Us Congress 2025-2026 Regular Session

Us Congress House Bill HB2450 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	I
2	2	119THCONGRESS
3	3	1
4	4	STSESSION H. R. 2450
5	5	To amend the Public Health Service Act, the Employee Retirement Income
6	6	Security Act of 1974, and the Internal Revenue Code of 1984 to increase
7	7	oversight of pharmacy benefit management services, and for other pur-
8	8	poses.
9	9	IN THE HOUSE OF REPRESENTATIVES
10	10	MARCH27, 2025
11	11	Ms. M
12	12	CDONALDRIVET(for herself, Mr. CARTERof Georgia, Mr. MENENDEZ,
13	13	and Mr. J
14	14	AMES) introduced the following bill; which was referred to the
15	15	Committee on Energy and Commerce, and in addition to the Committees
16	16	on Education and Workforce, and Ways and Means, for a period to be
17	17	subsequently determined by the Speaker, in each case for consideration
18	18	of such provisions as fall within the jurisdiction of the committee con-
19	19	cerned
20	20	A BILL
21	21	To amend the Public Health Service Act, the Employee Re-
22	22	tirement Income Security Act of 1974, and the Internal
23	23	Revenue Code of 1984 to increase oversight of pharmacy
24	24	benefit management services, and for other purposes.
25	25	Be it enacted by the Senate and House of Representa-1
26	26	tives of the United States of America in Congress assembled, 2
27	27	SECTION 1. SHORT TITLE. 3
28	28	This Act may be cited as the ‘‘Prescription Drug 4
29	29	Transparency and Affordability Act’’. 5
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32	32	•HR 2450 IH
33	33	SEC. 2. OVERSIGHT OF PHARMACY BENEFIT MANAGEMENT 1
34	34	SERVICES. 2
35	35	(a) P
36	36	UBLICHEALTHSERVICEACT.—Title XXVII of 3
37	37	the Public Health Service Act (42 U.S.C. 300gg et seq.) 4
38	38	is amended— 5
39	39	(1) in part D (42 U.S.C. 300gg–111 et seq.), 6
40	40	by adding at the end the following new section: 7
41	41	‘‘SEC. 2799A–11. OVERSIGHT OF ENTITIES THAT PROVIDE 8
42	42	PHARMACY BENEFIT MANAGEMENT SERV-9
43	43	ICES. 10
44	44	‘‘(a) I
45	45	NGENERAL.—For plan years beginning on or 11
46	46	after the date that is 30 months after the date of enact-12
47	47	ment of this section (referred to in this subsection and 13
48	48	subsection (b) as the ‘effective date’), a group health plan 14
49	49	or a health insurance issuer offering group health insur-15
50	50	ance coverage, or an entity providing pharmacy benefit 16
51	51	management services on behalf of such a plan or issuer, 17
52	52	shall not enter into a contract, including an extension or 18
53	53	renewal of a contract, entered into on or after the effective 19
54	54	date, with an applicable entity unless such applicable enti-20
55	55	ty agrees to— 21
56	56	‘‘(1) not limit or delay the disclosure of infor-22
57	57	mation to the group health plan (including such a 23
58	58	plan offered through a health insurance issuer) in 24
59	59	such a manner that prevents an entity providing 25
60	60	pharmacy benefit management services on behalf of 26
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63	63	•HR 2450 IH
64	64	a group health plan or health insurance issuer offer-1
65	65	ing group health insurance coverage from making 2
66	66	the reports described in subsection (b); and 3
67	67	‘‘(2) provide the entity providing pharmacy ben-4
68	68	efit management services on behalf of a group health 5
69	69	plan or health insurance issuer relevant information 6
70	70	necessary to make the reports described in sub-7
71	71	section (b). 8
72	72	‘‘(b) R
73	73	EPORTS.— 9
74	74	‘‘(1) I
75	75	N GENERAL.—For plan years beginning 10
76	76	on or after the effective date, in the case of any con-11
77	77	tract between a group health plan or a health insur-12
78	78	ance issuer offering group health insurance coverage 13
79	79	offered in connection with such a plan and an entity 14
80	80	providing pharmacy benefit management services on 15
81	81	behalf of such plan or issuer, including an extension 16
82	82	or renewal of such a contract, entered into on or 17
83	83	after the effective date, the entity providing phar-18
84	84	macy benefit management services on behalf of such 19
85	85	a group health plan or health insurance issuer, not 20
86	86	less frequently than every 6 months (or, at the re-21
87	87	quest of a group health plan, not less frequently 22
88	88	than quarterly, and under the same conditions, 23
89	89	terms, and cost of the semiannual report under this 24
90	90	subsection), shall submit to the group health plan a 25
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93	93	•HR 2450 IH
94	94	report in accordance with this section. Each such re-1
95	95	port shall be made available to such group health 2
96	96	plan in plain language, in a machine-readable for-3
97	97	mat, and as the Secretary may determine, other for-4
98	98	mats. Each such report shall include the information 5
99	99	described in paragraph (2). 6
100	100	‘‘(2) I
101	101	NFORMATION DESCRIBED .—For purposes 7
102	102	of paragraph (1), the information described in this 8
103	103	paragraph is, with respect to drugs covered by a 9
104	104	group health plan or group health insurance cov-10
105	105	erage offered by a health insurance issuer in connec-11
106	106	tion with a group health plan during each reporting 12
107	107	period— 13
108	108	‘‘(A) in the case of a group health plan 14
109	109	that is offered by a specified large employer or 15
110	110	that is a specified large plan, and is not offered 16
111	111	as health insurance coverage, or in the case of 17
112	112	health insurance coverage for which the election 18
113	113	under paragraph (3) is made for the applicable 19
114	114	reporting period— 20
115	115	‘‘(i) a list of drugs for which a claim 21
116	116	was filed and, with respect to each such 22
117	117	drug on such list— 23
118	118	‘‘(I) the contracted compensation 24
119	119	paid by the group health plan or 25
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122	122	•HR 2450 IH
123	123	health insurance issuer for each cov-1
124	124	ered drug (identified by the National 2
125	125	Drug Code) to the entity providing 3
126	126	pharmacy benefit management serv-4
127	127	ices or other applicable entity on be-5
128	128	half of the group health plan or health 6
129	129	insurance issuer; 7
130	130	‘‘(II) the contracted compensa-8
131	131	tion paid to the pharmacy, by any en-9
132	132	tity providing pharmacy benefit man-10
133	133	agement services or other applicable 11
134	134	entity on behalf of the group health 12
135	135	plan or health insurance issuer, for 13
136	136	each covered drug (identified by the 14
137	137	National Drug Code); 15
138	138	‘‘(III) for each such claim, the 16
139	139	difference between the amount paid 17
140	140	under subclause (I) and the amount 18
141	141	paid under subclause (II); 19
142	142	‘‘(IV) the proprietary name, es-20
143	143	tablished name or proper name, and 21
144	144	National Drug Code; 22
145	145	‘‘(V) for each claim for the drug 23
146	146	(including original prescriptions and 24
147	147	refills) and for each dosage unit of the 25
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150	150	•HR 2450 IH
151	151	drug for which a claim was filed, the 1
152	152	type of dispensing channel used to 2
153	153	furnish the drug, including retail, mail 3
154	154	order, or specialty pharmacy; 4
155	155	‘‘(VI) with respect to each drug 5
156	156	dispensed, for each type of dispensing 6
157	157	channel (including retail, mail order, 7
158	158	or specialty pharmacy)— 8
159	159	‘‘(aa) whether such drug is a 9
160	160	brand name drug or a generic 10
161	161	drug, and— 11
162	162	‘‘(AA) in the case of a 12
163	163	brand name drug, the whole-13
164	164	sale acquisition cost, listed 14
165	165	as cost per days supply and 15
166	166	cost per dosage unit, on the 16
167	167	date such drug was dis-17
168	168	pensed; and 18
169	169	‘‘(BB) in the case of a 19
170	170	generic drug, the average 20
171	171	wholesale price, listed as 21
172	172	cost per days supply and 22
173	173	cost per dosage unit, on the 23
174	174	date such drug was dis-24
175	175	pensed; and 25
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179	179	‘‘(bb) the total number of— 1
180	180	‘‘(AA) prescription 2
181	181	claims (including original 3
182	182	prescriptions and refills); 4
183	183	‘‘(BB) participants and 5
184	184	beneficiaries for whom a 6
185	185	claim for such drug was 7
186	186	filed through the applicable 8
187	187	dispensing channel; 9
188	188	‘‘(CC) dosage units and 10
189	189	dosage units per fill of such 11
190	190	drug; and 12
191	191	‘‘(DD) days supply of 13
192	192	such drug per fill; 14
193	193	‘‘(VII) the net price per course of 15
194	194	treatment or single fill, such as a 30- 16
195	195	day supply or 90-day supply to the 17
196	196	plan or coverage after rebates, fees, 18
197	197	alternative discounts, or other remu-19
198	198	neration received from applicable enti-20
199	199	ties; 21
200	200	‘‘(VIII) the total amount of out- 22
201	201	of-pocket spending by participants 23
202	202	and beneficiaries on such drug, in-24
203	203	cluding spending through copayments, 25
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207	207	coinsurance, and deductibles, but not 1
208	208	including any amounts spent by par-2
209	209	ticipants and beneficiaries on drugs 3
210	210	not covered under the plan or cov-4
211	211	erage, or for which no claim is sub-5
212	212	mitted under the plan or coverage; 6
213	213	‘‘(IX) the total net spending on 7
214	214	the drug; 8
215	215	‘‘(X) the total amount received, 9
216	216	or expected to be received, by the plan 10
217	217	or issuer from any applicable entity in 11
218	218	rebates, fees, alternative discounts, or 12
219	219	other remuneration; 13
220	220	‘‘(XI) the total amount received, 14
221	221	or expected to be received, by the enti-15
222	222	ty providing pharmacy benefit man-16
223	223	agement services, from applicable en-17
224	224	tities, in rebates, fees, alternative dis-18
225	225	counts, or other remuneration from 19
226	226	such entities— 20
227	227	‘‘(aa) for claims incurred 21
228	228	during the reporting period; and 22
229	229	‘‘(bb) that is related to utili-23
230	230	zation of such drug or spending 24
231	231	on such drug; and 25
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234	234	•HR 2450 IH
235	235	‘‘(XII) to the extent feasible, in-1
236	236	formation on the total amount of re-2
237	237	muneration for such drug, including 3
238	238	copayment assistance dollars paid, co-4
239	239	payment cards applied, or other dis-5
240	240	counts provided by each drug manu-6
241	241	facturer (or entity administering co-7
242	242	payment assistance on behalf of such 8
243	243	drug manufacturer), to the partici-9
244	244	pants and beneficiaries enrolled in 10
245	245	such plan or coverage; 11
246	246	‘‘(ii) a list of each therapeutic class 12
247	247	(as defined by the Secretary) for which a 13
248	248	claim was filed under the group health 14
249	249	plan or health insurance coverage during 15
250	250	the reporting period, and, with respect to 16
251	251	each such therapeutic class— 17
252	252	‘‘(I) the total gross spending on 18
253	253	drugs in such class before rebates, 19
254	254	price concessions, alternative dis-20
255	255	counts, or other remuneration from 21
256	256	applicable entities; 22
257	257	‘‘(II) the net spending in such 23
258	258	class after such rebates, price conces-24
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261	261	•HR 2450 IH
262	262	sions, alternative discounts, or other 1
263	263	remuneration from applicable entities; 2
264	264	‘‘(III) the total amount received, 3
265	265	or expected to be received, by the enti-4
266	266	ty providing pharmacy benefit man-5
267	267	agement services, from applicable en-6
268	268	tities, in rebates, fees, alternative dis-7
269	269	counts, or other remuneration from 8
270	270	such entities— 9
271	271	‘‘(aa) for claims incurred 10
272	272	during the reporting period; and 11
273	273	‘‘(bb) that is related to utili-12
274	274	zation of drugs or drug spending; 13
275	275	‘‘(IV) the average net spending 14
276	276	per 30-day supply and per 90-day 15
277	277	supply by the plan or by the issuer 16
278	278	with respect to such coverage and its 17
279	279	participants and beneficiaries, among 18
280	280	all drugs within the therapeutic class 19
281	281	for which a claim was filed during the 20
282	282	reporting period; 21
283	283	‘‘(V) the number of participants 22
284	284	and beneficiaries who filled a prescrip-23
285	285	tion for a drug in such class, includ-24
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288	288	•HR 2450 IH
289	289	ing the National Drug Code for each 1
290	290	such drug; 2
291	291	‘‘(VI) if applicable, a description 3
292	292	of the formulary tiers and utilization 4
293	293	mechanisms (such as prior authoriza-5
294	294	tion or step therapy) employed for 6
295	295	drugs in that class; and 7
296	296	‘‘(VII) the total out-of-pocket 8
297	297	spending under the plan or coverage 9
298	298	by participants and beneficiaries, in-10
299	299	cluding spending through copayments, 11
300	300	coinsurance, and deductibles, but not 12
301	301	including any amounts spent by par-13
302	302	ticipants and beneficiaries on drugs 14
303	303	not covered under the plan or cov-15
304	304	erage or for which no claim is sub-16
305	305	mitted under the plan or coverage; 17
306	306	‘‘(iii) with respect to any drug for 18
307	307	which gross spending under the group 19
308	308	health plan or health insurance coverage 20
309	309	exceeded $10,000 during the reporting pe-21
310	310	riod or, in the case that gross spending 22
311	311	under the group health plan or coverage 23
312	312	exceeded $10,000 during the reporting pe-24
313	313	riod with respect to fewer than 50 drugs, 25
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316	316	•HR 2450 IH
317	317	with respect to the 50 prescription drugs 1
318	318	with the highest spending during the re-2
319	319	porting period— 3
320	320	‘‘(I) a list of all other drugs in 4
321	321	the same therapeutic class as such 5
322	322	drug; 6
323	323	‘‘(II) if applicable, the rationale 7
324	324	for the formulary placement of such 8
325	325	drug in that therapeutic category or 9
326	326	class, selected from a list of standard 10
327	327	rationales established by the Sec-11
328	328	retary, in consultation with stake-12
329	329	holders; and 13
330	330	‘‘(III) any change in formulary 14
331	331	placement compared to the prior plan 15
332	332	year; and 16
333	333	‘‘(iv) in the case that such plan or 17
334	334	issuer (or an entity providing pharmacy 18
335	335	benefit management services on behalf of 19
336	336	such plan or issuer) has an affiliated phar-20
337	337	macy or pharmacy under common owner-21
338	338	ship, including mandatory mail and spe-22
339	339	cialty home delivery programs, retail and 23
340	340	mail auto-refill programs, and cost sharing 24
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343	343	•HR 2450 IH
344	344	assistance incentives funded by an entity 1
345	345	providing pharmacy benefit services— 2
346	346	‘‘(I) an explanation of any ben-3
347	347	efit design parameters that encourage 4
348	348	or require participants and bene-5
349	349	ficiaries in the plan or coverage to fill 6
350	350	prescriptions at mail order, specialty, 7
351	351	or retail pharmacies; 8
352	352	‘‘(II) the percentage of total pre-9
353	353	scriptions dispensed by such phar-10
354	354	macies to participants or beneficiaries 11
355	355	in such plan or coverage; and 12
356	356	‘‘(III) a list of all drugs dis-13
357	357	pensed by such pharmacies to partici-14
358	358	pants or beneficiaries enrolled in such 15
359	359	plan or coverage, and, with respect to 16
360	360	each drug dispensed— 17
361	361	‘‘(aa) the amount charged, 18
362	362	per dosage unit, per 30-day sup-19
363	363	ply, or per 90-day supply (as ap-20
364	364	plicable) to the plan or issuer, 21
365	365	and to participants and bene-22
366	366	ficiaries; 23
367	367	‘‘(bb) the median amount 24
368	368	charged to such plan or issuer, 25
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371	371	•HR 2450 IH
372	372	and the interquartile range of the 1
373	373	costs, per dosage unit, per 30- 2
374	374	day supply, and per 90-day sup-3
375	375	ply, including amounts paid by 4
376	376	the participants and bene-5
377	377	ficiaries, when the same drug is 6
378	378	dispensed by other pharmacies 7
379	379	that are not affiliated with or 8
380	380	under common ownership with 9
381	381	the entity and that are included 10
382	382	in the pharmacy network of such 11
383	383	plan or coverage; 12
384	384	‘‘(cc) the lowest cost per 13
385	385	dosage unit, per 30-day supply 14
386	386	and per 90-day supply, for each 15
387	387	such drug, including amounts 16
388	388	charged to the plan or coverage 17
389	389	and to participants and bene-18
390	390	ficiaries, that is available from 19
391	391	any pharmacy included in the 20
392	392	network of such plan or coverage; 21
393	393	and 22
394	394	‘‘(dd) the net acquisition 23
395	395	cost per dosage unit, per 30-day 24
396	396	supply, and per 90-day supply, if 25
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400	400	such drug is subject to a max-1
401	401	imum price discount; and 2
402	402	‘‘(B) with respect to any group health 3
403	403	plan, including group health insurance coverage 4
404	404	offered in connection with such a plan, regard-5
405	405	less of whether the plan or coverage is offered 6
406	406	by a specified large employer or whether it is a 7
407	407	specified large plan— 8
408	408	‘‘(i) a summary document for the 9
409	409	group health plan that includes such infor-10
410	410	mation described in clauses (i) through (iv) 11
411	411	of subparagraph (A), as specified by the 12
412	412	Secretary through guidance, program in-13
413	413	struction, or otherwise (with no require-14
414	414	ment of notice and comment rulemaking), 15
415	415	that the Secretary determines useful to 16
416	416	group health plans for purposes of select-17
417	417	ing pharmacy benefit management serv-18
418	418	ices, such as an estimated net price to 19
419	419	group health plan and participant or bene-20
420	420	ficiary, a cost per claim, the fee structure 21
421	421	or reimbursement model, and estimated 22
422	422	cost per participant or beneficiary; 23
423	423	‘‘(ii) a summary document for plans 24
424	424	and issuers to provide to participants and 25
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428	428	beneficiaries, which shall be made available 1
429	429	to participants or beneficiaries upon re-2
430	430	quest to their group health plan (including 3
431	431	in the case of group health insurance cov-4
432	432	erage offered in connection with such a 5
433	433	plan), that— 6
434	434	‘‘(I) contains such information 7
435	435	described in clauses (iii), (iv), (v), and 8
436	436	(vi), as applicable, as specified by the 9
437	437	Secretary through guidance, program 10
438	438	instruction, or otherwise (with no re-11
439	439	quirement of notice and comment 12
440	440	rulemaking) that the Secretary deter-13
441	441	mines useful to participants or bene-14
442	442	ficiaries in better understanding the 15
443	443	plan or coverage or benefits under 16
444	444	such plan or coverage; 17
445	445	‘‘(II) contains only aggregate in-18
446	446	formation; and 19
447	447	‘‘(III) states that participants 20
448	448	and beneficiaries may request specific, 21
449	449	claims-level information required to be 22
450	450	furnished under subsection (c) from 23
451	451	the group health plan or health insur-24
452	452	ance issuer; and 25
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456	456	‘‘(iii) with respect to drugs covered by 1
457	457	such plan or coverage during such report-2
458	458	ing period— 3
459	459	‘‘(I) the total net spending by the 4
460	460	plan or coverage for all such drugs; 5
461	461	‘‘(II) the total amount received, 6
462	462	or expected to be received, by the plan 7
463	463	or issuer from any applicable entity in 8
464	464	rebates, fees, alternative discounts, or 9
465	465	other remuneration; and 10
466	466	‘‘(III) to the extent feasible, in-11
467	467	formation on the total amount of re-12
468	468	muneration for such drugs, including 13
469	469	copayment assistance dollars paid, co-14
470	470	payment cards applied, or other dis-15
471	471	counts provided by each drug manu-16
472	472	facturer (or entity administering co-17
473	473	payment assistance on behalf of such 18
474	474	drug manufacturer) to participants 19
475	475	and beneficiaries; 20
476	476	‘‘(iv) amounts paid directly or indi-21
477	477	rectly in rebates, fees, or any other type of 22
478	478	compensation (as defined in section 23
479	479	408(b)(2)(B)(ii)(dd)(AA) of the Employee 24
480	480	Retirement Income Security Act) to bro-25
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484	484	kerage firms, brokers, consultants, advi-1
485	485	sors, or any other individual or firm, for— 2
486	486	‘‘(I) the referral of the group 3
487	487	health plan’s or health insurance 4
488	488	issuer’s business to an entity pro-5
489	489	viding pharmacy benefit management 6
490	490	services, including the identity of the 7
491	491	recipient of such amounts; 8
492	492	‘‘(II) consideration of the entity 9
493	493	providing pharmacy benefit manage-10
494	494	ment services by the group health 11
495	495	plan or health insurance issuer; or 12
496	496	‘‘(III) the retention of the entity 13
497	497	by the group health plan or health in-14
498	498	surance issuer; 15
499	499	‘‘(v) an explanation of any benefit de-16
500	500	sign parameters that encourage or require 17
501	501	participants and beneficiaries in such plan 18
502	502	or coverage to fill prescriptions at mail 19
503	503	order, specialty, or retail pharmacies that 20
504	504	are affiliated with or under common own-21
505	505	ership with the entity providing pharmacy 22
506	506	benefit management services under such 23
507	507	plan or coverage, including mandatory mail 24
508	508	and specialty home delivery programs, re-25
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511	511	•HR 2450 IH
512	512	tail and mail auto-refill programs, and 1
513	513	cost-sharing assistance incentives directly 2
514	514	or indirectly funded by such entity; and 3
515	515	‘‘(vi) total gross spending on all drugs 4
516	516	under the plan or coverage during the re-5
517	517	porting period. 6
518	518	‘‘(3) O
519	519	PT-IN FOR GROUP HEALTH INSURANCE 7
520	520	COVERAGE OFFERED BY A SPECIFIED LARGE EM -8
521	521	PLOYER OR THAT IS A SPECIFIED LARGE PLAN .—In 9
522	522	the case of group health insurance coverage offered 10
523	523	in connection with a group health plan that is of-11
524	524	fered by a specified large employer or is a specified 12
525	525	large plan, such group health plan may, on an an-13
526	526	nual basis, for plan years beginning on or after the 14
527	527	date that is 30 months after the date of enactment 15
528	528	of this section, elect to require an entity providing 16
529	529	pharmacy benefit management services on behalf of 17
530	530	the health insurance issuer to submit to such group 18
531	531	health plan a report that includes all of the informa-19
532	532	tion described in paragraph (2)(A), in addition to 20
533	533	the information described in paragraph (2)(B). 21
534	534	‘‘(4) P
535	535	RIVACY REQUIREMENTS .— 22
536	536	‘‘(A) I
537	537	N GENERAL.—An entity providing 23
538	538	pharmacy benefit management services on be-24
539	539	half of a group health plan or a health insur-25
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542	542	•HR 2450 IH
543	543	ance issuer offering group health insurance cov-1
544	544	erage shall report information under paragraph 2
545	545	(1) in a manner consistent with the privacy reg-3
546	546	ulations promulgated under section 13402(a) of 4
547	547	the Health Information Technology for Eco-5
548	548	nomic and Clinical Health Act and consistent 6
549	549	with the privacy regulations promulgated under 7
550	550	the Health Insurance Portability and Account-8
551	551	ability Act of 1996 in part 160 and subparts A 9
552	552	and E of part 164 of title 45, Code of Federal 10
553	553	Regulations (or successor regulations) (referred 11
554	554	to in this paragraph as the ‘HIPAA privacy 12
555	555	regulations’) and shall restrict the use and dis-13
556	556	closure of such information according to such 14
557	557	privacy regulations and such HIPAA privacy 15
558	558	regulations. 16
559	559	‘‘(B) A
560	560	DDITIONAL REQUIREMENTS .— 17
561	561	‘‘(i) I
562	562	N GENERAL.—An entity pro-18
563	563	viding pharmacy benefit management serv-19
564	564	ices on behalf of a group health plan or 20
565	565	health insurance issuer offering group 21
566	566	health insurance coverage that submits a 22
567	567	report under paragraph (1) shall ensure 23
568	568	that such report contains only summary 24
569	569	health information, as defined in section 25
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572	572	•HR 2450 IH
573	573	164.504(a) of title 45, Code of Federal 1
574	574	Regulations (or successor regulations). 2
575	575	‘‘(ii) R
576	576	ESTRICTIONS.—In carrying out 3
577	577	this subsection, a group health plan shall 4
578	578	comply with section 164.504(f) of title 45, 5
579	579	Code of Federal Regulations (or a suc-6
580	580	cessor regulation), and a plan sponsor shall 7
581	581	act in accordance with the terms of the 8
582	582	agreement described in such section. 9
583	583	‘‘(C) R
584	584	ULE OF CONSTRUCTION .— 10
585	585	‘‘(i) Nothing in this section shall be 11
586	586	construed to modify the requirements for 12
587	587	the creation, receipt, maintenance, or 13
588	588	transmission of protected health informa-14
589	589	tion under the HIPAA privacy regulations. 15
590	590	‘‘(ii) Nothing in this section shall be 16
591	591	construed to affect the application of any 17
592	592	Federal or State privacy or civil rights law, 18
593	593	including the HIPAA privacy regulations, 19
594	594	the Genetic Information Nondiscrimination 20
595	595	Act of 2008 (Public Law 110–233) (in-21
596	596	cluding the amendments made by such 22
597	597	Act), the Americans with Disabilities Act 23
598	598	of 1990 (42 U.S.C. 12101 et sec), section 24
599	599	504 of the Rehabilitation Act of 1973 (29 25
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602	602	•HR 2450 IH
603	603	U.S.C. 794), section 1557 of the Patient 1
604	604	Protection and Affordable Care Act (42 2
605	605	U.S.C. 18116), title VI of the Civil Rights 3
606	606	Act of 1964 (42 U.S.C. 2000d), and title 4
607	607	VII of the Civil Rights Act of 1964 (42 5
608	608	U.S.C. 2000e). 6
609	609	‘‘(D) W
610	610	RITTEN NOTICE.—Each plan year, 7
611	611	group health plans, including with respect to 8
612	612	group health insurance coverage offered in con-9
613	613	nection with a group health plan, shall provide 10
614	614	to each participant or beneficiary written notice 11
615	615	informing the participant or beneficiary of the 12
616	616	requirement for entities providing pharmacy 13
617	617	benefit management services on behalf of the 14
618	618	group health plan or health insurance issuer of-15
619	619	fering group health insurance coverage to sub-16
620	620	mit reports to group health plans under para-17
621	621	graph (1), as applicable, which may include in-18
622	622	corporating such notification in plan documents 19
623	623	provided to the participant or beneficiary, or 20
624	624	providing individual notification. 21
625	625	‘‘(E) L
626	626	IMITATION TO BUSINESS ASSOCI -22
627	627	ATES.—A group health plan receiving a report 23
628	628	under paragraph (1) may disclose such informa-24
629	629	tion only to the entity from which the report 25
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632	632	•HR 2450 IH
633	633	was received or to that entity’s business associ-1
634	634	ates as defined in section 160.103 of title 45, 2
635	635	Code of Federal Regulations (or successor regu-3
636	636	lations) or as permitted by the HIPAA privacy 4
637	637	regulations. 5
638	638	‘‘(F) C
639	639	LARIFICATION REGARDING PUBLIC 6
640	640	DISCLOSURE OF INFORMATION .—Nothing in 7
641	641	this section shall prevent an entity providing 8
642	642	pharmacy benefit management services on be-9
643	643	half of a group health plan or health insurance 10
644	644	issuer offering group health insurance coverage, 11
645	645	from placing reasonable restrictions on the pub-12
646	646	lic disclosure of the information contained in a 13
647	647	report described in paragraph (1), except that 14
648	648	such plan, issuer, or entity may not— 15
649	649	‘‘(i) restrict disclosure of such report 16
650	650	to the Department of Health and Human 17
651	651	Services, the Department of Labor, or the 18
652	652	Department of the Treasury; or 19
653	653	‘‘(ii) prevent disclosure for the pur-20
654	654	poses of subsection (c), or any other public 21
655	655	disclosure requirement under this section. 22
656	656	‘‘(G) L
657	657	IMITED FORM OF REPORT .—The 23
658	658	Secretary shall define through rulemaking a 24
659	659	limited form of the report under paragraph (1) 25
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662	662	•HR 2450 IH
663	663	required with respect to any group health plan 1
664	664	established by a plan sponsor that is, or is af-2
665	665	filiated with, a drug manufacturer, drug whole-3
666	666	saler, or other direct participant in the drug 4
667	667	supply chain, in order to prevent anti-competi-5
668	668	tive behavior. 6
669	669	‘‘(5) S
670	670	TANDARD FORMAT AND REGULATIONS .— 7
671	671	‘‘(A) I
672	672	N GENERAL.—Not later than 18 8
673	673	months after the date of enactment of this sec-9
674	674	tion, the Secretary shall specify through rule-10
675	675	making a standard format for entities providing 11
676	676	pharmacy benefit management services on be-12
677	677	half of group health plans and health insurance 13
678	678	issuers offering group health insurance cov-14
679	679	erage, to submit reports required under para-15
680	680	graph (1). 16
681	681	‘‘(B) A
682	682	DDITIONAL REGULATIONS .—Not 17
683	683	later than 18 months after the date of enact-18
684	684	ment of this section, the Secretary shall, 19
685	685	through rulemaking, promulgate any other final 20
686	686	regulations necessary to implement the require-21
687	687	ments of this section. In promulgating such 22
688	688	regulations, the Secretary shall, to the extent 23
689	689	practicable, align the reporting requirements 24
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692	692	•HR 2450 IH
693	693	under this section with the reporting require-1
694	694	ments under section 2799A–10. 2
695	695	‘‘(c) R
696	696	EQUIREMENTTOPROVIDEINFORMATION TO 3
697	697	P
698	698	ARTICIPANTS ORBENEFICIARIES.—A group health plan, 4
699	699	including with respect to group health insurance coverage 5
700	700	offered in connection with a group health plan, upon re-6
701	701	quest of a participant or beneficiary, shall provide to such 7
702	702	participant or beneficiary— 8
703	703	‘‘(1) the summary document described in sub-9
704	704	section (b)(2)(B)(ii); and 10
705	705	‘‘(2) the information described in subsection 11
706	706	(b)(2)(A)(i)(III) with respect to a claim made by or 12
707	707	on behalf of such participant or beneficiary. 13
708	708	‘‘(d) E
709	709	NFORCEMENT.— 14
710	710	‘‘(1) I
711	711	N GENERAL.—The Secretary shall enforce 15
712	712	this section. The enforcement authority under this 16
713	713	subsection shall apply only with respect to group 17
714	714	health plans (including group health insurance cov-18
715	715	erage offered in connection with such a plan) to 19
716	716	which the requirements of subparts I and II of part 20
717	717	A and part D apply in accordance with section 2722, 21
718	718	and with respect to entities providing pharmacy ben-22
719	719	efit management services on behalf of such plans 23
720	720	and applicable entities providing services on behalf 24
721	721	of such plans. 25
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724	724	•HR 2450 IH
725	725	‘‘(2) FAILURE TO PROVIDE INFORMATION .—A 1
726	726	group health plan, a health insurance issuer offering 2
727	727	group health insurance coverage, an entity providing 3
728	728	pharmacy benefit management services on behalf of 4
729	729	such a plan or issuer, or an applicable entity pro-5
730	730	viding services on behalf of such a plan or issuer 6
731	731	that violates subsection (a); an entity providing 7
732	732	pharmacy benefit management services on behalf of 8
733	733	such a plan or issuer that fails to provide the infor-9
734	734	mation required under subsection (b); or a group 10
735	735	health plan that fails to provide the information re-11
736	736	quired under subsection (c), shall be subject to a 12
737	737	civil monetary penalty in the amount of $10,000 for 13
738	738	each day during which such violation continues or 14
739	739	such information is not disclosed or reported. 15
740	740	‘‘(3) F
741	741	ALSE INFORMATION.—A health insurance 16
742	742	issuer, an entity providing pharmacy benefit man-17
743	743	agement services, or a third party administrator pro-18
744	744	viding services on behalf of such issuer offered by a 19
745	745	health insurance issuer that knowingly provides false 20
746	746	information under this section shall be subject to a 21
747	747	civil monetary penalty in an amount not to exceed 22
748	748	$100,000 for each item of false information. Such 23
749	749	civil monetary penalty shall be in addition to other 24
750	750	penalties as may be prescribed by law. 25
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753	753	•HR 2450 IH
754	754	‘‘(4) PROCEDURE.—The provisions of section 1
755	755	1128A of the Social Security Act, other than sub-2
756	756	sections (a) and (b) and the first sentence of sub-3
757	757	section (c)(1) of such section shall apply to civil 4
758	758	monetary penalties under this subsection in the 5
759	759	same manner as such provisions apply to a penalty 6
760	760	or proceeding under such section. 7
761	761	‘‘(5) W
762	762	AIVERS.—The Secretary may waive pen-8
763	763	alties under paragraph (2), or extend the period of 9
764	764	time for compliance with a requirement of this sec-10
765	765	tion, for an entity in violation of this section that 11
766	766	has made a good-faith effort to comply with the re-12
767	767	quirements in this section. 13
768	768	‘‘(e) R
769	769	ULE OFCONSTRUCTION.—Nothing in this sec-14
770	770	tion shall be construed to permit a health insurance issuer, 15
771	771	group health plan, entity providing pharmacy benefit man-16
772	772	agement services on behalf of a group health plan or 17
773	773	health insurance issuer, or other entity to restrict disclo-18
774	774	sure to, or otherwise limit the access of, the Secretary to 19
775	775	a report described in subsection (b)(1) or information re-20
776	776	lated to compliance with subsections (a), (b), (c), or (d) 21
777	777	by such issuer, plan, or entity. 22
778	778	‘‘(f) D
779	779	EFINITIONS.—In this section: 23
780	780	‘‘(1) A
781	781	PPLICABLE ENTITY.—The term ‘applica-24
782	782	ble entity’ means— 25
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785	785	•HR 2450 IH
786	786	‘‘(A) an applicable group purchasing orga-1
787	787	nization, drug manufacturer, distributor, whole-2
788	788	saler, rebate aggregator (or other purchasing 3
789	789	entity designed to aggregate rebates), or associ-4
790	790	ated third party; 5
791	791	‘‘(B) any subsidiary, parent, affiliate, or 6
792	792	subcontractor of a group health plan, health in-7
793	793	surance issuer, entity that provides pharmacy 8
794	794	benefit management services on behalf of such 9
795	795	a plan or issuer, or any entity described in sub-10
796	796	paragraph (A); or 11
797	797	‘‘(C) such other entity as the Secretary 12
798	798	may specify through rulemaking. 13
799	799	‘‘(2) A
800	800	PPLICABLE GROUP PURCHASING ORGANI -14
801	801	ZATION.—The term ‘applicable group purchasing or-15
802	802	ganization’ means a group purchasing organization 16
803	803	that is affiliated with or under common ownership 17
804	804	with an entity providing pharmacy benefit manage-18
805	805	ment services. 19
806	806	‘‘(3) C
807	807	ONTRACTED COMPENSATION .—The term 20
808	808	‘contracted compensation’ means the sum of any in-21
809	809	gredient cost and dispensing fee for a drug (inclusive 22
810	810	of the out-of-pocket costs to the participant or bene-23
811	811	ficiary), or another analogous compensation struc-24
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814	814	•HR 2450 IH
815	815	ture that the Secretary may specify through regula-1
816	816	tions. 2
817	817	‘‘(4) G
818	818	ROSS SPENDING .—The term ‘gross 3
819	819	spending’, with respect to prescription drug benefits 4
820	820	under a group health plan or health insurance cov-5
821	821	erage, means the amount spent by a group health 6
822	822	plan or health insurance issuer on prescription drug 7
823	823	benefits, calculated before the application of rebates, 8
824	824	fees, alternative discounts, or other remuneration. 9
825	825	‘‘(5) N
826	826	ET SPENDING.—The term ‘net spending’, 10
827	827	with respect to prescription drug benefits under a 11
828	828	group health plan or health insurance coverage, 12
829	829	means the amount spent by a group health plan or 13
830	830	health insurance issuer on prescription drug bene-14
831	831	fits, calculated after the application of rebates, fees, 15
832	832	alternative discounts, or other remuneration. 16
833	833	‘‘(6) P
834	834	LAN SPONSOR.—The term ‘plan sponsor’ 17
835	835	has the meaning given such term in section 3(16)(B) 18
836	836	of the Employee Retirement Income Security Act of 19
837	837	1974. 20
838	838	‘‘(7) R
839	839	EMUNERATION.—The term ‘remunera-21
840	840	tion’ has the meaning given such term by the Sec-22
841	841	retary through rulemaking, which shall be reevalu-23
842	842	ated by the Secretary every 5 years. 24
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845	845	•HR 2450 IH
846	846	‘‘(8) SPECIFIED LARGE EMPLOYER .—The term 1
847	847	‘specified large employer’ means, in connection with 2
848	848	a group health plan (including group health insur-3
849	849	ance coverage offered in connection with such a 4
850	850	plan) established or maintained by a single em-5
851	851	ployer, with respect to a calendar year or a plan 6
852	852	year, as applicable, an employer who employed an 7
853	853	average of at least 100 employees on business days 8
854	854	during the preceding calendar year or plan year and 9
855	855	who employs at least 1 employee on the first day of 10
856	856	the calendar year or plan year. 11
857	857	‘‘(9) S
858	858	PECIFIED LARGE PLAN.—The term ‘spec-12
859	859	ified large plan’ means a group health plan (includ-13
860	860	ing group health insurance coverage offered in con-14
861	861	nection with such a plan) established or maintained 15
862	862	by a plan sponsor described in clause (ii) or (iii) of 16
863	863	section 3(16)(B) of the Employee Retirement In-17
864	864	come Security Act of 1974 that had an average of 18
865	865	at least 100 participants on business days during 19
866	866	the preceding calendar year or plan year, as applica-20
867	867	ble. 21
868	868	‘‘(10) W
869	869	HOLESALE ACQUISITION COST .—The 22
870	870	term ‘wholesale acquisition cost’ has the meaning 23
871	871	given such term in section 1847A(c)(6)(B) of the 24
872	872	Social Security Act.’’; and 25
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875	875	•HR 2450 IH
876	876	(2) in section 2723 (42 U.S.C. 300gg–22)— 1
877	877	(A) in subsection (a)— 2
878	878	(i) in paragraph (1), by inserting 3
879	879	‘‘(other than section 2799A–11)’’ after 4
880	880	‘‘part D’’; and 5
881	881	(ii) in paragraph (2), by inserting 6
882	882	‘‘(other than section 2799A–11)’’ after 7
883	883	‘‘part D’’; and 8
884	884	(B) in subsection (b)— 9
885	885	(i) in paragraph (1), by inserting 10
886	886	‘‘(other than section 2799A–11)’’ after 11
887	887	‘‘part D’’; 12
888	888	(ii) in paragraph (2)(A), by inserting 13
889	889	‘‘(other than section 2799A–11)’’ after 14
890	890	‘‘part D’’; and 15
891	891	(iii) in paragraph (2)(C)(ii), by insert-16
892	892	ing ‘‘(other than section 2799A–11)’’ after 17
893	893	‘‘part D’’. 18
894	894	(b) E
895	895	MPLOYEERETIREMENTINCOMESECURITYACT 19
896	896	OF1974.— 20
897	897	(1) I
898	898	N GENERAL.—Subtitle B of title I of the 21
899	899	Employee Retirement Income Security Act of 1974 22
900	900	(29 U.S.C. 1021 et seq.) is amended— 23
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903	903	•HR 2450 IH
904	904	(A) in subpart B of part 7 (29 U.S.C. 1
905	905	1185 et seq.), by adding at the end the fol-2
906	906	lowing: 3
907	907	‘‘SEC. 726. OVERSIGHT OF ENTITIES THAT PROVIDE PHAR-4
908	908	MACY BENEFIT MANAGEMENT SERVICES. 5
909	909	‘‘(a) I
910	910	NGENERAL.—For plan years beginning on or 6
911	911	after the date that is 30 months after the date of enact-7
912	912	ment of this section (referred to in this subsection and 8
913	913	subsection (b) as the ‘effective date’), a group health plan 9
914	914	or a health insurance issuer offering group health insur-10
915	915	ance coverage, or an entity providing pharmacy benefit 11
916	916	management services on behalf of such a plan or issuer, 12
917	917	shall not enter into a contract, including an extension or 13
918	918	renewal of a contract, entered into on or after the effective 14
919	919	date, with an applicable entity unless such applicable enti-15
920	920	ty agrees to— 16
921	921	‘‘(1) not limit or delay the disclosure of infor-17
922	922	mation to the group health plan (including such a 18
923	923	plan offered through a health insurance issuer) in 19
924	924	such a manner that prevents an entity providing 20
925	925	pharmacy benefit management services on behalf of 21
926	926	a group health plan or health insurance issuer offer-22
927	927	ing group health insurance coverage from making 23
928	928	the reports described in subsection (b); and 24
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931	931	•HR 2450 IH
932	932	‘‘(2) provide the entity providing pharmacy ben-1
933	933	efit management services on behalf of a group health 2
934	934	plan or health insurance issuer relevant information 3
935	935	necessary to make the reports described in sub-4
936	936	section (b). 5
937	937	‘‘(b) R
938	938	EPORTS.— 6
939	939	‘‘(1) I
940	940	N GENERAL.—For plan years beginning 7
941	941	on or after the effective date, in the case of any con-8
942	942	tract between a group health plan or a health insur-9
943	943	ance issuer offering group health insurance coverage 10
944	944	offered in connection with such a plan and an entity 11
945	945	providing pharmacy benefit management services on 12
946	946	behalf of such plan or issuer, including an extension 13
947	947	or renewal of such a contract, entered into on or 14
948	948	after the effective date, the entity providing phar-15
949	949	macy benefit management services on behalf of such 16
950	950	a group health plan or health insurance issuer, not 17
951	951	less frequently than every 6 months (or, at the re-18
952	952	quest of a group health plan, not less frequently 19
953	953	than quarterly, and under the same conditions, 20
954	954	terms, and cost of the semiannual report under this 21
955	955	subsection), shall submit to the group health plan a 22
956	956	report in accordance with this section. Each such re-23
957	957	port shall be made available to such group health 24
958	958	plan in plain language, in a machine-readable for-25
959	959	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
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961	961	•HR 2450 IH
962	962	mat, and as the Secretary may determine, other for-1
963	963	mats. Each such report shall include the information 2
964	964	described in paragraph (2). 3
965	965	‘‘(2) I
966	966	NFORMATION DESCRIBED .—For purposes 4
967	967	of paragraph (1), the information described in this 5
968	968	paragraph is, with respect to drugs covered by a 6
969	969	group health plan or group health insurance cov-7
970	970	erage offered by a health insurance issuer in connec-8
971	971	tion with a group health plan during each reporting 9
972	972	period— 10
973	973	‘‘(A) in the case of a group health plan 11
974	974	that is offered by a specified large employer or 12
975	975	that is a specified large plan, and is not offered 13
976	976	as health insurance coverage, or in the case of 14
977	977	health insurance coverage for which the election 15
978	978	under paragraph (3) is made for the applicable 16
979	979	reporting period— 17
980	980	‘‘(i) a list of drugs for which a claim 18
981	981	was filed and, with respect to each such 19
982	982	drug on such list— 20
983	983	‘‘(I) the contracted compensation 21
984	984	paid by the group health plan or 22
985	985	health insurance issuer for each cov-23
986	986	ered drug (identified by the National 24
987	987	Drug Code) to the entity providing 25
988	988	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00034 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
989	989	ssavage on LAPJG3WLY3PROD with BILLS 35
990	990	•HR 2450 IH
991	991	pharmacy benefit management serv-1
992	992	ices or other applicable entity on be-2
993	993	half of the group health plan or health 3
994	994	insurance issuer; 4
995	995	‘‘(II) the contracted compensa-5
996	996	tion paid to the pharmacy, by any en-6
997	997	tity providing pharmacy benefit man-7
998	998	agement services or other applicable 8
999	999	entity on behalf of the group health 9
1000	1000	plan or health insurance issuer, for 10
1001	1001	each covered drug (identified by the 11
1002	1002	National Drug Code); 12
1003	1003	‘‘(III) for each such claim, the 13
1004	1004	difference between the amount paid 14
1005	1005	under subclause (I) and the amount 15
1006	1006	paid under subclause (II); 16
1007	1007	‘‘(IV) the proprietary name, es-17
1008	1008	tablished name or proper name, and 18
1009	1009	National Drug Code; 19
1010	1010	‘‘(V) for each claim for the drug 20
1011	1011	(including original prescriptions and 21
1012	1012	refills) and for each dosage unit of the 22
1013	1013	drug for which a claim was filed, the 23
1014	1014	type of dispensing channel used to 24
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1016	1016	ssavage on LAPJG3WLY3PROD with BILLS 36
1017	1017	•HR 2450 IH
1018	1018	furnish the drug, including retail, mail 1
1019	1019	order, or specialty pharmacy; 2
1020	1020	‘‘(VI) with respect to each drug 3
1021	1021	dispensed, for each type of dispensing 4
1022	1022	channel (including retail, mail order, 5
1023	1023	or specialty pharmacy)— 6
1024	1024	‘‘(aa) whether such drug is a 7
1025	1025	brand name drug or a generic 8
1026	1026	drug, and— 9
1027	1027	‘‘(AA) in the case of a 10
1028	1028	brand name drug, the whole-11
1029	1029	sale acquisition cost, listed 12
1030	1030	as cost per days supply and 13
1031	1031	cost per dosage unit, on the 14
1032	1032	date such drug was dis-15
1033	1033	pensed; and 16
1034	1034	‘‘(BB) in the case of a 17
1035	1035	generic drug, the average 18
1036	1036	wholesale price, listed as 19
1037	1037	cost per days supply and 20
1038	1038	cost per dosage unit, on the 21
1039	1039	date such drug was dis-22
1040	1040	pensed; and 23
1041	1041	‘‘(bb) the total number of— 24
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1044	1044	•HR 2450 IH
1045	1045	‘‘(AA) prescription 1
1046	1046	claims (including original 2
1047	1047	prescriptions and refills); 3
1048	1048	‘‘(BB) participants and 4
1049	1049	beneficiaries for whom a 5
1050	1050	claim for such drug was 6
1051	1051	filed through the applicable 7
1052	1052	dispensing channel; 8
1053	1053	‘‘(CC) dosage units and 9
1054	1054	dosage units per fill of such 10
1055	1055	drug; and 11
1056	1056	‘‘(DD) days supply of 12
1057	1057	such drug per fill; 13
1058	1058	‘‘(VII) the net price per course of 14
1059	1059	treatment or single fill, such as a 30- 15
1060	1060	day supply or 90-day supply to the 16
1061	1061	plan or coverage after rebates, fees, 17
1062	1062	alternative discounts, or other remu-18
1063	1063	neration received from applicable enti-19
1064	1064	ties; 20
1065	1065	‘‘(VIII) the total amount of out- 21
1066	1066	of-pocket spending by participants 22
1067	1067	and beneficiaries on such drug, in-23
1068	1068	cluding spending through copayments, 24
1069	1069	coinsurance, and deductibles, but not 25
1070	1070	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
1071	1071	ssavage on LAPJG3WLY3PROD with BILLS 38
1072	1072	•HR 2450 IH
1073	1073	including any amounts spent by par-1
1074	1074	ticipants and beneficiaries on drugs 2
1075	1075	not covered under the plan or cov-3
1076	1076	erage, or for which no claim is sub-4
1077	1077	mitted under the plan or coverage; 5
1078	1078	‘‘(IX) the total net spending on 6
1079	1079	the drug; 7
1080	1080	‘‘(X) the total amount received, 8
1081	1081	or expected to be received, by the plan 9
1082	1082	or issuer from any applicable entity in 10
1083	1083	rebates, fees, alternative discounts, or 11
1084	1084	other remuneration; 12
1085	1085	‘‘(XI) the total amount received, 13
1086	1086	or expected to be received, by the enti-14
1087	1087	ty providing pharmacy benefit man-15
1088	1088	agement services, from applicable en-16
1089	1089	tities, in rebates, fees, alternative dis-17
1090	1090	counts, or other remuneration from 18
1091	1091	such entities— 19
1092	1092	‘‘(aa) for claims incurred 20
1093	1093	during the reporting period; and 21
1094	1094	‘‘(bb) that is related to utili-22
1095	1095	zation of such drug or spending 23
1096	1096	on such drug; and 24
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1098	1098	ssavage on LAPJG3WLY3PROD with BILLS 39
1099	1099	•HR 2450 IH
1100	1100	‘‘(XII) to the extent feasible, in-1
1101	1101	formation on the total amount of re-2
1102	1102	muneration for such drug, including 3
1103	1103	copayment assistance dollars paid, co-4
1104	1104	payment cards applied, or other dis-5
1105	1105	counts provided by each drug manu-6
1106	1106	facturer (or entity administering co-7
1107	1107	payment assistance on behalf of such 8
1108	1108	drug manufacturer), to the partici-9
1109	1109	pants and beneficiaries enrolled in 10
1110	1110	such plan or coverage; 11
1111	1111	‘‘(ii) a list of each therapeutic class 12
1112	1112	(as defined by the Secretary) for which a 13
1113	1113	claim was filed under the group health 14
1114	1114	plan or health insurance coverage during 15
1115	1115	the reporting period, and, with respect to 16
1116	1116	each such therapeutic class— 17
1117	1117	‘‘(I) the total gross spending on 18
1118	1118	drugs in such class before rebates, 19
1119	1119	price concessions, alternative dis-20
1120	1120	counts, or other remuneration from 21
1121	1121	applicable entities; 22
1122	1122	‘‘(II) the net spending in such 23
1123	1123	class after such rebates, price conces-24
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1125	1125	ssavage on LAPJG3WLY3PROD with BILLS 40
1126	1126	•HR 2450 IH
1127	1127	sions, alternative discounts, or other 1
1128	1128	remuneration from applicable entities; 2
1129	1129	‘‘(III) the total amount received, 3
1130	1130	or expected to be received, by the enti-4
1131	1131	ty providing pharmacy benefit man-5
1132	1132	agement services, from applicable en-6
1133	1133	tities, in rebates, fees, alternative dis-7
1134	1134	counts, or other remuneration from 8
1135	1135	such entities— 9
1136	1136	‘‘(aa) for claims incurred 10
1137	1137	during the reporting period; and 11
1138	1138	‘‘(bb) that is related to utili-12
1139	1139	zation of drugs or drug spending; 13
1140	1140	‘‘(IV) the average net spending 14
1141	1141	per 30-day supply and per 90-day 15
1142	1142	supply by the plan or by the issuer 16
1143	1143	with respect to such coverage and its 17
1144	1144	participants and beneficiaries, among 18
1145	1145	all drugs within the therapeutic class 19
1146	1146	for which a claim was filed during the 20
1147	1147	reporting period; 21
1148	1148	‘‘(V) the number of participants 22
1149	1149	and beneficiaries who filled a prescrip-23
1150	1150	tion for a drug in such class, includ-24
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1152	1152	ssavage on LAPJG3WLY3PROD with BILLS 41
1153	1153	•HR 2450 IH
1154	1154	ing the National Drug Code for each 1
1155	1155	such drug; 2
1156	1156	‘‘(VI) if applicable, a description 3
1157	1157	of the formulary tiers and utilization 4
1158	1158	mechanisms (such as prior authoriza-5
1159	1159	tion or step therapy) employed for 6
1160	1160	drugs in that class; and 7
1161	1161	‘‘(VII) the total out-of-pocket 8
1162	1162	spending under the plan or coverage 9
1163	1163	by participants and beneficiaries, in-10
1164	1164	cluding spending through copayments, 11
1165	1165	coinsurance, and deductibles, but not 12
1166	1166	including any amounts spent by par-13
1167	1167	ticipants and beneficiaries on drugs 14
1168	1168	not covered under the plan or cov-15
1169	1169	erage or for which no claim is sub-16
1170	1170	mitted under the plan or coverage; 17
1171	1171	‘‘(iii) with respect to any drug for 18
1172	1172	which gross spending under the group 19
1173	1173	health plan or health insurance coverage 20
1174	1174	exceeded $10,000 during the reporting pe-21
1175	1175	riod or, in the case that gross spending 22
1176	1176	under the group health plan or coverage 23
1177	1177	exceeded $10,000 during the reporting pe-24
1178	1178	riod with respect to fewer than 50 drugs, 25
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1180	1180	ssavage on LAPJG3WLY3PROD with BILLS 42
1181	1181	•HR 2450 IH
1182	1182	with respect to the 50 prescription drugs 1
1183	1183	with the highest spending during the re-2
1184	1184	porting period— 3
1185	1185	‘‘(I) a list of all other drugs in 4
1186	1186	the same therapeutic class as such 5
1187	1187	drug; 6
1188	1188	‘‘(II) if applicable, the rationale 7
1189	1189	for the formulary placement of such 8
1190	1190	drug in that therapeutic category or 9
1191	1191	class, selected from a list of standard 10
1192	1192	rationales established by the Sec-11
1193	1193	retary, in consultation with stake-12
1194	1194	holders; and 13
1195	1195	‘‘(III) any change in formulary 14
1196	1196	placement compared to the prior plan 15
1197	1197	year; and 16
1198	1198	‘‘(iv) in the case that such plan or 17
1199	1199	issuer (or an entity providing pharmacy 18
1200	1200	benefit management services on behalf of 19
1201	1201	such plan or issuer) has an affiliated phar-20
1202	1202	macy or pharmacy under common owner-21
1203	1203	ship, including mandatory mail and spe-22
1204	1204	cialty home delivery programs, retail and 23
1205	1205	mail auto-refill programs, and cost sharing 24
1206	1206	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00042 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
1207	1207	ssavage on LAPJG3WLY3PROD with BILLS 43
1208	1208	•HR 2450 IH
1209	1209	assistance incentives funded by an entity 1
1210	1210	providing pharmacy benefit services— 2
1211	1211	‘‘(I) an explanation of any ben-3
1212	1212	efit design parameters that encourage 4
1213	1213	or require participants and bene-5
1214	1214	ficiaries in the plan or coverage to fill 6
1215	1215	prescriptions at mail order, specialty, 7
1216	1216	or retail pharmacies; 8
1217	1217	‘‘(II) the percentage of total pre-9
1218	1218	scriptions dispensed by such phar-10
1219	1219	macies to participants or beneficiaries 11
1220	1220	in such plan or coverage; and 12
1221	1221	‘‘(III) a list of all drugs dis-13
1222	1222	pensed by such pharmacies to partici-14
1223	1223	pants or beneficiaries enrolled in such 15
1224	1224	plan or coverage, and, with respect to 16
1225	1225	each drug dispensed— 17
1226	1226	‘‘(aa) the amount charged, 18
1227	1227	per dosage unit, per 30-day sup-19
1228	1228	ply, or per 90-day supply (as ap-20
1229	1229	plicable) to the plan or issuer, 21
1230	1230	and to participants and bene-22
1231	1231	ficiaries; 23
1232	1232	‘‘(bb) the median amount 24
1233	1233	charged to such plan or issuer, 25
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1235	1235	ssavage on LAPJG3WLY3PROD with BILLS 44
1236	1236	•HR 2450 IH
1237	1237	and the interquartile range of the 1
1238	1238	costs, per dosage unit, per 30- 2
1239	1239	day supply, and per 90-day sup-3
1240	1240	ply, including amounts paid by 4
1241	1241	the participants and bene-5
1242	1242	ficiaries, when the same drug is 6
1243	1243	dispensed by other pharmacies 7
1244	1244	that are not affiliated with or 8
1245	1245	under common ownership with 9
1246	1246	the entity and that are included 10
1247	1247	in the pharmacy network of such 11
1248	1248	plan or coverage; 12
1249	1249	‘‘(cc) the lowest cost per 13
1250	1250	dosage unit, per 30-day supply 14
1251	1251	and per 90-day supply, for each 15
1252	1252	such drug, including amounts 16
1253	1253	charged to the plan or coverage 17
1254	1254	and to participants and bene-18
1255	1255	ficiaries, that is available from 19
1256	1256	any pharmacy included in the 20
1257	1257	network of such plan or coverage; 21
1258	1258	and 22
1259	1259	‘‘(dd) the net acquisition 23
1260	1260	cost per dosage unit, per 30-day 24
1261	1261	supply, and per 90-day supply, if 25
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1263	1263	ssavage on LAPJG3WLY3PROD with BILLS 45
1264	1264	•HR 2450 IH
1265	1265	such drug is subject to a max-1
1266	1266	imum price discount; and 2
1267	1267	‘‘(B) with respect to any group health 3
1268	1268	plan, including group health insurance coverage 4
1269	1269	offered in connection with such a plan, regard-5
1270	1270	less of whether the plan or coverage is offered 6
1271	1271	by a specified large employer or whether it is a 7
1272	1272	specified large plan— 8
1273	1273	‘‘(i) a summary document for the 9
1274	1274	group health plan that includes such infor-10
1275	1275	mation described in clauses (i) through (iv) 11
1276	1276	of subparagraph (A), as specified by the 12
1277	1277	Secretary through guidance, program in-13
1278	1278	struction, or otherwise (with no require-14
1279	1279	ment of notice and comment rulemaking), 15
1280	1280	that the Secretary determines useful to 16
1281	1281	group health plans for purposes of select-17
1282	1282	ing pharmacy benefit management serv-18
1283	1283	ices, such as an estimated net price to 19
1284	1284	group health plan and participant or bene-20
1285	1285	ficiary, a cost per claim, the fee structure 21
1286	1286	or reimbursement model, and estimated 22
1287	1287	cost per participant or beneficiary; 23
1288	1288	‘‘(ii) a summary document for plans 24
1289	1289	and issuers to provide to participants and 25
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1292	1292	•HR 2450 IH
1293	1293	beneficiaries, which shall be made available 1
1294	1294	to participants or beneficiaries upon re-2
1295	1295	quest to their group health plan (including 3
1296	1296	in the case of group health insurance cov-4
1297	1297	erage offered in connection with such a 5
1298	1298	plan), that— 6
1299	1299	‘‘(I) contains such information 7
1300	1300	described in clauses (iii), (iv), (v), and 8
1301	1301	(vi), as applicable, as specified by the 9
1302	1302	Secretary through guidance, program 10
1303	1303	instruction, or otherwise (with no re-11
1304	1304	quirement of notice and comment 12
1305	1305	rulemaking) that the Secretary deter-13
1306	1306	mines useful to participants or bene-14
1307	1307	ficiaries in better understanding the 15
1308	1308	plan or coverage or benefits under 16
1309	1309	such plan or coverage; 17
1310	1310	‘‘(II) contains only aggregate in-18
1311	1311	formation; and 19
1312	1312	‘‘(III) states that participants 20
1313	1313	and beneficiaries may request specific, 21
1314	1314	claims-level information required to be 22
1315	1315	furnished under subsection (c) from 23
1316	1316	the group health plan or health insur-24
1317	1317	ance issuer; 25
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1320	1320	•HR 2450 IH
1321	1321	‘‘(iii) with respect to drugs covered by 1
1322	1322	such plan or coverage during such report-2
1323	1323	ing period— 3
1324	1324	‘‘(I) the total net spending by the 4
1325	1325	plan or coverage for all such drugs; 5
1326	1326	‘‘(II) the total amount received, 6
1327	1327	or expected to be received, by the plan 7
1328	1328	or issuer from any applicable entity in 8
1329	1329	rebates, fees, alternative discounts, or 9
1330	1330	other remuneration; and 10
1331	1331	‘‘(III) to the extent feasible, in-11
1332	1332	formation on the total amount of re-12
1333	1333	muneration for such drugs, including 13
1334	1334	copayment assistance dollars paid, co-14
1335	1335	payment cards applied, or other dis-15
1336	1336	counts provided by each drug manu-16
1337	1337	facturer (or entity administering co-17
1338	1338	payment assistance on behalf of such 18
1339	1339	drug manufacturer) to participants 19
1340	1340	and beneficiaries; 20
1341	1341	‘‘(iv) amounts paid directly or indi-21
1342	1342	rectly in rebates, fees, or any other type of 22
1343	1343	compensation (as defined in section 23
1344	1344	408(b)(2)(B)(ii)(dd)(AA)) to brokerage 24
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1347	1347	•HR 2450 IH
1348	1348	firms, brokers, consultants, advisors, or 1
1349	1349	any other individual or firm, for— 2
1350	1350	‘‘(I) the referral of the group 3
1351	1351	health plan’s or health insurance 4
1352	1352	issuer’s business to an entity pro-5
1353	1353	viding pharmacy benefit management 6
1354	1354	services, including the identity of the 7
1355	1355	recipient of such amounts; 8
1356	1356	‘‘(II) consideration of the entity 9
1357	1357	providing pharmacy benefit manage-10
1358	1358	ment services by the group health 11
1359	1359	plan or health insurance issuer; or 12
1360	1360	‘‘(III) the retention of the entity 13
1361	1361	by the group health plan or health in-14
1362	1362	surance issuer; 15
1363	1363	‘‘(v) an explanation of any benefit de-16
1364	1364	sign parameters that encourage or require 17
1365	1365	participants and beneficiaries in such plan 18
1366	1366	or coverage to fill prescriptions at mail 19
1367	1367	order, specialty, or retail pharmacies that 20
1368	1368	are affiliated with or under common own-21
1369	1369	ership with the entity providing pharmacy 22
1370	1370	benefit management services under such 23
1371	1371	plan or coverage, including mandatory mail 24
1372	1372	and specialty home delivery programs, re-25
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1375	1375	•HR 2450 IH
1376	1376	tail and mail auto-refill programs, and 1
1377	1377	cost-sharing assistance incentives directly 2
1378	1378	or indirectly funded by such entity; and 3
1379	1379	‘‘(vi) total gross spending on all drugs 4
1380	1380	under the plan or coverage during the re-5
1381	1381	porting period. 6
1382	1382	‘‘(3) O
1383	1383	PT-IN FOR GROUP HEALTH INSURANCE 7
1384	1384	COVERAGE OFFERED BY A SPECIFIED LARGE EM -8
1385	1385	PLOYER OR THAT IS A SPECIFIED LARGE PLAN .—In 9
1386	1386	the case of group health insurance coverage offered 10
1387	1387	in connection with a group health plan that is of-11
1388	1388	fered by a specified large employer or is a specified 12
1389	1389	large plan, such group health plan may, on an an-13
1390	1390	nual basis, for plan years beginning on or after the 14
1391	1391	date that is 30 months after the date of enactment 15
1392	1392	of this section, elect to require an entity providing 16
1393	1393	pharmacy benefit management services on behalf of 17
1394	1394	the health insurance issuer to submit to such group 18
1395	1395	health plan a report that includes all of the informa-19
1396	1396	tion described in paragraph (2)(A), in addition to 20
1397	1397	the information described in paragraph (2)(B). 21
1398	1398	‘‘(4) P
1399	1399	RIVACY REQUIREMENTS .— 22
1400	1400	‘‘(A) I
1401	1401	N GENERAL.—An entity providing 23
1402	1402	pharmacy benefit management services on be-24
1403	1403	half of a group health plan or a health insur-25
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1406	1406	•HR 2450 IH
1407	1407	ance issuer offering group health insurance cov-1
1408	1408	erage shall report information under paragraph 2
1409	1409	(1) in a manner consistent with the privacy reg-3
1410	1410	ulations promulgated under section 13402(a) of 4
1411	1411	the Health Information Technology for Eco-5
1412	1412	nomic and Clinical Health Act (42 U.S.C. 6
1413	1413	17932(a)) and consistent with the privacy regu-7
1414	1414	lations promulgated under the Health Insur-8
1415	1415	ance Portability and Accountability Act of 1996 9
1416	1416	in part 160 and subparts A and E of part 164 10
1417	1417	of title 45, Code of Federal Regulations (or suc-11
1418	1418	cessor regulations) (referred to in this para-12
1419	1419	graph as the ‘HIPAA privacy regulations’) and 13
1420	1420	shall restrict the use and disclosure of such in-14
1421	1421	formation according to such privacy regulations 15
1422	1422	and such HIPAA privacy regulations. 16
1423	1423	‘‘(B) A
1424	1424	DDITIONAL REQUIREMENTS .— 17
1425	1425	‘‘(i) I
1426	1426	N GENERAL.—An entity pro-18
1427	1427	viding pharmacy benefit management serv-19
1428	1428	ices on behalf of a group health plan or 20
1429	1429	health insurance issuer offering group 21
1430	1430	health insurance coverage that submits a 22
1431	1431	report under paragraph (1) shall ensure 23
1432	1432	that such report contains only summary 24
1433	1433	health information, as defined in section 25
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1436	1436	•HR 2450 IH
1437	1437	164.504(a) of title 45, Code of Federal 1
1438	1438	Regulations (or successor regulations). 2
1439	1439	‘‘(ii) R
1440	1440	ESTRICTIONS.—In carrying out 3
1441	1441	this subsection, a group health plan shall 4
1442	1442	comply with section 164.504(f) of title 45, 5
1443	1443	Code of Federal Regulations (or a suc-6
1444	1444	cessor regulation), and a plan sponsor shall 7
1445	1445	act in accordance with the terms of the 8
1446	1446	agreement described in such section. 9
1447	1447	‘‘(C) R
1448	1448	ULE OF CONSTRUCTION .— 10
1449	1449	‘‘(i) Nothing in this section shall be 11
1450	1450	construed to modify the requirements for 12
1451	1451	the creation, receipt, maintenance, or 13
1452	1452	transmission of protected health informa-14
1453	1453	tion under the HIPAA privacy regulations. 15
1454	1454	‘‘(ii) Nothing in this section shall be 16
1455	1455	construed to affect the application of any 17
1456	1456	Federal or State privacy or civil rights law, 18
1457	1457	including the HIPAA privacy regulations, 19
1458	1458	the Genetic Information Nondiscrimination 20
1459	1459	Act of 2008 (Public Law 110–233) (in-21
1460	1460	cluding the amendments made by such 22
1461	1461	Act), the Americans with Disabilities Act 23
1462	1462	of 1990 (42 U.S.C. 12101 et sec), section 24
1463	1463	504 of the Rehabilitation Act of 1973 (29 25
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1466	1466	•HR 2450 IH
1467	1467	U.S.C. 794), section 1557 of the Patient 1
1468	1468	Protection and Affordable Care Act (42 2
1469	1469	U.S.C. 18116), title VI of the Civil Rights 3
1470	1470	Act of 1964 (42 U.S.C. 2000d), and title 4
1471	1471	VII of the Civil Rights Act of 1964 (42 5
1472	1472	U.S.C. 2000e). 6
1473	1473	‘‘(D) W
1474	1474	RITTEN NOTICE.—Each plan year, 7
1475	1475	group health plans, including with respect to 8
1476	1476	group health insurance coverage offered in con-9
1477	1477	nection with a group health plan, shall provide 10
1478	1478	to each participant or beneficiary written notice 11
1479	1479	informing the participant or beneficiary of the 12
1480	1480	requirement for entities providing pharmacy 13
1481	1481	benefit management services on behalf of the 14
1482	1482	group health plan or health insurance issuer of-15
1483	1483	fering group health insurance coverage to sub-16
1484	1484	mit reports to group health plans under para-17
1485	1485	graph (1), as applicable, which may include in-18
1486	1486	corporating such notification in plan documents 19
1487	1487	provided to the participant or beneficiary, or 20
1488	1488	providing individual notification. 21
1489	1489	‘‘(E) L
1490	1490	IMITATION TO BUSINESS ASSOCI -22
1491	1491	ATES.—A group health plan receiving a report 23
1492	1492	under paragraph (1) may disclose such informa-24
1493	1493	tion only to the entity from which the report 25
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1496	1496	•HR 2450 IH
1497	1497	was received or to that entity’s business associ-1
1498	1498	ates as defined in section 160.103 of title 45, 2
1499	1499	Code of Federal Regulations (or successor regu-3
1500	1500	lations) or as permitted by the HIPAA privacy 4
1501	1501	regulations. 5
1502	1502	‘‘(F) C
1503	1503	LARIFICATION REGARDING PUBLIC 6
1504	1504	DISCLOSURE OF INFORMATION .—Nothing in 7
1505	1505	this section shall prevent an entity providing 8
1506	1506	pharmacy benefit management services on be-9
1507	1507	half of a group health plan or health insurance 10
1508	1508	issuer offering group health insurance coverage, 11
1509	1509	from placing reasonable restrictions on the pub-12
1510	1510	lic disclosure of the information contained in a 13
1511	1511	report described in paragraph (1), except that 14
1512	1512	such plan, issuer, or entity may not— 15
1513	1513	‘‘(i) restrict disclosure of such report 16
1514	1514	to the Department of Health and Human 17
1515	1515	Services, the Department of Labor, or the 18
1516	1516	Department of the Treasury; or 19
1517	1517	‘‘(ii) prevent disclosure for the pur-20
1518	1518	poses of subsection (c), or any other public 21
1519	1519	disclosure requirement under this section. 22
1520	1520	‘‘(G) L
1521	1521	IMITED FORM OF REPORT .—The 23
1522	1522	Secretary shall define through rulemaking a 24
1523	1523	limited form of the report under paragraph (1) 25
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1526	1526	•HR 2450 IH
1527	1527	required with respect to any group health plan 1
1528	1528	established by a plan sponsor that is, or is af-2
1529	1529	filiated with, a drug manufacturer, drug whole-3
1530	1530	saler, or other direct participant in the drug 4
1531	1531	supply chain, in order to prevent anti-competi-5
1532	1532	tive behavior. 6
1533	1533	‘‘(5) S
1534	1534	TANDARD FORMAT AND REGULATIONS .— 7
1535	1535	‘‘(A) I
1536	1536	N GENERAL.—Not later than 18 8
1537	1537	months after the date of enactment of this sec-9
1538	1538	tion, the Secretary shall specify through rule-10
1539	1539	making a standard format for entities providing 11
1540	1540	pharmacy benefit management services on be-12
1541	1541	half of group health plans and health insurance 13
1542	1542	issuers offering group health insurance cov-14
1543	1543	erage, to submit reports required under para-15
1544	1544	graph (1). 16
1545	1545	‘‘(B) A
1546	1546	DDITIONAL REGULATIONS .—Not 17
1547	1547	later than 18 months after the date of enact-18
1548	1548	ment of this section, the Secretary shall, 19
1549	1549	through rulemaking, promulgate any other final 20
1550	1550	regulations necessary to implement the require-21
1551	1551	ments of this section. In promulgating such 22
1552	1552	regulations, the Secretary shall, to the extent 23
1553	1553	practicable, align the reporting requirements 24
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1557	1557	under this section with the reporting require-1
1558	1558	ments under section 725. 2
1559	1559	‘‘(c) R
1560	1560	EQUIREMENTTOPROVIDEINFORMATION TO 3
1561	1561	P
1562	1562	ARTICIPANTS ORBENEFICIARIES.—A group health plan, 4
1563	1563	including with respect to group health insurance coverage 5
1564	1564	offered in connection with a group health plan, upon re-6
1565	1565	quest of a participant or beneficiary, shall provide to such 7
1566	1566	participant or beneficiary— 8
1567	1567	‘‘(1) the summary document described in sub-9
1568	1568	section (b)(2)(B)(ii); and 10
1569	1569	‘‘(2) the information described in subsection 11
1570	1570	(b)(2)(A)(i)(III) with respect to a claim made by or 12
1571	1571	on behalf of such participant or beneficiary. 13
1572	1572	‘‘(d) R
1573	1573	ULE OFCONSTRUCTION.—Nothing in this sec-14
1574	1574	tion shall be construed to permit a health insurance issuer, 15
1575	1575	group health plan, entity providing pharmacy benefit man-16
1576	1576	agement services on behalf of a group health plan or 17
1577	1577	health insurance issuer, or other entity to restrict disclo-18
1578	1578	sure to, or otherwise limit the access of, the Secretary to 19
1579	1579	a report described in subsection (b)(1) or information re-20
1580	1580	lated to compliance with subsections (a), (b), or (c) of this 21
1581	1581	section or section 502(c)(13) by such issuer, plan, or enti-22
1582	1582	ty. 23
1583	1583	‘‘(e) D
1584	1584	EFINITIONS.—In this section: 24
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1587	1587	•HR 2450 IH
1588	1588	‘‘(1) APPLICABLE ENTITY.—The term ‘applica-1
1589	1589	ble entity’ means— 2
1590	1590	‘‘(A) an applicable group purchasing orga-3
1591	1591	nization, drug manufacturer, distributor, whole-4
1592	1592	saler, rebate aggregator (or other purchasing 5
1593	1593	entity designed to aggregate rebates), or associ-6
1594	1594	ated third party; 7
1595	1595	‘‘(B) any subsidiary, parent, affiliate, or 8
1596	1596	subcontractor of a group health plan, health in-9
1597	1597	surance issuer, entity that provides pharmacy 10
1598	1598	benefit management services on behalf of such 11
1599	1599	a plan or issuer, or any entity described in sub-12
1600	1600	paragraph (A); or 13
1601	1601	‘‘(C) such other entity as the Secretary 14
1602	1602	may specify through rulemaking. 15
1603	1603	‘‘(2) A
1604	1604	PPLICABLE GROUP PURCHASING ORGANI -16
1605	1605	ZATION.—The term ‘applicable group purchasing or-17
1606	1606	ganization’ means a group purchasing organization 18
1607	1607	that is affiliated with or under common ownership 19
1608	1608	with an entity providing pharmacy benefit manage-20
1609	1609	ment services. 21
1610	1610	‘‘(3) C
1611	1611	ONTRACTED COMPENSATION .—The term 22
1612	1612	‘contracted compensation’ means the sum of any in-23
1613	1613	gredient cost and dispensing fee for a drug (inclusive 24
1614	1614	of the out-of-pocket costs to the participant or bene-25
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1617	1617	•HR 2450 IH
1618	1618	ficiary), or another analogous compensation struc-1
1619	1619	ture that the Secretary may specify through regula-2
1620	1620	tions. 3
1621	1621	‘‘(4) G
1622	1622	ROSS SPENDING .—The term ‘gross 4
1623	1623	spending’, with respect to prescription drug benefits 5
1624	1624	under a group health plan or health insurance cov-6
1625	1625	erage, means the amount spent by a group health 7
1626	1626	plan or health insurance issuer on prescription drug 8
1627	1627	benefits, calculated before the application of rebates, 9
1628	1628	fees, alternative discounts, or other remuneration. 10
1629	1629	‘‘(5) N
1630	1630	ET SPENDING.—The term ‘net spending’, 11
1631	1631	with respect to prescription drug benefits under a 12
1632	1632	group health plan or health insurance coverage, 13
1633	1633	means the amount spent by a group health plan or 14
1634	1634	health insurance issuer on prescription drug bene-15
1635	1635	fits, calculated after the application of rebates, fees, 16
1636	1636	alternative discounts, or other remuneration. 17
1637	1637	‘‘(6) P
1638	1638	LAN SPONSOR.—The term ‘plan sponsor’ 18
1639	1639	has the meaning given such term in section 19
1640	1640	3(16)(B). 20
1641	1641	‘‘(7) R
1642	1642	EMUNERATION.—The term ‘remunera-21
1643	1643	tion’ has the meaning given such term by the Sec-22
1644	1644	retary through rulemaking, which shall be reevalu-23
1645	1645	ated by the Secretary every 5 years. 24
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1649	1649	‘‘(8) SPECIFIED LARGE EMPLOYER .—The term 1
1650	1650	‘specified large employer’ means, in connection with 2
1651	1651	a group health plan (including group health insur-3
1652	1652	ance coverage offered in connection with such a 4
1653	1653	plan) established or maintained by a single em-5
1654	1654	ployer, with respect to a calendar year or a plan 6
1655	1655	year, as applicable, an employer who employed an 7
1656	1656	average of at least 100 employees on business days 8
1657	1657	during the preceding calendar year or plan year and 9
1658	1658	who employs at least 1 employee on the first day of 10
1659	1659	the calendar year or plan year. 11
1660	1660	‘‘(9) S
1661	1661	PECIFIED LARGE PLAN.—The term ‘spec-12
1662	1662	ified large plan’ means a group health plan (includ-13
1663	1663	ing group health insurance coverage offered in con-14
1664	1664	nection with such a plan) established or maintained 15
1665	1665	by a plan sponsor described in clause (ii) or (iii) of 16
1666	1666	section 3(16)(B) that had an average of at least 100 17
1667	1667	participants on business days during the preceding 18
1668	1668	calendar year or plan year, as applicable. 19
1669	1669	‘‘(10) W
1670	1670	HOLESALE ACQUISITION COST .—The 20
1671	1671	term ‘wholesale acquisition cost’ has the meaning 21
1672	1672	given such term in section 1847A(c)(6)(B) of the 22
1673	1673	Social Security Act (42 U.S.C. 1395w– 23
1674	1674	3a(c)(6)(B)).’’; 24
1675	1675	(B) in section 502 (29 U.S.C. 1132)— 25
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1678	1678	•HR 2450 IH
1679	1679	(i) in subsection (a)(6), by striking 1
1680	1680	‘‘or (9)’’ and inserting ‘‘(9), or (13)’’; 2
1681	1681	(ii) in subsection (b)(3), by striking 3
1682	1682	‘‘under subsection (c)(9)’’ and inserting 4
1683	1683	‘‘under paragraphs (9) and (13) of sub-5
1684	1684	section (c)’’; and 6
1685	1685	(iii) in subsection (c), by adding at 7
1686	1686	the end the following: 8
1687	1687	‘‘(13) S
1688	1688	ECRETARIAL ENFORCEMENT AUTHORITY 9
1689	1689	RELATING TO OVERSIGHT OF PHARMACY BENEFIT 10
1690	1690	MANAGEMENT SERVICES .— 11
1691	1691	‘‘(A) F
1692	1692	AILURE TO PROVIDE INFORMA -12
1693	1693	TION.—The Secretary may impose a penalty 13
1694	1694	against a plan administrator of a group health 14
1695	1695	plan, a health insurance issuer offering group 15
1696	1696	health insurance coverage, or an entity pro-16
1697	1697	viding pharmacy benefit management services 17
1698	1698	on behalf of such a plan or issuer, or an appli-18
1699	1699	cable entity (as defined in section 726(f)) that 19
1700	1700	violates section 726(a); an entity providing 20
1701	1701	pharmacy benefit management services on be-21
1702	1702	half of such a plan or issuer that fails to pro-22
1703	1703	vide the information required under section 23
1704	1704	726(b); or any person who causes a group 24
1705	1705	health plan to fail to provide the information 25
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1709	1709	required under section 726(c), in the amount of 1
1710	1710	$10,000 for each day during which such viola-2
1711	1711	tion continues or such information is not dis-3
1712	1712	closed or reported. 4
1713	1713	‘‘(B) F
1714	1714	ALSE INFORMATION .—The Sec-5
1715	1715	retary may impose a penalty against a plan ad-6
1716	1716	ministrator of a group health plan, a health in-7
1717	1717	surance issuer offering group health insurance 8
1718	1718	coverage, an entity providing pharmacy benefit 9
1719	1719	management services, or an applicable entity 10
1720	1720	(as defined in section 726(f)) that knowingly 11
1721	1721	provides false information under section 726, in 12
1722	1722	an amount not to exceed $100,000 for each 13
1723	1723	item of false information. Such penalty shall be 14
1724	1724	in addition to other penalties as may be pre-15
1725	1725	scribed by law. 16
1726	1726	‘‘(C) W
1727	1727	AIVERS.—The Secretary may waive 17
1728	1728	penalties under subparagraph (A), or extend 18
1729	1729	the period of time for compliance with a re-19
1730	1730	quirement of this section, for an entity in viola-20
1731	1731	tion of section 726 that has made a good-faith 21
1732	1732	effort to comply with the requirements of sec-22
1733	1733	tion 726.’’; and 23
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1737	1737	(C) in section 732(a) (29 U.S.C. 1
1738	1738	1191a(a)), by striking ‘‘section 711’’ and in-2
1739	1739	serting ‘‘sections 711 and 726’’. 3
1740	1740	(2) C
1741	1741	LERICAL AMENDMENT .—The table of con-4
1742	1742	tents in section 1 of the Employee Retirement In-5
1743	1743	come Security Act of 1974 (29 U.S.C. 1001 et seq.) 6
1744	1744	is amended by inserting after the item relating to 7
1745	1745	section 725 the following new item: 8
1746	1746	‘‘Sec. 726. Oversight of entities that provide pharmacy benefit management
1747	1747	services.’’.
1748	1748	(c) INTERNALREVENUECODE OF1986.— 9
1749	1749	(1) I
1750	1750	N GENERAL.—Chapter 100 of the Internal 10
1751	1751	Revenue Code of 1986 is amended— 11
1752	1752	(A) by adding at the end of subchapter B 12
1753	1753	the following: 13
1754	1754	‘‘SEC. 9826. OVERSIGHT OF ENTITIES THAT PROVIDE PHAR-14
1755	1755	MACY BENEFIT MANAGEMENT SERVICES. 15
1756	1756	‘‘(a) I
1757	1757	NGENERAL.—For plan years beginning on or 16
1758	1758	after the date that is 30 months after the date of enact-17
1759	1759	ment of this section (referred to in this subsection and 18
1760	1760	subsection (b) as the ‘effective date’), a group health plan, 19
1761	1761	or an entity providing pharmacy benefit management serv-20
1762	1762	ices on behalf of such a plan, shall not enter into a con-21
1763	1763	tract, including an extension or renewal of a contract, en-22
1764	1764	tered into on or after the effective date, with an applicable 23
1765	1765	entity unless such applicable entity agrees to— 24
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1769	1769	‘‘(1) not limit or delay the disclosure of infor-1
1770	1770	mation to the group health plan in such a manner 2
1771	1771	that prevents an entity providing pharmacy benefit 3
1772	1772	management services on behalf of a group health 4
1773	1773	plan from making the reports described in sub-5
1774	1774	section (b); and 6
1775	1775	‘‘(2) provide the entity providing pharmacy ben-7
1776	1776	efit management services on behalf of a group health 8
1777	1777	plan relevant information necessary to make the re-9
1778	1778	ports described in subsection (b). 10
1779	1779	‘‘(b) R
1780	1780	EPORTS.— 11
1781	1781	‘‘(1) I
1782	1782	N GENERAL.—For plan years beginning 12
1783	1783	on or after the effective date, in the case of any con-13
1784	1784	tract between a group health plan and an entity pro-14
1785	1785	viding pharmacy benefit management services on be-15
1786	1786	half of such plan, including an extension or renewal 16
1787	1787	of such a contract, entered into on or after the effec-17
1788	1788	tive date, the entity providing pharmacy benefit 18
1789	1789	management services on behalf of such a group 19
1790	1790	health plan, not less frequently than every 6 months 20
1791	1791	(or, at the request of a group health plan, not less 21
1792	1792	frequently than quarterly, and under the same con-22
1793	1793	ditions, terms, and cost of the semiannual report 23
1794	1794	under this subsection), shall submit to the group 24
1795	1795	health plan a report in accordance with this section. 25
1796	1796	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00062 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
1797	1797	ssavage on LAPJG3WLY3PROD with BILLS 63
1798	1798	•HR 2450 IH
1799	1799	Each such report shall be made available to such 1
1800	1800	group health plan in plain language, in a machine- 2
1801	1801	readable format, and as the Secretary may deter-3
1802	1802	mine, other formats. Each such report shall include 4
1803	1803	the information described in paragraph (2). 5
1804	1804	‘‘(2) I
1805	1805	NFORMATION DESCRIBED .—For purposes 6
1806	1806	of paragraph (1), the information described in this 7
1807	1807	paragraph is, with respect to drugs covered by a 8
1808	1808	group health plan during each reporting period— 9
1809	1809	‘‘(A) in the case of a group health plan 10
1810	1810	that is offered by a specified large employer or 11
1811	1811	that is a specified large plan, and is not offered 12
1812	1812	as health insurance coverage, or in the case of 13
1813	1813	health insurance coverage for which the election 14
1814	1814	under paragraph (3) is made for the applicable 15
1815	1815	reporting period— 16
1816	1816	‘‘(i) a list of drugs for which a claim 17
1817	1817	was filed and, with respect to each such 18
1818	1818	drug on such list— 19
1819	1819	‘‘(I) the contracted compensation 20
1820	1820	paid by the group health plan for each 21
1821	1821	covered drug (identified by the Na-22
1822	1822	tional Drug Code) to the entity pro-23
1823	1823	viding pharmacy benefit management 24
1824	1824	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00063 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
1825	1825	ssavage on LAPJG3WLY3PROD with BILLS 64
1826	1826	•HR 2450 IH
1827	1827	services or other applicable entity on 1
1828	1828	behalf of the group health plan; 2
1829	1829	‘‘(II) the contracted compensa-3
1830	1830	tion paid to the pharmacy, by any en-4
1831	1831	tity providing pharmacy benefit man-5
1832	1832	agement services or other applicable 6
1833	1833	entity on behalf of the group health 7
1834	1834	plan, for each covered drug (identified 8
1835	1835	by the National Drug Code); 9
1836	1836	‘‘(III) for each such claim, the 10
1837	1837	difference between the amount paid 11
1838	1838	under subclause (I) and the amount 12
1839	1839	paid under subclause (II); 13
1840	1840	‘‘(IV) the proprietary name, es-14
1841	1841	tablished name or proper name, and 15
1842	1842	National Drug Code; 16
1843	1843	‘‘(V) for each claim for the drug 17
1844	1844	(including original prescriptions and 18
1845	1845	refills) and for each dosage unit of the 19
1846	1846	drug for which a claim was filed, the 20
1847	1847	type of dispensing channel used to 21
1848	1848	furnish the drug, including retail, mail 22
1849	1849	order, or specialty pharmacy; 23
1850	1850	‘‘(VI) with respect to each drug 24
1851	1851	dispensed, for each type of dispensing 25
1852	1852	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00064 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
1853	1853	ssavage on LAPJG3WLY3PROD with BILLS 65
1854	1854	•HR 2450 IH
1855	1855	channel (including retail, mail order, 1
1856	1856	or specialty pharmacy)— 2
1857	1857	‘‘(aa) whether such drug is a 3
1858	1858	brand name drug or a generic 4
1859	1859	drug, and— 5
1860	1860	‘‘(AA) in the case of a 6
1861	1861	brand name drug, the whole-7
1862	1862	sale acquisition cost, listed 8
1863	1863	as cost per days supply and 9
1864	1864	cost per dosage unit, on the 10
1865	1865	date such drug was dis-11
1866	1866	pensed; and 12
1867	1867	‘‘(BB) in the case of a 13
1868	1868	generic drug, the average 14
1869	1869	wholesale price, listed as 15
1870	1870	cost per days supply and 16
1871	1871	cost per dosage unit, on the 17
1872	1872	date such drug was dis-18
1873	1873	pensed; and 19
1874	1874	‘‘(bb) the total number of— 20
1875	1875	‘‘(AA) prescription 21
1876	1876	claims (including original 22
1877	1877	prescriptions and refills); 23
1878	1878	‘‘(BB) participants and 24
1879	1879	beneficiaries for whom a 25
1880	1880	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00065 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
1881	1881	ssavage on LAPJG3WLY3PROD with BILLS 66
1882	1882	•HR 2450 IH
1883	1883	claim for such drug was 1
1884	1884	filed through the applicable 2
1885	1885	dispensing channel; 3
1886	1886	‘‘(CC) dosage units and 4
1887	1887	dosage units per fill of such 5
1888	1888	drug; and 6
1889	1889	‘‘(DD) days supply of 7
1890	1890	such drug per fill; 8
1891	1891	‘‘(VII) the net price per course of 9
1892	1892	treatment or single fill, such as a 30- 10
1893	1893	day supply or 90-day supply to the 11
1894	1894	plan after rebates, fees, alternative 12
1895	1895	discounts, or other remuneration re-13
1896	1896	ceived from applicable entities; 14
1897	1897	‘‘(VIII) the total amount of out- 15
1898	1898	of-pocket spending by participants 16
1899	1899	and beneficiaries on such drug, in-17
1900	1900	cluding spending through copayments, 18
1901	1901	coinsurance, and deductibles, but not 19
1902	1902	including any amounts spent by par-20
1903	1903	ticipants and beneficiaries on drugs 21
1904	1904	not covered under the plan, or for 22
1905	1905	which no claim is submitted under the 23
1906	1906	plan; 24
1907	1907	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00066 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
1908	1908	ssavage on LAPJG3WLY3PROD with BILLS 67
1909	1909	•HR 2450 IH
1910	1910	‘‘(IX) the total net spending on 1
1911	1911	the drug; 2
1912	1912	‘‘(X) the total amount received, 3
1913	1913	or expected to be received, by the plan 4
1914	1914	from any applicable entity in rebates, 5
1915	1915	fees, alternative discounts, or other 6
1916	1916	remuneration; 7
1917	1917	‘‘(XI) the total amount received, 8
1918	1918	or expected to be received, by the enti-9
1919	1919	ty providing pharmacy benefit man-10
1920	1920	agement services, from applicable en-11
1921	1921	tities, in rebates, fees, alternative dis-12
1922	1922	counts, or other remuneration from 13
1923	1923	such entities— 14
1924	1924	‘‘(aa) for claims incurred 15
1925	1925	during the reporting period; and 16
1926	1926	‘‘(bb) that is related to utili-17
1927	1927	zation of such drug or spending 18
1928	1928	on such drug; and 19
1929	1929	‘‘(XII) to the extent feasible, in-20
1930	1930	formation on the total amount of re-21
1931	1931	muneration for such drug, including 22
1932	1932	copayment assistance dollars paid, co-23
1933	1933	payment cards applied, or other dis-24
1934	1934	counts provided by each drug manu-25
1935	1935	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00067 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
1936	1936	ssavage on LAPJG3WLY3PROD with BILLS 68
1937	1937	•HR 2450 IH
1938	1938	facturer (or entity administering co-1
1939	1939	payment assistance on behalf of such 2
1940	1940	drug manufacturer), to the partici-3
1941	1941	pants and beneficiaries enrolled in 4
1942	1942	such plan; 5
1943	1943	‘‘(ii) a list of each therapeutic class 6
1944	1944	(as defined by the Secretary) for which a 7
1945	1945	claim was filed under the group health 8
1946	1946	plan during the reporting period, and, with 9
1947	1947	respect to each such therapeutic class— 10
1948	1948	‘‘(I) the total gross spending on 11
1949	1949	drugs in such class before rebates, 12
1950	1950	price concessions, alternative dis-13
1951	1951	counts, or other remuneration from 14
1952	1952	applicable entities; 15
1953	1953	‘‘(II) the net spending in such 16
1954	1954	class after such rebates, price conces-17
1955	1955	sions, alternative discounts, or other 18
1956	1956	remuneration from applicable entities; 19
1957	1957	‘‘(III) the total amount received, 20
1958	1958	or expected to be received, by the enti-21
1959	1959	ty providing pharmacy benefit man-22
1960	1960	agement services, from applicable en-23
1961	1961	tities, in rebates, fees, alternative dis-24
1962	1962	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00068 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
1963	1963	ssavage on LAPJG3WLY3PROD with BILLS 69
1964	1964	•HR 2450 IH
1965	1965	counts, or other remuneration from 1
1966	1966	such entities— 2
1967	1967	‘‘(aa) for claims incurred 3
1968	1968	during the reporting period; and 4
1969	1969	‘‘(bb) that is related to utili-5
1970	1970	zation of drugs or drug spending; 6
1971	1971	‘‘(IV) the average net spending 7
1972	1972	per 30-day supply and per 90-day 8
1973	1973	supply by the plan and its partici-9
1974	1974	pants and beneficiaries, among all 10
1975	1975	drugs within the therapeutic class for 11
1976	1976	which a claim was filed during the re-12
1977	1977	porting period; 13
1978	1978	‘‘(V) the number of participants 14
1979	1979	and beneficiaries who filled a prescrip-15
1980	1980	tion for a drug in such class, includ-16
1981	1981	ing the National Drug Code for each 17
1982	1982	such drug; 18
1983	1983	‘‘(VI) if applicable, a description 19
1984	1984	of the formulary tiers and utilization 20
1985	1985	mechanisms (such as prior authoriza-21
1986	1986	tion or step therapy) employed for 22
1987	1987	drugs in that class; and 23
1988	1988	‘‘(VII) the total out-of-pocket 24
1989	1989	spending under the plan by partici-25
1990	1990	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00069 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
1991	1991	ssavage on LAPJG3WLY3PROD with BILLS 70
1992	1992	•HR 2450 IH
1993	1993	pants and beneficiaries, including 1
1994	1994	spending through copayments, coin-2
1995	1995	surance, and deductibles, but not in-3
1996	1996	cluding any amounts spent by partici-4
1997	1997	pants and beneficiaries on drugs not 5
1998	1998	covered under the plan or for which 6
1999	1999	no claim is submitted under the plan; 7
2000	2000	‘‘(iii) with respect to any drug for 8
2001	2001	which gross spending under the group 9
2002	2002	health plan exceeded $10,000 during the 10
2003	2003	reporting period or, in the case that gross 11
2004	2004	spending under the group health plan ex-12
2005	2005	ceeded $10,000 during the reporting pe-13
2006	2006	riod with respect to fewer than 50 drugs, 14
2007	2007	with respect to the 50 prescription drugs 15
2008	2008	with the highest spending during the re-16
2009	2009	porting period— 17
2010	2010	‘‘(I) a list of all other drugs in 18
2011	2011	the same therapeutic class as such 19
2012	2012	drug; 20
2013	2013	‘‘(II) if applicable, the rationale 21
2014	2014	for the formulary placement of such 22
2015	2015	drug in that therapeutic category or 23
2016	2016	class, selected from a list of standard 24
2017	2017	rationales established by the Sec-25
2018	2018	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00070 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
2019	2019	ssavage on LAPJG3WLY3PROD with BILLS 71
2020	2020	•HR 2450 IH
2021	2021	retary, in consultation with stake-1
2022	2022	holders; and 2
2023	2023	‘‘(III) any change in formulary 3
2024	2024	placement compared to the prior plan 4
2025	2025	year; and 5
2026	2026	‘‘(iv) in the case that such plan (or an 6
2027	2027	entity providing pharmacy benefit manage-7
2028	2028	ment services on behalf of such plan) has 8
2029	2029	an affiliated pharmacy or pharmacy under 9
2030	2030	common ownership, including mandatory 10
2031	2031	mail and specialty home delivery programs, 11
2032	2032	retail and mail auto-refill programs, and 12
2033	2033	cost sharing assistance incentives funded 13
2034	2034	by an entity providing pharmacy benefit 14
2035	2035	services— 15
2036	2036	‘‘(I) an explanation of any ben-16
2037	2037	efit design parameters that encourage 17
2038	2038	or require participants and bene-18
2039	2039	ficiaries in the plan to fill prescrip-19
2040	2040	tions at mail order, specialty, or retail 20
2041	2041	pharmacies; 21
2042	2042	‘‘(II) the percentage of total pre-22
2043	2043	scriptions dispensed by such phar-23
2044	2044	macies to participants or beneficiaries 24
2045	2045	in such plan; and 25
2046	2046	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00071 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
2047	2047	ssavage on LAPJG3WLY3PROD with BILLS 72
2048	2048	•HR 2450 IH
2049	2049	‘‘(III) a list of all drugs dis-1
2050	2050	pensed by such pharmacies to partici-2
2051	2051	pants or beneficiaries enrolled in such 3
2052	2052	plan, and, with respect to each drug 4
2053	2053	dispensed— 5
2054	2054	‘‘(aa) the amount charged, 6
2055	2055	per dosage unit, per 30-day sup-7
2056	2056	ply, or per 90-day supply (as ap-8
2057	2057	plicable) to the plan, and to par-9
2058	2058	ticipants and beneficiaries; 10
2059	2059	‘‘(bb) the median amount 11
2060	2060	charged to such plan, and the 12
2061	2061	interquartile range of the costs, 13
2062	2062	per dosage unit, per 30-day sup-14
2063	2063	ply, and per 90-day supply, in-15
2064	2064	cluding amounts paid by the par-16
2065	2065	ticipants and beneficiaries, when 17
2066	2066	the same drug is dispensed by 18
2067	2067	other pharmacies that are not af-19
2068	2068	filiated with or under common 20
2069	2069	ownership with the entity and 21
2070	2070	that are included in the phar-22
2071	2071	macy network of such plan; 23
2072	2072	‘‘(cc) the lowest cost per 24
2073	2073	dosage unit, per 30-day supply 25
2074	2074	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00072 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
2075	2075	ssavage on LAPJG3WLY3PROD with BILLS 73
2076	2076	•HR 2450 IH
2077	2077	and per 90-day supply, for each 1
2078	2078	such drug, including amounts 2
2079	2079	charged to the plan and to par-3
2080	2080	ticipants and beneficiaries, that 4
2081	2081	is available from any pharmacy 5
2082	2082	included in the network of such 6
2083	2083	plan; and 7
2084	2084	‘‘(dd) the net acquisition 8
2085	2085	cost per dosage unit, per 30-day 9
2086	2086	supply, and per 90-day supply, if 10
2087	2087	such drug is subject to a max-11
2088	2088	imum price discount; and 12
2089	2089	‘‘(B) with respect to any group health 13
2090	2090	plan, regardless of whether the plan is offered 14
2091	2091	by a specified large employer or whether it is a 15
2092	2092	specified large plan— 16
2093	2093	‘‘(i) a summary document for the 17
2094	2094	group health plan that includes such infor-18
2095	2095	mation described in clauses (i) through (iv) 19
2096	2096	of subparagraph (A), as specified by the 20
2097	2097	Secretary through guidance, program in-21
2098	2098	struction, or otherwise (with no require-22
2099	2099	ment of notice and comment rulemaking), 23
2100	2100	that the Secretary determines useful to 24
2101	2101	group health plans for purposes of select-25
2102	2102	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00073 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
2103	2103	ssavage on LAPJG3WLY3PROD with BILLS 74
2104	2104	•HR 2450 IH
2105	2105	ing pharmacy benefit management serv-1
2106	2106	ices, such as an estimated net price to 2
2107	2107	group health plan and participant or bene-3
2108	2108	ficiary, a cost per claim, the fee structure 4
2109	2109	or reimbursement model, and estimated 5
2110	2110	cost per participant or beneficiary; 6
2111	2111	‘‘(ii) a summary document for plans 7
2112	2112	to provide to participants and beneficiaries, 8
2113	2113	which shall be made available to partici-9
2114	2114	pants or beneficiaries upon request to their 10
2115	2115	group health plan, that— 11
2116	2116	‘‘(I) contains such information 12
2117	2117	described in clauses (iii), (iv), (v), and 13
2118	2118	(vi), as applicable, as specified by the 14
2119	2119	Secretary through guidance, program 15
2120	2120	instruction, or otherwise (with no re-16
2121	2121	quirement of notice and comment 17
2122	2122	rulemaking) that the Secretary deter-18
2123	2123	mines useful to participants or bene-19
2124	2124	ficiaries in better understanding the 20
2125	2125	plan or benefits under such plan; 21
2126	2126	‘‘(II) contains only aggregate in-22
2127	2127	formation; and 23
2128	2128	‘‘(III) states that participants 24
2129	2129	and beneficiaries may request specific, 25
2130	2130	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00074 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
2131	2131	ssavage on LAPJG3WLY3PROD with BILLS 75
2132	2132	•HR 2450 IH
2133	2133	claims-level information required to be 1
2134	2134	furnished under subsection (c) from 2
2135	2135	the group health plan; and 3
2136	2136	‘‘(iii) with respect to drugs covered by 4
2137	2137	such plan during such reporting period— 5
2138	2138	‘‘(I) the total net spending by the 6
2139	2139	plan for all such drugs; 7
2140	2140	‘‘(II) the total amount received, 8
2141	2141	or expected to be received, by the plan 9
2142	2142	from any applicable entity in rebates, 10
2143	2143	fees, alternative discounts, or other 11
2144	2144	remuneration; and 12
2145	2145	‘‘(III) to the extent feasible, in-13
2146	2146	formation on the total amount of re-14
2147	2147	muneration for such drugs, including 15
2148	2148	copayment assistance dollars paid, co-16
2149	2149	payment cards applied, or other dis-17
2150	2150	counts provided by each drug manu-18
2151	2151	facturer (or entity administering co-19
2152	2152	payment assistance on behalf of such 20
2153	2153	drug manufacturer) to participants 21
2154	2154	and beneficiaries; 22
2155	2155	‘‘(iv) amounts paid directly or indi-23
2156	2156	rectly in rebates, fees, or any other type of 24
2157	2157	compensation (as defined in section 25
2158	2158	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00075 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
2159	2159	ssavage on LAPJG3WLY3PROD with BILLS 76
2160	2160	•HR 2450 IH
2161	2161	408(b)(2)(B)(ii)(dd)(AA) of the Employee 1
2162	2162	Retirement Income Security Act (29 2
2163	2163	U.S.C. 1108(b)(2)(B)(ii)(dd)(AA))) to bro-3
2164	2164	kerage firms, brokers, consultants, advi-4
2165	2165	sors, or any other individual or firm, for— 5
2166	2166	‘‘(I) the referral of the group 6
2167	2167	health plan’s business to an entity 7
2168	2168	providing pharmacy benefit manage-8
2169	2169	ment services, including the identity 9
2170	2170	of the recipient of such amounts; 10
2171	2171	‘‘(II) consideration of the entity 11
2172	2172	providing pharmacy benefit manage-12
2173	2173	ment services by the group health 13
2174	2174	plan; or 14
2175	2175	‘‘(III) the retention of the entity 15
2176	2176	by the group health plan; 16
2177	2177	‘‘(v) an explanation of any benefit de-17
2178	2178	sign parameters that encourage or require 18
2179	2179	participants and beneficiaries in such plan 19
2180	2180	to fill prescriptions at mail order, specialty, 20
2181	2181	or retail pharmacies that are affiliated with 21
2182	2182	or under common ownership with the enti-22
2183	2183	ty providing pharmacy benefit management 23
2184	2184	services under such plan, including manda-24
2185	2185	tory mail and specialty home delivery pro-25
2186	2186	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00076 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
2187	2187	ssavage on LAPJG3WLY3PROD with BILLS 77
2188	2188	•HR 2450 IH
2189	2189	grams, retail and mail auto-refill pro-1
2190	2190	grams, and cost-sharing assistance incen-2
2191	2191	tives directly or indirectly funded by such 3
2192	2192	entity; and 4
2193	2193	‘‘(vi) total gross spending on all drugs 5
2194	2194	under the plan during the reporting period. 6
2195	2195	‘‘(3) O
2196	2196	PT-IN FOR GROUP HEALTH INSURANCE 7
2197	2197	COVERAGE OFFERED BY A SPECIFIED LARGE EM -8
2198	2198	PLOYER OR THAT IS A SPECIFIED LARGE PLAN .—In 9
2199	2199	the case of group health insurance coverage offered 10
2200	2200	in connection with a group health plan that is of-11
2201	2201	fered by a specified large employer or is a specified 12
2202	2202	large plan, such group health plan may, on an an-13
2203	2203	nual basis, for plan years beginning on or after the 14
2204	2204	date that is 30 months after the date of enactment 15
2205	2205	of this section, elect to require an entity providing 16
2206	2206	pharmacy benefit management services on behalf of 17
2207	2207	the health insurance issuer to submit to such group 18
2208	2208	health plan a report that includes all of the informa-19
2209	2209	tion described in paragraph (2)(A), in addition to 20
2210	2210	the information described in paragraph (2)(B). 21
2211	2211	‘‘(4) P
2212	2212	RIVACY REQUIREMENTS .— 22
2213	2213	‘‘(A) I
2214	2214	N GENERAL.—An entity providing 23
2215	2215	pharmacy benefit management services on be-24
2216	2216	half of a group health plan shall report infor-25
2217	2217	VerDate Sep 11 2014 00:31 Apr 03, 2025 Jkt 059200 PO 00000 Frm 00077 Fmt 6652 Sfmt 6201 E:\BILLS\H2450.IH H2450
2218	2218	ssavage on LAPJG3WLY3PROD with BILLS 78
2219	2219	•HR 2450 IH
2220	2220	mation under paragraph (1) in a manner con-1
2221	2221	sistent with the privacy regulations promul-2
2222	2222	gated under section 13402(a) of the Health In-3
2223	2223	formation Technology for Economic and Clin-4
2224	2224	ical Health Act (42 U.S.C. 17932(a)) and con-5
2225	2225	sistent with the privacy regulations promul-6
2226	2226	gated under the Health Insurance Portability 7
2227	2227	and Accountability Act of 1996 in part 160 and 8
2228	2228	subparts A and E of part 164 of title 45, Code 9
2229	2229	of Federal Regulations (or successor regula-10
2230	2230	tions) (referred to in this paragraph as the 11
2231	2231	‘HIPAA privacy regulations’) and shall restrict 12
2232	2232	the use and disclosure of such information ac-13
2233	2233	cording to such privacy regulations and such 14
2234	2234	HIPAA privacy regulations. 15
2235	2235	‘‘(B) A
2236	2236	DDITIONAL REQUIREMENTS .— 16
2237	2237	‘‘(i) I
2238	2238	N GENERAL.—An entity pro-17
2239	2239	viding pharmacy benefit management serv-18
2240	2240	ices on behalf of a group health plan that 19
2241	2241	submits a report under paragraph (1) shall 20
2242	2242	ensure that such report contains only sum-21
2243	2243	mary health information, as defined in sec-22
2244	2244	tion 164.504(a) of title 45, Code of Fed-23
2245	2245	eral Regulations (or successor regulations). 24
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2249	2249	‘‘(ii) RESTRICTIONS.—In carrying out 1
2250	2250	this subsection, a group health plan shall 2
2251	2251	comply with section 164.504(f) of title 45, 3
2252	2252	Code of Federal Regulations (or a suc-4
2253	2253	cessor regulation), and a plan sponsor shall 5
2254	2254	act in accordance with the terms of the 6
2255	2255	agreement described in such section. 7
2256	2256	‘‘(C) R
2257	2257	ULE OF CONSTRUCTION .— 8
2258	2258	‘‘(i) Nothing in this section shall be 9
2259	2259	construed to modify the requirements for 10
2260	2260	the creation, receipt, maintenance, or 11
2261	2261	transmission of protected health informa-12
2262	2262	tion under the HIPAA privacy regulations. 13
2263	2263	‘‘(ii) Nothing in this section shall be 14
2264	2264	construed to affect the application of any 15
2265	2265	Federal or State privacy or civil rights law, 16
2266	2266	including the HIPAA privacy regulations, 17
2267	2267	the Genetic Information Nondiscrimination 18
2268	2268	Act of 2008 (Public Law 110–233) (in-19
2269	2269	cluding the amendments made by such 20
2270	2270	Act), the Americans with Disabilities Act 21
2271	2271	of 1990 (42 U.S.C. 12101 et sec), section 22
2272	2272	504 of the Rehabilitation Act of 1973 (29 23
2273	2273	U.S.C. 794), section 1557 of the Patient 24
2274	2274	Protection and Affordable Care Act (42 25
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2277	2277	•HR 2450 IH
2278	2278	U.S.C. 18116), title VI of the Civil Rights 1
2279	2279	Act of 1964 (42 U.S.C. 2000d), and title 2
2280	2280	VII of the Civil Rights Act of 1964 (42 3
2281	2281	U.S.C. 2000e). 4
2282	2282	‘‘(D) W
2283	2283	RITTEN NOTICE.—Each plan year, 5
2284	2284	group health plans shall provide to each partici-6
2285	2285	pant or beneficiary written notice informing the 7
2286	2286	participant or beneficiary of the requirement for 8
2287	2287	entities providing pharmacy benefit manage-9
2288	2288	ment services on behalf of the group health 10
2289	2289	plan to submit reports to group health plans 11
2290	2290	under paragraph (1), as applicable, which may 12
2291	2291	include incorporating such notification in plan 13
2292	2292	documents provided to the participant or bene-14
2293	2293	ficiary, or providing individual notification. 15
2294	2294	‘‘(E) L
2295	2295	IMITATION TO BUSINESS ASSOCI -16
2296	2296	ATES.—A group health plan receiving a report 17
2297	2297	under paragraph (1) may disclose such informa-18
2298	2298	tion only to the entity from which the report 19
2299	2299	was received or to that entity’s business associ-20
2300	2300	ates as defined in section 160.103 of title 45, 21
2301	2301	Code of Federal Regulations (or successor regu-22
2302	2302	lations) or as permitted by the HIPAA privacy 23
2303	2303	regulations. 24
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2307	2307	‘‘(F) CLARIFICATION REGARDING PUBLIC 1
2308	2308	DISCLOSURE OF INFORMATION .—Nothing in 2
2309	2309	this section shall prevent an entity providing 3
2310	2310	pharmacy benefit management services on be-4
2311	2311	half of a group health plan, from placing rea-5
2312	2312	sonable restrictions on the public disclosure of 6
2313	2313	the information contained in a report described 7
2314	2314	in paragraph (1), except that such plan or enti-8
2315	2315	ty may not— 9
2316	2316	‘‘(i) restrict disclosure of such report 10
2317	2317	to the Department of Health and Human 11
2318	2318	Services, the Department of Labor, or the 12
2319	2319	Department of the Treasury; or 13
2320	2320	‘‘(ii) prevent disclosure for the pur-14
2321	2321	poses of subsection (c), or any other public 15
2322	2322	disclosure requirement under this section. 16
2323	2323	‘‘(G) L
2324	2324	IMITED FORM OF REPORT .—The 17
2325	2325	Secretary shall define through rulemaking a 18
2326	2326	limited form of the report under paragraph (1) 19
2327	2327	required with respect to any group health plan 20
2328	2328	established by a plan sponsor that is, or is af-21
2329	2329	filiated with, a drug manufacturer, drug whole-22
2330	2330	saler, or other direct participant in the drug 23
2331	2331	supply chain, in order to prevent anti-competi-24
2332	2332	tive behavior. 25
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2336	2336	‘‘(5) STANDARD FORMAT AND REGULATIONS .— 1
2337	2337	‘‘(A) I
2338	2338	N GENERAL.—Not later than 18 2
2339	2339	months after the date of enactment of this sec-3
2340	2340	tion, the Secretary shall specify through rule-4
2341	2341	making a standard format for entities providing 5
2342	2342	pharmacy benefit management services on be-6
2343	2343	half of group health plans, to submit reports re-7
2344	2344	quired under paragraph (1). 8
2345	2345	‘‘(B) A
2346	2346	DDITIONAL REGULATIONS .—Not 9
2347	2347	later than 18 months after the date of enact-10
2348	2348	ment of this section, the Secretary shall, 11
2349	2349	through rulemaking, promulgate any other final 12
2350	2350	regulations necessary to implement the require-13
2351	2351	ments of this section. In promulgating such 14
2352	2352	regulations, the Secretary shall, to the extent 15
2353	2353	practicable, align the reporting requirements 16
2354	2354	under this section with the reporting require-17
2355	2355	ments under section 9825. 18
2356	2356	‘‘(c) R
2357	2357	EQUIREMENTTOPROVIDEINFORMATION TO 19
2358	2358	P
2359	2359	ARTICIPANTS ORBENEFICIARIES.—A group health plan, 20
2360	2360	upon request of a participant or beneficiary, shall provide 21
2361	2361	to such participant or beneficiary— 22
2362	2362	‘‘(1) the summary document described in sub-23
2363	2363	section (b)(2)(B)(ii); and 24
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2367	2367	‘‘(2) the information described in subsection 1
2368	2368	(b)(2)(A)(i)(III) with respect to a claim made by or 2
2369	2369	on behalf of such participant or beneficiary. 3
2370	2370	‘‘(d) R
2371	2371	ULE OFCONSTRUCTION.—Nothing in this sec-4
2372	2372	tion shall be construed to permit a health insurance issuer, 5
2373	2373	group health plan, entity providing pharmacy benefit man-6
2374	2374	agement services on behalf of a group health plan or 7
2375	2375	health insurance issuer, or other entity to restrict disclo-8
2376	2376	sure to, or otherwise limit the access of, the Secretary to 9
2377	2377	a report described in subsection (b)(1) or information re-10
2378	2378	lated to compliance with subsections (a), (b), or (c) of this 11
2379	2379	section or section 4980D(g) by such issuer, plan, or entity. 12
2380	2380	‘‘(e) D
2381	2381	EFINITIONS.—In this section: 13
2382	2382	‘‘(1) A
2383	2383	PPLICABLE ENTITY.—The term ‘applica-14
2384	2384	ble entity’ means— 15
2385	2385	‘‘(A) an applicable group purchasing orga-16
2386	2386	nization, drug manufacturer, distributor, whole-17
2387	2387	saler, rebate aggregator (or other purchasing 18
2388	2388	entity designed to aggregate rebates), or associ-19
2389	2389	ated third party; 20
2390	2390	‘‘(B) any subsidiary, parent, affiliate, or 21
2391	2391	subcontractor of a group health plan, health in-22
2392	2392	surance issuer, entity that provides pharmacy 23
2393	2393	benefit management services on behalf of such 24
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2397	2397	a plan or issuer, or any entity described in sub-1
2398	2398	paragraph (A); or 2
2399	2399	‘‘(C) such other entity as the Secretary 3
2400	2400	may specify through rulemaking. 4
2401	2401	‘‘(2) A
2402	2402	PPLICABLE GROUP PURCHASING ORGANI -5
2403	2403	ZATION.—The term ‘applicable group purchasing or-6
2404	2404	ganization’ means a group purchasing organization 7
2405	2405	that is affiliated with or under common ownership 8
2406	2406	with an entity providing pharmacy benefit manage-9
2407	2407	ment services. 10
2408	2408	‘‘(3) C
2409	2409	ONTRACTED COMPENSATION .—The term 11
2410	2410	‘contracted compensation’ means the sum of any in-12
2411	2411	gredient cost and dispensing fee for a drug (inclusive 13
2412	2412	of the out-of-pocket costs to the participant or bene-14
2413	2413	ficiary), or another analogous compensation struc-15
2414	2414	ture that the Secretary may specify through regula-16
2415	2415	tions. 17
2416	2416	‘‘(4) G
2417	2417	ROSS SPENDING .—The term ‘gross 18
2418	2418	spending’, with respect to prescription drug benefits 19
2419	2419	under a group health plan, means the amount spent 20
2420	2420	by a group health plan on prescription drug benefits, 21
2421	2421	calculated before the application of rebates, fees, al-22
2422	2422	ternative discounts, or other remuneration. 23
2423	2423	‘‘(5) N
2424	2424	ET SPENDING.—The term ‘net spending’, 24
2425	2425	with respect to prescription drug benefits under a 25
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2429	2429	group health plan, means the amount spent by a 1
2430	2430	group health plan on prescription drug benefits, cal-2
2431	2431	culated after the application of rebates, fees, alter-3
2432	2432	native discounts, or other remuneration. 4
2433	2433	‘‘(6) P
2434	2434	LAN SPONSOR.—The term ‘plan sponsor’ 5
2435	2435	has the meaning given such term in section 3(16)(B) 6
2436	2436	of the Employee Retirement Income Security Act of 7
2437	2437	1974 (29 U.S.C. 1002(16)(B)). 8
2438	2438	‘‘(7) R
2439	2439	EMUNERATION.—The term ‘remunera-9
2440	2440	tion’ has the meaning given such term by the Sec-10
2441	2441	retary, through rulemaking, which shall be reevalu-11
2442	2442	ated by the Secretary every 5 years. 12
2443	2443	‘‘(8) S
2444	2444	PECIFIED LARGE EMPLOYER .—The term 13
2445	2445	‘specified large employer’ means, in connection with 14
2446	2446	a group health plan established or maintained by a 15
2447	2447	single employer, with respect to a calendar year or 16
2448	2448	a plan year, as applicable, an employer who em-17
2449	2449	ployed an average of at least 100 employees on busi-18
2450	2450	ness days during the preceding calendar year or plan 19
2451	2451	year and who employs at least 1 employee on the 20
2452	2452	first day of the calendar year or plan year. 21
2453	2453	‘‘(9) S
2454	2454	PECIFIED LARGE PLAN.—The term ‘spec-22
2455	2455	ified large plan’ means a group health plan estab-23
2456	2456	lished or maintained by a plan sponsor described in 24
2457	2457	clause (ii) or (iii) of section 3(16)(B) of the Em-25
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2461	2461	ployee Retirement Income Security Act of 1974 (29 1
2462	2462	U.S.C. 1002(16)(B)) that had an average of at least 2
2463	2463	100 participants on business days during the pre-3
2464	2464	ceding calendar year or plan year, as applicable. 4
2465	2465	‘‘(10) W
2466	2466	HOLESALE ACQUISITION COST .—The 5
2467	2467	term ‘wholesale acquisition cost’ has the meaning 6
2468	2468	given such term in section 1847A(c)(6)(B) of the 7
2469	2469	Social Security Act (42 U.S.C. 1395w– 8
2470	2470	3a(c)(6)(B)).’’; 9
2471	2471	(2) E
2472	2472	XCEPTION FOR CERTAIN GROUP HEALTH 10
2473	2473	PLANS.—Section 9831(a)(2) of the Internal Revenue 11
2474	2474	Code of 1986 is amended by inserting ‘‘other than 12
2475	2475	with respect to section 9826,’’ before ‘‘any group 13
2476	2476	health plan’’. 14
2477	2477	(3) E
2478	2478	NFORCEMENT.—Section 4980D of the In-15
2479	2479	ternal Revenue Code of 1986 is amended by adding 16
2480	2480	at the end the following new subsection: 17
2481	2481	‘‘(g) A
2482	2482	PPLICATION TOREQUIREMENTSIMPOSED ON 18
2483	2483	C
2484	2484	ERTAINENTITIESPROVIDINGPHARMACYBENEFIT 19
2485	2485	M
2486	2486	ANAGEMENTSERVICES.—In the case of any requirement 20
2487	2487	under section 9826 that applies with respect to an entity 21
2488	2488	providing pharmacy benefit management services on be-22
2489	2489	half of a group health plan, any reference in this section 23
2490	2490	to such group health plan (and the reference in subsection 24
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2494	2494	(e)(1) to the employer) shall be treated as including a ref-1
2495	2495	erence to such entity.’’. 2
2496	2496	(4) C
2497	2497	LERICAL AMENDMENT .—The table of sec-3
2498	2498	tions for subchapter B of chapter 100 of the Inter-4
2499	2499	nal Revenue Code of 1986 is amended by adding at 5
2500	2500	the end the following new item: 6
2501	2501	‘‘Sec. 9826. Oversight of entities that provide pharmacy benefit management
2502	2502	services.’’.
2503	2503	Æ
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