Us Congress 2023-2024 Regular Session

Us Congress Senate Bill SB2666 Compare Versions

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

Old	New	Differences
1	1	II
2	2	118THCONGRESS
3	3	1
4	4	STSESSION S. 2666
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 1986 to provide
7	7	for requirements for electronic-prescribing for controlled substances under
8	8	group health plans and group and individual health insurance coverage.
9	9	IN THE SENATE OF THE UNITED STATES
10	10	JULY27, 2023
11	11	Ms. H
12	12	ASSAN(for herself and Mr. MULLIN) introduced the following bill; which
13	13	was read twice and referred to the Committee on Health, Education,
14	14	Labor, and Pensions
15	15	A BILL
16	16	To amend the Public Health Service Act, the Employee Re-
17	17	tirement Income Security Act of 1974, and the Internal
18	18	Revenue Code of 1986 to provide for requirements for
19	19	electronic-prescribing for controlled substances under
20	20	group health plans and group and individual health in-
21	21	surance coverage.
22	22	Be it enacted by the Senate and House of Representa-1
23	23	tives of the United States of America in Congress assembled, 2
24	24	SECTION 1. SHORT TITLE. 3
25	25	This Act may be cited as the ‘‘Electronic Prescribing 4
26	26	for Controlled Substances Act’’ or the ‘‘EPCS 2.0 Act’’. 5
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29	29	•S 2666 IS
30	30	SEC. 2. REQUIREMENTS FOR ELECTRONIC-PRESCRIBING 1
31	31	FOR CONTROLLED SUBSTANCES UNDER 2
32	32	GROUP HEALTH PLANS AND GROUP AND IN-3
33	33	DIVIDUAL HEALTH INSURANCE COVERAGE. 4
34	34	(a) P
35	35	UBLICHEALTHSERVICEACTAMENDMENT.— 5
36	36	Section 2799A–7 of the Public Health Service Act (42 6
37	37	U.S.C. 300gg–117) is amended by adding at the end the 7
38	38	following new subsection: 8
39	39	‘‘(d) R
40	40	EQUIREMENTS FOR ELECTRONIC-PRE-9
41	41	SCRIBING FORCONTROLLEDSUBSTANCES.— 10
42	42	‘‘(1) I
43	43	N GENERAL.—Except as provided pursu-11
44	44	ant to paragraph (2), for plan years beginning on or 12
45	45	after January 1, 2025, a group health plan and a 13
46	46	health insurance issuer offering group or individual 14
47	47	health insurance coverage, with respect to a partici-15
48	48	pating provider, as defined in section 2799–1(a)(3), 16
49	49	shall have in place policies, subject to paragraph (4), 17
50	50	that require any prescription for a schedule II, III, 18
51	51	IV, or V controlled substance (as defined by section 19
52	52	202 of the Controlled Substances Act) covered under 20
53	53	the plan or coverage that is transmitted by such a 21
54	54	health care practitioner for such a participant, bene-22
55	55	ficiary, or enrollee be electronically transmitted in 23
56	56	accordance with such standards, consistent with 24
57	57	standards established under paragraph (3) of section 25
58	58	1860D–4(e) of the Social Security Act, under an 26
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61	61	•S 2666 IS
62	62	electronic prescription drug program that meets re-1
63	63	quirements that are substantially similar (as jointly 2
64	64	determined by the Secretary, Secretary of the Treas-3
65	65	ury, and Secretary of Labor) to the requirements of 4
66	66	paragraph (2) of such section 1860D–4(e). 5
67	67	‘‘(2) E
68	68	XCEPTION FOR CERTAIN CIR -6
69	69	CUMSTANCES.—The Secretary, Secretary of the 7
70	70	Treasury, and Secretary of Labor shall jointly, 8
71	71	through rulemaking, specify circumstances and proc-9
72	72	esses by which the requirement under paragraph (1) 10
73	73	may be waived, with respect to a schedule II, III, 11
74	74	IV, or V controlled substance that is a prescription 12
75	75	drug covered by a group health plan or group or in-13
76	76	dividual health insurance coverage offered by a 14
77	77	health insurance issuer, including in the case of— 15
78	78	‘‘(A) a prescription described in any of 16
79	79	clauses (i) through (vi) of section 1860D– 17
80	80	4(e)(7)(B) of the Social Security Act; 18
81	81	‘‘(B) a prescription issued for an individual 19
82	82	who receives hospice care or for a resident of a 20
83	83	nursing facility (as defined in section 1919(a) 21
84	84	of the Social Security Act); 22
85	85	‘‘(C) a prescription issued under cir-23
86	86	cumstances in which electronic prescribing is 24
87	87	not available due to temporary technological or 25
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90	90	•S 2666 IS
91	91	electrical failure, as specified jointly by the Sec-1
92	92	retary, Secretary of the Treasury, and Sec-2
93	93	retary of Labor through rulemaking; and 3
94	94	‘‘(D) a prescription issued by a practi-4
95	95	tioner allowing for the dispensing of a non-pa-5
96	96	tient specific prescription pursuant to a stand-6
97	97	ing order, approved protocol for drug therapy, 7
98	98	collaborative drug management, or comprehen-8
99	99	sive medication management, in response to a 9
100	100	public health emergency or other circumstances 10
101	101	under which the practitioner may issue a non- 11
102	102	patient specific prescription. 12
103	103	‘‘(3) R
104	104	ULES OF CONSTRUCTION .— 13
105	105	‘‘(A) V
106	106	ERIFICATION.—Nothing in this sub-14
107	107	section shall be construed as requiring a dis-15
108	108	penser to verify that a health care practitioner, 16
109	109	with respect to a prescription for a schedule II, 17
110	110	III, IV, or V controlled substance that is a pre-18
111	111	scription drug covered under a group health 19
112	112	plan or group or individual health insurance 20
113	113	coverage offered by a health insurance issuer, 21
114	114	has a waiver (or is otherwise exempt) under 22
115	115	paragraph (2) from the requirement under 23
116	116	paragraph (1). 24
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119	119	•S 2666 IS
120	120	‘‘(B) AUTHORITY TO DISPENSE .—Nothing 1
121	121	in this subsection shall be construed as affect-2
122	122	ing the authority of a group health plan or 3
123	123	group or individual health insurance coverage 4
124	124	offered by a health insurance issuer to cover, or 5
125	125	the authority of a dispenser to continue to dis-6
126	126	pense, a prescription drug if the prescription 7
127	127	for such drug is an otherwise valid written, 8
128	128	oral, or fax prescription that is consistent with 9
129	129	applicable law. 10
130	130	‘‘(C) P
131	131	ATIENT CHOICE.—Nothing in this 11
132	132	subsection shall be construed as affecting the 12
133	133	ability of an individual who is a participant, 13
134	134	beneficiary, or enrollee of a group health plan 14
135	135	or group or individual health insurance cov-15
136	136	erage offered by a health insurance issuer and 16
137	137	who is prescribed a schedule II, III, IV, or V 17
138	138	controlled substance that is a prescription drug 18
139	139	covered under the plan or coverage to designate 19
140	140	a particular pharmacy to dispense a prescribed 20
141	141	controlled substance to the extent consistent 21
142	142	with the requirements under this subsection. 22
143	143	‘‘(4) P
144	144	ROHIBITIONS.—The policies established 23
145	145	pursuant to paragraph (1) by a group health plan or 24
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148	148	•S 2666 IS
149	149	health insurance issuer offering group or individual 1
150	150	health insurance coverage may not— 2
151	151	‘‘(A) require dispensers of a schedule II, 3
152	152	III, IV, or V controlled substance to confirm 4
153	153	that the prescription for the controlled sub-5
154	154	stance was electronically issued by a health care 6
155	155	practitioner in accordance with such policies, as 7
156	156	described in paragraph (1); 8
157	157	‘‘(B) require dispensers of such controlled 9
158	158	substances to submit information or data be-10
159	159	yond what is otherwise required to process a 11
160	160	prescription drug claim in order to confirm a 12
161	161	practitioner’s compliance with such policies; or 13
162	162	‘‘(C) reject, deny, or recoup reimbursement 14
163	163	for a prescription drug claim based on the for-15
164	164	mat in which the prescription was issued. 16
165	165	‘‘(5) C
166	166	ONSULTATION REQUIREMENT FOR RULE -17
167	167	MAKING.—In promulgating regulations to carry out 18
168	168	this subsection, the Secretary, Secretary of the 19
169	169	Treasury, and Secretary of Labor shall jointly con-20
170	170	sult with dispensers of controlled substances, State 21
171	171	insurance regulators, and health care practitioners.’’. 22
172	172	(b) E
173	173	MPLOYEERETIREMENTINCOMESECURITYACT 23
174	174	OF1974 AMENDMENT.—Section 722 of the Employee Re-24
175	175	tirement Income Security Act of 1974 (29 U.S.C. 1185k) 25
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178	178	•S 2666 IS
179	179	is amended by adding at the end the following new sub-1
180	180	section: 2
181	181	‘‘(d) R
182	182	EQUIREMENTS FOR ELECTRONIC-PRE-3
183	183	SCRIBING FORCONTROLLEDSUBSTANCES.— 4
184	184	‘‘(1) I
185	185	N GENERAL.—Except as provided pursu-5
186	186	ant to paragraph (2), for plan years beginning on or 6
187	187	after January 1, 2025, a group health plan and a 7
188	188	health insurance issuer offering group health insur-8
189	189	ance coverage, with respect to a participating pro-9
190	190	vider, as defined in section 716(a)(3), shall have in 10
191	191	place policies, subject to paragraph (4), that require 11
192	192	any prescription for a schedule II, III, IV, or V con-12
193	193	trolled substance (as defined by section 202 of the 13
194	194	Controlled Substances Act) covered under the plan 14
195	195	or coverage that is transmitted by such a health care 15
196	196	practitioner for such a participant or beneficiary be 16
197	197	electronically transmitted in accordance with such 17
198	198	standards, consistent with standards established 18
199	199	under paragraph (3) of section 1860D–4(e) of the 19
200	200	Social Security Act, under an electronic prescription 20
201	201	drug program that meets requirements that are sub-21
202	202	stantially similar (as jointly determined by the Sec-22
203	203	retary, Secretary of the Treasury, and Secretary of 23
204	204	Labor) to the requirements of paragraph (2) of such 24
205	205	section 1860D–4(e). 25
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208	208	•S 2666 IS
209	209	‘‘(2) EXCEPTION FOR CERTAIN CIR -1
210	210	CUMSTANCES.—The Secretary, Secretary of the 2
211	211	Treasury, and Secretary of Health and Human 3
212	212	Services shall jointly, through rulemaking, specify 4
213	213	circumstances and processes by which the require-5
214	214	ment under paragraph (1) may be waived, with re-6
215	215	spect to a schedule II, III, IV, or V controlled sub-7
216	216	stance that is a prescription drug covered by a group 8
217	217	health plan or group health insurance coverage of-9
218	218	fered by a health insurance issuer, including in the 10
219	219	case of— 11
220	220	‘‘(A) a prescription described in any of 12
221	221	clauses (i) through (vi) of section 1860D– 13
222	222	4(e)(7)(B) of the Social Security Act; 14
223	223	‘‘(B) a prescription issued for an individual 15
224	224	who receives hospice care or for a resident of a 16
225	225	nursing facility (as defined in section 1919(a) 17
226	226	of the Social Security Act); 18
227	227	‘‘(C) a prescription issued under cir-19
228	228	cumstances in which electronic prescribing is 20
229	229	not available due to temporary technological or 21
230	230	electrical failure, as specified jointly by the Sec-22
231	231	retary, Secretary of the Treasury, and Sec-23
232	232	retary of Health and Human Services through 24
233	233	rulemaking; and 25
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236	236	•S 2666 IS
237	237	‘‘(D) a prescription issued by a practi-1
238	238	tioner allowing for the dispensing of a non-pa-2
239	239	tient specific prescription pursuant to a stand-3
240	240	ing order, approved protocol for drug therapy, 4
241	241	collaborative drug management, or comprehen-5
242	242	sive medication management, in response to a 6
243	243	public health emergency or other circumstances 7
244	244	under which the practitioner may issue a non- 8
245	245	patient specific prescription. 9
246	246	‘‘(3) R
247	247	ULES OF CONSTRUCTION .— 10
248	248	‘‘(A) V
249	249	ERIFICATION.—Nothing in this sub-11
250	250	section shall be construed as requiring a dis-12
251	251	penser to verify that a health care practitioner, 13
252	252	with respect to a prescription for a schedule II, 14
253	253	III, IV, or V controlled substance that is a pre-15
254	254	scription drug covered under a group health 16
255	255	plan or group or individual health insurance 17
256	256	coverage offered by a health insurance issuer, 18
257	257	has a waiver (or is otherwise exempt) under 19
258	258	paragraph (2) from the requirement under 20
259	259	paragraph (1). 21
260	260	‘‘(B) A
261	261	UTHORITY TO DISPENSE .—Nothing 22
262	262	in this subsection shall be construed as affect-23
263	263	ing the authority of a group health plan or 24
264	264	group health insurance coverage offered by a 25
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267	267	•S 2666 IS
268	268	health insurance issuer to cover, or the author-1
269	269	ity of a dispenser to continue to dispense, a pre-2
270	270	scription drug if the prescription for such drug 3
271	271	is an otherwise valid written, oral, or fax pre-4
272	272	scription that is consistent with applicable law. 5
273	273	‘‘(C) P
274	274	ATIENT CHOICE.—Nothing in this 6
275	275	subsection shall be construed as affecting the 7
276	276	ability of an individual who is a participant or 8
277	277	beneficiary of a group health plan or group or 9
278	278	individual health insurance coverage offered by 10
279	279	a health insurance issuer and who is prescribed 11
280	280	a schedule II, III, IV, or V controlled substance 12
281	281	that is a prescription drug covered under the 13
282	282	plan or coverage to designate a particular phar-14
283	283	macy to dispense a prescribed controlled sub-15
284	284	stance to the extent consistent with the require-16
285	285	ments under this subsection. 17
286	286	‘‘(4) P
287	287	ROHIBITIONS.—The policies established 18
288	288	pursuant to paragraph (1) by a group health plan or 19
289	289	health insurance issuer offering group health insur-20
290	290	ance coverage may not— 21
291	291	‘‘(A) require dispensers of a schedule II, 22
292	292	III, IV, or V controlled substance to confirm 23
293	293	that the prescription for the controlled sub-24
294	294	stance was electronically issued by a health care 25
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297	297	•S 2666 IS
298	298	practitioner in accordance with such policies, as 1
299	299	described in paragraph (1); 2
300	300	‘‘(B) require dispensers of such controlled 3
301	301	substances to submit information or data be-4
302	302	yond what is otherwise required to process a 5
303	303	prescription drug claim in order to confirm a 6
304	304	practitioner’s compliance with such policies; or 7
305	305	‘‘(C) reject, deny, or recoup reimbursement 8
306	306	for a prescription drug claim based on the for-9
307	307	mat in which the prescription was issued. 10
308	308	‘‘(5) C
309	309	ONSULTATION REQUIREMENT FOR RULE -11
310	310	MAKING.—In promulgating regulations to carry out 12
311	311	this subsection, the Secretary, Secretary of the 13
312	312	Treasury, and Secretary of Health and Human 14
313	313	Services shall jointly consult with dispensers of con-15
314	314	trolled substances, State insurance regulators, and 16
315	315	health care practitioners.’’. 17
316	316	(c) I
317	317	NTERNALREVENUECODE OF1986 AMEND-18
318	318	MENT.—Section 9822 of the Internal Revenue Code of 19
319	319	1986 is amended by adding at the end the following new 20
320	320	subsection: 21
321	321	‘‘(d) R
322	322	EQUIREMENTS FOR ELECTRONIC-PRE-22
323	323	SCRIBING FORCONTROLLEDSUBSTANCES.— 23
324	324	‘‘(1) I
325	325	N GENERAL.—Except as provided pursu-24
326	326	ant to paragraph (2), for plan years beginning on or 25
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329	329	•S 2666 IS
330	330	after January 1, 2025, a group health plan, with re-1
331	331	spect to a participating provider, as defined in sec-2
332	332	tion 9816(a)(3), shall have in place policies, subject 3
333	333	to paragraph (4), that require any prescription for 4
334	334	a schedule II, III, IV, or V controlled substance (as 5
335	335	defined by section 202 of the Controlled Substances 6
336	336	Act) covered under the plan that is transmitted by 7
337	337	such a health care practitioner for such a participant 8
338	338	or beneficiary be electronically transmitted in ac-9
339	339	cordance with such standards, consistent with stand-10
340	340	ards established under paragraph (3) of section 11
341	341	1860D–4(e) of the Social Security Act, under an 12
342	342	electronic prescription drug program that meets re-13
343	343	quirements that are substantially similar (as jointly 14
344	344	determined by the Secretary, Secretary of the Treas-15
345	345	ury, and Secretary of Labor) to the requirements of 16
346	346	paragraph (2) of such section 1860D–4(e). 17
347	347	‘‘(2) E
348	348	XCEPTION FOR CERTAIN CIR -18
349	349	CUMSTANCES.—The Secretary, Secretary of Health 19
350	350	and Human Services, and Secretary of Labor shall 20
351	351	jointly, through rulemaking, specify circumstances 21
352	352	and processes by which the requirement under para-22
353	353	graph (1) may be waived, with respect to a schedule 23
354	354	II, III, IV, or V controlled substance that is a pre-24
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357	357	•S 2666 IS
358	358	scription drug covered by a group health, including 1
359	359	in the case of— 2
360	360	‘‘(A) a prescription described in any of 3
361	361	clauses (i) through (vi) of section 1860D– 4
362	362	4(e)(7)(B) of the Social Security Act; 5
363	363	‘‘(B) a prescription issued for an individual 6
364	364	who receives hospice care or for a resident of a 7
365	365	nursing facility (as defined in section 1919(a) 8
366	366	of the Social Security Act); 9
367	367	‘‘(C) a prescription issued under cir-10
368	368	cumstances in which electronic prescribing is 11
369	369	not available due to temporary technological or 12
370	370	electrical failure, as specified jointly by the Sec-13
371	371	retary, Secretary of Health and Human Serv-14
372	372	ices, and Secretary of Labor through rule-15
373	373	making; and 16
374	374	‘‘(D) a prescription issued by a practi-17
375	375	tioner allowing for the dispensing of a non-pa-18
376	376	tient specific prescription pursuant to a stand-19
377	377	ing order, approved protocol for drug therapy, 20
378	378	collaborative drug management, or comprehen-21
379	379	sive medication management, in response to a 22
380	380	public health emergency or other circumstances 23
381	381	under which the practitioner may issue a non- 24
382	382	patient specific prescription. 25
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385	385	•S 2666 IS
386	386	‘‘(3) RULES OF CONSTRUCTION .— 1
387	387	‘‘(A) V
388	388	ERIFICATION.—Nothing in this sub-2
389	389	section shall be construed as requiring a dis-3
390	390	penser to verify that a health care practitioner, 4
391	391	with respect to a prescription for a schedule II, 5
392	392	III, IV, or V controlled substance that is a pre-6
393	393	scription drug covered under a group health 7
394	394	plan, has a waiver (or is otherwise exempt) 8
395	395	under paragraph (2) from the requirement 9
396	396	under paragraph (1). 10
397	397	‘‘(B) A
398	398	UTHORITY TO DISPENSE .—Nothing 11
399	399	in this subsection shall be construed as affect-12
400	400	ing the ability of a group health plan to cover, 13
401	401	or the ability of a dispenser to continue to dis-14
402	402	pense, a prescription drug if the prescription 15
403	403	for such drug is an otherwise valid written, 16
404	404	oral, or fax prescription that is consistence with 17
405	405	applicable laws and regulations. 18
406	406	‘‘(C) P
407	407	ATIENT CHOICE.—Nothing in this 19
408	408	subsection shall be construed as affecting the 20
409	409	ability of an individual who is a participant or 21
410	410	beneficiary of a group health plan and who is 22
411	411	prescribed a schedule II, III, IV, or V con-23
412	412	trolled substance that is a prescription drug 24
413	413	covered under the plan to designate a particular 25
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416	416	•S 2666 IS
417	417	pharmacy to dispense a prescribed controlled 1
418	418	substance to the extent consistent with the re-2
419	419	quirements under this subsection. 3
420	420	‘‘(4) P
421	421	ROHIBITIONS.—The policies established 4
422	422	pursuant to paragraph (1) by a group health plan 5
423	423	may not— 6
424	424	‘‘(A) require dispensers of a schedule II, 7
425	425	III, IV, or V controlled substance to confirm 8
426	426	that the prescription for the controlled sub-9
427	427	stance was electronically issued by a health care 10
428	428	practitioner in accordance with such policies, as 11
429	429	described in paragraph (1); 12
430	430	‘‘(B) require dispensers of such controlled 13
431	431	substances to submit information or data be-14
432	432	yond what is otherwise required to process a 15
433	433	prescription drug claim in order to confirm a 16
434	434	practitioner’s compliance with such policies; or 17
435	435	‘‘(C) reject, deny, or recoup reimbursement 18
436	436	for a prescription drug claim based on the for-19
437	437	mat in which the prescription was issued. 20
438	438	‘‘(5) C
439	439	ONSULTATION REQUIREMENT FOR RULE -21
440	440	MAKING.—In promulgating regulations to carry out 22
441	441	this subsection, the Secretary, Secretary of Health 23
442	442	and Human Services, and Secretary of Labor shall 24
443	443	jointly consult with dispensers of controlled sub-25
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445	445	kjohnson on DSK79L0C42PROD with BILLS 16
446	446	•S 2666 IS
447	447	stances, State insurance regulators, and health care 1
448	448	practitioners.’’. 2
449	449	Æ
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