II 

118TH CONGRESS 

1ST SESSION S. 644 

To expand the take-home prescribing of methadone through pharmacies. 

IN THE SENATE OF THE UNITED STATES 

MARCH 2, 2023 

Mr. MARKEY (for himself, Mr. PAUL, Mr. SANDERS, Mr. BRAUN, Mr. BOOKER, and Ms. HASSAN) introduced the following bill; which was read twice 

and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To expand the take-home prescribing of methadone through 

pharmacies. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Modernizing Opioid 

5 Treatment Access Act’’. 

6 SEC. 2. EXPANSION OF METHADONE FOR OPIOID USE DIS7 ORDER THROUGH PRESCRIBING AND PHAR8 MACIES. 

9 (a) REGISTRATION; OTHER CARE BY TELE10 HEALTH.— 


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1 (1) DEFINITIONS.—In this subsection: 

2 (A) CONTROLLED SUBSTANCE; DETOXI3 FICATION TREATMENT; DISPENSE; MAINTE4 NANCE TREATMENT; OPIOID.—The terms ‘‘con5 trolled substance’’, ‘‘detoxification treatment’’, 

6 ‘‘dispense’’, ‘‘maintenance treatment’’, and 

7 ‘‘opioid’’ have the meanings given the terms in 

8 section 102 of the Controlled Substances Act 

9 (21 U.S.C. 802). 

10 (B) SECRETARY.—The term ‘‘Secretary’’ 

11 means the Secretary of Health and Human 

12 Services. 

13 (2) WAIVER.— 

14 (A) IN GENERAL.—The requirements of 

15 section 303(h) of Controlled Substances Act (21 

16 U.S.C. 823(h)) applicable to methadone medica17 tion for opioid use disorder are waived, and the 

18 Attorney General, in consultation with the Sec19 retary, shall register persons described in sub20 paragraph (B) to prescribe methadone for 

21 opioid use disorder to be dispensed through a 

22 pharmacy for individuals for unsupervised use. 

23 (B) PERSONS DESCRIBED.—Persons de24 scribed in this subparagraph are persons who— 


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1 (i) are licensed, registered, or other2 wise permitted, by the United States or the 

3 jurisdiction in which they practice, to pre4 scribe controlled substances in the course 

5 of professional practice; and 

6 (ii) are— 

7 (I) employees or contractors of 

8 an opioid treatment program; or 

9 (II) addiction medicine physi10 cians or addiction psychiatrists who 

11 hold a subspecialty board certification 

12 in addiction medicine from the Amer13 ican Board of Preventive Medicine, a 

14 board certification in addiction medi15 cine from the American Board of Ad16 diction Medicine, a subspecialty board 

17 certification in addiction psychiatry 

18 from the American Board of Psychi19 atry and Neurology, or a subspecialty 

20 board certification in addiction medi21 cine from the American Osteopathic 

22 Association. 

23 (C) REQUIREMENTS FOR PRESCRIBING

24 METHADONE.—The prescribing of methadone 

25 pursuant to subparagraph (A) shall be— 


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1 (i) exclusively by electronic prescribing 

2 and dispensed to the patient treated pursu3 ant to subparagraph (A); 

4 (ii) for a supply of not more than 30 

5 days pursuant to each prescription; and 

6 (iii) subject to the restrictions listed 

7 in section 8.12(i)(3) of title 42, Code of 

8 Federal Regulations, or successor regula9 tion or guidance. 

10 (D) REQUIREMENTS FOR DISPENSING

11 METHADONE.—The dispensing of methadone to 

12 an individual pursuant to subparagraph (A) 

13 shall be in addition to the other care that the 

14 individual continues to have access to through 

15 an opioid treatment program. 

16 (E) REGISTRATION REQUIREMENTS.—Per17 sons registered in a State pursuant to subpara18 graph (A) shall— 

19 (i) ensure and document, with respect 

20 to each patient treated pursuant to sub21 paragraph (A), informed consent to treat22 ment; and 

23 (ii) include in such informed consent, 

24 specific informed consent regarding dif25 ferences in confidentiality protections apVerDate Sep 11 2014 05:18 Mar 15, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S644.IS S644

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1 plicable when dispensing through an opioid 

2 treatment program versus dispensing 

3 through a pharmacy pursuant to subpara4 graph (A). 

5 (F) CESSATION AND WITHDRAWAL OF

6 REGISTRATION.—At the request of a State, the 

7 Attorney General, in consultation with the Sec8 retary, shall— 

9 (i) cease registering persons in the 

10 State pursuant to subparagraph (A); and 

11 (ii) withdraw any such registration in 

12 effect for a person in the State. 

13 (G) MAINTENANCE AND DETOXIFICATION

14 TREATMENT.—Maintenance treatment or de15 toxification treatment provided pursuant to sub16 paragraph (A) and other care provided in con17 junction with such treatment, such as coun18 seling and other ancillary services, may be pro19 vided by means of telehealth, as determined 

20 jointly by the State and the Secretary to be fea21 sible and appropriate. 

22 (b) ANNUAL REPORTING.—Not later than 180 days 

23 after the date of enactment of this Act, and annually 

24 thereafter, the Assistant Secretary for Mental Health and 

25 Substance Use and the Administrator of the Drug EnVerDate Sep 11 2014 05:18 Mar 15, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S644.IS S644

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1 forcement Administration shall jointly submit a report to 

2 Congress that includes— 

3 (1) the number of persons registered pursuant 

4 to subsection (a); 

5 (2) the number of patients being prescribed 

6 methadone pursuant to subsection (a); and 

7 (3) a list of the States in which persons are 

8 registered pursuant to such subsection (a). 

9 SEC. 3. SENSE OF CONGRESS ON NEED TO REDUCE BAR10 RIERS TO PATIENT CARE THROUGH OPIOID 

11 TREATMENT PROGRAMS. 

12 It is the sense of Congress that— 

13 (1) patients receiving services through opioid 

14 treatment programs face barriers to their care; and 

15 (2) each State should align the regulation of 

16 opioid treatment programs in a manner that is con17 sistent with the intent of this Act. 

Æ 


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