II 

117TH CONGRESS 

2D SESSION S. 3629 

To authorize a study on certain exemptions for treatment of opioid use 

disorder through opioid treatment programs during the COVID–19 public 

health emergency, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 10, 2022 

Mr. MARKEY (for himself and Mr. PAUL) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To authorize a study on certain exemptions for treatment 

of opioid use disorder through opioid treatment programs 

during the COVID–19 public health emergency, and for 

other purposes. 

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 ‘‘Opioid Treatment Ac5 cess Act of 2022’’. 


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1 SEC. 2. STUDY ON EXEMPTIONS FOR TREATMENT OF 

2 OPIOID USE DISORDER THROUGH OPIOID 

3 TREATMENT PROGRAMS DURING THE COVID– 

4 19 PUBLIC HEALTH EMERGENCY. 

5 (a) STUDY.—The Assistant Secretary for Mental 

6 Health and Substance Use shall conduct a study, in con7 sultation with patients and other stakeholders, on activi8 ties carried out pursuant to exemptions granted— 

9 (1) to a State (including the District of Colum10 bia or any territory of the United States) or an 

11 opioid treatment program; 

12 (2) pursuant to section 8.11(h) of title 42, Code 

13 of Federal Regulations; and 

14 (3) during the period— 

15 (A) beginning on the declaration of the 

16 public health emergency for the COVID–19 

17 pandemic under section 319 of the Public 

18 Health Service Act (42 U.S.C. 274); and 

19 (B) ending on the earlier of— 

20 (i) the termination of such public 

21 health emergency, including extensions 

22 thereof pursuant to such section 319; and 

23 (ii) the end of calendar year 2022. 

24 (b) ISSUES TO BE STUDIED.—The study under sub25 section (a) shall, with respect to exemptions described in 


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1 such subsection, include consideration of each of the fol2 lowing: 

3 (1) The number of participating patients in 

4 each State. 

5 (2) The percentage of participating patients in 

6 each State relative to the total number of patients 

7 in the respective State receiving treatment through 

8 an opioid treatment program. 

9 (3) The number of participating patients in 

10 each State who cease treatment. 

11 (4) The number of participating patients in 

12 each State who overdose on an opioid and cease 

13 treatment. 

14 (5) The number of participating patients in 

15 each State who overdose on an opioid and continue 

16 treatment. 

17 (6) The number of participating opioid treat18 ment programs in each State. 

19 (7) The percentage of participating opioid treat20 ment programs in each State relative to the total 

21 number of opioid treatment programs in the respec22 tive State. 

23 (8) The demographic, socioeconomic, and geo24 graphic characteristics of the participating patients 

25 and opioid treatment programs. 


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1 (9) Any additional costs or savings from exemp2 tions in each State. 

3 (10) An analysis of differences in the use of ex4 emptions among States. 

5 (11) Rates of medication adherence and diver6 sion. 

7 (c) PRIVACY.—The section does not authorize the dis8 closure by the Department of Health and Human Services 

9 of individually identifiable information about patients. 

10 (d) FEEDBACK.—In conducting the study under sub11 section (a), the Assistant Secretary for Mental Health and 

12 Substance Use shall gather feedback from the States and 

13 opioid treatment programs on their experiences in imple14 menting exemptions described in subsection (a). 

15 (e) REPORT.—Not later than 180 days after the end 

16 of the period described in subsection (a)(3)(B), and sub17 ject to subsection (c), the Assistant Secretary for Mental 

18 Health and Substance Use shall publish a report on the 

19 results of the study under this section. 

20 SEC. 3. CHANGES TO FEDERAL OPIOID TREATMENT STAND21 ARDS. 

22 (a) MOBILE MEDICATION UNITS.—Section 302(e) of 

23 the Controlled Substances Act (21 U.S.C. 822(e)) is 

24 amended by adding at the end the following: 


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1 ‘‘(3) Notwithstanding paragraph (1), a registrant 

2 that is dispensing pursuant to section 303(g) narcotic 

3 drugs to individuals for maintenance treatment or detoxi4 fication treatment shall not be required to have a separate 

5 registration to incorporate one or more mobile medication 

6 units into the registrant’s practice to dispense such nar7 cotics at locations other than the registrant’s principal 

8 place of business or professional practice described in 

9 paragraph (1), so long as the registrant meets such stand10 ards for operation of a mobile medication unit as the At11 torney General may establish.’’. 

12 (b) CLARIFICATION IN CONSIDERATION OF PA13 TIENTS’ RESPONSIBILITY IN HANDLING OPIOID DRUGS

14 FOR UNSUPERVISED USE.—Not later than 90 days after 

15 the date of enactment of this Act, the Secretary of Health 

16 and Human Services shall promulgate a final regulation, 

17 or issue guidance, clarifying section 8.12(i)(2)(i) of title 

18 42, Code of Federal Regulations (and making such other 

19 changes as may be necessary) so that a medical director 

20 may determine that a patient is sufficiently responsible in 

21 handling opioid drugs for unsupervised use, as described 

22 in such section 8.12(i)(2) of such title 42, even if there 

23 is evidence of recent use of drugs (opioid or nonnarcotic, 

24 including alcohol). 


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1 (c) PERIODS FOR TAKE-HOME SUPPLY REQUIRE2 MENTS.— 

3 (1) FIRST REGULATION.—Not later than 90 

4 days after the date of enactment of this Act, the 

5 Secretary of Health and Human Services shall pro6 mulgate a final regulation amending paragraphs 

7 (i)(3)(i) through (i)(3)(vi) of section 8.12 of title 42, 

8 Code of Federal Regulations (and making such other 

9 changes as may be necessary) so that— 

10 (A) the references to 90 days in para11 graphs (i)(3)(i) through (i)(3)(iii) of such sec12 tion 8.12 are each reduced to not more than 45 

13 days; 

14 (B) the reference to the remaining months 

15 of the first year in paragraph (i)(3)(iv) of such 

16 section 8.12 is reduced to the remaining days of 

17 not more than the first six months of treat18 ment; 

19 (C) the reference to 1 year in paragraph 

20 (i)(3)(v) of such section 8.12 is reduced to not 

21 more than 6 months; and 

22 (D) the reference to 2 years in paragraph 

23 (i)(3)(vi) of such section 8.12 is reduced to not 

24 more than 1 year. 


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1 (2) STUDY.—Not later than 18 months after 

2 the date of enactment of this Act, the Assistant Sec3 retary for Mental Health and Substance Use shall— 

4 (A) complete a study, in consultation with 

5 patients and other stakeholders, on the impacts 

6 on patient rehabilitation of the changes made 

7 by the regulation under paragraph (1) to the 

8 periods specified in section 8.12(i)(3) of title 

9 42, Code of Federal Regulations; 

10 (B) submit a report to the Congress on the 

11 results of such study; and 

12 (C) include in such report recommenda13 tions for policy changes. 

14 (3) SECOND REGULATION.— 

15 (A) IN GENERAL.—Not later than two 

16 years after the date of enactment of this Act, 

17 the Secretary of Health and Human Services 

18 shall promulgate a final regulation amending 

19 paragraphs (i)(3)(i) through (i)(3)(vi) of section 

20 8.12 of title 42, Code of Federal Regulations, 

21 as appropriate based on the findings of the 

22 study under paragraph (2). 

23 (B) LIMITATION.—The regulation under 

24 subparagraph (A) shall not amend section 8.12 


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1 of title 42, Code of Federal Regulations, so as 

2 to— 

3 (i) allow the dispensing of more than 

4 two consecutive doses of methadone for 

5 take-home use per week before the pa6 tient’s 30th day of treatment; or 

7 (ii) prohibit a patient determined to 

8 be responsible in handling opioids from 

9 being given a maximum of a one-month 

10 supply of methadone for take-home use 

11 after two years of continuous treatment. 

12 SEC. 4. EXPANSION OF TAKE-HOME PRESCRIBING OF 

13 METHADONE THROUGH PHARMACIES. 

14 (a) REGISTRATION; OTHER CARE BY TELE15 HEALTH.—Section 303(g) of the Controlled Substances 

16 Act (21 U.S.C. 823(g)) is amended— 

17 (1) in paragraph (1), by striking ‘‘in paragraph 

18 (2)’’ and inserting ‘‘in paragraphs (2) and (3)’’; and 

19 (2) by adding at the end the following: 

20 ‘‘(3)(A) At the request of a State, the Attorney Gen21 eral, in consultation with the Secretary, may, pursuant to 

22 paragraph (1), register persons described in subparagraph 

23 (B) to prescribe methadone to be dispensed through a 

24 pharmacy for individuals for unsupervised use. 


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1 ‘‘(B) Persons described in this subparagraph are per2 sons who— 

3 ‘‘(i) are licensed, registered, or otherwise per4 mitted, by the United States or the jurisdiction in 

5 which they practice, to prescribe controlled sub6 stances in the course of professional practice; and 

7 ‘‘(ii) are— 

8 ‘‘(I) employees or contractors of an opioid 

9 treatment program; or 

10 ‘‘(II) addiction medicine physicians or ad11 diction psychiatrists who hold a subspecialty 

12 board certification in addiction medicine from 

13 the American Board of Preventive Medicine, a 

14 board certification in addiction medicine from 

15 the American Board of Addiction Medicine, a 

16 subspecialty board certification in addiction 

17 psychiatry from the American Board of Psychi18 atry and Neurology, or a subspecialty board 

19 certification in addiction medicine from the 

20 American Osteopathic Association. 

21 ‘‘(C) The prescribing of methadone pursuant to sub22 paragraph (A) shall be— 

23 ‘‘(i) exclusively by electronic prescribing; 

24 ‘‘(ii) for a supply of not more than 1 month 

25 pursuant to each prescription; and 


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1 ‘‘(iii) subject to the restrictions listed in section 

2 8.12(i)(3) of title 42, Code of Federal Regulations, 

3 including any amendments or exemptions to such 

4 section pursuant to section 3(c) of the Opioid Treat5 ment Access Act of 2022, or successor regulations or 

6 guidance. 

7 ‘‘(D) The dispensing of methadone to an individual 

8 pursuant to subparagraph (A) shall be in addition to the 

9 other care which the individual continues to have access 

10 to through an opioid treatment program. 

11 ‘‘(E) Persons registered in a State pursuant to sub12 paragraph (A) shall— 

13 ‘‘(i) ensure and document, with respect to each 

14 patient treated pursuant to subparagraph (A), in15 formed consent to treatment; and 

16 ‘‘(ii) include in such informed consent, specific 

17 informed consent regarding differences in confiden18 tiality protections applicable when dispensing 

19 through an opioid treatment program versus dis20 pensing through a pharmacy pursuant to subpara21 graph (A). 

22 ‘‘(F) At the request of a State, the Attorney General, 

23 in consultation with the Secretary, shall— 

24 ‘‘(i) cease registering persons in the State pur25 suant to subparagraph (A); and 


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1 ‘‘(ii) withdraw any such registration in effect 

2 for a person in the State. 

3 ‘‘(G) Maintenance treatment or detoxification treat4 ment provided pursuant to subparagraph (A), as well as 

5 other care provided in conjunction with such treatment, 

6 such as counseling and other ancillary services, may be 

7 provided by means of telehealth as determined jointly by 

8 the State and the Secretary to be feasible and appro9 priate.’’. 

10 (b) ANNUAL REPORTING.—Not later than 6 months 

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

12 thereafter, the Assistant Secretary for Mental Health and 

13 Substance Use and the Administrator of the Drug En14 forcement Agency, acting jointly, shall submit a report to 

15 the Congress including— 

16 (1) the number of persons registered pursuant 

17 to section 303(g)(3) of the Controlled Substances 

18 Act, as added by subsection (a); 

19 (2) the number of patients being prescribed 

20 methadone pursuant to such section 303(g)(3); and 

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

22 registered pursuant to such section 303(g)(3). 


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1 SEC. 5. SENSE OF CONGRESS ON NEED TO REDUCE BAR2 RIERS TO PATIENT CARE THROUGH OPIOID 

3 TREATMENT PROGRAMS. 

4 It is the sense of the Congress that— 

5 (1) patients receiving services through opioid 

6 treatment programs face barriers to their care; and 

7 (2) each State should align its regulation of 

8 opioid treatment programs in a manner that is con9 sistent with the intent of this Act. 

Æ 


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