WLY3PROD with BILLS 26
827	827	•S 891 IS
828	828	‘‘(88) beginning January 1, 2028, provide, with 1
829	829	respect to an active duty relocated individual (as de-2
830	830	fined in subsection (uu)(1))— 3
831	831	‘‘(A) that, for purposes of determining eli-4
832	832	gibility for medical assistance under the State 5
833	833	plan (or waiver of such plan), such active duty 6
834	834	relocated individual is treated as a resident of 7
835	835	the State unless such individual voluntarily 8
836	836	elects not to be so treated for such purposes; 9
837	837	‘‘(B) that if, at the time of relocation (as 10
838	838	described in subsection (uu)(1)), such active 11
839	839	duty relocated individual is on a home and com-12
840	840	munity-based services waiting list (as defined in 13
841	841	subsection (uu)(2)), such individual remains on 14
842	842	such list until— 15
843	843	‘‘(i) the State completes an assess-16
844	844	ment and renders a decision with respect 17
845	845	to the eligibility of such individual to re-18
846	846	ceive the relevant home and community- 19
847	847	based services at the time a slot for such 20
848	848	services becomes available and, in the case 21
849	849	such decision is a denial of such eligibility, 22
850	850	such individual has exhausted the individ-23
851	851	ual’s opportunity for a fair hearing; or 24
852	852	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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854	854	•S 891 IS
855	855	‘‘(ii) such individual elects to be re-1
856	856	moved from such list; and 2
857	857	‘‘(C) payment for medical assistance fur-3
858	858	nished under the State plan (or a waiver of the 4
859	859	plan) on behalf of such active duty relocated in-5
860	860	dividual in the military service relocation State 6
861	861	(as referred to in subsection (uu)(1)(B)(i)), to 7
862	862	the extent that such assistance is available in 8
863	863	such military service relocation State in accord-9
864	864	ance with such guidance as the Secretary may 10
865	865	issue to ensure access to such assistance.’’; and 11
866	866	(2) by adding at the end the following new sub-12
867	867	section: 13
868	868	‘‘(uu) A
869	869	CTIVEDUTYRELOCATEDINDIVIDUAL; HOME 14
870	870	ANDCOMMUNITY-BASEDSERVICESWAITINGLIST.—For 15
871	871	purposes of subsection (a)(88) and this subsection: 16
872	872	‘‘(1) A
873	873	CTIVE DUTY RELOCATED INDIVIDUAL .— 17
874	874	The term ‘active duty relocated individual’ means an 18
875	875	individual— 19
876	876	‘‘(A) who— 20
877	877	‘‘(i) is enrolled under the State plan 21
878	878	(or waiver of such plan); or 22
879	879	‘‘(ii) with respect to an individual de-23
880	880	scribed in subparagraph (C)(ii), would be 24
881	881	so enrolled pursuant to subsection 25
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884	884	•S 891 IS
885	885	(a)(10)(A)(ii)(VI) if such individual began 1
886	886	receiving home and community-based serv-2
887	887	ices; 3
888	888	‘‘(B) who— 4
889	889	‘‘(i) is a member of the Armed Forces 5
890	890	engaged in active duty service and is relo-6
891	891	cated to another State (in this subsection 7
892	892	referred to as the ‘military service reloca-8
893	893	tion State’) by reason of such service; 9
894	894	‘‘(ii) would be described in clause (i) 10
895	895	except that the individual stopped being 11
896	896	engaged in active duty service (including 12
897	897	by reason of retirement from such service) 13
898	898	and the last day on which the individual 14
899	899	was engaged in active duty service oc-15
900	900	curred not more than 12 months ago; or 16
901	901	‘‘(iii) is a dependent (as defined by 17
902	902	the Secretary) of a member described in 18
903	903	clause (i) or (ii) who relocates to the mili-19
904	904	tary service relocation State with such 20
905	905	member; and 21
906	906	‘‘(C) who— 22
907	907	‘‘(i) was receiving home and commu-23
908	908	nity-based services (as defined in section 24
909	909	9817(a)(2)(B) of the American Rescue 25
910	910	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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912	912	•S 891 IS
913	913	Plan Act of 2021) at the time of such relo-1
914	914	cation; or 2
915	915	‘‘(ii) if the State maintains a home 3
916	916	and community-based services waiting list, 4
917	917	was on such home and community-based 5
918	918	services waiting list at the time of such re-6
919	919	location. 7
920	920	‘‘(2) H
921	921	OME AND COMMUNITY -BASED SERVICES 8
922	922	WAITING LIST.—The term ‘home and community- 9
923	923	based services waiting list’ means, in the case of a 10
924	924	State that has a limit on the number of individuals 11
925	925	who may receive home and community-based services 12
926	926	under section 1115(a), section 1915(c), or section 13
927	927	1915(j), a list maintained by such State of individ-14
928	928	uals who are requesting to receive such services 15
929	929	under 1 or more such sections but for whom the 16
930	930	State has not yet completed an assessment and ren-17
931	931	dered a decision with respect to the eligibility of 18
932	932	such individuals to receive the relevant home and 19
933	933	community-based services at the time a slot for such 20
934	934	services becomes available due to such limit.’’. 21
935	935	(b) I
936	936	MPLEMENTATION FUNDING.—There are appro-22
937	937	priated, out of any funds in the Treasury not otherwise 23
938	938	obligated, $1,000,000 for each of fiscal years 2025 24
939	939	through 2029, to remain available until expended, to the 25
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942	942	•S 891 IS
943	943	Secretary of Health and Human Services for purposes of 1
944	944	implementing the amendments made by subsection (a). 2
945	945	SEC. 105. ENSURING THE RELIABILITY OF ADDRESS INFOR-3
946	946	MATION PROVIDED UNDER THE MEDICAID 4
947	947	PROGRAM. 5
948	948	(a) I
949	949	NGENERAL.—Section 1902(a) of the Social Se-6
950	950	curity Act (42 U.S.C. 1396a(a)), as previously amended 7
951	951	by this title, is amended— 8
952	952	(1) in paragraph (87), by striking ‘‘and’’ at the 9
953	953	end; 10
954	954	(2) in paragraph (88), by striking the period at 11
955	955	the end and inserting ‘‘; and’’; and 12
956	956	(3) by inserting after paragraph (88) the fol-13
957	957	lowing new paragraph: 14
958	958	‘‘(89) beginning January 1, 2026, provide for a 15
959	959	process to regularly obtain address information for 16
960	960	individuals enrolled under such plan (or a waiver of 17
961	961	such plan) from reliable data sources (as described 18
962	962	in section 435.919(f)(1)(iii) of title 42, Code of Fed-19
963	963	eral Regulations (or a successor regulation)) and act 20
964	964	on any changes to such an address based on such in-21
965	965	formation in accordance with such section (or suc-22
966	966	cessor regulation), except that this paragraph shall 23
967	967	only apply in the case of the 50 States and the Dis-24
968	968	trict of Columbia.’’. 25
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971	971	•S 891 IS
972	972	(b) APPLICATION TOCHIP.—Section 2107(e)(1) of 1
973	973	the Social Security Act (42 U.S.C. 1397gg(e)(1)) is 2
974	974	amended— 3
975	975	(1) by redesignating subparagraphs (H) 4
976	976	through (U) as subparagraphs (I) through (V), re-5
977	977	spectively; and 6
978	978	(2) by inserting after subparagraph (G) the fol-7
979	979	lowing new subparagraph: 8
980	980	‘‘(H) Section 1902(a)(89) (relating to reg-9
981	981	ularly obtaining address information for enroll-10
982	982	ees).’’. 11
983	983	(c) E
984	984	NSURINGTRANSMISSION OFADDRESSINFOR-12
985	985	MATIONFROMMANAGEDCAREORGANIZATIONS.—Sec-13
986	986	tion 1932 of the Social Security Act (42 U.S.C. 1396u– 14
987	987	2) is amended by adding at the end the following new sub-15
988	988	section: 16
989	989	‘‘(j) T
990	990	RANSMISSION OF ADDRESSINFORMATION.— 17
991	991	Beginning January 1, 2026, each contract under a State 18
992	992	plan with a managed care entity under section 1903(m) 19
993	993	shall provide that the entity transmits to the State any 20
994	994	address information for an individual enrolled with the en-21
995	995	tity that is provided to such entity directly from, or 22
996	996	verified by such entity directly with, such individual.’’. 23
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999	999	•S 891 IS
1000	1000	SEC. 106. CODIFYING CERTAIN MEDICAID PROVIDER 1
1001	1001	SCREENING REQUIREMENTS RELATED TO 2
1002	1002	DECEASED PROVIDERS. 3
1003	1003	Section 1902(kk)(1) of the Social Security Act (42 4
1004	1004	U.S.C. 1396a(kk)(1)) is amended— 5
1005	1005	(1) by striking ‘‘The State’’ and inserting: 6
1006	1006	‘‘(A) I
1007	1007	N GENERAL.—The State’’; and 7
1008	1008	(2) by adding at the end the following new sub-8
1009	1009	paragraph: 9
1010	1010	‘‘(B) A
1011	1011	DDITIONAL PROVIDER SCREEN -10
1012	1012	ING.—Beginning January 1, 2027, as part of 11
1013	1013	the enrollment (or reenrollment or revalidation 12
1014	1014	of enrollment) of a provider or supplier under 13
1015	1015	this title, and not less frequently than quarterly 14
1016	1016	during the period that such provider or supplier 15
1017	1017	is so enrolled, the State conducts a check of the 16
1018	1018	Death Master File (as such term is defined in 17
1019	1019	section 203(d) of the Bipartisan Budget Act of 18
1020	1020	2013) to determine whether such provider or 19
1021	1021	supplier is deceased.’’. 20
1022	1022	SEC. 107. MODIFYING CERTAIN STATE REQUIREMENTS FOR 21
1023	1023	ENSURING DECEASED INDIVIDUALS DO NOT 22
1024	1024	REMAIN ENROLLED. 23
1025	1025	Section 1902 of the Social Security Act (42 U.S.C. 24
1026	1026	1396a), as previously amended by this title, is amended— 25
1027	1027	(1) in subsection (a)— 26
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1030	1030	•S 891 IS
1031	1031	(A) in paragraph (88), by striking ‘‘; and’’ 1
1032	1032	and inserting a semicolon; 2
1033	1033	(B) in paragraph (89), by striking the pe-3
1034	1034	riod at the end and inserting ‘‘; and’’; and 4
1035	1035	(C) by inserting after paragraph (89) the 5
1036	1036	following new paragraph: 6
1037	1037	‘‘(90) provide that the State shall comply with 7
1038	1038	the eligibility verification requirements under sub-8
1039	1039	section (vv), except that this paragraph shall apply 9
1040	1040	only in the case of the 50 States and the District 10
1041	1041	of Columbia.’’; and 11
1042	1042	(2) by adding at the end the following new sub-12
1043	1043	section: 13
1044	1044	‘‘(vv) V
1045	1045	ERIFICATION OFCERTAINELIGIBILITYCRI-14
1046	1046	TERIA.— 15
1047	1047	‘‘(1) I
1048	1048	N GENERAL.—For purposes of subsection 16
1049	1049	(a)(90), the eligibility verification requirements, be-17
1050	1050	ginning January 1, 2026, are as follows: 18
1051	1051	‘‘(A) Q
1052	1052	UARTERLY SCREENING TO VERIFY 19
1053	1053	ENROLLEE STATUS .—The State shall, not less 20
1054	1054	frequently than quarterly, review the Death 21
1055	1055	Master File (as such term is defined in section 22
1056	1056	203(d) of the Bipartisan Budget Act of 2013) 23
1057	1057	to determine whether any individuals enrolled 24
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1060	1060	•S 891 IS
1061	1061	for medical assistance under the State plan (or 1
1062	1062	waiver of such plan) are deceased. 2
1063	1063	‘‘(B) D
1064	1064	ISENROLLMENT UNDER STATE 3
1065	1065	PLAN.—If the State determines, based on infor-4
1066	1066	mation obtained from the Death Master File, 5
1067	1067	that an individual enrolled for medical assist-6
1068	1068	ance under the State plan (or waiver of such 7
1069	1069	plan) is deceased, the State shall— 8
1070	1070	‘‘(i) treat such information as factual 9
1071	1071	information confirming the death of a ben-10
1072	1072	eficiary for purposes of section 431.213(a) 11
1073	1073	of title 42, Code of Federal Regulations (or 12
1074	1074	any successor regulation); 13
1075	1075	‘‘(ii) disenroll such individual from the 14
1076	1076	State plan (or waiver of such plan); and 15
1077	1077	‘‘(iii) discontinue any payments for 16
1078	1078	medical assistance under this title made on 17
1079	1079	behalf of such individual (other than pay-18
1080	1080	ments for any items or services furnished 19
1081	1081	to such individual prior to the death of 20
1082	1082	such individual). 21
1083	1083	‘‘(C) R
1084	1084	EINSTATEMENT OF COVERAGE IN 22
1085	1085	THE EVENT OF ERROR .—If a State determines 23
1086	1086	that an individual was misidentified as deceased 24
1087	1087	based on information obtained from the Death 25
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1090	1090	•S 891 IS
1091	1091	Master File, and was erroneously disenrolled 1
1092	1092	from medical assistance under the State plan 2
1093	1093	(or waiver of such plan) based on such 3
1094	1094	misidentification, the State shall immediately 4
1095	1095	reenroll such individual under the State plan 5
1096	1096	(or waiver of such plan), retroactive to the date 6
1097	1097	of such disenrollment. 7
1098	1098	‘‘(2) R
1099	1099	ULE OF CONSTRUCTION .—Nothing under 8
1100	1100	this subsection shall be construed to preclude the 9
1101	1101	ability of a State to use other electronic data sources 10
1102	1102	to timely identify potentially deceased beneficiaries, 11
1103	1103	so long as the State is also in compliance with the 12
1104	1104	requirements of this subsection (and all other re-13
1105	1105	quirements under this title relating to Medicaid eli-14
1106	1106	gibility determination and redetermination).’’. 15
1107	1107	SEC. 108. ONE-YEAR DELAY OF MEDICAID AND CHIP RE-16
1108	1108	QUIREMENTS FOR HEALTH SCREENINGS, RE-17
1109	1109	FERRALS, AND CASE MANAGEMENT SERV-18
1110	1110	ICES FOR ELIGIBLE JUVENILES IN PUBLIC 19
1111	1111	INSTITUTIONS; STATE INTERIM WORK PLANS. 20
1112	1112	(a) I
1113	1113	NGENERAL.—Section 5121(d) of subtitle C of 21
1114	1114	title V of division FF of the Consolidated Appropriations 22
1115	1115	Act, 2023 (Public Law 117–328) is amended— 23
1116	1116	(1) by striking ‘‘The amendments made by this 24
1117	1117	section’’ and inserting the following: 25
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1120	1120	•S 891 IS
1121	1121	‘‘(1) IN GENERAL.—Subject to paragraph (2), 1
1122	1122	the amendments made by this section’’; and 2
1123	1123	(2) by adding at the end the following new 3
1124	1124	paragraph: 4
1125	1125	‘‘(2) D
1126	1126	ELAY OF DATE BY WHICH STATES MUST 5
1127	1127	COMPLY WITH CERTAIN JUVENILE JUSTICE -RE-6
1128	1128	LATED REQUIREMENTS .—A State shall not be re-7
1129	1129	garded as failing to comply with the requirements of 8
1130	1130	section 1902(a)(84)(D) or 2102(d)(2) of the Social 9
1131	1131	Security Act (42 U.S.C. 1396a(a)(84)(D), 10
1132	1132	1397bb(d)(2)) before January 1, 2026.’’. 11
1133	1133	(b) C
1134	1134	LARIFYINGNONAPPLICATION OF REQUIRE-12
1135	1135	MENTS TOINDIVIDUALS INFEDERALCUSTODY.— 13
1136	1136	(1) M
1137	1137	EDICAID.— 14
1138	1138	(A) Subparagraph (D) of section 15
1139	1139	1902(a)(84) of the Social Security Act (42 16
1140	1140	U.S.C. 1396a(a)(84)), as added by section 5121 17
1141	1141	of subtitle C of title V of division FF of the 18
1142	1142	Consolidated Appropriations Act, 2023 (Public 19
1143	1143	Law 117–328), is amended by striking ‘‘an in-20
1144	1144	dividual who is an eligible juvenile’’ and insert-21
1145	1145	ing ‘‘an individual (other than an individual 22
1146	1146	who is in Federal custody, including as an in-23
1147	1147	mate in a Federal prison) who is an eligible ju-24
1148	1148	venile’’. 25
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1151	1151	•S 891 IS
1152	1152	(B) Section 5122(a) of subtitle C of title 1
1153	1153	V of division FF of the Consolidated Appropria-2
1154	1154	tions Act, 2023 (Public Law 117–328) is 3
1155	1155	amended— 4
1156	1156	(i) by striking ‘‘paragraph (31)’’ each 5
1157	1157	place it appears and inserting ‘‘the last 6
1158	1158	numbered paragraph’’; and 7
1159	1159	(ii) in paragraph (1), by striking ‘‘an 8
1160	1160	individual who is an eligible juvenile’’ and 9
1161	1161	inserting ‘‘an individual (other than an in-10
1162	1162	dividual who is in Federal custody, includ-11
1163	1163	ing as an inmate in a Federal prison) who 12
1164	1164	is an eligible juvenile’’. 13
1165	1165	(2) CHIP.— 14
1166	1166	(A) Subsection (d)(2) of section 2102 of 15
1167	1167	the Social Security Act (42 U.S.C. 1397bb), as 16
1168	1168	added by section 5121 of subtitle C of title V 17
1169	1169	of division FF of the Consolidated Appropria-18
1170	1170	tions Act, 2023 (Public Law 117–328), is 19
1171	1171	amended by striking ‘‘a targeted low-income 20
1172	1172	child who’’ and inserting ‘‘a targeted low in-21
1173	1173	come child (other than a child who is in Federal 22
1174	1174	custody, including as an inmate in a Federal 23
1175	1175	prison) who’’. 24
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1178	1178	•S 891 IS
1179	1179	(B) Section 5122(b)(2) of subtitle C of 1
1180	1180	title V of division FF of the Consolidated Ap-2
1181	1181	propriations Act, 2023 (Public Law 117–328) 3
1182	1182	is amended by striking ‘‘a child who is’’ and in-4
1183	1183	serting ‘‘a child (other than a child who is in 5
1184	1184	Federal custody, including as an inmate in a 6
1185	1185	Federal prison) who is’’. 7
1186	1186	(3) E
1187	1187	FFECTIVE DATE.—The amendments made 8
1188	1188	by this subsection shall take effect as if enacted on 9
1189	1189	December 29, 2022. 10
1190	1190	(c) I
1191	1191	NTERIMWORKPLAN.—Not later than June 30, 11
1192	1192	2025, each State (as such term is defined in section 12
1193	1193	1101(a)(1) of the Social Security Act (42 U.S.C. 13
1194	1194	1301(a)(1)) for purposes of titles XIX and XXI of such 14
1195	1195	Act) shall submit to the Secretary of Health and Human 15
1196	1196	Services an interim work plan, in such form and con-16
1197	1197	taining such information as the Secretary may specify, de-17
1198	1198	scribing the State’s progress towards implementing, and 18
1199	1199	its plans to come into compliance with, the requirements 19
1200	1200	imposed by the amendments made by section 5121 of sub-20
1201	1201	title C of title V of division FF of the Consolidated Appro-21
1202	1202	priations Act, 2023 (Public Law 117–328), consistent 22
1203	1203	with the guidance issued by the Centers for Medicare & 23
1204	1204	Medicaid Services in State Health Official Letter #24– 24
1205	1205	004 on July 23, 2024. 25
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1208	1208	•S 891 IS
1209	1209	SEC. 109. STATE STUDIES AND HHS REPORT ON COSTS OF 1
1210	1210	PROVIDING MATERNITY, LABOR, AND DELIV-2
1211	1211	ERY SERVICES. 3
1212	1212	(a) S
1213	1213	TATESTUDY.— 4
1214	1214	(1) I
1215	1215	N GENERAL.—Not later than 24 months 5
1216	1216	after the date of enactment of this Act, and every 6
1217	1217	5 years thereafter, each State (as such term is de-7
1218	1218	fined in section 1101(a)(1) of the Social Security 8
1219	1219	Act (42 U.S.C. 1301(a)(1)) for purposes of titles 9
1220	1220	XIX and XXI of such Act) shall conduct a study on 10
1221	1221	the costs of providing maternity, labor, and delivery 11
1222	1222	services in applicable hospitals (as defined in para-12
1223	1223	graph (3)) and submit the results of such study to 13
1224	1224	the Secretary of Health and Human Services (re-14
1225	1225	ferred to in this section as the ‘‘Secretary’’). 15
1226	1226	(2) C
1227	1227	ONTENT OF STUDY .—A State study re-16
1228	1228	quired under paragraph (1) shall include the fol-17
1229	1229	lowing information (to the extent practicable) with 18
1230	1230	respect to maternity, labor, and delivery services fur-19
1231	1231	nished by applicable hospitals located in the State: 20
1232	1232	(A) An estimate of the cost of providing 21
1233	1233	maternity, labor, and delivery services at appli-22
1234	1234	cable hospitals, based on the expenditures a 23
1235	1235	representative sample of such hospitals incurred 24
1236	1236	for providing such services during the 2 most 25
1237	1237	recent years for which data is available. 26
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1241	1241	(B) An estimate of the cost of providing 1
1242	1242	maternity, labor, and delivery services at appli-2
1243	1243	cable hospitals that ceased providing labor and 3
1244	1244	delivery services within the past 5 years, based 4
1245	1245	on the expenditures a representative sample of 5
1246	1246	such hospitals incurred for providing such serv-6
1247	1247	ices during the 2 most recent years for which 7
1248	1248	data is available. 8
1249	1249	(C) To the extent data allows, an analysis 9
1250	1250	of the extent to which geographic location, com-10
1251	1251	munity demographics, and local economic fac-11
1252	1252	tors (as defined by the Secretary) affect the 12
1253	1253	cost of providing maternity, labor, and delivery 13
1254	1254	services at applicable hospitals, including the 14
1255	1255	cost of services that support the provision of 15
1256	1256	maternity, labor, and delivery services. 16
1257	1257	(D) The amounts applicable hospitals are 17
1258	1258	paid for maternity, labor, and delivery services, 18
1259	1259	by geographic location and hospital size, 19
1260	1260	under— 20
1261	1261	(i) Medicare; 21
1262	1262	(ii) the State Medicaid program, in-22
1263	1263	cluding payment amounts for such services 23
1264	1264	under fee-for-service payment arrange-24
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1267	1267	•S 891 IS
1268	1268	ments and under managed care (as appli-1
1269	1269	cable); 2
1270	1270	(iii) the State CHIP plan, including 3
1271	1271	payment amounts for such services under 4
1272	1272	fee-for-service payment arrangements and 5
1273	1273	under managed care (as applicable); and 6
1274	1274	(iv) private health insurance. 7
1275	1275	(E) A comparative payment rate anal-8
1276	1276	ysis— 9
1277	1277	(i) comparing payment rates for ma-10
1278	1278	ternity, labor, and delivery services (inclu-11
1279	1279	sive of all payments received by applicable 12
1280	1280	hospitals for furnishing maternity, labor, 13
1281	1281	and delivery services) under the State 14
1282	1282	Medicaid fee-for-service program to such 15
1283	1283	payment rates for such services under 16
1284	1284	Medicare (as described in section 17
1285	1285	447.203(b)(3) of title 42, Code of Federal 18
1286	1286	Regulations), other Federally-funded or 19
1287	1287	State-funded programs (including, to the 20
1288	1288	extent data is available, Medicaid managed 21
1289	1289	care rates), and to the payment rates for 22
1290	1290	such services, to the extent data is avail-23
1291	1291	able, of private health insurers within geo-24
1292	1292	graphic areas of the State; and 25
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1295	1295	•S 891 IS
1296	1296	(ii) analyzing different payment meth-1
1297	1297	ods for such services, such as the use of 2
1298	1298	bundled payments, quality incentives, and 3
1299	1299	low-volume adjustments. 4
1300	1300	(F) An evaluation, using such methodology 5
1301	1301	and parameters established by the Secretary, of 6
1302	1302	whether each hospital located in the State that 7
1303	1303	furnishes maternity, labor, and delivery services 8
1304	1304	is expected to experience in the next 3 years 9
1305	1305	significant changes in particular expenditures 10
1306	1306	or types of reimbursement for maternity, labor, 11
1307	1307	and delivery services. 12
1308	1308	(3) A
1309	1309	PPLICABLE HOSPITAL DEFINED .—For 13
1310	1310	purposes of this subsection, the term ‘‘applicable 14
1311	1311	hospital’’ means any hospital located in a State that 15
1312	1312	meets either of the following criteria: 16
1313	1313	(A) The hospital provides labor and deliv-17
1314	1314	ery services and more than 50 percent of the 18
1315	1315	hospital’s births (in the most recent year for 19
1316	1316	which such data is available) are financed by 20
1317	1317	the Medicaid program or CHIP. 21
1318	1318	(B) The hospital— 22
1319	1319	(i) is located in a rural area (as de-23
1320	1320	fined by the Federal Office of Rural 24
1321	1321	Health Policy for the purpose of rural 25
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1324	1324	•S 891 IS
1325	1325	health grant programs administered by 1
1326	1326	such Office); 2
1327	1327	(ii) based on the most recent 2 years 3
1328	1328	of data available (as determined by the 4
1329	1329	Secretary), furnished services for less than 5
1330	1330	an average of 300 births per year; and 6
1331	1331	(iii) provides labor and delivery serv-7
1332	1332	ices. 8
1333	1333	(4) A
1334	1334	SSISTANCE TO SMALL HOSPITALS IN COM -9
1335	1335	PILING COST INFORMATION .—There are appro-10
1336	1336	priated to the Secretary for fiscal year 2025, 11
1337	1337	$10,000,000 for the purpose of providing grants and 12
1338	1338	technical assistance to a hospital described in para-13
1339	1339	graph (3)(B) to enable such hospital to compile de-14
1340	1340	tailed information for use in the State studies re-15
1341	1341	quired under paragraph (1), to remain available 16
1342	1342	until expended. 17
1343	1343	(5) HHS
1344	1344	REPORT ON STATE STUDIES .—For 18
1345	1345	each year in which a State is required to conduct a 19
1346	1346	study under paragraph (1), the Secretary shall issue, 20
1347	1347	not later than 12 months after the date on which 21
1348	1348	the State submits to the Secretary the data de-22
1349	1349	scribed in such paragraph, a publicly available re-23
1350	1350	port that compiles and details the results of such 24
1351	1351	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00043 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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1353	1353	•S 891 IS
1354	1354	study and includes the information described in 1
1355	1355	paragraph (2). 2
1356	1356	(b) HHS R
1357	1357	EPORT ONNATIONALDATACOLLECTION 3
1358	1358	F
1359	1359	INDINGS.—Not later than 3 years after the date of en-4
1360	1360	actment of this Act, the Secretary shall submit to Con-5
1361	1361	gress, and make publicly available, a report analyzing the 6
1362	1362	first studies conducted by States under subsection (a)(1), 7
1363	1363	including recommendations for improving data collection 8
1364	1364	on the cost of providing maternity, labor, and delivery 9
1365	1365	services. 10
1366	1366	(c) I
1367	1367	MPLEMENTATION FUNDING.—In addition to the 11
1368	1368	amount appropriated under subsection (a)(4), there are 12
1369	1369	appropriated, out of any funds in the Treasury not other-13
1370	1370	wise obligated, $3,000,000 for fiscal year 2025, to remain 14
1371	1371	available until expended, to the Secretary of Health and 15
1372	1372	Human Services for purposes of implementing this sec-16
1373	1373	tion. 17
1374	1374	SEC. 110. MODIFYING CERTAIN DISPROPORTIONATE SHARE 18
1375	1375	HOSPITAL ALLOTMENTS. 19
1376	1376	(a) E
1377	1377	XTENDINGTENNESSEEDSH ALLOTMENTS.— 20
1378	1378	Section 1923(f)(6)(A)(vi) of the Social Security Act (42 21
1379	1379	U.S.C. 1396r–4(f)(6)(A)(vi)) is amended— 22
1380	1380	(1) in the heading, by striking ‘‘
1381	1381	2025’’ and in-23
1382	1382	serting ‘‘
1383	1383	2026 AND FOR THE 1ST QUARTER OF FISCAL 24
1384	1384	YEAR 2027’’; 25
1385	1385	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00044 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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1387	1387	•S 891 IS
1388	1388	(2) by striking ‘‘fiscal year 2025’’ and inserting 1
1389	1389	‘‘fiscal year 2026’’; and 2
1390	1390	(3) by inserting ‘‘, and the DSH allotment for 3
1391	1391	Tennessee for the 1st quarter of fiscal year 2027, 4
1392	1392	shall be $13,275,000’’ before the period. 5
1393	1393	(b) E
1394	1394	LIMINATING ANDDELAYINGDSH ALLOTMENT 6
1395	1395	R
1396	1396	EDUCTIONS.—Section 1923(f) of the Social Security Act 7
1397	1397	(42 U.S.C. 1396r–4(f)) is amended— 8
1398	1398	(1) in paragraph (7)(A)— 9
1399	1399	(A) in clause (i), in the matter preceding 10
1400	1400	subclause (I), by striking ‘‘April 1, 2025,’’ and 11
1401	1401	all that follows through ‘‘2027’’ and inserting 12
1402	1402	‘‘January 1, 2027, and ending September 30, 13
1403	1403	2027, and for fiscal year 2028’’; and 14
1404	1404	(B) in clause (ii), by striking ‘‘April 1, 15
1405	1405	2025,’’ and all that follows through ‘‘2027’’ and 16
1406	1406	inserting ‘‘January 1, 2027, and ending Sep-17
1407	1407	tember 30, 2027, and for fiscal year 2028’’; 18
1408	1408	and 19
1409	1409	(2) in paragraph (8), by striking ‘‘2027’’ and 20
1410	1410	inserting ‘‘2028’’. 21
1411	1411	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00045 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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1413	1413	•S 891 IS
1414	1414	SEC. 111. MODIFYING CERTAIN LIMITATIONS ON DIS-1
1415	1415	PROPORTIONATE SHARE HOSPITAL PAY-2
1416	1416	MENT ADJUSTMENTS UNDER THE MEDICAID 3
1417	1417	PROGRAM. 4
1418	1418	(a) I
1419	1419	NGENERAL.—Section 1923(g) of the Social Se-5
1420	1420	curity Act (42 U.S.C. 1396r–4(g)) is amended— 6
1421	1421	(1) in paragraph (1)— 7
1422	1422	(A) in subparagraph (A)— 8
1423	1423	(i) in the matter preceding clause (i), 9
1424	1424	by striking ‘‘(other than a hospital de-10
1425	1425	scribed in paragraph (2)(B))’’; 11
1426	1426	(ii) in clause (i), by inserting ‘‘with 12
1427	1427	respect to such hospital and year’’ after 13
1428	1428	‘‘described in subparagraph (B)’’; and 14
1429	1429	(iii) in clause (ii)— 15
1430	1430	(I) in subclause (I), by striking 16
1431	1431	‘‘and’’ at the end; 17
1432	1432	(II) in subclause (II), by striking 18
1433	1433	the period and inserting ‘‘; and’’; and 19
1434	1434	(III) by adding at the end the 20
1435	1435	following new subclause: 21
1436	1436	‘‘(III) payments made under title 22
1437	1437	XVIII or by an applicable plan (as de-23
1438	1438	fined in section 1862(b)(8)(F)) for 24
1439	1439	such services.’’; and 25
1440	1440	(B) in subparagraph (B)— 26
1441	1441	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00046 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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1443	1443	•S 891 IS
1444	1444	(i) in the matter preceding clause (i), 1
1445	1445	by striking ‘‘in this clause are’’ and insert-2
1446	1446	ing ‘‘in this subparagraph are, with respect 3
1447	1447	to a hospital and a year,’’; and 4
1448	1448	(ii) by adding at the end the following 5
1449	1449	new clause: 6
1450	1450	‘‘(iii) Individuals who are eligible for 7
1451	1451	medical assistance under the State plan or 8
1452	1452	under a waiver of such plan and for whom 9
1453	1453	the State plan or waiver is a payor for 10
1454	1454	such services after application of benefits 11
1455	1455	under title XVIII or under an applicable 12
1456	1456	plan (as defined in section 1862(b)(8)(F)), 13
1457	1457	but only if the hospital has in the aggre-14
1458	1458	gate incurred costs exceeding payments 15
1459	1459	under such State plan, waiver, title XVIII, 16
1460	1460	or applicable plan for such services fur-17
1461	1461	nished to such individuals during such 18
1462	1462	year.’’; 19
1463	1463	(2) by striking paragraph (2); 20
1464	1464	(3) by redesignating paragraph (3) as para-21
1465	1465	graph (2); and 22
1466	1466	(4) in paragraph (2), as so redesignated, by 23
1467	1467	striking ‘‘Notwithstanding paragraph (2) of this 24
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1470	1470	•S 891 IS
1471	1471	subsection (as in effect on October 1, 2021), para-1
1472	1472	graph (2)’’ and inserting ‘‘Paragraph (2)’’. 2
1473	1473	(b) E
1474	1474	FFECTIVEDATE.— 3
1475	1475	(1) I
1476	1476	N GENERAL.—Except as provided in para-4
1477	1477	graph (2), the amendments made by this section 5
1478	1478	shall apply to payment adjustments made under sec-6
1479	1479	tion 1923 of the Social Security Act (42 U.S.C. 7
1480	1480	1396r–4) for Medicaid State plan rate years begin-8
1481	1481	ning on or after the date of enactment of this Act. 9
1482	1482	(2) S
1483	1483	TATE OPTION TO DISTRIBUTE UNSPENT 10
1484	1484	DSH ALLOTMENTS FROM PRIOR YEARS UP TO MODI -11
1485	1485	FIED CAP.— 12
1486	1486	(A) I
1487	1487	N GENERAL.—If, for any Medicaid 13
1488	1488	State plan rate year that begins on or after Oc-14
1489	1489	tober 1, 2021, and before the date of enactment 15
1490	1490	of this Act, a State did not spend the full 16
1491	1491	amount of its Federal fiscal year allotment 17
1492	1492	under section 1923 of the Social Security Act 18
1493	1493	(42 U.S.C. 1396r–4) applicable to that State 19
1494	1494	plan rate year, the State may use the unspent 20
1495	1495	portion of such allotment to increase the 21
1496	1496	amount of any payment adjustment made to a 22
1497	1497	hospital for such rate year, provided that— 23
1498	1498	(i) such payment adjustment (as so 24
1499	1499	increased) is consistent with subsection (g) 25
1500	1500	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00048 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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1502	1502	•S 891 IS
1503	1503	of such section (as amended by this sec-1
1504	1504	tion); and 2
1505	1505	(ii) the total amount of all payment 3
1506	1506	adjustments for the State plan rate year 4
1507	1507	(as so increased) does not exceed the dis-5
1508	1508	proportionate share hospital allotment for 6
1509	1509	the State and applicable Federal fiscal 7
1510	1510	year under subsection (f) of such section. 8
1511	1511	(B) N
1512	1512	O RECOUPMENT OF PAYMENTS AL -9
1513	1513	READY MADE TO HOSPITALS .—A State shall not 10
1514	1514	recoup any payment adjustment made by the 11
1515	1515	State to a hospital for a Medicaid State plan 12
1516	1516	rate year described in subparagraph (A) if such 13
1517	1517	payment adjustment is consistent with section 14
1518	1518	1923(g) of such Act (42 U.S.C. 1396r–4(g)) as 15
1519	1519	in effect on October 1, 2021. 16
1520	1520	(C) A
1521	1521	UTHORITY TO PERMIT RETROACTIVE 17
1522	1522	MODIFICATION OF STATE PLAN AMENDMENTS 18
1523	1523	TO ALLOW FOR INCREASES .— 19
1524	1524	(i) I
1525	1525	N GENERAL.—Subject to para-20
1526	1526	graph (2), solely for the purpose of allow-21
1527	1527	ing a State to increase the amount of a 22
1528	1528	payment adjustment to a hospital for a 23
1529	1529	Medicaid State plan rate year described in 24
1530	1530	subparagraph (A) pursuant to this para-25
1531	1531	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00049 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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1533	1533	•S 891 IS
1534	1534	graph, a State may retroactively modify a 1
1535	1535	provision of the Medicaid State plan, a 2
1536	1536	waiver of such plan, or a State plan 3
1537	1537	amendment that relates to such rate year 4
1538	1538	and the Secretary may approve such modi-5
1539	1539	fication. 6
1540	1540	(ii) D
1541	1541	EADLINE.—A State may not 7
1542	1542	submit a request for approval of a retro-8
1543	1543	active modification to a provision of the 9
1544	1544	Medicaid State plan, a waiver of such plan, 10
1545	1545	or a State plan amendment for a Medicaid 11
1546	1546	State plan rate year after the date by 12
1547	1547	which the State is required to submit the 13
1548	1548	independent certified audit for that State 14
1549	1549	plan rate year as required under section 15
1550	1550	1923(j)(2) of the Social Security Act (42 16
1551	1551	U.S.C. 1396r–4(j)(2)). 17
1552	1552	(D) R
1553	1553	EPORTING.—If a State increases a 18
1554	1554	payment adjustment made to a hospital for a 19
1555	1555	Medicaid State plan rate year pursuant to this 20
1556	1556	paragraph, the State shall include information 21
1557	1557	on such increased payment adjustment as part 22
1558	1558	of the next annual report submitted by the 23
1559	1559	State under section 1923(j)(1) of the Social Se-24
1560	1560	curity Act (42 U.S.C. 1396r–4(j)(1)). 25
1561	1561	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00050 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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1563	1563	•S 891 IS
1564	1564	SEC. 112. ENSURING ACCURATE PAYMENTS TO PHAR-1
1565	1565	MACIES UNDER MEDICAID. 2
1566	1566	(a) I
1567	1567	NGENERAL.—Section 1927(f) of the Social Se-3
1568	1568	curity Act (42 U.S.C. 1396r–8(f)) is amended— 4
1569	1569	(1) in paragraph (1)(A)— 5
1570	1570	(A) by redesignating clause (ii) as clause 6
1571	1571	(iii); and 7
1572	1572	(B) by striking ‘‘and’’ after the semicolon 8
1573	1573	at the end of clause (i) and all that precedes it 9
1574	1574	through ‘‘(1)’’ and inserting the following: 10
1575	1575	‘‘(1) D
1576	1576	ETERMINING PHARMACY ACTUAL ACQUI -11
1577	1577	SITION COSTS.—The Secretary shall conduct a sur-12
1578	1578	vey of retail community pharmacy drug prices and 13
1579	1579	applicable non-retail pharmacy drug prices to deter-14
1580	1580	mine national average drug acquisition cost bench-15
1581	1581	marks (as such term is defined by the Secretary) as 16
1582	1582	follows: 17
1583	1583	‘‘(A) U
1584	1584	SE OF VENDOR .—The Secretary 18
1585	1585	may contract services for— 19
1586	1586	‘‘(i) with respect to retail community 20
1587	1587	pharmacies, the determination of retail 21
1588	1588	survey prices of the national average drug 22
1589	1589	acquisition cost for covered outpatient 23
1590	1590	drugs that represent a nationwide average 24
1591	1591	of consumer purchase prices for such 25
1592	1592	drugs, net of all discounts, rebates, and 26
1593	1593	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00051 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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1595	1595	•S 891 IS
1596	1596	other price concessions (to the extent any 1
1597	1597	information with respect to such discounts, 2
1598	1598	rebates, and other price concessions is 3
1599	1599	available) based on a monthly survey of 4
1600	1600	such pharmacies; 5
1601	1601	‘‘(ii) with respect to applicable non-re-6
1602	1602	tail pharmacies— 7
1603	1603	‘‘(I) the determination of survey 8
1604	1604	prices, separate from the survey prices 9
1605	1605	described in clause (i), of the non-re-10
1606	1606	tail national average drug acquisition 11
1607	1607	cost for covered outpatient drugs that 12
1608	1608	represent a nationwide average of con-13
1609	1609	sumer purchase prices for such drugs, 14
1610	1610	net of all discounts, rebates, and other 15
1611	1611	price concessions (to the extent any 16
1612	1612	information with respect to such dis-17
1613	1613	counts, rebates, and other price con-18
1614	1614	cessions is available) based on a 19
1615	1615	monthly survey of such pharmacies; 20
1616	1616	and 21
1617	1617	‘‘(II) at the discretion of the Sec-22
1618	1618	retary, for each type of applicable 23
1619	1619	non-retail pharmacy, the determina-24
1620	1620	tion of survey prices, separate from 25
1621	1621	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00052 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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1623	1623	•S 891 IS
1624	1624	the survey prices described in clause 1
1625	1625	(i) or subclause (I) of this clause, of 2
1626	1626	the national average drug acquisition 3
1627	1627	cost for such type of pharmacy for 4
1628	1628	covered outpatient drugs that rep-5
1629	1629	resent a nationwide average of con-6
1630	1630	sumer purchase prices for such drugs, 7
1631	1631	net of all discounts, rebates, and other 8
1632	1632	price concessions (to the extent any 9
1633	1633	information with respect to such dis-10
1634	1634	counts, rebates, and other price con-11
1635	1635	cessions is available) based on a 12
1636	1636	monthly survey of such pharmacies; 13
1637	1637	and’’; 14
1638	1638	(2) in subparagraph (B) of paragraph (1), by 15
1639	1639	striking ‘‘subparagraph (A)(ii)’’ and inserting ‘‘sub-16
1640	1640	paragraph (A)(iii)’’; 17
1641	1641	(3) in subparagraph (D) of paragraph (1), by 18
1642	1642	striking clauses (ii) and (iii) and inserting the fol-19
1643	1643	lowing: 20
1644	1644	‘‘(ii) The vendor must update the Sec-21
1645	1645	retary no less often than monthly on the 22
1646	1646	survey prices for covered outpatient drugs. 23
1647	1647	‘‘(iii) The vendor must differentiate, 24
1648	1648	in collecting and reporting survey data, for 25
1649	1649	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00053 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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1651	1651	•S 891 IS
1652	1652	all cost information collected, whether a 1
1653	1653	pharmacy is a retail community pharmacy 2
1654	1654	or an applicable non-retail pharmacy, in-3
1655	1655	cluding whether such pharmacy is an affil-4
1656	1656	iate (as defined in subsection (k)(14)), 5
1657	1657	and, in the case of an applicable non-retail 6
1658	1658	pharmacy, which type of applicable non-re-7
1659	1659	tail pharmacy it is using the relevant phar-8
1660	1660	macy type indicators included in the guid-9
1661	1661	ance required by subsection (d)(2) of sec-10
1662	1662	tion 112 of the Bipartisan Health Care 11
1663	1663	Act.’’; 12
1664	1664	(4) by adding at the end of paragraph (1) the 13
1665	1665	following: 14
1666	1666	‘‘(F) S
1667	1667	URVEY REPORTING .—In order to 15
1668	1668	meet the requirement of section 1902(a)(54), a 16
1669	1669	State shall require that any retail community 17
1670	1670	pharmacy or applicable non-retail pharmacy in 18
1671	1671	the State that receives any payment, reimburse-19
1672	1672	ment, administrative fee, discount, rebate, or 20
1673	1673	other price concession related to the dispensing 21
1674	1674	of covered outpatient drugs to individuals re-22
1675	1675	ceiving benefits under this title, regardless of 23
1676	1676	whether such payment, reimbursement, admin-24
1677	1677	istrative fee, discount, rebate, or other price 25
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1680	1680	•S 891 IS
1681	1681	concession is received from the State or a man-1
1682	1682	aged care entity or other specified entity (as 2
1683	1683	such terms are defined in section 3
1684	1684	1903(m)(9)(D)) directly or from a pharmacy 4
1685	1685	benefit manager or another entity that has a 5
1686	1686	contract with the State or a managed care enti-6
1687	1687	ty or other specified entity (as so defined), shall 7
1688	1688	respond to surveys conducted under this para-8
1689	1689	graph. 9
1690	1690	‘‘(G) S
1691	1691	URVEY INFORMATION .—Information 10
1692	1692	on national drug acquisition prices obtained 11
1693	1693	under this paragraph shall be made publicly 12
1694	1694	available in a form and manner to be deter-13
1695	1695	mined by the Secretary and shall include at 14
1696	1696	least the following: 15
1697	1697	‘‘(i) The monthly response rate to the 16
1698	1698	survey including a list of pharmacies not in 17
1699	1699	compliance with subparagraph (F). 18
1700	1700	‘‘(ii) The sampling methodology and 19
1701	1701	number of pharmacies sampled monthly. 20
1702	1702	‘‘(iii) Information on price concessions 21
1703	1703	to pharmacies, including discounts, re-22
1704	1704	bates, and other price concessions, to the 23
1705	1705	extent that such information may be pub-24
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1708	1708	•S 891 IS
1709	1709	licly released and has been collected by the 1
1710	1710	Secretary as part of the survey. 2
1711	1711	‘‘(H) P
1712	1712	ENALTIES.— 3
1713	1713	‘‘(i) I
1714	1714	N GENERAL.—Subject to clauses 4
1715	1715	(ii), (iii), and (iv), the Secretary shall en-5
1716	1716	force the provisions of this paragraph with 6
1717	1717	respect to a pharmacy through the estab-7
1718	1718	lishment of civil money penalties applicable 8
1719	1719	to a retail community pharmacy or an ap-9
1720	1720	plicable non-retail pharmacy. 10
1721	1721	‘‘(ii) B
1722	1722	ASIS FOR PENALTIES .—The 11
1723	1723	Secretary shall impose a civil money pen-12
1724	1724	alty established under this subparagraph 13
1725	1725	on a retail community pharmacy or appli-14
1726	1726	cable non-retail pharmacy if— 15
1727	1727	‘‘(I) the retail pharmacy or appli-16
1728	1728	cable non-retail pharmacy refuses or 17
1729	1729	otherwise fails to respond to a request 18
1730	1730	for information about prices in con-19
1731	1731	nection with a survey under this sub-20
1732	1732	section; 21
1733	1733	‘‘(II) knowingly provides false in-22
1734	1734	formation in response to such a sur-23
1735	1735	vey; or 24
1736	1736	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00056 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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1738	1738	•S 891 IS
1739	1739	‘‘(III) otherwise fails to comply 1
1740	1740	with the requirements established 2
1741	1741	under this paragraph. 3
1742	1742	‘‘(iii) P
1743	1743	ARAMETERS FOR PEN -4
1744	1744	ALTIES.— 5
1745	1745	‘‘(I) I
1746	1746	N GENERAL.—A civil money 6
1747	1747	penalty established under this sub-7
1748	1748	paragraph may be assessed with re-8
1749	1749	spect to each violation, and with re-9
1750	1750	spect to each non-compliant retail 10
1751	1751	community pharmacy (including a 11
1752	1752	pharmacy that is part of a chain) or 12
1753	1753	non-compliant applicable non-retail 13
1754	1754	pharmacy (including a pharmacy that 14
1755	1755	is part of a chain), in an amount not 15
1756	1756	to exceed $100,000 for each such vio-16
1757	1757	lation. 17
1758	1758	‘‘(II) C
1759	1759	ONSIDERATIONS.—In de-18
1760	1760	termining the amount of a civil money 19
1761	1761	penalty imposed under this subpara-20
1762	1762	graph, the Secretary may consider the 21
1763	1763	size, business structure, and type of 22
1764	1764	pharmacy involved, as well as the type 23
1765	1765	of violation and other relevant factors, 24
1766	1766	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00057 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
1767	1767	TKELLEY on LAP7H3WLY3PROD with BILLS 58
1768	1768	•S 891 IS
1769	1769	as determined appropriate by the Sec-1
1770	1770	retary. 2
1771	1771	‘‘(iv) R
1772	1772	ULE OF APPLICATION .—The 3
1773	1773	provisions of section 1128A (other than 4
1774	1774	subsections (a) and (b)) shall apply to a 5
1775	1775	civil money penalty under this subpara-6
1776	1776	graph in the same manner as such provi-7
1777	1777	sions apply to a civil money penalty or pro-8
1778	1778	ceeding under section 1128A(a). 9
1779	1779	‘‘(I) L
1780	1780	IMITATION ON USE OF APPLICABLE 10
1781	1781	NON-RETAIL PHARMACY PRICING INFORMA -11
1782	1782	TION.—No State shall use pricing information 12
1783	1783	reported by applicable non-retail pharmacies 13
1784	1784	under subparagraph (A)(ii) to develop or inform 14
1785	1785	payment methodologies for retail community 15
1786	1786	pharmacies.’’; 16
1787	1787	(5) in paragraph (2)— 17
1788	1788	(A) in subparagraph (A), by inserting ‘‘, 18
1789	1789	including payment rates and methodologies for 19
1790	1790	determining ingredient cost reimbursement 20
1791	1791	under managed care entities or other specified 21
1792	1792	entities (as such terms are defined in section 22
1793	1793	1903(m)(9)(D)),’’ after ‘‘under this title’’; and 23
1794	1794	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00058 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
1795	1795	TKELLEY on LAP7H3WLY3PROD with BILLS 59
1796	1796	•S 891 IS
1797	1797	(B) in subparagraph (B), by inserting 1
1798	1798	‘‘and the basis for such dispensing fees’’ before 2
1799	1799	the semicolon; 3
1800	1800	(6) by redesignating paragraph (4) as para-4
1801	1801	graph (5); 5
1802	1802	(7) by inserting after paragraph (3) the fol-6
1803	1803	lowing new paragraph: 7
1804	1804	‘‘(4) O
1805	1805	VERSIGHT.— 8
1806	1806	‘‘(A) I
1807	1807	N GENERAL.—The Inspector General 9
1808	1808	of the Department of Health and Human Serv-10
1809	1809	ices shall conduct periodic studies of the survey 11
1810	1810	data reported under this subsection, as appro-12
1811	1811	priate, including with respect to substantial 13
1812	1812	variations in acquisition costs or other applica-14
1813	1813	ble costs, as well as with respect to how internal 15
1814	1814	transfer prices and related party transactions 16
1815	1815	may influence the costs reported by pharmacies 17
1816	1816	that are affiliates (as defined in subsection 18
1817	1817	(k)(14)) or are owned by, controlled by, or re-19
1818	1818	lated under a common ownership structure with 20
1819	1819	a wholesaler, distributor, or other entity that 21
1820	1820	acquires covered outpatient drugs relative to 22
1821	1821	costs reported by pharmacies not affiliated with 23
1822	1822	such entities. The Inspector General shall pro-24
1823	1823	vide periodic updates to Congress on the results 25
1824	1824	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00059 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
1825	1825	TKELLEY on LAP7H3WLY3PROD with BILLS 60
1826	1826	•S 891 IS
1827	1827	of such studies, as appropriate, in a manner 1
1828	1828	that does not disclose trade secrets or other 2
1829	1829	proprietary information. 3
1830	1830	‘‘(B) A
1831	1831	PPROPRIATION.—There is appro-4
1832	1832	priated to the Inspector General of the Depart-5
1833	1833	ment of Health and Human Services, out of 6
1834	1834	any money in the Treasury not otherwise ap-7
1835	1835	propriated, $5,000,000 for fiscal year 2025, to 8
1836	1836	remain available until expended, to carry out 9
1837	1837	this paragraph.’’; and 10
1838	1838	(8) in paragraph (5), as so redesignated— 11
1839	1839	(A) by inserting ‘‘, and $9,000,000 for fis-12
1840	1840	cal year 2025 and each fiscal year thereafter,’’ 13
1841	1841	after ‘‘2010’’; and 14
1842	1842	(B) by inserting ‘‘Funds appropriated 15
1843	1843	under this paragraph for fiscal year 2025 and 16
1844	1844	any subsequent fiscal year shall remain avail-17
1845	1845	able until expended.’’ after the period. 18
1846	1846	(b) D
1847	1847	EFINITIONS.—Section 1927(k) of the Social Se-19
1848	1848	curity Act (42 U.S.C. 1396r–8(k)) is amended— 20
1849	1849	(1) in the matter preceding paragraph (1), by 21
1850	1850	striking ‘‘In the section’’ and inserting ‘‘In this sec-22
1851	1851	tion’’; and 23
1852	1852	(2) by adding at the end the following new 24
1853	1853	paragraphs: 25
1854	1854	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00060 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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1856	1856	•S 891 IS
1857	1857	‘‘(12) APPLICABLE NON-RETAIL PHARMACY .— 1
1858	1858	The term ‘applicable non-retail pharmacy’ means a 2
1859	1859	pharmacy that is licensed as a pharmacy by the 3
1860	1860	State and that is not a retail community pharmacy, 4
1861	1861	including a pharmacy that dispenses prescription 5
1862	1862	medications to patients primarily through mail and 6
1863	1863	specialty pharmacies. Such term does not include 7
1864	1864	nursing home pharmacies, long-term care facility 8
1865	1865	pharmacies, hospital pharmacies, clinics, charitable 9
1866	1866	or not-for-profit pharmacies, government phar-10
1867	1867	macies, or low dispensing pharmacies (as defined by 11
1868	1868	the Secretary). 12
1869	1869	‘‘(13) A
1870	1870	FFILIATE.—The term ‘affiliate’ means 13
1871	1871	any entity that is owned by, controlled by, or related 14
1872	1872	under a common ownership structure with a phar-15
1873	1873	macy benefit manager or a managed care entity or 16
1874	1874	other specified entity (as such terms are defined in 17
1875	1875	section 1903(m)(9)(D)).’’. 18
1876	1876	(c) E
1877	1877	FFECTIVEDATE.— 19
1878	1878	(1) I
1879	1879	N GENERAL.—Subject to paragraph (2), 20
1880	1880	the amendments made by this section shall take ef-21
1881	1881	fect on the first day of the first quarter that begins 22
1882	1882	on or after the date that is 6 months after the date 23
1883	1883	of enactment of this Act. 24
1884	1884	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00061 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
1885	1885	TKELLEY on LAP7H3WLY3PROD with BILLS 62
1886	1886	•S 891 IS
1887	1887	(2) DELAYED APPLICATION TO APPLICABLE 1
1888	1888	NON-RETAIL PHARMACIES .—The pharmacy survey 2
1889	1889	requirements established by the amendments to sec-3
1890	1890	tion 1927(f) of the Social Security Act (42 U.S.C. 4
1891	1891	1396r–8(f)) made by this section shall apply to re-5
1892	1892	tail community pharmacies beginning on the effec-6
1893	1893	tive date described in paragraph (1), but shall not 7
1894	1894	apply to applicable non-retail pharmacies until the 8
1895	1895	first day of the first quarter that begins on or after 9
1896	1896	the date that is 18 months after the date of enact-10
1897	1897	ment of this Act. 11
1898	1898	(d) I
1899	1899	DENTIFICATION OF APPLICABLENON-RETAIL 12
1900	1900	P
1901	1901	HARMACIES.— 13
1902	1902	(1) I
1903	1903	N GENERAL.—Not later than January 1, 14
1904	1904	2026, the Secretary of Health and Human Services 15
1905	1905	shall, in consultation with stakeholders as appro-16
1906	1906	priate, publish guidance specifying pharmacies that 17
1907	1907	meet the definition of applicable non-retail phar-18
1908	1908	macies (as such term is defined in subsection 19
1909	1909	(k)(12) of section 1927 of the Social Security Act 20
1910	1910	(42 U.S.C. 1396r–8), as added by subsection (b)), 21
1911	1911	and that will be subject to the survey requirements 22
1912	1912	under subsection (f)(1) of such section, as amended 23
1913	1913	by subsection (a). 24
1914	1914	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00062 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
1915	1915	TKELLEY on LAP7H3WLY3PROD with BILLS 63
1916	1916	•S 891 IS
1917	1917	(2) INCLUSION OF PHARMACY TYPE INDICA -1
1918	1918	TORS.—The guidance published under paragraph (1) 2
1919	1919	shall include pharmacy type indicators to distinguish 3
1920	1920	between different types of applicable non-retail phar-4
1921	1921	macies, such as pharmacies that dispense prescrip-5
1922	1922	tions primarily through the mail and pharmacies 6
1923	1923	that dispense prescriptions that require special han-7
1924	1924	dling or distribution. An applicable non-retail phar-8
1925	1925	macy may be identified through multiple pharmacy 9
1926	1926	type indicators. 10
1927	1927	(e) I
1928	1928	MPLEMENTATION.— 11
1929	1929	(1) I
1930	1930	N GENERAL.—Notwithstanding any other 12
1931	1931	provision of law, the Secretary of Health and 13
1932	1932	Human Services may implement the amendments 14
1933	1933	made by this section by program instruction or oth-15
1934	1934	erwise. 16
1935	1935	(2) N
1936	1936	ONAPPLICATION OF ADMINISTRATIVE PRO -17
1937	1937	CEDURE ACT.—Implementation of the amendments 18
1938	1938	made by this section shall be exempt from the re-19
1939	1939	quirements of section 553 of title 5, United States 20
1940	1940	Code. 21
1941	1941	(f) N
1942	1942	ONAPPLICATION OF PAPERWORKREDUCTION 22
1943	1943	A
1944	1944	CT.—Chapter 35 of title 44, United States Code, shall 23
1945	1945	not apply to any data collection undertaken by the Sec-24
1946	1946	retary of Health and Human Services under section 25
1947	1947	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00063 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
1948	1948	TKELLEY on LAP7H3WLY3PROD with BILLS 64
1949	1949	•S 891 IS
1950	1950	1927(f) of the Social Security Act (42 U.S.C. 1396r–8(f)), 1
1951	1951	as amended by this section. 2
1952	1952	SEC. 113. PREVENTING THE USE OF ABUSIVE SPREAD PRIC-3
1953	1953	ING IN MEDICAID. 4
1954	1954	(a) I
1955	1955	NGENERAL.—Section 1927 of the Social Secu-5
1956	1956	rity Act (42 U.S.C. 1396r–8) is amended— 6
1957	1957	(1) in subsection (e), by adding at the end the 7
1958	1958	following new paragraph: 8
1959	1959	‘‘(6) T
1960	1960	RANSPARENT PRESCRIPTION DRUG PASS - 9
1961	1961	THROUGH PRICING REQUIRED .— 10
1962	1962	‘‘(A) I
1963	1963	N GENERAL.—A contract between 11
1964	1964	the State and a pharmacy benefit manager (re-12
1965	1965	ferred to in this paragraph as a ‘PBM’), or a 13
1966	1966	contract between the State and a managed care 14
1967	1967	entity or other specified entity (as such terms 15
1968	1968	are defined in section 1903(m)(9)(D) and col-16
1969	1969	lectively referred to in this paragraph as the 17
1970	1970	‘entity’) that includes provisions making the en-18
1971	1971	tity responsible for coverage of covered out-19
1972	1972	patient drugs dispensed to individuals enrolled 20
1973	1973	with the entity, shall require that payment for 21
1974	1974	such drugs and related administrative services 22
1975	1975	(as applicable), including payments made by a 23
1976	1976	PBM on behalf of the State or entity, is based 24
1977	1977	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00064 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
1978	1978	TKELLEY on LAP7H3WLY3PROD with BILLS 65
1979	1979	•S 891 IS
1980	1980	on a transparent prescription drug pass- 1
1981	1981	through pricing model under which— 2
1982	1982	‘‘(i) any payment made by the entity 3
1983	1983	or the PBM (as applicable) for such a 4
1984	1984	drug— 5
1985	1985	‘‘(I) is limited to— 6
1986	1986	‘‘(aa) ingredient cost; and 7
1987	1987	‘‘(bb) a professional dis-8
1988	1988	pensing fee that is not less than 9
1989	1989	the professional dispensing fee 10
1990	1990	that the State would pay if the 11
1991	1991	State were making the payment 12
1992	1992	directly in accordance with the 13
1993	1993	State plan; 14
1994	1994	‘‘(II) is passed through in its en-15
1995	1995	tirety (except as reduced under Fed-16
1996	1996	eral or State laws and regulations in 17
1997	1997	response to instances of waste, fraud, 18
1998	1998	or abuse) by the entity or PBM to the 19
1999	1999	pharmacy or provider that dispenses 20
2000	2000	the drug; and 21
2001	2001	‘‘(III) is made in a manner that 22
2002	2002	is consistent with sections 447.502, 23
2003	2003	447.512, 447.514, and 447.518 of 24
2004	2004	title 42, Code of Federal Regulations 25
2005	2005	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00065 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2006	2006	TKELLEY on LAP7H3WLY3PROD with BILLS 66
2007	2007	•S 891 IS
2008	2008	(or any successor regulation) as if 1
2009	2009	such requirements applied directly to 2
2010	2010	the entity or the PBM, except that 3
2011	2011	any payment by the entity or the 4
2012	2012	PBM for the ingredient cost of such 5
2013	2013	drug purchased by a covered entity 6
2014	2014	(as defined in subsection (a)(5)(B)) 7
2015	2015	may exceed the actual acquisition cost 8
2016	2016	(as defined in 447.502 of title 42, 9
2017	2017	Code of Federal Regulations, or any 10
2018	2018	successor regulation) for such drug 11
2019	2019	if— 12
2020	2020	‘‘(aa) such drug was subject 13
2021	2021	to an agreement under section 14
2022	2022	340B of the Public Health Serv-15
2023	2023	ice Act; 16
2024	2024	‘‘(bb) such payment for the 17
2025	2025	ingredient cost of such drug does 18
2026	2026	not exceed the maximum pay-19
2027	2027	ment that would have been made 20
2028	2028	by the entity or the PBM for the 21
2029	2029	ingredient cost of such drug if 22
2030	2030	such drug had not been pur-23
2031	2031	chased by such covered entity; 24
2032	2032	and 25
2033	2033	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00066 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2034	2034	TKELLEY on LAP7H3WLY3PROD with BILLS 67
2035	2035	•S 891 IS
2036	2036	‘‘(cc) such covered entity re-1
2037	2037	ports to the Secretary (in a form 2
2038	2038	and manner specified by the Sec-3
2039	2039	retary), on an annual basis and 4
2040	2040	with respect to payments for the 5
2041	2041	ingredient costs of such drugs so 6
2042	2042	purchased by such covered entity 7
2043	2043	that are in excess of the actual 8
2044	2044	acquisition costs for such drugs, 9
2045	2045	the aggregate amount of such ex-10
2046	2046	cess; 11
2047	2047	‘‘(ii) payment to the entity or the 12
2048	2048	PBM (as applicable) for administrative 13
2049	2049	services performed by the entity or PBM is 14
2050	2050	limited to an administrative fee that re-15
2051	2051	flects the fair market value (as defined by 16
2052	2052	the Secretary) of such services; 17
2053	2053	‘‘(iii) the entity or the PBM (as appli-18
2054	2054	cable) makes available to the State, and 19
2055	2055	the Secretary upon request in a form and 20
2056	2056	manner specified by the Secretary, all costs 21
2057	2057	and payments related to covered outpatient 22
2058	2058	drugs and accompanying administrative 23
2059	2059	services (as described in clause (ii)) in-24
2060	2060	curred, received, or made by the entity or 25
2061	2061	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00067 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2062	2062	TKELLEY on LAP7H3WLY3PROD with BILLS 68
2063	2063	•S 891 IS
2064	2064	the PBM, broken down (as specified by the 1
2065	2065	Secretary), to the extent such costs and 2
2066	2066	payments are attributable to an individual 3
2067	2067	covered outpatient drug, by each such 4
2068	2068	drug, including any ingredient costs, pro-5
2069	2069	fessional dispensing fees, administrative 6
2070	2070	fees (as described in clause (ii)), post-sale 7
2071	2071	and post-invoice fees, discounts, or related 8
2072	2072	adjustments such as direct and indirect re-9
2073	2073	muneration fees, and any and all other re-10
2074	2074	muneration, as defined by the Secretary; 11
2075	2075	and 12
2076	2076	‘‘(iv) any form of spread pricing 13
2077	2077	whereby any amount charged or claimed by 14
2078	2078	the entity or the PBM (as applicable) that 15
2079	2079	exceeds the amount paid to the pharmacies 16
2080	2080	or providers on behalf of the State or enti-17
2081	2081	ty, including any post-sale or post-invoice 18
2082	2082	fees, discounts, or related adjustments 19
2083	2083	such as direct and indirect remuneration 20
2084	2084	fees or assessments, as defined by the Sec-21
2085	2085	retary, (after allowing for an administra-22
2086	2086	tive fee as described in clause (ii)) is not 23
2087	2087	allowable for purposes of claiming Federal 24
2088	2088	matching payments under this title. 25
2089	2089	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00068 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2090	2090	TKELLEY on LAP7H3WLY3PROD with BILLS 69
2091	2091	•S 891 IS
2092	2092	‘‘(B) PUBLICATION OF INFORMATION .— 1
2093	2093	The Secretary shall publish, not less frequently 2
2094	2094	than on an annual basis and in a manner that 3
2095	2095	does not disclose the identity of a particular 4
2096	2096	covered entity or organization, information re-5
2097	2097	ceived by the Secretary pursuant to subpara-6
2098	2098	graph (A)(iii)(III) that is broken out by State 7
2099	2099	and by each of the following categories of cov-8
2100	2100	ered entity within each such State: 9
2101	2101	‘‘(i) Covered entities described in sub-10
2102	2102	paragraph (A) of section 340B(a)(4) of the 11
2103	2103	Public Health Service Act. 12
2104	2104	‘‘(ii) Covered entities described in sub-13
2105	2105	paragraphs (B) through (K) of such sec-14
2106	2106	tion. 15
2107	2107	‘‘(iii) Covered entities described in 16
2108	2108	subparagraph (L) of such section. 17
2109	2109	‘‘(iv) Covered entities described in 18
2110	2110	subparagraph (M) of such section. 19
2111	2111	‘‘(v) Covered entities described in sub-20
2112	2112	paragraph (N) of such section. 21
2113	2113	‘‘(vi) Covered entities described in 22
2114	2114	subparagraph (O) of such section.’’; and 23
2115	2115	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00069 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2116	2116	TKELLEY on LAP7H3WLY3PROD with BILLS 70
2117	2117	•S 891 IS
2118	2118	(2) in subsection (k), as previously amended by 1
2119	2119	this title, by adding at the end the following new 2
2120	2120	paragraph: 3
2121	2121	‘‘(14) P
2122	2122	HARMACY BENEFIT MANAGER .—The 4
2123	2123	term ‘pharmacy benefit manager’ means any person 5
2124	2124	or entity that, either directly or through an inter-6
2125	2125	mediary, acts as a price negotiator or group pur-7
2126	2126	chaser on behalf of a State, managed care entity (as 8
2127	2127	defined in section 1903(m)(9)(D)), or other specified 9
2128	2128	entity (as so defined), or manages the prescription 10
2129	2129	drug benefits provided by a State, managed care en-11
2130	2130	tity, or other specified entity, including the proc-12
2131	2131	essing and payment of claims for prescription drugs, 13
2132	2132	the performance of drug utilization review, the proc-14
2133	2133	essing of drug prior authorization requests, the man-15
2134	2134	aging of appeals or grievances related to the pre-16
2135	2135	scription drug benefits, contracting with pharmacies, 17
2136	2136	controlling the cost of covered outpatient drugs, or 18
2137	2137	the provision of services related thereto. Such term 19
2138	2138	includes any person or entity that acts as a price ne-20
2139	2139	gotiator (with regard to payment amounts to phar-21
2140	2140	macies and providers for a covered outpatient drug 22
2141	2141	or the net cost of the drug) or group purchaser on 23
2142	2142	behalf of a State, managed care entity, or other 24
2143	2143	specified entity or that carries out 1 or more of the 25
2144	2144	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00070 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2145	2145	TKELLEY on LAP7H3WLY3PROD with BILLS 71
2146	2146	•S 891 IS
2147	2147	other activities described in the preceding sentence, 1
2148	2148	irrespective of whether such person or entity calls 2
2149	2149	itself a pharmacy benefit manager.’’. 3
2150	2150	(b) C
2151	2151	ONFORMINGAMENDMENTS.—Section 1903(m) 4
2152	2152	of such Act (42 U.S.C. 1396b(m)) is amended— 5
2153	2153	(1) in paragraph (2)(A)(xiii)— 6
2154	2154	(A) by striking ‘‘and (III)’’ and inserting 7
2155	2155	‘‘(III)’’; 8
2156	2156	(B) by inserting before the period at the 9
2157	2157	end the following: ‘‘, and (IV) if the contract in-10
2158	2158	cludes provisions making the entity responsible 11
2159	2159	for coverage of covered outpatient drugs, the 12
2160	2160	entity shall comply with the requirements of 13
2161	2161	section 1927(e)(6)’’; and 14
2162	2162	(C) by moving the margin 2 ems to the 15
2163	2163	left; and 16
2164	2164	(2) by adding at the end the following new 17
2165	2165	paragraph: 18
2166	2166	‘‘(10) No payment shall be made under this 19
2167	2167	title to a State with respect to expenditures incurred 20
2168	2168	by the State for payment for services provided by an 21
2169	2169	other specified entity (as defined in paragraph 22
2170	2170	(9)(D)(iii)) unless such services are provided in ac-23
2171	2171	cordance with a contract between the State and such 24
2172	2172	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00071 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2173	2173	TKELLEY on LAP7H3WLY3PROD with BILLS 72
2174	2174	•S 891 IS
2175	2175	entity which satisfies the requirements of paragraph 1
2176	2176	(2)(A)(xiii).’’. 2
2177	2177	(c) E
2178	2178	FFECTIVEDATE.—The amendments made by 3
2179	2179	this section shall apply to contracts between States and 4
2180	2180	managed care entities, other specified entities, or phar-5
2181	2181	macy benefit managers that have an effective date begin-6
2182	2182	ning on or after the date that is 18 months after the date 7
2183	2183	of enactment of this Act. 8
2184	2184	(d) I
2185	2185	MPLEMENTATION.— 9
2186	2186	(1) I
2187	2187	N GENERAL.—Notwithstanding any other 10
2188	2188	provision of law, the Secretary of Health and 11
2189	2189	Human Services may implement the amendments 12
2190	2190	made by this section by program instruction or oth-13
2191	2191	erwise. 14
2192	2192	(2) N
2193	2193	ONAPPLICATION OF ADMINISTRATIVE PRO -15
2194	2194	CEDURE ACT.—Implementation of the amendments 16
2195	2195	made by this section shall be exempt from the re-17
2196	2196	quirements of section 553 of title 5, United States 18
2197	2197	Code. 19
2198	2198	(e) N
2199	2199	ONAPPLICATION OF PAPERWORKREDUCTION 20
2200	2200	A
2201	2201	CT.—Chapter 35 of title 44, United States Code, shall 21
2202	2202	not apply to any data collection undertaken by the Sec-22
2203	2203	retary of Health and Human Services under section 23
2204	2204	1927(e) of the Social Security Act (42 U.S.C. 1396r– 24
2205	2205	8(e)), as amended by this section. 25
2206	2206	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00072 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2207	2207	TKELLEY on LAP7H3WLY3PROD with BILLS 73
2208	2208	•S 891 IS
2209	2209	TITLE II—MEDICARE 1
2210	2210	SEC. 201. EXTENSION OF INCREASED INPATIENT HOSPITAL 2
2211	2211	PAYMENT ADJUSTMENT FOR CERTAIN LOW- 3
2212	2212	VOLUME HOSPITALS. 4
2213	2213	(a) I
2214	2214	NGENERAL.—Section 1886(d)(12) of the Social 5
2215	2215	Security Act (42 U.S.C. 1395ww(d)(12)) is amended— 6
2216	2216	(1) in subparagraph (B), in the matter pre-7
2217	2217	ceding clause (i), by striking ‘‘fiscal year 2025 be-8
2218	2218	ginning on April 1, 2025, and ending on September 9
2219	2219	30, 2025, and in fiscal year 2026’’ and inserting 10
2220	2220	‘‘fiscal year 2026 beginning on January 1, 2026, 11
2221	2221	and ending on September 30, 2026, and in fiscal 12
2222	2222	year 2027’’; 13
2223	2223	(2) in subparagraph (C)(i)— 14
2224	2224	(A) in the matter preceding subclause (I), 15
2225	2225	by striking ‘‘through 2024 and the portion of 16
2226	2226	fiscal year 2025 beginning on October 1, 2024, 17
2227	2227	and ending on March 31, 2025’’ and inserting 18
2228	2228	‘‘through 2025 and the portion of fiscal year 19
2229	2229	2026 beginning on October 1, 2025, and ending 20
2230	2230	on December 31, 2025’’; 21
2231	2231	(B) in subclause (III), by striking 22
2232	2232	‘‘through 2024 and the portion of fiscal year 23
2233	2233	2025 beginning on October 1, 2024, and ending 24
2234	2234	on March 31, 2025’’ and inserting ‘‘through 25
2235	2235	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00073 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2236	2236	TKELLEY on LAP7H3WLY3PROD with BILLS 74
2237	2237	•S 891 IS
2238	2238	2025 and the portion of fiscal year 2026 begin-1
2239	2239	ning on October 1, 2025, and ending on De-2
2240	2240	cember 31, 2025’’; and 3
2241	2241	(C) in subclause (IV), by striking ‘‘fiscal 4
2242	2242	year 2025 beginning on April 1, 2025, and end-5
2243	2243	ing on September 30, 2025, and fiscal year 6
2244	2244	2026’’ and inserting ‘‘fiscal year 2026 begin-7
2245	2245	ning on January 1, 2026, and ending on Sep-8
2246	2246	tember 30, 2026, and fiscal year 2027’’; and 9
2247	2247	(3) in subparagraph (D)— 10
2248	2248	(A) in the matter preceding clause (i), by 11
2249	2249	striking ‘‘through 2024 or during the portion of 12
2250	2250	fiscal year 2025 beginning on October 1, 2024, 13
2251	2251	and ending on March 31, 2025’’ and inserting 14
2252	2252	‘‘through 2025 or during the portion of fiscal 15
2253	2253	year 2026 beginning on October 1, 2025, and 16
2254	2254	ending on December 31, 2025’’; and 17
2255	2255	(B) in clause (ii), by striking ‘‘through 18
2256	2256	2024 and the portion of fiscal year 2025 begin-19
2257	2257	ning on October 1, 2024, and ending on March 20
2258	2258	31, 2025’’ and inserting ‘‘through 2025 and the 21
2259	2259	portion of fiscal year 2026 beginning on Octo-22
2260	2260	ber 1, 2025, and ending on December 31, 23
2261	2261	2025’’. 24
2262	2262	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00074 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2263	2263	TKELLEY on LAP7H3WLY3PROD with BILLS 75
2264	2264	•S 891 IS
2265	2265	(b) IMPLEMENTATION.—Notwithstanding any other 1
2266	2266	provision of law, the Secretary of Health and Human 2
2267	2267	Services may implement the amendments made by this 3
2268	2268	section by program instruction or otherwise. 4
2269	2269	SEC. 202. EXTENSION OF THE MEDICARE-DEPENDENT HOS-5
2270	2270	PITAL (MDH) PROGRAM. 6
2271	2271	(a) I
2272	2272	NGENERAL.—Section 1886(d)(5)(G) of the So-7
2273	2273	cial Security Act (42 U.S.C. 1395ww(d)(5)(G)) is amend-8
2274	2274	ed— 9
2275	2275	(1) in clause (i), by striking ‘‘April 1, 2025’’ 10
2276	2276	and inserting ‘‘January 1, 2026’’; and 11
2277	2277	(2) in clause (ii)(II), by striking ‘‘April 1, 12
2278	2278	2025’’ and inserting ‘‘January 1, 2026’’. 13
2279	2279	(b) C
2280	2280	ONFORMINGAMENDMENTS.— 14
2281	2281	(1) I
2282	2282	N GENERAL.—Section 1886(b)(3)(D) of 15
2283	2283	the Social Security Act (42 U.S.C. 16
2284	2284	1395ww(b)(3)(D)) is amended— 17
2285	2285	(A) in the matter preceding clause (i), by 18
2286	2286	striking ‘‘April 1, 2025’’ and inserting ‘‘Janu-19
2287	2287	ary 1, 2026’’; and 20
2288	2288	(B) in clause (iv), by striking ‘‘through fis-21
2289	2289	cal year 2024 and the portion of fiscal year 22
2290	2290	2025 beginning on October 1, 2024, and ending 23
2291	2291	on March 31, 2025’’ and inserting ‘‘through fis-24
2292	2292	cal year 2025 and the portion of fiscal year 25
2293	2293	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00075 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2294	2294	TKELLEY on LAP7H3WLY3PROD with BILLS 76
2295	2295	•S 891 IS
2296	2296	2026 beginning on October 1, 2025, and ending 1
2297	2297	on December 31, 2025’’. 2
2298	2298	(2) P
2299	2299	ERMITTING HOSPITALS TO DECLINE RE -3
2300	2300	CLASSIFICATION.—Section 13501(e)(2) of the Omni-4
2301	2301	bus Budget Reconciliation Act of 1993 (42 U.S.C. 5
2302	2302	1395ww note) is amended by striking ‘‘through fis-6
2303	2303	cal year 2024, or the portion of fiscal year 2025 be-7
2304	2304	ginning on October 1, 2024, and ending on March 8
2305	2305	31, 2025’’ and inserting ‘‘through fiscal year 2025, 9
2306	2306	or the portion of fiscal year 2026 beginning on Octo-10
2307	2307	ber 1, 2025, and ending on December 31, 2025’’. 11
2308	2308	SEC. 203. EXTENSION OF ADD-ON PAYMENTS FOR AMBU-12
2309	2309	LANCE SERVICES. 13
2310	2310	Section 1834(l) of the Social Security Act (42 U.S.C. 14
2311	2311	1395m(l)) is amended— 15
2312	2312	(1) in paragraph (12)(A), by striking ‘‘April 1, 16
2313	2313	2025’’ and inserting ‘‘January 1, 2027’’; and 17
2314	2314	(2) in paragraph (13), by striking ‘‘April 1, 18
2315	2315	2025’’ each place it appears and inserting ‘‘January 19
2316	2316	1, 2027’’ in each such place. 20
2317	2317	SEC. 204. EXTENDING INCENTIVE PAYMENTS FOR PARTICI-21
2318	2318	PATION IN ELIGIBLE ALTERNATIVE PAYMENT 22
2319	2319	MODELS. 23
2320	2320	(a) I
2321	2321	NGENERAL.—Section 1833(z) of the Social Se-24
2322	2322	curity Act (42 U.S.C. 1395l(z)) is amended— 25
2323	2323	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00076 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2324	2324	TKELLEY on LAP7H3WLY3PROD with BILLS 77
2325	2325	•S 891 IS
2326	2326	(1) in paragraph (1)(A)— 1
2327	2327	(A) by striking ‘‘with 2026’’ and inserting 2
2328	2328	‘‘with 2027’’; and 3
2329	2329	(B) by inserting ‘‘, or, with respect to 4
2330	2330	2027, 3.53 percent’’ after ‘‘1.88 percent’’; 5
2331	2331	(2) in paragraph (2)— 6
2332	2332	(A) in subparagraph (B)— 7
2333	2333	(i) in the heading, by striking ‘‘
2334	2334	2026’’ 8
2335	2335	and inserting ‘‘
2336	2336	2027’’; and 9
2337	2337	(ii) in the matter preceding clause (i), 10
2338	2338	by striking ‘‘2026’’ and inserting ‘‘2027’’; 11
2339	2339	(B) in subparagraph (C)— 12
2340	2340	(i) in the heading, by striking ‘‘
2341	2341	2027’’ 13
2342	2342	and inserting ‘‘
2343	2343	2028’’; and 14
2344	2344	(ii) in the matter preceding clause (i), 15
2345	2345	by striking ‘‘2027’’ and inserting ‘‘2028’’; 16
2346	2346	and 17
2347	2347	(C) in subparagraph (D), by striking ‘‘and 18
2348	2348	2026’’ and inserting ‘‘2026, and 2027’’; and 19
2349	2349	(3) in paragraph (4)(B), by inserting ‘‘or, with 20
2350	2350	respect to 2027, 3.53 percent’’ after ‘‘1.88 percent’’. 21
2351	2351	(b) C
2352	2352	ONFORMING AMENDMENTS.—Section 22
2353	2353	1848(q)(1)(C)(iii) of the Social Security Act (42 U.S.C. 23
2354	2354	1395w–4(q)(1)(C)(iii)) is amended— 24
2355	2355	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00077 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2356	2356	TKELLEY on LAP7H3WLY3PROD with BILLS 78
2357	2357	•S 891 IS
2358	2358	(1) in subclause (II), by striking ‘‘2026’’ and 1
2359	2359	inserting ‘‘2027’’; and 2
2360	2360	(2) in subclause (III), by striking ‘‘2027’’ and 3
2361	2361	inserting ‘‘2028’’. 4
2362	2362	SEC. 205. TEMPORARY PAYMENT INCREASE UNDER THE 5
2363	2363	MEDICARE PHYSICIAN FEE SCHEDULE TO AC-6
2364	2364	COUNT FOR EXCEPTIONAL CIRCUMSTANCES. 7
2365	2365	(a) I
2366	2366	NGENERAL.—Section 1848(t)(1) of the Social 8
2367	2367	Security Act (42 U.S.C. 1395w–4(t)(1)) is amended— 9
2368	2368	(1) in subparagraph (D), by striking ‘‘and’’ at 10
2369	2369	the end; 11
2370	2370	(2) in subparagraph (E), by striking the period 12
2371	2371	at the end and inserting ‘‘; and’’; and 13
2372	2372	(3) by adding at the end the following new sub-14
2373	2373	paragraph: 15
2374	2374	‘‘(F) such services furnished on or after 16
2375	2375	March 15, 2025, and before January 1, 2026, 17
2376	2376	by 3.5375 percent.’’. 18
2377	2377	(b) C
2378	2378	ONFORMING AMENDMENT.—Section 19
2379	2379	1848(c)(2)(B)(iv)(V) is amended by striking ‘‘or 2024’’ 20
2380	2380	and inserting ‘‘2024, or 2025’’. 21
2381	2381	SEC. 206. EXTENSION OF FUNDING FOR QUALITY MEASURE 22
2382	2382	ENDORSEMENT, INPUT, AND SELECTION. 23
2383	2383	Section 1890(d)(2) of the Social Security Act (42 24
2384	2384	U.S.C. 1395aaa(d)(2)) is amended— 25
2385	2385	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00078 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2386	2386	TKELLEY on LAP7H3WLY3PROD with BILLS 79
2387	2387	•S 891 IS
2388	2388	(1) in the first sentence— 1
2389	2389	(A) by striking ‘‘$11,030,000’’ and insert-2
2390	2390	ing ‘‘$14,000,000’’; and 3
2391	2391	(B) by striking ‘‘March 31, 2025’’ and in-4
2392	2392	serting ‘‘December 31, 2025’’; and 5
2393	2393	(2) in the third sentence, by striking ‘‘March 6
2394	2394	31, 2025’’ and inserting ‘‘December 31, 2025’’. 7
2395	2395	SEC. 207. EXTENSION OF FUNDING OUTREACH AND ASSIST-8
2396	2396	ANCE FOR LOW-INCOME PROGRAMS. 9
2397	2397	(a) S
2398	2398	TATEHEALTHINSURANCEASSISTANCEPRO-10
2399	2399	GRAMS.—Subsection (a)(1)(B) of section 119 of the Medi-11
2400	2400	care Improvements for Patients and Providers Act of 2008 12
2401	2401	(42 U.S.C. 1395b–3 note) is amended— 13
2402	2402	(1) in clause (xiii), by striking ‘‘and’’ at the 14
2403	2403	end; 15
2404	2404	(2) in clause (xiv), by striking the period and 16
2405	2405	inserting ‘‘; and’’; and 17
2406	2406	(3) by inserting after clause (xiv) the following 18
2407	2407	new clause: 19
2408	2408	‘‘(xv) for the period beginning on 20
2409	2409	April 1, 2025, and ending on December 21
2410	2410	31, 2026, $26,250,000.’’. 22
2411	2411	(b) A
2412	2412	REAAGENCIES ON AGING.—Subsection 23
2413	2413	(b)(1)(B) of such section 119 is amended— 24
2414	2414	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00079 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2415	2415	TKELLEY on LAP7H3WLY3PROD with BILLS 80
2416	2416	•S 891 IS
2417	2417	(1) in clause (xiii), by striking ‘‘and’’ at the 1
2418	2418	end; 2
2419	2419	(2) in clause (xiv), by striking the period and 3
2420	2420	inserting ‘‘; and’’; and 4
2421	2421	(3) by inserting after clause (xiv) the following 5
2422	2422	new clause: 6
2423	2423	‘‘(xv) for the period beginning on 7
2424	2424	April 1, 2025, and ending on December 8
2425	2425	31, 2026, $26,250,000.’’. 9
2426	2426	(c) A
2427	2427	GING ANDDISABILITYRESOURCECENTERS.— 10
2428	2428	Subsection (c)(1)(B) of such section 119 is amended— 11
2429	2429	(1) in clause (xiii), by striking ‘‘and’’ at the 12
2430	2430	end; 13
2431	2431	(2) in clause (xiv), by striking the period and 14
2432	2432	inserting ‘‘; and’’; and 15
2433	2433	(3) by inserting after clause (xiv) the following 16
2434	2434	new clause: 17
2435	2435	‘‘(xv) for the period beginning on 18
2436	2436	April 1, 2025, and ending on December 19
2437	2437	31, 2026, $7,750,000.’’. 20
2438	2438	(d) C
2439	2439	OORDINATION OFEFFORTSTOINFORMOLDER 21
2440	2440	A
2441	2441	MERICANSABOUTBENEFITSAVAILABLEUNDERFED-22
2442	2442	ERAL ANDSTATEPROGRAMS.—Subsection (d)(2) of such 23
2443	2443	section 119 is amended— 24
2444	2444	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00080 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2445	2445	TKELLEY on LAP7H3WLY3PROD with BILLS 81
2446	2446	•S 891 IS
2447	2447	(1) in clause (xiii), by striking ‘‘and’’ at the 1
2448	2448	end; 2
2449	2449	(2) in clause (xiv), by striking the period and 3
2450	2450	inserting ‘‘; and’’; and 4
2451	2451	(3) by inserting after clause (xiv) the following 5
2452	2452	new clause: 6
2453	2453	‘‘(xv) for the period beginning on 7
2454	2454	April 1, 2025, and ending on December 8
2455	2455	31, 2026, $26,250,000.’’. 9
2456	2456	SEC. 208. EXTENSION OF THE WORK GEOGRAPHIC INDEX 10
2457	2457	FLOOR. 11
2458	2458	Section 1848(e)(1)(E) of the Social Security Act (42 12
2459	2459	U.S.C. 1395w–4(e)(1)(E)) is amended by striking ‘‘April 13
2460	2460	1, 2025’’ and inserting ‘‘January 1, 2026’’. 14
2461	2461	SEC. 209. EXTENSION OF CERTAIN TELEHEALTH FLEXIBILI-15
2462	2462	TIES. 16
2463	2463	(a) R
2464	2464	EMOVINGGEOGRAPHICREQUIREMENTS AND 17
2465	2465	E
2466	2466	XPANDINGORIGINATINGSITES FOR TELEHEALTH 18
2467	2467	S
2468	2468	ERVICES.—Section 1834(m) of the Social Security Act 19
2469	2469	(42 U.S.C. 1395m(m)) is amended— 20
2470	2470	(1) in paragraph (2)(B)(iii), by striking ‘‘end-21
2471	2471	ing March 31, 2025’’ and inserting ‘‘ending Decem-22
2472	2472	ber 31, 2026’’; and 23
2473	2473	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00081 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2474	2474	TKELLEY on LAP7H3WLY3PROD with BILLS 82
2475	2475	•S 891 IS
2476	2476	(2) in paragraph (4)(C)(iii), by striking ‘‘ending 1
2477	2477	on March 31, 2025’’ and inserting ‘‘ending on De-2
2478	2478	cember 31, 2026’’. 3
2479	2479	(b) E
2480	2480	XPANDINGPRACTITIONERSELIGIBLETOFUR-4
2481	2481	NISHTELEHEALTH SERVICES.—Section 1834(m)(4)(E) 5
2482	2482	of the Social Security Act (42 U.S.C. 1395m(m)(4)(E)) 6
2483	2483	is amended by striking ‘‘ending on March 31, 2025’’ and 7
2484	2484	inserting ‘‘ending on December 31, 2026’’. 8
2485	2485	(c) E
2486	2486	XTENDINGTELEHEALTHSERVICES FORFED-9
2487	2487	ERALLYQUALIFIEDHEALTHCENTERS AND RURAL 10
2488	2488	H
2489	2489	EALTHCLINICS.—Section 1834(m)(8) of the Social Se-11
2490	2490	curity Act (42 U.S.C. 1395m(m)(8)) is amended— 12
2491	2491	(1) in subparagraph (A), by striking ‘‘ending on 13
2492	2492	March 31, 2025’’ and inserting ‘‘ending on Decem-14
2493	2493	ber 31, 2026’’; 15
2494	2494	(2) in subparagraph (B)— 16
2495	2495	(A) in the subparagraph heading, by in-17
2496	2496	serting ‘‘
2497	2497	BEFORE APRIL 1, 2025’’ after ‘‘RULE’’; 18
2498	2498	(B) in clause (i), by striking ‘‘during the 19
2499	2499	periods for which subparagraph (A) applies’’ 20
2500	2500	and inserting ‘‘before April 1, 2025’’; and 21
2501	2501	(C) in clause (ii), by inserting ‘‘furnished 22
2502	2502	to an eligible telehealth individual before April 23
2503	2503	1, 2025’’ after ‘‘telehealth services’’; and 24
2504	2504	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00082 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2505	2505	TKELLEY on LAP7H3WLY3PROD with BILLS 83
2506	2506	•S 891 IS
2507	2507	(3) by adding at the end the following new sub-1
2508	2508	paragraph: 2
2509	2509	‘‘(C) P
2510	2510	AYMENT RULE FOR PORTION OF 3
2511	2511	2025 AND 2026.— 4
2512	2512	‘‘(i) I
2513	2513	N GENERAL.—A telehealth serv-5
2514	2514	ice furnished to an eligible telehealth indi-6
2515	2515	vidual by a Federally qualified health cen-7
2516	2516	ter or rural health clinic on or after April 8
2517	2517	1, 2025, and before January 1, 2027, shall 9
2518	2518	be paid as a Federally qualified health cen-10
2519	2519	ter service or rural health clinic service (as 11
2520	2520	applicable) under the prospective payment 12
2521	2521	system established under section 1834(o) 13
2522	2522	or the methodology for all-inclusive rates 14
2523	2523	established under section 1833(a)(3), re-15
2524	2524	spectively. 16
2525	2525	‘‘(ii) T
2526	2526	REATMENT OF COSTS .—Costs 17
2527	2527	associated with the furnishing of telehealth 18
2528	2528	services by a Federally qualified health 19
2529	2529	center or rural health clinic on or after 20
2530	2530	April 1, 2025, and before January 1, 21
2531	2531	2027, shall be considered allowable costs 22
2532	2532	for purposes of the prospective payment 23
2533	2533	system established under section 1834(o) 24
2534	2534	and the methodology for all-inclusive rates 25
2535	2535	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00083 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2536	2536	TKELLEY on LAP7H3WLY3PROD with BILLS 84
2537	2537	•S 891 IS
2538	2538	established under section 1833(a)(3), as 1
2539	2539	applicable. 2
2540	2540	‘‘(iii) R
2541	2541	EQUIRING MODIFIERS .—Not 3
2542	2542	later than July 1, 2025, the Secretary 4
2543	2543	shall establish requirements to include 1 or 5
2544	2544	more codes or modifiers, as determined ap-6
2545	2545	propriate by the Secretary, in the case of 7
2546	2546	claims for telehealth services furnished to 8
2547	2547	an eligible telehealth individual by a Feder-9
2548	2548	ally qualified health center or rural health 10
2549	2549	clinic.’’. 11
2550	2550	(d) D
2551	2551	ELAYING THE IN-PERSONREQUIREMENTS 12
2552	2552	U
2553	2553	NDERMEDICARE FOR MENTALHEALTHSERVICES 13
2554	2554	F
2555	2555	URNISHED THROUGH TELEHEALTH AND TELE-14
2556	2556	COMMUNICATIONS TECHNOLOGY.— 15
2557	2557	(1) D
2558	2558	ELAY IN REQUIREMENTS FOR MENTAL 16
2559	2559	HEALTH SERVICES FURNISHED THROUGH TELE -17
2560	2560	HEALTH.—Section 1834(m)(7)(B)(i) of the Social 18
2561	2561	Security Act (42 U.S.C. 1395m(m)(7)(B)(i)) is 19
2562	2562	amended, in the matter preceding subclause (I), by 20
2563	2563	striking ‘‘April 1, 2025’’ and inserting ‘‘January 1, 21
2564	2564	2027’’. 22
2565	2565	(2) M
2566	2566	ENTAL HEALTH VISITS FURNISHED BY 23
2567	2567	RURAL HEALTH CLINICS .—Section 1834(y)(2) of the 24
2568	2568	Social Security Act (42 U.S.C. 1395m(y)(2)) is 25
2569	2569	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00084 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
2570	2570	TKELLEY on LAP7H3WLY3PROD with BILLS 85
2571	2571	•S 891 IS
2572	2572	amended by striking ‘‘April 1, 2025’’ and inserting 1
2573	2573	‘‘January 1, 2027’’. 2
2574	2574	(3) M
2575	2575	ENTAL HEALTH VISITS FURNISHED BY 3
2576	2576	FEDERALLY QUALIFIED HEALTH CENTERS .—Section 4
2577	2577	1834(o)(4)(B) of the Social Security Act (42 U.S.C. 5
2578	2578	1395m(o)(4)(B)) is amended by striking ‘‘April 1, 6
2579	2579	2025’’ and inserting ‘‘January 1, 2027’’. 7
2580	2580	(e) A
2581	2581	LLOWING FOR THE FURNISHING OF AUDIO- 8
2582	2582	O
2583	2583	NLYTELEHEALTHSERVICES.—Section 1834(m)(9) of 9
2584	2584	the Social Security Act (42 U.S.C. 1395m(m)(9)) is 10
2585	2585	amended by striking ‘‘ending on March 31, 2025’’ and in-11
2586	2586	serting ‘‘ending on December 31, 2026’’. 12
2587	2587	(f) E
2588	2588	XTENDINGUSE OFTELEHEALTHTOCONDUCT 13
2589	2589	F
2590	2590	ACE-TO-FACEENCOUNTERPRIOR TORECERTIFICATION 14
2591	2591	OFELIGIBILITY FOR HOSPICECARE.—Section 15
2592	2592	1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C. 16
2593	2593	1395f(a)(7)(D)(i)(II)) is amended— 17
2594	2594	(1) by striking ‘‘ending on March 31, 2025’’ 18
2595	2595	and inserting ‘‘ending on December 31, 2026’’; and 19
2596	2596	(2) by inserting ‘‘, except that this subclause 20
2597	2597	shall not apply in the case of such an encounter with 21
2598	2598	an individual occurring on or after April 1, 2025, if 22
2599	2599	such individual is located in an area that is subject 23
2600	2600	to a moratorium on the enrollment of hospice pro-24
2601	2601	grams under this title pursuant to section 25
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2604	2604	•S 891 IS
2605	2605	1866(j)(7), if such individual is receiving hospice 1
2606	2606	care from a provider that is subject to enhanced 2
2607	2607	oversight under this title pursuant to section 3
2608	2608	1866(j)(3), or if such encounter is performed by a 4
2609	2609	hospice physician or nurse practitioner who is not 5
2610	2610	enrolled under section 1866(j) and is not an opt-out 6
2611	2611	physician or practitioner (as defined in section 7
2612	2612	1802(b)(6)(D))’’ before the semicolon. 8
2613	2613	(g) R
2614	2614	EQUIRINGMODIFIERS FORTELEHEALTHSERV-9
2615	2615	ICES INCERTAININSTANCES.—Section 1834(m) of the 10
2616	2616	Social Security Act (42 U.S.C. 1395m(m)) is amended by 11
2617	2617	adding at the end the following new paragraph: 12
2618	2618	‘‘(10) R
2619	2619	EQUIRED USE OF MODIFIERS IN CER -13
2620	2620	TAIN INSTANCES.—Not later than January 1, 2026, 14
2621	2621	the Secretary shall establish requirements to include 15
2622	2622	1 or more codes or modifiers, as determined appro-16
2623	2623	priate by the Secretary, in the case of— 17
2624	2624	‘‘(A) claims for telehealth services under 18
2625	2625	this subsection that are furnished through a 19
2626	2626	telehealth virtual platform— 20
2627	2627	‘‘(i) by a physician or practitioner 21
2628	2628	that contracts with an entity that owns 22
2629	2629	such virtual platform; or 23
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2633	2633	‘‘(ii) for which a physician or practi-1
2634	2634	tioner has a payment arrangement with an 2
2635	2635	entity for use of such virtual platform; and 3
2636	2636	‘‘(B) claims for telehealth services under 4
2637	2637	this subsection that are furnished incident to a 5
2638	2638	physician’s or practitioner’s professional serv-6
2639	2639	ice.’’. 7
2640	2640	(h) P
2641	2641	ROGRAMINSTRUCTIONAUTHORITY.—The Sec-8
2642	2642	retary of Health and Human Services may implement the 9
2643	2643	amendments made by this section through program in-10
2644	2644	struction or otherwise. 11
2645	2645	SEC. 210. REQUIRING MODIFIER FOR USE OF TELEHEALTH 12
2646	2646	TO CONDUCT FACE-TO-FACE ENCOUNTER 13
2647	2647	PRIOR TO RECERTIFICATION OF ELIGIBILITY 14
2648	2648	FOR HOSPICE CARE. 15
2649	2649	Section 1814(a)(7)(D)(i)(II) of the Social Security 16
2650	2650	Act (42 U.S.C. 1395f(a)(7)(D)(i)(II)), as amended by sec-17
2651	2651	tion 209(f), is further amended by inserting ‘‘, but only 18
2652	2652	if, in the case of such an encounter occurring on or after 19
2653	2653	January 1, 2026, any hospice claim includes 1 or more 20
2654	2654	modifiers or codes (as specified by the Secretary) to indi-21
2655	2655	cate that such encounter was conducted via telehealth’’ 22
2656	2656	after ‘‘as determined appropriate by the Secretary’’. 23
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2659	2659	•S 891 IS
2660	2660	SEC. 211. EXTENDING ACUTE HOSPITAL CARE AT HOME 1
2661	2661	WAIVER FLEXIBILITIES. 2
2662	2662	Section 1866G of the Social Security Act (42 U.S.C. 3
2663	2663	1395cc–7) is amended— 4
2664	2664	(1) in the section heading, by inserting ‘‘
2665	2665	THE 5
2666	2666	THOMAS R . CARPER, TIM SCOTT, BRAD R. 6
2667	2667	WENSTRUP, D.P.M., AND EARL BLUMENAUER ’’ 7
2668	2668	after ‘‘
2669	2669	EXTENSION OF ’’; 8
2670	2670	(2) in subsection (a)— 9
2671	2671	(A) in paragraph (1)— 10
2672	2672	(i) by striking ‘‘March 31, 2025’’ and 11
2673	2673	inserting ‘‘December 31, 2029’’; and 12
2674	2674	(ii) by striking ‘‘in the Acute Hospital 13
2675	2675	Care at Home initiative of the Secretary’’ 14
2676	2676	and inserting ‘‘in the Thomas R. Carper, 15
2677	2677	Tim Scott, Brad R. Wenstrup, D.P.M., 16
2678	2678	and Earl Blumenauer Acute Hospital Care 17
2679	2679	at Home initiative of the Secretary (in this 18
2680	2680	section referred to as the ‘Acute Hospital 19
2681	2681	Care at Home initiative’)’’; 20
2682	2682	(B) in paragraph (2), by striking ‘‘of the 21
2683	2683	Secretary’’; and 22
2684	2684	(C) in paragraph (3)(E), by adding at the 23
2685	2685	end the following new flush sentence: 24
2686	2686	‘‘The Secretary may require that such data and 25
2687	2687	information be submitted through a hospital’s 26
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2690	2690	•S 891 IS
2691	2691	cost report, through such survey instruments as 1
2692	2692	the Secretary may develop, through medical 2
2693	2693	record information, or through such other 3
2694	2694	means as the Secretary determines appro-4
2695	2695	priate.’’; 5
2696	2696	(3) in subsection (b)— 6
2697	2697	(A) in the subsection heading, by striking 7
2698	2698	‘‘S
2699	2699	TUDY’’ and inserting ‘‘INITIALSTUDY’’; 8
2700	2700	(B) in paragraph (1)(A), by striking ‘‘of 9
2701	2701	the Secretary’’; and 10
2702	2702	(C) in paragraph (3), by inserting ‘‘or sub-11
2703	2703	section (c)’’ before the period at the end; 12
2704	2704	(4) by redesignating subsections (c) and (d) as 13
2705	2705	subsections (d) and (e), respectively; and 14
2706	2706	(5) by inserting after subsection (b) the fol-15
2707	2707	lowing new subsection: 16
2708	2708	‘‘(c) S
2709	2709	UBSEQUENTSTUDY ANDREPORT.— 17
2710	2710	‘‘(1) I
2711	2711	N GENERAL.—Not later than September 18
2712	2712	30, 2028, the Secretary shall conduct a study to— 19
2713	2713	‘‘(A) analyze, to the extent practicable, the 20
2714	2714	criteria established by hospitals under the Acute 21
2715	2715	Hospital Care at Home initiative to determine 22
2716	2716	which individuals may be furnished services 23
2717	2717	under such initiative; and 24
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2721	2721	‘‘(B) analyze and compare (both within 1
2722	2722	and between hospitals participating in the ini-2
2723	2723	tiative, and relative to comparable hospitals 3
2724	2724	that do not participate in the initiative, for rel-4
2725	2725	evant parameters such as diagnosis-related 5
2726	2726	groups)— 6
2727	2727	‘‘(i) quality of care furnished to indi-7
2728	2728	viduals with similar conditions and charac-8
2729	2729	teristics in the inpatient setting and 9
2730	2730	through the Acute Hospital Care at Home 10
2731	2731	initiative, including health outcomes, hos-11
2732	2732	pital readmission rates (including readmis-12
2733	2733	sions both within and beyond 30 days post- 13
2734	2734	discharge), hospital mortality rates, length 14
2735	2735	of stay, infection rates, composition of care 15
2736	2736	team (including the types of labor used, 16
2737	2737	such as contracted labor), the ratio of 17
2738	2738	nursing staff, transfers from the hospital 18
2739	2739	to the home, transfers from the home to 19
2740	2740	the hospital (including the timing, fre-20
2741	2741	quency, and causes of such transfers), 21
2742	2742	transfers and discharges to post-acute care 22
2743	2743	settings (including the timing, frequency, 23
2744	2744	and causes of such transfers and dis-24
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2747	2747	•S 891 IS
2748	2748	charges), and patient and caregiver experi-1
2749	2749	ence of care; 2
2750	2750	‘‘(ii) clinical conditions treated and di-3
2751	2751	agnosis-related groups of discharges from 4
2752	2752	inpatient settings relative to discharges 5
2753	2753	from the Acute Hospital Care at Home ini-6
2754	2754	tiative; 7
2755	2755	‘‘(iii) costs incurred by the hospital 8
2756	2756	for furnishing care in inpatient settings 9
2757	2757	relative to costs incurred by the hospital 10
2758	2758	for furnishing care through the Acute Hos-11
2759	2759	pital Care at Home initiative, including 12
2760	2760	costs relating to staffing, equipment, food, 13
2761	2761	prescriptions, and other services, as deter-14
2762	2762	mined by the Secretary; 15
2763	2763	‘‘(iv) the quantity, mix, and intensity 16
2764	2764	of services (such as in-person visits and 17
2765	2765	virtual contacts with patients and the in-18
2766	2766	tensity of such services) furnished in inpa-19
2767	2767	tient settings relative to the Acute Hospital 20
2768	2768	Care at Home initiative, and, to the extent 21
2769	2769	practicable, the nature and extent of family 22
2770	2770	or caregiver involvement; 23
2771	2771	‘‘(v) socioeconomic information on in-24
2772	2772	dividuals treated in comparable inpatient 25
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2775	2775	•S 891 IS
2776	2776	settings relative to the initiative, including 1
2777	2777	racial and ethnic data, income, housing, 2
2778	2778	geographic proximity to the brick-and-mor-3
2779	2779	tar facility and whether such individuals 4
2780	2780	are dually eligible for benefits under this 5
2781	2781	title and title XIX; and 6
2782	2782	‘‘(vi) the quality of care, outcomes, 7
2783	2783	costs, quantity and intensity of services, 8
2784	2784	and other relevant metrics between individ-9
2785	2785	uals who entered into the Acute Hospital 10
2786	2786	Care at Home initiative directly from an 11
2787	2787	emergency department compared with indi-12
2788	2788	viduals who entered into the Acute Hos-13
2789	2789	pital Care at Home initiative directly from 14
2790	2790	an existing inpatient stay in a hospital. 15
2791	2791	‘‘(2) S
2792	2792	ELECTION BIAS.—In conducting the 16
2793	2793	study under paragraph (1), the Secretary shall, to 17
2794	2794	the extent practicable, analyze and compare individ-18
2795	2795	uals who participate and do not participate in the 19
2796	2796	initiative controlling for selection bias or other fac-20
2797	2797	tors that may impact the reliability of data. 21
2798	2798	‘‘(3) R
2799	2799	EPORT.—Not later than September 30, 22
2800	2800	2028, the Secretary of Health and Human Services 23
2801	2801	shall post on a website of the Centers for Medicare 24
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2803	2803	TKELLEY on LAP7H3WLY3PROD with BILLS 93
2804	2804	•S 891 IS
2805	2805	& Medicaid Services a report on the study conducted 1
2806	2806	under paragraph (1). 2
2807	2807	‘‘(4) F
2808	2808	UNDING.—In addition to amounts other-3
2809	2809	wise available, there is appropriated to the Centers 4
2810	2810	for Medicare & Medicaid Services Program Manage-5
2811	2811	ment Account for fiscal year 2026, out of any 6
2812	2812	amounts in the Treasury not otherwise appropriated, 7
2813	2813	$6,000,000, respectively, to remain available until 8
2814	2814	expended, for purposes of carrying out this section.’’. 9
2815	2815	SEC. 212. ENHANCING CERTAIN PROGRAM INTEGRITY RE-10
2816	2816	QUIREMENTS FOR DME UNDER MEDICARE. 11
2817	2817	(a) D
2818	2818	URABLEMEDICALEQUIPMENT.— 12
2819	2819	(1) I
2820	2820	N GENERAL.—Section 1834(a) of the So-13
2821	2821	cial Security Act (42 U.S.C. 1395m(a)) is amended 14
2822	2822	by adding at the end the following new paragraph: 15
2823	2823	‘‘(23) M
2824	2824	ASTER LIST INCLUSION AND CLAIM RE -16
2825	2825	VIEW FOR CERTAIN ITEMS .— 17
2826	2826	‘‘(A) M
2827	2827	ASTER LIST INCLUSION .—Begin-18
2828	2828	ning January 1, 2028, for purposes of the Mas-19
2829	2829	ter List described in section 414.234(b) of title 20
2830	2830	42, Code of Federal Regulations (or any suc-21
2831	2831	cessor regulation), an item for which payment 22
2832	2832	may be made under this subsection shall be 23
2833	2833	treated as having aberrant billing patterns (as 24
2834	2834	such term is used for purposes of such section) 25
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2838	2838	if the Secretary determines that, without ex-1
2839	2839	planatory contributing factors (such as fur-2
2840	2840	nishing emergent care services), a substantial 3
2841	2841	number of claims for such items under this sub-4
2842	2842	section are for such items ordered by a physi-5
2843	2843	cian or practitioner who has not previously 6
2844	2844	(during a period of not less than 24 months, as 7
2845	2845	established by the Secretary) furnished to the 8
2846	2846	individual involved any item or service for which 9
2847	2847	payment may be made under this title. 10
2848	2848	‘‘(B) C
2849	2849	LAIM REVIEW.—With respect to 11
2850	2850	items furnished on or after January 1, 2028, 12
2851	2851	that are included on the Master List pursuant 13
2852	2852	to subparagraph (A), if such an item is not sub-14
2853	2853	ject to a determination of coverage in advance 15
2854	2854	pursuant to paragraph (15)(C), the Secretary 16
2855	2855	may conduct prepayment review of claims for 17
2856	2856	payment for such item.’’. 18
2857	2857	(2) C
2858	2858	ONFORMING AMENDMENT FOR PROS -19
2859	2859	THETIC DEVICES, ORTHOTICS, AND PROSTHETICS.— 20
2860	2860	Section 1834(h)(3) of the Social Security Act (42 21
2861	2861	U.S.C. 1395m(h)(3)) is amended by inserting ‘‘, and 22
2862	2862	paragraph (23) of subsection (a) shall apply to pros-23
2863	2863	thetic devices, orthotics, and prosthetics in the same 24
2864	2864	manner as such provision applies to items for which 25
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2867	2867	•S 891 IS
2868	2868	payment may be made under such subsection’’ be-1
2869	2869	fore the period at the end. 2
2870	2870	(b) R
2871	2871	EPORT ONIDENTIFYINGCLINICALDIAGNOSTIC 3
2872	2872	L
2873	2873	ABORATORYTESTS ATHIGHRISK FORFRAUD ANDEF-4
2874	2874	FECTIVEMITIGATIONMEASURES.—Not later than Janu-5
2875	2875	ary 1, 2026, the Inspector General of the Department of 6
2876	2876	Health and Human Services shall submit to Congress a 7
2877	2877	report assessing fraud risks relating to claims for clinical 8
2878	2878	diagnostic laboratory tests for which payment may be 9
2879	2879	made under section 1834A of the Social Security Act (42 10
2880	2880	U.S.C. 1395m–1) and effective tools for reducing such 11
2881	2881	fraudulent claims. The report may include information re-12
2882	2882	garding— 13
2883	2883	(1) which, if any, clinical diagnostic laboratory 14
2884	2884	tests are identified as being at high risk of fraudu-15
2885	2885	lent claims, and an analysis of the factors that con-16
2886	2886	tribute to such risk; 17
2887	2887	(2) with respect to a clinical diagnostic labora-18
2888	2888	tory test identified under paragraph (1) as being at 19
2889	2889	high risk of fraudulent claims— 20
2890	2890	(A) the amount payable under such section 21
2891	2891	1834A with respect to such test; 22
2892	2892	(B) the number of such tests furnished to 23
2893	2893	individuals enrolled under part B of title XVIII 24
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2896	2896	•S 891 IS
2897	2897	of the Social Security Act (42 U.S.C. 1395j et 1
2898	2898	seq.); 2
2899	2899	(C) whether an order for such a test was 3
2900	2900	more likely to come from a provider with whom 4
2901	2901	the individual involved did not have a prior re-5
2902	2902	lationship, as determined on the basis of prior 6
2903	2903	payment experience; and 7
2904	2904	(D) the frequency with which a claim for 8
2905	2905	payment under such section 1834A included the 9
2906	2906	payment modifier identified by code 59 or 91; 10
2907	2907	and 11
2908	2908	(3) suggested strategies for reducing the num-12
2909	2909	ber of fraudulent claims made with respect to tests 13
2910	2910	so identified as being at high risk, including— 14
2911	2911	(A) an analysis of whether the Centers for 15
2912	2912	Medicare & Medicaid Services can detect aber-16
2913	2913	rant billing patterns with respect to such tests 17
2914	2914	in a timely manner; 18
2915	2915	(B) any strategies for identifying and mon-19
2916	2916	itoring the providers who are outliers with re-20
2917	2917	spect to the number of such tests that such pro-21
2918	2918	viders order; and 22
2919	2919	(C) targeted education efforts to mitigate 23
2920	2920	improper billing for such tests; and 24
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2923	2923	•S 891 IS
2924	2924	(4) such other information as the Inspector 1
2925	2925	General determines appropriate. 2
2926	2926	SEC. 213. GUIDANCE ON FURNISHING SERVICES VIA TELE-3
2927	2927	HEALTH TO INDIVIDUALS WITH LIMITED 4
2928	2928	ENGLISH PROFICIENCY. 5
2929	2929	(a) I
2930	2930	NGENERAL.—Not later than 1 year after the 6
2931	2931	date of the enactment of this section, the Secretary of 7
2932	2932	Health and Human Services, in consultation with 1 or 8
2933	2933	more entities from each of the categories described in 9
2934	2934	paragraphs (1) through (7) of subsection (b), shall issue 10
2935	2935	and disseminate, or update and revise as applicable, guid-11
2936	2936	ance for the entities described in such subsection on the 12
2937	2937	following: 13
2938	2938	(1) Best practices on facilitating and inte-14
2939	2939	grating use of interpreters during a telemedicine ap-15
2940	2940	pointment. 16
2941	2941	(2) Best practices on providing accessible in-17
2942	2942	structions on how to access telecommunications sys-18
2943	2943	tems (as such term is used for purposes of section 19
2944	2944	1834(m) of the Social Security Act (42 U.S.C. 20
2945	2945	1395m(m)) for individuals with limited English pro-21
2946	2946	ficiency. 22
2947	2947	(3) Best practices on improving access to dig-23
2948	2948	ital patient portals for individuals with limited 24
2949	2949	English proficiency. 25
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2952	2952	•S 891 IS
2953	2953	(4) Best practices on integrating the use of 1
2954	2954	video platforms that enable multi-person video calls 2
2955	2955	furnished via a telecommunications system for pur-3
2956	2956	poses of providing interpretation during a telemedi-4
2957	2957	cine appointment for an individual with limited 5
2958	2958	English proficiency. 6
2959	2959	(5) Best practices for providing patient mate-7
2960	2960	rials, communications, and instructions in multiple 8
2961	2961	languages, including text message appointment re-9
2962	2962	minders and prescription information. 10
2963	2963	(b) E
2964	2964	NTITIESDESCRIBED.—For purposes of sub-11
2965	2965	section (a), an entity described in this subsection is an 12
2966	2966	entity in 1 or more of the following categories: 13
2967	2967	(1) Health information technology service pro-14
2968	2968	viders, including— 15
2969	2969	(A) electronic medical record companies; 16
2970	2970	(B) remote patient monitoring companies; 17
2971	2971	and 18
2972	2972	(C) telehealth or mobile health vendors and 19
2973	2973	companies. 20
2974	2974	(2) Health care providers, including— 21
2975	2975	(A) physicians; and 22
2976	2976	(B) hospitals. 23
2977	2977	(3) Health insurers. 24
2978	2978	(4) Language service companies. 25
2979	2979	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00098 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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2981	2981	•S 891 IS
2982	2982	(5) Interpreter or translator professional asso-1
2983	2983	ciations. 2
2984	2984	(6) Health and language services quality certifi-3
2985	2985	cation organizations. 4
2986	2986	(7) Patient and consumer advocates, including 5
2987	2987	such advocates that work with individuals with lim-6
2988	2988	ited English proficiency. 7
2989	2989	SEC. 214. IN-HOME CARDIOPULMONARY REHABILITATION 8
2990	2990	FLEXIBILITIES. 9
2991	2991	(a) I
2992	2992	NGENERAL.—Section 1861(eee)(2) of the Social 10
2993	2993	Security Act (42 U.S.C. 1395x(eee)(2)) is amended— 11
2994	2994	(1) in subparagraph (A)(ii), by inserting ‘‘(in-12
2995	2995	cluding, with respect to items and services furnished 13
2996	2996	through audio and video real-time communications 14
2997	2997	technology (excluding audio-only) on or after April 15
2998	2998	1, 2025, and before January 1, 2027, in the home 16
2999	2999	of an individual who is an outpatient of the hos-17
3000	3000	pital)’’ after ‘‘outpatient basis’’; and 18
3001	3001	(2) in subparagraph (B), by inserting ‘‘(includ-19
3002	3002	ing, with respect to items and services furnished 20
3003	3003	through audio and video real-time communications 21
3004	3004	technology on or after April 1, 2025, and before 22
3005	3005	January 1, 2027, the virtual presence of such physi-23
3006	3006	cian, physician assistant, nurse practitioner, or clin-24
3007	3007	ical nurse specialist)’’ after ‘‘under the program’’. 25
3008	3008	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00099 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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3010	3010	•S 891 IS
3011	3011	(b) PROGRAMINSTRUCTIONAUTHORITY.—Notwith-1
3012	3012	standing any other provision of law, the Secretary of 2
3013	3013	Health and Human Services may implement the amend-3
3014	3014	ments made by this section by program instruction or oth-4
3015	3015	erwise. 5
3016	3016	SEC. 215. INCLUSION OF VIRTUAL DIABETES PREVENTION 6
3017	3017	PROGRAM SUPPLIERS IN MDPP EXPANDED 7
3018	3018	MODEL. 8
3019	3019	(a) I
3020	3020	NGENERAL.—Not later than January 1, 2026, 9
3021	3021	the Secretary shall revise the regulations under parts 410 10
3022	3022	and 424 of title 42, Code of Federal Regulations, to pro-11
3023	3023	vide that, for the period beginning January 1, 2026, and 12
3024	3024	ending December 31, 2030— 13
3025	3025	(1) an entity may participate in the MDPP by 14
3026	3026	offering only online MDPP services via synchronous 15
3027	3027	or asynchronous technology or telecommunications if 16
3028	3028	such entity meets the conditions for enrollment as 17
3029	3029	an MDPP supplier (as specified in section 18
3030	3030	424.205(b) of title 42, Code of Federal Regulations 19
3031	3031	(or a successor regulation)); 20
3032	3032	(2) if an entity participates in the MDPP in the 21
3033	3033	manner described in paragraph (1)— 22
3034	3034	(A) the administrative location of such en-23
3035	3035	tity shall be the address of the entity on file 24
3036	3036	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00100 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
3037	3037	TKELLEY on LAP7H3WLY3PROD with BILLS 101
3038	3038	•S 891 IS
3039	3039	under the Diabetes Prevention Recognition Pro-1
3040	3040	gram; and 2
3041	3041	(B) in the case of online MDPP services 3
3042	3042	furnished by such entity to an MDPP bene-4
3043	3043	ficiary who was not located in the same State 5
3044	3044	as the entity at the time such services were fur-6
3045	3045	nished, the entity shall not be prohibited from 7
3046	3046	submitting a claim for payment for such serv-8
3047	3047	ices solely by reason of the location of such ben-9
3048	3048	eficiary at such time; and 10
3049	3049	(3) no limit is applied on the number of times 11
3050	3050	an individual may enroll in the MDPP. 12
3051	3051	(b) D
3052	3052	EFINITIONS.—In this section: 13
3053	3053	(1) MDPP.—The term ‘‘MDPP’’ means the 14
3054	3054	Medicare Diabetes Prevention Program conducted 15
3055	3055	under section 1115A of the Social Security Act (42 16
3056	3056	U.S.C. 1315a), as described in the final rule pub-17
3057	3057	lished in the Federal Register entitled ‘‘Medicare 18
3058	3058	and Medicaid Programs; CY 2024 Payment Policies 19
3059	3059	Under the Physician Fee Schedule and Other 20
3060	3060	Changes to Part B Payment and Coverage Policies; 21
3061	3061	Medicare Shared Savings Program Requirements; 22
3062	3062	Medicare Advantage; Medicare and Medicaid Pro-23
3063	3063	vider and Supplier Enrollment Policies; and Basic 24
3064	3064	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00101 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
3065	3065	TKELLEY on LAP7H3WLY3PROD with BILLS 102
3066	3066	•S 891 IS
3067	3067	Health Program’’ (88 Fed. Reg. 78818 (November 1
3068	3068	16, 2023)) (or a successor regulation). 2
3069	3069	(2) R
3070	3070	EGULATORY TERMS .—The terms ‘‘Diabe-3
3071	3071	tes Prevention Recognition Program’’, ‘‘full CDC 4
3072	3072	DPRP recognition’’, ‘‘MDPP beneficiary’’, ‘‘MDPP 5
3073	3073	services’’, and ‘‘MDPP supplier’’ have the meanings 6
3074	3074	given each such term in section 410.79(b) of title 7
3075	3075	42, Code of Federal Regulations. 8
3076	3076	(3) S
3077	3077	ECRETARY.—The term ‘‘Secretary’’ means 9
3078	3078	the Secretary of Health and Human Services. 10
3079	3079	SEC. 216. MEDICATION-INDUCED MOVEMENT DISORDER 11
3080	3080	OUTREACH AND EDUCATION. 12
3081	3081	Not later than January 1, 2026, the Secretary shall 13
3082	3082	use existing communications mechanisms to provide edu-14
3083	3083	cation and outreach to physicians and appropriate non- 15
3084	3084	physician practitioners participating under the Medicare 16
3085	3085	program under title XVIII of the Social Security Act (42 17
3086	3086	U.S.C. 1395 et seq.) with respect to periodic screening for 18
3087	3087	medication-induced movement disorders that are associ-19
3088	3088	ated with the treatment of mental health disorders in at- 20
3089	3089	risk patients, as well as resources related to clinical guide-21
3090	3090	lines and best practices for furnishing such screening serv-22
3091	3091	ices through telehealth. Such education and outreach shall 23
3092	3092	include information on how to account for such screening 24
3093	3093	services in evaluation and management code selection. The 25
3094	3094	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00102 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
3095	3095	TKELLEY on LAP7H3WLY3PROD with BILLS 103
3096	3096	•S 891 IS
3097	3097	Secretary shall, to the extent practicable, seek input from 1
3098	3098	relevant stakeholders to inform such education and out-2
3099	3099	reach. Such education and outreach may also address 3
3100	3100	other relevant screening services furnished through tele-4
3101	3101	health, as the Secretary determines appropriate. 5
3102	3102	SEC. 217. REPORT ON WEARABLE MEDICAL DEVICES. 6
3103	3103	Not later than 18 months after the date of the enact-7
3104	3104	ment of this Act, the Comptroller General of the United 8
3105	3105	States shall conduct a technology assessment of, and sub-9
3106	3106	mit to Congress a report on, the capabilities and limita-10
3107	3107	tions of wearable medical devices used to support clinical 11
3108	3108	decision-making. Such report shall include a description 12
3109	3109	of— 13
3110	3110	(1) the potential for such devices to accurately 14
3111	3111	prescribe treatments; 15
3112	3112	(2) an examination of the benefits and chal-16
3113	3113	lenges of artificial intelligence to augment such ca-17
3114	3114	pabilities; and 18
3115	3115	(3) policy options to enhance the benefits and 19
3116	3116	mitigate potential challenges of developing or using 20
3117	3117	such devices. 21
3118	3118	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00103 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
3119	3119	TKELLEY on LAP7H3WLY3PROD with BILLS 104
3120	3120	•S 891 IS
3121	3121	SEC. 218. EXTENSION OF TEMPORARY INCLUSION OF AU-1
3122	3122	THORIZED ORAL ANTIVIRAL DRUGS AS COV-2
3123	3123	ERED PART D DRUGS. 3
3124	3124	Section 1860D–2(e)(1)(C) of the Social Security Act 4
3125	3125	(42 U.S.C. 1395w–102(e)(1)(C)) is amended by striking 5
3126	3126	‘‘March 31, 2025’’ and inserting ‘‘December 31, 2025’’. 6
3127	3127	SEC. 219. EXTENSION OF ADJUSTMENT TO CALCULATION 7
3128	3128	OF HOSPICE CAP AMOUNT. 8
3129	3129	Section 1814(i)(2)(B) of the Social Security Act (42 9
3130	3130	U.S.C. 1395f(i)(2)(B)) is amended— 10
3131	3131	(1) in clause (ii), by striking ‘‘2033’’ and in-11
3132	3132	serting ‘‘2034’’; and 12
3133	3133	(2) in clause (iii), by striking ‘‘2033’’ and in-13
3134	3134	serting ‘‘2034’’. 14
3135	3135	SEC. 220. MULTIYEAR CONTRACTING AUTHORITY FOR 15
3136	3136	MEDPAC AND MACPAC. 16
3137	3137	Section 3904 of title 41, United States Code, is 17
3138	3138	amended by adding at the end the following new sub-18
3139	3139	sections: 19
3140	3140	‘‘(i) T
3141	3141	HEMEDICAREPAYMENTADVISORYCOMMIS-20
3142	3142	SION.—The Medicare Payment Advisory Commission may 21
3143	3143	use available funds to enter into contracts for the procure-22
3144	3144	ment of severable services for a period that begins in one 23
3145	3145	fiscal year and ends in the next fiscal year and may enter 24
3146	3146	into multiyear contracts for the acquisition of property 25
3147	3147	and services to the same extent as executive agencies 26
3148	3148	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00104 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
3149	3149	TKELLEY on LAP7H3WLY3PROD with BILLS 105
3150	3150	•S 891 IS
3151	3151	under the authority of sections 3902 and 3903 of this 1
3152	3152	title. 2
3153	3153	‘‘(j) T
3154	3154	HEMEDICAID ANDCHIP PAYMENT ANDAC-3
3155	3155	CESSCOMMISSION.—The Medicaid and CHIP Payment 4
3156	3156	and Access Commission may use available funds to enter 5
3157	3157	into contracts for the procurement of severable services 6
3158	3158	for a period that begins in one fiscal year and ends in 7
3159	3159	the next fiscal year and may enter into multiyear contracts 8
3160	3160	for the acquisition of property and services to the same 9
3161	3161	extent as executive agencies under the authority of sec-10
3162	3162	tions 3902 and 3903 of this title.’’. 11
3163	3163	SEC. 221. CONTRACTING PARITY FOR MEDPAC AND 12
3164	3164	MACPAC. 13
3165	3165	In fiscal year 2025 and thereafter, for all contracts 14
3166	3166	for goods and services to which the Medicare and Payment 15
3167	3167	Advisory Commission or the Medicaid and CHIP Payment 16
3168	3168	and Access Commission is a party, the following Federal 17
3169	3169	Acquisition Regulation (FAR) clauses will apply: FAR 18
3170	3170	52.232–39 and FAR 52.233–4 (or a successor clause). 19
3171	3171	SEC. 222. ADJUSTMENTS TO MEDICARE PART D COST-SHAR-20
3172	3172	ING REDUCTIONS FOR LOW-INCOME INDIVID-21
3173	3173	UALS. 22
3174	3174	Section 1860D–14(a) of the Social Security Act (42 23
3175	3175	U.S.C. 1395w–114(a)) is amended— 24
3176	3176	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00105 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
3177	3177	TKELLEY on LAP7H3WLY3PROD with BILLS 106
3178	3178	•S 891 IS
3179	3179	(1) in paragraph (1)(D)(ii), by striking ‘‘that 1
3180	3180	does not exceed $1 for’’ and all that follows through 2
3181	3181	the period at the end and inserting ‘‘that does not 3
3182	3182	exceed— 4
3183	3183	‘‘(I) for a plan year before 5
3184	3184	2027— 6
3185	3185	‘‘(aa) for a generic drug or a 7
3186	3186	preferred drug that is a multiple 8
3187	3187	source drug (as defined in section 9
3188	3188	1927(k)(7)(A)(i)), $1 or, if less, 10
3189	3189	the copayment amount applicable 11
3190	3190	to an individual under clause 12
3191	3191	(iii); and 13
3192	3192	‘‘(bb) for any other drug, $3 14
3193	3193	or, if less, the copayment amount 15
3194	3194	applicable to an individual under 16
3195	3195	clause (iii); and 17
3196	3196	‘‘(II) for plan year 2027 and 18
3197	3197	each subsequent plan year— 19
3198	3198	‘‘(aa) for a generic drug, $0; 20
3199	3199	‘‘(bb) for a preferred drug 21
3200	3200	that is a multiple source drug (as 22
3201	3201	defined in section 23
3202	3202	1927(k)(7)(A)(i)), the dollar 24
3203	3203	amount applied under this clause 25
3204	3204	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00106 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
3205	3205	TKELLEY on LAP7H3WLY3PROD with BILLS 107
3206	3206	•S 891 IS
3207	3207	for such a drug for the preceding 1
3208	3208	plan year, increased by the an-2
3209	3209	nual percentage increase in the 3
3210	3210	consumer price index (all items; 4
3211	3211	U.S. city average) as of Sep-5
3212	3212	tember of such preceding year, 6
3213	3213	or, if less, the copayment amount 7
3214	3214	applicable to an individual under 8
3215	3215	clause (iii); and 9
3216	3216	‘‘(cc) for a drug not de-10
3217	3217	scribed in either item (aa) or 11
3218	3218	(bb), the dollar amount applied 12
3219	3219	under this clause for such a drug 13
3220	3220	for the preceding plan year, in-14
3221	3221	creased in the manner specified 15
3222	3222	in item (bb), or, if less, the co-16
3223	3223	payment amount applicable to an 17
3224	3224	individual under clause (iii). 18
3225	3225	Any amount established under item (bb) or 19
3226	3226	(cc) of subclause (II), that is based on an 20
3227	3227	increase of $1 or $3, that is not a multiple 21
3228	3228	of 5 cents or 10 cents, respectively, shall 22
3229	3229	be rounded to the nearest multiple of 5 23
3230	3230	cents or 10 cents, respectively.’’; and 24
3231	3231	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00107 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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3233	3233	•S 891 IS
3234	3234	(2) in paragraph (4)(A)(ii), by inserting ‘‘(be-1
3235	3235	fore 2027)’’ after ‘‘a subsequent year’’. 2
3236	3236	SEC. 223. REQUIRING ENHANCED AND ACCURATE LISTS OF 3
3237	3237	(REAL) HEALTH PROVIDERS ACT. 4
3238	3238	(a) I
3239	3239	NGENERAL.—Section 1852(c) of the Social Se-5
3240	3240	curity Act (42 U.S.C. 1395w–22(c)) is amended— 6
3241	3241	(1) in paragraph (1)(C)— 7
3242	3242	(A) by striking ‘‘plan, and any’’ and insert-8
3243	3243	ing ‘‘plan, any’’; and 9
3244	3244	(B) by inserting the following before the 10
3245	3245	period at the end: ‘‘, and, in the case of a speci-11
3246	3246	fied MA plan (as defined in paragraph (3)(C)), 12
3247	3247	for plan year 2027 and subsequent plan years, 13
3248	3248	the information described in paragraph (3)(B)’’; 14
3249	3249	and 15
3250	3250	(2) by adding at the end the following new 16
3251	3251	paragraph: 17
3252	3252	‘‘(3) P
3253	3253	ROVIDER DIRECTORY ACCURACY .— 18
3254	3254	‘‘(A) I
3255	3255	N GENERAL.—For plan year 2027 19
3256	3256	and subsequent plan years, each MA organiza-20
3257	3257	tion offering a specified MA plan (as defined in 21
3258	3258	subparagraph (C)) shall, for each such plan of-22
3259	3259	fered by the organization— 23
3260	3260	‘‘(i) maintain, on a publicly available 24
3261	3261	internet website, an accurate provider di-25
3262	3262	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00108 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
3263	3263	TKELLEY on LAP7H3WLY3PROD with BILLS 109
3264	3264	•S 891 IS
3265	3265	rectory that includes the information de-1
3266	3266	scribed in subparagraph (B); 2
3267	3267	‘‘(ii) not less frequently than once 3
3268	3268	every 90 days (or, in the case of a hospital 4
3269	3269	or any other facility determined appro-5
3270	3270	priate by the Secretary, at a lesser fre-6
3271	3271	quency specified by the Secretary but in no 7
3272	3272	case less frequently than once every 12 8
3273	3273	months), verify the provider directory in-9
3274	3274	formation of each provider listed in such 10
3275	3275	directory and, if applicable, update such 11
3276	3276	provider directory information; 12
3277	3277	‘‘(iii) if the organization is unable to 13
3278	3278	verify such information with respect to a 14
3279	3279	provider, include in such directory an indi-15
3280	3280	cation that the information of such pro-16
3281	3281	vider may not be up-to-date; and 17
3282	3282	‘‘(iv) remove a provider from such di-18
3283	3283	rectory within 5 business days if the orga-19
3284	3284	nization determines that the provider is no 20
3285	3285	longer a provider participating in the net-21
3286	3286	work of such plan. 22
3287	3287	‘‘(B) P
3288	3288	ROVIDER DIRECTORY INFORMA -23
3289	3289	TION.—The information described in this sub-24
3290	3290	paragraph is information enrollees may need to 25
3291	3291	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00109 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
3292	3292	TKELLEY on LAP7H3WLY3PROD with BILLS 110
3293	3293	•S 891 IS
3294	3294	access covered benefits from a provider with 1
3295	3295	which such organization offering such plan has 2
3296	3296	an agreement for furnishing items and services 3
3297	3297	covered under such plan such as name, spe-4
3298	3298	cialty, contact information, primary office or fa-5
3299	3299	cility address, whether the provider is accepting 6
3300	3300	new patients, accommodations for people with 7
3301	3301	disabilities, cultural and linguistic capabilities, 8
3302	3302	and telehealth capabilities. 9
3303	3303	‘‘(C) S
3304	3304	PECIFIED MA PLAN.—In this para-10
3305	3305	graph, the term ‘specified MA plan’ means— 11
3306	3306	‘‘(i) a network-based plan (as defined 12
3307	3307	in subsection (d)(5)(C)); or 13
3308	3308	‘‘(ii) a Medicare Advantage private 14
3309	3309	fee-for-service plan (as defined in section 15
3310	3310	1859(b)(2)) that meets the access stand-16
3311	3311	ards under subsection (d)(4), in whole or 17
3312	3312	in part, through entering into contracts or 18
3313	3313	agreements as provided for under subpara-19
3314	3314	graph (B) of such subsection.’’. 20
3315	3315	(b) A
3316	3316	CCOUNTABILITY FOR PROVIDERDIRECTORY 21
3317	3317	A
3318	3318	CCURACY.— 22
3319	3319	(1) C
3320	3320	OST SHARING FOR SERVICES FURNISHED 23
3321	3321	BASED ON RELIANCE ON INCORRECT PROVIDER DI -24
3322	3322	RECTORY INFORMATION .—Section 1852(d) of the 25
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3324	3324	TKELLEY on LAP7H3WLY3PROD with BILLS 111
3325	3325	•S 891 IS
3326	3326	Social Security Act (42 U.S.C. 1395w–22(d)) is 1
3327	3327	amended— 2
3328	3328	(A) in paragraph (1)(C)— 3
3329	3329	(i) in clause (ii), by striking ‘‘or’’ at 4
3330	3330	the end; 5
3331	3331	(ii) in clause (iii), by striking the 6
3332	3332	semicolon at the end and inserting ‘‘, or’’; 7
3333	3333	and 8
3334	3334	(iii) by adding at the end the fol-9
3335	3335	lowing new clause: 10
3336	3336	‘‘(iv) the services are furnished by a 11
3337	3337	provider that is not participating in the 12
3338	3338	network of a specified MA plan (as defined 13
3339	3339	in subsection (c)(3)(C)) but is listed in the 14
3340	3340	provider directory of such plan on the date 15
3341	3341	on which the appointment is made, as de-16
3342	3342	scribed in paragraph (7)(A);’’; and 17
3343	3343	(B) by adding at the end the following new 18
3344	3344	paragraph: 19
3345	3345	‘‘(7) C
3346	3346	OST SHARING FOR SERVICES FURNISHED 20
3347	3347	BASED ON RELIANCE ON INCORRECT PROVIDER DI -21
3348	3348	RECTORY INFORMATION .— 22
3349	3349	‘‘(A) I
3350	3350	N GENERAL.—For plan year 2027 23
3351	3351	and subsequent plan years, if an enrollee is fur-24
3352	3352	nished an item or service by a provider that is 25
3353	3353	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00111 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
3354	3354	TKELLEY on LAP7H3WLY3PROD with BILLS 112
3355	3355	•S 891 IS
3356	3356	not participating in the network of a specified 1
3357	3357	MA plan (as defined in subsection (c)(3)(C)) 2
3358	3358	but is listed in the provider directory of such 3
3359	3359	plan (as required to be provided to an enrollee 4
3360	3360	pursuant to subsection (c)(1)(C)) on the date 5
3361	3361	on which the appointment is made, and if such 6
3362	3362	item or service would otherwise be covered 7
3363	3363	under such plan if furnished by a provider that 8
3364	3364	is participating in the network of such plan, the 9
3365	3365	MA organization offering such plan shall ensure 10
3366	3366	that the enrollee is only responsible for the less-11
3367	3367	er of— 12
3368	3368	‘‘(i) the amount of cost sharing that 13
3369	3369	would apply if such provider had been par-14
3370	3370	ticipating in the network of such plan; or 15
3371	3371	‘‘(ii) the amount of cost sharing that 16
3372	3372	would otherwise apply (without regard to 17
3373	3373	this subparagraph). 18
3374	3374	‘‘(B) N
3375	3375	OTIFICATION REQUIREMENT .—For 19
3376	3376	plan year 2027 and subsequent plan years, each 20
3377	3377	MA organization that offers a specified MA 21
3378	3378	plan shall— 22
3379	3379	‘‘(i) notify enrollees of their cost-shar-23
3380	3380	ing protections under this paragraph and 24
3381	3381	make such notifications, to the extent 25
3382	3382	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00112 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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3384	3384	•S 891 IS
3385	3385	practicable, by not later than the first day 1
3386	3386	of an annual, coordinated election period 2
3387	3387	under section 1851(e)(3) with respect to a 3
3388	3388	year; 4
3389	3389	‘‘(ii) include information regarding 5
3390	3390	such cost-sharing protections in the pro-6
3391	3391	vider directory of each specified MA plan 7
3392	3392	offered by the MA organization.; and 8
3393	3393	‘‘(iii) notify enrollees of their cost- 9
3394	3394	sharing protections under this paragraph 10
3395	3395	in an explanation of benefits.’’. 11
3396	3396	(2) R
3397	3397	EQUIRED PROVIDER DIRECTORY ACCU -12
3398	3398	RACY ANALYSIS AND REPORTS .— 13
3399	3399	(A) I
3400	3400	N GENERAL.—Section 1857(e) of the 14
3401	3401	Social Security Act (42 U.S.C. 1395w–27(e)) is 15
3402	3402	amended by adding at the end the following 16
3403	3403	new paragraph: 17
3404	3404	‘‘(6) P
3405	3405	ROVIDER DIRECTORY ACCURACY ANAL -18
3406	3406	YSIS AND REPORTS.— 19
3407	3407	‘‘(A) I
3408	3408	N GENERAL.—Beginning with plan 20
3409	3409	years beginning on or after January 1, 2027, 21
3410	3410	subject to subparagraph (C), a contract under 22
3411	3411	this section with an MA organization shall re-23
3412	3412	quire the organization, for each specified MA 24
3413	3413	plan (as defined in section 1852(c)(3)(C)) of-25
3414	3414	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00113 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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3416	3416	•S 891 IS
3417	3417	fered by the organization to annually do the fol-1
3418	3418	lowing: 2
3419	3419	‘‘(i) Conduct an analysis estimating 3
3420	3420	the accuracy of the provider directory in-4
3421	3421	formation of such plan using a random 5
3422	3422	sample of providers included in such pro-6
3423	3423	vider directory as follows: 7
3424	3424	‘‘(I) Such a random sample shall 8
3425	3425	include a random sample of each spe-9
3426	3426	cialty of providers with a high inaccu-10
3427	3427	racy rate of provider directory infor-11
3428	3428	mation relative to other specialties of 12
3429	3429	providers, as determined by the Sec-13
3430	3430	retary. 14
3431	3431	‘‘(II) For purposes of subclause 15
3432	3432	(I), one type of specialty may be pro-16
3433	3433	viders specializing in mental health or 17
3434	3434	substance use disorder treatment. 18
3435	3435	‘‘(ii) Submit to the Secretary a report 19
3436	3436	containing the results of the analysis con-20
3437	3437	ducted under clause (i), including an accu-21
3438	3438	racy score for such provider directory in-22
3439	3439	formation (as determined using a plan 23
3440	3440	verification method specified by the Sec-24
3441	3441	retary under subparagraph (B)(i)). 25
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3444	3444	•S 891 IS
3445	3445	‘‘(B) DETERMINATION OF ACCURACY 1
3446	3446	SCORE.— 2
3447	3447	‘‘(i) I
3448	3448	N GENERAL.—The Secretary 3
3449	3449	shall specify plan verification methods, 4
3450	3450	such as using telephonic verification or 5
3451	3451	other approaches using data sources main-6
3452	3452	tained by an MA organization or using 7
3453	3453	publicly available data sets, that MA orga-8
3454	3454	nizations may use for estimating accuracy 9
3455	3455	scores of the provider directory information 10
3456	3456	of specified MA plans offered by such or-11
3457	3457	ganizations. 12
3458	3458	‘‘(ii) A
3459	3459	CCURACY SCORE METHOD -13
3460	3460	OLOGY.—With respect to each such meth-14
3461	3461	od specified by the Secretary as described 15
3462	3462	in clause (i), the Secretary shall specify a 16
3463	3463	methodology for MA organizations to use 17
3464	3464	in estimating such accuracy scores. Each 18
3465	3465	such methodology shall take into account 19
3466	3466	the administrative burden on plans and 20
3467	3467	providers and the relative importance of 21
3468	3468	certain provider directory information on 22
3469	3469	enrollee ability to access care. 23
3470	3470	‘‘(C) E
3471	3471	XCEPTION.—The Secretary may 24
3472	3472	waive the requirements of this paragraph in the 25
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3475	3475	•S 891 IS
3476	3476	case of a specified MA plan with low enrollment 1
3477	3477	(as defined by the Secretary). 2
3478	3478	‘‘(D) T
3479	3479	RANSPARENCY.—Beginning with 3
3480	3480	plan years beginning on or after January 1, 4
3481	3481	2028, the Secretary shall post accuracy scores 5
3482	3482	(as reported under subparagraph (A)(ii)), in a 6
3483	3483	machine readable file, on the internet website of 7
3484	3484	the Centers for Medicare & Medicaid Services.’’. 8
3485	3485	(B) P
3486	3486	ROVISION OF INFORMATION TO 9
3487	3487	BENEFICIARIES.—Section 1851(d)(4) of the So-10
3488	3488	cial Security Act (42 U.S.C. 1395w–21(d)(4)) 11
3489	3489	is amended by adding at the end the following 12
3490	3490	new subparagraph: 13
3491	3491	‘‘(F) P
3492	3492	ROVIDER DIRECTORY .—Beginning 14
3493	3493	with plan years beginning on or after January 15
3494	3494	1, 2028, the accuracy score of the plan’s pro-16
3495	3495	vider directory (as reported under section 17
3496	3496	1857(e)(6)(A)(ii)) listed prominently on the 18
3497	3497	plan’s provider directory.’’. 19
3498	3498	(C) F
3499	3499	UNDING.—In addition to amounts 20
3500	3500	otherwise available, there is appropriated to the 21
3501	3501	Centers for Medicare & Medicaid Services Pro-22
3502	3502	gram Management Account, out of any money 23
3503	3503	in the Treasury not otherwise appropriated, 24
3504	3504	$4,000,000 for fiscal year 2025, to remain 25
3505	3505	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00116 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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3507	3507	•S 891 IS
3508	3508	available until expended, to carry out the 1
3509	3509	amendments made by this paragraph. 2
3510	3510	(3) GAO
3511	3511	STUDY AND REPORT.— 3
3512	3512	(A) A
3513	3513	NALYSIS.—The Comptroller General 4
3514	3514	of the United States (in this paragraph referred 5
3515	3515	to as the ‘‘Comptroller General’’) shall conduct 6
3516	3516	a study of the implementation of the amend-7
3517	3517	ments made by paragraphs (1) and (2). To the 8
3518	3518	extent data are available and reliable, such 9
3519	3519	study shall include an analysis of— 10
3520	3520	(i) the use of cost-sharing protections 11
3521	3521	required under section 1852(d)(7)(A) of 12
3522	3522	the Social Security Act, as added by para-13
3523	3523	graph (1); 14
3524	3524	(ii) the trends in provider directory in-15
3525	3525	formation accuracy scores under section 16
3526	3526	1857(e)(6)(A)(ii) of the Social Security 17
3527	3527	Act (as added by paragraph (2)(A)), both 18
3528	3528	overall and among providers specializing in 19
3529	3529	mental health or substance use disorder 20
3530	3530	treatment; 21
3531	3531	(iii) provider response rates by plan 22
3532	3532	verification methods; 23
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3535	3535	•S 891 IS
3536	3536	(iv) administrative costs to providers 1
3537	3537	and Medicare Advantage organizations; 2
3538	3538	and 3
3539	3539	(v) other items determined appro-4
3540	3540	priate by the Comptroller General. 5
3541	3541	(B) R
3542	3542	EPORT.—Not later than January 15, 6
3543	3543	2032, the Comptroller General shall submit to 7
3544	3544	Congress a report containing the results of the 8
3545	3545	study conducted under subparagraph (A), to-9
3546	3546	gether with recommendations for such legisla-10
3547	3547	tion and administrative action as the Comp-11
3548	3548	troller General determines appropriate. 12
3549	3549	(c) G
3550	3550	UIDANCE ON MAINTAININGACCURATEPRO-13
3551	3551	VIDERDIRECTORIES.— 14
3552	3552	(1) S
3553	3553	TAKEHOLDER MEETING .— 15
3554	3554	(A) I
3555	3555	N GENERAL.—Not later than 3 16
3556	3556	months after the date of enactment of this Act, 17
3557	3557	the Secretary of Health and Human Services 18
3558	3558	(referred to in this subsection as the ‘‘Sec-19
3559	3559	retary’’) shall hold a public meeting to receive 20
3560	3560	input on approaches for maintaining accurate 21
3561	3561	provider directories for Medicare Advantage 22
3562	3562	plans under part C of title XVIII of the Social 23
3563	3563	Security Act (42 U.S.C. 1395w–21 et seq.), in-24
3564	3564	cluding input on approaches for reducing ad-25
3565	3565	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00118 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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3567	3567	•S 891 IS
3568	3568	ministrative burden, such as data standardiza-1
3569	3569	tion, and best practices to maintain accurate 2
3570	3570	provider directory information. 3
3571	3571	(B) P
3572	3572	ARTICIPANTS.—Participants of the 4
3573	3573	meeting under subparagraph (A) shall include 5
3574	3574	representatives from the Centers for Medicare & 6
3575	3575	Medicaid Services and the Assistant Secretary 7
3576	3576	for Technology Policy and Office of the Na-8
3577	3577	tional Coordinator for Health Information 9
3578	3578	Technology. Such meeting shall be open to the 10
3579	3579	public. To the extent practicable, the Secretary 11
3580	3580	shall include health care providers, companies 12
3581	3581	that specialize in relevant technologies, health 13
3582	3582	insurers, and patient advocates. 14
3583	3583	(2) G
3584	3584	UIDANCE TO MEDICARE ADVANTAGE OR -15
3585	3585	GANIZATIONS.—Not later than 12 months after the 16
3586	3586	date of enactment of this Act, the Secretary shall 17
3587	3587	issue guidance to Medicare Advantage organizations 18
3588	3588	offering Medicare Advantage plans under part C of 19
3589	3589	title XVIII of the Social Security Act (42 U.S.C. 20
3590	3590	1395w–21 et seq.) on maintaining accurate provider 21
3591	3591	directories for such plans, taking into consideration 22
3592	3592	input received during the stakeholder meeting under 23
3593	3593	paragraph (1). Such guidance may include the fol-24
3594	3594	lowing, as determined appropriate by the Secretary: 25
3595	3595	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00119 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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3597	3597	•S 891 IS
3598	3598	(A) Best practices for Medicare Advantage 1
3599	3599	organizations on how to work with providers to 2
3600	3600	maintain the accuracy of provider directories 3
3601	3601	and reduce provider and Medicare Advantage 4
3602	3602	organization burden with respect to maintaining 5
3603	3603	the accuracy of provider directories. 6
3604	3604	(B) Information on data sets and data 7
3605	3605	sources with information that could be used by 8
3606	3606	Medicare Advantage organizations to maintain 9
3607	3607	accurate provider directories. 10
3608	3608	(C) Approaches for utilizing data sources 11
3609	3609	maintained by Medicare Advantage organiza-12
3610	3610	tions and publicly available data sets to main-13
3611	3611	tain accurate provider directories. 14
3612	3612	(D) Information to be included in provider 15
3613	3613	directories that may be useful for Medicare 16
3614	3614	beneficiaries to assess plan networks when se-17
3615	3615	lecting a plan and accessing providers partici-18
3616	3616	pating in plan networks during the plan year. 19
3617	3617	(3) G
3618	3618	UIDANCE TO PART B PROVIDERS .—Not 20
3619	3619	later than 12 months after the date of enactment of 21
3620	3620	this Act, the Secretary shall issue guidance to pro-22
3621	3621	viders of services and suppliers who furnish items or 23
3622	3622	services for which benefits are available under part 24
3623	3623	B of title XVIII of the Social Security Act (42 25
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3626	3626	•S 891 IS
3627	3627	U.S.C. 1395j et seq.) on when to update the Na-1
3628	3628	tional Plan and Provider Enumeration System for 2
3629	3629	information changes. 3
3630	3630	SEC. 224. MEDICARE COVERAGE OF MULTI-CANCER EARLY 4
3631	3631	DETECTION SCREENING TESTS. 5
3632	3632	(a) C
3633	3633	OVERAGE.—Section 1861 of the Social Security 6
3634	3634	Act (42 U.S.C. 1395x) is amended— 7
3635	3635	(1) in subsection (s)(2)— 8
3636	3636	(A) by striking the semicolon at the end of 9
3637	3637	subparagraph (JJ) and inserting ‘‘; and’’; and 10
3638	3638	(B) by adding at the end the following new 11
3639	3639	subparagraph: 12
3640	3640	‘‘(KK) multi-cancer early detection screen-13
3641	3641	ing tests (as defined in subsection (nnn));’’; and 14
3642	3642	(2) by adding at the end the following new sub-15
3643	3643	section: 16
3644	3644	‘‘(nnn) M
3645	3645	ULTI-CANCEREARLYDETECTIONSCREEN-17
3646	3646	INGTESTS.— 18
3647	3647	‘‘(1) I
3648	3648	N GENERAL.—The term ‘multi-cancer 19
3649	3649	early detection screening test’ means a test fur-20
3650	3650	nished to an individual for the concurrent detection 21
3651	3651	of multiple cancer types across multiple organ sites 22
3652	3652	on or after January 1, 2029, that— 23
3653	3653	‘‘(A) is cleared under section 510(k), clas-24
3654	3654	sified under section 513(f)(2), or approved 25
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3657	3657	•S 891 IS
3658	3658	under section 515 of the Federal Food, Drug, 1
3659	3659	and Cosmetic Act; 2
3660	3660	‘‘(B) is— 3
3661	3661	‘‘(i) a genomic sequencing blood or 4
3662	3662	blood product test that includes the anal-5
3663	3663	ysis of cell-free nucleic acids; or 6
3664	3664	‘‘(ii) a test based on samples of bio-7
3665	3665	logical material that provide results com-8
3666	3666	parable to those obtained with a test de-9
3667	3667	scribed in clause (i), as determined by the 10
3668	3668	Secretary; and 11
3669	3669	‘‘(C) the Secretary determines is— 12
3670	3670	‘‘(i) reasonable and necessary for the 13
3671	3671	prevention or early detection of an illness 14
3672	3672	or disability; and 15
3673	3673	‘‘(ii) appropriate for individuals enti-16
3674	3674	tled to benefits under part A or enrolled 17
3675	3675	under part B. 18
3676	3676	‘‘(2) NCD
3677	3677	PROCESS.—In making determina-19
3678	3678	tions under paragraph (1)(C) regarding the coverage 20
3679	3679	of a new test, the Secretary shall use the process for 21
3680	3680	making national coverage determinations (as defined 22
3681	3681	in section 1869(f)(1)(B)) under this title.’’. 23
3682	3682	(b) P
3683	3683	AYMENT ANDSTANDARDS FOR MULTI-CANCER 24
3684	3684	E
3685	3685	ARLYDETECTIONSCREENINGTESTS.— 25
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3688	3688	•S 891 IS
3689	3689	(1) IN GENERAL.—Section 1834 of the Social 1
3690	3690	Security Act (42 U.S.C. 1395m) is amended by add-2
3691	3691	ing at the end the following new subsection: 3
3692	3692	‘‘(aa) P
3693	3693	AYMENT AND STANDARDS FOR MULTI-CAN-4
3694	3694	CEREARLYDETECTIONSCREENINGTESTS.— 5
3695	3695	‘‘(1) P
3696	3696	AYMENT AMOUNT .—The payment 6
3697	3697	amount for a multi-cancer early detection screening 7
3698	3698	test (as defined in section 1861(nnn)) is— 8
3699	3699	‘‘(A) with respect to such a test furnished 9
3700	3700	before January 1, 2031, equal to the payment 10
3701	3701	amount in effect on the date of the enactment 11
3702	3702	of this subsection for a multi-target stool 12
3703	3703	screening DNA test covered pursuant to section 13
3704	3704	1861(pp)(1)(D); and 14
3705	3705	‘‘(B) with respect to such a test furnished 15
3706	3706	on or after January 1, 2031, equal to the lesser 16
3707	3707	of— 17
3708	3708	‘‘(i) the amount described in subpara-18
3709	3709	graph (A); or 19
3710	3710	‘‘(ii) the payment amount determined 20
3711	3711	for such test under section 1834A. 21
3712	3712	‘‘(2) L
3713	3713	IMITATIONS.— 22
3714	3714	‘‘(A) I
3715	3715	N GENERAL.—No payment may be 23
3716	3716	made under this part for a multi-cancer early 24
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3719	3719	•S 891 IS
3720	3720	detection screening test furnished during a year 1
3721	3721	to an individual if— 2
3722	3722	‘‘(i) such individual— 3
3723	3723	‘‘(I) is under 50 years of age; or 4
3724	3724	‘‘(II) as of January 1 of such 5
3725	3725	year, has attained the age specified in 6
3726	3726	subparagraph (B) for such year; or 7
3727	3727	‘‘(ii) such a test was furnished to the 8
3728	3728	individual during the previous 11 months. 9
3729	3729	‘‘(B) A
3730	3730	GE SPECIFIED.—For purposes of 10
3731	3731	subparagraph (A)(i)(II), the age specified in 11
3732	3732	this subparagraph is— 12
3733	3733	‘‘(i) for 2029, 65 years of age; and 13
3734	3734	‘‘(ii) for a succeeding year, the age 14
3735	3735	specified in this subparagraph for the pre-15
3736	3736	ceding year, increased by 1 year. 16
3737	3737	‘‘(C) S
3738	3738	TANDARDS FOLLOWING USPSTF 17
3739	3739	RATING OF A OR B.—In the case of a multi-can-18
3740	3740	cer early detection screening test that is rec-19
3741	3741	ommended with a grade of A or B by the 20
3742	3742	United States Preventive Services Task Force, 21
3743	3743	beginning on the date on which coverage for 22
3744	3744	such test is provided pursuant to section 23
3745	3745	1861(ddd)(1), the preceding provisions of this 24
3746	3746	paragraph shall not apply.’’. 25
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3750	3750	(2) CONFORMING AMENDMENTS .— 1
3751	3751	(A) Section 1833 of the Social Security 2
3752	3752	Act (42 U.S.C. 1395l) is amended— 3
3753	3753	(i) in subsection (a)— 4
3754	3754	(I) in paragraph (1)(D)(i)(I), by 5
3755	3755	striking ‘‘section 1834(d)(1)’’ and in-6
3756	3756	serting ‘‘subsection (d)(1) or (aa) of 7
3757	3757	section 1834’’; and 8
3758	3758	(II) in paragraph (2)(D)(i)(I), by 9
3759	3759	striking ‘‘section 1834(d)(1)’’ and in-10
3760	3760	serting ‘‘subsection (d)(1) or (aa) of 11
3761	3761	section 1834’’; and 12
3762	3762	(ii) in subsection (h)(1)(A), by strik-13
3763	3763	ing ‘‘section 1834(d)(1)’’ and inserting 14
3764	3764	‘‘subsections (d)(1) and (aa) of section 15
3765	3765	1834’’. 16
3766	3766	(B) Section 1862(a)(1)(A) of the Social 17
3767	3767	Security Act (42 U.S.C. 1395y(a)(1)(A)) is 18
3768	3768	amended— 19
3769	3769	(i) by striking ‘‘or additional preven-20
3770	3770	tive services’’ and inserting ‘‘, additional 21
3771	3771	preventive services’’; and 22
3772	3772	(ii) by inserting ‘‘, or multi-cancer 23
3773	3773	early detection screening tests (as defined 24
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3776	3776	•S 891 IS
3777	3777	in section 1861(nnn))’’ after ‘‘(as de-1
3778	3778	scribed in section 1861(ddd)(1))’’. 2
3779	3779	(c) R
3780	3780	ULE OFCONSTRUCTIONRELATING TOOTHER 3
3781	3781	C
3782	3782	ANCERSCREENINGTESTS.—Nothing in this section, in-4
3783	3783	cluding the amendments made by this section, shall be 5
3784	3784	construed— 6
3785	3785	(1) in the case of an individual who undergoes 7
3786	3786	a multi-cancer early detection screening test, to af-8
3787	3787	fect coverage under part B of title XVIII of the So-9
3788	3788	cial Security Act for other cancer screening tests 10
3789	3789	covered under such title, such as screening tests for 11
3790	3790	breast, cervical, colorectal, lung, or prostate cancer; 12
3791	3791	or 13
3792	3792	(2) in the case of an individual who undergoes 14
3793	3793	another cancer screening test, to affect coverage 15
3794	3794	under such part for a multi-cancer early detection 16
3795	3795	screening test or the use of such a test as a diag-17
3796	3796	nostic or confirmatory test for a result of the other 18
3797	3797	cancer screening test. 19
3798	3798	SEC. 225. MEDICARE COVERAGE OF EXTERNAL INFUSION 20
3799	3799	PUMPS AND NON-SELF-ADMINISTRABLE 21
3800	3800	HOME INFUSION DRUGS. 22
3801	3801	(a) I
3802	3802	NGENERAL.—Section 1861(n) of the Social Se-23
3803	3803	curity Act (42 U.S.C. 1395x(n)) is amended by adding 24
3804	3804	at the end the following new sentence: ‘‘Beginning with 25
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3807	3807	•S 891 IS
3808	3808	the first calendar quarter beginning on or after the date 1
3809	3809	that is 1 year after the date of the enactment of this sen-2
3810	3810	tence, an external infusion pump and associated home in-3
3811	3811	fusion drug (as defined in subsection (iii)(3)(C)) or other 4
3812	3812	associated supplies that do not meet the appropriate for 5
3813	3813	use in the home requirement applied to the definition of 6
3814	3814	durable medical equipment under section 414.202 of title 7
3815	3815	42, Code of Federal Regulations (or any successor to such 8
3816	3816	regulation) shall be treated as meeting such requirement 9
3817	3817	if each of the following criteria is satisfied: 10
3818	3818	‘‘(1) The prescribing information approved by 11
3819	3819	the Food and Drug Administration for the home in-12
3820	3820	fusion drug associated with the pump instructs that 13
3821	3821	the drug should be administered by or under the su-14
3822	3822	pervision of a health care professional. 15
3823	3823	‘‘(2) A qualified home infusion therapy supplier 16
3824	3824	(as defined in subsection (iii)(3)(D)) administers or 17
3825	3825	supervises the administration of the drug or biologi-18
3826	3826	cal in a safe and effective manner in the patient’s 19
3827	3827	home (as defined in subsection (iii)(3)(B)). 20
3828	3828	‘‘(3) The prescribing information described in 21
3829	3829	paragraph (1) instructs that the drug should be in-22
3830	3830	fused at least 12 times per year— 23
3831	3831	‘‘(A) intravenously or subcutaneously; or 24
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3834	3834	•S 891 IS
3835	3835	‘‘(B) at infusion rates that the Secretary 1
3836	3836	determines would require the use of an external 2
3837	3837	infusion pump.’’. 3
3838	3838	(b) C
3839	3839	OSTSHARINGNOTIFICATION.—The Secretary 4
3840	3840	of Health and Human Services shall ensure that patients 5
3841	3841	are notified of the cost sharing for electing home infusion 6
3842	3842	therapy compared to other applicable settings of care for 7
3843	3843	the furnishing of infusion drugs under the Medicare pro-8
3844	3844	gram. 9
3845	3845	SEC. 226. ASSURING PHARMACY ACCESS AND CHOICE FOR 10
3846	3846	MEDICARE BENEFICIARIES. 11
3847	3847	(a) I
3848	3848	NGENERAL.—Section 1860D–4(b)(1) of the So-12
3849	3849	cial Security Act (42 U.S.C. 1395w–104(b)(1)) is amend-13
3850	3850	ed by striking subparagraph (A) and inserting the fol-14
3851	3851	lowing: 15
3852	3852	‘‘(A) I
3853	3853	N GENERAL.— 16
3854	3854	‘‘(i) P
3855	3855	ARTICIPATION OF ANY WILLING 17
3856	3856	PHARMACY.—A PDP sponsor offering a 18
3857	3857	prescription drug plan shall permit any 19
3858	3858	pharmacy that meets the standard contract 20
3859	3859	terms and conditions under such plan to 21
3860	3860	participate as a network pharmacy of such 22
3861	3861	plan. 23
3862	3862	‘‘(ii) C
3863	3863	ONTRACT TERMS AND CONDI -24
3864	3864	TIONS.— 25
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3867	3867	•S 891 IS
3868	3868	‘‘(I) IN GENERAL .—Notwith-1
3869	3869	standing any other provision of law, 2
3870	3870	for plan years beginning on or after 3
3871	3871	January 1, 2028, in accordance with 4
3872	3872	clause (i), contract terms and condi-5
3873	3873	tions offered by such PDP sponsor 6
3874	3874	shall be reasonable and relevant ac-7
3875	3875	cording to standards established by 8
3876	3876	the Secretary under subclause (II). 9
3877	3877	‘‘(II) S
3878	3878	TANDARDS.—Not later 10
3879	3879	than the first Monday in April of 11
3880	3880	2027, the Secretary shall establish 12
3881	3881	standards for reasonable and relevant 13
3882	3882	contract terms and conditions for pur-14
3883	3883	poses of this clause. 15
3884	3884	‘‘(III) R
3885	3885	EQUEST FOR INFORMA -16
3886	3886	TION.—Not later than April 1, 2026, 17
3887	3887	for purposes of establishing the stand-18
3888	3888	ards under subclause (II), the Sec-19
3889	3889	retary shall issue a request for infor-20
3890	3890	mation to seek input on trends in pre-21
3891	3891	scription drug plan and network phar-22
3892	3892	macy contract terms and conditions, 23
3893	3893	current prescription drug plan and 24
3894	3894	network pharmacy contracting prac-25
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3897	3897	•S 891 IS
3898	3898	tices, whether pharmacy reimburse-1
3899	3899	ment and dispensing fees paid by 2
3900	3900	PDP sponsors to network pharmacies 3
3901	3901	sufficiently cover the ingredient and 4
3902	3902	operational costs of such pharmacies, 5
3903	3903	the use and application of pharmacy 6
3904	3904	quality measures by PDP sponsors for 7
3905	3905	network pharmacies, PDP sponsor re-8
3906	3906	strictions or limitations on the dis-9
3907	3907	pensing of covered part D drugs by 10
3908	3908	network pharmacies (or any subsets of 11
3909	3909	such pharmacies), PDP sponsor au-12
3910	3910	diting practices for network phar-13
3911	3911	macies, areas in current regulations or 14
3912	3912	program guidance related to con-15
3913	3913	tracting between prescription drug 16
3914	3914	plans and network pharmacies requir-17
3915	3915	ing clarification or additional speci-18
3916	3916	ficity, factors for consideration in de-19
3917	3917	termining the reasonableness and rel-20
3918	3918	evance of contract terms and condi-21
3919	3919	tions between prescription drug plans 22
3920	3920	and network pharmacies, and other 23
3921	3921	issues as determined appropriate by 24
3922	3922	the Secretary.’’. 25
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3924	3924	TKELLEY on LAP7H3WLY3PROD with BILLS 131
3925	3925	•S 891 IS
3926	3926	(b) ESSENTIALRETAILPHARMACIES.—Section 1
3927	3927	1860D–42 of the Social Security Act (42 U.S.C. 1395w– 2
3928	3928	152) is amended by adding at the end the following new 3
3929	3929	subsection: 4
3930	3930	‘‘(e) E
3931	3931	SSENTIALRETAILPHARMACIES.— 5
3932	3932	‘‘(1) I
3933	3933	N GENERAL.—With respect to plan years 6
3934	3934	beginning on or after January 1, 2028, the Sec-7
3935	3935	retary shall publish reports, at least once every 2 8
3936	3936	years until 2034, and periodically thereafter, that 9
3937	3937	provide information, to the extent feasible, on— 10
3938	3938	‘‘(A) trends in ingredient cost reimburse-11
3939	3939	ment, dispensing fees, incentive payments and 12
3940	3940	other fees paid by PDP sponsors offering pre-13
3941	3941	scription drug plans and MA organizations of-14
3942	3942	fering MA–PD plans under this part to essen-15
3943	3943	tial retail pharmacies (as defined in paragraph 16
3944	3944	(2)) with respect to the dispensing of covered 17
3945	3945	part D drugs, including a comparison of such 18
3946	3946	trends between essential retail pharmacies and 19
3947	3947	pharmacies that are not essential retail phar-20
3948	3948	macies; 21
3949	3949	‘‘(B) trends in amounts paid to PDP spon-22
3950	3950	sors offering prescription drug plans and MA 23
3951	3951	organizations offering MA–PD plans under this 24
3952	3952	part by essential retail pharmacies with respect 25
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3955	3955	•S 891 IS
3956	3956	to the dispensing of covered part D drugs, in-1
3957	3957	cluding a comparison of such trends between 2
3958	3958	essential retail pharmacies and pharmacies that 3
3959	3959	are not essential retail pharmacies; 4
3960	3960	‘‘(C) trends in essential retail pharmacy 5
3961	3961	participation in pharmacy networks and pre-6
3962	3962	ferred pharmacy networks for prescription drug 7
3963	3963	plans offered by PDP sponsors and MA–PD 8
3964	3964	plans offered by MA organizations under this 9
3965	3965	part, including a comparison of such trends be-10
3966	3966	tween essential retail pharmacies and phar-11
3967	3967	macies that are not essential retail pharmacies; 12
3968	3968	‘‘(D) trends in the number of essential re-13
3969	3969	tail pharmacies, including variation in such 14
3970	3970	trends by geographic region or other factors; 15
3971	3971	‘‘(E) a comparison of cost-sharing for cov-16
3972	3972	ered part D drugs dispensed by essential retail 17
3973	3973	pharmacies that are network pharmacies for 18
3974	3974	prescription drug plans offered by PDP spon-19
3975	3975	sors and MA–PD plans offered by MA organi-20
3976	3976	zations under this part and cost-sharing for 21
3977	3977	covered part D drugs dispensed by other net-22
3978	3978	work pharmacies for such plans located in simi-23
3979	3979	lar geographic areas that are not essential retail 24
3980	3980	pharmacies; 25
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3983	3983	•S 891 IS
3984	3984	‘‘(F) a comparison of the volume of cov-1
3985	3985	ered part D drugs dispensed by essential retail 2
3986	3986	pharmacies that are network pharmacies for 3
3987	3987	prescription drug plans offered by PDP spon-4
3988	3988	sors and MA–PD plans offered by MA organi-5
3989	3989	zations under this part and such volume of dis-6
3990	3990	pensing by network pharmacies for such plans 7
3991	3991	located in similar geographic areas that are not 8
3992	3992	essential retail pharmacies, including informa-9
3993	3993	tion on any patterns or trends in such compari-10
3994	3994	son specific to certain types of covered part D 11
3995	3995	drugs, such as generic drugs or drugs specified 12
3996	3996	as specialty drugs by a PDP sponsor under a 13
3997	3997	prescription drug plan or an MA organization 14
3998	3998	under an MA–PD plan; and 15
3999	3999	‘‘(G) a comparison of the information de-16
4000	4000	scribed in subparagraphs (A) through (F) be-17
4001	4001	tween essential retail pharmacies that are net-18
4002	4002	work pharmacies for prescription drug plans of-19
4003	4003	fered by PDP sponsors under this part and es-20
4004	4004	sential retail pharmacies that are network phar-21
4005	4005	macies for MA–PD plans offered by MA organi-22
4006	4006	zations under this part. 23
4007	4007	‘‘(2) D
4008	4008	EFINITION OF ESSENTIAL RETAIL PHAR -24
4009	4009	MACY.—In this subsection, the term ‘essential retail 25
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4012	4012	•S 891 IS
4013	4013	pharmacy’ means, with respect to a plan year, a re-1
4014	4014	tail pharmacy that— 2
4015	4015	‘‘(A) is not a pharmacy that is an affiliate 3
4016	4016	as defined in paragraph (4); and 4
4017	4017	‘‘(B) is located in— 5
4018	4018	‘‘(i) a medically underserved area (as 6
4019	4019	designated pursuant to section 7
4020	4020	330(b)(3)(A) of the Public Health Service 8
4021	4021	Act); 9
4022	4022	‘‘(ii) a rural area in which there is no 10
4023	4023	other retail pharmacy within 10 miles, as 11
4024	4024	determined by the Secretary; 12
4025	4025	‘‘(iii) a suburban area in which there 13
4026	4026	is no other retail pharmacy within 2 miles, 14
4027	4027	as determined by the Secretary; or 15
4028	4028	‘‘(iv) an urban area in which there is 16
4029	4029	no other retail pharmacy within 1 mile, as 17
4030	4030	determined by the Secretary. 18
4031	4031	‘‘(3) L
4032	4032	IST OF ESSENTIAL RETAIL PHAR -19
4033	4033	MACIES.— 20
4034	4034	‘‘(A) P
4035	4035	UBLICATION OF LIST OF ESSENTIAL 21
4036	4036	RETAIL PHARMACIES.—For each plan year (be-22
4037	4037	ginning with plan year 2028), the Secretary 23
4038	4038	shall publish, on a publicly available internet 24
4039	4039	website of the Centers for Medicare & Medicaid 25
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4041	4041	TKELLEY on LAP7H3WLY3PROD with BILLS 135
4042	4042	•S 891 IS
4043	4043	Services, a list of pharmacies that meet the cri-1
4044	4044	teria described in subparagraphs (A) and (B) of 2
4045	4045	paragraph (2) to be considered an essential re-3
4046	4046	tail pharmacy. 4
4047	4047	‘‘(B) R
4048	4048	EQUIRED SUBMISSIONS FROM PDP 5
4049	4049	SPONSORS.—For each plan year (beginning 6
4050	4050	with plan year 2028), each PDP sponsor offer-7
4051	4051	ing a prescription drug plan and each MA orga-8
4052	4052	nization offering an MA–PD plan shall submit 9
4053	4053	to the Secretary, for the purposes of deter-10
4054	4054	mining retail pharmacies that meet the criterion 11
4055	4055	specified in subparagraph (A) of paragraph (2), 12
4056	4056	a list of retail pharmacies that are affiliates of 13
4057	4057	such sponsor or organization, or are affiliates of 14
4058	4058	a pharmacy benefit manager acting on behalf of 15
4059	4059	such sponsor or organization, at a time, and in 16
4060	4060	a form and manner, specified by the Secretary. 17
4061	4061	‘‘(C) R
4062	4062	EPORTING BY PDP SPONSORS AND 18
4063	4063	MA ORGANIZATIONS.—For each plan year be-19
4064	4064	ginning with plan year 2027, each PDP sponsor 20
4065	4065	offering a prescription drug plan and each MA 21
4066	4066	organization offering an MA–PD plan under 22
4067	4067	this part shall submit to the Secretary informa-23
4068	4068	tion on incentive payments and other fees paid 24
4069	4069	by such sponsor or organization to pharmacies, 25
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4072	4072	•S 891 IS
4073	4073	insofar as any such payments or fees are not 1
4074	4074	otherwise reported, at a time, and in a form 2
4075	4075	and manner, specified by the Secretary. 3
4076	4076	‘‘(D) I
4077	4077	MPLEMENTATION.—Notwithstanding 4
4078	4078	any other provision of law, the Secretary may 5
4079	4079	implement this paragraph by program instruc-6
4080	4080	tion or otherwise. 7
4081	4081	‘‘(E) N
4082	4082	ONAPPLICATION OF PAPERWORK 8
4083	4083	REDUCTION ACT .—Chapter 35 of title 44, 9
4084	4084	United States Code, shall not apply to the im-10
4085	4085	plementation of this paragraph. 11
4086	4086	‘‘(4) D
4087	4087	EFINITION OF AFFILIATE ; PHARMACY 12
4088	4088	BENEFIT MANAGER .—In this subsection, the terms 13
4089	4089	‘affiliate’ and ‘pharmacy benefit manager’ have the 14
4090	4090	meaning given those terms in section 1860D– 15
4091	4091	12(h)(7).’’. 16
4092	4092	(c) E
4093	4093	NFORCEMENT.— 17
4094	4094	(1) I
4095	4095	N GENERAL.—Section 1860D–4(b)(1) of 18
4096	4096	the Social Security Act (42 U.S.C. 1395w– 19
4097	4097	104(b)(1)) is amended by adding at the end the fol-20
4098	4098	lowing new subparagraph: 21
4099	4099	‘‘(F) E
4100	4100	NFORCEMENT OF STANDARDS FOR 22
4101	4101	REASONABLE AND RELEVANT CONTRACT TERMS 23
4102	4102	AND CONDITIONS.— 24
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4105	4105	•S 891 IS
4106	4106	‘‘(i) ALLEGATION SUBMISSION PROC -1
4107	4107	ESS.— 2
4108	4108	‘‘(I) I
4109	4109	N GENERAL.—Not later 3
4110	4110	than January 1, 2028, the Secretary 4
4111	4111	shall establish a process through 5
4112	4112	which a pharmacy may submit to the 6
4113	4113	Secretary an allegation of a violation 7
4114	4114	by a PDP sponsor offering a prescrip-8
4115	4115	tion drug plan of the standards for 9
4116	4116	reasonable and relevant contract 10
4117	4117	terms and conditions under subpara-11
4118	4118	graph (A)(ii), or of subclause (VIII) 12
4119	4119	of this clause. 13
4120	4120	‘‘(II) F
4121	4121	REQUENCY OF SUBMIS -14
4122	4122	SION.— 15
4123	4123	‘‘(aa) I
4124	4124	N GENERAL.—Except 16
4125	4125	as provided in item (bb), the alle-17
4126	4126	gation submission process under 18
4127	4127	this clause shall allow pharmacies 19
4128	4128	to submit any allegations of vio-20
4129	4129	lations described in subclause (I) 21
4130	4130	not more frequently than once 22
4131	4131	per plan year per contract be-23
4132	4132	tween a pharmacy and a PDP 24
4133	4133	sponsor. 25
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4136	4136	•S 891 IS
4137	4137	‘‘(bb) ALLEGATIONS RELAT-1
4138	4138	ING TO CONTRACT MODIFICA -2
4139	4139	TIONS.—In the case where a con-3
4140	4140	tract between a pharmacy and a 4
4141	4141	PDP sponsor is modified fol-5
4142	4142	lowing the submission of allega-6
4143	4143	tions by a pharmacy with respect 7
4144	4144	to such contract and plan year, 8
4145	4145	the allegation submission process 9
4146	4146	under this clause shall allow such 10
4147	4147	pharmacy to submit an additional 11
4148	4148	allegation related to those modi-12
4149	4149	fications with respect to such 13
4150	4150	contract and plan year. 14
4151	4151	‘‘(III) A
4152	4152	CCESS TO RELEVANT 15
4153	4153	DOCUMENTS AND MATERIALS .—A 16
4154	4154	PDP sponsor subject to an allegation 17
4155	4155	under this clause— 18
4156	4156	‘‘(aa) shall provide docu-19
4157	4157	ments or materials, as specified 20
4158	4158	by the Secretary, including con-21
4159	4159	tract offers made by such spon-22
4160	4160	sor to such pharmacy or cor-23
4161	4161	respondence related to such of-24
4162	4162	fers, to the Secretary at a time, 25
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4165	4165	•S 891 IS
4166	4166	and in a form and manner, speci-1
4167	4167	fied by the Secretary; and 2
4168	4168	‘‘(bb) shall not prohibit or 3
4169	4169	otherwise limit the ability of a 4
4170	4170	pharmacy to submit such docu-5
4171	4171	ments or materials to the Sec-6
4172	4172	retary for the purpose of submit-7
4173	4173	ting an allegation or providing 8
4174	4174	evidence for such an allegation 9
4175	4175	under this clause. 10
4176	4176	‘‘(IV) S
4177	4177	TANDARDIZED TEM -11
4178	4178	PLATE.—The Secretary shall establish 12
4179	4179	a standardized template for phar-13
4180	4180	macies to use for the submission of al-14
4181	4181	legations described in subclause (I). 15
4182	4182	Such template shall require that the 16
4183	4183	submission include a certification by 17
4184	4184	the pharmacy that the information in-18
4185	4185	cluded is accurate, complete, and true 19
4186	4186	to the best of the knowledge, informa-20
4187	4187	tion, and belief of such pharmacy. 21
4188	4188	‘‘(V) P
4189	4189	REVENTING FRIVOLOUS 22
4190	4190	ALLEGATIONS.—In the case where the 23
4191	4191	Secretary determines that a pharmacy 24
4192	4192	has submitted frivolous allegations 25
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4194	4194	TKELLEY on LAP7H3WLY3PROD with BILLS 140
4195	4195	•S 891 IS
4196	4196	under this clause on a routine basis, 1
4197	4197	the Secretary may temporarily pro-2
4198	4198	hibit such pharmacy from using the 3
4199	4199	allegation submission process under 4
4200	4200	this clause, as determined appropriate 5
4201	4201	by the Secretary. 6
4202	4202	‘‘(VI) E
4203	4203	XEMPTION FROM FREE -7
4204	4204	DOM OF INFORMATION ACT .—Allega-8
4205	4205	tions submitted under this clause shall 9
4206	4206	be exempt from disclosure under sec-10
4207	4207	tion 552 of title 5, United States 11
4208	4208	Code. 12
4209	4209	‘‘(VII) R
4210	4210	ULE OF CONSTRUC -13
4211	4211	TION.—Nothing in this clause shall be 14
4212	4212	construed as limiting the ability of a 15
4213	4213	pharmacy to pursue other legal ac-16
4214	4214	tions or remedies, consistent with ap-17
4215	4215	plicable Federal or State law, with re-18
4216	4216	spect to a potential violation of a re-19
4217	4217	quirement described in this subpara-20
4218	4218	graph. 21
4219	4219	‘‘(VIII) A
4220	4220	NTI-RETALIATION AND 22
4221	4221	ANTI-COERCION.—Consistent with ap-23
4222	4222	plicable Federal or State law, a PDP 24
4223	4223	sponsor shall not— 25
4224	4224	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00140 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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4226	4226	•S 891 IS
4227	4227	‘‘(aa) retaliate against a 1
4228	4228	pharmacy for submitting any al-2
4229	4229	legations under this clause; or 3
4230	4230	‘‘(bb) coerce, intimidate, 4
4231	4231	threaten, or interfere with the 5
4232	4232	ability of a pharmacy to submit 6
4233	4233	any such allegations. 7
4234	4234	‘‘(ii) I
4235	4235	NVESTIGATION.—The Secretary 8
4236	4236	shall investigate, as determined appro-9
4237	4237	priate by the Secretary, allegations sub-10
4238	4238	mitted pursuant to clause (i). 11
4239	4239	‘‘(iii) E
4240	4240	NFORCEMENT.— 12
4241	4241	‘‘(I) I
4242	4242	N GENERAL.—In the case 13
4243	4243	where the Secretary determines that a 14
4244	4244	PDP sponsor offering a prescription 15
4245	4245	drug plan has violated the standards 16
4246	4246	for reasonable and relevant contract 17
4247	4247	terms and conditions under subpara-18
4248	4248	graph (A)(ii), the Secretary may use 19
4249	4249	authorities under sections 1857(g) 20
4250	4250	and 1860D–12(b)(3)(E) to impose 21
4251	4251	civil monetary penalties or other inter-22
4252	4252	mediate sanctions. 23
4253	4253	‘‘(II) A
4254	4254	PPLICATION OF CIVIL 24
4255	4255	MONETARY PENALTIES .—The provi-25
4256	4256	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00141 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4257	4257	TKELLEY on LAP7H3WLY3PROD with BILLS 142
4258	4258	•S 891 IS
4259	4259	sions of section 1128A (other than 1
4260	4260	subsections (a) and (b)) shall apply to 2
4261	4261	a civil monetary penalty under this 3
4262	4262	clause in the same manner as such 4
4263	4263	provisions apply to a penalty or pro-5
4264	4264	ceeding under section 1128A(a).’’. 6
4265	4265	(2) C
4266	4266	ONFORMING AMENDMENT .—Section 7
4267	4267	1857(g)(1) of the Social Security Act (42 U.S.C. 8
4268	4268	1395w–27(g)(1)) is amended— 9
4269	4269	(A) in subparagraph (J), by striking ‘‘or’’ 10
4270	4270	after the semicolon; 11
4271	4271	(B) by redesignating subparagraph (K) as 12
4272	4272	subparagraph (L); 13
4273	4273	(C) by inserting after subparagraph (J), 14
4274	4274	the following new subparagraph: 15
4275	4275	‘‘(K) fails to comply with the standards for 16
4276	4276	reasonable and relevant contract terms and con-17
4277	4277	ditions under subparagraph (A)(ii) of section 18
4278	4278	1860D–4(b)(1); or’’; 19
4279	4279	(D) in subparagraph (L), as redesignated 20
4280	4280	by subparagraph (B), by striking ‘‘through (J)’’ 21
4281	4281	and inserting ‘‘through (K)’’; and 22
4282	4282	(E) in the flush matter following subpara-23
4283	4283	graph (L), as so redesignated, by striking ‘‘sub-24
4284	4284	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00142 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4285	4285	TKELLEY on LAP7H3WLY3PROD with BILLS 143
4286	4286	•S 891 IS
4287	4287	paragraphs (A) through (K)’’ and inserting 1
4288	4288	‘‘subparagraphs (A) through (L)’’. 2
4289	4289	(d) A
4290	4290	CCOUNTABILITY OF PHARMACYBENEFITMAN-3
4291	4291	AGERS FORVIOLATIONS OFREASONABLE ANDRELEVANT 4
4292	4292	C
4293	4293	ONTRACTTERMS ANDCONDITIONS.— 5
4294	4294	(1) I
4295	4295	N GENERAL.—Section 1860D–12(b) of the 6
4296	4296	Social Security Act (42 U.S.C. 1395w–112) is 7
4297	4297	amended by adding at the end the following new 8
4298	4298	paragraph: 9
4299	4299	‘‘(9) A
4300	4300	CCOUNTABILITY OF PHARMACY BENEFIT 10
4301	4301	MANAGERS FOR VIOLATIONS OF REASONABLE AND 11
4302	4302	RELEVANT CONTRACT TERMS AND CONDITIONS .— 12
4303	4303	For plan years beginning on or after January 1, 13
4304	4304	2028, each contract entered into with a PDP spon-14
4305	4305	sor under this part with respect to a prescription 15
4306	4306	drug plan offered by such sponsor shall provide that 16
4307	4307	any pharmacy benefit manager acting on behalf of 17
4308	4308	such sponsor has a written agreement with the PDP 18
4309	4309	sponsor under which the pharmacy benefit manager 19
4310	4310	agrees to reimburse the PDP sponsor for any 20
4311	4311	amounts paid by such sponsor under section 1860D– 21
4312	4312	4(b)(1)(F)(iii)(I) to the Secretary as a result of a 22
4313	4313	violation described in such section if such violation 23
4314	4314	is related to a responsibility delegated to the phar-24
4315	4315	macy benefit manager by such PDP sponsor.’’. 25
4316	4316	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00143 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4317	4317	TKELLEY on LAP7H3WLY3PROD with BILLS 144
4318	4318	•S 891 IS
4319	4319	(2) MA–PD PLANS.—Section 1857(f)(3) of the 1
4320	4320	Social Security Act (42 U.S.C. 1395w–27(f)(3)) is 2
4321	4321	amended by adding at the end the following new 3
4322	4322	subparagraph: 4
4323	4323	‘‘(F) A
4324	4324	CCOUNTABILITY OF PHARMACY 5
4325	4325	BENEFIT MANAGERS FOR VIOLATIONS OF REA -6
4326	4326	SONABLE AND RELEVANT CONTRACT TERMS .— 7
4327	4327	For plan years beginning on or after January 8
4328	4328	1, 2028, section 1860D–12(b)(9).’’. 9
4329	4329	(e) B
4330	4330	IENNIALREPORT ON ENFORCEMENT AND 10
4331	4331	O
4332	4332	VERSIGHT OF PHARMACYACCESSREQUIREMENTS.— 11
4333	4333	Section 1860D–42 of the Social Security Act (42 U.S.C. 12
4334	4334	1395w–152), as amended by subsection (b), is amended 13
4335	4335	by adding at the end the following new subsection: 14
4336	4336	‘‘(f) B
4337	4337	IENNIALREPORT ON ENFORCEMENT AND 15
4338	4338	O
4339	4339	VERSIGHT OFPHARMACYACCESSREQUIREMENTS.— 16
4340	4340	‘‘(1) I
4341	4341	N GENERAL.—Not later than 2 years 17
4342	4342	after the date of enactment of this subsection, and 18
4343	4343	at least once every 2 years thereafter, the Secretary 19
4344	4344	shall publish a report on enforcement and oversight 20
4345	4345	actions and activities undertaken by the Secretary 21
4346	4346	with respect to the requirements under section 22
4347	4347	1860D–4(b)(1). 23
4348	4348	‘‘(2) L
4349	4349	IMITATION.—A report under paragraph 24
4350	4350	(1) shall not disclose— 25
4351	4351	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00144 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4352	4352	TKELLEY on LAP7H3WLY3PROD with BILLS 145
4353	4353	•S 891 IS
4354	4354	‘‘(A) identifiable information about individ-1
4355	4355	uals or entities unless such information is oth-2
4356	4356	erwise publicly available; or 3
4357	4357	‘‘(B) trade secrets with respect to any enti-4
4358	4358	ties.’’. 5
4359	4359	(f) F
4360	4360	UNDING.—In addition to amounts otherwise 6
4361	4361	available, there is appropriated to the Centers for Medi-7
4362	4362	care & Medicaid Services Program Management Account, 8
4363	4363	out of any money in the Treasury not otherwise appro-9
4364	4364	priated, $188,000,000 for fiscal year 2025, to remain 10
4365	4365	available until expended, to carry out this section. 11
4366	4366	SEC. 227. MODERNIZING AND ENSURING PBM ACCOUNT-12
4367	4367	ABILITY. 13
4368	4368	(a) I
4369	4369	NGENERAL.— 14
4370	4370	(1) P
4371	4371	RESCRIPTION DRUG PLANS .—Section 15
4372	4372	1860D–12 of the Social Security Act (42 U.S.C. 16
4373	4373	1395w–112) is amended by adding at the end the 17
4374	4374	following new subsection: 18
4375	4375	‘‘(h) R
4376	4376	EQUIREMENTSRELATING TOPHARMACYBEN-19
4377	4377	EFITMANAGERS.—For plan years beginning on or after 20
4378	4378	January 1, 2028: 21
4379	4379	‘‘(1) A
4380	4380	GREEMENTS WITH PHARMACY BENEFIT 22
4381	4381	MANAGERS.—Each contract entered into with a 23
4382	4382	PDP sponsor under this part with respect to a pre-24
4383	4383	scription drug plan offered by such sponsor shall 25
4384	4384	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00145 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4385	4385	TKELLEY on LAP7H3WLY3PROD with BILLS 146
4386	4386	•S 891 IS
4387	4387	provide that any pharmacy benefit manager acting 1
4388	4388	on behalf of such sponsor has a written agreement 2
4389	4389	with the PDP sponsor under which the pharmacy 3
4390	4390	benefit manager, and any affiliates of such phar-4
4391	4391	macy benefit manager, as applicable, agree to meet 5
4392	4392	the following requirements: 6
4393	4393	‘‘(A) N
4394	4394	O INCOME OTHER THAN BONA FIDE 7
4395	4395	SERVICE FEES.— 8
4396	4396	‘‘(i) I
4397	4397	N GENERAL.—The pharmacy 9
4398	4398	benefit manager and any affiliate of such 10
4399	4399	pharmacy benefit manager shall not derive 11
4400	4400	any remuneration with respect to any serv-12
4401	4401	ices provided on behalf of any entity or in-13
4402	4402	dividual, in connection with the utilization 14
4403	4403	of covered part D drugs, from any such en-15
4404	4404	tity or individual other than bona fide serv-16
4405	4405	ice fees, subject to clauses (ii) and (iii). 17
4406	4406	‘‘(ii) I
4407	4407	NCENTIVE PAYMENTS .—For the 18
4408	4408	purposes of this subsection, an incentive 19
4409	4409	payment (as determined by the Secretary) 20
4410	4410	paid by a PDP sponsor to a pharmacy 21
4411	4411	benefit manager that is performing serv-22
4412	4412	ices on behalf of such sponsor shall be 23
4413	4413	deemed a ‘bona fide service fee’ (even if 24
4414	4414	such payment does not otherwise meet the 25
4415	4415	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00146 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4416	4416	TKELLEY on LAP7H3WLY3PROD with BILLS 147
4417	4417	•S 891 IS
4418	4418	definition of such term under paragraph 1
4419	4419	(7)(B)) if such payment is a flat dollar 2
4420	4420	amount, is consistent with fair market 3
4421	4421	value (as specified by the Secretary), is re-4
4422	4422	lated to services actually performed by the 5
4423	4423	pharmacy benefit manager or affiliate of 6
4424	4424	such pharmacy benefit manager, on behalf 7
4425	4425	of the PDP sponsor making such payment, 8
4426	4426	in connection with the utilization of cov-9
4427	4427	ered part D drugs, and meets additional 10
4428	4428	requirements, if any, as determined appro-11
4429	4429	priate by the Secretary. 12
4430	4430	‘‘(iii) C
4431	4431	LARIFICATION ON REBATES 13
4432	4432	AND DISCOUNTS USED TO LOWER COSTS 14
4433	4433	FOR COVERED PART D DRUGS .—Rebates, 15
4434	4434	discounts, and other price concessions re-16
4435	4435	ceived by a pharmacy benefit manager or 17
4436	4436	an affiliate of a pharmacy benefit manager 18
4437	4437	from manufacturers, even if such price 19
4438	4438	concessions are calculated as a percentage 20
4439	4439	of a drug’s price, shall not be considered a 21
4440	4440	violation of the requirements of clause (i) 22
4441	4441	if they are fully passed through to a PDP 23
4442	4442	sponsor and are compliant with all regu-24
4443	4443	latory and subregulatory requirements re-25
4444	4444	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00147 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4445	4445	TKELLEY on LAP7H3WLY3PROD with BILLS 148
4446	4446	•S 891 IS
4447	4447	lated to direct and indirect remuneration 1
4448	4448	for manufacturer rebates under this part, 2
4449	4449	including in cases where a PDP sponsor is 3
4450	4450	acting as a pharmacy benefit manager on 4
4451	4451	behalf of a prescription drug plan offered 5
4452	4452	by such PDP sponsor. 6
4453	4453	‘‘(iv) E
4454	4454	VALUATION OF REMUNERATION 7
4455	4455	ARRANGEMENTS.—Components of subsets 8
4456	4456	of remuneration arrangements (such as 9
4457	4457	fees or other forms of compensation paid 10
4458	4458	to or retained by the pharmacy benefit 11
4459	4459	manager or affiliate of such pharmacy ben-12
4460	4460	efit manager), as determined appropriate 13
4461	4461	by the Secretary, between pharmacy ben-14
4462	4462	efit managers or affiliates of such phar-15
4463	4463	macy benefit managers, as applicable, and 16
4464	4464	other entities involved in the dispensing or 17
4465	4465	utilization of covered part D drugs (includ-18
4466	4466	ing PDP sponsors, manufacturers, phar-19
4467	4467	macies, and other entities as determined 20
4468	4468	appropriate by the Secretary) shall be sub-21
4469	4469	ject to review by the Secretary, in con-22
4470	4470	sultation with the Office of the Inspector 23
4471	4471	General of the Department of Health and 24
4472	4472	Human Services, as determined appro-25
4473	4473	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00148 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4474	4474	TKELLEY on LAP7H3WLY3PROD with BILLS 149
4475	4475	•S 891 IS
4476	4476	priate by the Secretary. The Secretary, in 1
4477	4477	consultation with the Office of the Inspec-2
4478	4478	tor General, shall review whether remu-3
4479	4479	neration under such arrangements is con-4
4480	4480	sistent with fair market value (as specified 5
4481	4481	by the Secretary) through reviews and as-6
4482	4482	sessments of such remuneration, as deter-7
4483	4483	mined appropriate. 8
4484	4484	‘‘(v) D
4485	4485	ISGORGEMENT.—The pharmacy 9
4486	4486	benefit manager shall disgorge any remu-10
4487	4487	neration paid to such pharmacy benefit 11
4488	4488	manager or an affiliate of such pharmacy 12
4489	4489	benefit manager in violation of this sub-13
4490	4490	paragraph to the PDP sponsor. 14
4491	4491	‘‘(vi) A
4492	4492	DDITIONAL REQUIREMENTS .— 15
4493	4493	The pharmacy benefit manager shall— 16
4494	4494	‘‘(I) enter into a written agree-17
4495	4495	ment with any affiliate of such phar-18
4496	4496	macy benefit manager, under which 19
4497	4497	the affiliate shall identify and disgorge 20
4498	4498	any remuneration described in clause 21
4499	4499	(v) to the pharmacy benefit manager; 22
4500	4500	and 23
4501	4501	‘‘(II) attest, subject to any re-24
4502	4502	quirements determined appropriate by 25
4503	4503	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00149 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4504	4504	TKELLEY on LAP7H3WLY3PROD with BILLS 150
4505	4505	•S 891 IS
4506	4506	the Secretary, that the pharmacy ben-1
4507	4507	efit manager has entered into a writ-2
4508	4508	ten agreement described in subclause 3
4509	4509	(I) with any relevant affiliate of the 4
4510	4510	pharmacy benefit manager. 5
4511	4511	‘‘(B) T
4512	4512	RANSPARENCY REGARDING GUARAN -6
4513	4513	TEES AND COST PERFORMANCE EVALUA -7
4514	4514	TIONS.—The pharmacy benefit manager shall— 8
4515	4515	‘‘(i) define, interpret, and apply, in a 9
4516	4516	fully transparent and consistent manner 10
4517	4517	for purposes of calculating or otherwise 11
4518	4518	evaluating pharmacy benefit manager per-12
4519	4519	formance against pricing guarantees or 13
4520	4520	similar cost performance measurements re-14
4521	4521	lated to rebates, discounts, price conces-15
4522	4522	sions, or net costs, terms such as— 16
4523	4523	‘‘(I) ‘generic drug’, in a manner 17
4524	4524	consistent with the definition of the 18
4525	4525	term under section 423.4 of title 42, 19
4526	4526	Code of Federal Regulations, or a suc-20
4527	4527	cessor regulation; 21
4528	4528	‘‘(II) ‘brand name drug’, in a 22
4529	4529	manner consistent with the definition 23
4530	4530	of the term under section 423.4 of 24
4531	4531	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00150 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4532	4532	TKELLEY on LAP7H3WLY3PROD with BILLS 151
4533	4533	•S 891 IS
4534	4534	title 42, Code of Federal Regulations, 1
4535	4535	or a successor regulation; 2
4536	4536	‘‘(III) ‘specialty drug’; 3
4537	4537	‘‘(IV) ‘rebate’; and 4
4538	4538	‘‘(V) ‘discount’; 5
4539	4539	‘‘(ii) identify any drugs, claims, or 6
4540	4540	price concessions excluded from any pric-7
4541	4541	ing guarantee or other cost performance 8
4542	4542	measure in a clear and consistent manner; 9
4543	4543	and 10
4544	4544	‘‘(iii) where a pricing guarantee or 11
4545	4545	other cost performance measure is based 12
4546	4546	on a pricing benchmark other than the 13
4547	4547	wholesale acquisition cost (as defined in 14
4548	4548	section 1847A(c)(6)(B)) of a drug, cal-15
4549	4549	culate and provide a wholesale acquisition 16
4550	4550	cost-based equivalent to the pricing guar-17
4551	4551	antee or other cost performance measure. 18
4552	4552	‘‘(C) P
4553	4553	ROVISION OF INFORMATION .— 19
4554	4554	‘‘(i) I
4555	4555	N GENERAL.—Not later than 20
4556	4556	July 1 of each year, beginning in 2028, the 21
4557	4557	pharmacy benefit manager shall submit to 22
4558	4558	the PDP sponsor, and to the Secretary, a 23
4559	4559	report, in accordance with this subpara-24
4560	4560	graph, and shall make such report avail-25
4561	4561	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00151 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4562	4562	TKELLEY on LAP7H3WLY3PROD with BILLS 152
4563	4563	•S 891 IS
4564	4564	able to such sponsor at no cost to such 1
4565	4565	sponsor in a format specified by the Sec-2
4566	4566	retary under paragraph (5). Each such re-3
4567	4567	port shall include, with respect to such 4
4568	4568	PDP sponsor and each plan offered by 5
4569	4569	such sponsor, the following information 6
4570	4570	with respect to the previous plan year: 7
4571	4571	‘‘(I) A list of all drugs covered by 8
4572	4572	the plan that were dispensed includ-9
4573	4573	ing, with respect to each such drug— 10
4574	4574	‘‘(aa) the brand name, ge-11
4575	4575	neric or non-proprietary name, 12
4576	4576	and National Drug Code; 13
4577	4577	‘‘(bb) the number of plan 14
4578	4578	enrollees for whom the drug was 15
4579	4579	dispensed, the total number of 16
4580	4580	prescription claims for the drug 17
4581	4581	(including original prescriptions 18
4582	4582	and refills, counted as separate 19
4583	4583	claims), and the total number of 20
4584	4584	dosage units of the drug dis-21
4585	4585	pensed; 22
4586	4586	‘‘(cc) the number of pre-23
4587	4587	scription claims described in item 24
4588	4588	(bb) by each type of dispensing 25
4589	4589	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00152 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4590	4590	TKELLEY on LAP7H3WLY3PROD with BILLS 153
4591	4591	•S 891 IS
4592	4592	channel through which the drug 1
4593	4593	was dispensed, including retail, 2
4594	4594	mail order, specialty pharmacy, 3
4595	4595	long term care pharmacy, home 4
4596	4596	infusion pharmacy, or other types 5
4597	4597	of pharmacies or providers; 6
4598	4598	‘‘(dd) the average wholesale 7
4599	4599	acquisition cost, listed as cost per 8
4600	4600	day’s supply, cost per dosage 9
4601	4601	unit, and cost per typical course 10
4602	4602	of treatment (as applicable); 11
4603	4603	‘‘(ee) the average wholesale 12
4604	4604	price for the drug, listed as price 13
4605	4605	per day’s supply, price per dos-14
4606	4606	age unit, and price per typical 15
4607	4607	course of treatment (as applica-16
4608	4608	ble); 17
4609	4609	‘‘(ff) the total out-of-pocket 18
4610	4610	spending by plan enrollees on 19
4611	4611	such drug after application of 20
4612	4612	any benefits under the plan, in-21
4613	4613	cluding plan enrollee spending 22
4614	4614	through copayments, coinsurance, 23
4615	4615	and deductibles; 24
4616	4616	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00153 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4617	4617	TKELLEY on LAP7H3WLY3PROD with BILLS 154
4618	4618	•S 891 IS
4619	4619	‘‘(gg) total rebates paid by 1
4620	4620	the manufacturer on the drug as 2
4621	4621	reported under the Detailed DIR 3
4622	4622	Report (or any successor report) 4
4623	4623	submitted by such sponsor to the 5
4624	4624	Centers for Medicare & Medicaid 6
4625	4625	Services; 7
4626	4626	‘‘(hh) all other direct or in-8
4627	4627	direct remuneration on the drug 9
4628	4628	as reported under the Detailed 10
4629	4629	DIR Report (or any successor re-11
4630	4630	port) submitted by such sponsor 12
4631	4631	to the Centers for Medicare & 13
4632	4632	Medicaid Services; 14
4633	4633	‘‘(ii) the average pharmacy 15
4634	4634	reimbursement amount paid by 16
4635	4635	the plan for the drug in the ag-17
4636	4636	gregate and disaggregated by dis-18
4637	4637	pensing channel identified in item 19
4638	4638	(cc); 20
4639	4639	‘‘(jj) the average National 21
4640	4640	Average Drug Acquisition Cost 22
4641	4641	(NADAC); and 23
4642	4642	‘‘(kk) total manufacturer-de-24
4643	4643	rived revenue, inclusive of bona 25
4644	4644	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00154 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4645	4645	TKELLEY on LAP7H3WLY3PROD with BILLS 155
4646	4646	•S 891 IS
4647	4647	fide service fees, attributable to 1
4648	4648	the drug and retained by the 2
4649	4649	pharmacy benefit manager and 3
4650	4650	any affiliate of such pharmacy 4
4651	4651	benefit manager. 5
4652	4652	‘‘(II) In the case of a pharmacy 6
4653	4653	benefit manager that has an affiliate 7
4654	4654	that is a retail, mail order, or spe-8
4655	4655	cialty pharmacy, with respect to drugs 9
4656	4656	covered by such plan that were dis-10
4657	4657	pensed, the following information: 11
4658	4658	‘‘(aa) The percentage of 12
4659	4659	total prescriptions that were dis-13
4660	4660	pensed by pharmacies that are an 14
4661	4661	affiliate of the pharmacy benefit 15
4662	4662	manager for each drug. 16
4663	4663	‘‘(bb) The interquartile 17
4664	4664	range of the total combined costs 18
4665	4665	paid by the plan and plan enroll-19
4666	4666	ees, per dosage unit, per course 20
4667	4667	of treatment, per 30-day supply, 21
4668	4668	and per 90-day supply for each 22
4669	4669	drug dispensed by pharmacies 23
4670	4670	that are not an affiliate of the 24
4671	4671	pharmacy benefit manager and 25
4672	4672	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00155 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4673	4673	TKELLEY on LAP7H3WLY3PROD with BILLS 156
4674	4674	•S 891 IS
4675	4675	that are included in the phar-1
4676	4676	macy network of such plan. 2
4677	4677	‘‘(cc) The interquartile 3
4678	4678	range of the total combined costs 4
4679	4679	paid by the plan and plan enroll-5
4680	4680	ees, per dosage unit, per course 6
4681	4681	of treatment, per 30-day supply, 7
4682	4682	and per 90-day supply for each 8
4683	4683	drug dispensed by pharmacies 9
4684	4684	that are an affiliate of the phar-10
4685	4685	macy benefit manager and that 11
4686	4686	are included in the pharmacy 12
4687	4687	network of such plan. 13
4688	4688	‘‘(dd) The lowest total com-14
4689	4689	bined cost paid by the plan and 15
4690	4690	plan enrollees, per dosage unit, 16
4691	4691	per course of treatment, per 30- 17
4692	4692	day supply, and per 90-day sup-18
4693	4693	ply, for each drug that is avail-19
4694	4694	able from any pharmacy included 20
4695	4695	in the pharmacy network of such 21
4696	4696	plan. 22
4697	4697	‘‘(ee) The difference between 23
4698	4698	the average acquisition cost of 24
4699	4699	the affiliate, such as a pharmacy 25
4700	4700	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00156 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4701	4701	TKELLEY on LAP7H3WLY3PROD with BILLS 157
4702	4702	•S 891 IS
4703	4703	or other entity that acquires pre-1
4704	4704	scription drugs, that initially ac-2
4705	4705	quires the drug and the amount 3
4706	4706	reported under subclause (I)(jj) 4
4707	4707	for each drug. 5
4708	4708	‘‘(ff) A list inclusive of the 6
4709	4709	brand name, generic or non-pro-7
4710	4710	prietary name, and National 8
4711	4711	Drug Code of covered part D 9
4712	4712	drugs subject to an agreement 10
4713	4713	with a covered entity under sec-11
4714	4714	tion 340B of the Public Health 12
4715	4715	Service Act for which the phar-13
4716	4716	macy benefit manager or an affil-14
4717	4717	iate of the pharmacy benefit 15
4718	4718	manager had a contract or other 16
4719	4719	arrangement with such a covered 17
4720	4720	entity in the service area of such 18
4721	4721	plan. 19
4722	4722	‘‘(III) Where a drug approved 20
4723	4723	under section 505(c) of the Federal 21
4724	4724	Food, Drug, and Cosmetic Act (re-22
4725	4725	ferred to in this subclause as the ‘list-23
4726	4726	ed drug’) is covered by the plan, the 24
4727	4727	following information: 25
4728	4728	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00157 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4729	4729	TKELLEY on LAP7H3WLY3PROD with BILLS 158
4730	4730	•S 891 IS
4731	4731	‘‘(aa) A list of currently 1
4732	4732	marketed generic drugs approved 2
4733	4733	under section 505(j) of the Fed-3
4734	4734	eral Food, Drug, and Cosmetic 4
4735	4735	Act pursuant to an application 5
4736	4736	that references such listed drug 6
4737	4737	that are not covered by the plan, 7
4738	4738	are covered on the same for-8
4739	4739	mulary tier or a formulary tier 9
4740	4740	typically associated with higher 10
4741	4741	cost-sharing than the listed drug, 11
4742	4742	or are subject to utilization man-12
4743	4743	agement that the listed drug is 13
4744	4744	not subject to. 14
4745	4745	‘‘(bb) The estimated average 15
4746	4746	beneficiary cost-sharing under 16
4747	4747	the plan for a 30-day supply of 17
4748	4748	the listed drug. 18
4749	4749	‘‘(cc) Where a generic drug 19
4750	4750	listed under item (aa) is on a for-20
4751	4751	mulary tier typically associated 21
4752	4752	with higher cost-sharing than the 22
4753	4753	listed drug, the estimated aver-23
4754	4754	age cost-sharing that a bene-24
4755	4755	ficiary would have paid for a 30- 25
4756	4756	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00158 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4757	4757	TKELLEY on LAP7H3WLY3PROD with BILLS 159
4758	4758	•S 891 IS
4759	4759	day supply of each of the generic 1
4760	4760	drugs described in item (aa), had 2
4761	4761	the plan provided coverage for 3
4762	4762	such drugs on the same for-4
4763	4763	mulary tier as the listed drug. 5
4764	4764	‘‘(dd) A written justification 6
4765	4765	for providing more favorable cov-7
4766	4766	erage of the listed drug than the 8
4767	4767	generic drugs described in item 9
4768	4768	(aa). 10
4769	4769	‘‘(ee) The number of cur-11
4770	4770	rently marketed generic drugs 12
4771	4771	approved under section 505(j) of 13
4772	4772	the Federal Food, Drug, and 14
4773	4773	Cosmetic Act pursuant to an ap-15
4774	4774	plication that references such 16
4775	4775	listed drug. 17
4776	4776	‘‘(IV) Where a reference product 18
4777	4777	(as defined in section 351(i) of the 19
4778	4778	Public Health Service Act) is covered 20
4779	4779	by the plan, the following information: 21
4780	4780	‘‘(aa) A list of currently 22
4781	4781	marketed biosimilar biological 23
4782	4782	products licensed under section 24
4783	4783	351(k) of the Public Health 25
4784	4784	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00159 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4785	4785	TKELLEY on LAP7H3WLY3PROD with BILLS 160
4786	4786	•S 891 IS
4787	4787	Service Act pursuant to an appli-1
4788	4788	cation that refers to such ref-2
4789	4789	erence product that are not cov-3
4790	4790	ered by the plan, are covered on 4
4791	4791	the same formulary tier or a for-5
4792	4792	mulary tier typically associated 6
4793	4793	with higher cost-sharing than the 7
4794	4794	reference product, or are subject 8
4795	4795	to utilization management that 9
4796	4796	the reference product is not sub-10
4797	4797	ject to. 11
4798	4798	‘‘(bb) The estimated average 12
4799	4799	beneficiary cost-sharing under 13
4800	4800	the plan for a 30-day supply of 14
4801	4801	the reference product. 15
4802	4802	‘‘(cc) Where a biosimilar bi-16
4803	4803	ological product listed under item 17
4804	4804	(aa) is on a formulary tier typi-18
4805	4805	cally associated with higher cost- 19
4806	4806	sharing than the reference prod-20
4807	4807	uct, the estimated average cost- 21
4808	4808	sharing that a beneficiary would 22
4809	4809	have paid for a 30-day supply of 23
4810	4810	each of the biosimilar biological 24
4811	4811	products described in item (aa), 25
4812	4812	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00160 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4813	4813	TKELLEY on LAP7H3WLY3PROD with BILLS 161
4814	4814	•S 891 IS
4815	4815	had the plan provided coverage 1
4816	4816	for such products on the same 2
4817	4817	formulary tier as the reference 3
4818	4818	product. 4
4819	4819	‘‘(dd) A written justification 5
4820	4820	for providing more favorable cov-6
4821	4821	erage of the reference product 7
4822	4822	than the biosimilar biological 8
4823	4823	product described in item (aa). 9
4824	4824	‘‘(ee) The number of cur-10
4825	4825	rently marketed biosimilar bio-11
4826	4826	logical products licensed under 12
4827	4827	section 351(k) of the Public 13
4828	4828	Health Service Act, pursuant to 14
4829	4829	an application that refers to such 15
4830	4830	reference product. 16
4831	4831	‘‘(V) Total gross spending on 17
4832	4832	covered part D drugs by the plan, not 18
4833	4833	net of rebates, fees, discounts, or 19
4834	4834	other direct or indirect remuneration. 20
4835	4835	‘‘(VI) The total amount retained 21
4836	4836	by the pharmacy benefit manager or 22
4837	4837	an affiliate of such pharmacy benefit 23
4838	4838	manager in revenue related to utiliza-24
4839	4839	tion of covered part D drugs under 25
4840	4840	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00161 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4841	4841	TKELLEY on LAP7H3WLY3PROD with BILLS 162
4842	4842	•S 891 IS
4843	4843	that plan, inclusive of bona fide serv-1
4844	4844	ice fees. 2
4845	4845	‘‘(VII) The total spending on cov-3
4846	4846	ered part D drugs net of rebates, fees, 4
4847	4847	discounts, or other direct and indirect 5
4848	4848	remuneration by the plan. 6
4849	4849	‘‘(VIII) An explanation of any 7
4850	4850	benefit design parameters under such 8
4851	4851	plan that encourage plan enrollees to 9
4852	4852	fill prescriptions at pharmacies that 10
4853	4853	are an affiliate of such pharmacy ben-11
4854	4854	efit manager, such as mail and spe-12
4855	4855	cialty home delivery programs, and re-13
4856	4856	tail and mail auto-refill programs. 14
4857	4857	‘‘(IX) The following information: 15
4858	4858	‘‘(aa) A list of all brokers, 16
4859	4859	consultants, advisors, and audi-17
4860	4860	tors that receive compensation 18
4861	4861	from the pharmacy benefit man-19
4862	4862	ager or an affiliate of such phar-20
4863	4863	macy benefit manager for refer-21
4864	4864	rals, consulting, auditing, or 22
4865	4865	other services offered to PDP 23
4866	4866	sponsors related to pharmacy 24
4867	4867	benefit management services. 25
4868	4868	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00162 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4869	4869	TKELLEY on LAP7H3WLY3PROD with BILLS 163
4870	4870	•S 891 IS
4871	4871	‘‘(bb) The amount of com-1
4872	4872	pensation provided by such phar-2
4873	4873	macy benefit manager or affiliate 3
4874	4874	to each such broker, consultant, 4
4875	4875	advisor, and auditor. 5
4876	4876	‘‘(cc) The methodology for 6
4877	4877	calculating the amount of com-7
4878	4878	pensation provided by such phar-8
4879	4879	macy benefit manager or affil-9
4880	4880	iate, for each such broker, con-10
4881	4881	sultant, advisor, and auditor. 11
4882	4882	‘‘(X) A list of all affiliates of the 12
4883	4883	pharmacy benefit manager. 13
4884	4884	‘‘(XI) A summary document sub-14
4885	4885	mitted in a standardized template de-15
4886	4886	veloped by the Secretary that includes 16
4887	4887	such information described in sub-17
4888	4888	clauses (I) through (X). 18
4889	4889	‘‘(ii) W
4890	4890	RITTEN EXPLANATION OF CON -19
4891	4891	TRACTS OR AGREEMENTS WITH DRUG 20
4892	4892	MANUFACTURERS .— 21
4893	4893	‘‘(I) I
4894	4894	N GENERAL.—The phar-22
4895	4895	macy benefit manager shall, not later 23
4896	4896	than 30 days after the finalization of 24
4897	4897	any contract or agreement between 25
4898	4898	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00163 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4899	4899	TKELLEY on LAP7H3WLY3PROD with BILLS 164
4900	4900	•S 891 IS
4901	4901	such pharmacy benefit manager or an 1
4902	4902	affiliate of such pharmacy benefit 2
4903	4903	manager and a drug manufacturer (or 3
4904	4904	subsidiary, agent, or entity affiliated 4
4905	4905	with such drug manufacturer) that 5
4906	4906	makes rebates, discounts, payments, 6
4907	4907	or other financial incentives related to 7
4908	4908	one or more covered part D drugs or 8
4909	4909	other prescription drugs, as applica-9
4910	4910	ble, of the manufacturer directly or 10
4911	4911	indirectly contingent upon coverage, 11
4912	4912	formulary placement, or utilization 12
4913	4913	management conditions on any other 13
4914	4914	covered part D drugs or other pre-14
4915	4915	scription drugs, as applicable, submit 15
4916	4916	to the PDP sponsor a written expla-16
4917	4917	nation of such contract or agreement. 17
4918	4918	‘‘(II) R
4919	4919	EQUIREMENTS.—A writ-18
4920	4920	ten explanation under subclause (I) 19
4921	4921	shall— 20
4922	4922	‘‘(aa) include the manufac-21
4923	4923	turer subject to the contract or 22
4924	4924	agreement, all covered part D 23
4925	4925	drugs and other prescription 24
4926	4926	drugs, as applicable, subject to 25
4927	4927	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00164 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4928	4928	TKELLEY on LAP7H3WLY3PROD with BILLS 165
4929	4929	•S 891 IS
4930	4930	the contract or agreement and 1
4931	4931	the manufacturers of such drugs, 2
4932	4932	and a high-level description of 3
4933	4933	the terms of such contract or 4
4934	4934	agreement and how such terms 5
4935	4935	apply to such drugs; and 6
4936	4936	‘‘(bb) be certified by the 7
4937	4937	Chief Executive Officer, Chief Fi-8
4938	4938	nancial Officer, or General Coun-9
4939	4939	sel of such pharmacy benefit 10
4940	4940	manager, or affiliate of such 11
4941	4941	pharmacy benefit manager, as 12
4942	4942	applicable, or an individual dele-13
4943	4943	gated with the authority to sign 14
4944	4944	on behalf of one of these officers, 15
4945	4945	who reports directly to the offi-16
4946	4946	cer. 17
4947	4947	‘‘(III) D
4948	4948	EFINITION OF OTHER 18
4949	4949	PRESCRIPTION DRUGS.—For purposes 19
4950	4950	of this clause, the term ‘other pre-20
4951	4951	scription drugs’ means prescription 21
4952	4952	drugs covered as supplemental bene-22
4953	4953	fits under this part or prescription 23
4954	4954	drugs paid outside of this part. 24
4955	4955	‘‘(D) A
4956	4956	UDIT RIGHTS.— 25
4957	4957	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00165 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4958	4958	TKELLEY on LAP7H3WLY3PROD with BILLS 166
4959	4959	•S 891 IS
4960	4960	‘‘(i) IN GENERAL.—Not less than once 1
4961	4961	a year, at the request of the PDP sponsor, 2
4962	4962	the pharmacy benefit manager shall allow 3
4963	4963	for an audit of the pharmacy benefit man-4
4964	4964	ager to ensure compliance with all terms 5
4965	4965	and conditions under the written agree-6
4966	4966	ment described in this paragraph and the 7
4967	4967	accuracy of information reported under 8
4968	4968	subparagraph (C). 9
4969	4969	‘‘(ii) A
4970	4970	UDITOR.—The PDP sponsor 10
4971	4971	shall have the right to select an auditor. 11
4972	4972	The pharmacy benefit manager shall not 12
4973	4973	impose any limitations on the selection of 13
4974	4974	such auditor. 14
4975	4975	‘‘(iii) P
4976	4976	ROVISION OF INFORMATION .— 15
4977	4977	The pharmacy benefit manager shall make 16
4978	4978	available to such auditor all records, data, 17
4979	4979	contracts, and other information necessary 18
4980	4980	to confirm the accuracy of information 19
4981	4981	provided under subparagraph (C), subject 20
4982	4982	to reasonable restrictions on how such in-21
4983	4983	formation must be reported to prevent re-22
4984	4984	disclosure of such information. 23
4985	4985	‘‘(iv) T
4986	4986	IMING.—The pharmacy benefit 24
4987	4987	manager must provide information under 25
4988	4988	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00166 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
4989	4989	TKELLEY on LAP7H3WLY3PROD with BILLS 167
4990	4990	•S 891 IS
4991	4991	clause (iii) and other information, data, 1
4992	4992	and records relevant to the audit to such 2
4993	4993	auditor within 6 months of the initiation of 3
4994	4994	the audit and respond to requests for addi-4
4995	4995	tional information from such auditor with-5
4996	4996	in 30 days after the request for additional 6
4997	4997	information. 7
4998	4998	‘‘(v) I
4999	4999	NFORMATION FROM AFFILI -8
5000	5000	ATES.—The pharmacy benefit manager 9
5001	5001	shall be responsible for providing to such 10
5002	5002	auditor information required to be reported 11
5003	5003	under subparagraph (C) or under clause 12
5004	5004	(iii) of this subparagraph that is owned or 13
5005	5005	held by an affiliate of such pharmacy ben-14
5006	5006	efit manager. 15
5007	5007	‘‘(2) E
5008	5008	NFORCEMENT.— 16
5009	5009	‘‘(A) I
5010	5010	N GENERAL.—Each PDP sponsor 17
5011	5011	shall— 18
5012	5012	‘‘(i) disgorge to the Secretary any 19
5013	5013	amounts disgorged to the PDP sponsor by 20
5014	5014	a pharmacy benefit manager under para-21
5015	5015	graph (1)(A)(v); 22
5016	5016	‘‘(ii) require, in a written agreement 23
5017	5017	with any pharmacy benefit manager acting 24
5018	5018	on behalf of such sponsor or affiliate of 25
5019	5019	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00167 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5020	5020	TKELLEY on LAP7H3WLY3PROD with BILLS 168
5021	5021	•S 891 IS
5022	5022	such pharmacy benefit manager, that such 1
5023	5023	pharmacy benefit manager or affiliate re-2
5024	5024	imburse the PDP sponsor for any civil 3
5025	5025	money penalty imposed on the PDP spon-4
5026	5026	sor as a result of the failure of the phar-5
5027	5027	macy benefit manager or affiliate to meet 6
5028	5028	the requirements of paragraph (1) that are 7
5029	5029	applicable to the pharmacy benefit man-8
5030	5030	ager or affiliate under the agreement; and 9
5031	5031	‘‘(iii) require, in a written agreement 10
5032	5032	with any such pharmacy benefit manager 11
5033	5033	acting on behalf of such sponsor or affil-12
5034	5034	iate of such pharmacy benefit manager, 13
5035	5035	that such pharmacy benefit manager or af-14
5036	5036	filiate be subject to punitive remedies for 15
5037	5037	breach of contract for failure to comply 16
5038	5038	with the requirements applicable under 17
5039	5039	paragraph (1). 18
5040	5040	‘‘(B) R
5041	5041	EPORTING OF ALLEGED VIOLA -19
5042	5042	TIONS.—The Secretary shall make available and 20
5043	5043	maintain a mechanism for manufacturers, PDP 21
5044	5044	sponsors, pharmacies, and other entities that 22
5045	5045	have contractual relationships with pharmacy 23
5046	5046	benefit managers or affiliates of such pharmacy 24
5047	5047	benefit managers to report, on a confidential 25
5048	5048	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00168 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5049	5049	TKELLEY on LAP7H3WLY3PROD with BILLS 169
5050	5050	•S 891 IS
5051	5051	basis, alleged violations of paragraph (1)(A) or 1
5052	5052	subparagraph (C). 2
5053	5053	‘‘(C) A
5054	5054	NTI-RETALIATION AND ANTI -COER-3
5055	5055	CION.—Consistent with applicable Federal or 4
5056	5056	State law, a PDP sponsor shall not— 5
5057	5057	‘‘(i) retaliate against an individual or 6
5058	5058	entity for reporting an alleged violation 7
5059	5059	under subparagraph (B); or 8
5060	5060	‘‘(ii) coerce, intimidate, threaten, or 9
5061	5061	interfere with the ability of an individual 10
5062	5062	or entity to report any such alleged viola-11
5063	5063	tions. 12
5064	5064	‘‘(3) C
5065	5065	ERTIFICATION OF COMPLIANCE .— 13
5066	5066	‘‘(A) I
5067	5067	N GENERAL.—Each PDP sponsor 14
5068	5068	shall furnish to the Secretary (at a time and in 15
5069	5069	a manner specified by the Secretary) an annual 16
5070	5070	certification of compliance with this subsection, 17
5071	5071	as well as such information as the Secretary de-18
5072	5072	termines necessary to carry out this subsection. 19
5073	5073	‘‘(B) I
5074	5074	MPLEMENTATION.—Notwithstanding 20
5075	5075	any other provision of law, the Secretary may 21
5076	5076	implement this paragraph by program instruc-22
5077	5077	tion or otherwise. 23
5078	5078	‘‘(4) R
5079	5079	ULE OF CONSTRUCTION .—Nothing in 24
5080	5080	this subsection shall be construed as— 25
5081	5081	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00169 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5082	5082	TKELLEY on LAP7H3WLY3PROD with BILLS 170
5083	5083	•S 891 IS
5084	5084	‘‘(A) prohibiting flat dispensing fees or re-1
5085	5085	imbursement or payment for ingredient costs 2
5086	5086	(including customary, industry-standard dis-3
5087	5087	counts directly related to drug acquisition that 4
5088	5088	are retained by pharmacies or wholesalers) to 5
5089	5089	entities that acquire or dispense prescription 6
5090	5090	drugs; or 7
5091	5091	‘‘(B) modifying regulatory requirements or 8
5092	5092	sub-regulatory program instruction or guidance 9
5093	5093	related to pharmacy payment, reimbursement, 10
5094	5094	or dispensing fees. 11
5095	5095	‘‘(5) S
5096	5096	TANDARD FORMATS .— 12
5097	5097	‘‘(A) I
5098	5098	N GENERAL.—Not later than June 13
5099	5099	1, 2027, the Secretary shall specify standard, 14
5100	5100	machine-readable formats for pharmacy benefit 15
5101	5101	managers to submit annual reports required 16
5102	5102	under paragraph (1)(C)(i). 17
5103	5103	‘‘(B) I
5104	5104	MPLEMENTATION.—Notwithstanding 18
5105	5105	any other provision of law, the Secretary may 19
5106	5106	implement this paragraph by program instruc-20
5107	5107	tion or otherwise. 21
5108	5108	‘‘(6) C
5109	5109	ONFIDENTIALITY.— 22
5110	5110	‘‘(A) I
5111	5111	N GENERAL.—Information disclosed 23
5112	5112	by a pharmacy benefit manager, an affiliate of 24
5113	5113	a pharmacy benefit manager, a PDP sponsor, 25
5114	5114	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00170 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5115	5115	TKELLEY on LAP7H3WLY3PROD with BILLS 171
5116	5116	•S 891 IS
5117	5117	or a pharmacy under this subsection that is not 1
5118	5118	otherwise publicly available or available for pur-2
5119	5119	chase shall not be disclosed by the Secretary or 3
5120	5120	a PDP sponsor receiving the information, ex-4
5121	5121	cept that the Secretary may disclose the infor-5
5122	5122	mation for the following purposes: 6
5123	5123	‘‘(i) As the Secretary determines nec-7
5124	5124	essary to carry out this part. 8
5125	5125	‘‘(ii) To permit the Comptroller Gen-9
5126	5126	eral to review the information provided. 10
5127	5127	‘‘(iii) To permit the Director of the 11
5128	5128	Congressional Budget Office to review the 12
5129	5129	information provided. 13
5130	5130	‘‘(iv) To permit the Executive Direc-14
5131	5131	tor of the Medicare Payment Advisory 15
5132	5132	Commission to review the information pro-16
5133	5133	vided. 17
5134	5134	‘‘(v) To the Attorney General for the 18
5135	5135	purposes of conducting oversight and en-19
5136	5136	forcement under this title. 20
5137	5137	‘‘(vi) To the Inspector General of the 21
5138	5138	Department of Health and Human Serv-22
5139	5139	ices in accordance with its authorities 23
5140	5140	under the Inspector General Act of 1978 24
5141	5141	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00171 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5142	5142	TKELLEY on LAP7H3WLY3PROD with BILLS 172
5143	5143	•S 891 IS
5144	5144	(section 406 of title 5, United States 1
5145	5145	Code), and other applicable statutes. 2
5146	5146	‘‘(B) R
5147	5147	ESTRICTION ON USE OF INFORMA -3
5148	5148	TION.—The Secretary, the Comptroller General, 4
5149	5149	the Director of the Congressional Budget Of-5
5150	5150	fice, and the Executive Director of the Medicare 6
5151	5151	Payment Advisory Commission shall not report 7
5152	5152	on or disclose information disclosed pursuant to 8
5153	5153	subparagraph (A) to the public in a manner 9
5154	5154	that would identify— 10
5155	5155	‘‘(i) a specific pharmacy benefit man-11
5156	5156	ager, affiliate, pharmacy, manufacturer, 12
5157	5157	wholesaler, PDP sponsor, or plan; or 13
5158	5158	‘‘(ii) contract prices, rebates, dis-14
5159	5159	counts, or other remuneration for specific 15
5160	5160	drugs in a manner that may allow the 16
5161	5161	identification of specific contracting parties 17
5162	5162	or of such specific drugs. 18
5163	5163	‘‘(7) D
5164	5164	EFINITIONS.—For purposes of this sub-19
5165	5165	section: 20
5166	5166	‘‘(A) A
5167	5167	FFILIATE.—The term ‘affiliate’ 21
5168	5168	means, with respect to any pharmacy benefit 22
5169	5169	manager or PDP sponsor, any entity that, di-23
5170	5170	rectly or indirectly— 24
5171	5171	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00172 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5172	5172	TKELLEY on LAP7H3WLY3PROD with BILLS 173
5173	5173	•S 891 IS
5174	5174	‘‘(i) owns or is owned by, controls or 1
5175	5175	is controlled by, or is otherwise related in 2
5176	5176	any ownership structure to such pharmacy 3
5177	5177	benefit manager or PDP sponsor; or 4
5178	5178	‘‘(ii) acts as a contractor, principal, or 5
5179	5179	agent to such pharmacy benefit manager 6
5180	5180	or PDP sponsor, insofar as such con-7
5181	5181	tractor, principal, or agent performs any of 8
5182	5182	the functions described under subpara-9
5183	5183	graph (C). 10
5184	5184	‘‘(B) B
5185	5185	ONA FIDE SERVICE FEE.—The term 11
5186	5186	‘bona fide service fee’ means a fee that is reflec-12
5187	5187	tive of the fair market value (as specified by the 13
5188	5188	Secretary, through notice and comment rule-14
5189	5189	making) for a bona fide, itemized service actu-15
5190	5190	ally performed on behalf of an entity, that the 16
5191	5191	entity would otherwise perform (or contract for) 17
5192	5192	in the absence of the service arrangement and 18
5193	5193	that is not passed on in whole or in part to a 19
5194	5194	client or customer, whether or not the entity 20
5195	5195	takes title to the drug. Such fee must be a flat 21
5196	5196	dollar amount and shall not be directly or indi-22
5197	5197	rectly based on, or contingent upon— 23
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5199	5199	TKELLEY on LAP7H3WLY3PROD with BILLS 174
5200	5200	•S 891 IS
5201	5201	‘‘(i) drug price, such as wholesale ac-1
5202	5202	quisition cost or drug benchmark price 2
5203	5203	(such as average wholesale price); 3
5204	5204	‘‘(ii) the amount of discounts, rebates, 4
5205	5205	fees, or other direct or indirect remunera-5
5206	5206	tion with respect to covered part D drugs 6
5207	5207	dispensed to enrollees in a prescription 7
5208	5208	drug plan, except as permitted pursuant to 8
5209	5209	paragraph (1)(A)(ii); 9
5210	5210	‘‘(iii) coverage or formulary placement 10
5211	5211	decisions or the volume or value of any re-11
5212	5212	ferrals or business generated between the 12
5213	5213	parties to the arrangement; or 13
5214	5214	‘‘(iv) any other amounts or meth-14
5215	5215	odologies prohibited by the Secretary. 15
5216	5216	‘‘(C) P
5217	5217	HARMACY BENEFIT MANAGER .—The 16
5218	5218	term ‘pharmacy benefit manager’ means any 17
5219	5219	person or entity that, either directly or through 18
5220	5220	an intermediary, acts as a price negotiator or 19
5221	5221	group purchaser on behalf of a PDP sponsor or 20
5222	5222	prescription drug plan, or manages the pre-21
5223	5223	scription drug benefits provided by such spon-22
5224	5224	sor or plan, including the processing and pay-23
5225	5225	ment of claims for prescription drugs, the per-24
5226	5226	formance of drug utilization review, the proc-25
5227	5227	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00174 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5228	5228	TKELLEY on LAP7H3WLY3PROD with BILLS 175
5229	5229	•S 891 IS
5230	5230	essing of drug prior authorization requests, the 1
5231	5231	adjudication of appeals or grievances related to 2
5232	5232	the prescription drug benefit, contracting with 3
5233	5233	network pharmacies, controlling the cost of cov-4
5234	5234	ered part D drugs, or the provision of related 5
5235	5235	services. Such term includes any person or enti-6
5236	5236	ty that carries out one or more of the activities 7
5237	5237	described in the preceding sentence, irrespective 8
5238	5238	of whether such person or entity calls itself a 9
5239	5239	‘pharmacy benefit manager’.’’. 10
5240	5240	(2) MA–PD
5241	5241	PLANS.—Section 1857(f)(3) of the 11
5242	5242	Social Security Act (42 U.S.C. 1395w–27(f)(3)), as 12
5243	5243	amended by section 226(d)(2), is amended by adding 13
5244	5244	at the end the following new subparagraph: 14
5245	5245	‘‘(G) R
5246	5246	EQUIREMENTS RELATING TO PHAR -15
5247	5247	MACY BENEFIT MANAGERS .—For plan years be-16
5248	5248	ginning on or after January 1, 2028, section 17
5249	5249	1860D–12(h).’’. 18
5250	5250	(3) N
5251	5251	ONAPPLICATION OF PAPERWORK REDUC -19
5252	5252	TION ACT.—Chapter 35 of title 44, United States 20
5253	5253	Code, shall not apply to the implementation of this 21
5254	5254	subsection. 22
5255	5255	(4) F
5256	5256	UNDING.— 23
5257	5257	(A) S
5258	5258	ECRETARY.—In addition to amounts 24
5259	5259	otherwise available, there is appropriated to the 25
5260	5260	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00175 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5261	5261	TKELLEY on LAP7H3WLY3PROD with BILLS 176
5262	5262	•S 891 IS
5263	5263	Centers for Medicare & Medicaid Services Pro-1
5264	5264	gram Management Account, out of any money 2
5265	5265	in the Treasury not otherwise appropriated, 3
5266	5266	$113,000,000 for fiscal year 2025, to remain 4
5267	5267	available until expended, to carry out this sub-5
5268	5268	section. 6
5269	5269	(B) OIG.—In addition to amounts other-7
5270	5270	wise available, there is appropriated to the In-8
5271	5271	spector General of the Department of Health 9
5272	5272	and Human Services, out of any money in the 10
5273	5273	Treasury not otherwise appropriated, 11
5274	5274	$20,000,000 for fiscal year 2025, to remain 12
5275	5275	available until expended, to carry out this sub-13
5276	5276	section. 14
5277	5277	(b) GAO S
5278	5278	TUDY ANDREPORT ONPRICE-RELATED 15
5279	5279	C
5280	5280	OMPENSATIONACROSS THESUPPLYCHAIN.— 16
5281	5281	(1) S
5282	5282	TUDY.—The Comptroller General of the 17
5283	5283	United States (in this subsection referred to as the 18
5284	5284	‘‘Comptroller General’’) shall conduct a study de-19
5285	5285	scribing the use of compensation and payment struc-20
5286	5286	tures related to a prescription drug’s price within 21
5287	5287	the retail prescription drug supply chain in part D 22
5288	5288	of title XVIII of the Social Security Act (42 U.S.C. 23
5289	5289	1395w–101 et seq.). Such study shall summarize in-24
5290	5290	formation from Federal agencies and industry ex-25
5291	5291	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00176 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5292	5292	TKELLEY on LAP7H3WLY3PROD with BILLS 177
5293	5293	•S 891 IS
5294	5294	perts, to the extent available, with respect to the fol-1
5295	5295	lowing: 2
5296	5296	(A) The type, magnitude, other features 3
5297	5297	(such as the pricing benchmarks used), and 4
5298	5298	prevalence of compensation and payment struc-5
5299	5299	tures related to a prescription drug’s price, 6
5300	5300	such as calculating fee amounts as a percentage 7
5301	5301	of a prescription drug’s price, between inter-8
5302	5302	mediaries in the prescription drug supply chain, 9
5303	5303	including— 10
5304	5304	(i) pharmacy benefit managers; 11
5305	5305	(ii) PDP sponsors offering prescrip-12
5306	5306	tion drug plans and Medicare Advantage 13
5307	5307	organizations offering MA–PD plans; 14
5308	5308	(iii) drug wholesalers; 15
5309	5309	(iv) pharmacies; 16
5310	5310	(v) manufacturers; 17
5311	5311	(vi) pharmacy services administrative 18
5312	5312	organizations; 19
5313	5313	(vii) brokers, auditors, consultants, 20
5314	5314	and other entities that— 21
5315	5315	(I) advise PDP sponsors offering 22
5316	5316	prescription drug plans and Medicare 23
5317	5317	Advantage organizations offering MA– 24
5318	5318	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00177 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5319	5319	TKELLEY on LAP7H3WLY3PROD with BILLS 178
5320	5320	•S 891 IS
5321	5321	PD plans regarding pharmacy bene-1
5322	5322	fits; or 2
5323	5323	(II) review PDP sponsor and 3
5324	5324	Medicare Advantage organization con-4
5325	5325	tracts with pharmacy benefit man-5
5326	5326	agers; and 6
5327	5327	(viii) other service providers that con-7
5328	5328	tract with any of the entities described in 8
5329	5329	clauses (i) through (vii) that may use 9
5330	5330	price-related compensation and payment 10
5331	5331	structures, such as rebate aggregators (or 11
5332	5332	other entities that negotiate or process 12
5333	5333	price concessions on behalf of pharmacy 13
5334	5334	benefit managers, plan sponsors, or phar-14
5335	5335	macies). 15
5336	5336	(B) The primary business models and com-16
5337	5337	pensation structures for each category of inter-17
5338	5338	mediary described in subparagraph (A). 18
5339	5339	(C) Variation in price-related compensation 19
5340	5340	structures between affiliated entities (such as 20
5341	5341	entities with common ownership, either full or 21
5342	5342	partial, and subsidiary relationships) and unaf-22
5343	5343	filiated entities. 23
5344	5344	(D) Potential conflicts of interest among 24
5345	5345	contracting entities related to the use of pre-25
5346	5346	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00178 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5347	5347	TKELLEY on LAP7H3WLY3PROD with BILLS 179
5348	5348	•S 891 IS
5349	5349	scription drug price-related compensation struc-1
5350	5350	tures, such as the potential for fees or other 2
5351	5351	payments set as a percentage of a prescription 3
5352	5352	drug’s price to advantage formulary selection, 4
5353	5353	distribution, or purchasing of prescription drugs 5
5354	5354	with higher prices. 6
5355	5355	(E) Notable differences, if any, in the use 7
5356	5356	and level of price-based compensation struc-8
5357	5357	tures over time and between different market 9
5358	5358	segments, such as under part D of title XVIII 10
5359	5359	of the Social Security Act (42 U.S.C. 1395w– 11
5360	5360	101 et seq.) and the Medicaid program under 12
5361	5361	title XIX of such Act (42 U.S.C. 1396 et seq.). 13
5362	5362	(F) The effects of drug price-related com-14
5363	5363	pensation structures and alternative compensa-15
5364	5364	tion structures on Federal health care programs 16
5365	5365	and program beneficiaries, including with re-17
5366	5366	spect to cost-sharing, premiums, Federal out-18
5367	5367	lays, biosimilar and generic drug adoption and 19
5368	5368	utilization, drug shortage risks, and the poten-20
5369	5369	tial for fees set as a percentage of a drug’s 21
5370	5370	price to advantage the formulary selection, dis-22
5371	5371	tribution, or purchasing of drugs with higher 23
5372	5372	prices. 24
5373	5373	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00179 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5374	5374	TKELLEY on LAP7H3WLY3PROD with BILLS 180
5375	5375	•S 891 IS
5376	5376	(G) Other issues determined to be relevant 1
5377	5377	and appropriate by the Comptroller General. 2
5378	5378	(2) R
5379	5379	EPORT.—Not later than 2 years after the 3
5380	5380	date of enactment of this section, the Comptroller 4
5381	5381	General shall submit to Congress a report containing 5
5382	5382	the results of the study conducted under paragraph 6
5383	5383	(1), together with recommendations for such legisla-7
5384	5384	tion and administrative action as the Comptroller 8
5385	5385	General determines appropriate. 9
5386	5386	(c) M
5387	5387	EDPAC REPORTS ON AGREEMENTS WITH 10
5388	5388	P
5389	5389	HARMACYBENEFITMANAGERSWITHRESPECT TOPRE-11
5390	5390	SCRIPTIONDRUGPLANS ANDMA–PD PLANS.— 12
5391	5391	(1) I
5392	5392	N GENERAL.—The Medicare Payment Ad-13
5393	5393	visory Commission shall submit to Congress the fol-14
5394	5394	lowing reports: 15
5395	5395	(A) I
5396	5396	NITIAL REPORT.—Not later than the 16
5397	5397	first March 15 occurring after the date that is 17
5398	5398	2 years after the date on which the Secretary 18
5399	5399	makes the data available to the Commission, a 19
5400	5400	report regarding agreements with pharmacy 20
5401	5401	benefit managers with respect to prescription 21
5402	5402	drug plans and MA–PD plans. Such report 22
5403	5403	shall include, to the extent practicable— 23
5404	5404	(i) a description of trends and pat-24
5405	5405	terns, including relevant averages, totals, 25
5406	5406	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00180 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5407	5407	TKELLEY on LAP7H3WLY3PROD with BILLS 181
5408	5408	•S 891 IS
5409	5409	and other figures for the types of informa-1
5410	5410	tion submitted; 2
5411	5411	(ii) an analysis of any differences in 3
5412	5412	agreements and their effects on plan en-4
5413	5413	rollee out-of-pocket spending and average 5
5414	5414	pharmacy reimbursement, and other im-6
5415	5415	pacts; and 7
5416	5416	(iii) any recommendations the Com-8
5417	5417	mission determines appropriate. 9
5418	5418	(B) F
5419	5419	INAL REPORT.—Not later than 2 10
5420	5420	years after the date on which the Commission 11
5421	5421	submits the initial report under subparagraph 12
5422	5422	(A), a report describing any changes with re-13
5423	5423	spect to the information described in subpara-14
5424	5424	graph (A) over time, together with any rec-15
5425	5425	ommendations the Commission determines ap-16
5426	5426	propriate. 17
5427	5427	(2) F
5428	5428	UNDING.—In addition to amounts other-18
5429	5429	wise available, there is appropriated to the Medicare 19
5430	5430	Payment Advisory Commission, out of any money in 20
5431	5431	the Treasury not otherwise appropriated, 21
5432	5432	$1,000,000 for fiscal year 2025, to remain available 22
5433	5433	until expended, to carry out this subsection. 23
5434	5434	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00181 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5435	5435	TKELLEY on LAP7H3WLY3PROD with BILLS 182
5436	5436	•S 891 IS
5437	5437	SEC. 228. REQUIRING A SEPARATE IDENTIFICATION NUM-1
5438	5438	BER AND AN ATTESTATION FOR EACH OFF- 2
5439	5439	CAMPUS OUTPATIENT DEPARTMENT OF A 3
5440	5440	PROVIDER. 4
5441	5441	(a) I
5442	5442	NGENERAL.—Section 1833(t) of the Social Se-5
5443	5443	curity Act (42 U.S.C. 1395l(t)) is amended by adding at 6
5444	5444	the end the following new paragraph: 7
5445	5445	‘‘(23) U
5446	5446	SE OF UNIQUE HEALTH IDENTIFIERS ; 8
5447	5447	ATTESTATION.— 9
5448	5448	‘‘(A) I
5449	5449	N GENERAL.—No payment may be 10
5450	5450	made under this subsection (or under an appli-11
5451	5451	cable payment system pursuant to paragraph 12
5452	5452	(21)) for items and services furnished on or 13
5453	5453	after January 1, 2026, by an off-campus out-14
5454	5454	patient department of a provider (as defined in 15
5455	5455	subparagraph (C)) unless— 16
5456	5456	‘‘(i) such department has obtained, 17
5457	5457	and such items and services are billed 18
5458	5458	under, a standard unique health identifier 19
5459	5459	for health care providers (as described in 20
5460	5460	section 1173(b)) that is separate from 21
5461	5461	such identifier for such provider; 22
5462	5462	‘‘(ii) such provider has submitted to 23
5463	5463	the Secretary, during the 2-year period 24
5464	5464	ending on the date such items and services 25
5465	5465	are so furnished, an initial provider-based 26
5466	5466	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00182 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5467	5467	TKELLEY on LAP7H3WLY3PROD with BILLS 183
5468	5468	•S 891 IS
5469	5469	status attestation that such department is 1
5470	5470	compliant with the requirements described 2
5471	5471	in section 413.65 of title 42, Code of Fed-3
5472	5472	eral Regulations (or a successor regula-4
5473	5473	tion); and 5
5474	5474	‘‘(iii) after such provider has sub-6
5475	5475	mitted an attestation under clause (ii), 7
5476	5476	such provider has submitted a subsequent 8
5477	5477	attestation within the timeframe specified 9
5478	5478	by the Secretary. 10
5479	5479	‘‘(B) P
5480	5480	ROCESS FOR SUBMISSION AND RE -11
5481	5481	VIEW.—Not later than 1 year after the date of 12
5482	5482	enactment of this paragraph, the Secretary 13
5483	5483	shall, through notice and comment rulemaking, 14
5484	5484	establish a process for each provider with an 15
5485	5485	off-campus outpatient department of a provider 16
5486	5486	to submit an initial and subsequent attestation 17
5487	5487	pursuant to clauses (ii) and (iii), respectively, of 18
5488	5488	subparagraph (A), and for the Secretary to re-19
5489	5489	view each such attestation and determine, 20
5490	5490	through site visits, remote audits, or other 21
5491	5491	means (as determined appropriate by the Sec-22
5492	5492	retary), whether such department is compliant 23
5493	5493	with the requirements described in such sub-24
5494	5494	paragraph. 25
5495	5495	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00183 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5496	5496	TKELLEY on LAP7H3WLY3PROD with BILLS 184
5497	5497	•S 891 IS
5498	5498	‘‘(C) OFF-CAMPUS OUTPATIENT DEPART -1
5499	5499	MENT OF A PROVIDER DEFINED .—For purposes 2
5500	5500	of this paragraph, the term ‘off-campus out-3
5501	5501	patient department of a provider’ means a de-4
5502	5502	partment of a provider (as defined in section 5
5503	5503	413.65 of title 42, Code of Federal Regulations, 6
5504	5504	or any successor regulation) that is not lo-7
5505	5505	cated— 8
5506	5506	‘‘(i) on the campus (as defined in such 9
5507	5507	section) of such provider; or 10
5508	5508	‘‘(ii) within the distance (described in 11
5509	5509	such definition of campus) from a remote 12
5510	5510	location of a hospital facility (as defined in 13
5511	5511	such section).’’. 14
5512	5512	(b) HHS OIG A
5513	5513	NALYSIS.—Not later than January 15
5514	5514	1, 2030, the Inspector General of the Department of 16
5515	5515	Health and Human Services shall submit to Congress— 17
5516	5516	(1) an analysis of the process established by the 18
5517	5517	Secretary of Health and Human Services to conduct 19
5518	5518	the reviews and determinations described in section 20
5519	5519	1833(t)(23)(B) of the Social Security Act, as added 21
5520	5520	by subsection (a) of this section; and 22
5521	5521	(2) recommendations based on such analysis, as 23
5522	5522	the Inspector General determines appropriate. 24
5523	5523	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00184 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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5525	5525	•S 891 IS
5526	5526	SEC. 229. MEDICARE SEQUESTRATION. 1
5527	5527	Section 251A(6) of the Balanced Budget and Emer-2
5528	5528	gency Deficit Control Act of 1985 (2 U.S.C. 901a(6)) is 3
5529	5529	amended— 4
5530	5530	(1) in subparagraph (D), by striking ‘‘such 5
5531	5531	that,’’ and all that follows and inserting ‘‘such that 6
5532	5532	the payment reduction shall be 2.0 percent.’’; and 7
5533	5533	(2) by adding at the end the following: 8
5534	5534	‘‘(F) On the date on which the President sub-9
5535	5535	mits the budget under section 1105 of title 31, 10
5536	5536	United States Code, for fiscal year 2033, the Presi-11
5537	5537	dent shall order a sequestration of payments for the 12
5538	5538	Medicare programs specified in section 256(d), effec-13
5539	5539	tive upon issuance, such that, notwithstanding the 2 14
5540	5540	percent limit specified in subparagraph (A) for such 15
5541	5541	payments— 16
5542	5542	‘‘(i) with respect to the first 2 months in 17
5543	5543	which such order is effective for such fiscal 18
5544	5544	year, the payment reduction shall be 2.0 per-19
5545	5545	cent; and 20
5546	5546	‘‘(ii) with respect to the last 10 months in 21
5547	5547	which such order is effective for such fiscal 22
5548	5548	year, the payment reduction shall be 0 per-23
5549	5549	cent.’’. 24
5550	5550	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00185 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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5552	5552	•S 891 IS
5553	5553	SEC. 230. MEDICARE IMPROVEMENT FUND. 1
5554	5554	Section 1898(b)(1) of the Social Security Act (42 2
5555	5555	U.S.C. 1395iii(b)(1)) is amended by striking 3
5556	5556	‘‘$1,251,000,000’’ and inserting ‘‘$1,938,000,000’’. 4
5557	5557	TITLE III—HUMAN SERVICES 5
5558	5558	SEC. 301. SEXUAL RISK AVOIDANCE EDUCATION EXTEN-6
5559	5559	SION. 7
5560	5560	Section 510 of the Social Security Act (42 U.S.C. 8
5561	5561	710) is amended— 9
5562	5562	(1) in subsection (a)— 10
5563	5563	(A) in paragraph (1)— 11
5564	5564	(i) by striking ‘‘and for the period’’ 12
5565	5565	and inserting ‘‘for the period’’; 13
5566	5566	(ii) by inserting ‘‘for the period begin-14
5567	5567	ning on April 1, 2025, and ending on Sep-15
5568	5568	tember 30, 2025, and for the period begin-16
5569	5569	ning on October 1, 2025, and ending on 17
5570	5570	December 31, 2025,’’ before ‘‘allot to each 18
5571	5571	State’’; and 19
5572	5572	(iii) by striking ‘‘for fiscal year 2024 20
5573	5573	or 2025’’ and inserting ‘‘for fiscal year 21
5574	5574	2024, 2025, or 2026’’; and 22
5575	5575	(B) in paragraph (2), by striking ‘‘or 23
5576	5576	2025’’ each place it appears and inserting ‘‘, 24
5577	5577	2025, or 2026’’; and 25
5578	5578	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00186 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5579	5579	TKELLEY on LAP7H3WLY3PROD with BILLS 187
5580	5580	•S 891 IS
5581	5581	(2) in subsection (f)(1), by striking ‘‘and for 1
5582	5582	the period beginning on October 1, 2024, and ending 2
5583	5583	on March 31, 2025, an amount equal to the pro rata 3
5584	5584	portion of the amount appropriated for the cor-4
5585	5585	responding period for fiscal year 2024’’ and insert-5
5586	5586	ing ‘‘for the period beginning on October 1, 2024, 6
5587	5587	and ending on March 31, 2025, and for the period 7
5588	5588	beginning on April 1, 2025, and ending on Sep-8
5589	5589	tember 30, 2025, an amount equal to the pro rata 9
5590	5590	portion of the amount appropriated for the cor-10
5591	5591	responding period for fiscal year 2024, and for the 11
5592	5592	period beginning on October 1, 2025, and ending on 12
5593	5593	December 31, 2025, an amount equal to the pro 13
5594	5594	rata portion of the amount appropriated for the cor-14
5595	5595	responding period for fiscal year 2025’’ 15
5596	5596	SEC. 302. PERSONAL RESPONSIBILITY EDUCATION EXTEN-16
5597	5597	SION. 17
5598	5598	Section 513 of the Social Security Act (42 U.S.C. 18
5599	5599	713) is amended— 19
5600	5600	(1) in subsection (a)(1)— 20
5601	5601	(A) in subparagraph (A), in the matter 21
5602	5602	preceding clause (i)— 22
5603	5603	(i) by striking ‘‘and for the period’’ 23
5604	5604	and inserting ‘‘for the period’’; and 24
5605	5605	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00187 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5606	5606	TKELLEY on LAP7H3WLY3PROD with BILLS 188
5607	5607	•S 891 IS
5608	5608	(ii) by inserting ‘‘for the period begin-1
5609	5609	ning on April 1, 2025, and ending on Sep-2
5610	5610	tember 30, 2025, and for the period begin-3
5611	5611	ning on October 1, 2025, and ending on 4
5612	5612	December 31, 2025,’’ before ‘‘the Sec-5
5613	5613	retary shall allot’’; and 6
5614	5614	(B) in subparagraph (B)(i)— 7
5615	5615	(i) by striking ‘‘and for the period’’ 8
5616	5616	and inserting ‘‘for the period’’; and 9
5617	5617	(ii) by inserting ‘‘, for the period be-10
5618	5618	ginning on April 1, 2025, and ending on 11
5619	5619	September 30, 2025, and for the period 12
5620	5620	beginning on October 1, 2025, and ending 13
5621	5621	on December 31, 2025’’ before the period; 14
5622	5622	(2) in subsection (c)(3), by striking ‘‘fiscal year 15
5623	5623	2024 or 2025’’ and inserting ‘‘fiscal year 2024, 16
5624	5624	2025, or 2026’’; and 17
5625	5625	(3) in subsection (f), by striking ‘‘and for the 18
5626	5626	period beginning on October 1, 2024, and ending on 19
5627	5627	March 31, 2025, an amount equal to the pro rata 20
5628	5628	portion of the amount appropriated for the cor-21
5629	5629	responding period for fiscal year 2024’’ and insert-22
5630	5630	ing ‘‘for the period beginning on October 1, 2024, 23
5631	5631	and ending on March 31, 2025, and for the period 24
5632	5632	beginning on April 1, 2025, and ending on Sep-25
5633	5633	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00188 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5634	5634	TKELLEY on LAP7H3WLY3PROD with BILLS 189
5635	5635	•S 891 IS
5636	5636	tember 30, 2025, an amount equal to the pro rata 1
5637	5637	portion of the amount appropriated for the cor-2
5638	5638	responding period for fiscal year 2024, and for the 3
5639	5639	period beginning on October 1, 2025, and ending on 4
5640	5640	December 31, 2025, an amount equal to the pro 5
5641	5641	rata portion of the amount appropriated for the cor-6
5642	5642	responding period for fiscal year 2025’’. 7
5643	5643	SEC. 303. EXTENSION OF FUNDING FOR FAMILY-TO-FAMILY 8
5644	5644	HEALTH INFORMATION CENTERS. 9
5645	5645	Section 501(c)(1)(A)(viii) of the Social Security Act 10
5646	5646	(42 U.S.C. 701(c)(1)(A)(viii)) is amended— 11
5647	5647	(1) by striking ‘‘$3,000,000’’ and inserting 12
5648	5648	‘‘$7,500,000’’; and 13
5649	5649	(2) by striking ‘‘for the portion of fiscal year 14
5650	5650	2025 before April 1, 2025’’ and inserting ‘‘for the 15
5651	5651	period beginning on October 1, 2024, and ending on 16
5652	5652	December 31, 2025’’. 17
5653	5653	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00189 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5654	5654	TKELLEY on LAP7H3WLY3PROD with BILLS 190
5655	5655	•S 891 IS
5656	5656	TITLE IV—PUBLIC HEALTH 1
5657	5657	EXTENDERS 2
5658	5658	Subtitle A—Extensions 3
5659	5659	SEC. 401. EXTENSION FOR COMMUNITY HEALTH CENTERS, 4
5660	5660	NATIONAL HEALTH SERVICE CORPS, AND 5
5661	5661	TEACHING HEALTH CENTERS THAT OPERATE 6
5662	5662	GME PROGRAMS. 7
5663	5663	(a) E
5664	5664	XTENSION FOR COMMUNITYHEALTHCEN-8
5665	5665	TERS.—Section 10503(b)(1) of the Patient Protection and 9
5666	5666	Affordable Care Act (42 U.S.C. 254b–2(b)(1)) is amend-10
5667	5667	ed— 11
5668	5668	(1) in subparagraph (H), by striking ‘‘and’’ at 12
5669	5669	the end; 13
5670	5670	(2) in subparagraph (I), by striking the period 14
5671	5671	and inserting ‘‘, and $2,315,342,466 for the period 15
5672	5672	beginning on April 1, 2025, and ending on Sep-16
5673	5673	tember 30, 2025; and’’; and 17
5674	5674	(3) by adding at the end the following: 18
5675	5675	‘‘(J) $4,600,000,000 for fiscal year 2026; 19
5676	5676	and’’. 20
5677	5677	(b) E
5678	5678	XTENSION FOR THE NATIONALHEALTHSERV-21
5679	5679	ICECORPS.—Section 10503(b)(2) of the Patient Protec-22
5680	5680	tion and Affordable Care Act (42 U.S.C. 254b–2(b)(2)) 23
5681	5681	is amended— 24
5682	5682	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00190 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5683	5683	TKELLEY on LAP7H3WLY3PROD with BILLS 191
5684	5684	•S 891 IS
5685	5685	(1) in subparagraph (I), by striking ‘‘and’’ at 1
5686	5686	the end; 2
5687	5687	(2) in subparagraph (J), by striking the period 3
5688	5688	and inserting ‘‘, and $176,712,329 for the period be-4
5689	5689	ginning on April 1, 2025, and ending on September 5
5690	5690	30, 2025; and’’; and 6
5691	5691	(3) by adding at the end the following: 7
5692	5692	‘‘(J) $350,000,000 for fiscal year 2026.’’. 8
5693	5693	(c) T
5694	5694	EACHINGHEALTHCENTERSTHATOPERATE 9
5695	5695	G
5696	5696	RADUATEMEDICALEDUCATIONPROGRAMS.—Section 10
5697	5697	340H(g)(1) of the Public Health Service Act (42 U.S.C. 11
5698	5698	256h(g)(1)) is amended— 12
5699	5699	(1) in subparagraph (D), by striking ‘‘; and’’ 13
5700	5700	and inserting a semicolon; 14
5701	5701	(2) in subparagraph (E), by striking the period 15
5702	5702	and inserting a semicolon; and 16
5703	5703	(3) by adding at the end the following: ‘‘ 17
5704	5704	‘‘(F) $112,849,315 for the period begin-18
5705	5705	ning on January 1, 2025, and ending on Sep-19
5706	5706	tember 30, 2025; 20
5707	5707	‘‘(G) $225,000,000 for fiscal year 2026; 21
5708	5708	‘‘(H) $250,000,000 for fiscal year 2027; 22
5709	5709	‘‘(I) $275,000,000 for fiscal year 2028; 23
5710	5710	and 24
5711	5711	‘‘(J) $300,000,000 for fiscal year 2029.’’. 25
5712	5712	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00191 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5713	5713	TKELLEY on LAP7H3WLY3PROD with BILLS 192
5714	5714	•S 891 IS
5715	5715	(d) APPLICATION OFPROVISIONS.—Amounts appro-1
5716	5716	priated pursuant to the amendments made by this section 2
5717	5717	shall be subject to the requirements contained in Public 3
5718	5718	Law 118–47 for funds for programs authorized under sec-4
5719	5719	tions 330 through 340 of the Public Health Service Act 5
5720	5720	(42 U.S.C. 254b et seq.). 6
5721	5721	(e) C
5722	5722	ONFORMING AMENDMENTS.—Section 7
5723	5723	3014(h)(4) of title 18, United States Code, is amended 8
5724	5724	by striking ‘‘and section 3101(d) of the Health Extensions 9
5725	5725	and Other Matters Act, 2025’’ and inserting ‘‘section 10
5726	5726	3101(d) of the Health Extensions and Other Matters Act, 11
5727	5727	2025, and section 401(d) of the Bipartisan Health Care 12
5728	5728	Act’’. 13
5729	5729	SEC. 402. EXTENSION OF SPECIAL DIABETES PROGRAMS. 14
5730	5730	(a) E
5731	5731	XTENSION OFSPECIALDIABETESPROGRAMS 15
5732	5732	FORTYPEI DIABETES.—Section 330B(b)(2) of the Pub-16
5733	5733	lic Health Service Act (42 U.S.C. 254c–2(b)(2)) is amend-17
5734	5734	ed— 18
5735	5735	(1) in subparagraph (E), by striking ‘‘and’’ at 19
5736	5736	the end; 20
5737	5737	(2) in subparagraph (F), by striking the period 21
5738	5738	at the end and inserting ‘‘, and $110,327,296 for 22
5739	5739	the period beginning on April 1, 2025, and ending 23
5740	5740	on September 30, 2025; and’’; and 24
5741	5741	(3) by adding at the end the following: 25
5742	5742	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00192 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5743	5743	TKELLEY on LAP7H3WLY3PROD with BILLS 193
5744	5744	•S 891 IS
5745	5745	‘‘(G) $200,000,000 for fiscal year 2026, to 1
5746	5746	remain available until expended.’’. 2
5747	5747	(b) E
5748	5748	XTENDINGFUNDING FORSPECIALDIABETES 3
5749	5749	P
5750	5750	ROGRAMS FOR INDIANS.—Section 330C(c)(2) of the 4
5751	5751	Public Health Service Act (42 U.S.C. 254c–3(c)(2)) is 5
5752	5752	amended— 6
5753	5753	(1) in subparagraph (E), by striking ‘‘and’’ at 7
5754	5754	the end; 8
5755	5755	(2) in subparagraph (F), by striking the period 9
5756	5756	at the end and inserting ‘‘, and $110,327,296 for 10
5757	5757	the period beginning on April 1, 2025, and ending 11
5758	5758	on September 30, 2025; and’’; and 12
5759	5759	(3) by adding at the end the following: 13
5760	5760	‘‘(G) $200,000,000 for fiscal year 2026, to 14
5761	5761	remain available until expended.’’. 15
5762	5762	Subtitle B—World Trade Center 16
5763	5763	Health Program 17
5764	5764	SEC. 411. 9/11 RESPONDER AND SURVIVOR HEALTH FUND-18
5765	5765	ING CORRECTIONS. 19
5766	5766	(a) I
5767	5767	NGENERAL.—Section 3351(a)(2)(A) of the 20
5768	5768	Public Health Service Act (42 U.S.C. 300mm– 21
5769	5769	61(a)(2)(A)) is amended— 22
5770	5770	(1) in clause (x), by striking ‘‘; and’’ and insert-23
5771	5771	ing a semicolon; 24
5772	5772	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00193 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5773	5773	TKELLEY on LAP7H3WLY3PROD with BILLS 194
5774	5774	•S 891 IS
5775	5775	(2) by redesignating clause (xi) as clause (xii); 1
5776	5776	and 2
5777	5777	(3) by inserting after clause (x), the following: 3
5778	5778	‘‘(xi) for each of fiscal years 2026 4
5779	5779	through 2040— 5
5780	5780	‘‘(I) the amount determined 6
5781	5781	under this subparagraph for the pre-7
5782	5782	vious fiscal year multiplied by 1.05; 8
5783	5783	multiplied by 9
5784	5784	‘‘(II) the ratio of— 10
5785	5785	‘‘(aa) the total number of 11
5786	5786	individuals enrolled in the WTC 12
5787	5787	Program on July 1 of such pre-13
5788	5788	vious fiscal year; to 14
5789	5789	‘‘(bb) the total number of 15
5790	5790	individuals so enrolled on July 1 16
5791	5791	of the fiscal year prior to such 17
5792	5792	previous fiscal year; and’’. 18
5793	5793	(b) R
5794	5794	EPORT TOCONGRESS.— 19
5795	5795	(1) I
5796	5796	N GENERAL.—Not later than 3 years after 20
5797	5797	the date of enactment of this Act, the Secretary of 21
5798	5798	Health and Human Services (referred to in this sub-22
5799	5799	section as the ‘‘Secretary’’) shall conduct an assess-23
5800	5800	ment of anticipated budget authority and outlays of 24
5801	5801	the World Trade Center Health Program (referred 25
5802	5802	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00194 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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5804	5804	•S 891 IS
5805	5805	to in this subsection as the ‘‘Program’’) through the 1
5806	5806	duration of the Program and submit a report sum-2
5807	5807	marizing such assessment to— 3
5808	5808	(A) the Speaker and minority leader of the 4
5809	5809	House of Representatives; 5
5810	5810	(B) the majority and minority leaders of 6
5811	5811	the Senate; 7
5812	5812	(C) the Committee on Health, Education, 8
5813	5813	Labor, and Pensions and the Committee on the 9
5814	5814	Budget of the Senate; and 10
5815	5815	(D) the Committee on Energy and Com-11
5816	5816	merce and the Committee on the Budget of the 12
5817	5817	House of Representatives. 13
5818	5818	(2) I
5819	5819	NCLUSIONS.—The report required under 14
5820	5820	paragraph (1) shall include— 15
5821	5821	(A) a projection of Program budgetary 16
5822	5822	needs on a per-fiscal year basis through fiscal 17
5823	5823	year 2090; 18
5824	5824	(B) a review of Program modeling for each 19
5825	5825	of fiscal years 2017 through the fiscal year 20
5826	5826	prior to the fiscal year in which the report is 21
5827	5827	issued to assess how anticipated budgetary 22
5828	5828	needs compared to actual expenditures; 23
5829	5829	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00195 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5830	5830	TKELLEY on LAP7H3WLY3PROD with BILLS 196
5831	5831	•S 891 IS
5832	5832	(C) an assessment of the projected budget 1
5833	5833	authority and expenditures of the Program 2
5834	5834	through fiscal year 2090 by comparing— 3
5835	5835	(i) such projected authority and ex-4
5836	5836	penditures resulting from application of 5
5837	5837	section 3351(a)(2)(A) of the Public Health 6
5838	5838	Service Act (42 U.S.C. 300mm– 7
5839	5839	61(a)(2)(A)), as amended by subsection 8
5840	5840	(a); and 9
5841	5841	(ii) such projected authority and ex-10
5842	5842	penditures that would result if such section 11
5843	5843	were amended so that the formula under 12
5844	5844	clause (xi) of such section, as amended by 13
5845	5845	subsection (a), were to be extended 14
5846	5846	through fiscal year 2090; and 15
5847	5847	(D) any recommendations of the Secretary 16
5848	5848	to make changes to the formula under such sec-17
5849	5849	tion 3351(a)(2)(A), as so amended, to fully off-18
5850	5850	set anticipated Program expenditures through 19
5851	5851	fiscal year 2090. 20
5852	5852	(c) T
5853	5853	ECHNICALAMENDMENTS.—Title XXXIII of the 21
5854	5854	Public Health Service Act (42 U.S.C. 300mm et seq.) is 22
5855	5855	amended— 23
5856	5856	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00196 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5857	5857	TKELLEY on LAP7H3WLY3PROD with BILLS 197
5858	5858	•S 891 IS
5859	5859	(1) in section 3352(d) (42 U.S.C. 300mm– 1
5860	5860	62(d)), by striking ‘‘Any amounts’’ and inserting 2
5861	5861	‘‘Any unobligated amounts’’; 3
5862	5862	(2) in section 3353(d) (42 U.S.C. 300mm– 4
5863	5863	63(d)), by striking ‘‘Any amounts’’ and inserting 5
5864	5864	‘‘Any unobligated amounts’’; and 6
5865	5865	(3) in section 3354(d) (42 U.S.C. 300mm– 7
5866	5866	64(d)), by striking ‘‘Any amounts’’ and inserting 8
5867	5867	‘‘Any unobligated amounts’’. 9
5868	5868	TITLE V—SUPPORT ACT 10
5869	5869	REAUTHORIZATION 11
5870	5870	SEC. 501. SHORT TITLE. 12
5871	5871	This title may be cited as the ‘‘SUPPORT for Pa-13
5872	5872	tients and Communities Reauthorization Act of 2025’’. 14
5873	5873	Subtitle A—Prevention 15
5874	5874	SEC. 511. PRENATAL AND POSTNATAL HEALTH. 16
5875	5875	Section 317L(d) of the Public Health Service Act (42 17
5876	5876	U.S.C. 247b–13(d)) is amended by striking ‘‘such sums 18
5877	5877	as may be necessary for each of the fiscal years 2019 19
5878	5878	through 2023’’ and inserting ‘‘$4,250,000 for each of fis-20
5879	5879	cal years 2025 through 2029’’. 21
5880	5880	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00197 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5881	5881	TKELLEY on LAP7H3WLY3PROD with BILLS 198
5882	5882	•S 891 IS
5883	5883	SEC. 512. MONITORING AND EDUCATION REGARDING IN-1
5884	5884	FECTIONS ASSOCIATED WITH ILLICIT DRUG 2
5885	5885	USE AND OTHER RISK FACTORS. 3
5886	5886	Section 317N(d) of the Public Health Service Act (42 4
5887	5887	U.S.C. 247b–15(d)) is amended by striking ‘‘fiscal years 5
5888	5888	2019 through 2023’’ and inserting ‘‘fiscal years 2025 6
5889	5889	through 2029’’. 7
5890	5890	SEC. 513. PREVENTING OVERDOSES OF CONTROLLED SUB-8
5891	5891	STANCES. 9
5892	5892	(a) I
5893	5893	NGENERAL.—Section 392A of the Public 10
5894	5894	Health Service Act (42 U.S.C. 280b–1) is amended— 11
5895	5895	(1) in subsection (a)(2)— 12
5896	5896	(A) in subparagraph (C), by inserting ‘‘and 13
5897	5897	associated risks’’ before the period at the end; 14
5898	5898	and 15
5899	5899	(B) in subparagraph (D), by striking 16
5900	5900	‘‘opioids’’ and inserting ‘‘substances causing 17
5901	5901	overdose’’; and 18
5902	5902	(2) in subsection (b)(2)— 19
5903	5903	(A) in subparagraph (B), by inserting ‘‘, 20
5904	5904	and associated risk factors,’’ after ‘‘such 21
5905	5905	overdoses’’; 22
5906	5906	(B) in subparagraph (C), by striking ‘‘cod-23
5907	5907	ing’’ and inserting ‘‘monitoring and identi-24
5908	5908	fying’’; 25
5909	5909	(C) in subparagraph (E)— 26
5910	5910	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00198 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
5911	5911	TKELLEY on LAP7H3WLY3PROD with BILLS 199
5912	5912	•S 891 IS
5913	5913	(i) by inserting a comma after ‘‘public 1
5914	5914	health laboratories’’; and 2
5915	5915	(ii) by inserting ‘‘and other emerging 3
5916	5916	substances related’’ after ‘‘analogues’’; and 4
5917	5917	(D) in subparagraph (F), by inserting 5
5918	5918	‘‘and associated risk factors’’ after ‘‘overdoses’’. 6
5919	5919	(b) A
5920	5920	DDITIONALGRANTS.—Section 392A(a)(3) of 7
5921	5921	the Public Health Service Act (42 U.S.C. 280b–1(a)(3)) 8
5922	5922	is amended— 9
5923	5923	(1) in the matter preceding subparagraph (A), 10
5924	5924	by striking ‘‘and Indian Tribes—’’ and inserting 11
5925	5925	‘‘and Indian Tribes for the following purposes:’’; 12
5926	5926	(2) by amending subparagraph (A) to read as 13
5927	5927	follows: 14
5928	5928	‘‘(A) To carry out innovative projects for 15
5929	5929	grantees to detect, identify, and rapidly respond 16
5930	5930	to controlled substance misuse, abuse, and 17
5931	5931	overdoses, and associated risk factors, including 18
5932	5932	changes in patterns of such controlled sub-19
5933	5933	stance use. Such projects may include the use 20
5934	5934	of innovative, evidence-based strategies for de-21
5935	5935	tecting such patterns, such as wastewater sur-22
5936	5936	veillance, if proven to support actionable pre-23
5937	5937	vention strategies, in a manner consistent with 24
5938	5938	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00199 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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5940	5940	•S 891 IS
5941	5941	applicable Federal and State privacy laws.’’; 1
5942	5942	and 2
5943	5943	(3) in subparagraph (B), by striking ‘‘for any’’ 3
5944	5944	and inserting ‘‘For any’’. 4
5945	5945	(c) A
5946	5946	UTHORIZATION OF APPROPRIATIONS.—Section 5
5947	5947	392A(e) of the Public Health Service Act (42 U.S.C. 6
5948	5948	280b–1(e)) is amended by striking ‘‘$496,000,000 for 7
5949	5949	each of fiscal years 2019 through 2023’’ and inserting 8
5950	5950	‘‘$505,579,000 for each of fiscal years 2025 through 9
5951	5951	2029’’. 10
5952	5952	SEC. 514. SUPPORT FOR INDIVIDUALS AND FAMILIES IM-11
5953	5953	PACTED BY FETAL ALCOHOL SPECTRUM DIS-12
5954	5954	ORDER. 13
5955	5955	(a) I
5956	5956	NGENERAL.—Part O of title III of the Public 14
5957	5957	Health Service Act (42 U.S.C. 280f et seq.) is amended 15
5958	5958	to read as follows: 16
5959	5959	‘‘PART O—FETAL ALCOHOL SYNDROME 17
5960	5960	PREVENTION AND SERVICES PROGRAM 18
5961	5961	‘‘SEC. 399H. FETAL ALCOHOL SPECTRUM DISORDERS PRE-19
5962	5962	VENTION, INTERVENTION, AND SERVICES DE-20
5963	5963	LIVERY PROGRAM. 21
5964	5964	‘‘(a) I
5965	5965	NGENERAL.—The Secretary shall establish or 22
5966	5966	continue activities to support a comprehensive fetal alcohol 23
5967	5967	spectrum disorders (referred to in this section as ‘FASD’) 24
5968	5968	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00200 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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5970	5970	•S 891 IS
5971	5971	education, prevention, identification, intervention, and 1
5972	5972	services delivery program, which may include— 2
5973	5973	‘‘(1) an education and public awareness pro-3
5974	5974	gram to support, conduct, and evaluate the effective-4
5975	5975	ness of— 5
5976	5976	‘‘(A) educational programs targeting 6
5977	5977	health professions schools, social and other sup-7
5978	5978	portive services, educators and counselors and 8
5979	5979	other service providers in all phases of child-9
5980	5980	hood development, and other relevant service 10
5981	5981	providers, concerning the prevention, identifica-11
5982	5982	tion, and provision of services for infants, chil-12
5983	5983	dren, adolescents and adults with FASD; 13
5984	5984	‘‘(B) strategies to educate school-age chil-14
5985	5985	dren, including pregnant and high-risk youth, 15
5986	5986	concerning FASD; 16
5987	5987	‘‘(C) public and community awareness pro-17
5988	5988	grams concerning FASD; and 18
5989	5989	‘‘(D) strategies to coordinate information 19
5990	5990	and services across affected community agen-20
5991	5991	cies, including agencies providing social services 21
5992	5992	such as foster care, adoption, and social work, 22
5993	5993	agencies providing health services, and agencies 23
5994	5994	involved in education, vocational training and 24
5995	5995	civil and criminal justice; 25
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5998	5998	•S 891 IS
5999	5999	‘‘(2) supporting and conducting research on 1
6000	6000	FASD, as appropriate, including to— 2
6001	6001	‘‘(A) develop appropriate medical diag-3
6002	6002	nostic methods for identifying FASD; and 4
6003	6003	‘‘(B) develop effective culturally and lin-5
6004	6004	guistically appropriate evidence-based or evi-6
6005	6005	dence-informed interventions and appropriate 7
6006	6006	supports for preventing prenatal alcohol expo-8
6007	6007	sure, which may co-occur with exposure to other 9
6008	6008	substances; 10
6009	6009	‘‘(3) building State and Tribal capacity for the 11
6010	6010	identification, treatment, and support of individuals 12
6011	6011	with FASD and their families, which may include— 13
6012	6012	‘‘(A) utilizing and adapting existing Fed-14
6013	6013	eral, State, or Tribal programs to include 15
6014	6014	FASD identification and FASD-informed sup-16
6015	6015	port; 17
6016	6016	‘‘(B) developing and expanding screening 18
6017	6017	and diagnostic capacity for FASD; 19
6018	6018	‘‘(C) developing, implementing, and evalu-20
6019	6019	ating targeted FASD-informed intervention 21
6020	6020	programs for FASD; 22
6021	6021	‘‘(D) providing training with respect to 23
6022	6022	FASD for professionals across relevant sectors; 24
6023	6023	and 25
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6026	6026	•S 891 IS
6027	6027	‘‘(E) disseminating information about 1
6028	6028	FASD and support services to affected individ-2
6029	6029	uals and their families; and 3
6030	6030	‘‘(4) an applied research program concerning 4
6031	6031	intervention and prevention to support and conduct 5
6032	6032	service demonstration projects, clinical studies and 6
6033	6033	other research models providing advocacy, edu-7
6034	6034	cational and vocational training, counseling, medical 8
6035	6035	and mental health, and other supportive services, as 9
6036	6036	well as models that integrate and coordinate such 10
6037	6037	services, that are aimed at the unique challenges fac-11
6038	6038	ing individuals with Fetal Alcohol Syndrome or 12
6039	6039	Fetal Alcohol Effect and their families. 13
6040	6040	‘‘(b) G
6041	6041	RANTS ANDTECHNICALASSISTANCE.— 14
6042	6042	‘‘(1) I
6043	6043	N GENERAL.—The Secretary may award 15
6044	6044	grants, cooperative agreements and contracts and 16
6045	6045	provide technical assistance to eligible entities to 17
6046	6046	carry out subsection (a). 18
6047	6047	‘‘(2) E
6048	6048	LIGIBLE ENTITIES.—To be eligible to re-19
6049	6049	ceive a grant, or enter into a cooperative agreement 20
6050	6050	or contract, under this section, an entity shall— 21
6051	6051	‘‘(A) be a State, Indian Tribe or Tribal or-22
6052	6052	ganization, local government, scientific or aca-23
6053	6053	demic institution, or nonprofit organization; 24
6054	6054	and 25
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6057	6057	•S 891 IS
6058	6058	‘‘(B) prepare and submit to the Secretary 1
6059	6059	an application at such time, in such manner, 2
6060	6060	and containing such information as the Sec-3
6061	6061	retary may require, including a description of 4
6062	6062	the activities that the entity intends to carry 5
6063	6063	out using amounts received under this section. 6
6064	6064	‘‘(3) A
6065	6065	DDITIONAL APPLICATION CONTENTS .— 7
6066	6066	The Secretary may require that an eligible entity in-8
6067	6067	clude in the application submitted under paragraph 9
6068	6068	(2)(B)— 10
6069	6069	‘‘(A) a designation of an individual to 11
6070	6070	serve as a FASD State or Tribal coordinator of 12
6071	6071	activities such eligible entity proposes to carry 13
6072	6072	out through a grant, cooperative agreement, or 14
6073	6073	contract under this section; and 15
6074	6074	‘‘(B) a description of an advisory com-16
6075	6075	mittee the entity will establish to provide guid-17
6076	6076	ance for the entity on developing and imple-18
6077	6077	menting a statewide or Tribal strategic plan to 19
6078	6078	prevent FASD and provide for the identifica-20
6079	6079	tion, treatment, and support of individuals with 21
6080	6080	FASD and their families. 22
6081	6081	‘‘(c) D
6082	6082	EFINITION OFFASD-INFORMED.—For pur-23
6083	6083	poses of this section, the term ‘FASD-informed’, with re-24
6084	6084	spect to support or an intervention program, means that 25
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6087	6087	•S 891 IS
6088	6088	such support or intervention program uses culturally and 1
6089	6089	linguistically informed evidence-based or practice-based 2
6090	6090	interventions and appropriate resources to support an im-3
6091	6091	proved quality of life for an individual with FASD and 4
6092	6092	the family of such individual. 5
6093	6093	‘‘SEC. 399I. STRENGTHENING CAPACITY AND EDUCATION 6
6094	6094	FOR FETAL ALCOHOL SPECTRUM DIS-7
6095	6095	ORDERS. 8
6096	6096	‘‘(a) I
6097	6097	NGENERAL.—The Secretary shall award 9
6098	6098	grants, contracts, or cooperative agreements, as the Sec-10
6099	6099	retary determines appropriate, to public or nonprofit pri-11
6100	6100	vate entities with demonstrated expertise in the field of 12
6101	6101	fetal alcohol spectrum disorders (referred to in this section 13
6102	6102	as ‘FASD’). Such awards shall be for the purposes of 14
6103	6103	building local, Tribal, State, and nationwide capacities to 15
6104	6104	prevent the occurrence of FASD by carrying out the pro-16
6105	6105	grams described in subsection (b). 17
6106	6106	‘‘(b) P
6107	6107	ROGRAMS.—An entity receiving an award 18
6108	6108	under subsection (a) may use such award for the following 19
6109	6109	purposes: 20
6110	6110	‘‘(1) Developing and supporting public edu-21
6111	6111	cation and outreach activities to raise public aware-22
6112	6112	ness of the risks associated with alcohol consumption 23
6113	6113	during pregnancy. 24
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6116	6116	•S 891 IS
6117	6117	‘‘(2) Acting as a clearinghouse for evidence- 1
6118	6118	based resources on FASD prevention, identification, 2
6119	6119	and culturally and linguistically appropriate best 3
6120	6120	practices to help inform systems of care for individ-4
6121	6121	uals with FASD across their lifespan. 5
6122	6122	‘‘(3) Increasing awareness and understanding 6
6123	6123	of efficacious, evidence-based screening tools and 7
6124	6124	culturally and linguistically appropriate evidence- 8
6125	6125	based intervention services and best practices, which 9
6126	6126	may include improving the capacity for State, Trib-10
6127	6127	al, and local affiliates. 11
6128	6128	‘‘(4) Providing technical assistance to recipients 12
6129	6129	of grants, cooperative agreements, or contracts 13
6130	6130	under section 399H, as appropriate. 14
6131	6131	‘‘(c) A
6132	6132	PPLICATION.—To be eligible for a grant, con-15
6133	6133	tract, or cooperative agreement under this section, an enti-16
6134	6134	ty shall submit to the Secretary an application at such 17
6135	6135	time, in such manner, and containing such information as 18
6136	6136	the Secretary may require. 19
6137	6137	‘‘(d) S
6138	6138	UBCONTRACTING.—A public or private non-20
6139	6139	profit entity may carry out the following activities required 21
6140	6140	under this section through contracts or cooperative agree-22
6141	6141	ments with other public and private nonprofit entities with 23
6142	6142	demonstrated expertise in FASD: 24
6143	6143	‘‘(1) Resource development and dissemination. 25
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6146	6146	•S 891 IS
6147	6147	‘‘(2) Intervention services. 1
6148	6148	‘‘(3) Training and technical assistance. 2
6149	6149	‘‘SEC. 399J. AUTHORIZATION OF APPROPRIATIONS. 3
6150	6150	‘‘There are authorized to be appropriated to carry out 4
6151	6151	this part $12,500,000 for each of fiscal years 2025 5
6152	6152	through 2029.’’. 6
6153	6153	(b) R
6154	6154	EPORT.—Not later than 4 years after the date 7
6155	6155	of enactment of this Act, and every year thereafter, the 8
6156	6156	Secretary of Health and Human Services shall prepare 9
6157	6157	and submit to the Committee on Health, Education, 10
6158	6158	Labor, and Pensions of the Senate and the Committee on 11
6159	6159	Energy and Commerce of the House of Representatives 12
6160	6160	a report containing— 13
6161	6161	(1) a review of the activities carried out pursu-14
6162	6162	ant to sections 399H and 399I of the Public Health 15
6163	6163	Service Act, as amended, to advance public edu-16
6164	6164	cation and awareness of fetal alcohol spectrum dis-17
6165	6165	orders (referred to in this section as ‘‘FASD’’); 18
6166	6166	(2) a description of— 19
6167	6167	(A) the activities carried out pursuant to 20
6168	6168	such sections 399H and 399I to identify, pre-21
6169	6169	vent, and treat FASD; and 22
6170	6170	(B) methods used to evaluate the outcomes 23
6171	6171	of such activities; and 24
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6174	6174	•S 891 IS
6175	6175	(3) an assessment of activities carried out pur-1
6176	6176	suant to such sections 399H and 399I to support in-2
6177	6177	dividuals with FASD. 3
6178	6178	SEC. 515. PROMOTING STATE CHOICE IN PDMP SYSTEMS. 4
6179	6179	Section 399O(h) of the Public Health Service Act (42 5
6180	6180	U.S.C. 280g–3(h)) is amended by adding at the end the 6
6181	6181	following: 7
6182	6182	‘‘(5) P
6183	6183	ROMOTING STATE CHOICE .—Nothing in 8
6184	6184	this section shall be construed to authorize the Sec-9
6185	6185	retary to require States to use a specific vendor or 10
6186	6186	a specific interoperability connection other than to 11
6187	6187	align with nationally recognized, consensus-based 12
6188	6188	open standards, such as in accordance with sections 13
6189	6189	3001 and 3004.’’. 14
6190	6190	SEC. 516. FIRST RESPONDER TRAINING PROGRAM. 15
6191	6191	Section 546 of the Public Health Service Act (42 16
6192	6192	U.S.C. 290ee–1) is amended— 17
6193	6193	(1) in subsection (a), by striking ‘‘tribes and 18
6194	6194	tribal’’ and inserting ‘‘Tribes and Tribal’’; 19
6195	6195	(2) in subsections (a), (c), and (d)— 20
6196	6196	(A) by striking ‘‘approved or cleared’’ each 21
6197	6197	place it appears and inserting ‘‘approved, 22
6198	6198	cleared, or otherwise legally marketed’’; and 23
6199	6199	(B) by striking ‘‘opioid’’ each place it ap-24
6200	6200	pears; 25
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6203	6203	•S 891 IS
6204	6204	(3) in subsection (f)— 1
6205	6205	(A) by striking ‘‘approved or cleared’’ each 2
6206	6206	place it appears and inserting ‘‘approved, 3
6207	6207	cleared, or otherwise legally marketed’’; 4
6208	6208	(B) in paragraph (1), by striking ‘‘opioid’’; 5
6209	6209	(C) in paragraph (2)— 6
6210	6210	(i) by striking ‘‘opioid and heroin’’ 7
6211	6211	and inserting ‘‘opioid, heroin, and other 8
6212	6212	drug’’; and 9
6213	6213	(ii) by striking ‘‘opioid overdose’’ and 10
6214	6214	inserting ‘‘overdose’’; and 11
6215	6215	(D) in paragraph (3), by striking ‘‘opioid 12
6216	6216	and heroin’’; and 13
6217	6217	(4) in subsection (h), by striking ‘‘$36,000,000 14
6218	6218	for each of fiscal years 2019 through 2023’’ and in-15
6219	6219	serting ‘‘$56,000,000 for each of fiscal years 2025 16
6220	6220	through 2029’’. 17
6221	6221	SEC. 517. DONALD J. COHEN NATIONAL CHILD TRAUMATIC 18
6222	6222	STRESS INITIATIVE. 19
6223	6223	(a) T
6224	6224	ECHNICALAMENDMENT.—The second part G of 20
6225	6225	title V of the Public Health Service Act (42 U.S.C. 290kk 21
6226	6226	et seq.), as added by section 144 of the Community Re-22
6227	6227	newal Tax Relief Act (Public Law 106–554), is amend-23
6228	6228	ed— 24
6229	6229	(1) by redesignating such part as part J; and 25
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6233	6233	(2) by redesignating sections 581 through 584 1
6234	6234	as sections 596 through 596C, respectively. 2
6235	6235	(b) I
6236	6236	NGENERAL.—Section 582 of the Public Health 3
6237	6237	Service Act (42 U.S.C. 290hh–1) is amended— 4
6238	6238	(1) in the section heading, by striking ‘‘
6239	6239	VIO-5
6240	6240	LENCE RELATED STRESS ’’ and inserting ‘‘TRAU-6
6241	6241	MATIC EVENTS ’’; 7
6242	6242	(2) in subsection (a)— 8
6243	6243	(A) in the matter preceding paragraph (1), 9
6244	6244	by striking ‘‘tribes and tribal’’ and inserting 10
6245	6245	‘‘Tribes and Tribal’’; and 11
6246	6246	(B) in paragraph (2), by inserting ‘‘and 12
6247	6247	dissemination’’ after ‘‘the development’’; 13
6248	6248	(3) in subsection (b), by inserting ‘‘and dissemi-14
6249	6249	nation’’ after ‘‘the development’’; 15
6250	6250	(4) in subsection (d)— 16
6251	6251	(A) by striking ‘‘The NCTSI’’ and insert-17
6252	6252	ing the following: 18
6253	6253	‘‘(1) C
6254	6254	OORDINATING CENTER .—The NCTSI’’; 19
6255	6255	and 20
6256	6256	(B) by adding at the end the following: 21
6257	6257	‘‘(2) N
6258	6258	CTSI GRANTEES.—In carrying out sub-22
6259	6259	section (a)(2), NCTSI grantees shall develop 23
6260	6260	trainings and other resources, as applicable and ap-24
6261	6261	propriate, to support implementation of the evi-25
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6264	6264	•S 891 IS
6265	6265	dence-based practices developed and disseminated 1
6266	6266	under such subsection.’’; 2
6267	6267	(5) in subsection (e)— 3
6268	6268	(A) by redesignating paragraphs (1) and 4
6269	6269	(2) as subparagraphs (A) and (B), respectively, 5
6270	6270	and adjusting the margins accordingly; 6
6271	6271	(B) in subparagraph (A), as so redesig-7
6272	6272	nated, by inserting ‘‘and implementation’’ after 8
6273	6273	‘‘the dissemination’’; 9
6274	6274	(C) by striking ‘‘The NCTSI’’ and insert-10
6275	6275	ing the following: 11
6276	6276	‘‘(1) C
6277	6277	OORDINATING CENTER .—The NCTSI’’; 12
6278	6278	and 13
6279	6279	(D) by adding at the end the following: 14
6280	6280	‘‘(2) N
6281	6281	CTSI GRANTEES.—NCTSI grantees shall, 15
6282	6282	as appropriate, collaborate with other such grantees, 16
6283	6283	the NCTSI coordinating center, and the Secretary in 17
6284	6284	carrying out subsections (a)(2) and (d)(2).’’; 18
6285	6285	(6) by amending subsection (h) to read as fol-19
6286	6286	lows: 20
6287	6287	‘‘(h) A
6288	6288	PPLICATION ANDEVALUATION.—To be eligible 21
6289	6289	to receive a grant, contract, or cooperative agreement 22
6290	6290	under subsection (a), a public or nonprofit private entity 23
6291	6291	or an Indian Tribe or Tribal organization shall submit to 24
6292	6292	the Secretary an application at such time, in such manner, 25
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6295	6295	•S 891 IS
6296	6296	and containing such information and assurances as the 1
6297	6297	Secretary may require, including— 2
6298	6298	‘‘(1) a plan for the evaluation of the activities 3
6299	6299	funded under the grant, contract, or agreement, in-4
6300	6300	cluding both process and outcomes evaluation, and 5
6301	6301	the submission of an evaluation at the end of the 6
6302	6302	project period; and 7
6303	6303	‘‘(2) a description of how such entity, Indian 8
6304	6304	Tribe, or Tribal organization will support efforts led 9
6305	6305	by the Secretary or the NCTSI coordinating center, 10
6306	6306	as applicable, to evaluate activities carried out under 11
6307	6307	this section.’’; and 12
6308	6308	(7) by amending subsection (j) to read as fol-13
6309	6309	lows: 14
6310	6310	‘‘(j) A
6311	6311	UTHORIZATION OF APPROPRIATIONS.—There 15
6312	6312	is authorized to be appropriated to carry out this section— 16
6313	6313	‘‘(1) $93,887,000 for fiscal year 2025; 17
6314	6314	‘‘(2) $95,000,000 for fiscal year 2026; 18
6315	6315	‘‘(3) $97,000,000 for fiscal year 2027; 19
6316	6316	‘‘(4) $100,000,000 for fiscal year 2028; and 20
6317	6317	‘‘(5) $100,000,000 for fiscal year 2029.’’. 21
6318	6318	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00212 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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6320	6320	•S 891 IS
6321	6321	SEC. 518. PROTECTING SUICIDE PREVENTION LIFELINE 1
6322	6322	FROM CYBERSECURITY INCIDENTS. 2
6323	6323	(a) N
6324	6324	ATIONALSUICIDEPREVENTIONLIFELINEPRO-3
6325	6325	GRAM.—Section 520E–3(b) of the Public Health Service 4
6326	6326	Act (42 U.S.C. 290bb–36c(b)) is amended— 5
6327	6327	(1) in paragraph (4), by striking ‘‘and’’ at the 6
6328	6328	end; 7
6329	6329	(2) in paragraph (5), by striking the period at 8
6330	6330	the end and inserting ‘‘; and’’; and 9
6331	6331	(3) by adding at the end the following: 10
6332	6332	‘‘(6) taking such steps as may be necessary to 11
6333	6333	ensure the suicide prevention hotline is protected 12
6334	6334	from cybersecurity incidents and eliminates known 13
6335	6335	cybersecurity vulnerabilities.’’. 14
6336	6336	(b) R
6337	6337	EPORTING.—Section 520E–3 of the Public 15
6338	6338	Health Service Act (42 U.S.C. 290bb–36c) is amended— 16
6339	6339	(1) by redesignating subsection (f) as sub-17
6340	6340	section (g); and 18
6341	6341	(2) by inserting after subsection (e) the fol-19
6342	6342	lowing: 20
6343	6343	‘‘(f) C
6344	6344	YBERSECURITYREPORTING.— 21
6345	6345	‘‘(1) N
6346	6346	OTIFICATION.— 22
6347	6347	‘‘(A) I
6348	6348	N GENERAL.—The program’s net-23
6349	6349	work administrator receiving Federal funding 24
6350	6350	pursuant to subsection (a) shall report to the 25
6351	6351	Assistant Secretary, in a manner that protects 26
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6354	6354	•S 891 IS
6355	6355	personal privacy, consistent with applicable 1
6356	6356	Federal and State privacy laws— 2
6357	6357	‘‘(i) any identified cybersecurity 3
6358	6358	vulnerabilities to the program within a rea-4
6359	6359	sonable amount of time after identification 5
6360	6360	of such a vulnerability; and 6
6361	6361	‘‘(ii) any identified cybersecurity inci-7
6362	6362	dents to the program within a reasonable 8
6363	6363	amount of time after identification of such 9
6364	6364	incident. 10
6365	6365	‘‘(B) L
6366	6366	OCAL AND REGIONAL CRISIS CEN -11
6367	6367	TERS.—Local and regional crisis centers par-12
6368	6368	ticipating in the program shall report to the 13
6369	6369	program’s network administrator identified 14
6370	6370	under subparagraph (A), in a manner that pro-15
6371	6371	tects personal privacy, consistent with applica-16
6372	6372	ble Federal and State privacy laws— 17
6373	6373	‘‘(i) any identified cybersecurity 18
6374	6374	vulnerabilities to the program within a rea-19
6375	6375	sonable amount of time after identification 20
6376	6376	of such vulnerability; and 21
6377	6377	‘‘(ii) any identified cybersecurity inci-22
6378	6378	dents to the program within a reasonable 23
6379	6379	amount of time after identification of such 24
6380	6380	incident. 25
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6383	6383	•S 891 IS
6384	6384	‘‘(2) NOTIFICATION.—If the program’s network 1
6385	6385	administrator receiving funding pursuant to sub-2
6386	6386	section (a) discovers, or is informed by a local or re-3
6387	6387	gional crisis center pursuant to paragraph (1)(B) of, 4
6388	6388	a cybersecurity vulnerability or incident, within a 5
6389	6389	reasonable amount of time after such discovery or 6
6390	6390	receipt of information, such entity shall report the 7
6391	6391	vulnerability or incident to the Assistant Secretary. 8
6392	6392	‘‘(3) C
6393	6393	LARIFICATION.— 9
6394	6394	‘‘(A) O
6395	6395	VERSIGHT.— 10
6396	6396	‘‘(i) L
6397	6397	OCAL AND REGIONAL CRISIS 11
6398	6398	CENTERS.—Except as provided in clause 12
6399	6399	(ii), local and regional crisis centers par-13
6400	6400	ticipating in the program shall oversee all 14
6401	6401	technology each center employs in the pro-15
6402	6402	vision of services as a participant in the 16
6403	6403	program. 17
6404	6404	‘‘(ii) N
6405	6405	ETWORK ADMINISTRATOR .— 18
6406	6406	The program’s network administrator re-19
6407	6407	ceiving Federal funding pursuant to sub-20
6408	6408	section (a) shall oversee the technology 21
6409	6409	each crisis center employs in the provision 22
6410	6410	of services as a participant in the program 23
6411	6411	if such oversight responsibilities are estab-24
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6414	6414	•S 891 IS
6415	6415	lished in the applicable network participa-1
6416	6416	tion agreement. 2
6417	6417	‘‘(B) S
6418	6418	UPPLEMENT, NOT SUPPLANT.—The 3
6419	6419	cybersecurity incident reporting requirements 4
6420	6420	under this subsection shall supplement, and not 5
6421	6421	supplant, cybersecurity incident reporting re-6
6422	6422	quirements under other provisions of applicable 7
6423	6423	Federal law that are in effect on the date of the 8
6424	6424	enactment of the SUPPORT for Patients and 9
6425	6425	Communities Reauthorization Act of 2025.’’. 10
6426	6426	(c) S
6427	6427	TUDY.—Not later than 180 days after the date 11
6428	6428	of the enactment of this Act, the Comptroller General of 12
6429	6429	the United States shall— 13
6430	6430	(1) conduct and complete a study that evaluates 14
6431	6431	cybersecurity risks and vulnerabilities associated 15
6432	6432	with the 9–8–8 National Suicide Prevention Lifeline; 16
6433	6433	and 17
6434	6434	(2) submit a report on the findings of such 18
6435	6435	study to the Committee on Health, Education, 19
6436	6436	Labor, and Pensions of the Senate and the Com-20
6437	6437	mittee on Energy and Commerce of the House of 21
6438	6438	Representatives. 22
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6441	6441	•S 891 IS
6442	6442	SEC. 519. BRUCE’S LAW. 1
6443	6443	(a) Y
6444	6444	OUTHPREVENTION AND RECOVERY.—Section 2
6445	6445	7102(c) of the SUPPORT for Patients and Communities 3
6446	6446	Act (42 U.S.C. 290bb–7a(c)) is amended— 4
6447	6447	(1) in paragraph (3)(A)(i), by inserting ‘‘, 5
6448	6448	which may include strategies to increase education 6
6449	6449	and awareness of the potency and dangers of syn-7
6450	6450	thetic opioids (including drugs contaminated with 8
6451	6451	fentanyl) and, as appropriate, other emerging drug 9
6452	6452	use or misuse issues’’ before the semicolon; and 10
6453	6453	(2) in paragraph (4)(A), by inserting ‘‘and 11
6454	6454	strategies to increase education and awareness of 12
6455	6455	the potency and dangers of synthetic opioids (includ-13
6456	6456	ing drugs contaminated with fentanyl) and, as ap-14
6457	6457	propriate, emerging drug use or misuse issues’’ be-15
6458	6458	fore the semicolon. 16
6459	6459	(b) I
6460	6460	NTERDEPARTMENTAL SUBSTANCEUSEDIS-17
6461	6461	ORDERSCOORDINATINGCOMMITTEE.—Section 7022 of 18
6462	6462	the SUPPORT for Patients and Communities Act (42 19
6463	6463	U.S.C. 290aa note) is amended— 20
6464	6464	(1) by striking subsection (g) and inserting the 21
6465	6465	following: 22
6466	6466	‘‘(g) W
6467	6467	ORKINGGROUPS.— 23
6468	6468	‘‘(1) I
6469	6469	N GENERAL.—The Committee may estab-24
6470	6470	lish working groups for purposes of carrying out the 25
6471	6471	duties described in subsection (e). Any such working 26
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6474	6474	•S 891 IS
6475	6475	group shall be composed of members of the Com-1
6476	6476	mittee (or the designees of such members) and may 2
6477	6477	hold such meetings as are necessary to carry out the 3
6478	6478	duties delegated to the working group. 4
6479	6479	‘‘(2) A
6480	6480	DDITIONAL FEDERAL INTERAGENCY 5
6481	6481	WORK GROUP ON FENTANYL CONTAMINATION OF IL -6
6482	6482	LEGAL DRUGS.— 7
6483	6483	‘‘(A) E
6484	6484	STABLISHMENT.—The Secretary, 8
6485	6485	acting through the Committee, shall establish a 9
6486	6486	Federal Interagency Work Group on Fentanyl 10
6487	6487	Contamination of Illegal Drugs (referred to in 11
6488	6488	this paragraph as the ‘Work Group’) consisting 12
6489	6489	of representatives from relevant Federal depart-13
6490	6490	ments and agencies on the Committee. 14
6491	6491	‘‘(B) C
6492	6492	ONSULTATION.—The Work Group 15
6493	6493	shall consult with relevant stakeholders and 16
6494	6494	subject matter experts, including— 17
6495	6495	‘‘(i) State, Tribal, and local subject 18
6496	6496	matter experts in reducing, preventing, and 19
6497	6497	responding to drug overdose caused by 20
6498	6498	fentanyl-contamination of illicit drugs; and 21
6499	6499	‘‘(ii) family members of both adults 22
6500	6500	and youth who have overdosed by fentanyl- 23
6501	6501	contaminated illicit drugs. 24
6502	6502	‘‘(C) D
6503	6503	UTIES.—The Work Group shall— 25
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6505	6505	TKELLEY on LAP7H3WLY3PROD with BILLS 219
6506	6506	•S 891 IS
6507	6507	‘‘(i) examine Federal efforts to reduce 1
6508	6508	and prevent drug overdose by fentanyl-con-2
6509	6509	taminated illicit drugs; 3
6510	6510	‘‘(ii) identify strategies to improve 4
6511	6511	State, Tribal, and local responses to over-5
6512	6512	dose by fentanyl-contaminated illicit drugs; 6
6513	6513	‘‘(iii) coordinate with the Secretary, as 7
6514	6514	appropriate, in carrying out activities to 8
6515	6515	raise public awareness of synthetic opioids 9
6516	6516	and other emerging drug use and misuse 10
6517	6517	issues; 11
6518	6518	‘‘(iv) make recommendations to Con-12
6519	6519	gress for improving Federal programs, in-13
6520	6520	cluding with respect to the coordination of 14
6521	6521	efforts across such programs; and 15
6522	6522	‘‘(v) make recommendations for edu-16
6523	6523	cating youth on the potency and dangers of 17
6524	6524	drugs contaminated by fentanyl. 18
6525	6525	‘‘(D) A
6526	6526	NNUAL REPORT TO SECRETARY .— 19
6527	6527	The Work Group shall annually prepare and 20
6528	6528	submit to the Secretary, the Committee on 21
6529	6529	Health, Education, Labor, and Pensions of the 22
6530	6530	Senate, and the Committee on Energy and 23
6531	6531	Commerce and the Committee on Education 24
6532	6532	and the Workforce of the House of Representa-25
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6535	6535	•S 891 IS
6536	6536	tives, a report on the activities carried out by 1
6537	6537	the Work Group under subparagraph (C), in-2
6538	6538	cluding recommendations to reduce and prevent 3
6539	6539	drug overdose by fentanyl contamination of ille-4
6540	6540	gal drugs, in all populations, and specifically 5
6541	6541	among youth at risk for substance misuse.’’; 6
6542	6542	and 7
6543	6543	(2) by striking subsection (i) and inserting the 8
6544	6544	following: 9
6545	6545	‘‘(i) S
6546	6546	UNSET.—The Committee shall 10
6547	6547	terminate on September 30, 2029.’’. 11
6548	6548	SEC. 520. GUIDANCE ON AT-HOME DRUG DISPOSAL SYS-12
6549	6549	TEMS. 13
6550	6550	(a) I
6551	6551	NGENERAL.—Not later than one year after the 14
6552	6552	date of enactment of this Act, the Secretary of Health and 15
6553	6553	Human Services, in consultation with the Administrator 16
6554	6554	of the Drug Enforcement Administration, shall publish 17
6555	6555	guidance to facilitate the use of at-home safe disposal sys-18
6556	6556	tems for applicable drugs. 19
6557	6557	(b) C
6558	6558	ONTENTS.—The guidance under subsection (a) 20
6559	6559	shall include— 21
6560	6560	(1) recommended standards for effective at- 22
6561	6561	home drug disposal systems to meet applicable re-23
6562	6562	quirements enforced by the Food and Drug Adminis-24
6563	6563	tration; 25
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6566	6566	•S 891 IS
6567	6567	(2) recommended information to include as in-1
6568	6568	structions for use to disseminate with at-home drug 2
6569	6569	disposal systems; 3
6570	6570	(3) best practices and educational tools to sup-4
6571	6571	port the use of an at-home drug disposal system, as 5
6572	6572	appropriate; and 6
6573	6573	(4) recommended use of licensed health pro-7
6574	6574	viders for the dissemination of education, instruc-8
6575	6575	tion, and at-home drug disposal systems, as appro-9
6576	6576	priate. 10
6577	6577	SEC. 521. ASSESSMENT OF OPIOID DRUGS AND ACTIONS. 11
6578	6578	(a) I
6579	6579	NGENERAL.—Not later than one year after the 12
6580	6580	date of enactment of this Act, the Secretary of Health and 13
6581	6581	Human Services (referred to in this section as the ‘‘Sec-14
6582	6582	retary’’) shall publish on the website of the Food and 15
6583	6583	Drug Administration (referred to in this section as the 16
6584	6584	‘‘FDA’’) a report that outlines a plan for assessing opioid 17
6585	6585	analgesic drugs that are approved under section 505 of 18
6586	6586	the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 19
6587	6587	355) that addresses the public health effects of such opioid 20
6588	6588	analgesic drugs as part of the benefit-risk assessment and 21
6589	6589	the activities of the FDA that relate to facilitating the de-22
6590	6590	velopment of nonaddictive medical products intended to 23
6591	6591	treat pain or addiction. Such report shall include— 24
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6593	6593	TKELLEY on LAP7H3WLY3PROD with BILLS 222
6594	6594	•S 891 IS
6595	6595	(1) an update on the actions taken by the FDA 1
6596	6596	to consider the effectiveness, safety, benefit-risk pro-2
6597	6597	file, and use of approved opioid analgesic drugs; 3
6598	6598	(2) a timeline for an assessment of the potential 4
6599	6599	need, as appropriate, for labeling changes, revised or 5
6600	6600	additional postmarketing requirements, enforcement 6
6601	6601	actions, or withdrawals for opioid analgesic drugs; 7
6602	6602	(3) an overview of the steps that the FDA has 8
6603	6603	taken to support the development and approval of 9
6604	6604	nonaddictive medical products intended to treat pain 10
6605	6605	or addiction, and actions planned to further support 11
6606	6606	the development and approval of such products; and 12
6607	6607	(4) an overview of the consideration by the 13
6608	6608	FDA of clinical trial methodologies for analgesic 14
6609	6609	drugs, including the enriched enrollment randomized 15
6610	6610	withdrawal methodology, and the benefits and draw-16
6611	6611	backs associated with different trial methodologies 17
6612	6612	for such drugs, incorporating any public input re-18
6613	6613	ceived under subsection (b). 19
6614	6614	(b) P
6615	6615	UBLICINPUT.—In carrying out subsection (a), 20
6616	6616	the Secretary shall provide an opportunity for public input 21
6617	6617	concerning the regulation by the FDA of opioid analgesic 22
6618	6618	drugs, including scientific evidence that relates to condi-23
6619	6619	tions of use, safety, or benefit-risk assessment (including 24
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6622	6622	•S 891 IS
6623	6623	consideration of the public health effects) of such opioid 1
6624	6624	analgesic drugs. 2
6625	6625	SEC. 522. GRANT PROGRAM FOR STATE AND TRIBAL RE-3
6626	6626	SPONSE TO OPIOID USE DISORDERS. 4
6627	6627	The activities carried out pursuant to section 5
6628	6628	1003(b)(4)(A) of the 21st Century Cures Act (42 U.S.C. 6
6629	6629	290ee–3a(b)(4)(A)) may include facilitating access to 7
6630	6630	products used to prevent overdose deaths by detecting the 8
6631	6631	presence of one or more substances, such as fentanyl and 9
6632	6632	xylazine test strips, to the extent the purchase and posses-10
6633	6633	sion of such products is consistent with Federal and State 11
6634	6634	law. 12
6635	6635	Subtitle B—Treatment 13
6636	6636	SEC. 531. RESIDENTIAL TREATMENT PROGRAM FOR PREG-14
6637	6637	NANT AND POSTPARTUM WOMEN. 15
6638	6638	Section 508 of the Public Health Service Act (42 16
6639	6639	U.S.C. 290bb–1) is amended— 17
6640	6640	(1) in subsection (d)(11)(C), by striking ‘‘pro-18
6641	6641	viding health services’’ and inserting ‘‘providing 19
6642	6642	health care services’’; 20
6643	6643	(2) in subsection (g)— 21
6644	6644	(A) by inserting ‘‘a plan describing’’ after 22
6645	6645	‘‘will provide’’; and 23
6646	6646	(B) by adding at the end the following: 24
6647	6647	‘‘Such plan may include a description of how 25
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6649	6649	TKELLEY on LAP7H3WLY3PROD with BILLS 224
6650	6650	•S 891 IS
6651	6651	such applicant will target outreach to women 1
6652	6652	disproportionately impacted by maternal sub-2
6653	6653	stance use disorder.’’; and 3
6654	6654	(3) in subsection (s), by striking ‘‘$29,931,000 4
6655	6655	for each of fiscal years 2019 through 2023’’ and in-5
6656	6656	serting ‘‘$38,931,000 for each of fiscal years 2025 6
6657	6657	through 2029’’. 7
6658	6658	SEC. 532. IMPROVING ACCESS TO ADDICTION MEDICINE 8
6659	6659	PROVIDERS. 9
6660	6660	Section 597 of the Public Health Service Act (42 10
6661	6661	U.S.C. 290ll) is amended— 11
6662	6662	(1) in subsection (a)(1), by inserting ‘‘diag-12
6663	6663	nosis,’’ after ‘‘related to’’; and 13
6664	6664	(2) in subsection (b), by inserting ‘‘addiction 14
6665	6665	medicine,’’ after ‘‘psychiatry,’’. 15
6666	6666	SEC. 533. MENTAL AND BEHAVIORAL HEALTH EDUCATION 16
6667	6667	AND TRAINING GRANTS. 17
6668	6668	Section 756(f) of the Public Health Service Act (42 18
6669	6669	U.S.C. 294e–1(f)) is amended by striking ‘‘fiscal years 19
6670	6670	2023 through 2027’’ and inserting ‘‘fiscal years 2025 20
6671	6671	through 2029’’. 21
6672	6672	SEC. 534. LOAN REPAYMENT PROGRAM FOR SUBSTANCE 22
6673	6673	USE DISORDER TREATMENT WORKFORCE. 23
6674	6674	Section 781(j) of the Public Health Service Act (42 24
6675	6675	U.S.C. 295h(j)) is amended by striking ‘‘$25,000,000 for 25
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6677	6677	TKELLEY on LAP7H3WLY3PROD with BILLS 225
6678	6678	•S 891 IS
6679	6679	each of fiscal years 2019 through 2023’’ and inserting 1
6680	6680	‘‘$40,000,000 for each of fiscal years 2025 through 2
6681	6681	2029’’. 3
6682	6682	SEC. 535. DEVELOPMENT AND DISSEMINATION OF MODEL 4
6683	6683	TRAINING PROGRAMS FOR SUBSTANCE USE 5
6684	6684	DISORDER PATIENT RECORDS. 6
6685	6685	Section 7053 of the SUPPORT for Patients and 7
6686	6686	Communities Act (42 U.S.C. 290dd–2 note) is amended 8
6687	6687	by striking subsection (e). 9
6688	6688	SEC. 536. TASK FORCE ON BEST PRACTICES FOR TRAUMA- 10
6689	6689	INFORMED IDENTIFICATION, REFERRAL, AND 11
6690	6690	SUPPORT. 12
6691	6691	Section 7132 of the SUPPORT for Patients and 13
6692	6692	Communities Act (Public Law 115–271; 132 Stat. 4046) 14
6693	6693	is amended— 15
6694	6694	(1) in subsection (b)(1)— 16
6695	6695	(A) by redesignating subparagraph (CC) as 17
6696	6696	subparagraph (DD); and 18
6697	6697	(B) by inserting after subparagraph (BB) 19
6698	6698	the following: 20
6699	6699	‘‘(CC) The Administration for Community 21
6700	6700	Living.’’; 22
6701	6701	(2) in subsection (d)(1), in the matter pre-23
6702	6702	ceding subparagraph (A), by inserting ‘‘, develop-24
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6705	6705	•S 891 IS
6706	6706	mental disability service providers’’ before ‘‘, individ-1
6707	6707	uals who are’’; and 2
6708	6708	(3) in subsection (i), by striking ‘‘2023’’ and in-3
6709	6709	serting ‘‘2029’’. 4
6710	6710	SEC. 537. GRANTS TO ENHANCE ACCESS TO SUBSTANCE 5
6711	6711	USE DISORDER TREATMENT. 6
6712	6712	Section 3203 of the SUPPORT for Patients and 7
6713	6713	Communities Act (21 U.S.C. 823 note) is amended— 8
6714	6714	(1) by striking subsection (b); and 9
6715	6715	(2) by striking ‘‘(a) I
6716	6716	NGENERAL.—The Sec-10
6717	6717	retary’’ and inserting the following: ‘‘The Sec-11
6718	6718	retary’’. 12
6719	6719	SEC. 538. STATE GUIDANCE RELATED TO INDIVIDUALS 13
6720	6720	WITH SERIOUS MENTAL ILLNESS AND CHIL-14
6721	6721	DREN WITH SERIOUS EMOTIONAL DISTURB-15
6722	6722	ANCE. 16
6723	6723	(a) R
6724	6724	EVIEW OFUSE OFCERTAINFUNDING.—Not 17
6725	6725	later than 1 year after the date of enactment of this Act, 18
6726	6726	the Secretary of Health and Human Services (referred to 19
6727	6727	in this section as the ‘‘Secretary’’), acting through the As-20
6728	6728	sistant Secretary for Mental Health and Substance Use, 21
6729	6729	shall conduct a review of State use of funds made available 22
6730	6730	under the Community Mental Health Services Block 23
6731	6731	Grant program under subpart I of part B of title XIX 24
6732	6732	of the Public Health Service Act (42 U.S.C. 300x et seq.) 25
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6735	6735	•S 891 IS
6736	6736	(referred to in this section as the ‘‘block grant program’’) 1
6737	6737	for first episode psychosis activities. Such review shall con-2
6738	6738	sider the following: 3
6739	6739	(1) How States use funds for evidence-based 4
6740	6740	treatments and services according to the standard of 5
6741	6741	care for individuals with early serious mental illness 6
6742	6742	and children with a serious emotional disturbance. 7
6743	6743	(2) The percentages of the State funding under 8
6744	6744	the block grant program expended on early serious 9
6745	6745	mental illness and first episode psychosis, and the 10
6746	6746	number of individuals served under such funds. 11
6747	6747	(b) R
6748	6748	EPORT ANDGUIDANCE.— 12
6749	6749	(1) R
6750	6750	EPORT.—Not later than 180 days after 13
6751	6751	the completion of the review under subsection (a), 14
6752	6752	the Secretary shall submit to the Committee on 15
6753	6753	Health, Education, Labor, and Pensions and the 16
6754	6754	Committee on Appropriations of the Senate and the 17
6755	6755	Committee on Energy and Commerce and the Com-18
6756	6756	mittee on Appropriations of the House of Represent-19
6757	6757	atives a report describing— 20
6758	6758	(A) the findings of the review under sub-21
6759	6759	section (a); and 22
6760	6760	(B) any recommendations for changes to 23
6761	6761	the block grant program that would facilitate 24
6762	6762	improved outcomes for individuals with serious 25
6763	6763	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00227 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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6765	6765	•S 891 IS
6766	6766	mental illness and children with serious emo-1
6767	6767	tional disturbance. 2
6768	6768	(2) G
6769	6769	UIDANCE.—Not later than 1 year after 3
6770	6770	the date on which the report is submitted under 4
6771	6771	paragraph (1), the Secretary shall update the guid-5
6772	6772	ance provided to States under the block grant pro-6
6773	6773	gram on coordinated specialty care and other evi-7
6774	6774	dence-based mental health care services for individ-8
6775	6775	uals with serious mental illness and children with a 9
6776	6776	serious emotional disturbance, based on the findings 10
6777	6777	and recommendations of such report. 11
6778	6778	SEC. 539. REVIEWING THE SCHEDULING OF APPROVED 12
6779	6779	PRODUCTS CONTAINING A COMBINATION OF 13
6780	6780	BUPRENORPHINE AND NALOXONE. 14
6781	6781	(a) S
6782	6782	ECRETARY OFHHS.—The Secretary of Health 15
6783	6783	and Human Services shall, consistent with the require-16
6784	6784	ments and procedures set forth in sections 201 and 202 17
6785	6785	of the Controlled Substances Act (21 U.S.C. 811, 812)— 18
6786	6786	(1) review the relevant data pertaining to the 19
6787	6787	scheduling of products containing a combination of 20
6788	6788	buprenorphine and naloxone that have been ap-21
6789	6789	proved under section 505 of the Federal Food, 22
6790	6790	Drug, and Cosmetic Act (21 U.S.C. 355); and 23
6791	6791	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00228 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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6793	6793	•S 891 IS
6794	6794	(2) if appropriate, request that the Attorney 1
6795	6795	General initiate rulemaking proceedings to revise the 2
6796	6796	schedules accordingly with respect to such products. 3
6797	6797	(b) A
6798	6798	TTORNEYGENERAL.—The Attorney General 4
6799	6799	shall review any request made by the Secretary of Health 5
6800	6800	and Human Services under subsection (a)(2) and deter-6
6801	6801	mine whether to initiate proceedings to revise the sched-7
6802	6802	ules in accordance with the criteria set forth in sections 8
6803	6803	201 and 202 of the Controlled Substances Act (21 U.S.C. 9
6804	6804	811, 812). 10
6805	6805	Subtitle C—Recovery 11
6806	6806	SEC. 541. BUILDING COMMUNITIES OF RECOVERY. 12
6807	6807	Section 547(f) of the Public Health Service Act (42 13
6808	6808	U.S.C. 290ee–2(f)) is amended by striking ‘‘$5,000,000 14
6809	6809	for each of fiscal years 2019 through 2023’’ and inserting 15
6810	6810	‘‘$16,000,000 for each of fiscal years 2025 through 16
6811	6811	2029’’. 17
6812	6812	SEC. 542. PEER SUPPORT TECHNICAL ASSISTANCE CEN-18
6813	6813	TER. 19
6814	6814	Section 547A of the Public Health Service Act (42 20
6815	6815	U.S.C. 290ee–2a) is amended— 21
6816	6816	(1) in subsection (b)(4), by striking ‘‘building; 22
6817	6817	and’’ and inserting the following: ‘‘building, such 23
6818	6818	as— 24
6819	6819	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00229 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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6821	6821	•S 891 IS
6822	6822	‘‘(A) professional development of peer sup-1
6823	6823	port specialists; and 2
6824	6824	‘‘(B) making recovery support services 3
6825	6825	available in nonclinical settings; and’’; 4
6826	6826	(2) by redesignating subsections (d) and (e) as 5
6827	6827	subsections (e) and (f), respectively; 6
6828	6828	(3) by inserting after subsection (c) the fol-7
6829	6829	lowing: 8
6830	6830	‘‘(d) R
6831	6831	EGIONALCENTERS.— 9
6832	6832	‘‘(1) I
6833	6833	N GENERAL.—The Secretary may estab-10
6834	6834	lish one regional technical assistance center (referred 11
6835	6835	to in this subsection as the ‘Regional Center’), with 12
6836	6836	existing resources, to assist the Center in carrying 13
6837	6837	out activities described in subsection (b) within the 14
6838	6838	geographic region of such Regional Center in a man-15
6839	6839	ner that is tailored to the needs of such region. 16
6840	6840	‘‘(2) E
6841	6841	VALUATION.—Not later than 4 years 17
6842	6842	after the date of enactment of the SUPPORT for 18
6843	6843	Patients and Communities Reauthorization Act of 19
6844	6844	2025, the Secretary shall evaluate the activities of 20
6845	6845	the Regional Center and submit to the Committee 21
6846	6846	on Health, Education, Labor, and Pensions of the 22
6847	6847	Senate and the Committee on Energy and Com-23
6848	6848	merce of the House of Representatives a report on 24
6849	6849	the findings of such evaluation, including— 25
6850	6850	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00230 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
6851	6851	TKELLEY on LAP7H3WLY3PROD with BILLS 231
6852	6852	•S 891 IS
6853	6853	‘‘(A) a description of the distinct roles and 1
6854	6854	responsibilities of the Regional Center and the 2
6855	6855	Center; 3
6856	6856	‘‘(B) available information relating to the 4
6857	6857	outcomes of the Regional Center under this 5
6858	6858	subsection, such as any impact on the oper-6
6859	6859	ations and efficiency of the Center relating to 7
6860	6860	requests for technical assistance and support 8
6861	6861	within the region of such Regional Center; 9
6862	6862	‘‘(C) a description of any gaps or areas of 10
6863	6863	duplication relating to the activities of the Re-11
6864	6864	gional Center and the Center within such re-12
6865	6865	gion; and 13
6866	6866	‘‘(D) recommendations relating to the 14
6867	6867	modification, expansion, or termination of the 15
6868	6868	Regional Center under this subsection. 16
6869	6869	‘‘(3) T
6870	6870	ERMINATION.—This subsection shall ter-17
6871	6871	minate on September 30, 2029.’’; and 18
6872	6872	(4) in subsection (f), as so redesignated, by 19
6873	6873	striking ‘‘$1,000,000 for each of fiscal years 2019 20
6874	6874	through 2023’’ and inserting ‘‘$2,000,000 for each 21
6875	6875	of fiscal years 2025 through 2029’’. 22
6876	6876	SEC. 543. COMPREHENSIVE OPIOID RECOVERY CENTERS. 23
6877	6877	Section 552 of the Public Health Service Act (42 24
6878	6878	U.S.C. 290ee–7) is amended— 25
6879	6879	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00231 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
6880	6880	TKELLEY on LAP7H3WLY3PROD with BILLS 232
6881	6881	•S 891 IS
6882	6882	(1) in subsection (d)(2)— 1
6883	6883	(A) in the matter preceding subparagraph 2
6884	6884	(A), by striking ‘‘and in such manner’’ and in-3
6885	6885	serting ‘‘, in such manner, and containing such 4
6886	6886	information and assurances, including relevant 5
6887	6887	documentation,’’; and 6
6888	6888	(B) in subparagraph (A), by striking ‘‘is 7
6889	6889	capable of coordinating with other entities to 8
6890	6890	carry out’’ and inserting ‘‘has the demonstrated 9
6891	6891	capability to carry out, through referral or con-10
6892	6892	tractual arrangements’’; 11
6893	6893	(2) in subsection (h)— 12
6894	6894	(A) by redesignating paragraphs (1) 13
6895	6895	through (4) as subparagraphs (A) through (D), 14
6896	6896	respectively, and adjusting the margins accord-15
6897	6897	ingly; 16
6898	6898	(B) by striking ‘‘With respect to’’ and in-17
6899	6899	serting the following: 18
6900	6900	‘‘(1) I
6901	6901	N GENERAL.—With respect to’’; and 19
6902	6902	(C) by adding at the end the following: 20
6903	6903	‘‘(2) A
6904	6904	DDITIONAL REPORTING FOR CERTAIN EL -21
6905	6905	IGIBLE ENTITIES.—An entity carrying out activities 22
6906	6906	described in subsection (g) through referral or con-23
6907	6907	tractual arrangements shall include in the submis-24
6908	6908	sions required under paragraph (1) information re-25
6909	6909	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00232 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
6910	6910	TKELLEY on LAP7H3WLY3PROD with BILLS 233
6911	6911	•S 891 IS
6912	6912	lated to the status of such referrals or contractual 1
6913	6913	arrangements, including an assessment of whether 2
6914	6914	such referrals or contractual arrangements are sup-3
6915	6915	porting the ability of such entity to carry out such 4
6916	6916	activities.’’; and 5
6917	6917	(3) in subsection (j), by striking ‘‘2019 through 6
6918	6918	2023’’ and inserting ‘‘2025 through 2029’’. 7
6919	6919	SEC. 544. YOUTH PREVENTION AND RECOVERY. 8
6920	6920	Section 7102(c) of the SUPPORT for Patients and 9
6921	6921	Communities Act (42 U.S.C. 290bb–7a(c)) (as amended 10
6922	6922	by section 110(a)) is amended— 11
6923	6923	(1) in paragraph (2)— 12
6924	6924	(A) in subparagraph (A)— 13
6925	6925	(i) in clause (i)— 14
6926	6926	(I) by inserting ‘‘, or a consor-15
6927	6927	tium of local educational agencies,’’ 16
6928	6928	after ‘‘a local educational agency’’; 17
6929	6929	and 18
6930	6930	(II) by striking ‘‘high schools’’ 19
6931	6931	and inserting ‘‘secondary schools’’; 20
6932	6932	and 21
6933	6933	(ii) in clause (vi), by striking ‘‘tribe, 22
6934	6934	or tribal’’ and inserting ‘‘Tribe, or Tribal’’; 23
6935	6935	(B) by amending subparagraph (E) to read 24
6936	6936	as follows: 25
6937	6937	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00233 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
6938	6938	TKELLEY on LAP7H3WLY3PROD with BILLS 234
6939	6939	•S 891 IS
6940	6940	‘‘(E) INDIAN TRIBE; TRIBAL ORGANIZA-1
6941	6941	TION.—The terms ‘Indian Tribe’ and ‘Tribal 2
6942	6942	organization’ have the meanings given such 3
6943	6943	terms in section 4 of the Indian Self-Deter-4
6944	6944	mination and Education Assistance Act (25 5
6945	6945	U.S.C. 5304).’’; 6
6946	6946	(C) by redesignating subparagraph (K) as 7
6947	6947	subparagraph (L); and 8
6948	6948	(D) by inserting after subparagraph (J) 9
6949	6949	the following: 10
6950	6950	‘‘(K) S
6951	6951	ECONDARY SCHOOL .—The term 11
6952	6952	‘secondary school’ has the meaning given such 12
6953	6953	term in section 8101 of the Elementary and 13
6954	6954	Secondary Education Act of 1965 (20 U.S.C. 14
6955	6955	7801).’’; 15
6956	6956	(2) in paragraph (3)(A), in the matter pre-16
6957	6957	ceding clause (i)— 17
6958	6958	(A) by striking ‘‘and abuse’’; and 18
6959	6959	(B) by inserting ‘‘at increased risk for sub-19
6960	6960	stance misuse’’ after ‘‘specific populations’’; 20
6961	6961	(3) in paragraph (4)— 21
6962	6962	(A) in the matter preceding subparagraph 22
6963	6963	(A), by striking ‘‘Indian tribes’’ and inserting 23
6964	6964	‘‘Indian Tribes’’; 24
6965	6965	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00234 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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6967	6967	•S 891 IS
6968	6968	(B) in subparagraph (A), by striking ‘‘and 1
6969	6969	abuse’’; and 2
6970	6970	(C) in subparagraph (B), by striking ‘‘peer 3
6971	6971	mentoring’’ and inserting ‘‘peer-to-peer sup-4
6972	6972	port’’; 5
6973	6973	(4) in paragraph (5), by striking ‘‘tribal’’ and 6
6974	6974	inserting ‘‘Tribal’’; 7
6975	6975	(5) in paragraph (6)(A)— 8
6976	6976	(A) in clause (iv), by striking ‘‘; and’’ and 9
6977	6977	inserting a semicolon; and 10
6978	6978	(B) by adding at the end the following: 11
6979	6979	‘‘(vi) a plan to sustain the activities 12
6980	6980	carried out under the grant program, after 13
6981	6981	the grant program has ended; and’’; 14
6982	6982	(6) in paragraph (8), by striking ‘‘2022’’ and 15
6983	6983	inserting ‘‘2027’’; and 16
6984	6984	(7) by amending paragraph (9) to read as fol-17
6985	6985	lows: 18
6986	6986	‘‘(9) A
6987	6987	UTHORIZATION OF APPROPRIATIONS .— 19
6988	6988	To carry out this subsection, there are authorized to 20
6989	6989	be appropriated— 21
6990	6990	‘‘(A) $10,000,000 for fiscal year 2025; 22
6991	6991	‘‘(B) $12,000,000 for fiscal year 2026; 23
6992	6992	‘‘(C) $13,000,000 for fiscal year 2027; 24
6993	6993	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00235 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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6995	6995	•S 891 IS
6996	6996	‘‘(D) $14,000,000 for fiscal year 2028; 1
6997	6997	and 2
6998	6998	‘‘(E) $15,000,000 for fiscal year 2029.’’. 3
6999	6999	SEC. 545. CAREER ACT. 4
7000	7000	(a) I
7001	7001	NGENERAL.—Section 7183 of the SUPPORT 5
7002	7002	for Patients and Communities Act (42 U.S.C. 290ee–8) 6
7003	7003	is amended— 7
7004	7004	(1) in the section heading, by inserting ‘‘; 8
7005	7005	TREATMENT , RECOVERY, AND WORKFORCE 9
7006	7006	SUPPORT GRANTS ’’ after ‘‘CAREER ACT’’; 10
7007	7007	(2) in subsection (b), by inserting ‘‘each’’ before 11
7008	7008	‘‘for a period’’; 12
7009	7009	(3) in subsection (c)— 13
7010	7010	(A) in paragraph (1), by striking ‘‘the 14
7011	7011	rates described in paragraph (2)’’ and inserting 15
7012	7012	‘‘the average rates for calendar years 2018 16
7013	7013	through 2022 described in paragraph (2)’’; and 17
7014	7014	(B) by amending paragraph (2) to read as 18
7015	7015	follows: 19
7016	7016	‘‘(2) R
7017	7017	ATES.—The rates described in this para-20
7018	7018	graph are the following: 21
7019	7019	‘‘(A) The highest age-adjusted average 22
7020	7020	rates of drug overdose deaths for calendar years 23
7021	7021	2018 through 2022 based on data from the 24
7022	7022	Centers for Disease Control and Prevention, in-25
7023	7023	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00236 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7024	7024	TKELLEY on LAP7H3WLY3PROD with BILLS 237
7025	7025	•S 891 IS
7026	7026	cluding, if necessary, provisional data for cal-1
7027	7027	endar year 2022. 2
7028	7028	‘‘(B) The highest average rates of unem-3
7029	7029	ployment for calendar years 2018 through 2022 4
7030	7030	based on data provided by the Bureau of Labor 5
7031	7031	Statistics. 6
7032	7032	‘‘(C) The lowest average labor force par-7
7033	7033	ticipation rates for calendar years 2018 through 8
7034	7034	2022 based on data provided by the Bureau of 9
7035	7035	Labor Statistics.’’; 10
7036	7036	(4) in subsection (g)— 11
7037	7037	(A) in each of paragraphs (1) and (3), by 12
7038	7038	redesignating subparagraphs (A) and (B) as 13
7039	7039	clauses (i) and (ii), respectively, and adjusting 14
7040	7040	the margins accordingly; 15
7041	7041	(B) by redesignating paragraphs (1) 16
7042	7042	through (3) as subparagraphs (A) through (C), 17
7043	7043	respectively, and adjusting the margins accord-18
7044	7044	ingly; 19
7045	7045	(C) in the matter preceding subparagraph 20
7046	7046	(A) (as so redesignated), by striking ‘‘An enti-21
7047	7047	ty’’ and inserting the following: 22
7048	7048	‘‘(1) I
7049	7049	N GENERAL.—An entity’’; and 23
7050	7050	(D) by adding at the end the following: 24
7051	7051	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00237 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7052	7052	TKELLEY on LAP7H3WLY3PROD with BILLS 238
7053	7053	•S 891 IS
7054	7054	‘‘(2) TRANSPORTATION SERVICES .—An entity 1
7055	7055	receiving a grant under this section may use not 2
7056	7056	more than 5 percent of the funds for providing 3
7057	7057	transportation for individuals to participate in an ac-4
7058	7058	tivity supported by a grant under this section, which 5
7059	7059	transportation shall be to or from a place of work 6
7060	7060	or a place where the individual is receiving voca-7
7061	7061	tional education or job training services or receiving 8
7062	7062	services directly linked to treatment of or recovery 9
7063	7063	from a substance use disorder. 10
7064	7064	‘‘(3) L
7065	7065	IMITATION.—The Secretary may not re-11
7066	7066	quire an entity to, or give priority to an entity that 12
7067	7067	plans to, use the funds of a grant under this section 13
7068	7068	for activities that are not specified in this sub-14
7069	7069	section.’’; 15
7070	7070	(5) in subsection (i)(2), by inserting ‘‘, which 16
7071	7071	shall include employment and earnings outcomes de-17
7072	7072	scribed in subclauses (I) and (III) of section 18
7073	7073	116(b)(2)(A)(i) of the Workforce Innovation and 19
7074	7074	Opportunity Act (29 U.S.C. 3141(b)(2)(A)(i)) with 20
7075	7075	respect to the participation of such individuals with 21
7076	7076	a substance use disorder in programs and activities 22
7077	7077	funded by the grant under this section’’ after ‘‘sub-23
7078	7078	section (g)’’; 24
7079	7079	(6) in subsection (j)— 25
7080	7080	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00238 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7081	7081	TKELLEY on LAP7H3WLY3PROD with BILLS 239
7082	7082	•S 891 IS
7083	7083	(A) in paragraph (1), by inserting ‘‘for 1
7084	7084	grants awarded prior to the date of enactment 2
7085	7085	of the SUPPORT for Patients and Commu-3
7086	7086	nities Reauthorization Act of 2025’’ after 4
7087	7087	‘‘grant period under this section’’; and 5
7088	7088	(B) in paragraph (2)— 6
7089	7089	(i) in the matter preceding subpara-7
7090	7090	graph (A), by striking ‘‘2 years after sub-8
7091	7091	mitting the preliminary report required 9
7092	7092	under paragraph (1)’’ and inserting ‘‘Sep-10
7093	7093	tember 30, 2029’’; and 11
7094	7094	(ii) in subparagraph (A), by striking 12
7095	7095	‘‘(g)(3)’’ and inserting ‘‘(g)(1)(C)’’; and 13
7096	7096	(7) in subsection (k), by striking ‘‘$5,000,000 14
7097	7097	for each of fiscal years 2019 through 2023’’ and in-15
7098	7098	serting ‘‘$12,000,000 for each of fiscal years 2025 16
7099	7099	through 2029’’. 17
7100	7100	(b) R
7101	7101	EAUTHORIZATION OF THE CAREER ACT; RE-18
7102	7102	COVERYHOUSINGPILOTPROGRAM.— 19
7103	7103	(1) I
7104	7104	N GENERAL.—Section 8071 of the SUP-20
7105	7105	PORT for Patients and Communities Act (42 21
7106	7106	U.S.C. 5301 note; Public Law 115–271) is amend-22
7107	7107	ed— 23
7108	7108	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00239 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7109	7109	TKELLEY on LAP7H3WLY3PROD with BILLS 240
7110	7110	•S 891 IS
7111	7111	(A) by striking the section heading and in-1
7112	7112	serting ‘‘
7113	7113	CAREER ACT; RECOVERY HOUSING 2
7114	7114	PILOT PROGRAM ’’; 3
7115	7115	(B) in subsection (a), by striking ‘‘through 4
7116	7116	2023’’ and inserting ‘‘through 2029’’; 5
7117	7117	(C) in subsection (b)— 6
7118	7118	(i) in paragraph (1), by striking ‘‘not 7
7119	7119	later than 60 days after the date of enact-8
7120	7120	ment of this Act’’ and inserting ‘‘not later 9
7121	7121	than 60 days after the date of enactment 10
7122	7122	of the SUPPORT for Patients and Com-11
7123	7123	munities Reauthorization Act of 2025’’; 12
7124	7124	and 13
7125	7125	(ii) in paragraph (2)(B)(i)— 14
7126	7126	(I) in subclause (I)— 15
7127	7127	(aa) by striking ‘‘for cal-16
7128	7128	endar years 2013 through 2017’’; 17
7129	7129	and 18
7130	7130	(bb) by inserting ‘‘for cal-19
7131	7131	endar years 2018 through 2022’’ 20
7132	7132	after ‘‘rates of unemployment’’; 21
7133	7133	(II) in subclause (II)— 22
7134	7134	(aa) by striking ‘‘for cal-23
7135	7135	endar years 2013 through 2017’’; 24
7136	7136	and 25
7137	7137	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00240 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7138	7138	TKELLEY on LAP7H3WLY3PROD with BILLS 241
7139	7139	•S 891 IS
7140	7140	(bb) by inserting ‘‘for cal-1
7141	7141	endar years 2018 through 2022’’ 2
7142	7142	after ‘‘participation rates’’; and 3
7143	7143	(III) by striking subclause (III) 4
7144	7144	and inserting the following: 5
7145	7145	‘‘(III) The highest age-adjusted 6
7146	7146	average rates of drug overdose deaths 7
7147	7147	for calendar years 2018 through 2022 8
7148	7148	based on data from the Centers for 9
7149	7149	Disease Control and Prevention, in-10
7150	7150	cluding, if necessary, provisional data 11
7151	7151	for calendar year 2022.’’; and 12
7152	7152	(D) in subsection (f), by striking ‘‘For the 13
7153	7153	2-year period following the date of enactment of 14
7154	7154	this Act, the’’ and inserting ‘‘The’’. 15
7155	7155	(2) C
7156	7156	ONFORMING AMENDMENT .—Subtitle F of 16
7157	7157	title VIII of the SUPPORT for Patients and Com-17
7158	7158	munities Act (Public Law 115–271; 132 Stat. 4095) 18
7159	7159	is amended by striking the subtitle heading and in-19
7160	7160	serting the following: ‘‘Subtitle F—CAREER 20
7161	7161	Act; Recovery Housing Pilot Program ’’ . 21
7162	7162	(c) C
7163	7163	LERICALAMENDMENTS.—The table of contents 22
7164	7164	in section 1(b) of the SUPPORT for Patients and Com-23
7165	7165	munities Act (Public Law 115–271; 132 Stat. 3894) is 24
7166	7166	amended— 25
7167	7167	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00241 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7168	7168	TKELLEY on LAP7H3WLY3PROD with BILLS 242
7169	7169	•S 891 IS
7170	7170	(1) by striking the item relating to section 7183 1
7171	7171	and inserting the following: 2
7172	7172	‘‘Sec. 7183. CAREER Act; treatment, recovery, and workforce support
7173	7173	grants.’’;
7174	7174	(2) by striking the item relating to subtitle F 3
7175	7175	of title VIII and inserting the following: 4
7176	7176	‘‘Subtitle F—CAREER Act; Recovery Housing Pilot Program’’; and
7177	7177	(3) by striking the item relating to section 8071 5
7178	7178	and inserting the following: 6
7179	7179	‘‘Sec. 8071. CAREER Act; Recovery Housing Pilot Program.’’.
7180	7180	SEC. 546. ADDRESSING ECONOMIC AND WORKFORCE IM-
7181	7181	7
7182	7182	PACTS OF THE OPIOID CRISIS. 8
7183	7183	Section 8041(g)(1) of the SUPPORT for Patients 9
7184	7184	and Communities Act (29 U.S.C. 3225a(g)(1)) is amended 10
7185	7185	by striking ‘‘2023’’ and inserting ‘‘2029’’. 11
7186	7186	Subtitle D—Miscellaneous Matters 12
7187	7187	SEC. 551. DELIVERY OF A CONTROLLED SUBSTANCE BY A 13
7188	7188	PHARMACY TO A PRESCRIBING PRACTI-14
7189	7189	TIONER. 15
7190	7190	Section 309A(a) of the Controlled Substances Act 16
7191	7191	(21 U.S.C. 829a(a)) is amended by striking paragraph (2) 17
7192	7192	and inserting the following: 18
7193	7193	‘‘(2) the controlled substance is a drug in 19
7194	7194	schedule III, IV, or V to be administered— 20
7195	7195	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00242 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7196	7196	TKELLEY on LAP7H3WLY3PROD with BILLS 243
7197	7197	•S 891 IS
7198	7198	‘‘(A) by injection or implantation for the 1
7199	7199	purpose of maintenance or detoxification treat-2
7200	7200	ment; or 3
7201	7201	‘‘(B) subject to a risk evaluation and miti-4
7202	7202	gation strategy pursuant to section 505–1 of 5
7203	7203	the Federal Food, Drug, and Cosmetic Act (21 6
7204	7204	U.S.C. 355–1) that includes elements to assure 7
7205	7205	safe use of the drug described in subsection 8
7206	7206	(f)(3)(E) of such section, including a require-9
7207	7207	ment for post-administration monitoring by a 10
7208	7208	health care provider.’’. 11
7209	7209	SEC. 552. TECHNICAL CORRECTION ON CONTROLLED SUB-12
7210	7210	STANCES DISPENSING. 13
7211	7211	Effective as if included in the enactment of Public 14
7212	7212	Law 117–328— 15
7213	7213	(1) section 1252(a) of division FF of Public 16
7214	7214	Law 117–328 (136 Stat. 5681) is amended, in the 17
7215	7215	matter being inserted into section 302(e) of the Con-18
7216	7216	trolled Substances Act, by striking ‘‘303(g)’’ and in-19
7217	7217	serting ‘‘303(h)’’; 20
7218	7218	(2) section 1262 of division FF of Public Law 21
7219	7219	117–328 (136 Stat. 5681) is amended— 22
7220	7220	(A) in subsection (a)— 23
7221	7221	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00243 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7222	7222	TKELLEY on LAP7H3WLY3PROD with BILLS 244
7223	7223	•S 891 IS
7224	7224	(i) in the matter preceding paragraph 1
7225	7225	(1), by striking ‘‘303(g)’’ and inserting 2
7226	7226	‘‘303(h)’’; 3
7227	7227	(ii) in the matter being stricken by 4
7228	7228	subsection (a)(2), by striking ‘‘(g)(1)’’ and 5
7229	7229	inserting ‘‘(h)(1)’’; and 6
7230	7230	(iii) in the matter being inserted by 7
7231	7231	subsection (a)(2), by striking ‘‘(g) Practi-8
7232	7232	tioners’’ and inserting ‘‘(h) Practitioners’’; 9
7233	7233	and 10
7234	7234	(B) in subsection (b)— 11
7235	7235	(i) in the matter being stricken by 12
7236	7236	paragraph (1), by striking ‘‘303(g)(1)’’ 13
7237	7237	and inserting ‘‘303(h)(1)’’; 14
7238	7238	(ii) in the matter being inserted by 15
7239	7239	paragraph (1), by striking ‘‘303(g)’’ and 16
7240	7240	inserting ‘‘303(h)’’; 17
7241	7241	(iii) in the matter being stricken by 18
7242	7242	paragraph (2)(A), by striking ‘‘303(g)(2)’’ 19
7243	7243	and inserting ‘‘303(h)(2)’’; 20
7244	7244	(iv) in the matter being stricken by 21
7245	7245	paragraph (3), by striking ‘‘303(g)(2)(B)’’ 22
7246	7246	and inserting ‘‘303(h)(2)(B)’’; 23
7247	7247	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00244 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7248	7248	TKELLEY on LAP7H3WLY3PROD with BILLS 245
7249	7249	•S 891 IS
7250	7250	(v) in the matter being stricken by 1
7251	7251	paragraph (5), by striking ‘‘303(g)’’ and 2
7252	7252	inserting ‘‘303(h)’’; and 3
7253	7253	(vi) in the matter being stricken by 4
7254	7254	paragraph (6), by striking ‘‘303(g)’’ and 5
7255	7255	inserting ‘‘303(h)’’; and 6
7256	7256	(3) section 1263(b) of division FF of Public 7
7257	7257	Law 117–328 (136 Stat. 5685) is amended— 8
7258	7258	(A) by striking ‘‘303(g)(2)’’ and inserting 9
7259	7259	‘‘303(h)(2)’’; and 10
7260	7260	(B) by striking ‘‘(21 U.S.C. 823(g)(2))’’ 11
7261	7261	and inserting ‘‘(21 U.S.C. 823(h)(2))’’. 12
7262	7262	SEC. 553. REQUIRED TRAINING FOR PRESCRIBERS OF CON-13
7263	7263	TROLLED SUBSTANCES. 14
7264	7264	(a) I
7265	7265	NGENERAL.—Section 303 of the Controlled 15
7266	7266	Substances Act (21 U.S.C. 823) is amended— 16
7267	7267	(1) by redesignating the second subsection des-17
7268	7268	ignated as subsection (l) as subsection (m); and 18
7269	7269	(2) in subsection (m)(1), as so redesignated— 19
7270	7270	(A) in subparagraph (A)— 20
7271	7271	(i) in clause (iv)— 21
7272	7272	(I) in subclause (I)— 22
7273	7273	(aa) by inserting ‘‘the Amer-23
7274	7274	ican Academy of Family Physi-24
7275	7275	cians, the American Podiatric 25
7276	7276	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00245 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7277	7277	TKELLEY on LAP7H3WLY3PROD with BILLS 246
7278	7278	•S 891 IS
7279	7279	Medical Association, the Acad-1
7280	7280	emy of General Dentistry, the 2
7281	7281	American Optometric Associa-3
7282	7282	tion,’’ before ‘‘or any other orga-4
7283	7283	nization’’; 5
7284	7284	(bb) by striking ‘‘or the 6
7285	7285	Commission’’ and inserting ‘‘the 7
7286	7286	Commission’’; and 8
7287	7287	(cc) by inserting ‘‘, or the 9
7288	7288	Council on Podiatric Medical 10
7289	7289	Education’’ before the semicolon 11
7290	7290	at the end; and 12
7291	7291	(II) in subclause (III), by insert-13
7292	7292	ing ‘‘or the American Academy of 14
7293	7293	Family Physicians’’ after ‘‘Associa-15
7294	7294	tion’’; and 16
7295	7295	(ii) in clause (v), in the matter pre-17
7296	7296	ceding subclause (I)— 18
7297	7297	(I) by striking ‘‘osteopathic medi-19
7298	7298	cine, dental surgery’’ and inserting 20
7299	7299	‘‘osteopathic medicine, podiatric medi-21
7300	7300	cine, dental surgery’’; and 22
7301	7301	(II) by striking ‘‘or dental medi-23
7302	7302	cine curriculum’’ and inserting ‘‘or 24
7303	7303	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00246 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7304	7304	TKELLEY on LAP7H3WLY3PROD with BILLS 247
7305	7305	•S 891 IS
7306	7306	dental or podiatric medicine cur-1
7307	7307	riculum’’; and 2
7308	7308	(B) in subparagraph (B)— 3
7309	7309	(i) in clause (i)— 4
7310	7310	(I) by inserting ‘‘the American 5
7311	7311	Pharmacists Association, the Accredi-6
7312	7312	tation Council on Pharmacy Edu-7
7313	7313	cation, the American Psychiatric 8
7314	7314	Nurses Association, the American 9
7315	7315	Academy of Nursing, the American 10
7316	7316	Academy of Family Physicians,’’ be-11
7317	7317	fore ‘‘or any other organization’’; and 12
7318	7318	(II) by inserting ‘‘, the American 13
7319	7319	Academy of Family Physicians,’’ be-14
7320	7320	fore ‘‘or the Accreditation Council’’; 15
7321	7321	and 16
7322	7322	(ii) in clause (ii)— 17
7323	7323	(I) by striking ‘‘or accredited 18
7324	7324	school’’ and inserting ‘‘, an accredited 19
7325	7325	school’’; and 20
7326	7326	(II) by inserting ‘‘, or an accred-21
7327	7327	ited school of pharmacy’’ before ‘‘in 22
7328	7328	the United States’’. 23
7329	7329	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00247 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7330	7330	TKELLEY on LAP7H3WLY3PROD with BILLS 248
7331	7331	•S 891 IS
7332	7332	(b) EFFECTIVEDATE.—The amendment made by 1
7333	7333	subsection (a) shall take effect as if enacted on December 2
7334	7334	29, 2022. 3
7335	7335	SEC. 554. EXTENSION OF TEMPORARY ORDER FOR 4
7336	7336	FENTANYL-RELATED SUBSTANCES. 5
7337	7337	Effective as if included in the enactment of the Tem-6
7338	7338	porary Reauthorization and Study of the Emergency 7
7339	7339	Scheduling of Fentanyl Analogues Act (Public Law 116– 8
7340	7340	114), section 2 of such Act is amended by striking ‘‘March 9
7341	7341	31, 2025’’ and inserting ‘‘September 30, 2026’’. 10
7342	7342	TITLE VI—PANDEMIC AND ALL- 11
7343	7343	HAZARDS PREPAREDNESS 12
7344	7344	AND RESPONSE 13
7345	7345	SEC. 601. SHORT TITLE. 14
7346	7346	This title may be cited as the ‘‘Pandemic and All- 15
7347	7347	Hazards Preparedness and Response Act’’. 16
7348	7348	Subtitle A—State and Local 17
7349	7349	Readiness and Response 18
7350	7350	SEC. 611. TEMPORARY REASSIGNMENT OF STATE AND 19
7351	7351	LOCAL PERSONNEL DURING A PUBLIC 20
7352	7352	HEALTH EMERGENCY. 21
7353	7353	Section 319(e) of the Public Health Service Act (42 22
7354	7354	U.S.C. 247d(e)) is amended— 23
7355	7355	(1) in paragraph (1), by striking ‘‘tribal organi-24
7356	7356	zation or such Governor or tribal organization’s des-25
7357	7357	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00248 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7358	7358	TKELLEY on LAP7H3WLY3PROD with BILLS 249
7359	7359	•S 891 IS
7360	7360	ignee’’ and inserting ‘‘Tribal organization or the des-1
7361	7361	ignee of the Governor or Tribal organization, or the 2
7362	7362	State or Tribal health official’’; 3
7363	7363	(2) in paragraph (2)(B)— 4
7364	7364	(A) in the matter preceding clause (i), by 5
7365	7365	striking ‘‘tribal organization’’ and inserting 6
7366	7366	‘‘Tribal organization, or the State or Tribal 7
7367	7367	health official’’; and 8
7368	7368	(B) in clause (v), by striking ‘‘tribal orga-9
7369	7369	nization’’ and inserting ‘‘Tribal organization or 10
7370	7370	State or Tribal health official’’; 11
7371	7371	(3) in paragraph (6)— 12
7372	7372	(A) in the matter preceding subparagraph 13
7373	7373	(A)— 14
7374	7374	(i) by striking ‘‘Reauthorization Act 15
7375	7375	of 2013’’ and inserting ‘‘and Response 16
7376	7376	Act’’; and 17
7377	7377	(ii) by striking ‘‘appropriate commit-18
7378	7378	tees of the Congress’’ and inserting ‘‘Com-19
7379	7379	mittee on Health, Education, Labor, and 20
7380	7380	Pensions of the Senate and the Committee 21
7381	7381	on Energy and Commerce of the House of 22
7382	7382	Representatives’’; and 23
7383	7383	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00249 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7384	7384	TKELLEY on LAP7H3WLY3PROD with BILLS 250
7385	7385	•S 891 IS
7386	7386	(B) in subparagraph (A), by inserting ‘‘, 1
7387	7387	including requests from State or Tribal health 2
7388	7388	officials’’ before the semicolon; 3
7389	7389	(4) in paragraph (7)(A), by striking ‘‘tribal or-4
7390	7390	ganization’’ and inserting ‘‘Tribal organization’’; and 5
7391	7391	(5) in paragraph (8), by striking ‘‘March 31, 6
7392	7392	2025’’ and inserting ‘‘December 31, 2026’’. 7
7393	7393	SEC. 612. PUBLIC HEALTH EMERGENCY PREPAREDNESS 8
7394	7394	PROGRAM. 9
7395	7395	Section 319C–1 of the Public Health Service Act (42 10
7396	7396	U.S.C. 247d–3a) is amended— 11
7397	7397	(1) in subsection (b)(2)— 12
7398	7398	(A) in subparagraph (A)(ii), by striking 13
7399	7399	‘‘influenza’’ and inserting ‘‘response planning’’; 14
7400	7400	and 15
7401	7401	(B) in subparagraph (H), by inserting ‘‘, 16
7402	7402	such as community-based organizations, includ-17
7403	7403	ing faith-based organizations, and other public 18
7404	7404	and private entities’’ after ‘‘stakeholders’’; 19
7405	7405	(2) in subsection (g)— 20
7406	7406	(A) in paragraph (1), in the matter pre-21
7407	7407	ceding subparagraph (A), by inserting ‘‘and the 22
7408	7408	ability of each entity receiving an award under 23
7409	7409	subsection (a) to respond to all-hazards 24
7410	7410	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00250 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7411	7411	TKELLEY on LAP7H3WLY3PROD with BILLS 251
7412	7412	•S 891 IS
7413	7413	threats’’ before the period at the end of the 1
7414	7414	first sentence; 2
7415	7415	(B) in paragraph (2)— 3
7416	7416	(i) in the paragraph heading, by strik-4
7417	7417	ing ‘‘
7418	7418	INFLUENZA’’ and inserting ‘‘RE-5
7419	7419	SPONSE’’; and 6
7420	7420	(ii) in subparagraph (A)— 7
7421	7421	(I) by striking ‘‘to pandemic in-8
7422	7422	fluenza’’ and inserting ‘‘to a pathogen 9
7423	7423	causing a pandemic, including pan-10
7424	7424	demic influenza’’; and 11
7425	7425	(II) by striking ‘‘such pandemic 12
7426	7426	influenza’’ and inserting ‘‘such pan-13
7427	7427	demic response’’; 14
7428	7428	(C) in paragraph (5)— 15
7429	7429	(i) in the paragraph heading, by strik-16
7430	7430	ing ‘‘
7431	7431	INFLUENZA’’ and inserting ‘‘PAN-17
7432	7432	DEMIC RESPONSE’’; 18
7433	7433	(ii) in the matter preceding subpara-19
7434	7434	graph (A), by striking ‘‘2019’’ and insert-20
7435	7435	ing ‘‘2026’’; 21
7436	7436	(iii) in subparagraph (A), by striking 22
7437	7437	‘‘2018’’ and inserting ‘‘2025’’; and 23
7438	7438	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00251 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7439	7439	TKELLEY on LAP7H3WLY3PROD with BILLS 252
7440	7440	•S 891 IS
7441	7441	(iv) in subparagraph (B), by striking 1
7442	7442	‘‘pandemic influenza’’ and inserting ‘‘a 2
7443	7443	pathogen causing a pandemic’’; and 3
7444	7444	(D) in paragraph (6)— 4
7445	7445	(i) in subparagraph (A), in the matter 5
7446	7446	preceding clause (i), by striking ‘‘The 6
7447	7447	amounts described in this paragraph are 7
7448	7448	the following amounts that are payable to 8
7449	7449	an entity for activities described in this 9
7450	7450	section or section 319C–2’’ and inserting 10
7451	7451	‘‘The Secretary shall withhold from an en-11
7452	7452	tity pursuant to paragraph (5) for non-12
7453	7453	compliance with the requirements of this 13
7454	7454	section or section 319C–2 as follows’’; and 14
7455	7455	(ii) in subparagraph (B), by inserting 15
7456	7456	‘‘with respect to the requirements of this 16
7457	7457	section or section 319C–2’’ after ‘‘para-17
7458	7458	graph (5)’’; and 18
7459	7459	(3) in subsection (h)(1)(A), by striking 19
7460	7460	‘‘$685,000,000 for each of fiscal years 2019 through 20
7461	7461	2023’’ and inserting ‘‘$735,000,000 for each of fis-21
7462	7462	cal years 2025 and 2026, to remain available 22
7463	7463	through December 31, 2026’’. 23
7464	7464	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00252 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7465	7465	TKELLEY on LAP7H3WLY3PROD with BILLS 253
7466	7466	•S 891 IS
7467	7467	SEC. 613. HOSPITAL PREPAREDNESS PROGRAM. 1
7468	7468	(a) I
7469	7469	NCREASINGPARTICIPATION BY EMS IN THE 2
7470	7470	H
7471	7471	OSPITALPREPAREDNESSPROGRAM.— 3
7472	7472	(1) I
7473	7473	N GENERAL.—Section 319C–2 of the Pub-4
7474	7474	lic Health Service Act (42 U.S.C. 247d–3b) is 5
7475	7475	amended— 6
7476	7476	(A) in subsection (b)(1)(A)— 7
7477	7477	(i) in clause (iii)(III), by striking ‘‘; 8
7478	7478	and’’ and inserting a semicolon; and 9
7479	7479	(ii) by striking clause (iv) and insert-10
7480	7480	ing the following: 11
7481	7481	‘‘(iv) one or more emergency medical 12
7482	7482	service organizations; and 13
7483	7483	‘‘(v) to the extent practicable, one or 14
7484	7484	more emergency management organiza-15
7485	7485	tions; and’’; and 16
7486	7486	(B) in subsection (g)(1)— 17
7487	7487	(i) by striking ‘‘(1) L
7488	7488	OCAL RESPONSE 18
7489	7489	CAPABILITIES’’ and inserting: 19
7490	7490	‘‘(1) L
7491	7491	OCAL RESPONSE CAPABILITIES .— 20
7492	7492	‘‘(A) P
7493	7493	ROGRAM COORDINATION .—’’; 21
7494	7494	(ii) by striking ‘‘extent practicable, 22
7495	7495	ensure’’ and inserting the following: ‘‘ex-23
7496	7496	tent practicable— 24
7497	7497	‘‘(i) ensure’’; 25
7498	7498	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00253 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7499	7499	TKELLEY on LAP7H3WLY3PROD with BILLS 254
7500	7500	•S 891 IS
7501	7501	(iii) by striking the period and insert-1
7502	7502	ing ‘‘; and’’; and 2
7503	7503	(iv) by adding at the end the fol-3
7504	7504	lowing: 4
7505	7505	‘‘(ii) seek to increase participation of 5
7506	7506	eligible entities described in subsection 6
7507	7507	(b)(1)(A) with lower participation rates 7
7508	7508	relative to other eligible entities, such as 8
7509	7509	emergency medical services organizations 9
7510	7510	and health care facilities in underserved 10
7511	7511	areas.’’. 11
7512	7512	(2) P
7513	7513	REFERENCES.—Section 319C– 12
7514	7514	2(d)(1)(A)(iii) of the Public Health Service Act (42 13
7515	7515	U.S.C. 247d–3b(d)(1)(A)(iii)) is amended by strik-14
7516	7516	ing ‘‘subsection (b)(1)(A)(ii)’’ and inserting ‘‘clauses 15
7517	7517	(ii) and (iv) of subsection (b)(1)(A)’’. 16
7518	7518	(b) I
7519	7519	MPROVINGMEDICALREADINESS ANDRESPONSE 17
7520	7520	C
7521	7521	APABILITIES.—Section 319C–2 of the Public Health 18
7522	7522	Service Act (42 U.S.C. 247d–3b) is amended— 19
7523	7523	(1) in subsection (b)(2)— 20
7524	7524	(A) in subparagraph (A), by striking 21
7525	7525	‘‘and’’ at the end; 22
7526	7526	(B) in subparagraph (B), by striking the 23
7527	7527	period and inserting ‘‘; and’’; and 24
7528	7528	(C) by inserting at the end the following: 25
7529	7529	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00254 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7530	7530	TKELLEY on LAP7H3WLY3PROD with BILLS 255
7531	7531	•S 891 IS
7532	7532	‘‘(C) designate a lead entity to administer such 1
7533	7533	award and support coordination between entities de-2
7534	7534	scribed in this subsection.’’; 3
7535	7535	(2) in subsection (g)(1), as amended by sub-4
7536	7536	section (a)(1)(B), by adding at the end the fol-5
7537	7537	lowing: 6
7538	7538	‘‘(B) R
7539	7539	EGIONAL OPERATIONS .—An eligible 7
7540	7540	entity shall establish and maintain, or leverage 8
7541	7541	an existing, capability to enable coordination of 9
7542	7542	regional medical operations, which may include 10
7543	7543	systems to facilitate information sharing and 11
7544	7544	coordination, within a coalition described under 12
7545	7545	subsection (b)(1)(A) and, as appropriate, 13
7546	7546	among multiple coalitions that are in close geo-14
7547	7547	graphic proximity to each other.’’; and 15
7548	7548	(3) in subsection (j)(1)— 16
7549	7549	(A) in subparagraph (A), by striking ‘‘for 17
7550	7550	each of fiscal years 2019 through 2023’’ and 18
7551	7551	inserting ‘‘for each of fiscal years 2025 and 19
7552	7552	2026, to remain available through December 20
7553	7553	31, 2026’’; and 21
7554	7554	(B) in subparagraph (B)(iii), by striking 22
7555	7555	‘‘September 30, 2023’’ and inserting ‘‘Decem-23
7556	7556	ber 31, 2026’’. 24
7557	7557	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00255 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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7559	7559	•S 891 IS
7560	7560	SEC. 614. FACILITIES AND CAPACITIES OF THE CENTERS 1
7561	7561	FOR DISEASE CONTROL AND PREVENTION TO 2
7562	7562	COMBAT PUBLIC HEALTH SECURITY 3
7563	7563	THREATS. 4
7564	7564	Section 319D(h) of the Public Health Service Act (42 5
7565	7565	U.S.C. 247d–4(h)) is amended— 6
7566	7566	(1) in paragraph (1), by striking ‘‘$25,000,000 7
7567	7567	for each of fiscal years 2022 and 2023’’ and insert-8
7568	7568	ing ‘‘$40,000,000 for each of fiscal years 2025 and 9
7569	7569	2026’’, to remain available through December 31, 10
7570	7570	2026; and 11
7571	7571	(2) in paragraph (2), by striking ‘‘2022 and 12
7572	7572	2023’’ and inserting ‘‘2025 and 2026, to remain 13
7573	7573	available through December 31, 2026’’. 14
7574	7574	SEC. 615. PILOT PROGRAM TO SUPPORT STATE MEDICAL 15
7575	7575	STOCKPILES. 16
7576	7576	(a) I
7577	7577	NGENERAL.—Section 319F–2(i) of the Public 17
7578	7578	Health Service Act (42 U.S.C. 247d–6b(i)) is amended— 18
7579	7579	(1) in paragraph (2)(B)(i)— 19
7580	7580	(A) in subclause (I), by striking ‘‘and 20
7581	7581	2024’’ and inserting ‘‘through 2025’’; and 21
7582	7582	(B) in subclause (II), by striking ‘‘2025’’ 22
7583	7583	and inserting ‘‘2026’’; 23
7584	7584	(2) in paragraph (4)— 24
7585	7585	(A) in subparagraph (G), by striking ‘‘; 25
7586	7586	and’’ at the end and inserting a semicolon; 26
7587	7587	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00256 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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7589	7589	•S 891 IS
7590	7590	(B) by redesignating subparagraph (H) as 1
7591	7591	subparagraph (I); 2
7592	7592	(C) by inserting after subparagraph (G) 3
7593	7593	the following: 4
7594	7594	‘‘(H) facilitate the sharing of best practices 5
7595	7595	among States within a consortia of States in re-6
7596	7596	ceipt of funding related to establishing and 7
7597	7597	maintaining a stockpile of medical products; 8
7598	7598	and’’; and 9
7599	7599	(D) in subparagraph (I), as so redesig-10
7600	7600	nated, by striking ‘‘State efforts’’ and inserting 11
7601	7601	‘‘State or regional efforts’’; 12
7602	7602	(3) by redesignating paragraphs (5) through 13
7603	7603	(9) as paragraphs (6) through (10), respectively; 14
7604	7604	(4) by inserting after paragraph (4) the fol-15
7605	7605	lowing: 16
7606	7606	‘‘(5) C
7607	7607	OORDINATION.—An entity in receipt of 17
7608	7608	an award under paragraph (1), in carrying out the 18
7609	7609	activities under this subsection, shall coordinate with 19
7610	7610	appropriate health care entities, health officials, and 20
7611	7611	emergency management officials within the jurisdic-21
7612	7612	tion of such State or States.’’; and 22
7613	7613	(5) in paragraph (10), as so redesignated, by 23
7614	7614	striking ‘‘$3,500,000,000 for each of fiscal years 24
7615	7615	2023 and 2024’’ and inserting ‘‘$3,365,000,000 for 25
7616	7616	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00257 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7617	7617	TKELLEY on LAP7H3WLY3PROD with BILLS 258
7618	7618	•S 891 IS
7619	7619	fiscal year 2025, and $3,265,000,000 for fiscal year 1
7620	7620	2026’’. 2
7621	7621	(b) GAO R
7622	7622	EPORT.—Section 2409(b) of the PRE-3
7623	7623	VENT Pandemics Act (Public Law 117–328) is amend-4
7624	7624	ed— 5
7625	7625	(1) in paragraph (2), by striking ‘‘; and’’ and 6
7626	7626	inserting a semicolon; 7
7627	7627	(2) in paragraph (3), by striking the period and 8
7628	7628	inserting ‘‘; and’’; and 9
7629	7629	(3) by adding at the end the following: 10
7630	7630	‘‘(4) the impact of any regional stockpiling ap-11
7631	7631	proaches carried out under subsection (i)(1) of sec-12
7632	7632	tion 319F–2 of the Public Health Service Act (42 13
7633	7633	U.S.C. 247d–6b).’’. 14
7634	7634	SEC. 616. ENHANCING DOMESTIC WASTEWATER SURVEIL-15
7635	7635	LANCE FOR PATHOGEN DETECTION. 16
7636	7636	(a) I
7637	7637	NGENERAL.—Title III of the Public Health 17
7638	7638	Service Act is amended by inserting after section 317V 18
7639	7639	(42 U.S.C. 247b–24) the following: 19
7640	7640	‘‘SEC. 317W. WASTEWATER SURVEILLANCE FOR PATHOGEN 20
7641	7641	DETECTION. 21
7642	7642	‘‘(a) W
7643	7643	ASTEWATERSURVEILLANCE SYSTEM.—The 22
7644	7644	Secretary, acting through the Director of the Centers for 23
7645	7645	Disease Control and Prevention and in coordination with 24
7646	7646	other Federal departments and agencies, shall award 25
7647	7647	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00258 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7648	7648	TKELLEY on LAP7H3WLY3PROD with BILLS 259
7649	7649	•S 891 IS
7650	7650	grants, contracts, or cooperative agreements to eligible en-1
7651	7651	tities to establish, maintain, or improve activities related 2
7652	7652	to the detection and monitoring of infectious diseases 3
7653	7653	through wastewater for public health emergency prepared-4
7654	7654	ness and response purposes. 5
7655	7655	‘‘(b) E
7656	7656	LIGIBLEENTITIES.—To be eligible to receive 6
7657	7657	an award under this section, an entity shall— 7
7658	7658	‘‘(1) be a State, Tribal, or local health depart-8
7659	7659	ment, or a partnership between such a health de-9
7660	7660	partment and other public and private entities; and 10
7661	7661	‘‘(2) submit to the Secretary an application at 11
7662	7662	such time, in such manner, and containing such in-12
7663	7663	formation as the Secretary may reasonably require, 13
7664	7664	which shall include— 14
7665	7665	‘‘(A) a description of activities proposed to 15
7666	7666	be carried out pursuant to an award under sub-16
7667	7667	section (a); 17
7668	7668	‘‘(B) factors such entity proposes to use to 18
7669	7669	select wastewater sampling sites; 19
7670	7670	‘‘(C) factors such entity proposes to use to 20
7671	7671	determine whether a response to findings from 21
7672	7672	such wastewater sampling may be warranted, 22
7673	7673	and a plan for responding, as appropriate, con-23
7674	7674	sistent with applicable plans developed by such 24
7675	7675	entity pursuant to section 319C–1; 25
7676	7676	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00259 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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7678	7678	•S 891 IS
7679	7679	‘‘(D) a plan to sustain such wastewater 1
7680	7680	surveillance activities described in such applica-2
7681	7681	tion following the conclusion of the award pe-3
7682	7682	riod; and 4
7683	7683	‘‘(E) any additional information the Sec-5
7684	7684	retary may require. 6
7685	7685	‘‘(c) C
7686	7686	ONSIDERATION.—In making awards under sub-7
7687	7687	section (a), the Secretary may give priority to eligible enti-8
7688	7688	ties that have submitted an application that— 9
7689	7689	‘‘(1) details plans to provide public access to 10
7690	7690	deidentified data generated through such wastewater 11
7691	7691	surveillance activities in a manner that allows for 12
7692	7692	comparison to such data generated by other recipi-13
7693	7693	ents of an award under subsection (a); and 14
7694	7694	‘‘(2) provides an assessment of community 15
7695	7695	needs related to ongoing infectious disease moni-16
7696	7696	toring, including estimates of the incidence and 17
7697	7697	prevalence of infectious diseases that can be detected 18
7698	7698	in wastewater and availability, at the time of the ap-19
7699	7699	plication, of other forms of infectious disease detec-20
7700	7700	tion in the jurisdiction. 21
7701	7701	‘‘(d) U
7702	7702	SE OFFUNDS.—An eligible entity shall, as ap-22
7703	7703	propriate, use amounts awarded under this section to— 23
7704	7704	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00260 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7705	7705	TKELLEY on LAP7H3WLY3PROD with BILLS 261
7706	7706	•S 891 IS
7707	7707	‘‘(1) establish or enhance existing capacity and 1
7708	7708	capabilities to conduct wastewater sampling, testing, 2
7709	7709	and related analysis; 3
7710	7710	‘‘(2) conduct wastewater surveillance, as appro-4
7711	7711	priate, in areas or facilities with increased risk of in-5
7712	7712	fectious disease outbreaks and limited ability to uti-6
7713	7713	lize other forms of infectious disease detection, such 7
7714	7714	as at individual facilities, institutions, and locations 8
7715	7715	in rural areas or areas in which wastewater is not 9
7716	7716	treated through the relevant local utility of the juris-10
7717	7717	diction; and 11
7718	7718	‘‘(3) implement projects that use evidence-based 12
7719	7719	or innovative practices to conduct wastewater sur-13
7720	7720	veillance activities. 14
7721	7721	‘‘(e) P
7722	7722	ARTNERSHIPS.—In carrying out activities 15
7723	7723	under this section, eligible entities shall identify opportuni-16
7724	7724	ties to partner with other public or private entities to le-17
7725	7725	verage relevant capabilities maintained by such entities, 18
7726	7726	as appropriate and consistent with this section. 19
7727	7727	‘‘(f) T
7728	7728	ECHNICALASSISTANCE.—The Secretary, in 20
7729	7729	consultation with the heads of other applicable Federal 21
7730	7730	agencies and departments, as appropriate, shall provide 22
7731	7731	technical assistance to recipients of awards under this sec-23
7732	7732	tion to facilitate the planning, development, and imple-24
7733	7733	mentation of activities described in subsection (d). 25
7734	7734	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00261 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7735	7735	TKELLEY on LAP7H3WLY3PROD with BILLS 262
7736	7736	•S 891 IS
7737	7737	‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 1
7738	7738	carry out this section, there is authorized to be appro-2
7739	7739	priated $20,000,000 for each of fiscal years 2025 and 3
7740	7740	2026, to remain available through December 31, 2026.’’. 4
7741	7741	(b) W
7742	7742	ASTEWATERSURVEILLANCERESEARCH.— 5
7743	7743	(1) I
7744	7744	N GENERAL.—The Secretary of Health and 6
7745	7745	Human Services (in this subsection referred to as 7
7746	7746	the ‘‘Secretary’’) shall continue to conduct or sup-8
7747	7747	port research on the use of wastewater surveillance 9
7748	7748	to detect and monitor emerging infectious diseases, 10
7749	7749	which may include— 11
7750	7750	(A) research to improve the efficiency and 12
7751	7751	effectiveness of wastewater sample collection 13
7752	7752	and analysis and increase the sensitivity and 14
7753	7753	specificity of wastewater testing methods; and 15
7754	7754	(B) implementation and development of 16
7755	7755	evidence-based practices to facilitate the esti-17
7756	7756	mation of the incidence and prevalence of infec-18
7757	7757	tious disease within a community. 19
7758	7758	(2) N
7759	7759	ON-DUPLICATION OF EFFORT .—The Sec-20
7760	7760	retary shall ensure that activities carried out under 21
7761	7761	this subsection do not unnecessarily duplicate efforts 22
7762	7762	of other agencies and offices within the Department 23
7763	7763	of Health and Human Services related to wastewater 24
7764	7764	surveillance. 25
7765	7765	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00262 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7766	7766	TKELLEY on LAP7H3WLY3PROD with BILLS 263
7767	7767	•S 891 IS
7768	7768	SEC. 617. REAUTHORIZATION OF MOSQUITO ABATEMENT 1
7769	7769	FOR SAFETY AND HEALTH PROGRAM. 2
7770	7770	Section 317S of the Public Health Service Act (42 3
7771	7771	U.S.C. 247b–21) is amended— 4
7772	7772	(1) in subsection (a)(3)(A), by striking ‘‘sub-5
7773	7773	section (b)(3)’’ and inserting ‘‘subsection (b)(4)’’; 6
7774	7774	(2) in subsection (b)— 7
7775	7775	(A) by redesignating paragraphs (3) 8
7776	7776	through (6) as paragraphs (4) through (7), re-9
7777	7777	spectively; and 10
7778	7778	(B) by inserting after paragraph (2) the 11
7779	7779	following: 12
7780	7780	‘‘(3) C
7781	7781	ONSIDERATIONS.—The Secretary may 13
7782	7782	consider the use of innovative and novel technology 14
7783	7783	for mosquito prevention and control in making 15
7784	7784	grants under paragraph (1).’’; 16
7785	7785	(3) by amending subsection (d) to read as fol-17
7786	7786	lows: 18
7787	7787	‘‘(d) U
7788	7788	SES OFFUNDS.—Amounts appropriated under 19
7789	7789	subsection (f) may be used by the Secretary to provide 20
7790	7790	training and technical assistance with respect to the plan-21
7791	7791	ning, development, and operation of assessments and 22
7792	7792	plans under subsection (a) and control programs under 23
7793	7793	subsection (b). The Secretary may provide such training 24
7794	7794	and technical assistance directly or through awards of 25
7795	7795	grants or contracts to public and private entities.’’; and 26
7796	7796	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00263 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7797	7797	TKELLEY on LAP7H3WLY3PROD with BILLS 264
7798	7798	•S 891 IS
7799	7799	(4) in subsection (f)(1), by striking ‘‘2019 1
7800	7800	through 2023’’ and inserting ‘‘2025 and 2026, to re-2
7801	7801	main available through December 31, 2026’’. 3
7802	7802	Subtitle B—Federal Planning and 4
7803	7803	Coordination 5
7804	7804	SEC. 621. ALL-HAZARDS EMERGENCY PREPAREDNESS AND 6
7805	7805	RESPONSE. 7
7806	7806	Section 2811 of the Public Health Service Act (42 8
7807	7807	U.S.C. 300hh–10) is amended— 9
7808	7808	(1) in subsection (b)— 10
7809	7809	(A) in paragraph (3)— 11
7810	7810	(i) by striking ‘‘Oversee advanced re-12
7811	7811	search, development, and procurement’’ 13
7812	7812	and inserting the following: 14
7813	7813	‘‘(A) I
7814	7814	N GENERAL.—Oversee advanced re-15
7815	7815	search, development, procurement, and replen-16
7816	7816	ishment’’; and 17
7817	7817	(ii) by adding at the end the fol-18
7818	7818	lowing: 19
7819	7819	‘‘(B) D
7820	7820	EVELOPMENT OF REQUIRE -20
7821	7821	MENTS.—Lead the development and approval, 21
7822	7822	and, on a routine basis, the review and update, 22
7823	7823	of requirements for such countermeasures and 23
7824	7824	products, including related capabilities, to in-24
7825	7825	form the advanced research, development, pro-25
7826	7826	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00264 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7827	7827	TKELLEY on LAP7H3WLY3PROD with BILLS 265
7828	7828	•S 891 IS
7829	7829	curement, and replenishment decisions of the 1
7830	7830	Secretary.’’; 2
7831	7831	(B) in paragraph (4)— 3
7832	7832	(i) in subparagraph (F)— 4
7833	7833	(I) in the matter preceding clause 5
7834	7834	(i), by striking ‘‘and in consultation 6
7835	7835	with the Secretary of Homeland Secu-7
7836	7836	rity,’’; and 8
7837	7837	(II) in clause (i), by inserting 9
7838	7838	‘‘enhance’’ after ‘‘capabilities and’’; 10
7839	7839	(ii) in subparagraph (G)— 11
7840	7840	(I) in the matter preceding clause 12
7841	7841	(i), by inserting ‘‘the Office of Pan-13
7842	7842	demic Preparedness and Response 14
7843	7843	Policy,’’ after ‘‘Veterans Affairs,’’; 15
7844	7844	(II) in clause (i), by striking 16
7845	7845	‘‘based on’’ and inserting ‘‘based on— 17
7846	7846	’’; 18
7847	7847	(III) in clause (ii), by striking ‘‘; 19
7848	7848	and’’ at the end and inserting a semi-20
7849	7849	colon; 21
7850	7850	(IV) in clause (iii), by striking 22
7851	7851	the period and inserting ‘‘; and’’; and 23
7852	7852	(V) by adding at the end the fol-24
7853	7853	lowing: 25
7854	7854	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00265 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
7855	7855	TKELLEY on LAP7H3WLY3PROD with BILLS 266
7856	7856	•S 891 IS
7857	7857	‘‘(iv) that include, as appropriate, par-1
7858	7858	ticipation by relevant industry, academia, 2
7859	7859	professional societies, and other stake-3
7860	7860	holders.’’; 4
7861	7861	(iii) in subparagraph (H)— 5
7862	7862	(I) by inserting ‘‘and the Direc-6
7863	7863	tor of the Office of Pandemic Pre-7
7864	7864	paredness and Response Policy’’ after 8
7865	7865	‘‘Security Affairs’’; and 9
7866	7866	(II) by inserting ‘‘and medical 10
7867	7867	product and supply capacity planning 11
7868	7868	pursuant to subparagraph (J), includ-12
7869	7869	ing discussion of any relevant identi-13
7870	7870	fied supply chain vulnerabilities’’ be-14
7871	7871	fore the period at the end; 15
7872	7872	(iv) in subparagraph (I), by inserting 16
7873	7873	‘‘the Director of the Office of Pandemic 17
7874	7874	Preparedness and Response Policy,’’ after 18
7875	7875	‘‘Security Affairs,’’; and 19
7876	7876	(v) in subparagraph (J)(i), in the 20
7877	7877	matter preceding subclause (I), by insert-21
7878	7878	ing ‘‘(including ancillary medical supplies 22
7879	7879	and components of medical products, such 23
7880	7880	as active pharmaceutical ingredients, key 24
7881	7881	starting materials, medical device compo-25
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7884	7884	•S 891 IS
7885	7885	nents, testing kits, reagents, and other 1
7886	7886	testing supplies)’’ after ‘‘supply needs’’; 2
7887	7887	and 3
7888	7888	(C) in paragraph (7)— 4
7889	7889	(i) in the matter preceding subpara-5
7890	7890	graph (A), by inserting ‘‘and the require-6
7891	7891	ments developed pursuant to paragraph 7
7892	7892	(3)(B)’’ after ‘‘subsection (d)’’; 8
7893	7893	(ii) by redesignating subparagraphs 9
7894	7894	(E) and (F) as subparagraphs (F) and 10
7895	7895	(G), respectively; and 11
7896	7896	(iii) by inserting after subparagraph 12
7897	7897	(D) the following: 13
7898	7898	‘‘(E) include a professional judgment of 14
7899	7899	anticipated budget needs for each future fiscal 15
7900	7900	year accounted for in such plan to account for 16
7901	7901	the full range of anticipated medical counter-17
7902	7902	measure needs and life-cycle costs to address 18
7903	7903	such priorities and requirements;’’; 19
7904	7904	(2) in subsection (d)— 20
7905	7905	(A) by amending paragraph (1) to read as 21
7906	7906	follows: 22
7907	7907	‘‘(1) I
7908	7908	N GENERAL.—Not later than March 15, 23
7909	7909	2020, and biennially thereafter, the Assistant Sec-24
7910	7910	retary for Preparedness and Response shall develop 25
7911	7911	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00267 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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7913	7913	•S 891 IS
7914	7914	and submit to the Committee on Health, Education, 1
7915	7915	Labor, and Pensions of the Senate and the Com-2
7916	7916	mittee on Energy and Commerce of the House of 3
7917	7917	Representatives a coordinated strategy for medical 4
7918	7918	countermeasures to address chemical, biological, ra-5
7919	7919	diological, and nuclear threats, informed by the re-6
7920	7920	quirements developed pursuant to subsection 7
7921	7921	(b)(3)(B). Not later than 180 days after the submis-8
7922	7922	sion of such strategy to such committees, the Assist-9
7923	7923	ant Secretary for Preparedness and Response shall 10
7924	7924	submit an accompanying implementation plan to 11
7925	7925	such committees. In developing such a strategy and 12
7926	7926	plan, the Assistant Secretary for Preparedness and 13
7927	7927	Response shall consult with the Public Health Emer-14
7928	7928	gency Medical Countermeasures Enterprise estab-15
7929	7929	lished under section 2811–1. Such strategy and plan 16
7930	7930	shall be known as the Public Health Emergency 17
7931	7931	Medical Countermeasures Enterprise Strategy and 18
7932	7932	Implementation Plan.’’; and 19
7933	7933	(B) in paragraph (2), in the matter pre-20
7934	7934	ceding subparagraph (A), by inserting ‘‘strategy 21
7935	7935	and’’ before ‘‘plan’’; and 22
7936	7936	(3) in subsection (f)— 23
7937	7937	(A) in paragraph (1), in the matter pre-24
7938	7938	ceding subparagraph (A), by inserting ‘‘, includ-25
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7941	7941	•S 891 IS
7942	7942	ing such agents that are an emerging infectious 1
7943	7943	disease’’ after ‘‘become a pandemic’’; and 2
7944	7944	(B) in paragraph (2)(A), by striking 3
7945	7945	‘‘$250,000,000 for each of fiscal years 2019 4
7946	7946	through 2023’’ and inserting ‘‘$335,000,000 5
7947	7947	for each of fiscal years 2025 and 2026, to re-6
7948	7948	main available through December 31, 2026’’. 7
7949	7949	SEC. 622. NATIONAL HEALTH SECURITY STRATEGY. 8
7950	7950	Section 2802 of the Public Health Service Act (42 9
7951	7951	U.S.C. 300hh–1) is amended— 10
7952	7952	(1) in subsection (a)(3)— 11
7953	7953	(A) by striking ‘‘In 2022, the’’ and insert-12
7954	7954	ing ‘‘The’’; and 13
7955	7955	(B) by inserting ‘‘, maintaining, and sus-14
7956	7956	taining’’ after ‘‘establishing’’; and 15
7957	7957	(2) in subsection (b)— 16
7958	7958	(A) in paragraph (2)— 17
7959	7959	(i) in subparagraph (A), by inserting 18
7960	7960	‘‘that support interagency coordination and 19
7961	7961	availability of information, as appropriate’’ 20
7962	7962	before the period; 21
7963	7963	(ii) in subparagraph (B), by inserting 22
7964	7964	‘‘rapid testing,’’ after ‘‘and supplies,’’; 23
7965	7965	(B) in paragraph (3)— 24
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7968	7968	•S 891 IS
7969	7969	(i) in the matter preceding subpara-1
7970	7970	graph (A), by inserting ‘‘and blood banks’’ 2
7971	7971	after ‘‘dental health facilities’’; 3
7972	7972	(ii) in subparagraph (C), by inserting 4
7973	7973	‘‘and current capacity of facilities within 5
7974	7974	such systems, as applicable’’ before the pe-6
7975	7975	riod; and 7
7976	7976	(iii) in subparagraph (D), by inserting 8
7977	7977	‘‘and other medical products and medical 9
7978	7978	supplies consistent with the activities car-10
7979	7979	ried out under section 2811(b)(4)(J)’’ be-11
7980	7980	fore the period; 12
7981	7981	(C) in paragraph (5), by inserting ‘‘appli-13
7982	7982	cable federally funded activities and’’ after ‘‘(in-14
7983	7983	cluding’’; 15
7984	7984	(D) in paragraph (8)— 16
7985	7985	(i) in subparagraph (A), by inserting 17
7986	7986	‘‘public health and medical’’ before ‘‘activi-18
7987	7987	ties’’; and 19
7988	7988	(ii) in subparagraph (B), by striking 20
7989	7989	‘‘familiarity with’’ and inserting ‘‘under-21
7990	7990	standing of, and coordination between,’’; 22
7991	7991	(E) by redesignating paragraphs (9) and 23
7992	7992	(10) as paragraphs (10) and (12), respectively; 24
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7995	7995	•S 891 IS
7996	7996	(F) by inserting after paragraph (8) the 1
7997	7997	following: 2
7998	7998	‘‘(9) O
7999	7999	THER SETTINGS.—Supporting Federal, 3
8000	8000	State, local, and Tribal coordination and planning 4
8001	8001	with respect to facilities in which there is an in-5
8002	8002	creased risk of infectious disease outbreaks, includ-6
8003	8003	ing such facilities that address the needs of at-risk 7
8004	8004	individuals, in the event of a public health emer-8
8005	8005	gency declared under section 319.’’; 9
8006	8006	(G) by inserting after subparagraph (10), 10
8007	8007	as so redesignated, the following: 11
8008	8008	‘‘(11) O
8009	8009	THER HAZARDS .—Assessing current 12
8010	8010	and potential health security threats from natural 13
8011	8011	disasters with respect to public health and medical 14
8012	8012	preparedness and response.’’; 15
8013	8013	(H) by inserting after paragraph (12), as 16
8014	8014	so redesignated, the following: 17
8015	8015	‘‘(13) C
8016	8016	YBERSECURITY RESILIENCY OF HEALTH 18
8017	8017	CARE SYSTEMS.—Consistent with the requirements 19
8018	8018	of section 2218 of the Homeland Security Act of 20
8019	8019	2002, strengthening the ability of States, local com-21
8020	8020	munities, and Tribal communities to prepare for, re-22
8021	8021	spond to, and be resilient against cybersecurity 23
8022	8022	vulnerabilities or cybersecurity attacks that affect 24
8023	8023	public health and health information technology, and 25
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8026	8026	•S 891 IS
8027	8027	encouraging health care facilities to use recognized 1
8028	8028	security practices meeting or exceeding the ap-2
8029	8029	proaches established under section 405(d) of the Cy-3
8030	8030	bersecurity Act of 2015.’’; and 4
8031	8031	(I) by striking ‘‘tribal’’ each place it ap-5
8032	8032	pears and inserting ‘‘Tribal’’. 6
8033	8033	SEC. 623. IMPROVING DEVELOPMENT AND DISTRIBUTION 7
8034	8034	OF DIAGNOSTIC TESTS. 8
8035	8035	Section 319B of the Public Health Service Act (42 9
8036	8036	U.S.C. 247d–2) is amended to read as follows: 10
8037	8037	‘‘SEC. 319B. IMPROVING DEVELOPMENT AND DISTRIBU-11
8038	8038	TION OF DIAGNOSTIC TESTS. 12
8039	8039	‘‘(a) D
8040	8040	IAGNOSTICTESTINGPREPAREDNESSPLAN.— 13
8041	8041	The Secretary shall develop, make publicly available, not 14
8042	8042	later than 1 year after the date of enactment of the Pan-15
8043	8043	demic and All-Hazards Preparedness and Response Act, 16
8044	8044	and update not less frequently than every 3 years there-17
8045	8045	after, a plan for the rapid development, validation, author-18
8046	8046	ization, manufacture, procurement, and distribution of di-19
8047	8047	agnostic tests, and for rapid scaling of testing capacity, 20
8048	8048	in response to chemical, biological, radiological, or nuclear 21
8049	8049	threats, including emerging infectious diseases, for which 22
8050	8050	a public health emergency is declared under section 319, 23
8051	8051	or that has significant potential to cause such a public 24
8052	8052	health emergency. 25
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8055	8055	•S 891 IS
8056	8056	‘‘(b) PURPOSES.—The purpose of the plan under sub-1
8057	8057	section (a) shall be to— 2
8058	8058	‘‘(1) facilitate the development and utilization 3
8059	8059	of diagnostic tests; 4
8060	8060	‘‘(2) describe the processes for the rapid devel-5
8061	8061	opment, validation, authorization, manufacture, pro-6
8062	8062	curement, and distribution of diagnostic tests, and 7
8063	8063	for rapid scaling of testing capacity; and 8
8064	8064	‘‘(3) facilitate coordination and collaboration 9
8065	8065	among public and private entities to improve the 10
8066	8066	rapid development and utilization of diagnostic test-11
8067	8067	ing during a public health emergency. 12
8068	8068	‘‘(c) C
8069	8069	ONSIDERATIONS.—The plan under subsection 13
8070	8070	(a) shall take into consideration— 14
8071	8071	‘‘(1) domestic capacity, including any such ca-15
8072	8072	pacity established through partnerships with public 16
8073	8073	and private entities pursuant to subsection (e), to 17
8074	8074	support the development, validation, manufacture, 18
8075	8075	procurement, and distribution of tests, and the rapid 19
8076	8076	scaling of testing capacity; 20
8077	8077	‘‘(2) novel technologies and platforms that— 21
8078	8078	‘‘(A) may be used to improve testing capa-22
8079	8079	bilities, including— 23
8080	8080	‘‘(i) high-throughput laboratory 24
8081	8081	diagnostics; 25
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8084	8084	•S 891 IS
8085	8085	‘‘(ii) point-of-care diagnostics; and 1
8086	8086	‘‘(iii) rapid at-home diagnostics; 2
8087	8087	‘‘(B) improve the accessibility of diagnostic 3
8088	8088	tests; and 4
8089	8089	‘‘(C) facilitate the development and manu-5
8090	8090	facture of diagnostic tests; 6
8091	8091	‘‘(3) medical supply needs related to testing, in-7
8092	8092	cluding diagnostic testing, equipment, supplies, and 8
8093	8093	component parts, and any potential vulnerabilities 9
8094	8094	related to the availability of such medical supplies 10
8095	8095	and related planning needs, consistent with section 11
8096	8096	2811(b)(4)(J); 12
8097	8097	‘‘(4) strategies for the rapid and efficient dis-13
8098	8098	tribution of tests locally, regionally, or nationwide 14
8099	8099	and appropriate scaling of laboratory testing capac-15
8100	8100	ity; and 16
8101	8101	‘‘(5) assessment of such strategies through 17
8102	8102	drills and operational exercises carried out under 18
8103	8103	section 2811(b)(4)(G), as appropriate. 19
8104	8104	‘‘(d) C
8105	8105	OORDINATION.—To inform the development 20
8106	8106	and update of the plan under subsection (a), and in car-21
8107	8107	rying out activities to implement such plan, the Secretary 22
8108	8108	shall coordinate with industry, such as device manufactur-23
8109	8109	ers, clinical and reference laboratories, and medical prod-24
8110	8110	uct distributors, States, local governmental entities, In-25
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8113	8113	•S 891 IS
8114	8114	dian Tribes and Tribal organizations, and other relevant 1
8115	8115	public and private entities. 2
8116	8116	‘‘(e) C
8117	8117	APACITYBUILDING.—The Secretary may con-3
8118	8118	tract with public and private entities, as appropriate, to 4
8119	8119	increase domestic capacity in the rapid development, vali-5
8120	8120	dation, authorization, manufacture, procurement, and dis-6
8121	8121	tribution of diagnostic tests, as appropriate, to State, 7
8122	8122	local, and Tribal health departments and other appro-8
8123	8123	priate entities for immediate public health response activi-9
8124	8124	ties to address an infectious disease with respect to which 10
8125	8125	a public health emergency is declared under section 319, 11
8126	8126	or that has significant potential to cause such a public 12
8127	8127	health emergency.’’. 13
8128	8128	SEC. 624. COMBATING ANTIMICROBIAL RESISTANCE. 14
8129	8129	(a) I
8130	8130	NGENERAL.—Section 319E of the Public 15
8131	8131	Health Service Act (42 U.S.C. 247d–5) is amended— 16
8132	8132	(1) in subsection (a)— 17
8133	8133	(A) in paragraph (1), by inserting ‘‘and ac-18
8134	8134	tivities’’ after ‘‘Federal programs’’; 19
8135	8135	(B) in paragraph (2)— 20
8136	8136	(i) by striking ‘‘public health constitu-21
8137	8137	encies, manufacturers, veterinary and med-22
8138	8138	ical professional societies and others’’ and 23
8139	8139	inserting ‘‘the Advisory Council described 24
8140	8140	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00275 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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8142	8142	•S 891 IS
8143	8143	in subsection (b) and relevant public and 1
8144	8144	private entities’’; and 2
8145	8145	(ii) by inserting ‘‘, pursuant to para-3
8146	8146	graph (4),’’ after ‘‘comprehensive plan’’; 4
8147	8147	(C) by amending paragraph (3) to read as 5
8148	8148	follows: 6
8149	8149	‘‘(3) A
8150	8150	GENDA.—The task force described in 7
8151	8151	paragraph (1) shall consider factors the Secretary 8
8152	8152	considers appropriate, including factors to— 9
8153	8153	‘‘(A) slow the emergence of resistant bac-10
8154	8154	teria and fungi and prevent the spread of re-11
8155	8155	sistant infections; 12
8156	8156	‘‘(B) strengthen activities to combat resist-13
8157	8157	ance with respect to zoonotic diseases; 14
8158	8158	‘‘(C) advance development and use of rapid 15
8159	8159	and innovative capabilities, including diagnostic 16
8160	8160	tests, for identification and characterization of 17
8161	8161	resistant bacteria and fungi; 18
8162	8162	‘‘(D) accelerate basic and applied research 19
8163	8163	and development for new antibiotics, 20
8164	8164	antifungals, and other related therapeutics and 21
8165	8165	vaccines; and 22
8166	8166	‘‘(E) support international collaboration 23
8167	8167	and capacities for antimicrobial-resistance pre-24
8168	8168	vention, detection, and control.’’; 25
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8172	8172	(D) by redesignating paragraph (4) as 1
8173	8173	paragraph (5); 2
8174	8174	(E) by inserting after paragraph (3) the 3
8175	8175	following: 4
8176	8176	‘‘(4) A
8177	8177	CTION PLAN.—Not later than October 1, 5
8178	8178	2026, and every 5 years thereafter, the task force 6
8179	8179	described in paragraph (1) shall develop and submit 7
8180	8180	to the Committee on Health, Education, Labor, and 8
8181	8181	Pensions and the Committee on Appropriations of 9
8182	8182	the Senate and the Committee on Energy and Com-10
8183	8183	merce and the Committee on Appropriations of the 11
8184	8184	House of Representatives a plan regarding Federal 12
8185	8185	programs and activities to combat antimicrobial re-13
8186	8186	sistance, including measurable outcomes, as appro-14
8187	8187	priate, informed by— 15
8188	8188	‘‘(A) the agenda described in paragraph 16
8189	8189	(3); 17
8190	8190	‘‘(B) input provided by the Advisory Coun-18
8191	8191	cil described in subsection (b); and 19
8192	8192	‘‘(C) input from other relevant stake-20
8193	8193	holders provided pursuant to paragraph (2).’’; 21
8194	8194	(2) by redesignating subsections (b) through (o) 22
8195	8195	as subsections (c) through (p), respectively; 23
8196	8196	(3) by inserting after subsection (a) the fol-24
8197	8197	lowing: 25
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8200	8200	•S 891 IS
8201	8201	‘‘(b) ADVISORYCOUNCIL.— 1
8202	8202	‘‘(1) I
8203	8203	N GENERAL.—The Secretary may con-2
8204	8204	tinue the Presidential Advisory Council on Com-3
8205	8205	bating Antibiotic-Resistant Bacteria, referred to in 4
8206	8206	this subsection as the ‘Advisory Council’. 5
8207	8207	‘‘(2) D
8208	8208	UTIES.—The Advisory Council shall ad-6
8209	8209	vise and provide information and recommendations 7
8210	8210	to the Secretary, acting through the Task Force es-8
8211	8211	tablished under subsection (a), regarding Federal 9
8212	8212	programs and activities intended to reduce or com-10
8213	8213	bat antimicrobial-resistant bacteria or fungi that 11
8214	8214	may present a public health threat and improve ca-12
8215	8215	pabilities to prevent, diagnose, mitigate, or treat 13
8216	8216	such resistance. Such advice, information, and rec-14
8217	8217	ommendations may be related to improving Federal 15
8218	8218	efforts related to factors described in subsection 16
8219	8219	(a)(3) and other topics related to antimicrobial re-17
8220	8220	sistance, as appropriate. 18
8221	8221	‘‘(3) M
8222	8222	EETINGS AND COORDINATION .— 19
8223	8223	‘‘(A) M
8224	8224	EETINGS.—The Advisory Council 20
8225	8225	shall meet not less frequently than biannually 21
8226	8226	and, to the extent practicable, in coordination 22
8227	8227	with meetings of the task force established 23
8228	8228	under subsection (a). 24
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8232	8232	‘‘(B) COORDINATION.—The Advisory 1
8233	8233	Council shall, to the greatest extent practicable, 2
8234	8234	coordinate activities carried out by the Council 3
8235	8235	with the task force established under subsection 4
8236	8236	(a). 5
8237	8237	‘‘(4) FACA.—Chapter 10 of title 5, United 6
8238	8238	States Code, shall apply to the activities and duties 7
8239	8239	of the Advisory Council. 8
8240	8240	‘‘(5) S
8241	8241	UNSET.— 9
8242	8242	‘‘(A) I
8243	8243	N GENERAL.—The Advisory Council 10
8244	8244	under this subsection shall terminate on De-11
8245	8245	cember 31, 2026. 12
8246	8246	‘‘(B) E
8247	8247	XTENSION OF ADVISORY COUN -13
8248	8248	CIL.—Not later than October 1, 2026, the Sec-14
8249	8249	retary shall submit to the Committee on 15
8250	8250	Health, Education, Labor, and Pensions of the 16
8251	8251	Senate and the Committee on Energy and Com-17
8252	8252	merce of the House of Representatives a report 18
8253	8253	that includes a recommendation on whether the 19
8254	8254	Advisory Council should be extended, and iden-20
8255	8255	tifying whether there are other committees, 21
8256	8256	councils, or task forces that have overlapping or 22
8257	8257	similar duties to that of the Advisory Council, 23
8258	8258	and whether such committees, councils, or task 24
8259	8259	forces should be combined, restructured, or 25
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8262	8262	•S 891 IS
8263	8263	eliminated, including with respect to the task 1
8264	8264	force established under subsection (a).’’; and 2
8265	8265	(4) in subsection (n), as so redesignated, by 3
8266	8266	striking ‘‘(f) through (j)’’ and inserting ‘‘(g) through 4
8267	8267	(k)’’. 5
8268	8268	(b) C
8269	8269	ONFORMINGAMENDMENT.—Section 505 of the 6
8270	8270	Pandemic and All-Hazards Preparedness and Advancing 7
8271	8271	Innovation Act of 2019 (42 U.S.C. 247d–5 note; Public 8
8272	8272	Law 116–22) is amended by striking subsection (a) and 9
8273	8273	all that follows through ‘‘Not later’’ in subsection (e) and 10
8274	8274	inserting the following: 11
8275	8275	‘‘Not later’’. 12
8276	8276	SEC. 625. STRATEGIC NATIONAL STOCKPILE AND MATE-13
8277	8277	RIAL THREATS. 14
8278	8278	Section 319F–2 of the Public Health Service Act (42 15
8279	8279	U.S.C. 247d–6b) is amended— 16
8280	8280	(1) in subsection (a)— 17
8281	8281	(A) in paragraph (2)— 18
8282	8282	(i) in subparagraph (A), by inserting 19
8283	8283	‘‘Such review shall include a description of 20
8284	8284	how the Secretary manages and mitigates 21
8285	8285	risks associated with gaps between current 22
8286	8286	inventory levels and stockpiling goals, 23
8287	8287	prioritizes such risks, and tracks progress 24
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8290	8290	•S 891 IS
8291	8291	toward mitigation of such risks.’’ after the 1
8292	8292	first sentence; and 2
8293	8293	(ii) in subparagraph (B)(i), by amend-3
8294	8294	ing subclause (IV) to read as follows: 4
8295	8295	‘‘(IV) the emergency health secu-5
8296	8296	rity threat or threats such counter-6
8297	8297	measure procurement is intended to 7
8298	8298	address, including— 8
8299	8299	‘‘(aa) whether such procure-9
8300	8300	ment is consistent with meeting 10
8301	8301	emergency health security needs 11
8302	8302	associated with such threat or 12
8303	8303	threats; and 13
8304	8304	‘‘(bb) in the case of a coun-14
8305	8305	termeasure that addresses a bio-15
8306	8306	logical agent, whether such agent 16
8307	8307	has an increased likelihood to be-17
8308	8308	come resistant to, more resistant 18
8309	8309	to, or evade, such counter-19
8310	8310	measure relative to other avail-20
8311	8311	able medical countermeasures;’’; 21
8312	8312	(B) in paragraph (3)— 22
8313	8313	(i) in subparagraph (B), by striking 23
8314	8314	‘‘are followed, regularly reviewed, and up-24
8315	8315	dated with respect to such stockpile’’ and 25
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8318	8318	•S 891 IS
8319	8319	inserting ‘‘with respect to such stockpile 1
8320	8320	are followed, regularly reviewed, and up-2
8321	8321	dated to reflect best practices’’; 3
8322	8322	(ii) in subparagraph (I), by inserting 4
8323	8323	‘‘, through a standard operating proce-5
8324	8324	dure,’’ after ‘‘ensure’’; 6
8325	8325	(iii) by redesignating subparagraphs 7
8326	8326	(H) through (K) as subparagraphs (I) 8
8327	8327	through (L), respectively; 9
8328	8328	(iv) by inserting after subparagraph 10
8329	8329	(G) the following: 11
8330	8330	‘‘(H) utilize tools to enable the timely and 12
8331	8331	accurate tracking of the contents of the stock-13
8332	8332	pile throughout the deployment of such con-14
8333	8333	tents, including tracking of the location and ge-15
8334	8334	ographic distribution and utilization of such 16
8335	8335	contents;’’; 17
8336	8336	(v) in subparagraph (K), as so redes-18
8337	8337	ignated, by striking ‘‘; and’’ at the end and 19
8338	8338	inserting a semicolon; 20
8339	8339	(vi) in subparagraph (L), as so redes-21
8340	8340	ignated, by striking the period and insert-22
8341	8341	ing ‘‘; and’’; and 23
8342	8342	(vii) by adding at the end the fol-24
8343	8343	lowing: 25
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8346	8346	•S 891 IS
8347	8347	‘‘(M) communicate to relevant vendors re-1
8348	8348	garding modifications, renewals, extensions, or 2
8349	8349	terminations of contracts, or the intent to exer-3
8350	8350	cise options for such contracts, within 30 days, 4
8351	8351	as practicable, of such determination, including 5
8352	8352	through the development of a contract notifica-6
8353	8353	tion process.’’; 7
8354	8354	(C) in paragraph (5)(B), in the matter 8
8355	8355	preceding clause (i), by inserting ‘‘, which may 9
8356	8356	accompany the review required under paragraph 10
8357	8357	(2),’’ after ‘‘Representatives a report’’; and 11
8358	8358	(D) in paragraph (6)(A)— 12
8359	8359	(i) by redesignating clauses (viii) 13
8360	8360	through (x) as clauses (ix) through (xi), re-14
8361	8361	spectively; and 15
8362	8362	(ii) by inserting after clause (vii) the 16
8363	8363	following: 17
8364	8364	‘‘(viii) with respect to any change in 18
8365	8365	the Federal organizational management of 19
8366	8366	the stockpile, an assessment and compari-20
8367	8367	son of any differences in the processes and 21
8368	8368	operations resulting from such change, in-22
8369	8369	cluding— 23
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8372	8372	•S 891 IS
8373	8373	‘‘(I) planning for potential coun-1
8374	8374	termeasure deployment, distribution, 2
8375	8375	or dispensing capabilities; 3
8376	8376	‘‘(II) organizational structure; 4
8377	8377	‘‘(III) communication with rel-5
8378	8378	evant stakeholders related to procure-6
8379	8379	ment decisions; 7
8380	8380	‘‘(IV) processes related to pro-8
8381	8381	curement, deployment, and use of 9
8382	8382	stockpiled countermeasures; 10
8383	8383	‘‘(V) communication and coordi-11
8384	8384	nation with the Public Health Emer-12
8385	8385	gency Medical Countermeasures En-13
8386	8386	terprise and other related Federal en-14
8387	8387	tities; 15
8388	8388	‘‘(VI) inventory management; 16
8389	8389	and 17
8390	8390	‘‘(VII) availability and use of re-18
8391	8391	sources for such activities;’’; and 19
8392	8392	(2) in subsection (c)(2)(C), by striking 20
8393	8393	‘‘promptly’’ and inserting ‘‘, not later than 60 days 21
8394	8394	after each such determination,’’; 22
8395	8395	(3) in subsection (f)(1), by striking 23
8396	8396	‘‘$610,000,000 for each of fiscal years 2019 through 24
8397	8397	2021, and $750,000,000 for each of fiscal years 25
8398	8398	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00284 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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8400	8400	•S 891 IS
8401	8401	2022 and 2023’’ and inserting ‘‘$1,100,000,000 for 1
8402	8402	fiscal year 2025, and $1,210,000,000 for fiscal year 2
8403	8403	2026’’; and 3
8404	8404	(4) in subsection (g)(1), by striking ‘‘2019 4
8405	8405	through 2028’’ and inserting ‘‘2025 through 2034’’. 5
8406	8406	SEC. 626. MEDICAL COUNTERMEASURES FOR VIRAL 6
8407	8407	THREATS WITH PANDEMIC POTENTIAL. 7
8408	8408	Section 319L of the Public Health Service Act (42 8
8409	8409	U.S.C. 247d–7e) is amended— 9
8410	8410	(1) in subsection (c)— 10
8411	8411	(A) in paragraph (4)— 11
8412	8412	(i) in subparagraph (D)— 12
8413	8413	(I) in clause (ii), by striking ‘‘; 13
8414	8414	and’’ and inserting a semicolon; and 14
8415	8415	(II) by redesignating clause (iii) 15
8416	8416	as clause (iv); and 16
8417	8417	(III) by inserting after clause (ii) 17
8418	8418	the following: 18
8419	8419	‘‘(iii) research and development of 19
8420	8420	medical countermeasures for priority virus 20
8421	8421	families that have significant potential to 21
8422	8422	cause a pandemic, including such counter-22
8423	8423	measures that take either pathogen-specific 23
8424	8424	or pathogen-agnostic approaches, and plat-24
8425	8425	form technologies to improve the develop-25
8426	8426	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00285 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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8428	8428	•S 891 IS
8429	8429	ment and manufacture of such medical 1
8430	8430	countermeasures; and’’; and 2
8431	8431	(ii) in subparagraph (F)(ii), by insert-3
8432	8432	ing ‘‘or priority virus families and other 4
8433	8433	viral pathogens that pose a threat due to 5
8434	8434	their significant potential to cause a pan-6
8435	8435	demic,’’ after ‘‘pandemic influenza,’’; and 7
8436	8436	(B) in paragraph (5), by adding at the end 8
8437	8437	the following: 9
8438	8438	‘‘(I) N
8439	8439	OTIFICATION.—In awarding con-10
8440	8440	tracts, grants, cooperative agreements, or other 11
8441	8441	transactions under this section, the Secretary 12
8442	8442	shall communicate to relevant vendors regard-13
8443	8443	ing modifications, renewals, extensions, or ter-14
8444	8444	minations of contracts, including through the 15
8445	8445	development of a contract notification process, 16
8446	8446	within 30 days of such determination, as prac-17
8447	8447	ticable.’’; 18
8448	8448	(2) in subsection (d)(2), by striking 19
8449	8449	‘‘$611,700,000 for each of fiscal years 2019 through 20
8450	8450	2023’’ and inserting ‘‘$950,000,000 for each of fis-21
8451	8451	cal years 2025 and 2026’’; and 22
8452	8452	(3) in subsection (e)(1), by amending subpara-23
8453	8453	graph (D) to read as follows: 24
8454	8454	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00286 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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8456	8456	•S 891 IS
8457	8457	‘‘(D) SUNSET.—This paragraph shall cease 1
8458	8458	to have force or effect after December 31, 2
8459	8459	2026.’’. 3
8460	8460	SEC. 627. PUBLIC HEALTH EMERGENCY MEDICAL COUN-4
8461	8461	TERMEASURES ENTERPRISE. 5
8462	8462	Section 2811–1 of the Public Health Service Act (42 6
8463	8463	U.S.C. 300hh–10a) is amended— 7
8464	8464	(1) in subsection (b)— 8
8465	8465	(A) by redesignating paragraph (11) as 9
8466	8466	paragraph (13); 10
8467	8467	(B) by inserting after paragraph (10) the 11
8468	8468	following: 12
8469	8469	‘‘(11) The Director of the Biomedical Advanced 13
8470	8470	Research and Development Authority. 14
8471	8471	‘‘(12) The Director of the Strategic National 15
8472	8472	Stockpile.’’; and 16
8473	8473	(C) in paragraph (13), as so redesignated, 17
8474	8474	by striking ‘‘the Director of the Biomedical Ad-18
8475	8475	vanced Research and Development Authority, 19
8476	8476	the Director of the Strategic National Stock-20
8477	8477	pile, the Director of the National Institute of 21
8478	8478	Allergy and Infectious Diseases,’’ and inserting 22
8479	8479	‘‘the Director of the National Institute of Al-23
8480	8480	lergy and Infectious Diseases’’; and 24
8481	8481	(2) in subsection (c)— 25
8482	8482	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00287 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
8483	8483	TKELLEY on LAP7H3WLY3PROD with BILLS 288
8484	8484	•S 891 IS
8485	8485	(A) in paragraph (1)— 1
8486	8486	(i) by redesignating subparagraph (D) 2
8487	8487	as subparagraph (E); and 3
8488	8488	(ii) by inserting after subparagraph 4
8489	8489	(C) the following: 5
8490	8490	‘‘(D) Assist the Secretary in developing 6
8491	8491	strategies for appropriate and evidence-based 7
8492	8492	allocation and distribution of countermeasures 8
8493	8493	to jurisdictions, in a manner that supports the 9
8494	8494	availability and use of such countermeasures, 10
8495	8495	for public health and medical preparedness and 11
8496	8496	response needs.’’; 12
8497	8497	(B) in paragraph (2), by inserting ‘‘rel-13
8498	8498	evant stakeholders, including industry,’’ after 14
8499	8499	‘‘consider input from’’; and 15
8500	8500	(C) by adding at the end the following: 16
8501	8501	‘‘(3) I
8502	8502	NFORMATION SHARING .—The Secretary 17
8503	8503	shall, as appropriate and in a manner that does not 18
8504	8504	compromise national security, communicate and 19
8505	8505	share information related to recommendations made 20
8506	8506	and strategies developed under paragraph (1) with 21
8507	8507	relevant stakeholders, including industry and State, 22
8508	8508	local, and Tribal public health departments.’’. 23
8509	8509	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00288 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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8511	8511	•S 891 IS
8512	8512	SEC. 628. FELLOWSHIP AND TRAINING PROGRAMS. 1
8513	8513	Section 317G of the Public Health Service Act (42 2
8514	8514	U.S.C. 247b–8) is amended— 3
8515	8515	(1) by striking ‘‘The Secretary,’’ and inserting 4
8516	8516	the following: 5
8517	8517	‘‘(a) I
8518	8518	NGENERAL.—The Secretary,’’; and 6
8519	8519	(2) by adding at the end the following: 7
8520	8520	‘‘(b) N
8521	8521	ONCOMPETITIVECONVERSION.— 8
8522	8522	‘‘(1) I
8523	8523	N GENERAL.—The Secretary may non-9
8524	8524	competitively convert an individual who has com-10
8525	8525	pleted an epidemiology, surveillance, or laboratory 11
8526	8526	fellowship or training program under subsection (a) 12
8527	8527	to a career-conditional appointment without regard 13
8528	8528	to the provisions of subchapter I of chapter 33 of 14
8529	8529	title 5, United States Code, provided that such indi-15
8530	8530	vidual meets qualification requirements for the ap-16
8531	8531	pointment.’’. 17
8532	8532	SEC. 629. REGIONAL BIOCONTAINMENT RESEARCH LAB-18
8533	8533	ORATORIES. 19
8534	8534	(a) I
8535	8535	NGENERAL.—The Secretary of Health and 20
8536	8536	Human Services (referred to in this section as the ‘‘Sec-21
8537	8537	retary’’) shall make awards to establish or maintain, as 22
8538	8538	applicable, not fewer than 12 regional biocontainment lab-23
8539	8539	oratories, for purposes of— 24
8540	8540	(1) conducting biomedical research to support 25
8541	8541	public health and medical preparedness for, and 26
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8544	8544	•S 891 IS
8545	8545	rapid response to, biological agents, including emerg-1
8546	8546	ing infectious diseases; 2
8547	8547	(2) ensuring the availability of surge capacity 3
8548	8548	for purposes of responding to such biological agents; 4
8549	8549	(3) supporting information sharing between, 5
8550	8550	and the dissemination of findings to, researchers and 6
8551	8551	other relevant individuals to facilitate collaboration 7
8552	8552	between industry and academia; and 8
8553	8553	(4) providing, as appropriate and applicable, 9
8554	8554	technical assistance and training to researchers and 10
8555	8555	other relevant individuals to support the biomedical 11
8556	8556	research workforce in improving the management 12
8557	8557	and mitigation of safety and security risks in the 13
8558	8558	conduct of research involving such biological agents. 14
8559	8559	(b) R
8560	8560	EQUIREMENTS.—As a condition of receiving a 15
8561	8561	grant under this section, a regional biocontainment labora-16
8562	8562	tory shall agree to such oversight activities as the Sec-17
8563	8563	retary determines appropriate, including periodic meetings 18
8564	8564	with relevant officials of the Department of Health and 19
8565	8565	Human Services, facility inspections, and other activities 20
8566	8566	as necessary and appropriate to ensure compliance with 21
8567	8567	the terms and conditions of such award. 22
8568	8568	(c) W
8569	8569	ORKINGGROUP.—The Secretary shall establish 23
8570	8570	a Working Group, consisting of a representative from each 24
8571	8571	entity in receipt of an award under subsection (a). The 25
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8574	8574	•S 891 IS
8575	8575	Working Group shall make recommendations to the Sec-1
8576	8576	retary in administering awards under this section, for pur-2
8577	8577	poses of— 3
8578	8578	(1) improving the quality and consistency of ap-4
8579	8579	plicable procedures and practices within laboratories 5
8580	8580	funded pursuant to subsection (a); and 6
8581	8581	(2) ensuring coordination, as appropriate, of 7
8582	8582	federally funded activities carried out at such labora-8
8583	8583	tories. 9
8584	8584	(d) D
8585	8585	EFINITION.—In this section, the term ‘‘regional 10
8586	8586	biocontainment laboratory’’ means a Biosafety or Animal 11
8587	8587	Biosafety Level–3 and Level–2 facility located at an insti-12
8588	8588	tution in the United States that is designated by the Sec-13
8589	8589	retary to carry out the activities described in subsection 14
8590	8590	(a). 15
8591	8591	(e) A
8592	8592	UTHORIZATION OFAPPROPRIATIONS.—To carry 16
8593	8593	out this section, there are authorized to be appropriated 17
8594	8594	$52,000,000 for each of fiscal years 2025 and 2026, to 18
8595	8595	remain available through December 31, 2026. 19
8596	8596	(f) A
8597	8597	DMINISTRATIVEEXPENSES.—Of the amount 20
8598	8598	available to carry out this section for a fiscal year, the 21
8599	8599	Secretary may use not more than 5 percent for the admin-22
8600	8600	istrative expenses of carrying out this section, including 23
8601	8601	expenses related to carrying out subsection (c). 24
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8604	8604	•S 891 IS
8605	8605	(g) REPORT TOCONGRESS.—Not later than 1 year 1
8606	8606	after the date of the enactment of this Act, and biannually 2
8607	8607	thereafter, the Secretary, in consultation with the heads 3
8608	8608	of applicable Federal departments and agencies shall re-4
8609	8609	port to the Committee on Health, Education, Labor, and 5
8610	8610	Pensions of the Senate and the Committee on Energy and 6
8611	8611	Commerce of the House of Representatives on— 7
8612	8612	(1) the activities and accomplishments of the 8
8613	8613	regional biocontainment laboratories; 9
8614	8614	(2) any published or disseminated research 10
8615	8615	findings based on research conducted in such labora-11
8616	8616	tories in the applicable year; 12
8617	8617	(3) oversight activities carried out by the Sec-13
8618	8618	retary pursuant to subsection (b); 14
8619	8619	(4) activities undertaken by the Secretary to 15
8620	8620	take into consideration the capacity and capabilities 16
8621	8621	of the network of regional biocontainment labora-17
8622	8622	tories in activities to prepare for and respond to bio-18
8623	8623	logical agents, which may include leveraging such ca-19
8624	8624	pacity and capabilities to support the Laboratory 20
8625	8625	Response Network, as applicable and appropriate; 21
8626	8626	(5) plans for the maintenance and sustainment 22
8627	8627	of federally funded activities conducted at the re-23
8628	8628	gional biocontainment laboratories, consistent with 24
8629	8629	the strategy required under section 2312 of the 25
8630	8630	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00292 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
8631	8631	TKELLEY on LAP7H3WLY3PROD with BILLS 293
8632	8632	•S 891 IS
8633	8633	PREVENT Pandemics Act (Public Law 117–328); 1
8634	8634	and 2
8635	8635	(6) activities undertaken by the Secretary to co-3
8636	8636	ordinate with the heads of other relevant Federal de-4
8637	8637	partments and agencies to ensure that work carried 5
8638	8638	out by each such facility on behalf of the Secretary 6
8639	8639	and such other relevant heads is prioritized, is com-7
8640	8640	plementary to the work carried out by other such fa-8
8641	8641	cilities and other relevant federally funded activities, 9
8642	8642	and avoids unnecessary duplication. 10
8643	8643	SEC. 629A. LIMITATION RELATED TO COUNTRIES OF CON-11
8644	8644	CERN CONDUCTING CERTAIN RESEARCH. 12
8645	8645	Section 2315(c) of the PREVENT Pandemics Act 13
8646	8646	(42 U.S.C. 6627) is amended to read as follows: 14
8647	8647	‘‘(c) L
8648	8648	IMITATIONS ONCOUNTRIES OFCONCERNCON-15
8649	8649	DUCTINGCERTAINRESEARCH.— 16
8650	8650	‘‘(1) I
8651	8651	N GENERAL.—The Secretary of Health 17
8652	8652	and Human Services (referred to in this subsection 18
8653	8653	as the ‘Secretary’) shall not fund research that may 19
8654	8654	reasonably be anticipated to involve the creation, 20
8655	8655	transfer, and use of enhanced pathogens of pan-21
8656	8656	demic potential or biological agents or toxins listed 22
8657	8657	pursuant to section 351A(a)(1) of the Public Health 23
8658	8658	Service Act if such research is conducted by a for-24
8659	8659	eign entity at a facility located in a country that is 25
8660	8660	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00293 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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8662	8662	•S 891 IS
8663	8663	determined to be a country of concern as defined in 1
8664	8664	paragraph (2). 2
8665	8665	‘‘(2) C
8666	8666	OUNTRIES OF CONCERN .— 3
8667	8667	‘‘(A) D
8668	8668	EFINITION.—For purposes of this 4
8669	8669	subsection, a ‘country of concern’ means the 5
8670	8670	People’s Republic of China, the Democratic 6
8671	8671	People’s Republic of Korea, the Russian Fed-7
8672	8672	eration, the Islamic Republic of Iran, and any 8
8673	8673	other country as determined pursuant to sub-9
8674	8674	paragraph (B). 10
8675	8675	‘‘(B) A
8676	8676	DDITIONAL COUNTRIES .—The Di-11
8677	8677	rector of National Intelligence (referred to in 12
8678	8678	this subsection as the ‘Director’) shall, in con-13
8679	8679	sultation with the Secretary, add additional 14
8680	8680	countries of concern for purposes of paragraph 15
8681	8681	(1), only if— 16
8682	8682	‘‘(i) the Director determines that evi-17
8683	8683	dence exists that a country has malicious 18
8684	8684	intent related to the creation, enhance-19
8685	8685	ment, transfer, or use of pathogens of pan-20
8686	8686	demic potential or biological agents or tox-21
8687	8687	ins listed pursuant to such section 22
8688	8688	351A(a)(1); and 23
8689	8689	‘‘(ii) in a manner that does not com-24
8690	8690	promise national security, the Director 25
8691	8691	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00294 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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8693	8693	•S 891 IS
8694	8694	provides such evidence in a report sub-1
8695	8695	mitted to the Committee on Health, Edu-2
8696	8696	cation, Labor, and Pensions of the Senate 3
8697	8697	and the Committee on Energy and Com-4
8698	8698	merce of the House of Representatives. 5
8699	8699	‘‘(C) L
8700	8700	IMITATION.—Paragraph (1) shall 6
8701	8701	not take effect with respect to a country of con-7
8702	8702	cern identified under subparagraph (B) until 8
8703	8703	the date that is 15 days after the date on which 9
8704	8704	the Director submits the report described in 10
8705	8705	subparagraph (B)(ii). 11
8706	8706	‘‘(3) C
8707	8707	LARIFICATION.— 12
8708	8708	‘‘(A) I
8709	8709	N GENERAL.—The requirement of 13
8710	8710	paragraph (1) may be waived by the President 14
8711	8711	for the duration of the initial response to an 15
8712	8712	outbreak of a novel emerging infectious disease 16
8713	8713	if the President determines that such require-17
8714	8714	ment impedes the ability of the Federal Govern-18
8715	8715	ment to immediately respond to such outbreak. 19
8716	8716	‘‘(B) N
8717	8717	OTIFICATION.—The President shall 20
8718	8718	notify such committees of Congress not later 21
8719	8719	than 48 hours after exercising the waiver under 22
8720	8720	subparagraph (A), and shall provide updates to 23
8721	8721	such committees related to the use of such 24
8722	8722	waiver every 15 days thereafter. 25
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8725	8725	•S 891 IS
8726	8726	‘‘(4) SUNSET.—The limitation under this sub-1
8727	8727	section shall expire on December 31, 2026.’’. 2
8728	8728	Subtitle C—Addressing the Needs 3
8729	8729	of All Individuals 4
8730	8730	SEC. 631. IMPROVING ACCESS TO CERTAIN PROGRAMS. 5
8731	8731	(a) P
8732	8732	ROCEDURESRELATED TO THE TRANSITION OF 6
8733	8733	C
8734	8734	ERTAINCLAIMS.— 7
8735	8735	(1) P
8736	8736	ROCEDURES FOR CORRECTING SUBMIS -8
8737	8737	SIONS.— 9
8738	8738	(A) R
8739	8739	EQUESTS INITIALLY SUBMITTED 10
8740	8740	UNDER SECTION 319F–4.— 11
8741	8741	(i) I
8742	8742	N GENERAL.—In the case of a re-12
8743	8743	quest for compensation submitted under 13
8744	8744	section 319F–4 of the Public Health Serv-14
8745	8745	ice Act (42 U.S.C. 247d–6e) for an injury 15
8746	8746	or death related to a medical product for 16
8747	8747	active immunization to prevent coronavirus 17
8748	8748	disease 2019 that the Secretary determines 18
8749	8749	to be ineligible pursuant to subsection 19
8750	8750	(b)(4)(B) of such section 319F–4, the Sec-20
8751	8751	retary shall, not later than 30 days after 21
8752	8752	such determination, notify the individual 22
8753	8753	submitting the request of such determina-23
8754	8754	tion. 24
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8757	8757	•S 891 IS
8758	8758	(ii) SUBMISSION OF PETITION .—An 1
8759	8759	individual who receives a notification de-2
8760	8760	scribed in clause (i) shall be eligible to sub-3
8761	8761	mit a petition to the United States Court 4
8762	8762	of Federal Claims under section 2111 of 5
8763	8763	the Public Health Service Act (42 U.S.C. 6
8764	8764	300aa–11) with respect to the same med-7
8765	8765	ical product administration claimed in the 8
8766	8766	request submitted under section 319F–4 of 9
8767	8767	such Act (42 U.S.C. 247d–6e), provided 10
8768	8768	such petition is submitted not later than 11
8769	8769	the later of— 12
8770	8770	(I) 1 year after receiving such 13
8771	8771	notification under clause (i); or 14
8772	8772	(II) the last date on which the 15
8773	8773	individual otherwise would be eligible 16
8774	8774	to submit a petition relating to such 17
8775	8775	injury, as specified in section 2116 of 18
8776	8776	such Act (42 U.S.C. 300aa–16). 19
8777	8777	(iii) E
8778	8778	LIGIBILITY.—To be eligible to 20
8779	8779	submit a petition in accordance with clause 21
8780	8780	(ii), the petitioner shall have submitted the 22
8781	8781	request that was determined to be ineli-23
8782	8782	gible as described in clause (i) not later 24
8783	8783	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00297 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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8785	8785	•S 891 IS
8786	8786	than the applicable deadline for filing a pe-1
8787	8787	tition under such section 2116. 2
8788	8788	(B) R
8789	8789	EQUESTS INITIALLY SUBMITTED 3
8790	8790	UNDER SECTION 2111.— 4
8791	8791	(i) I
8792	8792	N GENERAL.—If a special master 5
8793	8793	determines that— 6
8794	8794	(I) a petition submitted under 7
8795	8795	section 2111 of the Public Health 8
8796	8796	Service Act (42 U.S.C. 300aa–11) re-9
8797	8797	lated to a medical product for active 10
8798	8798	immunization to prevent coronavirus 11
8799	8799	disease 2019 that is ineligible for the 12
8800	8800	program under subtitle 2 of title XXI 13
8801	8801	of the Public Health Service Act (42 14
8802	8802	U.S.C. 300aa–10 et seq.) because it 15
8803	8803	relates to a medical product adminis-16
8804	8804	tered at a time when the medical 17
8805	8805	product was not included in the table 18
8806	8806	under section 2114 of such Act (42 19
8807	8807	U.S.C. 300aa–14); and 20
8808	8808	(II) the medical product was ad-21
8809	8809	ministered when it was a covered 22
8810	8810	countermeasure subject to a declara-23
8811	8811	tion under section 319F–3(b) of such 24
8812	8812	Act (42 U.S.C. 247d–6d(b)), 25
8813	8813	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00298 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
8814	8814	TKELLEY on LAP7H3WLY3PROD with BILLS 299
8815	8815	•S 891 IS
8816	8816	the special master shall, not later than 30 1
8817	8817	days after such determination, notify the 2
8818	8818	petitioner of such determination. 3
8819	8819	(ii) S
8820	8820	UBMISSION OF REQUEST .—An 4
8821	8821	individual who receives a notification de-5
8822	8822	scribed in clause (i) shall be eligible to sub-6
8823	8823	mit a request for compensation under sec-7
8824	8824	tion 319F–4(b) of the Public Health Serv-8
8825	8825	ice Act (42 U.S.C. 247d–6e(b)) with re-9
8826	8826	spect to the same medical product adminis-10
8827	8827	tration claimed in the petition submitted 11
8828	8828	under section 2111 of such Act (42 U.S.C. 12
8829	8829	300aa–11)— 13
8830	8830	(I) not later than 1 year after re-14
8831	8831	ceiving such notification; or 15
8832	8832	(II) in the case that the notifica-16
8833	8833	tion is issued after judicial review of 17
8834	8834	the petition under subsection (e) or 18
8835	8835	(f) of section 2112 of such Act (42 19
8836	8836	U.S.C. 300aa–12), not later than 1 20
8837	8837	year after the judgment of the United 21
8838	8838	States Court of Federal Claims or the 22
8839	8839	mandate is issued by the United 23
8840	8840	States Court of Appeals for the Fed-24
8841	8841	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00299 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
8842	8842	TKELLEY on LAP7H3WLY3PROD with BILLS 300
8843	8843	•S 891 IS
8844	8844	eral Circuit pursuant to such sub-1
8845	8845	section (e) or (f). 2
8846	8846	(iii) E
8847	8847	LIGIBILITY.—To be eligible to 3
8848	8848	submit a request for compensation in ac-4
8849	8849	cordance with clause (ii), the individual 5
8850	8850	submitting the request shall have sub-6
8851	8851	mitted the petition under section 2111 of 7
8852	8852	the Public Health Service Act (42 U.S.C. 8
8853	8853	300aa–11) that was determined to be ineli-9
8854	8854	gible not later than 1 year after the date 10
8855	8855	of administration of the medical product. 11
8856	8856	(2) C
8857	8857	HANGES TO CERTAIN PROGRAMS .— 12
8858	8858	(A) S
8859	8859	ECTION 319F–4.—Section 319F–4 of 13
8860	8860	the Public Health Service Act (42 U.S.C. 14
8861	8861	247d–6e) is amended— 15
8862	8862	(i) in subsection (b)(4)— 16
8863	8863	(I) by striking ‘‘Except as pro-17
8864	8864	vided’’ and inserting the following: 18
8865	8865	‘‘(A) I
8866	8866	N GENERAL.—Except as provided’’; 19
8867	8867	and 20
8868	8868	(II) by adding at the end the fol-21
8869	8869	lowing: 22
8870	8870	‘‘(B) E
8871	8871	XCLUSION OF INJURIES ELIGIBLE 23
8872	8872	FOR PETITION UNDER TITLE XXI .—Notwith-24
8873	8873	standing any other provision of this section, no 25
8874	8874	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00300 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
8875	8875	TKELLEY on LAP7H3WLY3PROD with BILLS 301
8876	8876	•S 891 IS
8877	8877	individual may be eligible for compensation 1
8878	8878	under this section with respect to a vaccine 2
8879	8879	that, at the time it was administered, was in-3
8880	8880	cluded in the Vaccine Injury Table under sec-4
8881	8881	tion 2114.’’; and 5
8882	8882	(ii) in subsection (d)(3)— 6
8883	8883	(I) by striking ‘‘This section’’ 7
8884	8884	and inserting the following: 8
8885	8885	‘‘(A) I
8886	8886	N GENERAL.—This section’’; and 9
8887	8887	(II) by adding at the end the fol-10
8888	8888	lowing: 11
8889	8889	‘‘(B) E
8890	8890	XHAUSTION OF REMEDIES .—A cov-12
8891	8891	ered individual shall not be considered to have 13
8892	8892	exhausted remedies as described in paragraph 14
8893	8893	(1), nor be eligible to seek remedy under section 15
8894	8894	319F–3(d), unless such individual has provided 16
8895	8895	to the Secretary all supporting documentation 17
8896	8896	necessary to facilitate the determinations re-18
8897	8897	quired under subsection (b)(4).’’. 19
8898	8898	(B) T
8899	8899	ITLE XXI.—Title XXI of the Public 20
8900	8900	Health Service Act (42 U.S.C. 300aa–1 et seq.) 21
8901	8901	is amended— 22
8902	8902	(i) in section 2111(a)(2)(A) (42 23
8903	8903	U.S.C. 300aa–11(a)(2)(A)), in the matter 24
8904	8904	preceding clause (i), by inserting ‘‘con-25
8905	8905	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00301 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
8906	8906	TKELLEY on LAP7H3WLY3PROD with BILLS 302
8907	8907	•S 891 IS
8908	8908	taining the information required under 1
8909	8909	subsection (c)’’ after ‘‘unless a petition’’; 2
8910	8910	(ii) in section 2112(d) (42 U.S.C. 3
8911	8911	300aa–12(d))— 4
8912	8912	(I) by adding at the end of para-5
8913	8913	graph (1) the following: ‘‘Such des-6
8914	8914	ignation shall not occur until the peti-7
8915	8915	tioner has filed all materials required 8
8916	8916	under section 2111(c).’’; and 9
8917	8917	(II) in paragraph (3)(A)(ii), by 10
8918	8918	striking ‘‘the petition was filed’’ and 11
8919	8919	inserting ‘‘on which the chief special 12
8920	8920	master makes the designation pursu-13
8921	8921	ant to paragraph (1)’’; 14
8922	8922	(iii) in section 2114(e) (42 U.S.C. 15
8923	8923	300aa–14(e)), by adding at the end the 16
8924	8924	following: 17
8925	8925	‘‘(4) L
8926	8926	ICENSURE REQUIREMENT .—Notwith-18
8927	8927	standing paragraphs (2) and (3), the Secretary may 19
8928	8928	not revise the Vaccine Injury Table to include a vac-20
8929	8929	cine for which the Centers for Disease Control and 21
8930	8930	Prevention has issued a recommendation for routine 22
8931	8931	use in children or pregnant women until at least one 23
8932	8932	application for such vaccine has been approved 24
8933	8933	under section 351. Upon such revision of the Vac-25
8934	8934	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00302 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
8935	8935	TKELLEY on LAP7H3WLY3PROD with BILLS 303
8936	8936	•S 891 IS
8937	8937	cine Injury Table, all vaccines in a vaccine category 1
8938	8938	on the Vaccine Injury Table, including vaccines au-2
8939	8939	thorized under emergency use pursuant to section 3
8940	8940	564 of the Federal Food, Drug, and Cosmetic Act, 4
8941	8941	shall be considered included in the Vaccine Injury 5
8942	8942	Table.’’; and 6
8943	8943	(iv) in section 2116 (42 U.S.C. 7
8944	8944	300aa–16), by adding at the end the fol-8
8945	8945	lowing: 9
8946	8946	‘‘(d) C
8947	8947	LARIFICATION.—Notwithstanding subsections 10
8948	8948	(a) and (b), an injury or death related to a vaccine admin-11
8949	8949	istered at a time when the vaccine was a covered counter-12
8950	8950	measure subject to a declaration under section 319F–3(b) 13
8951	8951	shall not be eligible for compensation under the Pro-14
8952	8952	gram.’’. 15
8953	8953	(b) A
8954	8954	CCELERATING INJURYCOMPENSATION PRO-16
8955	8955	GRAMADMINISTRATION AND ENSURINGPROGRAMINTEG-17
8956	8956	RITY.— 18
8957	8957	(1) P
8958	8958	ETITIONS FOR COMPENSATION .—Section 19
8959	8959	2111(a)(2)(A)(i) of the Public Health Service Act 20
8960	8960	(42 U.S.C. 300aa–11(a)(2)(A)(i)) is amended— 21
8961	8961	(A) in subclause (I), by striking ‘‘, and’’ 22
8962	8962	and inserting a semicolon; 23
8963	8963	(B) in subclause (II)— 24
8964	8964	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00303 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
8965	8965	TKELLEY on LAP7H3WLY3PROD with BILLS 304
8966	8966	•S 891 IS
8967	8967	(i) by moving the margin 2 ems to the 1
8968	8968	right; and 2
8969	8969	(ii) by striking ‘‘, or’’ and inserting ‘‘; 3
8970	8970	and’’; and 4
8971	8971	(C) by adding at the end the following: 5
8972	8972	‘‘(III) the judgment described in subclause 6
8973	8973	(I) does not result from a petitioner’s motion to 7
8974	8974	dismiss the case; or’’. 8
8975	8975	(2) D
8976	8976	ETERMINATION OF GOOD FAITH .—Section 9
8977	8977	2115(e)(1) of the Public Health Service Act (42 10
8978	8978	U.S.C. 300aa–15(e)(1)) is amended by adding at the 11
8979	8979	end the following: ‘‘When making a determination of 12
8980	8980	good faith under this paragraph, the special master 13
8981	8981	or court may consider whether the petitioner dem-14
8982	8982	onstrated an intention to obtain compensation on 15
8983	8983	such petition and was not merely seeking to satisfy 16
8984	8984	the exhaustion requirement under section 2121(b).’’. 17
8985	8985	(c) E
8986	8986	XTENSION OF DEADLINESTOSUBMITRE-18
8987	8987	QUESTS FORCOMPENSATION FOR CERTAININJURIES.— 19
8988	8988	(1) I
8989	8989	N GENERAL.—With respect to claims filed 20
8990	8990	under section 319F–4 of the Public Health Service 21
8991	8991	Act (42 U.S.C. 247d–6e) alleging a covered injury 22
8992	8992	caused by the administration or use of a covered 23
8993	8993	countermeasure pursuant to a declaration under sec-24
8994	8994	tion 319F–3(b) of such Act (42 U.S.C. 247d–6d(b)) 25
8995	8995	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00304 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
8996	8996	TKELLEY on LAP7H3WLY3PROD with BILLS 305
8997	8997	•S 891 IS
8998	8998	relating to coronavirus disease 2019, the following 1
8999	8999	shall apply: 2
9000	9000	(A) Notwithstanding the filing deadline ap-3
9001	9001	plicable under such section 319F–4, the claim 4
9002	9002	shall be filed within 3 years of the administra-5
9003	9003	tion or use of the covered countermeasure, or 1 6
9004	9004	year after the date of enactment of this Act, 7
9005	9005	whichever is later, and, if a claim filed under 8
9006	9006	such section 319F–4 with respect to such ad-9
9007	9007	ministration or use was filed before the date of 10
9008	9008	enactment of this Act and denied on the basis 11
9009	9009	of having not been filed within the time period 12
9010	9010	required under subsection (b)(4) of such section 13
9011	9011	319F–4, such claim may be refiled pursuant to 14
9012	9012	this subparagraph. 15
9013	9013	(B) With respect to a claim relating to the 16
9014	9014	administration of a medical product for active 17
9015	9015	immunization to prevent coronavirus disease 18
9016	9016	2019 such a claim may be filed under the such 19
9017	9017	section 319F–4 only if the administration of 20
9018	9018	such vaccine occurred prior to the addition of 21
9019	9019	the vaccine to the Vaccine Injury Table under 22
9020	9020	section 2114 of the Public Health Service Act 23
9021	9021	(42 U.S.C. 300aa–14). 24
9022	9022	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00305 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
9023	9023	TKELLEY on LAP7H3WLY3PROD with BILLS 306
9024	9024	•S 891 IS
9025	9025	SEC. 632. SUPPORTING AT-RISK INDIVIDUALS DURING 1
9026	9026	EMERGENCY RESPONSES. 2
9027	9027	(a) T
9028	9028	ECHNICALASSISTANCE FORAT-RISKINDIVID-3
9029	9029	UALS ANDDISASTERS.— 4
9030	9030	(1) I
9031	9031	N GENERAL.—The Secretary of Health and 5
9032	9032	Human Services (referred to in this section as the 6
9033	9033	‘‘Secretary’’) may provide appropriate technical as-7
9034	9034	sistance to States, localities, Tribes, and other appli-8
9035	9035	cable entities related to addressing the unique needs 9
9036	9036	and considerations of at-risk individuals, as defined 10
9037	9037	in section 2802(b)(4) of the Public Health Service 11
9038	9038	Act (42 U.S.C. 300hh–1(b)(4)), in the event of a 12
9039	9039	public health emergency declared by the Secretary 13
9040	9040	pursuant to section 319 of the Public Health Service 14
9041	9041	Act (42 U.S.C. 247d). 15
9042	9042	(2) T
9043	9043	ECHNICAL ASSISTANCE .—The technical 16
9044	9044	assistance described in paragraph (1) shall include— 17
9045	9045	(A) developing, identifying, evaluating, and 18
9046	9046	disseminating evidence-based or evidence-in-19
9047	9047	formed strategies to improve health and address 20
9048	9048	other near-term or long-term outcomes for at- 21
9049	9049	risk individuals related to public health emer-22
9050	9050	gencies, including by addressing such unique 23
9051	9051	needs and considerations in carrying out public 24
9052	9052	health and medical activities to prepare for, re-25
9053	9053	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00306 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
9054	9054	TKELLEY on LAP7H3WLY3PROD with BILLS 307
9055	9055	•S 891 IS
9056	9056	spond to, and recover from, such public health 1
9057	9057	emergencies; and 2
9058	9058	(B) assisting applicable entities, through 3
9059	9059	contracts or cooperative agreements, as appro-4
9060	9060	priate, in the implementation of such evidence- 5
9061	9061	based strategies. 6
9062	9062	(3) C
9063	9063	ONSULTATION.—In carrying out activities 7
9064	9064	under paragraph (2), the Secretary shall take into 8
9065	9065	consideration relevant findings and recommendations 9
9066	9066	of, and, as appropriate, consult with, the National 10
9067	9067	Advisory Committee on Individuals with Disabilities 11
9068	9068	and Disasters established under section 2811C of 12
9069	9069	the Public Health Service Act (42 U.S.C. 300hh– 13
9070	9070	10d), the National Advisory Committee on Children 14
9071	9071	and Disasters under section 2811A of such Act (42 15
9072	9072	U.S.C. 300hh–10b), and the National Advisory 16
9073	9073	Committee on Seniors and Disasters under section 17
9074	9074	2811B of such Act (42 U.S.C. 300hh–10c). 18
9075	9075	(b) C
9076	9076	RISISSTANDARDS OFCARE.—Not later than 2 19
9077	9077	years after the date of enactment of this Act, the Sec-20
9078	9078	retary, acting through the Director of the Office for Civil 21
9079	9079	Rights of the Department of Health and Human Services, 22
9080	9080	shall issue guidance to States and localities on the develop-23
9081	9081	ment or modification of State and local crisis standards 24
9082	9082	of care for use during the response to a public health 25
9083	9083	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00307 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
9084	9084	TKELLEY on LAP7H3WLY3PROD with BILLS 308
9085	9085	•S 891 IS
9086	9086	emergency declared by the Governor of a State or by the 1
9087	9087	Secretary under section 319 of the Public Health Service 2
9088	9088	Act (42 U.S.C. 247d), or a major disaster or emergency 3
9089	9089	declared by the President under section 401 or 501, re-4
9090	9090	spectively, of the Robert T. Stafford Disaster Relief and 5
9091	9091	Emergency Assistance Act (42 U.S.C. 5170, 5191) to en-6
9092	9092	sure that such standards of care are consistent with the 7
9093	9093	nondiscrimination requirements of section 504 of the Re-8
9094	9094	habilitation Act of 1973 (29 U.S.C. 794), title II of the 9
9095	9095	Americans with Disabilities Act of 1990 (42 U.S.C. 12131 10
9096	9096	et seq.), and the Age Discrimination Act of 1975 (42 11
9097	9097	U.S.C. 6101 et seq.). 12
9098	9098	SEC. 633. NATIONAL ADVISORY COMMITTEES. 13
9099	9099	(a) N
9100	9100	ATIONALADVISORYCOMMITTEE ONCHILDREN 14
9101	9101	ANDDISASTERS.—Subsection (g) of section 2811A of the 15
9102	9102	Public Health Service Act (42 U.S.C. 300hh–10b) is 16
9103	9103	amended to read as follows: 17
9104	9104	‘‘(g) S
9105	9105	UNSET.— 18
9106	9106	‘‘(1) I
9107	9107	N GENERAL.—The Advisory Committee 19
9108	9108	shall terminate on December 31, 2026. 20
9109	9109	‘‘(2) E
9110	9110	XTENSION OF ADVISORY COMMITTEE .— 21
9111	9111	Not later than October 1, 2025, the Secretary shall 22
9112	9112	submit to Congress a recommendation on whether 23
9113	9113	the Advisory Committee should be extended beyond 24
9114	9114	the date described in paragraph (1).’’. 25
9115	9115	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00308 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
9116	9116	TKELLEY on LAP7H3WLY3PROD with BILLS 309
9117	9117	•S 891 IS
9118	9118	(b) NATIONALADVISORYCOMMITTEE ON SENIORS 1
9119	9119	ANDDISASTERS.—Section 2811B of the Public Health 2
9120	9120	Service Act (42 U.S.C. 300hh–10c) is amended— 3
9121	9121	(1) in subsection (d)— 4
9122	9122	(A) in paragraph (1)— 5
9123	9123	(i) by inserting ‘‘and departments’’ 6
9124	9124	after ‘‘agencies’’; and 7
9125	9125	(ii) by striking ‘‘17 members’’ and in-8
9126	9126	serting ‘‘25 members’’; and 9
9127	9127	(B) in paragraph (2)— 10
9128	9128	(i) by striking subparagraphs (J) and 11
9129	9129	(K); 12
9130	9130	(ii) by redesignating subparagraphs 13
9131	9131	(A) through (I) and (L) as clauses (i) 14
9132	9132	through (x), respectively, and adjusting the 15
9133	9133	margins accordingly; 16
9134	9134	(iii) by inserting before clause (i), as 17
9135	9135	so redesignated, the following: 18
9136	9136	‘‘(B) F
9137	9137	EDERAL MEMBERS .—The Federal 19
9138	9138	members shall include the following:’’; and 20
9139	9139	(iv) by inserting before subparagraph 21
9140	9140	(B), as so designated, the following: 22
9141	9141	‘‘(A) N
9142	9142	ON-FEDERAL MEMBERS .—The Sec-23
9143	9143	retary in consultation with such other heads of 24
9144	9144	agencies and departments as may be appro-25
9145	9145	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00309 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
9146	9146	TKELLEY on LAP7H3WLY3PROD with BILLS 310
9147	9147	•S 891 IS
9148	9148	priate, shall appoint to the Advisory Committee 1
9149	9149	under paragraph (1) at least 13 individuals, in-2
9150	9150	cluding the following: 3
9151	9151	‘‘(i) At least 3 non-Federal health 4
9152	9152	care providers with expertise in geriatric 5
9153	9153	medical disaster planning, preparedness, 6
9154	9154	response, or recovery. 7
9155	9155	‘‘(ii) At least 3 representatives of 8
9156	9156	State, local, territorial, or Tribal agencies 9
9157	9157	with expertise in geriatric disaster plan-10
9158	9158	ning, preparedness, response, or recovery. 11
9159	9159	‘‘(iii) At least 2 non-Federal profes-12
9160	9160	sionals with training in gerontology, such 13
9161	9161	as social workers, scientists, human serv-14
9162	9162	ices specialists, or other non-medical pro-15
9163	9163	fessionals, with experience in disaster plan-16
9164	9164	ning, preparedness, response, or recovery 17
9165	9165	among other adults.’’; and 18
9166	9166	(2) by amending subsection (g) to read as fol-19
9167	9167	lows: 20
9168	9168	‘‘(g) S
9169	9169	UNSET.—The Advisory Committee shall termi-21
9170	9170	nate on December 31, 2026.’’. 22
9171	9171	(c) N
9172	9172	ATIONALADVISORYCOMMITTEE ON INDIVID-23
9173	9173	UALSWITHDISABILITIES AND DISASTERS.—Section 24
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9176	9176	•S 891 IS
9177	9177	2811C of the Public Health Service Act (42 U.S.C. 1
9178	9178	300hh–10d) is amended— 2
9179	9179	(1) by redesignating subsections (c) through (g) 3
9180	9180	as subsections (d) through (h), respectively; 4
9181	9181	(2) by inserting after subsection (b) the fol-5
9182	9182	lowing: 6
9183	9183	‘‘(c) A
9184	9184	DDITIONALDUTIES.—The Advisory Committee 7
9185	9185	may provide advice and recommendations to the Secretary 8
9186	9186	with respect to individuals with disabilities and the med-9
9187	9187	ical and public health grants and cooperative agreements 10
9188	9188	as applicable to preparedness and response activities 11
9189	9189	under this title and title III.’’; 12
9190	9190	(3) in subsection (d), as so redesignated— 13
9191	9191	(A) in paragraph (1), by striking ‘‘17 14
9192	9192	members’’ and inserting ‘‘25 members’’; 15
9193	9193	(B) in paragraph (2)— 16
9194	9194	(i) by striking subparagraphs (K) 17
9195	9195	through (M); 18
9196	9196	(ii) by redesignating subparagraphs 19
9197	9197	(A) through (J) as clauses (i) through (x), 20
9198	9198	respectively, and adjusting the margins ac-21
9199	9199	cordingly; 22
9200	9200	(iii) by inserting before clause (i), as 23
9201	9201	so redesignated, the following: 24
9202	9202	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00311 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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9204	9204	•S 891 IS
9205	9205	‘‘(B) FEDERAL MEMBERS .—The Federal 1
9206	9206	members shall include the following:’’; 2
9207	9207	(iv) by adding at the end of subpara-3
9208	9208	graph (B), as so designated, the following: 4
9209	9209	‘‘(xi) Representatives of such other 5
9210	9210	Federal agencies as the Secretary deter-6
9211	9211	mines necessary to fulfill the duties of the 7
9212	9212	Advisory Committee.’’; and 8
9213	9213	(v) by inserting before subparagraph 9
9214	9214	(B), as so designated, the following: 10
9215	9215	‘‘(A) N
9216	9216	ON-FEDERAL MEMBERS .—The Sec-11
9217	9217	retary in consultation with such other heads of 12
9218	9218	agencies and departments as may be appro-13
9219	9219	priate, shall appoint to the Advisory Committee 14
9220	9220	under paragraph (1) at least 13 individuals, in-15
9221	9221	cluding the following: 16
9222	9222	‘‘(i) At least 4 non-Federal health 17
9223	9223	care professionals with expertise in dis-18
9224	9224	ability accessibility before, during, and 19
9225	9225	after disasters, medical and mass care dis-20
9226	9226	aster planning, preparedness, response, or 21
9227	9227	recovery. 22
9228	9228	‘‘(ii) At least 3 representatives of 23
9229	9229	State, local, Tribal, or territorial agencies 24
9230	9230	with expertise in disaster planning, pre-25
9231	9231	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00312 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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9233	9233	•S 891 IS
9234	9234	paredness, response, or recovery for indi-1
9235	9235	viduals with disabilities. 2
9236	9236	‘‘(iii) At least 4 individuals with a dis-3
9237	9237	ability with expertise in disaster planning, 4
9238	9238	preparedness, response, or recovery for in-5
9239	9239	dividuals with disabilities. 6
9240	9240	‘‘(iv) Other members as the Secretary 7
9241	9241	determines appropriate, of whom— 8
9242	9242	‘‘(I) at least one such member 9
9243	9243	shall represent a local, State, or na-10
9244	9244	tional organization with expertise in 11
9245	9245	individuals with disabilities; 12
9246	9246	‘‘(II) at least one such member 13
9247	9247	shall be an individual with a dis-14
9248	9248	ability; and 15
9249	9249	‘‘(III) at least one such member 16
9250	9250	shall be an individual with expertise in 17
9251	9251	the needs of housing services, includ-18
9252	9252	ing during the response to, and recov-19
9253	9253	ery from, disasters.’’; and 20
9254	9254	(C) by adding at the end the following: 21
9255	9255	‘‘(3) C
9256	9256	ONSIDERATION.—In appointing members, 22
9257	9257	including the Chair, to the Committee under this 23
9258	9258	subsection, the Secretary may give consideration to 24
9259	9259	disability status.’’; and 25
9260	9260	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00313 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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9262	9262	•S 891 IS
9263	9263	(4) by amending subsection (h), as so redesig-1
9264	9264	nated, to read as follows: 2
9265	9265	‘‘(h) S
9266	9266	UNSET.—The Advisory Committee shall termi-3
9267	9267	nate on December 31, 2026.’’. 4
9268	9268	SEC. 634. NATIONAL ACADEMIES STUDY ON PRIZES. 5
9269	9269	(a) I
9270	9270	NGENERAL.—Not later than 90 days after the 6
9271	9271	date of enactment of this Act, the Secretary of Health and 7
9272	9272	Human Services shall seek to enter into an agreement 8
9273	9273	with the National Academies of Sciences, Engineering, 9
9274	9274	and Medicine (referred to in this section as the ‘‘National 10
9275	9275	Academies’’) to conduct a study to examine— 11
9276	9276	(1) alternative models for directly funding, or 12
9277	9277	stimulating investment in, biomedical research and 13
9278	9278	development that delink research and development 14
9279	9279	costs from the prices of drugs, including the pro-15
9280	9280	gressive replacement of patents and regulatory 16
9281	9281	exclusivities on new drugs with a combination of ex-17
9282	9282	panded support for research and innovation prizes to 18
9283	9283	reward the successful development of drugs or 19
9284	9284	achievement of related milestones; 20
9285	9285	(2) the dollar amount of innovation prizes for 21
9286	9286	different stages of research and development of dif-22
9287	9287	ferent classes or types of drugs, and total annual 23
9288	9288	funding, that would be necessary to stimulate invest-24
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9291	9291	•S 891 IS
9292	9292	ment sufficient to achieve such successful drug de-1
9293	9293	velopment and related milestones; 2
9294	9294	(3) the relative effectiveness and efficiency of 3
9295	9295	such alternative models in stimulating innovation, 4
9296	9296	compared to the status quo that includes patents 5
9297	9297	and regulatory exclusivities; 6
9298	9298	(4) strategies to implement such alternative 7
9299	9299	models described in paragraph (1), including a 8
9300	9300	phased transition; and 9
9301	9301	(5) the anticipated economic and societal im-10
9302	9302	pacts of such alternative models, including an as-11
9303	9303	sessment of impact on— 12
9304	9304	(A) the number and variety of new drugs 13
9305	9305	that would be developed, approved, and mar-14
9306	9306	keted in the United States, including such new 15
9307	9307	drugs intended to prevent, diagnose, or treat a 16
9308	9308	rare disease or condition; 17
9309	9309	(B) the rate at which new drugs would be 18
9310	9310	developed, approved, and marketed in the 19
9311	9311	United States; 20
9312	9312	(C) access to medication; 21
9313	9313	(D) health outcomes; 22
9314	9314	(E) average lifespan and disease burden in 23
9315	9315	the United States; 24
9316	9316	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00315 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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9318	9318	•S 891 IS
9319	9319	(F) the number of manufacturers that 1
9320	9320	would be seeking approval for a drug or bring-2
9321	9321	ing a drug to market for the first time; 3
9322	9322	(G) Federal discretionary and mandatory 4
9323	9323	spending; and 5
9324	9324	(H) public and private insurance markets. 6
9325	9325	(b) R
9326	9326	EQUIREMENTS.—In conducting the study pursu-7
9327	9327	ant to subsection (a), the National Academies shall hold 8
9328	9328	not fewer than 2 public listening sessions to solicit feed-9
9329	9329	back from interested parties, including representatives of 10
9330	9330	academia, professional societies, patient advocates, public 11
9331	9331	health organizations, relevant Federal departments and 12
9332	9332	agencies, drug developers, representatives of other rel-13
9333	9333	evant industries, and subject matter experts. 14
9334	9334	(c) R
9335	9335	EPORT.—Not later than 2 years after the agree-15
9336	9336	ment under subsection (a), the National Academies shall 16
9337	9337	submit to the Committee on Health, Education, Labor, 17
9338	9338	and Pensions and the Committee on Appropriations of the 18
9339	9339	Senate and the Committee on Energy and Commerce and 19
9340	9340	the Committee on Appropriations of the House of Rep-20
9341	9341	resentatives a report on the study conducted pursuant to 21
9342	9342	subsection (a). 22
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9345	9345	•S 891 IS
9346	9346	Subtitle D—Additional 1
9347	9347	Reauthorizations 2
9348	9348	SEC. 641. MEDICAL COUNTERMEASURE PRIORITY REVIEW 3
9349	9349	VOUCHER. 4
9350	9350	Section 565A(g) of the Federal Food, Drug, and Cos-5
9351	9351	metic Act (21 U.S.C. 360bbb–4a) is amended by striking 6
9352	9352	‘‘October 1, 2023’’ and inserting ‘‘December 31, 2026’’. 7
9353	9353	SEC. 642. EPIDEMIC INTELLIGENCE SERVICE. 8
9354	9354	Section 317F(c)(2) of the Public Health Service Act 9
9355	9355	(42 U.S.C. 247b–7(c)(2)) is amended by striking ‘‘2019 10
9356	9356	through 2023’’ and inserting ‘‘2025 and 2026, to remain 11
9357	9357	available through December 31, 2026’’. 12
9358	9358	SEC. 643. MONITORING AND DISTRIBUTION OF CERTAIN 13
9359	9359	MEDICAL COUNTERMEASURES. 14
9360	9360	Section 319A(e) of the Public Health Service Act (42 15
9361	9361	U.S.C. 247d–1(e)) is amended by striking ‘‘2019 through 16
9362	9362	2023’’ and inserting ‘‘2025 and 2026, to remain available 17
9363	9363	through December 31, 2026’’. 18
9364	9364	SEC. 644. REGIONAL HEALTH CARE EMERGENCY PRE-19
9365	9365	PAREDNESS AND RESPONSE SYSTEMS. 20
9366	9366	Section 319C–3 of the Public Health Service Act (42 21
9367	9367	U.S.C. 247d–3c) is amended— 22
9368	9368	(1) in subsection (b)(3), by striking ‘‘under 23
9369	9369	the’’ and all that follows through ‘‘such Act)’’ and 24
9370	9370	inserting ‘‘under law’’; and 25
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9373	9373	•S 891 IS
9374	9374	(2) in subsection (e)(2), by striking ‘‘September 1
9375	9375	30, 2023’’ and inserting ‘‘December 31, 2026’’. 2
9376	9376	SEC. 645. EMERGENCY SYSTEM FOR ADVANCE REGISTRA-3
9377	9377	TION OF VOLUNTEER HEALTH PROFES-4
9378	9378	SIONALS. 5
9379	9379	(1) I
9380	9380	N GENERAL.—Section 319I of the Public 6
9381	9381	Health Service Act (42 U.S.C. 247d–7b) is amend-7
9382	9382	ed— 8
9383	9383	(A) in subsection (a), by striking ‘‘Not 9
9384	9384	later than 12 months after the date of enact-10
9385	9385	ment of the Pandemic and All-Hazards Pre-11
9386	9386	paredness Act, the Secretary shall link existing 12
9387	9387	State verification systems to maintain a single 13
9388	9388	national interoperable network of systems,’’ and 14
9389	9389	inserting ‘‘The Secretary shall continue to 15
9390	9390	maintain a single national interoperable net-16
9391	9391	work of verification systems,’’ and 17
9392	9392	(B) in subsection (k), by striking ‘‘2019 18
9393	9393	through 2023’’ and inserting ‘‘2025 and 2026, 19
9394	9394	to remain available through December 31, 20
9395	9395	2026’’. 21
9396	9396	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00318 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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9398	9398	•S 891 IS
9399	9399	SEC. 646. ENSURING COLLABORATION AND COORDINATION 1
9400	9400	IN MEDICAL COUNTERMEASURE DEVELOP-2
9401	9401	MENT. 3
9402	9402	Section 319L–1(b) of the Public Health Service Act 4
9403	9403	(42 U.S.C. 247d–7f(b)) is amended by striking ‘‘March 5
9404	9404	31, 2025’’ and inserting ‘‘December 31, 2026’’. 6
9405	9405	SEC. 647. MILITARY AND CIVILIAN PARTNERSHIP FOR 7
9406	9406	TRAUMA READINESS. 8
9407	9407	Section 1291(g) of the Public Health Service Act (42 9
9408	9408	U.S.C. 300d–91(g)) is amended by striking ‘‘2019 10
9409	9409	through 2023’’ and inserting ‘‘2025 and 2026, to remain 11
9410	9410	available through December 31, 2026’’. 12
9411	9411	SEC. 648. NATIONAL DISASTER MEDICAL SYSTEM. 13
9412	9412	Section 2812 of the Public Health Service Act (42 14
9413	9413	U.S.C. 300hh–11) is amended— 15
9414	9414	(1) in subsection (c)(4)(B), by striking ‘‘March 16
9415	9415	31, 2025’’ and inserting ‘‘December 31, 2026’’; and 17
9416	9416	(2) in subsection (g), by striking ‘‘$57,400,000 18
9417	9417	for each of fiscal years 2019 through 2023’’ and in-19
9418	9418	serting ‘‘$65,900,000 for each of fiscal years 2025 20
9419	9419	and 2026, to remain available through December 31, 21
9420	9420	2026’’. 22
9421	9421	SEC. 649. VOLUNTEER MEDICAL RESERVE CORPS. 23
9422	9422	Section 2813(i) of the Public Health Service Act (42 24
9423	9423	U.S.C. 300hh–15(i)) is amended by striking ‘‘2019 25
9424	9424	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00319 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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9426	9426	•S 891 IS
9427	9427	through 2023’’ and inserting ‘‘2025 through 2026, to re-1
9428	9428	main available through December 31, 2026’’. 2
9429	9429	SEC. 649A. EPIDEMIOLOGY-LABORATORY CAPACITY. 3
9430	9430	Section 2821(b) of the Public Health Service Act (42 4
9431	9431	U.S.C. 300hh–31(b)) is amended, in the matter preceding 5
9432	9432	paragraph (1), by striking ‘‘2019 through 2023’’ and in-6
9433	9433	serting ‘‘2025 and 2026, to remain available through De-7
9434	9434	cember 31, 2026’’. 8
9435	9435	TITLE VII—PUBLIC HEALTH 9
9436	9436	PROGRAMS 10
9437	9437	SEC. 701. ACTION FOR DENTAL HEALTH. 11
9438	9438	Section 340G(f) of the Public Health Service Act (42 12
9439	9439	U.S.C. 256g(f)) is amended by striking ‘‘$13,903,000 for 13
9440	9440	each of fiscal years 2019 through 2023’’ and inserting 14
9441	9441	‘‘$15,000,000 for each of fiscal years 2025 through 2029, 15
9442	9442	to remain available until expended’’. 16
9443	9443	SEC. 702. PREEMIE. 17
9444	9444	(a) R
9445	9445	ESEARCHRELATING TOPRETERMLABOR AND 18
9446	9446	D
9447	9447	ELIVERY AND THECARE, TREATMENT, ANDOUTCOMES 19
9448	9448	OFPRETERM ANDLOWBIRTHWEIGHTINFANTS.— 20
9449	9449	(1) I
9450	9450	N GENERAL.—Section 3(e) of the Pre-21
9451	9451	maturity Research Expansion and Education for 22
9452	9452	Mothers who deliver Infants Early Act (42 U.S.C. 23
9453	9453	247b–4f(e)) is amended by striking ‘‘fiscal years 24
9454	9454	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00320 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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9456	9456	•S 891 IS
9457	9457	2019 through 2023’’ and inserting ‘‘fiscal years 1
9458	9458	2025 through 2029’’. 2
9459	9459	(2) T
9460	9460	ECHNICAL CORRECTION .—Effective as if 3
9461	9461	included in the enactment of the PREEMIE Reau-4
9462	9462	thorization Act of 2018 (Public Law 115–328), sec-5
9463	9463	tion 2 of such Act is amended, in the matter pre-6
9464	9464	ceding paragraph (1), by striking ‘‘Section 2’’ and 7
9465	9465	inserting ‘‘Section 3’’. 8
9466	9466	(b) I
9467	9467	NTERAGENCY WORKINGGROUP.—Section 5(a) 9
9468	9468	of the PREEMIE Reauthorization Act of 2018 (Public 10
9469	9469	Law 115–328) is amended by striking ‘‘The Secretary of 11
9470	9470	Health and Human Services, in collaboration with other 12
9471	9471	departments, as appropriate, may establish’’ and inserting 13
9472	9472	‘‘Not later than 18 months after the date of the enactment 14
9473	9473	of the Bipartisan Health Care Act, the Secretary of 15
9474	9474	Health and Human Services, in collaboration with other 16
9475	9475	departments, as appropriate, shall establish’’. 17
9476	9476	(c) S
9477	9477	TUDY ONPRETERMBIRTHS.— 18
9478	9478	(1) I
9479	9479	N GENERAL.—The Secretary of Health and 19
9480	9480	Human Services shall enter into appropriate ar-20
9481	9481	rangements with the National Academies of 21
9482	9482	Sciences, Engineering, and Medicine under which 22
9483	9483	the National Academies shall— 23
9484	9484	(A) not later than 30 days after the date 24
9485	9485	of enactment of this Act, convene a committee 25
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9489	9489	of experts in maternal health to study pre-1
9490	9490	mature births in the United States; and 2
9491	9491	(B) upon completion of the study under 3
9492	9492	subparagraph (A)— 4
9493	9493	(i) approve by consensus a report on 5
9494	9494	the results of such study; 6
9495	9495	(ii) include in such report— 7
9496	9496	(I) an assessment of each of the 8
9497	9497	topics listed in paragraph (2); 9
9498	9498	(II) the analysis required by 10
9499	9499	paragraph (3); and 11
9500	9500	(III) the raw data used to de-12
9501	9501	velop such report; and 13
9502	9502	(iii) not later than 24 months after 14
9503	9503	the date of enactment of this Act, transmit 15
9504	9504	such report to— 16
9505	9505	(I) the Secretary of Health and 17
9506	9506	Human Services; 18
9507	9507	(II) the Committee on Energy 19
9508	9508	and Commerce of the House of Rep-20
9509	9509	resentatives; and 21
9510	9510	(III) the Committee on Finance 22
9511	9511	and the Committee on Health, Edu-23
9512	9512	cation, Labor, and Pensions of the 24
9513	9513	Senate. 25
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9517	9517	(2) ASSESSMENT TOPICS.—The topics listed in 1
9518	9518	this subsection are each of the following: 2
9519	9519	(A) The financial costs of premature birth 3
9520	9520	to society, including— 4
9521	9521	(i) an analysis of stays in neonatal in-5
9522	9522	tensive care units and the cost of such 6
9523	9523	stays; 7
9524	9524	(ii) long-term costs of stays in such 8
9525	9525	units to society and the family involved 9
9526	9526	post-discharge; and 10
9527	9527	(iii) health care costs for families 11
9528	9528	post-discharge from such units (such as 12
9529	9529	medications, therapeutic services, co-pay-13
9530	9530	ments for visits, and specialty equipment). 14
9531	9531	(B) The factors that impact preterm birth 15
9532	9532	rates. 16
9533	9533	(C) Opportunities for earlier detection of 17
9534	9534	premature birth risk factors, including— 18
9535	9535	(i) opportunities to improve maternal 19
9536	9536	and infant health; and 20
9537	9537	(ii) opportunities for public health 21
9538	9538	programs to provide support and resources 22
9539	9539	for parents in-hospital, in non-hospital set-23
9540	9540	tings, and post-discharge. 24
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9544	9544	(3) ANALYSIS.—The analysis required by this 1
9545	9545	subsection is an analysis of— 2
9546	9546	(A) targeted research strategies to develop 3
9547	9547	effective drugs, treatments, or interventions to 4
9548	9548	bring at-risk pregnancies to term; 5
9549	9549	(B) State and other programs’ best prac-6
9550	9550	tices with respect to reducing premature birth 7
9551	9551	rates; and 8
9552	9552	(C) precision medicine and preventative 9
9553	9553	care approaches starting early in the life course 10
9554	9554	(including during pregnancy) with a focus on 11
9555	9555	behavioral and biological influences on pre-12
9556	9556	mature birth, child health, and the trajectory of 13
9557	9557	such approaches into adulthood. 14
9558	9558	SEC. 703. PREVENTING MATERNAL DEATHS. 15
9559	9559	(a) M
9560	9560	ATERNALMORTALITYREVIEWCOMMITTEE.— 16
9561	9561	Section 317K(d) of the Public Health Service Act (42 17
9562	9562	U.S.C. 247b–12(d)) is amended— 18
9563	9563	(1) in paragraph (1)(A), by inserting ‘‘(includ-19
9564	9564	ing obstetricians and gynecologists)’’ after ‘‘clinical 20
9565	9565	specialties’’; and 21
9566	9566	(2) in paragraph (3)(A)(i)— 22
9567	9567	(A) in subclause (I), by striking ‘‘as appli-23
9568	9568	cable’’ and inserting ‘‘if available’’; and 24
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9572	9572	(B) in subclause (III), by striking ‘‘, as ap-1
9573	9573	propriate’’ and inserting ‘‘and coordinating with 2
9574	9574	death certifiers to improve the collection of 3
9575	9575	death record reports and the quality of death 4
9576	9576	records, including by amending cause of death 5
9577	9577	information on a death certificate, as appro-6
9578	9578	priate’’. 7
9579	9579	(b) B
9580	9580	ESTPRACTICESRELATING TO THE PREVEN-8
9581	9581	TION OFMATERNALMORTALITY.—Section 317K of the 9
9582	9582	Public Health Service Act (42 U.S.C. 247b–12) is amend-10
9583	9583	ed— 11
9584	9584	(1) by redesignating subsections (e) and (f) as 12
9585	9585	subsections (f) and (g), respectively; and 13
9586	9586	(2) by inserting after subsection (d) the fol-14
9587	9587	lowing: 15
9588	9588	‘‘(e) B
9589	9589	ESTPRACTICESRELATING TO THE PREVEN-16
9590	9590	TION OFMATERNALMORTALITY.— 17
9591	9591	‘‘(1) I
9592	9592	N GENERAL.—The Secretary, acting 18
9593	9593	through the Director of the Centers for Disease 19
9594	9594	Control and Prevention, shall, in consultation with 20
9595	9595	the Administrator of the Health Resources and Serv-21
9596	9596	ices Administration, disseminate to hospitals, State 22
9597	9597	professional society groups, and perinatal quality 23
9598	9598	collaboratives, best practices on how to prevent ma-24
9599	9599	ternal mortality and morbidity that consider and re-25
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9602	9602	•S 891 IS
9603	9603	flect best practices identified through other relevant 1
9604	9604	Federal maternal health programs. 2
9605	9605	‘‘(2) F
9606	9606	REQUENCY.—The Secretary, acting 3
9607	9607	through the Director of the Centers for Disease 4
9608	9608	Control and Prevention, shall disseminate the best 5
9609	9609	practices referred to in paragraph (1) not less than 6
9610	9610	once per fiscal year.’’. 7
9611	9611	(c) E
9612	9612	XTENSION.—Subsection (g) of section 317K of 8
9613	9613	the Public Health Service Act (42 U.S.C. 247b–12), as 9
9614	9614	redesignated by subsection (b), is amended by striking 10
9615	9615	‘‘$58,000,000 for each of fiscal years 2019 through 2023’’ 11
9616	9616	and inserting ‘‘$100,000,000 for each of fiscal years 2025 12
9617	9617	through 2029’’. 13
9618	9618	SEC. 704. SICKLE CELL DISEASE PREVENTION AND TREAT-14
9619	9619	MENT. 15
9620	9620	(a) I
9621	9621	NGENERAL.—Section 1106(b) of the Public 16
9622	9622	Health Service Act (42 U.S.C. 300b–5(b)) is amended— 17
9623	9623	(1) in paragraph (1)(A)(iii), by striking ‘‘pre-18
9624	9624	vention and treatment of sickle cell disease’’ and in-19
9625	9625	serting ‘‘treatment of sickle cell disease and the pre-20
9626	9626	vention and treatment of complications of sickle cell 21
9627	9627	disease’’; 22
9628	9628	(2) in paragraph (2)(D), by striking ‘‘preven-23
9629	9629	tion and treatment of sickle cell disease’’ and insert-24
9630	9630	ing ‘‘treatment of sickle cell disease and the preven-25
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9633	9633	•S 891 IS
9634	9634	tion and treatment of complications of sickle cell dis-1
9635	9635	ease’’; 2
9636	9636	(3) in paragraph (3)— 3
9637	9637	(A) in subparagraph (A), by striking 4
9638	9638	‘‘enter into a contract with’’ and inserting 5
9639	9639	‘‘make a grant to, or enter into a contract or 6
9640	9640	cooperative agreement with,’’; and 7
9641	9641	(B) in subparagraph (B), in each of 8
9642	9642	clauses (ii) and (iii), by striking ‘‘prevention 9
9643	9643	and treatment of sickle cell disease’’ and insert-10
9644	9644	ing ‘‘treatment of sickle cell disease and the 11
9645	9645	prevention and treatment of complications of 12
9646	9646	sickle cell disease’’; and 13
9647	9647	(4) in paragraph (6), by striking ‘‘$4,455,000 14
9648	9648	for each of fiscal years 2019 through 2023’’ and in-15
9649	9649	serting ‘‘$8,205,000 for each of fiscal years 2025 16
9650	9650	through 2029’’. 17
9651	9651	(b) S
9652	9652	ENSE OFCONGRESS.—It is the sense of Con-18
9653	9653	gress that further research should be undertaken to ex-19
9654	9654	pand the understanding of the causes of, and to find cures 20
9655	9655	for, heritable blood disorders, including sickle cell disease. 21
9656	9656	SEC. 705. TRAUMATIC BRAIN INJURIES. 22
9657	9657	(a) T
9658	9658	HEBILLPASCRELL, JR., NATIONALPROGRAM 23
9659	9659	FORTRAUMATICBRAININJURYSURVEILLANCE AND 24
9660	9660	R
9661	9661	EGISTRIES.— 25
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9664	9664	•S 891 IS
9665	9665	(1) PREVENTION OF TRAUMATIC BRAIN IN -1
9666	9666	JURY.—Section 393B of the Public Health Service 2
9667	9667	Act (42 U.S.C. 280b–1c) is amended— 3
9668	9668	(A) in subsection (a), by inserting ‘‘and 4
9669	9669	prevalence’’ after ‘‘incidence’’; 5
9670	9670	(B) in subsection (b)— 6
9671	9671	(i) in paragraph (1), by inserting 7
9672	9672	‘‘and reduction of associated injuries and 8
9673	9673	fatalities’’ before the semicolon; 9
9674	9674	(ii) in paragraph (2), by inserting 10
9675	9675	‘‘and related risk factors’’ before the semi-11
9676	9676	colon; and 12
9677	9677	(iii) in paragraph (3)— 13
9678	9678	(I) in the matter preceding sub-14
9679	9679	paragraph (A), by striking ‘‘2020’’ 15
9680	9680	each place it appears and inserting 16
9681	9681	‘‘2030’’; and 17
9682	9682	(II) in subparagraph (A)— 18
9683	9683	(aa) in clause (i), by striking 19
9684	9684	‘‘; and’’ and inserting a semi-20
9685	9685	colon; 21
9686	9686	(bb) by redesignating clause 22
9687	9687	(ii) as clause (iv); 23
9688	9688	(cc) by inserting after clause 24
9689	9689	(i) the following: 25
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9693	9693	‘‘(ii) populations at higher risk of 1
9694	9694	traumatic brain injury, including popu-2
9695	9695	lations whose increased risk is due to occu-3
9696	9696	pational or circumstantial factors; 4
9697	9697	‘‘(iii) causes of, and risk factors for, 5
9698	9698	traumatic brain injury; and’’; and 6
9699	9699	(dd) in clause (iv), as so re-7
9700	9700	designated, by striking ‘‘arising 8
9701	9701	from traumatic brain injury’’ and 9
9702	9702	inserting ‘‘, which may include 10
9703	9703	related mental health and other 11
9704	9704	conditions, arising from trau-12
9705	9705	matic brain injury, including’’; 13
9706	9706	and 14
9707	9707	(C) in subsection (c), by inserting ‘‘, and 15
9708	9708	other relevant Federal departments and agen-16
9709	9709	cies’’ before the period at the end. 17
9710	9710	(2) N
9711	9711	ATIONAL PROGRAM FOR TRAUMATIC 18
9712	9712	BRAIN INJURY SURVEILLANCE AND REGISTRIES .— 19
9713	9713	Section 393C of the Public Health Service Act (42 20
9714	9714	U.S.C. 280b–1d) is amended— 21
9715	9715	(A) by amending the section heading to 22
9716	9716	read as follows: ‘‘
9717	9717	THE BILL PASCRELL , JR., 23
9718	9718	NATIONAL PROGRAM FOR TRAUMATIC 24
9719	9719	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00329 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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9721	9721	•S 891 IS
9722	9722	BRAIN INJURY SURVEILLANCE AND REG -1
9723	9723	ISTRIES’’; 2
9724	9724	(B) in subsection (a)— 3
9725	9725	(i) in the matter preceding paragraph 4
9726	9726	(1), by inserting ‘‘to identify populations 5
9727	9727	that may be at higher risk for traumatic 6
9728	9728	brain injuries, to collect data on the causes 7
9729	9729	of, and risk factors for, traumatic brain in-8
9730	9730	juries,’’ after ‘‘related disability,’’; 9
9731	9731	(ii) in paragraph (1), by inserting ‘‘, 10
9732	9732	including the occupation of the individual, 11
9733	9733	when relevant to the circumstances sur-12
9734	9734	rounding the injury’’ before the semicolon; 13
9735	9735	and 14
9736	9736	(iii) in paragraph (4), by inserting 15
9737	9737	‘‘short- and long-term’’ before ‘‘outcomes’’; 16
9738	9738	(C) by striking subsection (b); 17
9739	9739	(D) by redesignating subsection (c) as sub-18
9740	9740	section (b); 19
9741	9741	(E) in subsection (b), as so redesignated, 20
9742	9742	by inserting ‘‘and evidence-based practices to 21
9743	9743	identify and address concussion’’ before the pe-22
9744	9744	riod at the end; and 23
9745	9745	(F) by adding at the end the following: 24
9746	9746	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00330 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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9748	9748	•S 891 IS
9749	9749	‘‘(c) AVAILABILITY OF INFORMATION.—The Sec-1
9750	9750	retary, acting through the Director of the Centers for Dis-2
9751	9751	ease Control and Prevention, shall make publicly available 3
9752	9752	aggregated information on traumatic brain injury and 4
9753	9753	concussion described in this section, including on the 5
9754	9754	website of the Centers for Disease Control and Prevention. 6
9755	9755	Such website, to the extent feasible, shall include aggre-7
9756	9756	gated information on populations that may be at higher 8
9757	9757	risk for traumatic brain injuries and strategies for pre-9
9758	9758	venting or reducing risk of traumatic brain injury that are 10
9759	9759	tailored to such populations.’’. 11
9760	9760	(3) A
9761	9761	UTHORIZATION OF APPROPRIATIONS .— 12
9762	9762	Section 394A of the Public Health Service Act (42 13
9763	9763	U.S.C. 280b–3) is amended— 14
9764	9764	(A) in subsection (a), by striking ‘‘1994, 15
9765	9765	and’’ and inserting ‘‘1994,’’; and 16
9766	9766	(B) in subsection (b), by striking ‘‘2020 17
9767	9767	through 2024’’ and inserting ‘‘2025 through 18
9768	9768	2029’’. 19
9769	9769	(b) S
9770	9770	TATEGRANTPROGRAMS.— 20
9771	9771	(1) S
9772	9772	TATE GRANTS FOR PROJECTS REGARDING 21
9773	9773	TRAUMATIC BRAIN INJURY .—Section 1252 of the 22
9774	9774	Public Health Service Act (42 U.S.C. 300d–52) is 23
9775	9775	amended— 24
9776	9776	(A) in subsection (b)(2)— 25
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9779	9779	•S 891 IS
9780	9780	(i) by inserting ‘‘, taking into consid-1
9781	9781	eration populations that may be at higher 2
9782	9782	risk for traumatic brain injuries’’ after 3
9783	9783	‘‘outreach programs’’; and 4
9784	9784	(ii) by inserting ‘‘Tribal,’’ after 5
9785	9785	‘‘State,’’; 6
9786	9786	(B) in subsection (c), by adding at the end 7
9787	9787	the following: 8
9788	9788	‘‘(3) M
9789	9789	AINTENANCE OF EFFORT .—With respect 9
9790	9790	to activities for which a grant awarded under sub-10
9791	9791	section (a) is to be expended, a State or American 11
9792	9792	Indian consortium shall agree to maintain expendi-12
9793	9793	tures of non-Federal amounts for such activities at 13
9794	9794	a level that is not less than the level of such expendi-14
9795	9795	tures maintained by the State or American Indian 15
9796	9796	consortium for the fiscal year preceding the fiscal 16
9797	9797	year for which the State or American Indian consor-17
9798	9798	tium receives such a grant. 18
9799	9799	‘‘(4) W
9800	9800	AIVER.—The Secretary may, upon the 19
9801	9801	request of a State or American Indian consortium, 20
9802	9802	waive not more than 50 percent of the matching 21
9803	9803	fund amount under paragraph (1), if the Secretary 22
9804	9804	determines that such matching fund amount would 23
9805	9805	result in an inability of the State or American In-24
9806	9806	dian consortium to carry out the purposes under 25
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9810	9810	subsection (a). A waiver provided by the Secretary 1
9811	9811	under this paragraph shall apply only to the fiscal 2
9812	9812	year involved.’’; 3
9813	9813	(C) in subsection (e)(3)(B)— 4
9814	9814	(i) by striking ‘‘(such as third party 5
9815	9815	payers, State agencies, community-based 6
9816	9816	providers, schools, and educators)’’; and 7
9817	9817	(ii) by inserting ‘‘(such as third party 8
9818	9818	payers, State agencies, community-based 9
9819	9819	providers, schools, and educators)’’ after 10
9820	9820	‘‘professionals’’; 11
9821	9821	(D) in subsection (h), by striking para-12
9822	9822	graphs (1) and (2) and inserting the following: 13
9823	9823	‘‘(1) A
9824	9824	MERICAN INDIAN CONSORTIUM ; STATE.— 14
9825	9825	The terms ‘American Indian consortium’ and ‘State’ 15
9826	9826	have the meanings given such terms in section 1253. 16
9827	9827	‘‘(2) T
9828	9828	RAUMATIC BRAIN INJURY .— 17
9829	9829	‘‘(A) I
9830	9830	N GENERAL.—Subject to subpara-18
9831	9831	graph (B), the term ‘traumatic brain injury’— 19
9832	9832	‘‘(i) means an acquired injury to the 20
9833	9833	brain; 21
9834	9834	‘‘(ii) may include— 22
9835	9835	‘‘(I) brain injuries caused by an-23
9836	9836	oxia due to trauma; and 24
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9840	9840	‘‘(II) damage to the brain from 1
9841	9841	an internal or external source that re-2
9842	9842	sults in infection, toxicity, surgery, or 3
9843	9843	vascular disorders not associated with 4
9844	9844	aging; and 5
9845	9845	‘‘(iii) does not include brain dysfunc-6
9846	9846	tion caused by congenital or degenerative 7
9847	9847	disorders, or birth trauma. 8
9848	9848	‘‘(B) R
9849	9849	EVISIONS TO DEFINITION .—The 9
9850	9850	Secretary may revise the definition of the term 10
9851	9851	‘traumatic brain injury’ under this paragraph, 11
9852	9852	as the Secretary determines necessary, after 12
9853	9853	consultation with States and other appropriate 13
9854	9854	public or nonprofit private entities.’’; and 14
9855	9855	(E) in subsection (i), by striking ‘‘2020 15
9856	9856	through 2024’’ and inserting ‘‘2025 through 16
9857	9857	2029’’. 17
9858	9858	(2) S
9859	9859	TATE GRANTS FOR PROTECTION AND AD -18
9860	9860	VOCACY SERVICES.—Section 1253(l) of the Public 19
9861	9861	Health Service Act (42 U.S.C. 300d–53(l)) is 20
9862	9862	amended by striking ‘‘2020 through 2024’’ and in-21
9863	9863	serting ‘‘2025 through 2029’’. 22
9864	9864	(c) R
9865	9865	EPORT TOCONGRESS.—Not later than 2 years 23
9866	9866	after the date of enactment of this Act, the Secretary of 24
9867	9867	Health and Human Services (referred to in this Act as 25
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9871	9871	the ‘‘Secretary’’) shall submit to the Committee on 1
9872	9872	Health, Education, Labor, and Pensions of the Senate and 2
9873	9873	the Committee on Energy and Commerce of the House 3
9874	9874	of Representatives a report that contains— 4
9875	9875	(1) an overview of populations who may be at 5
9876	9876	higher risk for traumatic brain injury, such as indi-6
9877	9877	viduals affected by domestic violence or sexual as-7
9878	9878	sault and public safety officers as defined in section 8
9879	9879	1204 of the Omnibus Crime Control and Safe 9
9880	9880	Streets Act of 1968 (34 U.S.C. 10284); 10
9881	9881	(2) an outline of existing surveys and activities 11
9882	9882	of the Centers for Disease Control and Prevention 12
9883	9883	on traumatic brain injuries and any steps the agency 13
9884	9884	has taken to address gaps in data collection related 14
9885	9885	to such higher risk populations, which may include 15
9886	9886	leveraging surveys such as the National Intimate 16
9887	9887	Partner and Sexual Violence Survey to collect data 17
9888	9888	on traumatic brain injuries; 18
9889	9889	(3) an overview of any outreach or education ef-19
9890	9890	forts to reach such higher risk populations; and 20
9891	9891	(4) any challenges associated with reaching 21
9892	9892	such higher risk populations. 22
9893	9893	(d) S
9894	9894	TUDY ONLONG-TERMSYMPTOMS OR CONDI-23
9895	9895	TIONSRELATED TOTRAUMATICBRAININJURY.— 24
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9899	9899	(1) IN GENERAL.—The Secretary, in consulta-1
9900	9900	tion with stakeholders and the heads of other rel-2
9901	9901	evant Federal departments and agencies, as appro-3
9902	9902	priate, shall conduct, either directly or through a 4
9903	9903	contract with a nonprofit private entity, a study to— 5
9904	9904	(A) examine the incidence and prevalence 6
9905	9905	of long-term or chronic symptoms or conditions 7
9906	9906	in individuals who have experienced a traumatic 8
9907	9907	brain injury; 9
9908	9908	(B) examine the evidence base of research 10
9909	9909	related to the chronic effects of traumatic brain 11
9910	9910	injury across the lifespan; 12
9911	9911	(C) examine any correlations between trau-13
9912	9912	matic brain injury and increased risk of other 14
9913	9913	conditions, such as dementia and mental health 15
9914	9914	conditions; 16
9915	9915	(D) assess existing services available for 17
9916	9916	individuals with such long-term or chronic 18
9917	9917	symptoms or conditions; and 19
9918	9918	(E) identify any gaps in research related to 20
9919	9919	such long-term or chronic symptoms or condi-21
9920	9920	tions of individuals who have experienced a 22
9921	9921	traumatic brain injury. 23
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9924	9924	•S 891 IS
9925	9925	(2) PUBLIC REPORT.—Not later than 2 years 1
9926	9926	after the date of enactment of this Act, the Sec-2
9927	9927	retary shall— 3
9928	9928	(A) submit to the Committee on Energy 4
9929	9929	and Commerce of the House of Representatives 5
9930	9930	and the Committee on Health, Education, 6
9931	9931	Labor, and Pensions of the Senate a report de-7
9932	9932	tailing the findings, conclusions, and rec-8
9933	9933	ommendations of the study described in para-9
9934	9934	graph (1); and 10
9935	9935	(B) in the case that such study is con-11
9936	9936	ducted directly by the Secretary, make the re-12
9937	9937	port described in subparagraph (A) publicly 13
9938	9938	available on the website of the Department of 14
9939	9939	Health and Human Services. 15
9940	9940	SEC. 706. LIFESPAN RESPITE CARE. 16
9941	9941	(a) D
9942	9942	EFINITION OFFAMILYCAREGIVER.—Section 17
9943	9943	2901(5) of the Public Health Service Act (42 U.S.C. 18
9944	9944	300ii(5)) is amended by striking ‘‘unpaid adult’’ and in-19
9945	9945	serting ‘‘unpaid individual’’. 20
9946	9946	(b) F
9947	9947	UNDING.—Section 2905 of the Public Health 21
9948	9948	Service Act (42 U.S.C. 300ii–4) is amended by striking 22
9949	9949	‘‘fiscal years 2020 through fiscal year 2024’’ and inserting 23
9950	9950	‘‘fiscal years 2025 through 2029’’. 24
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9953	9953	•S 891 IS
9954	9954	SEC. 707. DR. LORNA BREEN HEALTH CARE PROVIDER PRO-1
9955	9955	TECTION. 2
9956	9956	(a) D
9957	9957	ISSEMINATION OFBESTPRACTICES.— Section 3
9958	9958	2 of the Dr. Lorna Breen Health Care Provider Protection 4
9959	9959	Act (Public Law 117–105) is amended by striking ‘‘2 5
9960	9960	years’’ and inserting ‘‘5 years’’. 6
9961	9961	(b) E
9962	9962	DUCATION AND AWARENESSINITIATIVEEN-7
9963	9963	COURAGINGUSE OFMENTALHEALTH ANDSUBSTANCE 8
9964	9964	U
9965	9965	SEDISORDERSERVICES BYHEALTHCAREPROFES-9
9966	9966	SIONALS.—Section 3 of the Dr. Lorna Breen Health Care 10
9967	9967	Provider Protection Act (Public Law 117–105) is amend-11
9968	9968	ed— 12
9969	9969	(1) in subsection (b), by inserting ‘‘and annu-13
9970	9970	ally thereafter,’’ after ‘‘of this Act,’’; and 14
9971	9971	(2) in subsection (c), by striking ‘‘2022 through 15
9972	9972	2024’’ and inserting ‘‘2025 through 2029’’. 16
9973	9973	(c) P
9974	9974	ROGRAMSTOPROMOTEMENTALHEALTH 17
9975	9975	A
9976	9976	MONG THEHEALTHPROFESSIONALWORKFORCE.—The 18
9977	9977	second section 764 of the Public Health Service Act (42 19
9978	9978	U.S.C. 294t), as added by section 4 of the Dr. Lorna 20
9979	9979	Breen Health Care Provider Protection Act (Public Law 21
9980	9980	117–105), is amended— 22
9981	9981	(1) by redesignating such section 764 as section 23
9982	9982	764A; 24
9983	9983	(2) in subsection (a)(3)— 25
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9986	9986	•S 891 IS
9987	9987	(A) by striking ‘‘to eligible entities in’’ and 1
9988	9988	inserting ‘‘to eligible entities that— 2
9989	9989	‘‘(A) are in’’; 3
9990	9990	(B) by striking the period and inserting ‘‘; 4
9991	9991	or’’; and 5
9992	9992	(C) by adding at the end the following: 6
9993	9993	‘‘(B) have a focus on the reduction of ad-7
9994	9994	ministrative burden on health care workers.’’; 8
9995	9995	(3) in subsection (c), by inserting ‘‘not less 9
9996	9996	than’’ after ‘‘period of’’; and 10
9997	9997	(4) in subsection (f), by striking ‘‘2022 through 11
9998	9998	2024’’ and inserting ‘‘2025 through 2029’’. 12
9999	9999	SEC. 708. SCREENS FOR CANCER. 13
10000	10000	(a) N
10001	10001	ATIONALBREAST AND CERVICALCANCER 14
10002	10002	E
10003	10003	ARLYDETECTIONPROGRAM.—Title XV of the Public 15
10004	10004	Health Service Act (42 U.S.C. 300k et seq.) is amended— 16
10005	10005	(1) in section 1501 (42 U.S.C. 300k)— 17
10006	10006	(A) in subsection (a)— 18
10007	10007	(i) in paragraph (2), by striking ‘‘the 19
10008	10008	provision of appropriate follow-up services 20
10009	10009	and support services such as case manage-21
10010	10010	ment’’ and inserting ‘‘that appropriate fol-22
10011	10011	low-up services are provided’’; 23
10012	10012	(ii) in paragraph (3), by striking 24
10013	10013	‘‘programs for the detection and control’’ 25
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10016	10016	•S 891 IS
10017	10017	and inserting ‘‘for the prevention, detec-1
10018	10018	tion, and control’’; 2
10019	10019	(iii) in paragraph (4), by striking ‘‘the 3
10020	10020	detection and control’’ and inserting ‘‘the 4
10021	10021	prevention, detection, and control’’; 5
10022	10022	(iv) in paragraph (5)— 6
10023	10023	(I) by striking ‘‘monitor’’ and in-7
10024	10024	serting ‘‘ensure’’; and 8
10025	10025	(II) by striking ‘‘; and’’ and in-9
10026	10026	serting a semicolon; 10
10027	10027	(v) by redesignating paragraph (6) as 11
10028	10028	paragraph (9); 12
10029	10029	(vi) by inserting after paragraph (5) 13
10030	10030	the following: 14
10031	10031	‘‘(6) to enhance appropriate support activities 15
10032	10032	to increase breast and cervical cancer screenings, 16
10033	10033	such as navigation of health care services, implemen-17
10034	10034	tation of evidence-based or evidence-informed strate-18
10035	10035	gies to increase breast and cervical cancer screening 19
10036	10036	in health care settings, and facilitation of access to 20
10037	10037	health care settings; 21
10038	10038	‘‘(7) to reduce disparities in breast and cervical 22
10039	10039	cancer incidence, morbidity, and mortality, including 23
10040	10040	in populations with higher than average rates; 24
10041	10041	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00340 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10043	10043	•S 891 IS
10044	10044	‘‘(8) to improve access to breast and cervical 1
10045	10045	cancer screening and diagnostic services and reduce 2
10046	10046	related barriers, including factors that relate to neg-3
10047	10047	ative health outcomes; and’’; and 4
10048	10048	(vii) in paragraph (9), as so redesig-5
10049	10049	nated, by striking ‘‘through (5)’’ and in-6
10050	10050	serting ‘‘through (8)’’; and 7
10051	10051	(B) by striking subsection (d); 8
10052	10052	(2) in section 1503 (42 U.S.C. 300m)— 9
10053	10053	(A) in subsection (a)— 10
10054	10054	(i) in paragraph (1), by striking 11
10055	10055	‘‘that, initially’’ and all that follows 12
10056	10056	through the semicolon and inserting ‘‘that 13
10057	10057	appropriate breast and cervical cancer 14
10058	10058	screening and diagnostic services are pro-15
10059	10059	vided consistent with relevant evidence- 16
10060	10060	based recommendations; and’’; 17
10061	10061	(ii) by striking paragraphs (2) and 18
10062	10062	(4); 19
10063	10063	(iii) by redesignating paragraph (3) as 20
10064	10064	paragraph (2); and 21
10065	10065	(iv) in paragraph (2), as so redesig-22
10066	10066	nated, by striking ‘‘; and’’ and inserting a 23
10067	10067	period; and 24
10068	10068	(B) by striking subsection (d); 25
10069	10069	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00341 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10071	10071	•S 891 IS
10072	10072	(3) in section 1508(b) (42 U.S.C. 300n–4(b))— 1
10073	10073	(A) by striking ‘‘1 year after the date of 2
10074	10074	the enactment of the National Breast and Cer-3
10075	10075	vical Cancer Early Detection Program Reau-4
10076	10076	thorization of 2007, and annually thereafter,’’ 5
10077	10077	and inserting ‘‘2 years after the date of enact-6
10078	10078	ment of the Bipartisan Health Care Act, and 7
10079	10079	every 5 years thereafter,’’; 8
10080	10080	(B) by striking ‘‘Labor and Human Re-9
10081	10081	sources’’ and inserting ‘‘Health, Education, 10
10082	10082	Labor, and Pensions’’; and 11
10083	10083	(C) by striking ‘‘preceding fiscal year’’ and 12
10084	10084	inserting ‘‘preceding 2 fiscal years in the case 13
10085	10085	of the first report after the date of enactment 14
10086	10086	of the Bipartisan Health Care Act and pre-15
10087	10087	ceding 5 fiscal years for each report there-16
10088	10088	after’’; and 17
10089	10089	(4) in section 1510(a) (42 U.S.C. 300n–5(a))— 18
10090	10090	(A) by striking ‘‘2011, and’’ and inserting 19
10091	10091	‘‘2011,’’; and 20
10092	10092	(B) by inserting ‘‘, and $235,500,000 for 21
10093	10093	each of fiscal years 2025 through 2029’’ before 22
10094	10094	the period at the end before the period at the 23
10095	10095	end. 24
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10098	10098	•S 891 IS
10099	10099	(b) GAO STUDY.—Not later than September 30, 1
10100	10100	2027, the Comptroller General of the United States shall 2
10101	10101	report to the Committee on Health, Education, Labor, and 3
10102	10102	Pensions of the Senate and the Committee on Energy and 4
10103	10103	Commerce of the House of Representatives on the work 5
10104	10104	of the National Breast and Cervical Cancer Early Detec-6
10105	10105	tion Program, including— 7
10106	10106	(1) an estimate of the number of individuals eli-8
10107	10107	gible for services provided under such program; 9
10108	10108	(2) a summary of trends in the number of indi-10
10109	10109	viduals served through such program; and 11
10110	10110	(3) an assessment of any factors that may be 12
10111	10111	driving the trends identified under paragraph (2), 13
10112	10112	including any barriers to accessing breast and cer-14
10113	10113	vical cancer screenings provided by such program. 15
10114	10114	SEC. 709. DEONDRA DIXON INCLUDE PROJECT. 16
10115	10115	Part B of title IV of the Public Health Service Act 17
10116	10116	(42 U.S.C. 284 et seq.) is amended by adding at the end 18
10117	10117	the following: 19
10118	10118	‘‘SEC. 409K. DOWN SYNDROME RESEARCH. 20
10119	10119	‘‘(a) I
10120	10120	NGENERAL.—The Director of NIH shall carry 21
10121	10121	out a program of research, training, and investigation re-22
10122	10122	lated to Down syndrome to be known as the ‘INvestigation 23
10123	10123	of Co-occurring conditions across the Lifespan to Under-24
10124	10124	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00343 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10126	10126	•S 891 IS
10127	10127	stand Down syndromE Project’ or the ‘INCLUDE 1
10128	10128	Project’. 2
10129	10129	‘‘(b) P
10130	10130	ROGRAMELEMENTS.—The program under 3
10131	10131	subsection (a) shall include— 4
10132	10132	‘‘(1) high-risk, high reward research on the ef-5
10133	10133	fects of trisomy 21 on human development and 6
10134	10134	health; 7
10135	10135	‘‘(2) promoting research for participants with 8
10136	10136	Down syndrome across the lifespan, including cohort 9
10137	10137	studies to facilitate improved understanding of 10
10138	10138	Down syndrome and co-occurring conditions and de-11
10139	10139	velopment of new interventions; 12
10140	10140	‘‘(3) expanding the number of clinical trials 13
10141	10141	that are inclusive of, or expressly for, participants 14
10142	10142	with Down syndrome, including novel biomedical and 15
10143	10143	pharmacological interventions and other therapies 16
10144	10144	designed to promote or enhance activities of daily 17
10145	10145	living; 18
10146	10146	‘‘(4) research on the biological mechanisms in 19
10147	10147	individuals with Down syndrome pertaining to struc-20
10148	10148	tural, functional, and behavioral anomalies and dys-21
10149	10149	function as well as stunted growth; 22
10150	10150	‘‘(5) supporting research to improve diagnosis 23
10151	10151	and treatment of conditions co-occurring with Down 24
10152	10152	syndrome, including the identification of biomarkers 25
10153	10153	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00344 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10155	10155	•S 891 IS
10156	10156	related to risk factors, diagnosis, and clinical re-1
10157	10157	search and therapeutics; 2
10158	10158	‘‘(6) research on the causes of increased preva-3
10159	10159	lence, and concurrent treatment, of co-occurring con-4
10160	10160	ditions, such as Alzheimer’s disease and related de-5
10161	10161	mentias and autoimmunity, in individuals with Down 6
10162	10162	syndrome; and 7
10163	10163	‘‘(7) research, training, and investigation on im-8
10164	10164	proving the quality of life of individuals with Down 9
10165	10165	syndrome and their families. 10
10166	10166	‘‘(c) C
10167	10167	OORDINATION; PRIORITIZINGNONDUPLICA-11
10168	10168	TIVERESEARCH.—The Director of NIH shall ensure 12
10169	10169	that— 13
10170	10170	‘‘(1) the programs and activities of the insti-14
10171	10171	tutes and centers of the National Institutes of 15
10172	10172	Health relating to Down syndrome and co-occurring 16
10173	10173	conditions are coordinated, including through the 17
10174	10174	Office of the Director of NIH and priority-setting 18
10175	10175	reviews conducted pursuant to section 402(b)(3); 19
10176	10176	and 20
10177	10177	‘‘(2) such institutes and centers, prioritize, as 21
10178	10178	appropriate, Down syndrome research that does not 22
10179	10179	duplicate existing research activities of the National 23
10180	10180	Institutes of Health. 24
10181	10181	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00345 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10183	10183	•S 891 IS
10184	10184	‘‘(d) CONSULTATION WITHSTAKEHOLDERS.—In 1
10185	10185	carrying out activities under this section, the Director of 2
10186	10186	NIH shall, as appropriate and to the maximum extent fea-3
10187	10187	sible, consult with relevant stakeholders, including patient 4
10188	10188	advocates, to ensure that such activities take into consid-5
10189	10189	eration the needs of individuals with Down syndrome. 6
10190	10190	‘‘(e) B
10191	10191	IENNIALREPORTS TOCONGRESS.— 7
10192	10192	‘‘(1) I
10193	10193	N GENERAL.—The Director of NIH shall 8
10194	10194	submit, on a biennial basis, to the Committee on 9
10195	10195	Energy and Commerce and the Subcommittee on 10
10196	10196	Labor, Health and Human Services, Education, and 11
10197	10197	Related Agencies of the Committee on Appropria-12
10198	10198	tions of the House of Representatives and the Com-13
10199	10199	mittee on Health, Education, Labor, and Pensions 14
10200	10200	and the Subcommittee on Labor, Health and 15
10201	10201	Human Services, Education, and Related Agencies 16
10202	10202	of the Committee on Appropriations of the Senate, 17
10203	10203	a report that catalogs the research conducted or 18
10204	10204	supported under this section. 19
10205	10205	‘‘(2) C
10206	10206	ONTENTS.—Each report under para-20
10207	10207	graph (1) shall include— 21
10208	10208	‘‘(A) identification of the institute or cen-22
10209	10209	ter involved; 23
10210	10210	‘‘(B) a statement of whether the research 24
10211	10211	is or was being carried out directly by such in-25
10212	10212	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00346 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10214	10214	•S 891 IS
10215	10215	stitute or center or by multiple institutes and 1
10216	10216	centers; and 2
10217	10217	‘‘(C) identification of any resulting real- 3
10218	10218	world evidence that is or may be used for clin-4
10219	10219	ical research and medical care for patients with 5
10220	10220	Down syndrome.’’. 6
10221	10221	SEC. 710. IMPROVE INITIATIVE. 7
10222	10222	Part B of title IV of the Public Health Service Act 8
10223	10223	(42 U.S.C. 284 et seq.), as amended by section 710, is 9
10224	10224	further amended by adding at the end the following: 10
10225	10225	‘‘SEC. 409L. IMPROVE INITIATIVE. 11
10226	10226	‘‘(a) I
10227	10227	NGENERAL.—The Director of the National In-12
10228	10228	stitutes of Health shall carry out a program of research 13
10229	10229	to improve health outcomes to be known as the Imple-14
10230	10230	menting a Maternal health and PRegnancy Outcomes Vi-15
10231	10231	sion for Everyone Initiative (referred to in this section as 16
10232	10232	the ‘Initiative’). 17
10233	10233	‘‘(b) O
10234	10234	BJECTIVES.—The Initiative shall— 18
10235	10235	‘‘(1) advance research to— 19
10236	10236	‘‘(A) reduce preventable causes of maternal 20
10237	10237	mortality and severe maternal morbidity; 21
10238	10238	‘‘(B) reduce health disparities related to 22
10239	10239	maternal health outcomes, including such dis-23
10240	10240	parities associated with medically underserved 24
10241	10241	populations; and 25
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10244	10244	•S 891 IS
10245	10245	‘‘(C) improve health for pregnant and 1
10246	10246	postpartum women before, during, and after 2
10247	10247	pregnancy; 3
10248	10248	‘‘(2) use an integrated approach to understand 4
10249	10249	the factors, including biological, behavioral, and 5
10250	10250	other factors, that affect maternal mortality and se-6
10251	10251	vere maternal morbidity by building an evidence 7
10252	10252	base for improved outcomes in specific regions of the 8
10253	10253	United States; and 9
10254	10254	‘‘(3) target health disparities associated with 10
10255	10255	maternal mortality and severe maternal morbidity 11
10256	10256	by— 12
10257	10257	‘‘(A) implementing and evaluating commu-13
10258	10258	nity-based interventions for disproportionately 14
10259	10259	affected women; and 15
10260	10260	‘‘(B) identifying risk factors and the un-16
10261	10261	derlying biological mechanisms associated with 17
10262	10262	leading causes of maternal mortality and severe 18
10263	10263	maternal morbidity in the United States. 19
10264	10264	‘‘(c) S
10265	10265	UNSET.—The authority under this section shall 20
10266	10266	expire on September 30, 2029.’’. 21
10267	10267	SEC. 711. ORGAN PROCUREMENT AND TRANSPLANTATION 22
10268	10268	NETWORK. 23
10269	10269	Section 372 of the Public Health Service Act (42 24
10270	10270	U.S.C. 274) is amended— 25
10271	10271	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00348 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10273	10273	•S 891 IS
10274	10274	(1) in subsection (b)(2)— 1
10275	10275	(A) by moving the margins of subpara-2
10276	10276	graphs (M) through (O) 2 ems to the left; 3
10277	10277	(B) in subparagraph (A)— 4
10278	10278	(i) in clause (i), by striking ‘‘, and’’ 5
10279	10279	and inserting ‘‘; and’’; and 6
10280	10280	(ii) in clause (ii), by striking the 7
10281	10281	comma at the end and inserting a semi-8
10282	10282	colon; 9
10283	10283	(C) in subparagraph (C), by striking 10
10284	10284	‘‘twenty-four-hour telephone service’’ and in-11
10285	10285	serting ‘‘24-hour telephone or information tech-12
10286	10286	nology service’’; 13
10287	10287	(D) in each of subparagraphs (B) through 14
10288	10288	(M), by striking the comma at the end and in-15
10289	10289	serting a semicolon; 16
10290	10290	(E) in subparagraph (N), by striking 17
10291	10291	‘‘transportation, and’’ and inserting ‘‘transpor-18
10292	10292	tation;’’; 19
10293	10293	(F) in subparagraph (O), by striking the 20
10294	10294	period and inserting a semicolon; and 21
10295	10295	(G) by adding at the end the following: 22
10296	10296	‘‘(P) encourage the integration of electronic 23
10297	10297	health records systems through application program-24
10298	10298	ming interfaces (or successor technologies) among 25
10299	10299	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00349 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10301	10301	•S 891 IS
10302	10302	hospitals, organ procurement organizations, and 1
10303	10303	transplant centers, including the use of automated 2
10304	10304	electronic hospital referrals and the grant of remote, 3
10305	10305	electronic access to hospital electronic health records 4
10306	10306	of potential donors by organ procurement organiza-5
10307	10307	tions, in a manner that complies with the privacy 6
10308	10308	regulations promulgated under the Health Insurance 7
10309	10309	Portability and Accountability Act of 1996, at part 8
10310	10310	160 of title 45, Code of Federal Regulations, and 9
10311	10311	subparts A, C, and E of part 164 of such title (or 10
10312	10312	any successor regulations); and 11
10313	10313	‘‘(Q) consider establishing a dashboard to dis-12
10314	10314	play the number of transplants performed, the types 13
10315	10315	of transplants performed, the number and types of 14
10316	10316	organs that entered the Organ Procurement and 15
10317	10317	Transplantation Network system and failed to be 16
10318	10318	transplanted, and other appropriate statistics, which 17
10319	10319	should be updated more frequently than annually.’’; 18
10320	10320	and 19
10321	10321	(2) by adding at the end the following: 20
10322	10322	‘‘(d) R
10323	10323	EGISTRATIONFEES.— 21
10324	10324	‘‘(1) I
10325	10325	N GENERAL.—The Secretary may collect 22
10326	10326	registration fees from any member of the Organ 23
10327	10327	Procurement and Transplantation Network for each 24
10328	10328	transplant candidate such member places on the list 25
10329	10329	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00350 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10331	10331	•S 891 IS
10332	10332	described in subsection (b)(2)(A)(i). Such registra-1
10333	10333	tion fees shall be collected and distributed only to 2
10334	10334	support the operation of the Organ Procurement 3
10335	10335	and Transplantation Network. Such registration fees 4
10336	10336	are authorized to remain available until expended. 5
10337	10337	‘‘(2) C
10338	10338	OLLECTION.—The Secretary may collect 6
10339	10339	the registration fees under paragraph (1) directly or 7
10340	10340	through awards made under subsection (b)(1)(A). 8
10341	10341	‘‘(3) D
10342	10342	ISTRIBUTION.—Any amounts collected 9
10343	10343	under this subsection shall— 10
10344	10344	‘‘(A) be credited to the currently applicable 11
10345	10345	appropriation, account, or fund of the Depart-12
10346	10346	ment of Health and Human Services as discre-13
10347	10347	tionary offsetting collections; and 14
10348	10348	‘‘(B) be available, only to the extent and in 15
10349	10349	the amounts provided in advance in appropria-16
10350	10350	tions Acts, to distribute such fees among 17
10351	10351	awardees described in subsection (b)(1)(A). 18
10352	10352	‘‘(4) T
10353	10353	RANSPARENCY.—The Secretary shall— 19
10354	10354	‘‘(A) promptly post on the website of the 20
10355	10355	Organ Procurement and Transplantation Net-21
10356	10356	work— 22
10357	10357	‘‘(i) the amount of registration fees 23
10358	10358	collected under this subsection from each 24
10359	10359	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00351 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
10360	10360	TKELLEY on LAP7H3WLY3PROD with BILLS 352
10361	10361	•S 891 IS
10362	10362	member of the Organ Procurement and 1
10363	10363	Transplantation Network; and 2
10364	10364	‘‘(ii) a list of activities such fees are 3
10365	10365	used to support; and 4
10366	10366	‘‘(B) update the information posted pursu-5
10367	10367	ant to subparagraph (A), as applicable for each 6
10368	10368	calendar quarter for which fees are collected 7
10369	10369	under paragraph (1). 8
10370	10370	‘‘(5) GAO
10371	10371	REVIEW.—Not later than 2 years 9
10372	10372	after the date of enactment of this subsection, the 10
10373	10373	Comptroller General of the United States shall, to 11
10374	10374	the extent data are available— 12
10375	10375	‘‘(A) conduct a review concerning the ac-13
10376	10376	tivities under this subsection; and 14
10377	10377	‘‘(B) submit to the Committee on Health, 15
10378	10378	Education, Labor, and Pensions and the Com-16
10379	10379	mittee on Finance of the Senate and the Com-17
10380	10380	mittee on Energy and Commerce of the House 18
10381	10381	of Representatives, a report on such review, in-19
10382	10382	cluding related recommendations, as applicable. 20
10383	10383	‘‘(6) S
10384	10384	UNSET.—The authority to collect reg-21
10385	10385	istration fees under paragraph (1) shall expire on 22
10386	10386	the date that is 3 years after the date of enactment 23
10387	10387	of the Bipartisan Health Care Act.’’. 24
10388	10388	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00352 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10390	10390	•S 891 IS
10391	10391	SEC. 712. HONOR OUR LIVING DONORS. 1
10392	10392	(a) N
10393	10393	OCONSIDERATION OF INCOME OFORGANRE-2
10394	10394	CIPIENT.—Section 377 of the Public Health Service Act 3
10395	10395	(42 U.S.C. 274f) is amended— 4
10396	10396	(1) by redesignating subsections (c) through (f) 5
10397	10397	as subsections (d) through (g), respectively; 6
10398	10398	(2) by inserting after subsection (b) the fol-7
10399	10399	lowing: 8
10400	10400	‘‘(c) N
10401	10401	OCONSIDERATION OFINCOME OFORGANRE-9
10402	10402	CIPIENT.—The recipient of a grant under this section, in 10
10403	10403	providing reimbursement to a donating individual through 11
10404	10404	such grant, shall not give any consideration to the income 12
10405	10405	of the organ recipient.’’; and 13
10406	10406	(3) in subsection (f), as so redesignated— 14
10407	10407	(A) in paragraph (1), by striking ‘‘sub-15
10408	10408	section (c)(1)’’ and inserting ‘‘subsection 16
10409	10409	(d)(1)’’; and 17
10410	10410	(B) in paragraph (2), by striking ‘‘sub-18
10411	10411	section (c)(2)’’ and inserting ‘‘subsection 19
10412	10412	(d)(2)’’. 20
10413	10413	(b) R
10414	10414	EMOVAL OFEXPECTATION OF PAYMENTS BY 21
10415	10415	O
10416	10416	RGANRECIPIENTS.—Section 377(e) of the Public 22
10417	10417	Health Service Act (42 U.S.C. 274f(e)), as redesignated 23
10418	10418	by subsection (a)(1), is amended— 24
10419	10419	(1) in paragraph (1), by adding ‘‘or’’ at the 25
10420	10420	end; 26
10421	10421	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00353 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10423	10423	•S 891 IS
10424	10424	(2) in paragraph (2), by striking ‘‘; or’’ and in-1
10425	10425	serting a period; and 2
10426	10426	(3) by striking paragraph (3). 3
10427	10427	(c) A
10428	10428	NNUALREPORT.—Section 377 of the Public 4
10429	10429	Health Service Act (42 U.S.C. 274f), as amended by sub-5
10430	10430	sections (a) and (b), is amended by adding at the end the 6
10431	10431	following: 7
10432	10432	‘‘(h) A
10433	10433	NNUALREPORT.—Not later than December 31 8
10434	10434	of each year, beginning in fiscal year 2026, the Secretary 9
10435	10435	shall— 10
10436	10436	‘‘(1) prepare, submit to the Congress, and make 11
10437	10437	public a report on whether grants under this section 12
10438	10438	provided adequate funding during the preceding fis-13
10439	10439	cal year to reimburse all donating individuals par-14
10440	10440	ticipating in the grant program under this section 15
10441	10441	for all qualifying expenses; and 16
10442	10442	‘‘(2) include in each such report— 17
10443	10443	‘‘(A) the estimated number of all donating 18
10444	10444	individuals participating in the grant program 19
10445	10445	under this section who did not receive reim-20
10446	10446	bursement for all qualifying expenses during 21
10447	10447	the preceding fiscal year; and 22
10448	10448	‘‘(B) the total amount of funding that is 23
10449	10449	estimated to be necessary to fully reimburse all 24
10450	10450	donating individuals participating in the grant 25
10451	10451	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00354 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
10452	10452	TKELLEY on LAP7H3WLY3PROD with BILLS 355
10453	10453	•S 891 IS
10454	10454	program under this section for all qualifying ex-1
10455	10455	penses.’’. 2
10456	10456	SEC. 713. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 3
10457	10457	Section 409I(d)(1) of the Public Health Service Act 4
10458	10458	(42 U.S.C. 284m(d)(1)) is amended by striking ‘‘section,’’ 5
10459	10459	and all that follows through the period at the end and 6
10460	10460	inserting ‘‘section, $25,000,000 for each of fiscal years 7
10461	10461	2025 through 2027.’’. 8
10462	10462	TITLE VIII—FOOD AND DRUG 9
10463	10463	ADMINISTRATION 10
10464	10464	Subtitle A—Give Kids a Chance 11
10465	10465	SEC. 801. RESEARCH INTO PEDIATRIC USES OF DRUGS; AD-12
10466	10466	DITIONAL AUTHORITIES OF FOOD AND DRUG 13
10467	10467	ADMINISTRATION REGARDING MOLECU-14
10468	10468	LARLY TARGETED CANCER DRUGS. 15
10469	10469	(a) I
10470	10470	NGENERAL.— 16
10471	10471	(1) A
10472	10472	DDITIONAL ACTIVE INGREDIENT FOR AP -17
10473	10473	PLICATION DRUG; LIMITATION REGARDING NOVEL - 18
10474	10474	COMBINATION APPLICATION DRUG .—Section 19
10475	10475	505B(a)(3) of the Federal Food, Drug, and Cos-20
10476	10476	metic Act (21 U.S.C. 355c(a)(3)) is amended— 21
10477	10477	(A) by redesignating subparagraphs (B) 22
10478	10478	and (C) as subparagraphs (C) and (D), respec-23
10479	10479	tively; and 24
10480	10480	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00355 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10482	10482	•S 891 IS
10483	10483	(B) by striking subparagraph (A) and in-1
10484	10484	serting the following: 2
10485	10485	‘‘(A) I
10486	10486	N GENERAL.—For purposes of para-3
10487	10487	graph (1)(B), the investigation described in this 4
10488	10488	paragraph is a molecularly targeted pediatric 5
10489	10489	cancer investigation of— 6
10490	10490	‘‘(i) the drug or biological product for 7
10491	10491	which the application referred to in such 8
10492	10492	paragraph is submitted; or 9
10493	10493	‘‘(ii) such drug or biological product 10
10494	10494	used in combination with— 11
10495	10495	‘‘(I) an active ingredient of a 12
10496	10496	drug or biological product— 13
10497	10497	‘‘(aa) for which an approved 14
10498	10498	application under section 505(j) 15
10499	10499	under this Act or under section 16
10500	10500	351(k) of the Public Health 17
10501	10501	Service Act is in effect; and 18
10502	10502	‘‘(bb) that is determined by 19
10503	10503	the Secretary, after consultation 20
10504	10504	with the applicant, to be part of 21
10505	10505	the standard of care for treating 22
10506	10506	a pediatric cancer; or 23
10507	10507	‘‘(II) an active ingredient of a 24
10508	10508	drug or biological product— 25
10509	10509	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00356 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
10510	10510	TKELLEY on LAP7H3WLY3PROD with BILLS 357
10511	10511	•S 891 IS
10512	10512	‘‘(aa) for which an approved 1
10513	10513	application under section 505(b) 2
10514	10514	of this Act or section 351(a) of 3
10515	10515	the Public Health Service Act to 4
10516	10516	treat an adult cancer is in effect 5
10517	10517	and is held by the same person 6
10518	10518	submitting the application under 7
10519	10519	paragraph (1)(B); and 8
10520	10520	‘‘(bb) that is directed at a 9
10521	10521	molecular target that the Sec-10
10522	10522	retary determines to be substan-11
10523	10523	tially relevant to the growth or 12
10524	10524	progression of a pediatric cancer. 13
10525	10525	‘‘(B) A
10526	10526	DDITIONAL REQUIREMENTS .— 14
10527	10527	‘‘(i) D
10528	10528	ESIGN OF INVESTIGATION .—A 15
10529	10529	molecularly targeted pediatric cancer inves-16
10530	10530	tigation referred to in subparagraph (A) 17
10531	10531	shall be designed to yield clinically mean-18
10532	10532	ingful pediatric study data that is gathered 19
10533	10533	using appropriate formulations for each 20
10534	10534	age group for which the study is required, 21
10535	10535	regarding dosing, safety, and preliminary 22
10536	10536	efficacy to inform potential pediatric label-23
10537	10537	ing. 24
10538	10538	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00357 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10540	10540	•S 891 IS
10541	10541	‘‘(ii) LIMITATION.—An investigation 1
10542	10542	described in subparagraph (A)(ii) may be 2
10543	10543	required only if the drug or biological 3
10544	10544	product for which the application referred 4
10545	10545	to in paragraph (1)(B) contains either— 5
10546	10546	‘‘(I) a single new active ingre-6
10547	10547	dient; or 7
10548	10548	‘‘(II) more than one active ingre-8
10549	10549	dient, if an application for the com-9
10550	10550	bination of active ingredients has not 10
10551	10551	previously been approved but each ac-11
10552	10552	tive ingredient is in a drug product 12
10553	10553	that has been previously approved to 13
10554	10554	treat an adult cancer. 14
10555	10555	‘‘(iii) R
10556	10556	ESULTS OF ALREADY -COM-15
10557	10557	PLETED PRECLINICAL STUDIES OF APPLI -16
10558	10558	CATION DRUG.—With respect to an inves-17
10559	10559	tigation required pursuant to paragraph 18
10560	10560	(1)(B), the Secretary may require the re-19
10561	10561	sults of any completed preclinical studies 20
10562	10562	relevant to the initial pediatric study plan 21
10563	10563	be submitted to the Secretary at the same 22
10564	10564	time that the initial pediatric study plan 23
10565	10565	required under subsection (e)(1) is sub-24
10566	10566	mitted. 25
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10569	10569	•S 891 IS
10570	10570	‘‘(iv) RULE OF CONSTRUCTION RE -1
10571	10571	GARDING INACTIVE INGREDIENTS .—With 2
10572	10572	respect to a combination of active ingredi-3
10573	10573	ents referred to in subparagraph (A)(ii), 4
10574	10574	such subparagraph shall not be construed 5
10575	10575	as addressing the use of inactive ingredi-6
10576	10576	ents with such combination.’’. 7
10577	10577	(2) D
10578	10578	ETERMINATION OF APPLICABLE REQUIRE -8
10579	10579	MENTS.—Section 505B(e)(1) of the Federal Food, 9
10580	10580	Drug, and Cosmetic Act (21 U.S.C. 355c(e)(1)) is 10
10581	10581	amended by adding at the end the following: ‘‘The 11
10582	10582	Secretary shall determine whether subparagraph (A) 12
10583	10583	or (B) of subsection (a)(1) applies with respect to an 13
10584	10584	application before the date on which the applicant is 14
10585	10585	required to submit the initial pediatric study plan 15
10586	10586	under paragraph (2)(A).’’. 16
10587	10587	(3) C
10588	10588	LARIFYING APPLICABILITY .—Section 17
10589	10589	505B(a)(1) of the Federal Food, Drug, and Cos-18
10590	10590	metic Act (21 U.S.C. 355c(a)(1)) is amended by 19
10591	10591	adding at the end the following: 20
10592	10592	‘‘(C) R
10593	10593	ULE OF CONSTRUCTION .—No appli-21
10594	10594	cation that is subject to the requirements of 22
10595	10595	subparagraph (B) shall be subject to the re-23
10596	10596	quirements of subparagraph (A), and no appli-24
10597	10597	cation (or supplement to an application) that is 25
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10599	10599	TKELLEY on LAP7H3WLY3PROD with BILLS 360
10600	10600	•S 891 IS
10601	10601	subject to the requirements of subparagraph 1
10602	10602	(A) shall be subject to the requirements of sub-2
10603	10603	paragraph (B).’’. 3
10604	10604	(4) C
10605	10605	ONFORMING AMENDMENTS .—Section 4
10606	10606	505B(a) of the Federal Food, Drug, and Cosmetic 5
10607	10607	Act (21 U.S.C. 355c(a)) is amended— 6
10608	10608	(A) in paragraph (3)(C), as redesignated 7
10609	10609	by paragraph (1)(A) of this subsection, by 8
10610	10610	striking ‘‘investigations described in this para-9
10611	10611	graph’’ and inserting ‘‘investigations referred to 10
10612	10612	in subparagraph (A)’’; and 11
10613	10613	(B) in paragraph (3)(D), as redesignated 12
10614	10614	by paragraph (1)(A) of this subsection, by 13
10615	10615	striking ‘‘the assessments under paragraph 14
10616	10616	(2)(B)’’ and inserting ‘‘the assessments re-15
10617	10617	quired under paragraph (1)(A)’’. 16
10618	10618	(b) G
10619	10619	UIDANCE.—The Secretary of Health and 17
10620	10620	Human Services, acting through the Commissioner of 18
10621	10621	Food and Drugs, shall— 19
10622	10622	(1) not later than 12 months after the date of 20
10623	10623	enactment of this Act, issue draft guidance on the 21
10624	10624	implementation of the amendments made by sub-22
10625	10625	section (a); and 23
10626	10626	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00360 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10628	10628	•S 891 IS
10629	10629	(2) not later than 12 months after closing the 1
10630	10630	comment period on such draft guidance, finalize 2
10631	10631	such guidance. 3
10632	10632	(c) A
10633	10633	PPLICABILITY.—The amendments made by this 4
10634	10634	section apply with respect to any application under section 5
10635	10635	505(b) of the Federal Food, Drug, and Cosmetic Act (21 6
10636	10636	U.S.C. 355(b)) and any application under section 351(a) 7
10637	10637	of the Public Health Service Act (42 U.S.C. 262(a)), that 8
10638	10638	is submitted on or after the date that is 3 years after the 9
10639	10639	date of enactment of this Act. 10
10640	10640	(d) R
10641	10641	EPORTS TOCONGRESS.— 11
10642	10642	(1) S
10643	10643	ECRETARY OF HEALTH AND HUMAN SERV -12
10644	10644	ICES.—Not later than 6 years after the date of en-13
10645	10645	actment of this Act, the Secretary of Health and 14
10646	10646	Human Services shall submit to the Committee on 15
10647	10647	Energy and Commerce of the House of Representa-16
10648	10648	tives and the Committee on Health, Education, 17
10649	10649	Labor, and Pensions of the Senate a report on the 18
10650	10650	Secretary’s efforts, in coordination with industry, to 19
10651	10651	ensure implementation of the amendments made by 20
10652	10652	subsection (a). 21
10653	10653	(2) GAO
10654	10654	STUDY AND REPORT.— 22
10655	10655	(A) S
10656	10656	TUDY.—Not later than 8 years after 23
10657	10657	the date of enactment of this Act, the Comp-24
10658	10658	troller General of the United States shall con-25
10659	10659	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00361 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
10660	10660	TKELLEY on LAP7H3WLY3PROD with BILLS 362
10661	10661	•S 891 IS
10662	10662	duct a study of the effectiveness of requiring 1
10663	10663	assessments and investigations described in sec-2
10664	10664	tion 505B of the Federal Food, Drug, and Cos-3
10665	10665	metic Act (21 U.S.C.355c), as amended by sub-4
10666	10666	section (a), in the development of drugs and bi-5
10667	10667	ological products for pediatric cancer indica-6
10668	10668	tions, including consideration of any benefits to, 7
10669	10669	or burdens on, pediatric cancer drug develop-8
10670	10670	ment. 9
10671	10671	(B) F
10672	10672	INDINGS.—Not later than 10 years 10
10673	10673	after the date of enactment of this Act, the 11
10674	10674	Comptroller General shall submit to the Com-12
10675	10675	mittee on Energy and Commerce of the House 13
10676	10676	of Representatives and the Committee on 14
10677	10677	Health, Education, Labor, and Pensions of the 15
10678	10678	Senate a report containing the findings of the 16
10679	10679	study conducted under subparagraph (A). 17
10680	10680	SEC. 802. ENSURING COMPLETION OF PEDIATRIC STUDY 18
10681	10681	REQUIREMENTS. 19
10682	10682	(a) E
10683	10683	QUALACCOUNTABILITY FOR PEDIATRICSTUDY 20
10684	10684	R
10685	10685	EQUIREMENTS.—Section 505B(d) of the Federal Food, 21
10686	10686	Drug, and Cosmetic Act (21 U.S.C. 355c(d)) is amend-22
10687	10687	ed— 23
10688	10688	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00362 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
10689	10689	TKELLEY on LAP7H3WLY3PROD with BILLS 363
10690	10690	•S 891 IS
10691	10691	(1) in paragraph (1), by striking ‘‘Beginning 1
10692	10692	270’’ and inserting ‘‘N
10693	10693	ONCOMPLIANCE LETTER .— 2
10694	10694	Beginning 270’’; 3
10695	10695	(2) in paragraph (2)— 4
10696	10696	(A) by striking ‘‘The drug or’’ and insert-5
10697	10697	ing ‘‘E
10698	10698	FFECT OF NONCOMPLIANCE .—The drug 6
10699	10699	or’’; and 7
10700	10700	(B) by striking ‘‘(except that the drug or 8
10701	10701	biological product shall not be subject to action 9
10702	10702	under section 303)’’ and inserting ‘‘(except that 10
10703	10703	the drug or biological product shall be subject 11
10704	10704	to action under section 303 only if such person 12
10705	10705	demonstrated a lack of due diligence in satis-13
10706	10706	fying the applicable requirement)’’; and 14
10707	10707	(3) by adding at the end the following: 15
10708	10708	‘‘(3) L
10709	10709	IMITATION.—The Secretary shall not 16
10710	10710	issue enforcement actions under section 303 for fail-17
10711	10711	ures under this subsection in the case of a drug or 18
10712	10712	biological product that is no longer marketed.’’. 19
10713	10713	(b) D
10714	10714	UEDILIGENCE.—Section 505B(d) of the Fed-20
10715	10715	eral Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)), 21
10716	10716	as amended by subsection (a), is further amended by add-22
10717	10717	ing at the end the following: 23
10718	10718	‘‘(4) D
10719	10719	UE DILIGENCE.—Before the Secretary 24
10720	10720	may conclude that a person failed to submit or oth-25
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10722	10722	TKELLEY on LAP7H3WLY3PROD with BILLS 364
10723	10723	•S 891 IS
10724	10724	erwise meet a requirement as described in the mat-1
10725	10725	ter preceding paragraph (1), the Secretary shall— 2
10726	10726	‘‘(A) issue a noncompliance letter pursuant 3
10727	10727	to paragraph (1); 4
10728	10728	‘‘(B) provide such person with a 45-day 5
10729	10729	period beginning on the date of receipt of such 6
10730	10730	noncompliance letter to respond in writing as 7
10731	10731	set forth in such paragraph; and 8
10732	10732	‘‘(C) after reviewing such written response, 9
10733	10733	determine whether the person demonstrated a 10
10734	10734	lack of due diligence in satisfying such require-11
10735	10735	ment.’’. 12
10736	10736	(c) C
10737	10737	ONFORMING AMENDMENTS.—Section 13
10738	10738	303(f)(4)(A) of the Federal Food, Drug, and Cosmetic Act 14
10739	10739	(21 U.S.C. 333(f)(4)(A)) is amended by striking ‘‘or 505– 15
10740	10740	1’’ and inserting ‘‘505–1, or 505B’’. 16
10741	10741	(d) T
10742	10742	RANSITIONRULE.—The Secretary of Health 17
10743	10743	and Human Services may take enforcement action under 18
10744	10744	section 303 of the Federal Food, Drug, and Cosmetic Act 19
10745	10745	(21 U.S.C. 333) only for failures described in section 20
10746	10746	505B(d) of such Act (21 U.S.C. 355c(d)) that occur on 21
10747	10747	or after the date that is 180 days after the date of enact-22
10748	10748	ment of this Act. 23
10749	10749	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00364 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
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10751	10751	•S 891 IS
10752	10752	SEC. 803. FDA REPORT ON PREA ENFORCEMENT. 1
10753	10753	Section 508(b) of the Food and Drug Administration 2
10754	10754	Safety and Innovation Act (21 U.S.C. 355c–1(b)) is 3
10755	10755	amended— 4
10756	10756	(1) in paragraph (11), by striking the semicolon 5
10757	10757	at the end and inserting ‘‘, including an evaluation 6
10758	10758	of compliance with deadlines provided for in defer-7
10759	10759	rals and deferral extensions;’’; 8
10760	10760	(2) in paragraph (15), by striking ‘‘and’’ at the 9
10761	10761	end; 10
10762	10762	(3) in paragraph (16), by striking the period at 11
10763	10763	the end and inserting ‘‘; and’’; and 12
10764	10764	(4) by adding at the end the following: 13
10765	10765	‘‘(17) a listing of penalties, settlements, or pay-14
10766	10766	ments under section 303 of the Federal Food, Drug, 15
10767	10767	and Cosmetic Act (21 U.S.C. 353) for failure to 16
10768	10768	comply with requirements under such section 505B, 17
10769	10769	including, for each penalty, settlement, or payment, 18
10770	10770	the name of the drug, the sponsor thereof, and the 19
10771	10771	amount of the penalty, settlement, or payment im-20
10772	10772	posed; and’’. 21
10773	10773	SEC. 804. EXTENSION OF AUTHORITY TO ISSUE PRIORITY 22
10774	10774	REVIEW VOUCHERS TO ENCOURAGE TREAT-23
10775	10775	MENTS FOR RARE PEDIATRIC DISEASES. 24
10776	10776	(a) E
10777	10777	XTENSION.—Paragraph (5) of section 529(b) of 25
10778	10778	the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 26
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10780	10780	TKELLEY on LAP7H3WLY3PROD with BILLS 366
10781	10781	•S 891 IS
10782	10782	360ff(b)) is amended by striking ‘‘December 20, 2024, un-1
10783	10783	less’’ and all that follows through the period at the end 2
10784	10784	and inserting ‘‘September 30, 2029.’’. 3
10785	10785	(b) U
10786	10786	SERFEEPAYMENT.—Section 529(c)(4) of the 4
10787	10787	Federal Food, Drug, and Cosmetic Act (21 U.S.C. 5
10788	10788	360ff(c)(4)) is amended by striking subparagraph (A) and 6
10789	10789	inserting the following: 7
10790	10790	‘‘(A) I
10791	10791	N GENERAL.—The priority review 8
10792	10792	user fee required by this subsection shall be due 9
10793	10793	upon the submission of a human drug applica-10
10794	10794	tion under section 505(b)(1) or section 351(a) 11
10795	10795	of the Public Health Service Act for which the 12
10796	10796	priority review voucher is used. All other user 13
10797	10797	fees associated with the human drug application 14
10798	10798	shall be due as required by the Secretary or 15
10799	10799	under applicable law.’’. 16
10800	10800	(c) GAO R
10801	10801	EPORT ONEFFECTIVENESS OFRAREPE-17
10802	10802	DIATRICDISEASEPRIORITYVOUCHERAWARDS IN 18
10803	10803	I
10804	10804	NCENTIVIZINGRAREPEDIATRICDISEASEDRUGDEVEL-19
10805	10805	OPMENT.— 20
10806	10806	(1) GAO
10807	10807	STUDY.— 21
10808	10808	(A) S
10809	10809	TUDY.—The Comptroller General of 22
10810	10810	the United States shall conduct a study of the 23
10811	10811	effectiveness of awarding rare pediatric disease 24
10812	10812	priority vouchers under section 529 of the Fed-25
10813	10813	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00366 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
10814	10814	TKELLEY on LAP7H3WLY3PROD with BILLS 367
10815	10815	•S 891 IS
10816	10816	eral Food, Drug, and Cosmetic Act (21 U.S.C. 1
10817	10817	360ff), as amended by subsection (a), in the de-2
10818	10818	velopment of human drug products that treat or 3
10819	10819	prevent rare pediatric diseases (as defined in 4
10820	10820	such section 529). 5
10821	10821	(B) C
10822	10822	ONTENTS OF STUDY .—In conducting 6
10823	10823	the study under subparagraph (A), the Comp-7
10824	10824	troller General shall examine the following: 8
10825	10825	(i) The indications for each drug or 9
10826	10826	biological product that— 10
10827	10827	(I) is the subject of a rare pedi-11
10828	10828	atric disease product application (as 12
10829	10829	defined in section 529 of the Federal 13
10830	10830	Food, Drug, and Cosmetic Act (21 14
10831	10831	U.S.C. 360ff)) for which a priority re-15
10832	10832	view voucher was awarded; and 16
10833	10833	(II) was approved under section 17
10834	10834	505 of the Federal Food, Drug, and 18
10835	10835	Cosmetic Act (42 U.S.C. 355) or li-19
10836	10836	censed under section 351 of the Pub-20
10837	10837	lic Health Service Act (42 U.S.C. 21
10838	10838	262). 22
10839	10839	(ii) Whether, and to what extent, an 23
10840	10840	unmet need related to the treatment or 24
10841	10841	prevention of a rare pediatric disease was 25
10842	10842	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00367 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
10843	10843	TKELLEY on LAP7H3WLY3PROD with BILLS 368
10844	10844	•S 891 IS
10845	10845	met through the approval or licensure of 1
10846	10846	such a drug or biological product. 2
10847	10847	(iii) The size of the company to which 3
10848	10848	a priority review voucher was awarded 4
10849	10849	under section 529 of the Federal Food, 5
10850	10850	Drug, and Cosmetic Act (21 U.S.C. 360ff) 6
10851	10851	for such a drug or biological product. 7
10852	10852	(iv) The value of such priority review 8
10853	10853	voucher if transferred. 9
10854	10854	(v) Identification of each drug for 10
10855	10855	which a priority review voucher awarded 11
10856	10856	under such section 529 was used. 12
10857	10857	(vi) The size of the company using 13
10858	10858	each priority review voucher awarded 14
10859	10859	under such section 529. 15
10860	10860	(vii) The length of the period of time 16
10861	10861	between the date on which a priority re-17
10862	10862	view voucher was awarded under such sec-18
10863	10863	tion 529 and the date on which it was 19
10864	10864	used. 20
10865	10865	(viii) Whether, and to what extent, an 21
10866	10866	unmet need related to the treatment or 22
10867	10867	prevention of a rare pediatric disease was 23
10868	10868	met through the approval under section 24
10869	10869	505 of the Federal Food, Drug, and Cos-25
10870	10870	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00368 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
10871	10871	TKELLEY on LAP7H3WLY3PROD with BILLS 369
10872	10872	•S 891 IS
10873	10873	metic Act (42 U.S.C. 355) or licensure 1
10874	10874	under section 351 of the Public Health 2
10875	10875	Service Act (42 U.S.C. 262) of a drug for 3
10876	10876	which a priority review voucher was used. 4
10877	10877	(ix) Whether, and to what extent, 5
10878	10878	companies were motivated by the avail-6
10879	10879	ability of priority review vouchers under 7
10880	10880	section 529 of the Federal Food, Drug, 8
10881	10881	and Cosmetic Act (21 U.S.C. 360ff) to at-9
10882	10882	tempt to develop a drug for a rare pedi-10
10883	10883	atric disease. 11
10884	10884	(x) Whether, and to what extent, pedi-12
10885	10885	atric review vouchers awarded under such 13
10886	10886	section were successful in stimulating de-14
10887	10887	velopment and expedited patient access to 15
10888	10888	drug products for treatment or prevention 16
10889	10889	of a rare pediatric disease that wouldn’t 17
10890	10890	otherwise take place without the incentive 18
10891	10891	provided by such vouchers. 19
10892	10892	(xi) The impact of such priority re-20
10893	10893	view vouchers on the workload, review 21
10894	10894	process, and public health prioritization ef-22
10895	10895	forts of the Food and Drug Administra-23
10896	10896	tion. 24
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10898	10898	TKELLEY on LAP7H3WLY3PROD with BILLS 370
10899	10899	•S 891 IS
10900	10900	(xii) Any other incentives in Federal 1
10901	10901	law that exist for companies developing 2
10902	10902	drugs or biological products described in 3
10903	10903	clause (i). 4
10904	10904	(2) R
10905	10905	EPORT ON FINDINGS .—Not later than 5 5
10906	10906	years after the date of the enactment of this Act, the 6
10907	10907	Comptroller General of the United States shall sub-7
10908	10908	mit to the Committee on Energy and Commerce of 8
10909	10909	the House of Representatives and the Committee on 9
10910	10910	Health, Education, Labor, and Pensions of the Sen-10
10911	10911	ate a report containing the findings of the study 11
10912	10912	conducted under paragraph (1). 12
10913	10913	SEC. 805. LIMITATIONS ON EXCLUSIVE APPROVAL OR LI-13
10914	10914	CENSURE OF ORPHAN DRUGS. 14
10915	10915	(a) I
10916	10916	NGENERAL.—Section 527 of the Federal Food, 15
10917	10917	Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 16
10918	10918	(1) in subsection (a), in the matter following 17
10919	10919	paragraph (2), by striking ‘‘same disease or condi-18
10920	10920	tion’’ and inserting ‘‘same approved use or indica-19
10921	10921	tion within such rare disease or condition’’; 20
10922	10922	(2) in subsection (b)— 21
10923	10923	(A) in the matter preceding paragraph (1), 22
10924	10924	by striking ‘‘same rare disease or condition’’ 23
10925	10925	and inserting ‘‘same approved use or indication 24
10926	10926	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00370 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
10927	10927	TKELLEY on LAP7H3WLY3PROD with BILLS 371
10928	10928	•S 891 IS
10929	10929	for which such 7-year period applies to such al-1
10930	10930	ready approved or licensed drug’’; and 2
10931	10931	(B) in paragraph (1), by inserting ‘‘, relat-3
10932	10932	ing to the approved use or indication,’’ after 4
10933	10933	‘‘the needs’’; 5
10934	10934	(3) in subsection (c)(1), by striking ‘‘same rare 6
10935	10935	disease or condition as the already approved drug’’ 7
10936	10936	and inserting ‘‘same use or indication for which the 8
10937	10937	already approved or licensed drug was approved or 9
10938	10938	licensed’’; and 10
10939	10939	(4) by adding at the end the following: 11
10940	10940	‘‘(f) A
10941	10941	PPROVEDUSE ORINDICATIONDEFINED.—In 12
10942	10942	this section, the term ‘approved use or indication’ means 13
10943	10943	the use or indication approved under section 505 of this 14
10944	10944	Act or licensed under section 351 of the Public Health 15
10945	10945	Service Act for a drug designated under section 526 for 16
10946	10946	a rare disease or condition.’’. 17
10947	10947	(b) A
10948	10948	PPLICATION OFAMENDMENTS.—The amend-18
10949	10949	ments made by subsection (a) shall apply with respect to 19
10950	10950	any drug designated under section 526 of the Federal 20
10951	10951	Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regard-21
10952	10952	less of the date on which the drug was so designated, and 22
10953	10953	regardless of the date on which the drug was approved 23
10954	10954	under section 505 of such Act (21 U.S.C. 355) or licensed 24
10955	10955	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00371 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
10956	10956	TKELLEY on LAP7H3WLY3PROD with BILLS 372
10957	10957	•S 891 IS
10958	10958	under section 351 of the Public Health Service Act (42 1
10959	10959	U.S.C. 262). 2
10960	10960	Subtitle B—United States-Abraham 3
10961	10961	Accords Cooperation and Security 4
10962	10962	SEC. 811. ESTABLISHMENT OF ABRAHAM ACCORDS OFFICE 5
10963	10963	WITHIN FOOD AND DRUG ADMINISTRATION. 6
10964	10964	(a) I
10965	10965	NGENERAL.—Chapter X of the Federal Food, 7
10966	10966	Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend-8
10967	10967	ed by adding at the end the following: 9
10968	10968	‘‘SEC. 1015. ABRAHAM ACCORDS OFFICE. 10
10969	10969	‘‘(a) I
10970	10970	NGENERAL.—The Secretary, acting through 11
10971	10971	the Commissioner of Food and Drugs, shall establish with-12
10972	10972	in the Food and Drug Administration an office, to be 13
10973	10973	known as the Abraham Accords Office, to be headed by 14
10974	10974	a director. 15
10975	10975	‘‘(b) O
10976	10976	FFICE.—Not later than 2 years after the date 16
10977	10977	of enactment of this section, the Secretary shall— 17
10978	10978	‘‘(1) in consultation with the governments of 18
10979	10979	Abraham Accords countries, as well as appropriate 19
10980	10980	United States Government diplomatic and security 20
10981	10981	personnel— 21
10982	10982	‘‘(A) select the location of the Abraham 22
10983	10983	Accords Office in an Abraham Accords country; 23
10984	10984	and 24
10985	10985	‘‘(B) establish such office; and 25
10986	10986	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00372 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
10987	10987	TKELLEY on LAP7H3WLY3PROD with BILLS 373
10988	10988	•S 891 IS
10989	10989	‘‘(2) assign to such office such personnel of the 1
10990	10990	Food and Drug Administration as the Secretary de-2
10991	10991	termines necessary to carry out the functions of 3
10992	10992	such office. 4
10993	10993	‘‘(c) D
10994	10994	UTIES.—The Secretary, acting through the Di-5
10995	10995	rector of the Abraham Accords Office, shall— 6
10996	10996	‘‘(1) after the Abraham Accords Office is estab-7
10997	10997	lished— 8
10998	10998	‘‘(A) as part of the Food and Drug Admin-9
10999	10999	istration’s work to strengthen the international 10
11000	11000	oversight of regulated commodities, provide 11
11001	11001	technical assistance to regulatory partners in 12
11002	11002	Abraham Accords countries on strengthening 13
11003	11003	regulatory oversight and converging regulatory 14
11004	11004	requirements for the oversight of regulated 15
11005	11005	products, including good manufacturing prac-16
11006	11006	tices and other issues relevant to manufacturing 17
11007	11007	medical products that are regulated by the 18
11008	11008	Food and Drug Administration; and 19
11009	11009	‘‘(B) facilitate interactions between the 20
11010	11010	Food and Drug Administration and interested 21
11011	11011	parties in Abraham Accords countries, including 22
11012	11012	by sharing relevant information regarding 23
11013	11013	United States regulatory pathways with such 24
11014	11014	parties, and facilitate feedback on the research, 25
11015	11015	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00373 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11016	11016	TKELLEY on LAP7H3WLY3PROD with BILLS 374
11017	11017	•S 891 IS
11018	11018	development, and manufacturing of products 1
11019	11019	regulated in accordance with this Act; and 2
11020	11020	‘‘(2) carry out other functions and activities as 3
11021	11021	the Secretary determines to be necessary to carry 4
11022	11022	out this section. 5
11023	11023	‘‘(d) A
11024	11024	BRAHAMACCORDSCOUNTRYDEFINED.—In 6
11025	11025	this section, the term ‘Abraham Accords country’ means 7
11026	11026	a country identified by the Department of State as having 8
11027	11027	signed the Abraham Accords Declaration. 9
11028	11028	‘‘(e) N
11029	11029	ATIONALSECURITY.—Nothing in this section 10
11030	11030	shall be construed to require any action inconsistent with 11
11031	11031	a national security recommendation provided by the Fed-12
11032	11032	eral Government.’’. 13
11033	11033	(b) R
11034	11034	EPORT TOCONGRESS.— 14
11035	11035	(1) I
11036	11036	N GENERAL.—Not later than 3 years after 15
11037	11037	the date of enactment of this Act, the Secretary of 16
11038	11038	Health and Human Services shall submit to the 17
11039	11039	Congress a report on the Abraham Accords Office, 18
11040	11040	including— 19
11041	11041	(A) an evaluation of how the Office has ad-20
11042	11042	vanced progress toward conformance with Food 21
11043	11043	and Drug Administration regulatory require-22
11044	11044	ments by manufacturers in the Abraham Ac-23
11045	11045	cords countries; 24
11046	11046	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00374 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11047	11047	TKELLEY on LAP7H3WLY3PROD with BILLS 375
11048	11048	•S 891 IS
11049	11049	(B) a numerical count of parties that the 1
11050	11050	Office has helped facilitate interactions or feed-2
11051	11051	back pursuant to section 1015(c)(1)(B) of the 3
11052	11052	Federal Food, Drug, and Cosmetic Act (as 4
11053	11053	added by subsection (a)); 5
11054	11054	(C) a summary of technical assistance pro-6
11055	11055	vided to regulatory partners in Abraham Ac-7
11056	11056	cords countries pursuant to subparagraph (A) 8
11057	11057	of such section 1015(c)(1); and 9
11058	11058	(D) recommendations for increasing and 10
11059	11059	improving coordination between the Food and 11
11060	11060	Drug Administration and entities in Abraham 12
11061	11061	Accords countries. 13
11062	11062	(2) A
11063	11063	BRAHAM ACCORDS COUNTRY DEFINED .— 14
11064	11064	In this subsection, the term ‘‘Abraham Accords 15
11065	11065	country’’ has the meaning given such term in section 16
11066	11066	1015(d) of the Federal Food, Drug, and Cosmetic 17
11067	11067	Act (as added by subsection (a)). 18
11068	11068	TITLE IX—LOWERING 19
11069	11069	PRESCRIPTION DRUG COSTS 20
11070	11070	SEC. 901. OVERSIGHT OF PHARMACY BENEFIT MANAGE-21
11071	11071	MENT SERVICES. 22
11072	11072	(a) P
11073	11073	UBLICHEALTHSERVICEACT.—Title XXVII of 23
11074	11074	the Public Health Service Act (42 U.S.C. 300gg et seq.) 24
11075	11075	is amended— 25
11076	11076	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00375 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11077	11077	TKELLEY on LAP7H3WLY3PROD with BILLS 376
11078	11078	•S 891 IS
11079	11079	(1) in part D (42 U.S.C. 300gg–111 et seq.), 1
11080	11080	by adding at the end the following new section: 2
11081	11081	‘‘SEC. 2799A–11. OVERSIGHT OF ENTITIES THAT PROVIDE 3
11082	11082	PHARMACY BENEFIT MANAGEMENT SERV-4
11083	11083	ICES. 5
11084	11084	‘‘(a) I
11085	11085	NGENERAL.—For plan years beginning on or 6
11086	11086	after the date that is 30 months after the date of enact-7
11087	11087	ment of this section (referred to in this subsection and 8
11088	11088	subsection (b) as the ‘effective date’), a group health plan 9
11089	11089	or a health insurance issuer offering group health insur-10
11090	11090	ance coverage, or an entity providing pharmacy benefit 11
11091	11091	management services on behalf of such a plan or issuer, 12
11092	11092	shall not enter into a contract, including an extension or 13
11093	11093	renewal of a contract, entered into on or after the effective 14
11094	11094	date, with an applicable entity unless such applicable enti-15
11095	11095	ty agrees to— 16
11096	11096	‘‘(1) not limit or delay the disclosure of infor-17
11097	11097	mation to the group health plan (including such a 18
11098	11098	plan offered through a health insurance issuer) in 19
11099	11099	such a manner that prevents an entity providing 20
11100	11100	pharmacy benefit management services on behalf of 21
11101	11101	a group health plan or health insurance issuer offer-22
11102	11102	ing group health insurance coverage from making 23
11103	11103	the reports described in subsection (b); and 24
11104	11104	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00376 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11105	11105	TKELLEY on LAP7H3WLY3PROD with BILLS 377
11106	11106	•S 891 IS
11107	11107	‘‘(2) provide the entity providing pharmacy ben-1
11108	11108	efit management services on behalf of a group health 2
11109	11109	plan or health insurance issuer relevant information 3
11110	11110	necessary to make the reports described in sub-4
11111	11111	section (b). 5
11112	11112	‘‘(b) R
11113	11113	EPORTS.— 6
11114	11114	‘‘(1) I
11115	11115	N GENERAL.—For plan years beginning 7
11116	11116	on or after the effective date, in the case of any con-8
11117	11117	tract between a group health plan or a health insur-9
11118	11118	ance issuer offering group health insurance coverage 10
11119	11119	offered in connection with such a plan and an entity 11
11120	11120	providing pharmacy benefit management services on 12
11121	11121	behalf of such plan or issuer, including an extension 13
11122	11122	or renewal of such a contract, entered into on or 14
11123	11123	after the effective date, the entity providing phar-15
11124	11124	macy benefit management services on behalf of such 16
11125	11125	a group health plan or health insurance issuer, not 17
11126	11126	less frequently than every 6 months (or, at the re-18
11127	11127	quest of a group health plan, not less frequently 19
11128	11128	than quarterly, and under the same conditions, 20
11129	11129	terms, and cost of the semiannual report under this 21
11130	11130	subsection), shall submit to the group health plan a 22
11131	11131	report in accordance with this section. Each such re-23
11132	11132	port shall be made available to such group health 24
11133	11133	plan in plain language, in a machine-readable for-25
11134	11134	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00377 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11135	11135	TKELLEY on LAP7H3WLY3PROD with BILLS 378
11136	11136	•S 891 IS
11137	11137	mat, and as the Secretary may determine, other for-1
11138	11138	mats. Each such report shall include the information 2
11139	11139	described in paragraph (2). 3
11140	11140	‘‘(2) I
11141	11141	NFORMATION DESCRIBED .—For purposes 4
11142	11142	of paragraph (1), the information described in this 5
11143	11143	paragraph is, with respect to drugs covered by a 6
11144	11144	group health plan or group health insurance cov-7
11145	11145	erage offered by a health insurance issuer in connec-8
11146	11146	tion with a group health plan during each reporting 9
11147	11147	period— 10
11148	11148	‘‘(A) in the case of a group health plan 11
11149	11149	that is offered by a specified large employer or 12
11150	11150	that is a specified large plan, and is not offered 13
11151	11151	as health insurance coverage, or in the case of 14
11152	11152	health insurance coverage for which the election 15
11153	11153	under paragraph (3) is made for the applicable 16
11154	11154	reporting period— 17
11155	11155	‘‘(i) a list of drugs for which a claim 18
11156	11156	was filed and, with respect to each such 19
11157	11157	drug on such list— 20
11158	11158	‘‘(I) the contracted compensation 21
11159	11159	paid by the group health plan or 22
11160	11160	health insurance issuer for each cov-23
11161	11161	ered drug (identified by the National 24
11162	11162	Drug Code) to the entity providing 25
11163	11163	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00378 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11164	11164	TKELLEY on LAP7H3WLY3PROD with BILLS 379
11165	11165	•S 891 IS
11166	11166	pharmacy benefit management serv-1
11167	11167	ices or other applicable entity on be-2
11168	11168	half of the group health plan or health 3
11169	11169	insurance issuer; 4
11170	11170	‘‘(II) the contracted compensa-5
11171	11171	tion paid to the pharmacy, by any en-6
11172	11172	tity providing pharmacy benefit man-7
11173	11173	agement services or other applicable 8
11174	11174	entity on behalf of the group health 9
11175	11175	plan or health insurance issuer, for 10
11176	11176	each covered drug (identified by the 11
11177	11177	National Drug Code); 12
11178	11178	‘‘(III) for each such claim, the 13
11179	11179	difference between the amount paid 14
11180	11180	under subclause (I) and the amount 15
11181	11181	paid under subclause (II); 16
11182	11182	‘‘(IV) the proprietary name, es-17
11183	11183	tablished name or proper name, and 18
11184	11184	the National Drug Code; 19
11185	11185	‘‘(V) for each claim for the drug 20
11186	11186	(including original prescriptions and 21
11187	11187	refills) and for each dosage unit of the 22
11188	11188	drug for which a claim was filed, the 23
11189	11189	type of dispensing channel used to 24
11190	11190	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00379 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11191	11191	TKELLEY on LAP7H3WLY3PROD with BILLS 380
11192	11192	•S 891 IS
11193	11193	furnish the drug, including retail, mail 1
11194	11194	order, or specialty pharmacy; 2
11195	11195	‘‘(VI) with respect to each drug 3
11196	11196	dispensed, for each type of dispensing 4
11197	11197	channel (including retail, mail order, 5
11198	11198	or specialty pharmacy)— 6
11199	11199	‘‘(aa) whether such drug is a 7
11200	11200	brand name drug or a generic 8
11201	11201	drug, and— 9
11202	11202	‘‘(AA) in the case of a 10
11203	11203	brand name drug, the whole-11
11204	11204	sale acquisition cost, listed 12
11205	11205	as cost per days supply and 13
11206	11206	cost per dosage unit, on the 14
11207	11207	date such drug was dis-15
11208	11208	pensed; and 16
11209	11209	‘‘(BB) in the case of a 17
11210	11210	generic drug, the average 18
11211	11211	wholesale price, listed as 19
11212	11212	cost per days supply and 20
11213	11213	cost per dosage unit, on the 21
11214	11214	date such drug was dis-22
11215	11215	pensed; and 23
11216	11216	‘‘(bb) the total number of— 24
11217	11217	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00380 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11218	11218	TKELLEY on LAP7H3WLY3PROD with BILLS 381
11219	11219	•S 891 IS
11220	11220	‘‘(AA) prescription 1
11221	11221	claims (including original 2
11222	11222	prescriptions and refills); 3
11223	11223	‘‘(BB) participants and 4
11224	11224	beneficiaries for whom a 5
11225	11225	claim for such drug was 6
11226	11226	filed through the applicable 7
11227	11227	dispensing channel; 8
11228	11228	‘‘(CC) dosage units and 9
11229	11229	dosage units per fill of such 10
11230	11230	drug; and 11
11231	11231	‘‘(DD) days supply of 12
11232	11232	such drug per fill; 13
11233	11233	‘‘(VII) the net price per course of 14
11234	11234	treatment or single fill, such as a 30- 15
11235	11235	day supply or 90-day supply to the 16
11236	11236	plan or coverage after rebates, fees, 17
11237	11237	alternative discounts, or other remu-18
11238	11238	neration received from applicable enti-19
11239	11239	ties; 20
11240	11240	‘‘(VIII) the total amount of out- 21
11241	11241	of-pocket spending by participants 22
11242	11242	and beneficiaries on such drug, in-23
11243	11243	cluding spending through copayments, 24
11244	11244	coinsurance, and deductibles, but not 25
11245	11245	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00381 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11246	11246	TKELLEY on LAP7H3WLY3PROD with BILLS 382
11247	11247	•S 891 IS
11248	11248	including any amounts spent by par-1
11249	11249	ticipants and beneficiaries on drugs 2
11250	11250	not covered under the plan or cov-3
11251	11251	erage, or for which no claim is sub-4
11252	11252	mitted under the plan or coverage; 5
11253	11253	‘‘(IX) the total net spending on 6
11254	11254	the drug; 7
11255	11255	‘‘(X) the total amount received, 8
11256	11256	or expected to be received, by the plan 9
11257	11257	or issuer from any applicable entity in 10
11258	11258	rebates, fees, alternative discounts, or 11
11259	11259	other remuneration; 12
11260	11260	‘‘(XI) the total amount received, 13
11261	11261	or expected to be received, by the enti-14
11262	11262	ty providing pharmacy benefit man-15
11263	11263	agement services, from applicable en-16
11264	11264	tities, in rebates, fees, alternative dis-17
11265	11265	counts, or other remuneration from 18
11266	11266	such entities— 19
11267	11267	‘‘(aa) for claims incurred 20
11268	11268	during the reporting period; and 21
11269	11269	‘‘(bb) that is related to utili-22
11270	11270	zation of such drug or spending 23
11271	11271	on such drug; and 24
11272	11272	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00382 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11273	11273	TKELLEY on LAP7H3WLY3PROD with BILLS 383
11274	11274	•S 891 IS
11275	11275	‘‘(XII) to the extent feasible, in-1
11276	11276	formation on the total amount of re-2
11277	11277	muneration for such drug, including 3
11278	11278	copayment assistance dollars paid, co-4
11279	11279	payment cards applied, or other dis-5
11280	11280	counts provided by each drug manu-6
11281	11281	facturer (or entity administering co-7
11282	11282	payment assistance on behalf of such 8
11283	11283	drug manufacturer), to the partici-9
11284	11284	pants and beneficiaries enrolled in 10
11285	11285	such plan or coverage; 11
11286	11286	‘‘(ii) a list of each therapeutic class 12
11287	11287	(as defined by the Secretary) for which a 13
11288	11288	claim was filed under the group health 14
11289	11289	plan or health insurance coverage during 15
11290	11290	the reporting period, and, with respect to 16
11291	11291	each such therapeutic class— 17
11292	11292	‘‘(I) the total gross spending on 18
11293	11293	drugs in such class before rebates, 19
11294	11294	price concessions, alternative dis-20
11295	11295	counts, or other remuneration from 21
11296	11296	applicable entities; 22
11297	11297	‘‘(II) the net spending in such 23
11298	11298	class after such rebates, price conces-24
11299	11299	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00383 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11300	11300	TKELLEY on LAP7H3WLY3PROD with BILLS 384
11301	11301	•S 891 IS
11302	11302	sions, alternative discounts, or other 1
11303	11303	remuneration from applicable entities; 2
11304	11304	‘‘(III) the total amount received, 3
11305	11305	or expected to be received, by the enti-4
11306	11306	ty providing pharmacy benefit man-5
11307	11307	agement services, from applicable en-6
11308	11308	tities, in rebates, fees, alternative dis-7
11309	11309	counts, or other remuneration from 8
11310	11310	such entities— 9
11311	11311	‘‘(aa) for claims incurred 10
11312	11312	during the reporting period; and 11
11313	11313	‘‘(bb) that is related to utili-12
11314	11314	zation of drugs or drug spending; 13
11315	11315	‘‘(IV) the average net spending 14
11316	11316	per 30-day supply and per 90-day 15
11317	11317	supply by the plan or by the issuer 16
11318	11318	with respect to such coverage and its 17
11319	11319	participants and beneficiaries, among 18
11320	11320	all drugs within the therapeutic class 19
11321	11321	for which a claim was filed during the 20
11322	11322	reporting period; 21
11323	11323	‘‘(V) the number of participants 22
11324	11324	and beneficiaries who filled a prescrip-23
11325	11325	tion for a drug in such class, includ-24
11326	11326	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00384 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11327	11327	TKELLEY on LAP7H3WLY3PROD with BILLS 385
11328	11328	•S 891 IS
11329	11329	ing the National Drug Code for each 1
11330	11330	such drug; 2
11331	11331	‘‘(VI) if applicable, a description 3
11332	11332	of the formulary tiers and utilization 4
11333	11333	mechanisms (such as prior authoriza-5
11334	11334	tion or step therapy) employed for 6
11335	11335	drugs in that class; and 7
11336	11336	‘‘(VII) the total out-of-pocket 8
11337	11337	spending under the plan or coverage 9
11338	11338	by participants and beneficiaries, in-10
11339	11339	cluding spending through copayments, 11
11340	11340	coinsurance, and deductibles, but not 12
11341	11341	including any amounts spent by par-13
11342	11342	ticipants and beneficiaries on drugs 14
11343	11343	not covered under the plan or cov-15
11344	11344	erage or for which no claim is sub-16
11345	11345	mitted under the plan or coverage; 17
11346	11346	‘‘(iii) with respect to any drug for 18
11347	11347	which gross spending under the group 19
11348	11348	health plan or health insurance coverage 20
11349	11349	exceeded $10,000 during the reporting pe-21
11350	11350	riod or, in the case that gross spending 22
11351	11351	under the group health plan or coverage 23
11352	11352	exceeded $10,000 during the reporting pe-24
11353	11353	riod with respect to fewer than 50 drugs, 25
11354	11354	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00385 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11355	11355	TKELLEY on LAP7H3WLY3PROD with BILLS 386
11356	11356	•S 891 IS
11357	11357	with respect to the 50 prescription drugs 1
11358	11358	with the highest spending during the re-2
11359	11359	porting period— 3
11360	11360	‘‘(I) a list of all other drugs in 4
11361	11361	the same therapeutic class as such 5
11362	11362	drug; 6
11363	11363	‘‘(II) if applicable, the rationale 7
11364	11364	for the formulary placement of such 8
11365	11365	drug in that therapeutic category or 9
11366	11366	class, selected from a list of standard 10
11367	11367	rationales established by the Sec-11
11368	11368	retary, in consultation with stake-12
11369	11369	holders; and 13
11370	11370	‘‘(III) any change in formulary 14
11371	11371	placement compared to the prior plan 15
11372	11372	year; and 16
11373	11373	‘‘(iv) in the case that such plan or 17
11374	11374	issuer (or an entity providing pharmacy 18
11375	11375	benefit management services on behalf of 19
11376	11376	such plan or issuer) has an affiliated phar-20
11377	11377	macy or pharmacy under common owner-21
11378	11378	ship, including mandatory mail and spe-22
11379	11379	cialty home delivery programs, retail and 23
11380	11380	mail auto-refill programs, and cost sharing 24
11381	11381	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00386 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11382	11382	TKELLEY on LAP7H3WLY3PROD with BILLS 387
11383	11383	•S 891 IS
11384	11384	assistance incentives funded by an entity 1
11385	11385	providing pharmacy benefit services— 2
11386	11386	‘‘(I) an explanation of any ben-3
11387	11387	efit design parameters that encourage 4
11388	11388	or require participants and bene-5
11389	11389	ficiaries in the plan or coverage to fill 6
11390	11390	prescriptions at mail order, specialty, 7
11391	11391	or retail pharmacies; 8
11392	11392	‘‘(II) the percentage of total pre-9
11393	11393	scriptions dispensed by such phar-10
11394	11394	macies to participants or beneficiaries 11
11395	11395	in such plan or coverage; and 12
11396	11396	‘‘(III) a list of all drugs dis-13
11397	11397	pensed by such pharmacies to partici-14
11398	11398	pants or beneficiaries enrolled in such 15
11399	11399	plan or coverage, and, with respect to 16
11400	11400	each drug dispensed— 17
11401	11401	‘‘(aa) the amount charged, 18
11402	11402	per dosage unit, per 30-day sup-19
11403	11403	ply, or per 90-day supply (as ap-20
11404	11404	plicable) to the plan or issuer, 21
11405	11405	and to participants and bene-22
11406	11406	ficiaries; 23
11407	11407	‘‘(bb) the median amount 24
11408	11408	charged to such plan or issuer, 25
11409	11409	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00387 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11410	11410	TKELLEY on LAP7H3WLY3PROD with BILLS 388
11411	11411	•S 891 IS
11412	11412	and the interquartile range of the 1
11413	11413	costs, per dosage unit, per 30- 2
11414	11414	day supply, and per 90-day sup-3
11415	11415	ply, including amounts paid by 4
11416	11416	the participants and bene-5
11417	11417	ficiaries, when the same drug is 6
11418	11418	dispensed by other pharmacies 7
11419	11419	that are not affiliated with or 8
11420	11420	under common ownership with 9
11421	11421	the entity and that are included 10
11422	11422	in the pharmacy network of such 11
11423	11423	plan or coverage; 12
11424	11424	‘‘(cc) the lowest cost per 13
11425	11425	dosage unit, per 30-day supply 14
11426	11426	and per 90-day supply, for each 15
11427	11427	such drug, including amounts 16
11428	11428	charged to the plan or coverage 17
11429	11429	and to participants and bene-18
11430	11430	ficiaries, that is available from 19
11431	11431	any pharmacy included in the 20
11432	11432	network of such plan or coverage; 21
11433	11433	and 22
11434	11434	‘‘(dd) the net acquisition 23
11435	11435	cost per dosage unit, per 30-day 24
11436	11436	supply, and per 90-day supply, if 25
11437	11437	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00388 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11438	11438	TKELLEY on LAP7H3WLY3PROD with BILLS 389
11439	11439	•S 891 IS
11440	11440	such drug is subject to a max-1
11441	11441	imum price discount; and 2
11442	11442	‘‘(B) with respect to any group health 3
11443	11443	plan, including group health insurance coverage 4
11444	11444	offered in connection with such a plan, regard-5
11445	11445	less of whether the plan or coverage is offered 6
11446	11446	by a specified large employer or whether it is a 7
11447	11447	specified large plan— 8
11448	11448	‘‘(i) a summary document for the 9
11449	11449	group health plan that includes such infor-10
11450	11450	mation described in clauses (i) through (iv) 11
11451	11451	of subparagraph (A), as specified by the 12
11452	11452	Secretary through guidance, program in-13
11453	11453	struction, or otherwise (with no require-14
11454	11454	ment of notice and comment rulemaking), 15
11455	11455	that the Secretary determines useful to 16
11456	11456	group health plans for purposes of select-17
11457	11457	ing pharmacy benefit management serv-18
11458	11458	ices, such as an estimated net price to 19
11459	11459	group health plan and participant or bene-20
11460	11460	ficiary, a cost per claim, the fee structure 21
11461	11461	or reimbursement model, and estimated 22
11462	11462	cost per participant or beneficiary; 23
11463	11463	‘‘(ii) a summary document for plans 24
11464	11464	and issuers to provide to participants and 25
11465	11465	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00389 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11466	11466	TKELLEY on LAP7H3WLY3PROD with BILLS 390
11467	11467	•S 891 IS
11468	11468	beneficiaries, which shall be made available 1
11469	11469	to participants or beneficiaries upon re-2
11470	11470	quest to their group health plan (including 3
11471	11471	in the case of group health insurance cov-4
11472	11472	erage offered in connection with such a 5
11473	11473	plan), that— 6
11474	11474	‘‘(I) contains such information 7
11475	11475	described in clauses (iii), (iv), (v), and 8
11476	11476	(vi), as applicable, as specified by the 9
11477	11477	Secretary through guidance, program 10
11478	11478	instruction, or otherwise (with no re-11
11479	11479	quirement of notice and comment 12
11480	11480	rulemaking) that the Secretary deter-13
11481	11481	mines useful to participants or bene-14
11482	11482	ficiaries in better understanding the 15
11483	11483	plan or coverage or benefits under 16
11484	11484	such plan or coverage; 17
11485	11485	‘‘(II) contains only aggregate in-18
11486	11486	formation; and 19
11487	11487	‘‘(III) states that participants 20
11488	11488	and beneficiaries may request specific, 21
11489	11489	claims-level information required to be 22
11490	11490	furnished under subsection (c) from 23
11491	11491	the group health plan or health insur-24
11492	11492	ance issuer; and 25
11493	11493	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00390 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11494	11494	TKELLEY on LAP7H3WLY3PROD with BILLS 391
11495	11495	•S 891 IS
11496	11496	‘‘(iii) with respect to drugs covered by 1
11497	11497	such plan or coverage during such report-2
11498	11498	ing period— 3
11499	11499	‘‘(I) the total net spending by the 4
11500	11500	plan or coverage for all such drugs; 5
11501	11501	‘‘(II) the total amount received, 6
11502	11502	or expected to be received, by the plan 7
11503	11503	or issuer from any applicable entity in 8
11504	11504	rebates, fees, alternative discounts, or 9
11505	11505	other remuneration; and 10
11506	11506	‘‘(III) to the extent feasible, in-11
11507	11507	formation on the total amount of re-12
11508	11508	muneration for such drugs, including 13
11509	11509	copayment assistance dollars paid, co-14
11510	11510	payment cards applied, or other dis-15
11511	11511	counts provided by each drug manu-16
11512	11512	facturer (or entity administering co-17
11513	11513	payment assistance on behalf of such 18
11514	11514	drug manufacturer) to participants 19
11515	11515	and beneficiaries; 20
11516	11516	‘‘(iv) amounts paid directly or indi-21
11517	11517	rectly in rebates, fees, or any other type of 22
11518	11518	compensation (as defined in section 23
11519	11519	408(b)(2)(B)(ii)(dd)(AA) of the Employee 24
11520	11520	Retirement Income Security Act) to bro-25
11521	11521	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00391 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11522	11522	TKELLEY on LAP7H3WLY3PROD with BILLS 392
11523	11523	•S 891 IS
11524	11524	kerage firms, brokers, consultants, advi-1
11525	11525	sors, or any other individual or firm, for— 2
11526	11526	‘‘(I) the referral of the group 3
11527	11527	health plan’s or health insurance 4
11528	11528	issuer’s business to an entity pro-5
11529	11529	viding pharmacy benefit management 6
11530	11530	services, including the identity of the 7
11531	11531	recipient of such amounts; 8
11532	11532	‘‘(II) consideration of the entity 9
11533	11533	providing pharmacy benefit manage-10
11534	11534	ment services by the group health 11
11535	11535	plan or health insurance issuer; or 12
11536	11536	‘‘(III) the retention of the entity 13
11537	11537	by the group health plan or health in-14
11538	11538	surance issuer; 15
11539	11539	‘‘(v) an explanation of any benefit de-16
11540	11540	sign parameters that encourage or require 17
11541	11541	participants and beneficiaries in such plan 18
11542	11542	or coverage to fill prescriptions at mail 19
11543	11543	order, specialty, or retail pharmacies that 20
11544	11544	are affiliated with or under common own-21
11545	11545	ership with the entity providing pharmacy 22
11546	11546	benefit management services under such 23
11547	11547	plan or coverage, including mandatory mail 24
11548	11548	and specialty home delivery programs, re-25
11549	11549	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00392 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11550	11550	TKELLEY on LAP7H3WLY3PROD with BILLS 393
11551	11551	•S 891 IS
11552	11552	tail and mail auto-refill programs, and 1
11553	11553	cost-sharing assistance incentives directly 2
11554	11554	or indirectly funded by such entity; and 3
11555	11555	‘‘(vi) total gross spending on all drugs 4
11556	11556	under the plan or coverage during the re-5
11557	11557	porting period. 6
11558	11558	‘‘(3) O
11559	11559	PT-IN FOR GROUP HEALTH INSURANCE 7
11560	11560	COVERAGE OFFERED BY A SPECIFIED LARGE EM -8
11561	11561	PLOYER OR THAT IS A SPECIFIED LARGE PLAN .—In 9
11562	11562	the case of group health insurance coverage offered 10
11563	11563	in connection with a group health plan that is of-11
11564	11564	fered by a specified large employer or is a specified 12
11565	11565	large plan, such group health plan may, on an an-13
11566	11566	nual basis, for plan years beginning on or after the 14
11567	11567	date that is 30 months after the date of enactment 15
11568	11568	of this section, elect to require an entity providing 16
11569	11569	pharmacy benefit management services on behalf of 17
11570	11570	the health insurance issuer to submit to such group 18
11571	11571	health plan a report that includes all of the informa-19
11572	11572	tion described in paragraph (2)(A), in addition to 20
11573	11573	the information described in paragraph (2)(B). 21
11574	11574	‘‘(4) P
11575	11575	RIVACY REQUIREMENTS .— 22
11576	11576	‘‘(A) I
11577	11577	N GENERAL.—An entity providing 23
11578	11578	pharmacy benefit management services on be-24
11579	11579	half of a group health plan or a health insur-25
11580	11580	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00393 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11581	11581	TKELLEY on LAP7H3WLY3PROD with BILLS 394
11582	11582	•S 891 IS
11583	11583	ance issuer offering group health insurance cov-1
11584	11584	erage shall report information under paragraph 2
11585	11585	(1) in a manner consistent with the privacy reg-3
11586	11586	ulations promulgated under section 13402(a) of 4
11587	11587	the Health Information Technology for Eco-5
11588	11588	nomic and Clinical Health Act and consistent 6
11589	11589	with the privacy regulations promulgated under 7
11590	11590	the Health Insurance Portability and Account-8
11591	11591	ability Act of 1996 in part 160 and subparts A 9
11592	11592	and E of part 164 of title 45, Code of Federal 10
11593	11593	Regulations (or successor regulations) (referred 11
11594	11594	to in this paragraph as the ‘HIPAA privacy 12
11595	11595	regulations’) and shall restrict the use and dis-13
11596	11596	closure of such information according to such 14
11597	11597	privacy regulations and such HIPAA privacy 15
11598	11598	regulations. 16
11599	11599	‘‘(B) A
11600	11600	DDITIONAL REQUIREMENTS .— 17
11601	11601	‘‘(i) I
11602	11602	N GENERAL.—An entity pro-18
11603	11603	viding pharmacy benefit management serv-19
11604	11604	ices on behalf of a group health plan or 20
11605	11605	health insurance issuer offering group 21
11606	11606	health insurance coverage that submits a 22
11607	11607	report under paragraph (1) shall ensure 23
11608	11608	that such report contains only summary 24
11609	11609	health information, as defined in section 25
11610	11610	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00394 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11611	11611	TKELLEY on LAP7H3WLY3PROD with BILLS 395
11612	11612	•S 891 IS
11613	11613	164.504(a) of title 45, Code of Federal 1
11614	11614	Regulations (or successor regulations). 2
11615	11615	‘‘(ii) R
11616	11616	ESTRICTIONS.—In carrying out 3
11617	11617	this subsection, a group health plan shall 4
11618	11618	comply with section 164.504(f) of title 45, 5
11619	11619	Code of Federal Regulations (or a suc-6
11620	11620	cessor regulation), and a plan sponsor shall 7
11621	11621	act in accordance with the terms of the 8
11622	11622	agreement described in such section. 9
11623	11623	‘‘(C) R
11624	11624	ULE OF CONSTRUCTION .— 10
11625	11625	‘‘(i) Nothing in this section shall be 11
11626	11626	construed to modify the requirements for 12
11627	11627	the creation, receipt, maintenance, or 13
11628	11628	transmission of protected health informa-14
11629	11629	tion under the HIPAA privacy regulations. 15
11630	11630	‘‘(ii) Nothing in this section shall be 16
11631	11631	construed to affect the application of any 17
11632	11632	Federal or State privacy or civil rights law, 18
11633	11633	including the HIPAA privacy regulations, 19
11634	11634	the Genetic Information Nondiscrimination 20
11635	11635	Act of 2008 (Public Law 110–233) (in-21
11636	11636	cluding the amendments made by such 22
11637	11637	Act), the Americans with Disabilities Act 23
11638	11638	of 1990 (42 U.S.C. 12101 et seq.), section 24
11639	11639	504 of the Rehabilitation Act of 1973 (29 25
11640	11640	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00395 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11641	11641	TKELLEY on LAP7H3WLY3PROD with BILLS 396
11642	11642	•S 891 IS
11643	11643	U.S.C. 794), section 1557 of the Patient 1
11644	11644	Protection and Affordable Care Act (42 2
11645	11645	U.S.C. 18116), title VI of the Civil Rights 3
11646	11646	Act of 1964 (42 U.S.C. 2000d), and title 4
11647	11647	VII of the Civil Rights Act of 1964 (42 5
11648	11648	U.S.C. 2000e). 6
11649	11649	‘‘(D) W
11650	11650	RITTEN NOTICE.—Each plan year, 7
11651	11651	group health plans, including with respect to 8
11652	11652	group health insurance coverage offered in con-9
11653	11653	nection with a group health plan, shall provide 10
11654	11654	to each participant or beneficiary written notice 11
11655	11655	informing the participant or beneficiary of the 12
11656	11656	requirement for entities providing pharmacy 13
11657	11657	benefit management services on behalf of the 14
11658	11658	group health plan or health insurance issuer of-15
11659	11659	fering group health insurance coverage to sub-16
11660	11660	mit reports to group health plans under para-17
11661	11661	graph (1), as applicable, which may include in-18
11662	11662	corporating such notification in plan documents 19
11663	11663	provided to the participant or beneficiary, or 20
11664	11664	providing individual notification. 21
11665	11665	‘‘(E) L
11666	11666	IMITATION TO BUSINESS ASSOCI -22
11667	11667	ATES.—A group health plan receiving a report 23
11668	11668	under paragraph (1) may disclose such informa-24
11669	11669	tion only to the entity from which the report 25
11670	11670	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00396 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11671	11671	TKELLEY on LAP7H3WLY3PROD with BILLS 397
11672	11672	•S 891 IS
11673	11673	was received or to that entity’s business associ-1
11674	11674	ates as defined in section 160.103 of title 45, 2
11675	11675	Code of Federal Regulations (or successor regu-3
11676	11676	lations) or as permitted by the HIPAA privacy 4
11677	11677	regulations. 5
11678	11678	‘‘(F) C
11679	11679	LARIFICATION REGARDING PUBLIC 6
11680	11680	DISCLOSURE OF INFORMATION .—Nothing in 7
11681	11681	this section shall prevent an entity providing 8
11682	11682	pharmacy benefit management services on be-9
11683	11683	half of a group health plan or health insurance 10
11684	11684	issuer offering group health insurance coverage, 11
11685	11685	from placing reasonable restrictions on the pub-12
11686	11686	lic disclosure of the information contained in a 13
11687	11687	report described in paragraph (1), except that 14
11688	11688	such plan, issuer, or entity may not— 15
11689	11689	‘‘(i) restrict disclosure of such report 16
11690	11690	to the Department of Health and Human 17
11691	11691	Services, the Department of Labor, or the 18
11692	11692	Department of the Treasury; or 19
11693	11693	‘‘(ii) prevent disclosure for the pur-20
11694	11694	poses of subsection (c), or any other public 21
11695	11695	disclosure requirement under this section. 22
11696	11696	‘‘(G) L
11697	11697	IMITED FORM OF REPORT .—The 23
11698	11698	Secretary shall define through rulemaking a 24
11699	11699	limited form of the report under paragraph (1) 25
11700	11700	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00397 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11701	11701	TKELLEY on LAP7H3WLY3PROD with BILLS 398
11702	11702	•S 891 IS
11703	11703	required with respect to any group health plan 1
11704	11704	established by a plan sponsor that is, or is af-2
11705	11705	filiated with, a drug manufacturer, drug whole-3
11706	11706	saler, or other direct participant in the drug 4
11707	11707	supply chain, in order to prevent anti-competi-5
11708	11708	tive behavior. 6
11709	11709	‘‘(5) S
11710	11710	TANDARD FORMAT AND REGULATIONS .— 7
11711	11711	‘‘(A) I
11712	11712	N GENERAL.—Not later than 18 8
11713	11713	months after the date of enactment of this sec-9
11714	11714	tion, the Secretary shall specify through rule-10
11715	11715	making a standard format for entities providing 11
11716	11716	pharmacy benefit management services on be-12
11717	11717	half of group health plans and health insurance 13
11718	11718	issuers offering group health insurance cov-14
11719	11719	erage, to submit reports required under para-15
11720	11720	graph (1). 16
11721	11721	‘‘(B) A
11722	11722	DDITIONAL REGULATIONS .—Not 17
11723	11723	later than 18 months after the date of enact-18
11724	11724	ment of this section, the Secretary shall, 19
11725	11725	through rulemaking, promulgate any other final 20
11726	11726	regulations necessary to implement the require-21
11727	11727	ments of this section. In promulgating such 22
11728	11728	regulations, the Secretary shall, to the extent 23
11729	11729	practicable, align the reporting requirements 24
11730	11730	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00398 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11731	11731	TKELLEY on LAP7H3WLY3PROD with BILLS 399
11732	11732	•S 891 IS
11733	11733	under this section with the reporting require-1
11734	11734	ments under section 2799A–10. 2
11735	11735	‘‘(c) R
11736	11736	EQUIREMENTTOPROVIDEINFORMATION TO 3
11737	11737	P
11738	11738	ARTICIPANTS ORBENEFICIARIES.—A group health plan, 4
11739	11739	including with respect to group health insurance coverage 5
11740	11740	offered in connection with a group health plan, upon re-6
11741	11741	quest of a participant or beneficiary, shall provide to such 7
11742	11742	participant or beneficiary— 8
11743	11743	‘‘(1) the summary document described in sub-9
11744	11744	section (b)(2)(B)(ii); and 10
11745	11745	‘‘(2) the information described in subsection 11
11746	11746	(b)(2)(A)(i)(III) with respect to a claim made by or 12
11747	11747	on behalf of such participant or beneficiary. 13
11748	11748	‘‘(d) E
11749	11749	NFORCEMENT.— 14
11750	11750	‘‘(1) I
11751	11751	N GENERAL.—The Secretary shall enforce 15
11752	11752	this section. The enforcement authority under this 16
11753	11753	subsection shall apply only with respect to group 17
11754	11754	health plans (including group health insurance cov-18
11755	11755	erage offered in connection with such a plan) to 19
11756	11756	which the requirements of subparts I and II of part 20
11757	11757	A and part D apply in accordance with section 2722, 21
11758	11758	and with respect to entities providing pharmacy ben-22
11759	11759	efit management services on behalf of such plans 23
11760	11760	and applicable entities providing services on behalf 24
11761	11761	of such plans. 25
11762	11762	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00399 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11763	11763	TKELLEY on LAP7H3WLY3PROD with BILLS 400
11764	11764	•S 891 IS
11765	11765	‘‘(2) FAILURE TO PROVIDE INFORMATION .—A 1
11766	11766	group health plan, a health insurance issuer offering 2
11767	11767	group health insurance coverage, an entity providing 3
11768	11768	pharmacy benefit management services on behalf of 4
11769	11769	such a plan or issuer, or an applicable entity pro-5
11770	11770	viding services on behalf of such a plan or issuer 6
11771	11771	that violates subsection (a); an entity providing 7
11772	11772	pharmacy benefit management services on behalf of 8
11773	11773	such a plan or issuer that fails to provide the infor-9
11774	11774	mation required under subsection (b); or a group 10
11775	11775	health plan that fails to provide the information re-11
11776	11776	quired under subsection (c), shall be subject to a 12
11777	11777	civil monetary penalty in the amount of $10,000 for 13
11778	11778	each day during which such violation continues or 14
11779	11779	such information is not disclosed or reported. 15
11780	11780	‘‘(3) F
11781	11781	ALSE INFORMATION.—A health insurance 16
11782	11782	issuer, an entity providing pharmacy benefit man-17
11783	11783	agement services, or a third party administrator pro-18
11784	11784	viding services on behalf of such issuer offered by a 19
11785	11785	health insurance issuer that knowingly provides false 20
11786	11786	information under this section shall be subject to a 21
11787	11787	civil monetary penalty in an amount not to exceed 22
11788	11788	$100,000 for each item of false information. Such 23
11789	11789	civil monetary penalty shall be in addition to other 24
11790	11790	penalties as may be prescribed by law. 25
11791	11791	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00400 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11792	11792	TKELLEY on LAP7H3WLY3PROD with BILLS 401
11793	11793	•S 891 IS
11794	11794	‘‘(4) PROCEDURE.—The provisions of section 1
11795	11795	1128A of the Social Security Act, other than sub-2
11796	11796	sections (a) and (b) and the first sentence of sub-3
11797	11797	section (c)(1) of such section shall apply to civil 4
11798	11798	monetary penalties under this subsection in the 5
11799	11799	same manner as such provisions apply to a penalty 6
11800	11800	or proceeding under such section. 7
11801	11801	‘‘(5) W
11802	11802	AIVERS.—The Secretary may waive pen-8
11803	11803	alties under paragraph (2), or extend the period of 9
11804	11804	time for compliance with a requirement of this sec-10
11805	11805	tion, for an entity in violation of this section that 11
11806	11806	has made a good-faith effort to comply with the re-12
11807	11807	quirements in this section. 13
11808	11808	‘‘(e) R
11809	11809	ULE OFCONSTRUCTION.—Nothing in this sec-14
11810	11810	tion shall be construed to permit a health insurance issuer, 15
11811	11811	group health plan, entity providing pharmacy benefit man-16
11812	11812	agement services on behalf of a group health plan or 17
11813	11813	health insurance issuer, or other entity to restrict disclo-18
11814	11814	sure to, or otherwise limit the access of, the Secretary to 19
11815	11815	a report described in subsection (b)(1) or information re-20
11816	11816	lated to compliance with subsections (a), (b), (c), or (d) 21
11817	11817	by such issuer, plan, or entity. 22
11818	11818	‘‘(f) D
11819	11819	EFINITIONS.—In this section: 23
11820	11820	‘‘(1) A
11821	11821	PPLICABLE ENTITY.—The term ‘applica-24
11822	11822	ble entity’ means— 25
11823	11823	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00401 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11824	11824	TKELLEY on LAP7H3WLY3PROD with BILLS 402
11825	11825	•S 891 IS
11826	11826	‘‘(A) an applicable group purchasing orga-1
11827	11827	nization, drug manufacturer, distributor, whole-2
11828	11828	saler, rebate aggregator (or other purchasing 3
11829	11829	entity designed to aggregate rebates), or associ-4
11830	11830	ated third party; 5
11831	11831	‘‘(B) any subsidiary, parent, affiliate, or 6
11832	11832	subcontractor of a group health plan, health in-7
11833	11833	surance issuer, entity that provides pharmacy 8
11834	11834	benefit management services on behalf of such 9
11835	11835	a plan or issuer, or any entity described in sub-10
11836	11836	paragraph (A); or 11
11837	11837	‘‘(C) such other entity as the Secretary 12
11838	11838	may specify through rulemaking. 13
11839	11839	‘‘(2) A
11840	11840	PPLICABLE GROUP PURCHASING ORGANI -14
11841	11841	ZATION.—The term ‘applicable group purchasing or-15
11842	11842	ganization’ means a group purchasing organization 16
11843	11843	that is affiliated with or under common ownership 17
11844	11844	with an entity providing pharmacy benefit manage-18
11845	11845	ment services. 19
11846	11846	‘‘(3) C
11847	11847	ONTRACTED COMPENSATION .—The term 20
11848	11848	‘contracted compensation’ means the sum of any in-21
11849	11849	gredient cost and dispensing fee for a drug (inclusive 22
11850	11850	of the out-of-pocket costs to the participant or bene-23
11851	11851	ficiary), or another analogous compensation struc-24
11852	11852	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00402 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11853	11853	TKELLEY on LAP7H3WLY3PROD with BILLS 403
11854	11854	•S 891 IS
11855	11855	ture that the Secretary may specify through regula-1
11856	11856	tions. 2
11857	11857	‘‘(4) G
11858	11858	ROSS SPENDING .—The term ‘gross 3
11859	11859	spending’, with respect to prescription drug benefits 4
11860	11860	under a group health plan or health insurance cov-5
11861	11861	erage, means the amount spent by a group health 6
11862	11862	plan or health insurance issuer on prescription drug 7
11863	11863	benefits, calculated before the application of rebates, 8
11864	11864	fees, alternative discounts, or other remuneration. 9
11865	11865	‘‘(5) N
11866	11866	ET SPENDING.—The term ‘net spending’, 10
11867	11867	with respect to prescription drug benefits under a 11
11868	11868	group health plan or health insurance coverage, 12
11869	11869	means the amount spent by a group health plan or 13
11870	11870	health insurance issuer on prescription drug bene-14
11871	11871	fits, calculated after the application of rebates, fees, 15
11872	11872	alternative discounts, or other remuneration. 16
11873	11873	‘‘(6) P
11874	11874	LAN SPONSOR.—The term ‘plan sponsor’ 17
11875	11875	has the meaning given such term in section 3(16)(B) 18
11876	11876	of the Employee Retirement Income Security Act of 19
11877	11877	1974. 20
11878	11878	‘‘(7) R
11879	11879	EMUNERATION.—The term ‘remunera-21
11880	11880	tion’ has the meaning given such term by the Sec-22
11881	11881	retary through rulemaking, which shall be reevalu-23
11882	11882	ated by the Secretary every 5 years. 24
11883	11883	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00403 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11884	11884	TKELLEY on LAP7H3WLY3PROD with BILLS 404
11885	11885	•S 891 IS
11886	11886	‘‘(8) SPECIFIED LARGE EMPLOYER .—The term 1
11887	11887	‘specified large employer’ means, in connection with 2
11888	11888	a group health plan (including group health insur-3
11889	11889	ance coverage offered in connection with such a 4
11890	11890	plan) established or maintained by a single em-5
11891	11891	ployer, with respect to a calendar year or a plan 6
11892	11892	year, as applicable, an employer who employed an 7
11893	11893	average of at least 100 employees on business days 8
11894	11894	during the preceding calendar year or plan year and 9
11895	11895	who employs at least 1 employee on the first day of 10
11896	11896	the calendar year or plan year. 11
11897	11897	‘‘(9) S
11898	11898	PECIFIED LARGE PLAN.—The term ‘spec-12
11899	11899	ified large plan’ means a group health plan (includ-13
11900	11900	ing group health insurance coverage offered in con-14
11901	11901	nection with such a plan) established or maintained 15
11902	11902	by a plan sponsor described in clause (ii) or (iii) of 16
11903	11903	section 3(16)(B) of the Employee Retirement In-17
11904	11904	come Security Act of 1974 that had an average of 18
11905	11905	at least 100 participants on business days during 19
11906	11906	the preceding calendar year or plan year, as applica-20
11907	11907	ble. 21
11908	11908	‘‘(10) W
11909	11909	HOLESALE ACQUISITION COST .—The 22
11910	11910	term ‘wholesale acquisition cost’ has the meaning 23
11911	11911	given such term in section 1847A(c)(6)(B) of the 24
11912	11912	Social Security Act.’’; and 25
11913	11913	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00404 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11914	11914	TKELLEY on LAP7H3WLY3PROD with BILLS 405
11915	11915	•S 891 IS
11916	11916	(2) in section 2723 (42 U.S.C. 300gg–22)— 1
11917	11917	(A) in subsection (a)— 2
11918	11918	(i) in paragraph (1), by inserting 3
11919	11919	‘‘(other than section 2799A–11)’’ after 4
11920	11920	‘‘part D’’; and 5
11921	11921	(ii) in paragraph (2), by inserting 6
11922	11922	‘‘(other than section 2799A–11)’’ after 7
11923	11923	‘‘part D’’; and 8
11924	11924	(B) in subsection (b)— 9
11925	11925	(i) in paragraph (1), by inserting 10
11926	11926	‘‘(other than section 2799A–11)’’ after 11
11927	11927	‘‘part D’’; 12
11928	11928	(ii) in paragraph (2)(A), by inserting 13
11929	11929	‘‘(other than section 2799A–11)’’ after 14
11930	11930	‘‘part D’’; and 15
11931	11931	(iii) in paragraph (2)(C)(ii), by insert-16
11932	11932	ing ‘‘(other than section 2799A–11)’’ after 17
11933	11933	‘‘part D’’. 18
11934	11934	(b) E
11935	11935	MPLOYEERETIREMENTINCOMESECURITYACT 19
11936	11936	OF1974.— 20
11937	11937	(1) I
11938	11938	N GENERAL.—Subtitle B of title I of the 21
11939	11939	Employee Retirement Income Security Act of 1974 22
11940	11940	(29 U.S.C. 1021 et seq.) is amended— 23
11941	11941	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00405 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11942	11942	TKELLEY on LAP7H3WLY3PROD with BILLS 406
11943	11943	•S 891 IS
11944	11944	(A) in subpart B of part 7 (29 U.S.C. 1
11945	11945	1185 et seq.), by adding at the end the fol-2
11946	11946	lowing: 3
11947	11947	‘‘SEC. 726. OVERSIGHT OF ENTITIES THAT PROVIDE PHAR-4
11948	11948	MACY BENEFIT MANAGEMENT SERVICES. 5
11949	11949	‘‘(a) I
11950	11950	NGENERAL.—For plan years beginning on or 6
11951	11951	after the date that is 30 months after the date of enact-7
11952	11952	ment of this section (referred to in this subsection and 8
11953	11953	subsection (b) as the ‘effective date’), a group health plan 9
11954	11954	or a health insurance issuer offering group health insur-10
11955	11955	ance coverage, or an entity providing pharmacy benefit 11
11956	11956	management services on behalf of such a plan or issuer, 12
11957	11957	shall not enter into a contract, including an extension or 13
11958	11958	renewal of a contract, entered into on or after the effective 14
11959	11959	date, with an applicable entity unless such applicable enti-15
11960	11960	ty agrees to— 16
11961	11961	‘‘(1) not limit or delay the disclosure of infor-17
11962	11962	mation to the group health plan (including such a 18
11963	11963	plan offered through a health insurance issuer) in 19
11964	11964	such a manner that prevents an entity providing 20
11965	11965	pharmacy benefit management services on behalf of 21
11966	11966	a group health plan or health insurance issuer offer-22
11967	11967	ing group health insurance coverage from making 23
11968	11968	the reports described in subsection (b); and 24
11969	11969	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00406 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
11970	11970	TKELLEY on LAP7H3WLY3PROD with BILLS 407
11971	11971	•S 891 IS
11972	11972	‘‘(2) provide the entity providing pharmacy ben-1
11973	11973	efit management services on behalf of a group health 2
11974	11974	plan or health insurance issuer relevant information 3
11975	11975	necessary to make the reports described in sub-4
11976	11976	section (b). 5
11977	11977	‘‘(b) R
11978	11978	EPORTS.— 6
11979	11979	‘‘(1) I
11980	11980	N GENERAL.—For plan years beginning 7
11981	11981	on or after the effective date, in the case of any con-8
11982	11982	tract between a group health plan or a health insur-9
11983	11983	ance issuer offering group health insurance coverage 10
11984	11984	offered in connection with such a plan and an entity 11
11985	11985	providing pharmacy benefit management services on 12
11986	11986	behalf of such plan or issuer, including an extension 13
11987	11987	or renewal of such a contract, entered into on or 14
11988	11988	after the effective date, the entity providing phar-15
11989	11989	macy benefit management services on behalf of such 16
11990	11990	a group health plan or health insurance issuer, not 17
11991	11991	less frequently than every 6 months (or, at the re-18
11992	11992	quest of a group health plan, not less frequently 19
11993	11993	than quarterly, and under the same conditions, 20
11994	11994	terms, and cost of the semiannual report under this 21
11995	11995	subsection), shall submit to the group health plan a 22
11996	11996	report in accordance with this section. Each such re-23
11997	11997	port shall be made available to such group health 24
11998	11998	plan in plain language, in a machine-readable for-25
11999	11999	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00407 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12000	12000	TKELLEY on LAP7H3WLY3PROD with BILLS 408
12001	12001	•S 891 IS
12002	12002	mat, and as the Secretary may determine, other for-1
12003	12003	mats. Each such report shall include the information 2
12004	12004	described in paragraph (2). 3
12005	12005	‘‘(2) I
12006	12006	NFORMATION DESCRIBED .—For purposes 4
12007	12007	of paragraph (1), the information described in this 5
12008	12008	paragraph is, with respect to drugs covered by a 6
12009	12009	group health plan or group health insurance cov-7
12010	12010	erage offered by a health insurance issuer in connec-8
12011	12011	tion with a group health plan during each reporting 9
12012	12012	period— 10
12013	12013	‘‘(A) in the case of a group health plan 11
12014	12014	that is offered by a specified large employer or 12
12015	12015	that is a specified large plan, and is not offered 13
12016	12016	as health insurance coverage, or in the case of 14
12017	12017	health insurance coverage for which the election 15
12018	12018	under paragraph (3) is made for the applicable 16
12019	12019	reporting period— 17
12020	12020	‘‘(i) a list of drugs for which a claim 18
12021	12021	was filed and, with respect to each such 19
12022	12022	drug on such list— 20
12023	12023	‘‘(I) the contracted compensation 21
12024	12024	paid by the group health plan or 22
12025	12025	health insurance issuer for each cov-23
12026	12026	ered drug (identified by the National 24
12027	12027	Drug Code) to the entity providing 25
12028	12028	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00408 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12029	12029	TKELLEY on LAP7H3WLY3PROD with BILLS 409
12030	12030	•S 891 IS
12031	12031	pharmacy benefit management serv-1
12032	12032	ices or other applicable entity on be-2
12033	12033	half of the group health plan or health 3
12034	12034	insurance issuer; 4
12035	12035	‘‘(II) the contracted compensa-5
12036	12036	tion paid to the pharmacy, by any en-6
12037	12037	tity providing pharmacy benefit man-7
12038	12038	agement services or other applicable 8
12039	12039	entity on behalf of the group health 9
12040	12040	plan or health insurance issuer, for 10
12041	12041	each covered drug (identified by the 11
12042	12042	National Drug Code); 12
12043	12043	‘‘(III) for each such claim, the 13
12044	12044	difference between the amount paid 14
12045	12045	under subclause (I) and the amount 15
12046	12046	paid under subclause (II); 16
12047	12047	‘‘(IV) the proprietary name, es-17
12048	12048	tablished name or proper name, and 18
12049	12049	the National Drug Code; 19
12050	12050	‘‘(V) for each claim for the drug 20
12051	12051	(including original prescriptions and 21
12052	12052	refills) and for each dosage unit of the 22
12053	12053	drug for which a claim was filed, the 23
12054	12054	type of dispensing channel used to 24
12055	12055	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00409 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12056	12056	TKELLEY on LAP7H3WLY3PROD with BILLS 410
12057	12057	•S 891 IS
12058	12058	furnish the drug, including retail, mail 1
12059	12059	order, or specialty pharmacy; 2
12060	12060	‘‘(VI) with respect to each drug 3
12061	12061	dispensed, for each type of dispensing 4
12062	12062	channel (including retail, mail order, 5
12063	12063	or specialty pharmacy)— 6
12064	12064	‘‘(aa) whether such drug is a 7
12065	12065	brand name drug or a generic 8
12066	12066	drug, and— 9
12067	12067	‘‘(AA) in the case of a 10
12068	12068	brand name drug, the whole-11
12069	12069	sale acquisition cost, listed 12
12070	12070	as cost per days supply and 13
12071	12071	cost per dosage unit, on the 14
12072	12072	date such drug was dis-15
12073	12073	pensed; and 16
12074	12074	‘‘(BB) in the case of a 17
12075	12075	generic drug, the average 18
12076	12076	wholesale price, listed as 19
12077	12077	cost per days supply and 20
12078	12078	cost per dosage unit, on the 21
12079	12079	date such drug was dis-22
12080	12080	pensed; and 23
12081	12081	‘‘(bb) the total number of— 24
12082	12082	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00410 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12083	12083	TKELLEY on LAP7H3WLY3PROD with BILLS 411
12084	12084	•S 891 IS
12085	12085	‘‘(AA) prescription 1
12086	12086	claims (including original 2
12087	12087	prescriptions and refills); 3
12088	12088	‘‘(BB) participants and 4
12089	12089	beneficiaries for whom a 5
12090	12090	claim for such drug was 6
12091	12091	filed through the applicable 7
12092	12092	dispensing channel; 8
12093	12093	‘‘(CC) dosage units and 9
12094	12094	dosage units per fill of such 10
12095	12095	drug; and 11
12096	12096	‘‘(DD) days supply of 12
12097	12097	such drug per fill; 13
12098	12098	‘‘(VII) the net price per course of 14
12099	12099	treatment or single fill, such as a 30- 15
12100	12100	day supply or 90-day supply to the 16
12101	12101	plan or coverage after rebates, fees, 17
12102	12102	alternative discounts, or other remu-18
12103	12103	neration received from applicable enti-19
12104	12104	ties; 20
12105	12105	‘‘(VIII) the total amount of out- 21
12106	12106	of-pocket spending by participants 22
12107	12107	and beneficiaries on such drug, in-23
12108	12108	cluding spending through copayments, 24
12109	12109	coinsurance, and deductibles, but not 25
12110	12110	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00411 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12111	12111	TKELLEY on LAP7H3WLY3PROD with BILLS 412
12112	12112	•S 891 IS
12113	12113	including any amounts spent by par-1
12114	12114	ticipants and beneficiaries on drugs 2
12115	12115	not covered under the plan or cov-3
12116	12116	erage, or for which no claim is sub-4
12117	12117	mitted under the plan or coverage; 5
12118	12118	‘‘(IX) the total net spending on 6
12119	12119	the drug; 7
12120	12120	‘‘(X) the total amount received, 8
12121	12121	or expected to be received, by the plan 9
12122	12122	or issuer from any applicable entity in 10
12123	12123	rebates, fees, alternative discounts, or 11
12124	12124	other remuneration; 12
12125	12125	‘‘(XI) the total amount received, 13
12126	12126	or expected to be received, by the enti-14
12127	12127	ty providing pharmacy benefit man-15
12128	12128	agement services, from applicable en-16
12129	12129	tities, in rebates, fees, alternative dis-17
12130	12130	counts, or other remuneration from 18
12131	12131	such entities— 19
12132	12132	‘‘(aa) for claims incurred 20
12133	12133	during the reporting period; and 21
12134	12134	‘‘(bb) that is related to utili-22
12135	12135	zation of such drug or spending 23
12136	12136	on such drug; and 24
12137	12137	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00412 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12138	12138	TKELLEY on LAP7H3WLY3PROD with BILLS 413
12139	12139	•S 891 IS
12140	12140	‘‘(XII) to the extent feasible, in-1
12141	12141	formation on the total amount of re-2
12142	12142	muneration for such drug, including 3
12143	12143	copayment assistance dollars paid, co-4
12144	12144	payment cards applied, or other dis-5
12145	12145	counts provided by each drug manu-6
12146	12146	facturer (or entity administering co-7
12147	12147	payment assistance on behalf of such 8
12148	12148	drug manufacturer), to the partici-9
12149	12149	pants and beneficiaries enrolled in 10
12150	12150	such plan or coverage; 11
12151	12151	‘‘(ii) a list of each therapeutic class 12
12152	12152	(as defined by the Secretary) for which a 13
12153	12153	claim was filed under the group health 14
12154	12154	plan or health insurance coverage during 15
12155	12155	the reporting period, and, with respect to 16
12156	12156	each such therapeutic class— 17
12157	12157	‘‘(I) the total gross spending on 18
12158	12158	drugs in such class before rebates, 19
12159	12159	price concessions, alternative dis-20
12160	12160	counts, or other remuneration from 21
12161	12161	applicable entities; 22
12162	12162	‘‘(II) the net spending in such 23
12163	12163	class after such rebates, price conces-24
12164	12164	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00413 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12165	12165	TKELLEY on LAP7H3WLY3PROD with BILLS 414
12166	12166	•S 891 IS
12167	12167	sions, alternative discounts, or other 1
12168	12168	remuneration from applicable entities; 2
12169	12169	‘‘(III) the total amount received, 3
12170	12170	or expected to be received, by the enti-4
12171	12171	ty providing pharmacy benefit man-5
12172	12172	agement services, from applicable en-6
12173	12173	tities, in rebates, fees, alternative dis-7
12174	12174	counts, or other remuneration from 8
12175	12175	such entities— 9
12176	12176	‘‘(aa) for claims incurred 10
12177	12177	during the reporting period; and 11
12178	12178	‘‘(bb) that is related to utili-12
12179	12179	zation of drugs or drug spending; 13
12180	12180	‘‘(IV) the average net spending 14
12181	12181	per 30-day supply and per 90-day 15
12182	12182	supply by the plan or by the issuer 16
12183	12183	with respect to such coverage and its 17
12184	12184	participants and beneficiaries, among 18
12185	12185	all drugs within the therapeutic class 19
12186	12186	for which a claim was filed during the 20
12187	12187	reporting period; 21
12188	12188	‘‘(V) the number of participants 22
12189	12189	and beneficiaries who filled a prescrip-23
12190	12190	tion for a drug in such class, includ-24
12191	12191	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00414 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12192	12192	TKELLEY on LAP7H3WLY3PROD with BILLS 415
12193	12193	•S 891 IS
12194	12194	ing the National Drug Code for each 1
12195	12195	such drug; 2
12196	12196	‘‘(VI) if applicable, a description 3
12197	12197	of the formulary tiers and utilization 4
12198	12198	mechanisms (such as prior authoriza-5
12199	12199	tion or step therapy) employed for 6
12200	12200	drugs in that class; and 7
12201	12201	‘‘(VII) the total out-of-pocket 8
12202	12202	spending under the plan or coverage 9
12203	12203	by participants and beneficiaries, in-10
12204	12204	cluding spending through copayments, 11
12205	12205	coinsurance, and deductibles, but not 12
12206	12206	including any amounts spent by par-13
12207	12207	ticipants and beneficiaries on drugs 14
12208	12208	not covered under the plan or cov-15
12209	12209	erage or for which no claim is sub-16
12210	12210	mitted under the plan or coverage; 17
12211	12211	‘‘(iii) with respect to any drug for 18
12212	12212	which gross spending under the group 19
12213	12213	health plan or health insurance coverage 20
12214	12214	exceeded $10,000 during the reporting pe-21
12215	12215	riod or, in the case that gross spending 22
12216	12216	under the group health plan or coverage 23
12217	12217	exceeded $10,000 during the reporting pe-24
12218	12218	riod with respect to fewer than 50 drugs, 25
12219	12219	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00415 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12220	12220	TKELLEY on LAP7H3WLY3PROD with BILLS 416
12221	12221	•S 891 IS
12222	12222	with respect to the 50 prescription drugs 1
12223	12223	with the highest spending during the re-2
12224	12224	porting period— 3
12225	12225	‘‘(I) a list of all other drugs in 4
12226	12226	the same therapeutic class as such 5
12227	12227	drug; 6
12228	12228	‘‘(II) if applicable, the rationale 7
12229	12229	for the formulary placement of such 8
12230	12230	drug in that therapeutic category or 9
12231	12231	class, selected from a list of standard 10
12232	12232	rationales established by the Sec-11
12233	12233	retary, in consultation with stake-12
12234	12234	holders; and 13
12235	12235	‘‘(III) any change in formulary 14
12236	12236	placement compared to the prior plan 15
12237	12237	year; and 16
12238	12238	‘‘(iv) in the case that such plan or 17
12239	12239	issuer (or an entity providing pharmacy 18
12240	12240	benefit management services on behalf of 19
12241	12241	such plan or issuer) has an affiliated phar-20
12242	12242	macy or pharmacy under common owner-21
12243	12243	ship, including mandatory mail and spe-22
12244	12244	cialty home delivery programs, retail and 23
12245	12245	mail auto-refill programs, and cost sharing 24
12246	12246	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00416 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12247	12247	TKELLEY on LAP7H3WLY3PROD with BILLS 417
12248	12248	•S 891 IS
12249	12249	assistance incentives funded by an entity 1
12250	12250	providing pharmacy benefit services— 2
12251	12251	‘‘(I) an explanation of any ben-3
12252	12252	efit design parameters that encourage 4
12253	12253	or require participants and bene-5
12254	12254	ficiaries in the plan or coverage to fill 6
12255	12255	prescriptions at mail order, specialty, 7
12256	12256	or retail pharmacies; 8
12257	12257	‘‘(II) the percentage of total pre-9
12258	12258	scriptions dispensed by such phar-10
12259	12259	macies to participants or beneficiaries 11
12260	12260	in such plan or coverage; and 12
12261	12261	‘‘(III) a list of all drugs dis-13
12262	12262	pensed by such pharmacies to partici-14
12263	12263	pants or beneficiaries enrolled in such 15
12264	12264	plan or coverage, and, with respect to 16
12265	12265	each drug dispensed— 17
12266	12266	‘‘(aa) the amount charged, 18
12267	12267	per dosage unit, per 30-day sup-19
12268	12268	ply, or per 90-day supply (as ap-20
12269	12269	plicable) to the plan or issuer, 21
12270	12270	and to participants and bene-22
12271	12271	ficiaries; 23
12272	12272	‘‘(bb) the median amount 24
12273	12273	charged to such plan or issuer, 25
12274	12274	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00417 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12275	12275	TKELLEY on LAP7H3WLY3PROD with BILLS 418
12276	12276	•S 891 IS
12277	12277	and the interquartile range of the 1
12278	12278	costs, per dosage unit, per 30- 2
12279	12279	day supply, and per 90-day sup-3
12280	12280	ply, including amounts paid by 4
12281	12281	the participants and bene-5
12282	12282	ficiaries, when the same drug is 6
12283	12283	dispensed by other pharmacies 7
12284	12284	that are not affiliated with or 8
12285	12285	under common ownership with 9
12286	12286	the entity and that are included 10
12287	12287	in the pharmacy network of such 11
12288	12288	plan or coverage; 12
12289	12289	‘‘(cc) the lowest cost per 13
12290	12290	dosage unit, per 30-day supply 14
12291	12291	and per 90-day supply, for each 15
12292	12292	such drug, including amounts 16
12293	12293	charged to the plan or coverage 17
12294	12294	and to participants and bene-18
12295	12295	ficiaries, that is available from 19
12296	12296	any pharmacy included in the 20
12297	12297	network of such plan or coverage; 21
12298	12298	and 22
12299	12299	‘‘(dd) the net acquisition 23
12300	12300	cost per dosage unit, per 30-day 24
12301	12301	supply, and per 90-day supply, if 25
12302	12302	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00418 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12303	12303	TKELLEY on LAP7H3WLY3PROD with BILLS 419
12304	12304	•S 891 IS
12305	12305	such drug is subject to a max-1
12306	12306	imum price discount; and 2
12307	12307	‘‘(B) with respect to any group health 3
12308	12308	plan, including group health insurance coverage 4
12309	12309	offered in connection with such a plan, regard-5
12310	12310	less of whether the plan or coverage is offered 6
12311	12311	by a specified large employer or whether it is a 7
12312	12312	specified large plan— 8
12313	12313	‘‘(i) a summary document for the 9
12314	12314	group health plan that includes such infor-10
12315	12315	mation described in clauses (i) through (iv) 11
12316	12316	of subparagraph (A), as specified by the 12
12317	12317	Secretary through guidance, program in-13
12318	12318	struction, or otherwise (with no require-14
12319	12319	ment of notice and comment rulemaking), 15
12320	12320	that the Secretary determines useful to 16
12321	12321	group health plans for purposes of select-17
12322	12322	ing pharmacy benefit management serv-18
12323	12323	ices, such as an estimated net price to 19
12324	12324	group health plan and participant or bene-20
12325	12325	ficiary, a cost per claim, the fee structure 21
12326	12326	or reimbursement model, and estimated 22
12327	12327	cost per participant or beneficiary; 23
12328	12328	‘‘(ii) a summary document for plans 24
12329	12329	and issuers to provide to participants and 25
12330	12330	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00419 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12331	12331	TKELLEY on LAP7H3WLY3PROD with BILLS 420
12332	12332	•S 891 IS
12333	12333	beneficiaries, which shall be made available 1
12334	12334	to participants or beneficiaries upon re-2
12335	12335	quest to their group health plan (including 3
12336	12336	in the case of group health insurance cov-4
12337	12337	erage offered in connection with such a 5
12338	12338	plan), that— 6
12339	12339	‘‘(I) contains such information 7
12340	12340	described in clauses (iii), (iv), (v), and 8
12341	12341	(vi), as applicable, as specified by the 9
12342	12342	Secretary through guidance, program 10
12343	12343	instruction, or otherwise (with no re-11
12344	12344	quirement of notice and comment 12
12345	12345	rulemaking) that the Secretary deter-13
12346	12346	mines useful to participants or bene-14
12347	12347	ficiaries in better understanding the 15
12348	12348	plan or coverage or benefits under 16
12349	12349	such plan or coverage; 17
12350	12350	‘‘(II) contains only aggregate in-18
12351	12351	formation; and 19
12352	12352	‘‘(III) states that participants 20
12353	12353	and beneficiaries may request specific, 21
12354	12354	claims-level information required to be 22
12355	12355	furnished under subsection (c) from 23
12356	12356	the group health plan or health insur-24
12357	12357	ance issuer; and 25
12358	12358	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00420 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12359	12359	TKELLEY on LAP7H3WLY3PROD with BILLS 421
12360	12360	•S 891 IS
12361	12361	‘‘(iii) with respect to drugs covered by 1
12362	12362	such plan or coverage during such report-2
12363	12363	ing period— 3
12364	12364	‘‘(I) the total net spending by the 4
12365	12365	plan or coverage for all such drugs; 5
12366	12366	‘‘(II) the total amount received, 6
12367	12367	or expected to be received, by the plan 7
12368	12368	or issuer from any applicable entity in 8
12369	12369	rebates, fees, alternative discounts, or 9
12370	12370	other remuneration; and 10
12371	12371	‘‘(III) to the extent feasible, in-11
12372	12372	formation on the total amount of re-12
12373	12373	muneration for such drugs, including 13
12374	12374	copayment assistance dollars paid, co-14
12375	12375	payment cards applied, or other dis-15
12376	12376	counts provided by each drug manu-16
12377	12377	facturer (or entity administering co-17
12378	12378	payment assistance on behalf of such 18
12379	12379	drug manufacturer) to participants 19
12380	12380	and beneficiaries; 20
12381	12381	‘‘(iv) amounts paid directly or indi-21
12382	12382	rectly in rebates, fees, or any other type of 22
12383	12383	compensation (as defined in section 23
12384	12384	408(b)(2)(B)(ii)(dd)(AA)) to brokerage 24
12385	12385	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00421 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12386	12386	TKELLEY on LAP7H3WLY3PROD with BILLS 422
12387	12387	•S 891 IS
12388	12388	firms, brokers, consultants, advisors, or 1
12389	12389	any other individual or firm, for— 2
12390	12390	‘‘(I) the referral of the group 3
12391	12391	health plan’s or health insurance 4
12392	12392	issuer’s business to an entity pro-5
12393	12393	viding pharmacy benefit management 6
12394	12394	services, including the identity of the 7
12395	12395	recipient of such amounts; 8
12396	12396	‘‘(II) consideration of the entity 9
12397	12397	providing pharmacy benefit manage-10
12398	12398	ment services by the group health 11
12399	12399	plan or health insurance issuer; or 12
12400	12400	‘‘(III) the retention of the entity 13
12401	12401	by the group health plan or health in-14
12402	12402	surance issuer; 15
12403	12403	‘‘(v) an explanation of any benefit de-16
12404	12404	sign parameters that encourage or require 17
12405	12405	participants and beneficiaries in such plan 18
12406	12406	or coverage to fill prescriptions at mail 19
12407	12407	order, specialty, or retail pharmacies that 20
12408	12408	are affiliated with or under common own-21
12409	12409	ership with the entity providing pharmacy 22
12410	12410	benefit management services under such 23
12411	12411	plan or coverage, including mandatory mail 24
12412	12412	and specialty home delivery programs, re-25
12413	12413	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00422 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12414	12414	TKELLEY on LAP7H3WLY3PROD with BILLS 423
12415	12415	•S 891 IS
12416	12416	tail and mail auto-refill programs, and 1
12417	12417	cost-sharing assistance incentives directly 2
12418	12418	or indirectly funded by such entity; and 3
12419	12419	‘‘(vi) total gross spending on all drugs 4
12420	12420	under the plan or coverage during the re-5
12421	12421	porting period. 6
12422	12422	‘‘(3) O
12423	12423	PT-IN FOR GROUP HEALTH INSURANCE 7
12424	12424	COVERAGE OFFERED BY A SPECIFIED LARGE EM -8
12425	12425	PLOYER OR THAT IS A SPECIFIED LARGE PLAN .—In 9
12426	12426	the case of group health insurance coverage offered 10
12427	12427	in connection with a group health plan that is of-11
12428	12428	fered by a specified large employer or is a specified 12
12429	12429	large plan, such group health plan may, on an an-13
12430	12430	nual basis, for plan years beginning on or after the 14
12431	12431	date that is 30 months after the date of enactment 15
12432	12432	of this section, elect to require an entity providing 16
12433	12433	pharmacy benefit management services on behalf of 17
12434	12434	the health insurance issuer to submit to such group 18
12435	12435	health plan a report that includes all of the informa-19
12436	12436	tion described in paragraph (2)(A), in addition to 20
12437	12437	the information described in paragraph (2)(B). 21
12438	12438	‘‘(4) P
12439	12439	RIVACY REQUIREMENTS .— 22
12440	12440	‘‘(A) I
12441	12441	N GENERAL.—An entity providing 23
12442	12442	pharmacy benefit management services on be-24
12443	12443	half of a group health plan or a health insur-25
12444	12444	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00423 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12445	12445	TKELLEY on LAP7H3WLY3PROD with BILLS 424
12446	12446	•S 891 IS
12447	12447	ance issuer offering group health insurance cov-1
12448	12448	erage shall report information under paragraph 2
12449	12449	(1) in a manner consistent with the privacy reg-3
12450	12450	ulations promulgated under section 13402(a) of 4
12451	12451	the Health Information Technology for Eco-5
12452	12452	nomic and Clinical Health Act (42 U.S.C. 6
12453	12453	17932(a)) and consistent with the privacy regu-7
12454	12454	lations promulgated under the Health Insur-8
12455	12455	ance Portability and Accountability Act of 1996 9
12456	12456	in part 160 and subparts A and E of part 164 10
12457	12457	of title 45, Code of Federal Regulations (or suc-11
12458	12458	cessor regulations) (referred to in this para-12
12459	12459	graph as the ‘HIPAA privacy regulations’) and 13
12460	12460	shall restrict the use and disclosure of such in-14
12461	12461	formation according to such privacy regulations 15
12462	12462	and such HIPAA privacy regulations. 16
12463	12463	‘‘(B) A
12464	12464	DDITIONAL REQUIREMENTS .— 17
12465	12465	‘‘(i) I
12466	12466	N GENERAL.—An entity pro-18
12467	12467	viding pharmacy benefit management serv-19
12468	12468	ices on behalf of a group health plan or 20
12469	12469	health insurance issuer offering group 21
12470	12470	health insurance coverage that submits a 22
12471	12471	report under paragraph (1) shall ensure 23
12472	12472	that such report contains only summary 24
12473	12473	health information, as defined in section 25
12474	12474	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00424 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12475	12475	TKELLEY on LAP7H3WLY3PROD with BILLS 425
12476	12476	•S 891 IS
12477	12477	164.504(a) of title 45, Code of Federal 1
12478	12478	Regulations (or successor regulations). 2
12479	12479	‘‘(ii) R
12480	12480	ESTRICTIONS.—In carrying out 3
12481	12481	this subsection, a group health plan shall 4
12482	12482	comply with section 164.504(f) of title 45, 5
12483	12483	Code of Federal Regulations (or a suc-6
12484	12484	cessor regulation), and a plan sponsor shall 7
12485	12485	act in accordance with the terms of the 8
12486	12486	agreement described in such section. 9
12487	12487	‘‘(C) R
12488	12488	ULE OF CONSTRUCTION .— 10
12489	12489	‘‘(i) Nothing in this section shall be 11
12490	12490	construed to modify the requirements for 12
12491	12491	the creation, receipt, maintenance, or 13
12492	12492	transmission of protected health informa-14
12493	12493	tion under the HIPAA privacy regulations. 15
12494	12494	‘‘(ii) Nothing in this section shall be 16
12495	12495	construed to affect the application of any 17
12496	12496	Federal or State privacy or civil rights law, 18
12497	12497	including the HIPAA privacy regulations, 19
12498	12498	the Genetic Information Nondiscrimination 20
12499	12499	Act of 2008 (Public Law 110–233) (in-21
12500	12500	cluding the amendments made by such 22
12501	12501	Act), the Americans with Disabilities Act 23
12502	12502	of 1990 (42 U.S.C. 12101 et seq.), section 24
12503	12503	504 of the Rehabilitation Act of 1973 (29 25
12504	12504	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00425 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12505	12505	TKELLEY on LAP7H3WLY3PROD with BILLS 426
12506	12506	•S 891 IS
12507	12507	U.S.C. 794), section 1557 of the Patient 1
12508	12508	Protection and Affordable Care Act (42 2
12509	12509	U.S.C. 18116), title VI of the Civil Rights 3
12510	12510	Act of 1964 (42 U.S.C. 2000d), and title 4
12511	12511	VII of the Civil Rights Act of 1964 (42 5
12512	12512	U.S.C. 2000e). 6
12513	12513	‘‘(D) W
12514	12514	RITTEN NOTICE.—Each plan year, 7
12515	12515	group health plans, including with respect to 8
12516	12516	group health insurance coverage offered in con-9
12517	12517	nection with a group health plan, shall provide 10
12518	12518	to each participant or beneficiary written notice 11
12519	12519	informing the participant or beneficiary of the 12
12520	12520	requirement for entities providing pharmacy 13
12521	12521	benefit management services on behalf of the 14
12522	12522	group health plan or health insurance issuer of-15
12523	12523	fering group health insurance coverage to sub-16
12524	12524	mit reports to group health plans under para-17
12525	12525	graph (1), as applicable, which may include in-18
12526	12526	corporating such notification in plan documents 19
12527	12527	provided to the participant or beneficiary, or 20
12528	12528	providing individual notification. 21
12529	12529	‘‘(E) L
12530	12530	IMITATION TO BUSINESS ASSOCI -22
12531	12531	ATES.—A group health plan receiving a report 23
12532	12532	under paragraph (1) may disclose such informa-24
12533	12533	tion only to the entity from which the report 25
12534	12534	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00426 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12535	12535	TKELLEY on LAP7H3WLY3PROD with BILLS 427
12536	12536	•S 891 IS
12537	12537	was received or to that entity’s business associ-1
12538	12538	ates as defined in section 160.103 of title 45, 2
12539	12539	Code of Federal Regulations (or successor regu-3
12540	12540	lations) or as permitted by the HIPAA privacy 4
12541	12541	regulations. 5
12542	12542	‘‘(F) C
12543	12543	LARIFICATION REGARDING PUBLIC 6
12544	12544	DISCLOSURE OF INFORMATION .—Nothing in 7
12545	12545	this section shall prevent an entity providing 8
12546	12546	pharmacy benefit management services on be-9
12547	12547	half of a group health plan or health insurance 10
12548	12548	issuer offering group health insurance coverage, 11
12549	12549	from placing reasonable restrictions on the pub-12
12550	12550	lic disclosure of the information contained in a 13
12551	12551	report described in paragraph (1), except that 14
12552	12552	such plan, issuer, or entity may not— 15
12553	12553	‘‘(i) restrict disclosure of such report 16
12554	12554	to the Department of Health and Human 17
12555	12555	Services, the Department of Labor, or the 18
12556	12556	Department of the Treasury; or 19
12557	12557	‘‘(ii) prevent disclosure for the pur-20
12558	12558	poses of subsection (c), or any other public 21
12559	12559	disclosure requirement under this section. 22
12560	12560	‘‘(G) L
12561	12561	IMITED FORM OF REPORT .—The 23
12562	12562	Secretary shall define through rulemaking a 24
12563	12563	limited form of the report under paragraph (1) 25
12564	12564	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00427 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12565	12565	TKELLEY on LAP7H3WLY3PROD with BILLS 428
12566	12566	•S 891 IS
12567	12567	required with respect to any group health plan 1
12568	12568	established by a plan sponsor that is, or is af-2
12569	12569	filiated with, a drug manufacturer, drug whole-3
12570	12570	saler, or other direct participant in the drug 4
12571	12571	supply chain, in order to prevent anti-competi-5
12572	12572	tive behavior. 6
12573	12573	‘‘(5) S
12574	12574	TANDARD FORMAT AND REGULATIONS .— 7
12575	12575	‘‘(A) I
12576	12576	N GENERAL.—Not later than 18 8
12577	12577	months after the date of enactment of this sec-9
12578	12578	tion, the Secretary shall specify through rule-10
12579	12579	making a standard format for entities providing 11
12580	12580	pharmacy benefit management services on be-12
12581	12581	half of group health plans and health insurance 13
12582	12582	issuers offering group health insurance cov-14
12583	12583	erage, to submit reports required under para-15
12584	12584	graph (1). 16
12585	12585	‘‘(B) A
12586	12586	DDITIONAL REGULATIONS .—Not 17
12587	12587	later than 18 months after the date of enact-18
12588	12588	ment of this section, the Secretary shall, 19
12589	12589	through rulemaking, promulgate any other final 20
12590	12590	regulations necessary to implement the require-21
12591	12591	ments of this section. In promulgating such 22
12592	12592	regulations, the Secretary shall, to the extent 23
12593	12593	practicable, align the reporting requirements 24
12594	12594	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00428 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12595	12595	TKELLEY on LAP7H3WLY3PROD with BILLS 429
12596	12596	•S 891 IS
12597	12597	under this section with the reporting require-1
12598	12598	ments under section 725. 2
12599	12599	‘‘(c) R
12600	12600	EQUIREMENTTOPROVIDEINFORMATION TO 3
12601	12601	P
12602	12602	ARTICIPANTS ORBENEFICIARIES.—A group health plan, 4
12603	12603	including with respect to group health insurance coverage 5
12604	12604	offered in connection with a group health plan, upon re-6
12605	12605	quest of a participant or beneficiary, shall provide to such 7
12606	12606	participant or beneficiary— 8
12607	12607	‘‘(1) the summary document described in sub-9
12608	12608	section (b)(2)(B)(ii); and 10
12609	12609	‘‘(2) the information described in subsection 11
12610	12610	(b)(2)(A)(i)(III) with respect to a claim made by or 12
12611	12611	on behalf of such participant or beneficiary. 13
12612	12612	‘‘(d) R
12613	12613	ULE OFCONSTRUCTION.—Nothing in this sec-14
12614	12614	tion shall be construed to permit a health insurance issuer, 15
12615	12615	group health plan, entity providing pharmacy benefit man-16
12616	12616	agement services on behalf of a group health plan or 17
12617	12617	health insurance issuer, or other entity to restrict disclo-18
12618	12618	sure to, or otherwise limit the access of, the Secretary to 19
12619	12619	a report described in subsection (b)(1) or information re-20
12620	12620	lated to compliance with subsections (a), (b), or (c) of this 21
12621	12621	section or section 502(c)(13) by such issuer, plan, or enti-22
12622	12622	ty. 23
12623	12623	‘‘(e) D
12624	12624	EFINITIONS.—In this section: 24
12625	12625	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00429 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12626	12626	TKELLEY on LAP7H3WLY3PROD with BILLS 430
12627	12627	•S 891 IS
12628	12628	‘‘(1) APPLICABLE ENTITY.—The term ‘applica-1
12629	12629	ble entity’ means— 2
12630	12630	‘‘(A) an applicable group purchasing orga-3
12631	12631	nization, drug manufacturer, distributor, whole-4
12632	12632	saler, rebate aggregator (or other purchasing 5
12633	12633	entity designed to aggregate rebates), or associ-6
12634	12634	ated third party; 7
12635	12635	‘‘(B) any subsidiary, parent, affiliate, or 8
12636	12636	subcontractor of a group health plan, health in-9
12637	12637	surance issuer, entity that provides pharmacy 10
12638	12638	benefit management services on behalf of such 11
12639	12639	a plan or issuer, or any entity described in sub-12
12640	12640	paragraph (A); or 13
12641	12641	‘‘(C) such other entity as the Secretary 14
12642	12642	may specify through rulemaking. 15
12643	12643	‘‘(2) A
12644	12644	PPLICABLE GROUP PURCHASING ORGANI -16
12645	12645	ZATION.—The term ‘applicable group purchasing or-17
12646	12646	ganization’ means a group purchasing organization 18
12647	12647	that is affiliated with or under common ownership 19
12648	12648	with an entity providing pharmacy benefit manage-20
12649	12649	ment services. 21
12650	12650	‘‘(3) C
12651	12651	ONTRACTED COMPENSATION .—The term 22
12652	12652	‘contracted compensation’ means the sum of any in-23
12653	12653	gredient cost and dispensing fee for a drug (inclusive 24
12654	12654	of the out-of-pocket costs to the participant or bene-25
12655	12655	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00430 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12656	12656	TKELLEY on LAP7H3WLY3PROD with BILLS 431
12657	12657	•S 891 IS
12658	12658	ficiary), or another analogous compensation struc-1
12659	12659	ture that the Secretary may specify through regula-2
12660	12660	tions. 3
12661	12661	‘‘(4) G
12662	12662	ROSS SPENDING .—The term ‘gross 4
12663	12663	spending’, with respect to prescription drug benefits 5
12664	12664	under a group health plan or health insurance cov-6
12665	12665	erage, means the amount spent by a group health 7
12666	12666	plan or health insurance issuer on prescription drug 8
12667	12667	benefits, calculated before the application of rebates, 9
12668	12668	fees, alternative discounts, or other remuneration. 10
12669	12669	‘‘(5) N
12670	12670	ET SPENDING.—The term ‘net spending’, 11
12671	12671	with respect to prescription drug benefits under a 12
12672	12672	group health plan or health insurance coverage, 13
12673	12673	means the amount spent by a group health plan or 14
12674	12674	health insurance issuer on prescription drug bene-15
12675	12675	fits, calculated after the application of rebates, fees, 16
12676	12676	alternative discounts, or other remuneration. 17
12677	12677	‘‘(6) P
12678	12678	LAN SPONSOR.—The term ‘plan sponsor’ 18
12679	12679	has the meaning given such term in section 19
12680	12680	3(16)(B). 20
12681	12681	‘‘(7) R
12682	12682	EMUNERATION.—The term ‘remunera-21
12683	12683	tion’ has the meaning given such term by the Sec-22
12684	12684	retary through rulemaking, which shall be reevalu-23
12685	12685	ated by the Secretary every 5 years. 24
12686	12686	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00431 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12687	12687	TKELLEY on LAP7H3WLY3PROD with BILLS 432
12688	12688	•S 891 IS
12689	12689	‘‘(8) SPECIFIED LARGE EMPLOYER .—The term 1
12690	12690	‘specified large employer’ means, in connection with 2
12691	12691	a group health plan (including group health insur-3
12692	12692	ance coverage offered in connection with such a 4
12693	12693	plan) established or maintained by a single em-5
12694	12694	ployer, with respect to a calendar year or a plan 6
12695	12695	year, as applicable, an employer who employed an 7
12696	12696	average of at least 100 employees on business days 8
12697	12697	during the preceding calendar year or plan year and 9
12698	12698	who employs at least 1 employee on the first day of 10
12699	12699	the calendar year or plan year. 11
12700	12700	‘‘(9) S
12701	12701	PECIFIED LARGE PLAN.—The term ‘spec-12
12702	12702	ified large plan’ means a group health plan (includ-13
12703	12703	ing group health insurance coverage offered in con-14
12704	12704	nection with such a plan) established or maintained 15
12705	12705	by a plan sponsor described in clause (ii) or (iii) of 16
12706	12706	section 3(16)(B) that had an average of at least 100 17
12707	12707	participants on business days during the preceding 18
12708	12708	calendar year or plan year, as applicable. 19
12709	12709	‘‘(10) W
12710	12710	HOLESALE ACQUISITION COST .—The 20
12711	12711	term ‘wholesale acquisition cost’ has the meaning 21
12712	12712	given such term in section 1847A(c)(6)(B) of the 22
12713	12713	Social Security Act (42 U.S.C. 1395w– 23
12714	12714	3a(c)(6)(B)).’’; 24
12715	12715	(B) in section 502 (29 U.S.C. 1132)— 25
12716	12716	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00432 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12717	12717	TKELLEY on LAP7H3WLY3PROD with BILLS 433
12718	12718	•S 891 IS
12719	12719	(i) in subsection (a)(6), by striking 1
12720	12720	‘‘or (9)’’ and inserting ‘‘(9), or (13)’’; 2
12721	12721	(ii) in subsection (b)(3), by striking 3
12722	12722	‘‘under subsection (c)(9)’’ and inserting 4
12723	12723	‘‘under paragraphs (9) and (13) of sub-5
12724	12724	section (c)’’; and 6
12725	12725	(iii) in subsection (c), by adding at 7
12726	12726	the end the following: 8
12727	12727	‘‘(13) S
12728	12728	ECRETARIAL ENFORCEMENT AUTHORITY 9
12729	12729	RELATING TO OVERSIGHT OF PHARMACY BENEFIT 10
12730	12730	MANAGEMENT SERVICES .— 11
12731	12731	‘‘(A) F
12732	12732	AILURE TO PROVIDE INFORMA -12
12733	12733	TION.—The Secretary may impose a penalty 13
12734	12734	against a plan administrator of a group health 14
12735	12735	plan, a health insurance issuer offering group 15
12736	12736	health insurance coverage, or an entity pro-16
12737	12737	viding pharmacy benefit management services 17
12738	12738	on behalf of such a plan or issuer, or an appli-18
12739	12739	cable entity (as defined in section 726(f)) that 19
12740	12740	violates section 726(a); an entity providing 20
12741	12741	pharmacy benefit management services on be-21
12742	12742	half of such a plan or issuer that fails to pro-22
12743	12743	vide the information required under section 23
12744	12744	726(b); or any person who causes a group 24
12745	12745	health plan to fail to provide the information 25
12746	12746	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00433 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12747	12747	TKELLEY on LAP7H3WLY3PROD with BILLS 434
12748	12748	•S 891 IS
12749	12749	required under section 726(c), in the amount of 1
12750	12750	$10,000 for each day during which such viola-2
12751	12751	tion continues or such information is not dis-3
12752	12752	closed or reported. 4
12753	12753	‘‘(B) F
12754	12754	ALSE INFORMATION .—The Sec-5
12755	12755	retary may impose a penalty against a plan ad-6
12756	12756	ministrator of a group health plan, a health in-7
12757	12757	surance issuer offering group health insurance 8
12758	12758	coverage, an entity providing pharmacy benefit 9
12759	12759	management services, or an applicable entity 10
12760	12760	(as defined in section 726(f)) that knowingly 11
12761	12761	provides false information under section 726, in 12
12762	12762	an amount not to exceed $100,000 for each 13
12763	12763	item of false information. Such penalty shall be 14
12764	12764	in addition to other penalties as may be pre-15
12765	12765	scribed by law. 16
12766	12766	‘‘(C) W
12767	12767	AIVERS.—The Secretary may waive 17
12768	12768	penalties under subparagraph (A), or extend 18
12769	12769	the period of time for compliance with a re-19
12770	12770	quirement of this section, for an entity in viola-20
12771	12771	tion of section 726 that has made a good-faith 21
12772	12772	effort to comply with the requirements of sec-22
12773	12773	tion 726.’’; and 23
12774	12774	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00434 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12775	12775	TKELLEY on LAP7H3WLY3PROD with BILLS 435
12776	12776	•S 891 IS
12777	12777	(C) in section 732(a) (29 U.S.C. 1
12778	12778	1191a(a)), by striking ‘‘section 711’’ and in-2
12779	12779	serting ‘‘sections 711 and 726’’. 3
12780	12780	(2) C
12781	12781	LERICAL AMENDMENT .—The table of con-4
12782	12782	tents in section 1 of the Employee Retirement In-5
12783	12783	come Security Act of 1974 (29 U.S.C. 1001 et seq.) 6
12784	12784	is amended by inserting after the item relating to 7
12785	12785	section 725 the following new item: 8
12786	12786	‘‘Sec. 726. Oversight of entities that provide pharmacy benefit management
12787	12787	services.’’.
12788	12788	(c) INTERNALREVENUECODE OF1986.— 9
12789	12789	(1) I
12790	12790	N GENERAL.—Chapter 100 of the Internal 10
12791	12791	Revenue Code of 1986 is amended— 11
12792	12792	(A) by adding at the end of subchapter B 12
12793	12793	the following: 13
12794	12794	‘‘SEC. 9826. OVERSIGHT OF ENTITIES THAT PROVIDE PHAR-14
12795	12795	MACY BENEFIT MANAGEMENT SERVICES. 15
12796	12796	‘‘(a) I
12797	12797	NGENERAL.—For plan years beginning on or 16
12798	12798	after the date that is 30 months after the date of enact-17
12799	12799	ment of this section (referred to in this subsection and 18
12800	12800	subsection (b) as the ‘effective date’), a group health plan, 19
12801	12801	or an entity providing pharmacy benefit management serv-20
12802	12802	ices on behalf of such a plan, shall not enter into a con-21
12803	12803	tract, including an extension or renewal of a contract, en-22
12804	12804	tered into on or after the effective date, with an applicable 23
12805	12805	entity unless such applicable entity agrees to— 24
12806	12806	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00435 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12807	12807	TKELLEY on LAP7H3WLY3PROD with BILLS 436
12808	12808	•S 891 IS
12809	12809	‘‘(1) not limit or delay the disclosure of infor-1
12810	12810	mation to the group health plan in such a manner 2
12811	12811	that prevents an entity providing pharmacy benefit 3
12812	12812	management services on behalf of a group health 4
12813	12813	plan from making the reports described in sub-5
12814	12814	section (b); and 6
12815	12815	‘‘(2) provide the entity providing pharmacy ben-7
12816	12816	efit management services on behalf of a group health 8
12817	12817	plan relevant information necessary to make the re-9
12818	12818	ports described in subsection (b). 10
12819	12819	‘‘(b) R
12820	12820	EPORTS.— 11
12821	12821	‘‘(1) I
12822	12822	N GENERAL.—For plan years beginning 12
12823	12823	on or after the effective date, in the case of any con-13
12824	12824	tract between a group health plan and an entity pro-14
12825	12825	viding pharmacy benefit management services on be-15
12826	12826	half of such plan, including an extension or renewal 16
12827	12827	of such a contract, entered into on or after the effec-17
12828	12828	tive date, the entity providing pharmacy benefit 18
12829	12829	management services on behalf of such a group 19
12830	12830	health plan, not less frequently than every 6 months 20
12831	12831	(or, at the request of a group health plan, not less 21
12832	12832	frequently than quarterly, and under the same con-22
12833	12833	ditions, terms, and cost of the semiannual report 23
12834	12834	under this subsection), shall submit to the group 24
12835	12835	health plan a report in accordance with this section. 25
12836	12836	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00436 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12837	12837	TKELLEY on LAP7H3WLY3PROD with BILLS 437
12838	12838	•S 891 IS
12839	12839	Each such report shall be made available to such 1
12840	12840	group health plan in plain language, in a machine- 2
12841	12841	readable format, and as the Secretary may deter-3
12842	12842	mine, other formats. Each such report shall include 4
12843	12843	the information described in paragraph (2). 5
12844	12844	‘‘(2) I
12845	12845	NFORMATION DESCRIBED .—For purposes 6
12846	12846	of paragraph (1), the information described in this 7
12847	12847	paragraph is, with respect to drugs covered by a 8
12848	12848	group health plan during each reporting period— 9
12849	12849	‘‘(A) in the case of a group health plan 10
12850	12850	that is offered by a specified large employer or 11
12851	12851	that is a specified large plan, and is not offered 12
12852	12852	as health insurance coverage, or in the case of 13
12853	12853	health insurance coverage for which the election 14
12854	12854	under paragraph (3) is made for the applicable 15
12855	12855	reporting period— 16
12856	12856	‘‘(i) a list of drugs for which a claim 17
12857	12857	was filed and, with respect to each such 18
12858	12858	drug on such list— 19
12859	12859	‘‘(I) the contracted compensation 20
12860	12860	paid by the group health plan for each 21
12861	12861	covered drug (identified by the Na-22
12862	12862	tional Drug Code) to the entity pro-23
12863	12863	viding pharmacy benefit management 24
12864	12864	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00437 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12865	12865	TKELLEY on LAP7H3WLY3PROD with BILLS 438
12866	12866	•S 891 IS
12867	12867	services or other applicable entity on 1
12868	12868	behalf of the group health plan; 2
12869	12869	‘‘(II) the contracted compensa-3
12870	12870	tion paid to the pharmacy, by any en-4
12871	12871	tity providing pharmacy benefit man-5
12872	12872	agement services or other applicable 6
12873	12873	entity on behalf of the group health 7
12874	12874	plan, for each covered drug (identified 8
12875	12875	by the National Drug Code); 9
12876	12876	‘‘(III) for each such claim, the 10
12877	12877	difference between the amount paid 11
12878	12878	under subclause (I) and the amount 12
12879	12879	paid under subclause (II); 13
12880	12880	‘‘(IV) the proprietary name, es-14
12881	12881	tablished name or proper name, and 15
12882	12882	the National Drug Code; 16
12883	12883	‘‘(V) for each claim for the drug 17
12884	12884	(including original prescriptions and 18
12885	12885	refills) and for each dosage unit of the 19
12886	12886	drug for which a claim was filed, the 20
12887	12887	type of dispensing channel used to 21
12888	12888	furnish the drug, including retail, mail 22
12889	12889	order, or specialty pharmacy; 23
12890	12890	‘‘(VI) with respect to each drug 24
12891	12891	dispensed, for each type of dispensing 25
12892	12892	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00438 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12893	12893	TKELLEY on LAP7H3WLY3PROD with BILLS 439
12894	12894	•S 891 IS
12895	12895	channel (including retail, mail order, 1
12896	12896	or specialty pharmacy)— 2
12897	12897	‘‘(aa) whether such drug is a 3
12898	12898	brand name drug or a generic 4
12899	12899	drug, and— 5
12900	12900	‘‘(AA) in the case of a 6
12901	12901	brand name drug, the whole-7
12902	12902	sale acquisition cost, listed 8
12903	12903	as cost per days supply and 9
12904	12904	cost per dosage unit, on the 10
12905	12905	date such drug was dis-11
12906	12906	pensed; and 12
12907	12907	‘‘(BB) in the case of a 13
12908	12908	generic drug, the average 14
12909	12909	wholesale price, listed as 15
12910	12910	cost per days supply and 16
12911	12911	cost per dosage unit, on the 17
12912	12912	date such drug was dis-18
12913	12913	pensed; and 19
12914	12914	‘‘(bb) the total number of— 20
12915	12915	‘‘(AA) prescription 21
12916	12916	claims (including original 22
12917	12917	prescriptions and refills); 23
12918	12918	‘‘(BB) participants and 24
12919	12919	beneficiaries for whom a 25
12920	12920	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00439 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12921	12921	TKELLEY on LAP7H3WLY3PROD with BILLS 440
12922	12922	•S 891 IS
12923	12923	claim for such drug was 1
12924	12924	filed through the applicable 2
12925	12925	dispensing channel; 3
12926	12926	‘‘(CC) dosage units and 4
12927	12927	dosage units per fill of such 5
12928	12928	drug; and 6
12929	12929	‘‘(DD) days supply of 7
12930	12930	such drug per fill; 8
12931	12931	‘‘(VII) the net price per course of 9
12932	12932	treatment or single fill, such as a 30- 10
12933	12933	day supply or 90-day supply to the 11
12934	12934	plan after rebates, fees, alternative 12
12935	12935	discounts, or other remuneration re-13
12936	12936	ceived from applicable entities; 14
12937	12937	‘‘(VIII) the total amount of out- 15
12938	12938	of-pocket spending by participants 16
12939	12939	and beneficiaries on such drug, in-17
12940	12940	cluding spending through copayments, 18
12941	12941	coinsurance, and deductibles, but not 19
12942	12942	including any amounts spent by par-20
12943	12943	ticipants and beneficiaries on drugs 21
12944	12944	not covered under the plan, or for 22
12945	12945	which no claim is submitted under the 23
12946	12946	plan; 24
12947	12947	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00440 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12948	12948	TKELLEY on LAP7H3WLY3PROD with BILLS 441
12949	12949	•S 891 IS
12950	12950	‘‘(IX) the total net spending on 1
12951	12951	the drug; 2
12952	12952	‘‘(X) the total amount received, 3
12953	12953	or expected to be received, by the plan 4
12954	12954	from any applicable entity in rebates, 5
12955	12955	fees, alternative discounts, or other 6
12956	12956	remuneration; 7
12957	12957	‘‘(XI) the total amount received, 8
12958	12958	or expected to be received, by the enti-9
12959	12959	ty providing pharmacy benefit man-10
12960	12960	agement services, from applicable en-11
12961	12961	tities, in rebates, fees, alternative dis-12
12962	12962	counts, or other remuneration from 13
12963	12963	such entities— 14
12964	12964	‘‘(aa) for claims incurred 15
12965	12965	during the reporting period; and 16
12966	12966	‘‘(bb) that is related to utili-17
12967	12967	zation of such drug or spending 18
12968	12968	on such drug; and 19
12969	12969	‘‘(XII) to the extent feasible, in-20
12970	12970	formation on the total amount of re-21
12971	12971	muneration for such drug, including 22
12972	12972	copayment assistance dollars paid, co-23
12973	12973	payment cards applied, or other dis-24
12974	12974	counts provided by each drug manu-25
12975	12975	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00441 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
12976	12976	TKELLEY on LAP7H3WLY3PROD with BILLS 442
12977	12977	•S 891 IS
12978	12978	facturer (or entity administering co-1
12979	12979	payment assistance on behalf of such 2
12980	12980	drug manufacturer), to the partici-3
12981	12981	pants and beneficiaries enrolled in 4
12982	12982	such plan; 5
12983	12983	‘‘(ii) a list of each therapeutic class 6
12984	12984	(as defined by the Secretary) for which a 7
12985	12985	claim was filed under the group health 8
12986	12986	plan during the reporting period, and, with 9
12987	12987	respect to each such therapeutic class— 10
12988	12988	‘‘(I) the total gross spending on 11
12989	12989	drugs in such class before rebates, 12
12990	12990	price concessions, alternative dis-13
12991	12991	counts, or other remuneration from 14
12992	12992	applicable entities; 15
12993	12993	‘‘(II) the net spending in such 16
12994	12994	class after such rebates, price conces-17
12995	12995	sions, alternative discounts, or other 18
12996	12996	remuneration from applicable entities; 19
12997	12997	‘‘(III) the total amount received, 20
12998	12998	or expected to be received, by the enti-21
12999	12999	ty providing pharmacy benefit man-22
13000	13000	agement services, from applicable en-23
13001	13001	tities, in rebates, fees, alternative dis-24
13002	13002	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00442 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13003	13003	TKELLEY on LAP7H3WLY3PROD with BILLS 443
13004	13004	•S 891 IS
13005	13005	counts, or other remuneration from 1
13006	13006	such entities— 2
13007	13007	‘‘(aa) for claims incurred 3
13008	13008	during the reporting period; and 4
13009	13009	‘‘(bb) that is related to utili-5
13010	13010	zation of drugs or drug spending; 6
13011	13011	‘‘(IV) the average net spending 7
13012	13012	per 30-day supply and per 90-day 8
13013	13013	supply by the plan and its partici-9
13014	13014	pants and beneficiaries, among all 10
13015	13015	drugs within the therapeutic class for 11
13016	13016	which a claim was filed during the re-12
13017	13017	porting period; 13
13018	13018	‘‘(V) the number of participants 14
13019	13019	and beneficiaries who filled a prescrip-15
13020	13020	tion for a drug in such class, includ-16
13021	13021	ing the National Drug Code for each 17
13022	13022	such drug; 18
13023	13023	‘‘(VI) if applicable, a description 19
13024	13024	of the formulary tiers and utilization 20
13025	13025	mechanisms (such as prior authoriza-21
13026	13026	tion or step therapy) employed for 22
13027	13027	drugs in that class; and 23
13028	13028	‘‘(VII) the total out-of-pocket 24
13029	13029	spending under the plan by partici-25
13030	13030	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00443 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13031	13031	TKELLEY on LAP7H3WLY3PROD with BILLS 444
13032	13032	•S 891 IS
13033	13033	pants and beneficiaries, including 1
13034	13034	spending through copayments, coin-2
13035	13035	surance, and deductibles, but not in-3
13036	13036	cluding any amounts spent by partici-4
13037	13037	pants and beneficiaries on drugs not 5
13038	13038	covered under the plan or for which 6
13039	13039	no claim is submitted under the plan; 7
13040	13040	‘‘(iii) with respect to any drug for 8
13041	13041	which gross spending under the group 9
13042	13042	health plan exceeded $10,000 during the 10
13043	13043	reporting period or, in the case that gross 11
13044	13044	spending under the group health plan ex-12
13045	13045	ceeded $10,000 during the reporting pe-13
13046	13046	riod with respect to fewer than 50 drugs, 14
13047	13047	with respect to the 50 prescription drugs 15
13048	13048	with the highest spending during the re-16
13049	13049	porting period— 17
13050	13050	‘‘(I) a list of all other drugs in 18
13051	13051	the same therapeutic class as such 19
13052	13052	drug; 20
13053	13053	‘‘(II) if applicable, the rationale 21
13054	13054	for the formulary placement of such 22
13055	13055	drug in that therapeutic category or 23
13056	13056	class, selected from a list of standard 24
13057	13057	rationales established by the Sec-25
13058	13058	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00444 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13059	13059	TKELLEY on LAP7H3WLY3PROD with BILLS 445
13060	13060	•S 891 IS
13061	13061	retary, in consultation with stake-1
13062	13062	holders; and 2
13063	13063	‘‘(III) any change in formulary 3
13064	13064	placement compared to the prior plan 4
13065	13065	year; and 5
13066	13066	‘‘(iv) in the case that such plan (or an 6
13067	13067	entity providing pharmacy benefit manage-7
13068	13068	ment services on behalf of such plan) has 8
13069	13069	an affiliated pharmacy or pharmacy under 9
13070	13070	common ownership, including mandatory 10
13071	13071	mail and specialty home delivery programs, 11
13072	13072	retail and mail auto-refill programs, and 12
13073	13073	cost sharing assistance incentives funded 13
13074	13074	by an entity providing pharmacy benefit 14
13075	13075	services— 15
13076	13076	‘‘(I) an explanation of any ben-16
13077	13077	efit design parameters that encourage 17
13078	13078	or require participants and bene-18
13079	13079	ficiaries in the plan to fill prescrip-19
13080	13080	tions at mail order, specialty, or retail 20
13081	13081	pharmacies; 21
13082	13082	‘‘(II) the percentage of total pre-22
13083	13083	scriptions dispensed by such phar-23
13084	13084	macies to participants or beneficiaries 24
13085	13085	in such plan; and 25
13086	13086	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00445 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13087	13087	TKELLEY on LAP7H3WLY3PROD with BILLS 446
13088	13088	•S 891 IS
13089	13089	‘‘(III) a list of all drugs dis-1
13090	13090	pensed by such pharmacies to partici-2
13091	13091	pants or beneficiaries enrolled in such 3
13092	13092	plan, and, with respect to each drug 4
13093	13093	dispensed— 5
13094	13094	‘‘(aa) the amount charged, 6
13095	13095	per dosage unit, per 30-day sup-7
13096	13096	ply, or per 90-day supply (as ap-8
13097	13097	plicable) to the plan, and to par-9
13098	13098	ticipants and beneficiaries; 10
13099	13099	‘‘(bb) the median amount 11
13100	13100	charged to such plan, and the 12
13101	13101	interquartile range of the costs, 13
13102	13102	per dosage unit, per 30-day sup-14
13103	13103	ply, and per 90-day supply, in-15
13104	13104	cluding amounts paid by the par-16
13105	13105	ticipants and beneficiaries, when 17
13106	13106	the same drug is dispensed by 18
13107	13107	other pharmacies that are not af-19
13108	13108	filiated with or under common 20
13109	13109	ownership with the entity and 21
13110	13110	that are included in the phar-22
13111	13111	macy network of such plan; 23
13112	13112	‘‘(cc) the lowest cost per 24
13113	13113	dosage unit, per 30-day supply 25
13114	13114	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00446 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13115	13115	TKELLEY on LAP7H3WLY3PROD with BILLS 447
13116	13116	•S 891 IS
13117	13117	and per 90-day supply, for each 1
13118	13118	such drug, including amounts 2
13119	13119	charged to the plan and to par-3
13120	13120	ticipants and beneficiaries, that 4
13121	13121	is available from any pharmacy 5
13122	13122	included in the network of such 6
13123	13123	plan; and 7
13124	13124	‘‘(dd) the net acquisition 8
13125	13125	cost per dosage unit, per 30-day 9
13126	13126	supply, and per 90-day supply, if 10
13127	13127	such drug is subject to a max-11
13128	13128	imum price discount; and 12
13129	13129	‘‘(B) with respect to any group health 13
13130	13130	plan, regardless of whether the plan is offered 14
13131	13131	by a specified large employer or whether it is a 15
13132	13132	specified large plan— 16
13133	13133	‘‘(i) a summary document for the 17
13134	13134	group health plan that includes such infor-18
13135	13135	mation described in clauses (i) through (iv) 19
13136	13136	of subparagraph (A), as specified by the 20
13137	13137	Secretary through guidance, program in-21
13138	13138	struction, or otherwise (with no require-22
13139	13139	ment of notice and comment rulemaking), 23
13140	13140	that the Secretary determines useful to 24
13141	13141	group health plans for purposes of select-25
13142	13142	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00447 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13143	13143	TKELLEY on LAP7H3WLY3PROD with BILLS 448
13144	13144	•S 891 IS
13145	13145	ing pharmacy benefit management serv-1
13146	13146	ices, such as an estimated net price to 2
13147	13147	group health plan and participant or bene-3
13148	13148	ficiary, a cost per claim, the fee structure 4
13149	13149	or reimbursement model, and estimated 5
13150	13150	cost per participant or beneficiary; 6
13151	13151	‘‘(ii) a summary document for plans 7
13152	13152	to provide to participants and beneficiaries, 8
13153	13153	which shall be made available to partici-9
13154	13154	pants or beneficiaries upon request to their 10
13155	13155	group health plan, that— 11
13156	13156	‘‘(I) contains such information 12
13157	13157	described in clauses (iii), (iv), (v), and 13
13158	13158	(vi), as applicable, as specified by the 14
13159	13159	Secretary through guidance, program 15
13160	13160	instruction, or otherwise (with no re-16
13161	13161	quirement of notice and comment 17
13162	13162	rulemaking) that the Secretary deter-18
13163	13163	mines useful to participants or bene-19
13164	13164	ficiaries in better understanding the 20
13165	13165	plan or benefits under such plan; 21
13166	13166	‘‘(II) contains only aggregate in-22
13167	13167	formation; and 23
13168	13168	‘‘(III) states that participants 24
13169	13169	and beneficiaries may request specific, 25
13170	13170	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00448 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13171	13171	TKELLEY on LAP7H3WLY3PROD with BILLS 449
13172	13172	•S 891 IS
13173	13173	claims-level information required to be 1
13174	13174	furnished under subsection (c) from 2
13175	13175	the group health plan; and 3
13176	13176	‘‘(iii) with respect to drugs covered by 4
13177	13177	such plan during such reporting period— 5
13178	13178	‘‘(I) the total net spending by the 6
13179	13179	plan for all such drugs; 7
13180	13180	‘‘(II) the total amount received, 8
13181	13181	or expected to be received, by the plan 9
13182	13182	from any applicable entity in rebates, 10
13183	13183	fees, alternative discounts, or other 11
13184	13184	remuneration; and 12
13185	13185	‘‘(III) to the extent feasible, in-13
13186	13186	formation on the total amount of re-14
13187	13187	muneration for such drugs, including 15
13188	13188	copayment assistance dollars paid, co-16
13189	13189	payment cards applied, or other dis-17
13190	13190	counts provided by each drug manu-18
13191	13191	facturer (or entity administering co-19
13192	13192	payment assistance on behalf of such 20
13193	13193	drug manufacturer) to participants 21
13194	13194	and beneficiaries; 22
13195	13195	‘‘(iv) amounts paid directly or indi-23
13196	13196	rectly in rebates, fees, or any other type of 24
13197	13197	compensation (as defined in section 25
13198	13198	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00449 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13199	13199	TKELLEY on LAP7H3WLY3PROD with BILLS 450
13200	13200	•S 891 IS
13201	13201	408(b)(2)(B)(ii)(dd)(AA) of the Employee 1
13202	13202	Retirement Income Security Act (29 2
13203	13203	U.S.C. 1108(b)(2)(B)(ii)(dd)(AA))) to bro-3
13204	13204	kerage firms, brokers, consultants, advi-4
13205	13205	sors, or any other individual or firm, for— 5
13206	13206	‘‘(I) the referral of the group 6
13207	13207	health plan’s business to an entity 7
13208	13208	providing pharmacy benefit manage-8
13209	13209	ment services, including the identity 9
13210	13210	of the recipient of such amounts; 10
13211	13211	‘‘(II) consideration of the entity 11
13212	13212	providing pharmacy benefit manage-12
13213	13213	ment services by the group health 13
13214	13214	plan; or 14
13215	13215	‘‘(III) the retention of the entity 15
13216	13216	by the group health plan; 16
13217	13217	‘‘(v) an explanation of any benefit de-17
13218	13218	sign parameters that encourage or require 18
13219	13219	participants and beneficiaries in such plan 19
13220	13220	to fill prescriptions at mail order, specialty, 20
13221	13221	or retail pharmacies that are affiliated with 21
13222	13222	or under common ownership with the enti-22
13223	13223	ty providing pharmacy benefit management 23
13224	13224	services under such plan, including manda-24
13225	13225	tory mail and specialty home delivery pro-25
13226	13226	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00450 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13227	13227	TKELLEY on LAP7H3WLY3PROD with BILLS 451
13228	13228	•S 891 IS
13229	13229	grams, retail and mail auto-refill pro-1
13230	13230	grams, and cost-sharing assistance incen-2
13231	13231	tives directly or indirectly funded by such 3
13232	13232	entity; and 4
13233	13233	‘‘(vi) total gross spending on all drugs 5
13234	13234	under the plan during the reporting period. 6
13235	13235	‘‘(3) O
13236	13236	PT-IN FOR GROUP HEALTH INSURANCE 7
13237	13237	COVERAGE OFFERED BY A SPECIFIED LARGE EM -8
13238	13238	PLOYER OR THAT IS A SPECIFIED LARGE PLAN .—In 9
13239	13239	the case of group health insurance coverage offered 10
13240	13240	in connection with a group health plan that is of-11
13241	13241	fered by a specified large employer or is a specified 12
13242	13242	large plan, such group health plan may, on an an-13
13243	13243	nual basis, for plan years beginning on or after the 14
13244	13244	date that is 30 months after the date of enactment 15
13245	13245	of this section, elect to require an entity providing 16
13246	13246	pharmacy benefit management services on behalf of 17
13247	13247	the health insurance issuer to submit to such group 18
13248	13248	health plan a report that includes all of the informa-19
13249	13249	tion described in paragraph (2)(A), in addition to 20
13250	13250	the information described in paragraph (2)(B). 21
13251	13251	‘‘(4) P
13252	13252	RIVACY REQUIREMENTS .— 22
13253	13253	‘‘(A) I
13254	13254	N GENERAL.—An entity providing 23
13255	13255	pharmacy benefit management services on be-24
13256	13256	half of a group health plan shall report infor-25
13257	13257	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00451 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13258	13258	TKELLEY on LAP7H3WLY3PROD with BILLS 452
13259	13259	•S 891 IS
13260	13260	mation under paragraph (1) in a manner con-1
13261	13261	sistent with the privacy regulations promul-2
13262	13262	gated under section 13402(a) of the Health In-3
13263	13263	formation Technology for Economic and Clin-4
13264	13264	ical Health Act (42 U.S.C. 17932(a)) and con-5
13265	13265	sistent with the privacy regulations promul-6
13266	13266	gated under the Health Insurance Portability 7
13267	13267	and Accountability Act of 1996 in part 160 and 8
13268	13268	subparts A and E of part 164 of title 45, Code 9
13269	13269	of Federal Regulations (or successor regula-10
13270	13270	tions) (referred to in this paragraph as the 11
13271	13271	‘HIPAA privacy regulations’) and shall restrict 12
13272	13272	the use and disclosure of such information ac-13
13273	13273	cording to such privacy regulations and such 14
13274	13274	HIPAA privacy regulations. 15
13275	13275	‘‘(B) A
13276	13276	DDITIONAL REQUIREMENTS .— 16
13277	13277	‘‘(i) I
13278	13278	N GENERAL.—An entity pro-17
13279	13279	viding pharmacy benefit management serv-18
13280	13280	ices on behalf of a group health plan that 19
13281	13281	submits a report under paragraph (1) shall 20
13282	13282	ensure that such report contains only sum-21
13283	13283	mary health information, as defined in sec-22
13284	13284	tion 164.504(a) of title 45, Code of Fed-23
13285	13285	eral Regulations (or successor regulations). 24
13286	13286	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00452 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13287	13287	TKELLEY on LAP7H3WLY3PROD with BILLS 453
13288	13288	•S 891 IS
13289	13289	‘‘(ii) RESTRICTIONS.—In carrying out 1
13290	13290	this subsection, a group health plan shall 2
13291	13291	comply with section 164.504(f) of title 45, 3
13292	13292	Code of Federal Regulations (or a suc-4
13293	13293	cessor regulation), and a plan sponsor shall 5
13294	13294	act in accordance with the terms of the 6
13295	13295	agreement described in such section. 7
13296	13296	‘‘(C) R
13297	13297	ULE OF CONSTRUCTION .— 8
13298	13298	‘‘(i) Nothing in this section shall be 9
13299	13299	construed to modify the requirements for 10
13300	13300	the creation, receipt, maintenance, or 11
13301	13301	transmission of protected health informa-12
13302	13302	tion under the HIPAA privacy regulations. 13
13303	13303	‘‘(ii) Nothing in this section shall be 14
13304	13304	construed to affect the application of any 15
13305	13305	Federal or State privacy or civil rights law, 16
13306	13306	including the HIPAA privacy regulations, 17
13307	13307	the Genetic Information Nondiscrimination 18
13308	13308	Act of 2008 (Public Law 110–233) (in-19
13309	13309	cluding the amendments made by such 20
13310	13310	Act), the Americans with Disabilities Act 21
13311	13311	of 1990 (42 U.S.C. 12101 et seq.), section 22
13312	13312	504 of the Rehabilitation Act of 1973 (29 23
13313	13313	U.S.C. 794), section 1557 of the Patient 24
13314	13314	Protection and Affordable Care Act (42 25
13315	13315	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00453 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13316	13316	TKELLEY on LAP7H3WLY3PROD with BILLS 454
13317	13317	•S 891 IS
13318	13318	U.S.C. 18116), title VI of the Civil Rights 1
13319	13319	Act of 1964 (42 U.S.C. 2000d), and title 2
13320	13320	VII of the Civil Rights Act of 1964 (42 3
13321	13321	U.S.C. 2000e). 4
13322	13322	‘‘(D) W
13323	13323	RITTEN NOTICE.—Each plan year, 5
13324	13324	group health plans shall provide to each partici-6
13325	13325	pant or beneficiary written notice informing the 7
13326	13326	participant or beneficiary of the requirement for 8
13327	13327	entities providing pharmacy benefit manage-9
13328	13328	ment services on behalf of the group health 10
13329	13329	plan to submit reports to group health plans 11
13330	13330	under paragraph (1), as applicable, which may 12
13331	13331	include incorporating such notification in plan 13
13332	13332	documents provided to the participant or bene-14
13333	13333	ficiary, or providing individual notification. 15
13334	13334	‘‘(E) L
13335	13335	IMITATION TO BUSINESS ASSOCI -16
13336	13336	ATES.—A group health plan receiving a report 17
13337	13337	under paragraph (1) may disclose such informa-18
13338	13338	tion only to the entity from which the report 19
13339	13339	was received or to that entity’s business associ-20
13340	13340	ates as defined in section 160.103 of title 45, 21
13341	13341	Code of Federal Regulations (or successor regu-22
13342	13342	lations) or as permitted by the HIPAA privacy 23
13343	13343	regulations. 24
13344	13344	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00454 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13345	13345	TKELLEY on LAP7H3WLY3PROD with BILLS 455
13346	13346	•S 891 IS
13347	13347	‘‘(F) CLARIFICATION REGARDING PUBLIC 1
13348	13348	DISCLOSURE OF INFORMATION .—Nothing in 2
13349	13349	this section shall prevent an entity providing 3
13350	13350	pharmacy benefit management services on be-4
13351	13351	half of a group health plan, from placing rea-5
13352	13352	sonable restrictions on the public disclosure of 6
13353	13353	the information contained in a report described 7
13354	13354	in paragraph (1), except that such plan or enti-8
13355	13355	ty may not— 9
13356	13356	‘‘(i) restrict disclosure of such report 10
13357	13357	to the Department of Health and Human 11
13358	13358	Services, the Department of Labor, or the 12
13359	13359	Department of the Treasury; or 13
13360	13360	‘‘(ii) prevent disclosure for the pur-14
13361	13361	poses of subsection (c), or any other public 15
13362	13362	disclosure requirement under this section. 16
13363	13363	‘‘(G) L
13364	13364	IMITED FORM OF REPORT .—The 17
13365	13365	Secretary shall define through rulemaking a 18
13366	13366	limited form of the report under paragraph (1) 19
13367	13367	required with respect to any group health plan 20
13368	13368	established by a plan sponsor that is, or is af-21
13369	13369	filiated with, a drug manufacturer, drug whole-22
13370	13370	saler, or other direct participant in the drug 23
13371	13371	supply chain, in order to prevent anti-competi-24
13372	13372	tive behavior. 25
13373	13373	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00455 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13374	13374	TKELLEY on LAP7H3WLY3PROD with BILLS 456
13375	13375	•S 891 IS
13376	13376	‘‘(5) STANDARD FORMAT AND REGULATIONS .— 1
13377	13377	‘‘(A) I
13378	13378	N GENERAL.—Not later than 18 2
13379	13379	months after the date of enactment of this sec-3
13380	13380	tion, the Secretary shall specify through rule-4
13381	13381	making a standard format for entities providing 5
13382	13382	pharmacy benefit management services on be-6
13383	13383	half of group health plans, to submit reports re-7
13384	13384	quired under paragraph (1). 8
13385	13385	‘‘(B) A
13386	13386	DDITIONAL REGULATIONS .—Not 9
13387	13387	later than 18 months after the date of enact-10
13388	13388	ment of this section, the Secretary shall, 11
13389	13389	through rulemaking, promulgate any other final 12
13390	13390	regulations necessary to implement the require-13
13391	13391	ments of this section. In promulgating such 14
13392	13392	regulations, the Secretary shall, to the extent 15
13393	13393	practicable, align the reporting requirements 16
13394	13394	under this section with the reporting require-17
13395	13395	ments under section 9825. 18
13396	13396	‘‘(c) R
13397	13397	EQUIREMENTTOPROVIDEINFORMATION TO 19
13398	13398	P
13399	13399	ARTICIPANTS ORBENEFICIARIES.—A group health plan, 20
13400	13400	upon request of a participant or beneficiary, shall provide 21
13401	13401	to such participant or beneficiary— 22
13402	13402	‘‘(1) the summary document described in sub-23
13403	13403	section (b)(2)(B)(ii); and 24
13404	13404	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00456 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13405	13405	TKELLEY on LAP7H3WLY3PROD with BILLS 457
13406	13406	•S 891 IS
13407	13407	‘‘(2) the information described in subsection 1
13408	13408	(b)(2)(A)(i)(III) with respect to a claim made by or 2
13409	13409	on behalf of such participant or beneficiary. 3
13410	13410	‘‘(d) R
13411	13411	ULE OFCONSTRUCTION.—Nothing in this sec-4
13412	13412	tion shall be construed to permit a health insurance issuer, 5
13413	13413	group health plan, entity providing pharmacy benefit man-6
13414	13414	agement services on behalf of a group health plan or 7
13415	13415	health insurance issuer, or other entity to restrict disclo-8
13416	13416	sure to, or otherwise limit the access of, the Secretary to 9
13417	13417	a report described in subsection (b)(1) or information re-10
13418	13418	lated to compliance with subsections (a), (b), or (c) of this 11
13419	13419	section or section 4980D(g) by such issuer, plan, or entity. 12
13420	13420	‘‘(e) D
13421	13421	EFINITIONS.—In this section: 13
13422	13422	‘‘(1) A
13423	13423	PPLICABLE ENTITY.—The term ‘applica-14
13424	13424	ble entity’ means— 15
13425	13425	‘‘(A) an applicable group purchasing orga-16
13426	13426	nization, drug manufacturer, distributor, whole-17
13427	13427	saler, rebate aggregator (or other purchasing 18
13428	13428	entity designed to aggregate rebates), or associ-19
13429	13429	ated third party; 20
13430	13430	‘‘(B) any subsidiary, parent, affiliate, or 21
13431	13431	subcontractor of a group health plan, health in-22
13432	13432	surance issuer, entity that provides pharmacy 23
13433	13433	benefit management services on behalf of such 24
13434	13434	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00457 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13435	13435	TKELLEY on LAP7H3WLY3PROD with BILLS 458
13436	13436	•S 891 IS
13437	13437	a plan or issuer, or any entity described in sub-1
13438	13438	paragraph (A); or 2
13439	13439	‘‘(C) such other entity as the Secretary 3
13440	13440	may specify through rulemaking. 4
13441	13441	‘‘(2) A
13442	13442	PPLICABLE GROUP PURCHASING ORGANI -5
13443	13443	ZATION.—The term ‘applicable group purchasing or-6
13444	13444	ganization’ means a group purchasing organization 7
13445	13445	that is affiliated with or under common ownership 8
13446	13446	with an entity providing pharmacy benefit manage-9
13447	13447	ment services. 10
13448	13448	‘‘(3) C
13449	13449	ONTRACTED COMPENSATION .—The term 11
13450	13450	‘contracted compensation’ means the sum of any in-12
13451	13451	gredient cost and dispensing fee for a drug (inclusive 13
13452	13452	of the out-of-pocket costs to the participant or bene-14
13453	13453	ficiary), or another analogous compensation struc-15
13454	13454	ture that the Secretary may specify through regula-16
13455	13455	tions. 17
13456	13456	‘‘(4) G
13457	13457	ROSS SPENDING .—The term ‘gross 18
13458	13458	spending’, with respect to prescription drug benefits 19
13459	13459	under a group health plan, means the amount spent 20
13460	13460	by a group health plan on prescription drug benefits, 21
13461	13461	calculated before the application of rebates, fees, al-22
13462	13462	ternative discounts, or other remuneration. 23
13463	13463	‘‘(5) N
13464	13464	ET SPENDING.—The term ‘net spending’, 24
13465	13465	with respect to prescription drug benefits under a 25
13466	13466	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00458 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13467	13467	TKELLEY on LAP7H3WLY3PROD with BILLS 459
13468	13468	•S 891 IS
13469	13469	group health plan, means the amount spent by a 1
13470	13470	group health plan on prescription drug benefits, cal-2
13471	13471	culated after the application of rebates, fees, alter-3
13472	13472	native discounts, or other remuneration. 4
13473	13473	‘‘(6) P
13474	13474	LAN SPONSOR.—The term ‘plan sponsor’ 5
13475	13475	has the meaning given such term in section 3(16)(B) 6
13476	13476	of the Employee Retirement Income Security Act of 7
13477	13477	1974 (29 U.S.C. 1002(16)(B)). 8
13478	13478	‘‘(7) R
13479	13479	EMUNERATION.—The term ‘remunera-9
13480	13480	tion’ has the meaning given such term by the Sec-10
13481	13481	retary, through rulemaking, which shall be reevalu-11
13482	13482	ated by the Secretary every 5 years. 12
13483	13483	‘‘(8) S
13484	13484	PECIFIED LARGE EMPLOYER .—The term 13
13485	13485	‘specified large employer’ means, in connection with 14
13486	13486	a group health plan established or maintained by a 15
13487	13487	single employer, with respect to a calendar year or 16
13488	13488	a plan year, as applicable, an employer who em-17
13489	13489	ployed an average of at least 100 employees on busi-18
13490	13490	ness days during the preceding calendar year or plan 19
13491	13491	year and who employs at least 1 employee on the 20
13492	13492	first day of the calendar year or plan year. 21
13493	13493	‘‘(9) S
13494	13494	PECIFIED LARGE PLAN.—The term ‘spec-22
13495	13495	ified large plan’ means a group health plan estab-23
13496	13496	lished or maintained by a plan sponsor described in 24
13497	13497	clause (ii) or (iii) of section 3(16)(B) of the Em-25
13498	13498	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00459 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13499	13499	TKELLEY on LAP7H3WLY3PROD with BILLS 460
13500	13500	•S 891 IS
13501	13501	ployee Retirement Income Security Act of 1974 (29 1
13502	13502	U.S.C. 1002(16)(B)) that had an average of at least 2
13503	13503	100 participants on business days during the pre-3
13504	13504	ceding calendar year or plan year, as applicable. 4
13505	13505	‘‘(10) W
13506	13506	HOLESALE ACQUISITION COST .—The 5
13507	13507	term ‘wholesale acquisition cost’ has the meaning 6
13508	13508	given such term in section 1847A(c)(6)(B) of the 7
13509	13509	Social Security Act (42 U.S.C. 1395w– 8
13510	13510	3a(c)(6)(B)).’’; 9
13511	13511	(2) E
13512	13512	XCEPTION FOR CERTAIN GROUP HEALTH 10
13513	13513	PLANS.—Section 9831(a)(2) of the Internal Revenue 11
13514	13514	Code of 1986 is amended by inserting ‘‘other than 12
13515	13515	with respect to section 9826,’’ before ‘‘any group 13
13516	13516	health plan’’. 14
13517	13517	(3) E
13518	13518	NFORCEMENT.—Section 4980D of the In-15
13519	13519	ternal Revenue Code of 1986 is amended by adding 16
13520	13520	at the end the following new subsection: 17
13521	13521	‘‘(g) A
13522	13522	PPLICATION TOREQUIREMENTSIMPOSED ON 18
13523	13523	C
13524	13524	ERTAINENTITIESPROVIDINGPHARMACYBENEFIT 19
13525	13525	M
13526	13526	ANAGEMENTSERVICES.—In the case of any requirement 20
13527	13527	under section 9826 that applies with respect to an entity 21
13528	13528	providing pharmacy benefit management services on be-22
13529	13529	half of a group health plan, any reference in this section 23
13530	13530	to such group health plan (and the reference in subsection 24
13531	13531	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00460 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13532	13532	TKELLEY on LAP7H3WLY3PROD with BILLS 461
13533	13533	•S 891 IS
13534	13534	(e)(1) to the employer) shall be treated as including a ref-1
13535	13535	erence to such entity.’’. 2
13536	13536	(4) C
13537	13537	LERICAL AMENDMENT .—The table of sec-3
13538	13538	tions for subchapter B of chapter 100 of the Inter-4
13539	13539	nal Revenue Code of 1986 is amended by adding at 5
13540	13540	the end the following new item: 6
13541	13541	‘‘Sec. 9826. Oversight of entities that provide pharmacy benefit management
13542	13542	services.’’.
13543	13543	SEC. 902. FULL REBATE PASS THROUGH TO PLAN; EXCEP-
13544	13544	7
13545	13545	TION FOR INNOCENT PLAN FIDUCIARIES. 8
13546	13546	(a) I
13547	13547	NGENERAL.—Section 408(b)(2) of the Em-9
13548	13548	ployee Retirement Income Security Act of 1974 (29 10
13549	13549	U.S.C. 1108(b)(2)) is amended— 11
13550	13550	(1) in subparagraph (B)(viii)— 12
13551	13551	(A) by redesignating subclauses (II) 13
13552	13552	through (IV) as subclauses (III) through (V), 14
13553	13553	respectively; 15
13554	13554	(B) in subclause (I)— 16
13555	13555	(i) by striking ‘‘subclause (II)’’ and 17
13556	13556	inserting ‘‘subclause (III)’’; and 18
13557	13557	(ii) by striking ‘‘subclauses (II) and 19
13558	13558	(III)’’ and inserting ‘‘subclauses (III) and 20
13559	13559	(IV)’’; and 21
13560	13560	(C) by inserting after subclause (I) the fol-22
13561	13561	lowing: 23
13562	13562	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00461 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13563	13563	TKELLEY on LAP7H3WLY3PROD with BILLS 462
13564	13564	•S 891 IS
13565	13565	‘‘(II) Pursuant to subsection (a), subpara-1
13566	13566	graphs (C) and (D) of section 406(a)(1) shall not 2
13567	13567	apply to a responsible plan fiduciary, notwith-3
13568	13568	standing any failure to remit required amounts 4
13569	13569	under subparagraph (C)(i), if the following condi-5
13570	13570	tions are met: 6
13571	13571	‘‘(aa) The responsible plan fiduciary did 7
13572	13572	not know that the covered service provider 8
13573	13573	failed or would fail to make required remit-9
13574	13574	tances and reasonably believed that the covered 10
13575	13575	service provider remitted such required 11
13576	13576	amounts. 12
13577	13577	‘‘(bb) The responsible plan fiduciary, upon 13
13578	13578	discovering that the covered service provider 14
13579	13579	failed to remit the required amounts, requests 15
13580	13580	in writing that the covered service provider 16
13581	13581	remit such amounts. 17
13582	13582	‘‘(cc) If the covered service provider fails 18
13583	13583	to comply with a written request described in 19
13584	13584	subclause (III) within 90 days of the request, 20
13585	13585	the responsible plan fiduciary notifies the Sec-21
13586	13586	retary of the covered service provider’s failure, 22
13587	13587	in accordance with subclauses (III) and (IV).’’; 23
13588	13588	and 24
13589	13589	(2) by adding at the end the following: 25
13590	13590	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00462 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13591	13591	TKELLEY on LAP7H3WLY3PROD with BILLS 463
13592	13592	•S 891 IS
13593	13593	‘‘(C)(i)(I) For plan years beginning on or after 1
13594	13594	the date that is 30 months after the date of enact-2
13595	13595	ment of this subparagraph (referred to in this clause 3
13596	13596	as the ‘effective date’), no contract or arrangement 4
13597	13597	or renewal or extension of a contract or arrange-5
13598	13598	ment, entered into on or after the effective date, for 6
13599	13599	services between a covered plan and a covered serv-7
13600	13600	ice provider, through a health insurance issuer offer-8
13601	13601	ing group health insurance coverage, a third-party 9
13602	13602	administrator, an entity providing pharmacy benefit 10
13603	13603	management services, or other entity, for pharmacy 11
13604	13604	benefit management services, is reasonable within 12
13605	13605	the meaning of this paragraph unless such entity 13
13606	13606	providing pharmacy benefit management services— 14
13607	13607	‘‘(aa) remits 100 percent of rebates, fees, 15
13608	13608	alternative discounts, and other remuneration 16
13609	13609	received from any applicable entity that are re-17
13610	13610	lated to utilization of drugs or drug spending 18
13611	13611	under such health plan or health insurance cov-19
13612	13612	erage, to the group health plan or health insur-20
13613	13613	ance issuer offering group health insurance cov-21
13614	13614	erage; and 22
13615	13615	‘‘(bb) does not enter into any contract for 23
13616	13616	pharmacy benefit management services on be-24
13617	13617	half of such a plan or coverage, with an applica-25
13618	13618	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00463 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13619	13619	TKELLEY on LAP7H3WLY3PROD with BILLS 464
13620	13620	•S 891 IS
13621	13621	ble entity unless 100 percent of rebates, fees, 1
13622	13622	alternative discounts, and other remuneration 2
13623	13623	received under such contract that are related to 3
13624	13624	the utilization of drugs or drug spending under 4
13625	13625	such group health plan or health insurance cov-5
13626	13626	erage are remitted to the group health plan or 6
13627	13627	health insurance issuer by the entity providing 7
13628	13628	pharmacy benefit management services. 8
13629	13629	‘‘(II) Nothing in subclause (I) shall be con-9
13630	13630	strued to affect the term of a contract or arrange-10
13631	13631	ment, as in effect on the effective date (as described 11
13632	13632	in such subclause), except that such subclause shall 12
13633	13633	apply to any renewal or extension of such a contract 13
13634	13634	or arrangement entered into on or after such effec-14
13635	13635	tive date, as so described. 15
13636	13636	‘‘(ii) With respect to such rebates, fees, alter-16
13637	13637	native discounts, and other remuneration— 17
13638	13638	‘‘(I) the rebates, fees, alternative dis-18
13639	13639	counts, and other remuneration under clause 19
13640	13640	(i)(I) shall be— 20
13641	13641	‘‘(aa) remitted— 21
13642	13642	‘‘(AA) on a quarterly basis, to 22
13643	13643	the group health plan or the group 23
13644	13644	health insurance issuer, not later than 24
13645	13645	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00464 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13646	13646	TKELLEY on LAP7H3WLY3PROD with BILLS 465
13647	13647	•S 891 IS
13648	13648	90 days after the end of each quarter; 1
13649	13649	or 2
13650	13650	‘‘(BB) in the case of an under-3
13651	13651	payment in a remittance for a prior 4
13652	13652	quarter, as soon as practicable, but 5
13653	13653	not later than 90 days after notice of 6
13654	13654	the underpayment is first given; 7
13655	13655	‘‘(bb) fully disclosed and enumerated 8
13656	13656	to the group health plan or health insur-9
13657	13657	ance issuer; and 10
13658	13658	‘‘(cc) returned to the covered service 11
13659	13659	provider for pharmacy benefit management 12
13660	13660	services on behalf of the group health plan 13
13661	13661	if any audit by a plan sponsor, issuer or a 14
13662	13662	third party designated by a plan sponsor, 15
13663	13663	indicates that the amounts received are in-16
13664	13664	correct after such amounts have been paid 17
13665	13665	to the group health plan or health insur-18
13666	13666	ance issuer; 19
13667	13667	‘‘(II) the Secretary may establish proce-20
13668	13668	dures for the remittance of rebates fees, alter-21
13669	13669	native discounts, and other remuneration under 22
13670	13670	subclause (I)(aa) and the disclosure of rebates, 23
13671	13671	fees, alternative discounts, and other remunera-24
13672	13672	tion under subclause (I)(bb); and 25
13673	13673	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00465 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13674	13674	TKELLEY on LAP7H3WLY3PROD with BILLS 466
13675	13675	•S 891 IS
13676	13676	‘‘(III) the records of such rebates, fees, al-1
13677	13677	ternative discounts, and other remuneration 2
13678	13678	shall be available for audit by the plan sponsor, 3
13679	13679	issuer, or a third party designated by a plan 4
13680	13680	sponsor, not less than once per plan year. 5
13681	13681	‘‘(iii) To ensure that an entity providing phar-6
13682	13682	macy benefit management services is able to meet 7
13683	13683	the requirements of clause (ii)(I), a rebate 8
13684	13684	aggregator (or other purchasing entity designed to 9
13685	13685	aggregate rebates) and an applicable group pur-10
13686	13686	chasing organization shall remit such rebates to the 11
13687	13687	entity providing pharmacy benefit management serv-12
13688	13688	ices not later than 45 days after the end of each 13
13689	13689	quarter. 14
13690	13690	‘‘(iv) A third-party administrator of a group 15
13691	13691	health plan, a health insurance issuer offering group 16
13692	13692	health insurance coverage, or a covered service pro-17
13693	13693	vider for pharmacy benefit management services 18
13694	13694	under such health plan or health insurance coverage 19
13695	13695	shall make rebate contracts with rebate aggregators 20
13696	13696	or drug manufacturers available for audit by such 21
13697	13697	plan sponsor or designated third party, subject to 22
13698	13698	reasonable restrictions (as determined by the Sec-23
13699	13699	retary) on confidentiality to prevent re-disclosure of 24
13700	13700	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00466 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13701	13701	TKELLEY on LAP7H3WLY3PROD with BILLS 467
13702	13702	•S 891 IS
13703	13703	such contracts or use of such information in audits 1
13704	13704	for purposes unrelated to this section. 2
13705	13705	‘‘(v) Audits carried out under clauses (ii)(III) 3
13706	13706	and (iv) shall be performed by an auditor selected by 4
13707	13707	the responsible plan fiduciary. Payment for such au-5
13708	13708	dits shall not be made, whether directly or indirectly, 6
13709	13709	by the entity providing pharmacy benefit manage-7
13710	13710	ment services. 8
13711	13711	‘‘(vi) Nothing in this subparagraph shall be 9
13712	13712	construed to— 10
13713	13713	‘‘(I) prohibit reasonable payments to enti-11
13714	13714	ties offering pharmacy benefit management 12
13715	13715	services for bona fide services using a fee struc-13
13716	13716	ture not described in this subparagraph, pro-14
13717	13717	vided that such fees are transparent and quan-15
13718	13718	tifiable to group health plans and health insur-16
13719	13719	ance issuers; 17
13720	13720	‘‘(II) require a third-party administrator of 18
13721	13721	a group health plan or covered service provider 19
13722	13722	for pharmacy benefit management services 20
13723	13723	under such health plan or health insurance cov-21
13724	13724	erage to remit bona fide service fees to the 22
13725	13725	group health plan; 23
13726	13726	‘‘(III) limit the ability of a group health 24
13727	13727	plan or health insurance issuer to pass through 25
13728	13728	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00467 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13729	13729	TKELLEY on LAP7H3WLY3PROD with BILLS 468
13730	13730	•S 891 IS
13731	13731	rebates, fees, alternative discounts, and other 1
13732	13732	remuneration to the participant or beneficiary; 2
13733	13733	or 3
13734	13734	‘‘(IV) modify the requirements for the cre-4
13735	13735	ation, receipt, maintenance, or transmission of 5
13736	13736	protected health information under the privacy 6
13737	13737	regulations promulgated under the Health In-7
13738	13738	surance Portability and Accountability Act of 8
13739	13739	1996 in part 160 and subparts A and E of part 9
13740	13740	164 of title 45, Code of Federal Regulations (or 10
13741	13741	successor regulations). 11
13742	13742	‘‘(vii) For purposes of this subparagraph— 12
13743	13743	‘‘(I) the terms ‘applicable entity’ and ‘ap-13
13744	13744	plicable group purchasing organization’ have 14
13745	13745	the meanings given such terms in section 15
13746	13746	726(e); 16
13747	13747	‘‘(II) the terms ‘covered plan’, ‘covered 17
13748	13748	service provider’, and ‘responsible plan fidu-18
13749	13749	ciary’ have the meanings given such terms in 19
13750	13750	subparagraph (B); and 20
13751	13751	‘‘(III) the terms ‘group health insurance 21
13752	13752	coverage’, ‘health insurance coverage’, and 22
13753	13753	‘health insurance issuer’ have the meanings 23
13754	13754	given such terms in section 733.’’. 24
13755	13755	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00468 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13756	13756	TKELLEY on LAP7H3WLY3PROD with BILLS 469
13757	13757	•S 891 IS
13758	13758	(b) RULE OFCONSTRUCTION.—Subclause (II)(aa) of 1
13759	13759	section 408(b)(2)(B)(viii) of the Employee Retirement In-2
13760	13760	come Security Act of 1974 (29 U.S.C. 3
13761	13761	1108(b)(2)(B)(viii)), as amended by subsection (a), shall 4
13762	13762	not be construed to relieve or limit a responsible plan fidu-5
13763	13763	ciary from the duty to monitor the practices of any covered 6
13764	13764	service provider that contracts with the applicable covered 7
13765	13765	plan, including for the purposes of ensuring the reason-8
13766	13766	ableness of compensation. For purposes of this subsection, 9
13767	13767	the terms ‘‘covered plan’’, ‘‘covered service provider’’, and 10
13768	13768	‘‘responsible plan fiduciary’’ have the meanings given such 11
13769	13769	terms in section 408(b)(2)(B)(ii) of the Employee Retire-12
13770	13770	ment Income Security Act of 1974 (29 U.S.C. 13
13771	13771	1108(b)(2)(B)(ii)). 14
13772	13772	(c) C
13773	13773	LARIFICATION OF COVEREDSERVICEPRO-15
13774	13774	VIDER.— 16
13775	13775	(1) S
13776	13776	ERVICES.— 17
13777	13777	(A) I
13778	13778	N GENERAL .—Section 18
13779	13779	408(b)(2)(B)(ii)(I)(bb) of the Employee Retire-19
13780	13780	ment Income Security Act of 1974 (29 U.S.C. 20
13781	13781	1108(b)(2)(B)(ii)(I)(bb)) is amended— 21
13782	13782	(i) in subitem (AA) by striking ‘‘Bro-22
13783	13783	kerage services,’’ and inserting ‘‘Services 23
13784	13784	(including brokerage services),’’; and 24
13785	13785	(ii) in subitem (BB)— 25
13786	13786	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00469 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13787	13787	TKELLEY on LAP7H3WLY3PROD with BILLS 470
13788	13788	•S 891 IS
13789	13789	(I) by striking ‘‘Consulting,’’ and 1
13790	13790	inserting ‘‘Other services,’’; and 2
13791	13791	(II) by striking ‘‘related to the 3
13792	13792	development or implementation of 4
13793	13793	plan design’’ and all that follows 5
13794	13794	through the period at the end and in-6
13795	13795	serting ‘‘including any of the fol-7
13796	13796	lowing: plan design, insurance or in-8
13797	13797	surance product selection (including 9
13798	13798	vision and dental), recordkeeping, 10
13799	13799	medical management, benefits admin-11
13800	13800	istration selection (including vision 12
13801	13801	and dental), stop-loss insurance, phar-13
13802	13802	macy benefit management services, 14
13803	13803	wellness design and management serv-15
13804	13804	ices, transparency tools, group pur-16
13805	13805	chasing organization agreements and 17
13806	13806	services, participation in and services 18
13807	13807	from preferred vendor panels, disease 19
13808	13808	management, compliance services, em-20
13809	13809	ployee assistance programs, or third- 21
13810	13810	party administration services, or con-22
13811	13811	sulting services related to any such 23
13812	13812	services.’’. 24
13813	13813	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00470 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13814	13814	TKELLEY on LAP7H3WLY3PROD with BILLS 471
13815	13815	•S 891 IS
13816	13816	(B) SENSE OF CONGRESS.—It is the sense 1
13817	13817	of Congress that the amendment made by sub-2
13818	13818	paragraph (A) clarifies the existing requirement 3
13819	13819	of covered service providers with respect to 4
13820	13820	services described in section 5
13821	13821	408(b)(2)(B)(ii)(I)(bb)(BB) of the Employee 6
13822	13822	Retirement Income Security Act of 1974 (29 7
13823	13823	U.S.C. 1108(b)(2)(B)(ii)(I)(bb)(BB)) that were 8
13824	13824	in effect since the application date described in 9
13825	13825	section 202(e) of the No Surprises Act (Public 10
13826	13826	Law 116–260; 29 U.S.C. 1108 note), and does 11
13827	13827	not impose any additional requirement under 12
13828	13828	section 408(b)(2)(B) of such Act. 13
13829	13829	(2) C
13830	13830	ERTAIN ARRANGEMENTS FOR PHARMACY 14
13831	13831	BENEFIT MANAGEMENT SERVICES CONSIDERED AS 15
13832	13832	INDIRECT.— 16
13833	13833	(A) I
13834	13834	N GENERAL.—Section 408(b)(2)(B)(i) 17
13835	13835	of the Employee Retirement Income Security 18
13836	13836	Act of 1974 (29 U.S.C. 1108(b)(2)(B)(i)) is 19
13837	13837	amended— 20
13838	13838	(i) by striking ‘‘requirements of this 21
13839	13839	clause’’ and inserting ‘‘requirements of this 22
13840	13840	subparagraph’’; and 23
13841	13841	(ii) by adding at the end the fol-24
13842	13842	lowing: ‘‘For purposes of applying section 25
13843	13843	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00471 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13844	13844	TKELLEY on LAP7H3WLY3PROD with BILLS 472
13845	13845	•S 891 IS
13846	13846	406(a)(1)(C) with respect to a transaction 1
13847	13847	described under this subparagraph or sub-2
13848	13848	paragraph (C), a contract or arrangement 3
13849	13849	for services between a covered plan and an 4
13850	13850	entity providing services to the plan, in-5
13851	13851	cluding a health insurance issuer providing 6
13852	13852	health insurance coverage in connection 7
13853	13853	with the covered plan, in which such entity 8
13854	13854	contracts, in connection with such plan, 9
13855	13855	with a service provider for pharmacy ben-10
13856	13856	efit management services, shall be consid-11
13857	13857	ered an indirect furnishing of goods, serv-12
13858	13858	ices, or facilities between the covered plan 13
13859	13859	and the service provider for pharmacy ben-14
13860	13860	efit management services acting as the 15
13861	13861	party in interest.’’. 16
13862	13862	(B) H
13863	13863	EALTH INSURANCE ISSUER AND 17
13864	13864	HEALTH INSURANCE COVERAGE DEFINED .— 18
13865	13865	Section 408(b)(2)(B)(ii)(I)(aa) of such Act (29 19
13866	13866	U.S.C. 1108(b)(2)(B)(ii)(I)(aa)) is amended by 20
13867	13867	inserting before the period at the end ‘‘and the 21
13868	13868	terms ‘health insurance coverage’ and ‘health 22
13869	13869	insurance issuer’ have the meanings given such 23
13870	13870	terms in section 733(b)’’. 24
13871	13871	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00472 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13872	13872	TKELLEY on LAP7H3WLY3PROD with BILLS 473
13873	13873	•S 891 IS
13874	13874	(C) TECHNICAL AMENDMENT .—Section 1
13875	13875	408(b)(2)(B)(ii)(I)(aa) of the Employee Retire-2
13876	13876	ment Income Security Act of 1974 (29 U.S.C. 3
13877	13877	1108(b)(2)(B)(ii)(I)(aa)) is amended by insert-4
13878	13878	ing ‘‘in’’ after ‘‘defined’’. 5
13879	13879	SEC. 903. INCREASING TRANSPARENCY IN GENERIC DRUG 6
13880	13880	APPLICATIONS. 7
13881	13881	(a) I
13882	13882	NGENERAL.—Section 505(j)(3) of the Federal 8
13883	13883	Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is 9
13884	13884	amended by adding at the end the following: 10
13885	13885	‘‘(H)(i) Upon request (in controlled correspondence 11
13886	13886	or an analogous process) by a person that has submitted 12
13887	13887	or intends to submit an abbreviated application under this 13
13888	13888	subsection for a drug that is required by regulation to con-14
13889	13889	tain one or more of the same inactive ingredients in the 15
13890	13890	same concentrations as the listed drug referred to, or for 16
13891	13891	which the Secretary determines there is a scientific jus-17
13892	13892	tification for an approach that is in vitro, in whole or in 18
13893	13893	part, to be used to demonstrate bioequivalence for a drug 19
13894	13894	if such a drug contains one or more of the same inactive 20
13895	13895	ingredients in the same concentrations as the listed drug 21
13896	13896	referred to, the Secretary shall inform the person whether 22
13897	13897	such drug is qualitatively and quantitatively the same as 23
13898	13898	the listed drug. The Secretary may also provide such infor-24
13899	13899	mation to such a person on the Secretary’s own initiative 25
13900	13900	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00473 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13901	13901	TKELLEY on LAP7H3WLY3PROD with BILLS 474
13902	13902	•S 891 IS
13903	13903	during the review of an abbreviated application under this 1
13904	13904	subsection for such drug. 2
13905	13905	‘‘(ii) Notwithstanding section 301(j), if the Secretary 3
13906	13906	determines that such drug is not qualitatively or quan-4
13907	13907	titatively the same as the listed drug, the Secretary shall 5
13908	13908	identify and disclose to the person— 6
13909	13909	‘‘(I) the ingredient or ingredients that cause 7
13910	13910	such drug not to be qualitatively or quantitatively 8
13911	13911	the same as the listed drug; and 9
13912	13912	‘‘(II) for any ingredient for which there is an 10
13913	13913	identified quantitative deviation, the amount of such 11
13914	13914	deviation. 12
13915	13915	‘‘(iii) If the Secretary determines that such drug is 13
13916	13916	qualitatively and quantitatively the same as the listed 14
13917	13917	drug, the Secretary shall not change or rescind such deter-15
13918	13918	mination after the submission of an abbreviated applica-16
13919	13919	tion for such drug under this subsection unless— 17
13920	13920	‘‘(I) the formulation of the listed drug has been 18
13921	13921	changed and the Secretary has determined that the 19
13922	13922	prior listed drug formulation was withdrawn for rea-20
13923	13923	sons of safety or effectiveness; or 21
13924	13924	‘‘(II) the Secretary makes a written determina-22
13925	13925	tion that the prior determination must be changed 23
13926	13926	because an error has been identified. 24
13927	13927	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00474 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13928	13928	TKELLEY on LAP7H3WLY3PROD with BILLS 475
13929	13929	•S 891 IS
13930	13930	‘‘(iv) If the Secretary makes a written determination 1
13931	13931	described in clause (iii)(II), the Secretary shall provide no-2
13932	13932	tice and a copy of the written determination to the person 3
13933	13933	making the request under clause (i). 4
13934	13934	‘‘(v) The disclosures authorized under clauses (i) and 5
13935	13935	(ii) are disclosures authorized by law, including for pur-6
13936	13936	poses of section 1905 of title 18, United States Code. This 7
13937	13937	subparagraph shall not otherwise be construed to author-8
13938	13938	ize the disclosure of nonpublic qualitative or quantitative 9
13939	13939	information about the ingredients in a listed drug, or to 10
13940	13940	affect the status, if any, of such information as trade se-11
13941	13941	cret or confidential commercial information for purposes 12
13942	13942	of section 301(j) of this Act, section 552 of title 5, United 13
13943	13943	States Code, or section 1905 of title 18, United States 14
13944	13944	Code.’’. 15
13945	13945	(b) G
13946	13946	UIDANCE.— 16
13947	13947	(1) I
13948	13948	N GENERAL.—Not later than one year 17
13949	13949	after the date of enactment of this Act, the Sec-18
13950	13950	retary of Health and Human Services shall issue 19
13951	13951	draft guidance, or update guidance, describing how 20
13952	13952	the Secretary will determine whether a drug is quali-21
13953	13953	tatively and quantitatively the same as the listed 22
13954	13954	drug (as such terms are used in section 23
13955	13955	505(j)(3)(H) of the Federal Food, Drug, and Cos-24
13956	13956	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00475 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13957	13957	TKELLEY on LAP7H3WLY3PROD with BILLS 476
13958	13958	•S 891 IS
13959	13959	metic Act, as added by subsection (a)), including 1
13960	13960	with respect to assessing pH adjusters. 2
13961	13961	(2) P
13962	13962	ROCESS.—In issuing guidance under this 3
13963	13963	subsection, the Secretary of Health and Human 4
13964	13964	Services shall— 5
13965	13965	(A) publish draft guidance; 6
13966	13966	(B) provide a period of at least 60 days for 7
13967	13967	comment on the draft guidance; and 8
13968	13968	(C) after considering any comments re-9
13969	13969	ceived and not later than one year after the 10
13970	13970	close of the comment period on the draft guid-11
13971	13971	ance, publish final guidance. 12
13972	13972	(c) A
13973	13973	PPLICABILITY.—Section 505(j)(3)(H) of the 13
13974	13974	Federal Food, Drug, and Cosmetic Act, as added by sub-14
13975	13975	section (a), applies beginning on the date of enactment 15
13976	13976	of this Act, irrespective of the date on which the guidance 16
13977	13977	required by subsection (b) is finalized. 17
13978	13978	SEC. 904. TITLE 35 AMENDMENTS. 18
13979	13979	(a) I
13980	13980	NGENERAL.—Section 271(e) of title 35, United 19
13981	13981	States Code, is amended— 20
13982	13982	(1) in paragraph (2)(C), in the flush text fol-21
13983	13983	lowing clause (ii), by adding at the end the fol-22
13984	13984	lowing: ‘‘With respect to a submission described in 23
13985	13985	clause (ii), the act of infringement shall extend to 24
13986	13986	any patent that claims the biological product, a 25
13987	13987	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00476 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
13988	13988	TKELLEY on LAP7H3WLY3PROD with BILLS 477
13989	13989	•S 891 IS
13990	13990	method of using the biological product, or a method 1
13991	13991	or product used to manufacture the biological prod-2
13992	13992	uct.’’; and 3
13993	13993	(2) by adding at the end the following: 4
13994	13994	‘‘(7)(A) Subject to subparagraphs (C), (D), and (E), 5
13995	13995	if the sponsor of an approved application for a reference 6
13996	13996	product, as defined in section 351(i) of the Public Health 7
13997	13997	Service Act (42 U.S.C. 262(i)) (referred to in this para-8
13998	13998	graph as the ‘reference product sponsor’), brings an action 9
13999	13999	for infringement under this section against an applicant 10
14000	14000	for approval of a biological product under section 351(k) 11
14001	14001	of such Act that references that reference product (re-12
14002	14002	ferred to in this paragraph as the ‘subsection (k) appli-13
14003	14003	cant’), the reference product sponsor may assert in the 14
14004	14004	action a total of not more than 20 patents of the type 15
14005	14005	described in subparagraph (B), not more than 10 of which 16
14006	14006	shall have issued after the date specified in section 17
14007	14007	351(l)(7)(A) of such Act. 18
14008	14008	‘‘(B) The patents described in this subparagraph are 19
14009	14009	patents that satisfy each of the following requirements: 20
14010	14010	‘‘(i) Patents that claim the biological product 21
14011	14011	that is the subject of an application under section 22
14012	14012	351(k) of the Public Health Service Act (42 U.S.C. 23
14013	14013	262(k)) (or a use of that product) or a method or 24
14014	14014	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00477 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
14015	14015	TKELLEY on LAP7H3WLY3PROD with BILLS 478
14016	14016	•S 891 IS
14017	14017	product used in the manufacture of such biological 1
14018	14018	product. 2
14019	14019	‘‘(ii) Patents that are included on the list of 3
14020	14020	patents described in paragraph (3)(A) of section 4
14021	14021	351(l) of the Public Health Service Act (42 U.S.C. 5
14022	14022	262(l)), including as provided under paragraph (7) 6
14023	14023	of such section 351(l). 7
14024	14024	‘‘(iii) Patents that— 8
14025	14025	‘‘(I) have an actual filing date of more 9
14026	14026	than 4 years after the date on which the ref-10
14027	14027	erence product is approved; or 11
14028	14028	‘‘(II) include a claim to a method in a 12
14029	14029	manufacturing process that is not used by the 13
14030	14030	reference product sponsor. 14
14031	14031	‘‘(C) The court in which an action described in sub-15
14032	14032	paragraph (A) is brought may increase the number of pat-16
14033	14033	ents limited under that subparagraph— 17
14034	14034	‘‘(i) if the request to increase that number is 18
14035	14035	made without undue delay; and 19
14036	14036	‘‘(ii)(I) if the interest of justice so requires; or 20
14037	14037	‘‘(II) for good cause shown, which— 21
14038	14038	‘‘(aa) shall be established if the subsection 22
14039	14039	(k) applicant fails to provide information re-23
14040	14040	quired section 351(k)(2)(A) of the Public 24
14041	14041	Health Service Act (42 U.S.C. 262(k)(2)(A)) 25
14042	14042	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00478 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
14043	14043	TKELLEY on LAP7H3WLY3PROD with BILLS 479
14044	14044	•S 891 IS
14045	14045	that would enable the reference product sponsor 1
14046	14046	to form a reasonable belief with respect to 2
14047	14047	whether a claim of infringement under this sec-3
14048	14048	tion could reasonably be asserted; and 4
14049	14049	‘‘(bb) may be established— 5
14050	14050	‘‘(AA) if there is a material change to 6
14051	14051	the biological product (or process with re-7
14052	14052	spect to the biological product) of the sub-8
14053	14053	section (k) applicant that is the subject of 9
14054	14054	the application; 10
14055	14055	‘‘(BB) if, with respect to a patent on 11
14056	14056	the supplemental list described in section 12
14057	14057	351(l)(7)(A) of Public Health Service Act 13
14058	14058	(42 U.S.C. 262(l)(7)(A)), the patent would 14
14059	14059	have issued before the date specified in 15
14060	14060	such section 351(l)(7)(A) but for the fail-16
14061	14061	ure of the Office to issue the patent or a 17
14062	14062	delay in the issuance of the patent, as de-18
14063	14063	scribed in paragraph (1) of section 154(b) 19
14064	14064	and subject to the limitations under para-20
14065	14065	graph (2) of such section 154(b); or 21
14066	14066	‘‘(CC) for another reason that shows 22
14067	14067	good cause, as determined appropriate by 23
14068	14068	the court. 24
14069	14069	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00479 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
14070	14070	TKELLEY on LAP7H3WLY3PROD with BILLS 480
14071	14071	•S 891 IS
14072	14072	‘‘(D) In determining whether good cause has been 1
14073	14073	shown for the purposes of subparagraph (C)(ii)(II), a 2
14074	14074	court may consider whether the reference product sponsor 3
14075	14075	has provided a reasonable description of the identity and 4
14076	14076	relevance of any information beyond the subsection (k) ap-5
14077	14077	plication that the court believes is necessary to enable the 6
14078	14078	court to form a belief with respect to whether a claim of 7
14079	14079	infringement under this section could reasonably be as-8
14080	14080	serted. 9
14081	14081	‘‘(E) The limitation imposed under subparagraph 10
14082	14082	(A)— 11
14083	14083	‘‘(i) shall apply only if the subsection (k) appli-12
14084	14084	cant completes all actions required under paragraphs 13
14085	14085	(2)(A), (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of 14
14086	14086	section 351(l) of the Public Health Service Act (42 15
14087	14087	U.S.C. 262(l)); and 16
14088	14088	‘‘(ii) shall not apply with respect to any patent 17
14089	14089	that claims, with respect to a biological product, a 18
14090	14090	method for using that product in therapy, diagnosis, 19
14091	14091	or prophylaxis, such as an indication or method of 20
14092	14092	treatment or other condition of use.’’. 21
14093	14093	(b) A
14094	14094	PPLICABILITY.—The amendments made by sub-22
14095	14095	section (a) shall apply with respect to an application sub-23
14096	14096	mitted under section 351(k) of the Public Health Service 24
14097	14097	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00480 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
14098	14098	TKELLEY on LAP7H3WLY3PROD with BILLS 481
14099	14099	•S 891 IS
14100	14100	Act (42 U.S.C. 262(k)) on or after the date of enactment 1
14101	14101	of this Act. 2
14102	14102	TITLE X—MISCELLANEOUS 3
14103	14103	SEC. 1001. EXTENSION OF SAFE HARBOR FOR ABSENCE OF 4
14104	14104	DEDUCTIBLE FOR TELEHEALTH. 5
14105	14105	Section 223(c)(2)(E)(ii) of the Internal Revenue 6
14106	14106	Code of 1986 is amended to read as follows: 7
14107	14107	‘‘(ii) S
14108	14108	AFE HARBOR FOR ABSENCE OF 8
14109	14109	DEDUCTIBLE FOR TELEHEALTH .— 9
14110	14110	‘‘(I) I
14111	14111	N GENERAL.—In the case 10
14112	14112	of an eligible month or an eligible 11
14113	14113	plan year, a plan shall not fail to be 12
14114	14114	treated as a high deductible health 13
14115	14115	plan by reason of failing to have a de-14
14116	14116	ductible for telehealth and other re-15
14117	14117	mote care services. 16
14118	14118	‘‘(II) E
14119	14119	LIGIBLE MONTH .—For 17
14120	14120	purposes of this clause, the term ‘eli-18
14121	14121	gible month’ means months beginning 19
14122	14122	after March 31, 2022, and before 20
14123	14123	January 1, 2023, and months begin-21
14124	14124	ning after March 31, 2025, and be-22
14125	14125	fore January 1, 2026. 23
14126	14126	‘‘(III) E
14127	14127	LIGIBLE PLAN YEAR .— 24
14128	14128	For purposes of this clause, the term 25
14129	14129	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00481 Fmt 6652 Sfmt 6201 E:\BILLS\S891.IS S891
14130	14130	TKELLEY on LAP7H3WLY3PROD with BILLS 482
14131	14131	•S 891 IS
14132	14132	‘eligible plan year’ means plan years 1
14133	14133	beginning— 2
14134	14134	‘‘(aa) on or before December 3
14135	14135	31, 2021, 4
14136	14136	‘‘(bb) after December 31, 5
14137	14137	2022, and before January 1, 6
14138	14138	2025, or 7
14139	14139	‘‘(cc) after December 31, 8
14140	14140	2024, and before January 1, 9
14141	14141	2027.’’. 10
14142	14142	Æ
14143	14143	VerDate Sep 11 2014 17:45 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00482 Fmt 6652 Sfmt 6301 E:\BILLS\S891.IS S891
14144	14144	TKELLEY on LAP7H3WLY3PROD with BILLS