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117TH CONGRESS 

1ST SESSION H. R. 6279 

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 HOUSE OF REPRESENTATIVES 

DECEMBER 14, 2021 

Mr. NORCROSS (for himself and Mr. TRONE) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such 

provisions as fall within the jurisdiction of the committee concerned 

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 in determining whether a patient is sufficiently responsible 

21 in handling opioid drugs for unsupervised use, as de22 scribed in such section 8.12(i)(2) of such title 42, shall 

23 not consider whether the patient has an absence of recent 

24 abuse of drugs (opioid or nonnarcotic), including alcohol, 

25 as the sole consideration in determining whether a patient 


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1 is sufficiently responsible in handling opioid drugs for un2 supervised use, as described in such section 8.12(i)(2). 

3 (c) PERIODS FOR TAKE-HOME SUPPLY REQUIRE4 MENTS.— 

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

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

7 Secretary of Health and Human Services shall pro8 mulgate a final regulation amending paragraphs 

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

10 Code of Federal Regulations (and making such other 

11 changes as may be necessary) so that— 

12 (A) the references to 90 days in para13 graphs (i)(3)(i) through (i)(3)(iii) of such sec14 tion 8.12 are each reduced to not more than 45 

15 days; 

16 (B) the reference to the remaining months 

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

18 section 8.12 is reduced to the remaining days of 

19 not more than the first six months of treat20 ment; 

21 (C) the reference to 1 year in paragraph 

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

23 more than 6 months; and 


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1 (D) the reference to 2 years in paragraph 

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

3 more than 1 year. 

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

5 the date of enactment of this Act, the Assistant Sec6 retary for Mental Health and Substance Use shall— 

7 (A) complete a study, in consultation with 

8 patients and other stakeholders, on the impacts 

9 on patient rehabilitation of the changes made 

10 by the regulation under paragraph (1) to the 

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

12 42, Code of Federal Regulations; 

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

14 results of such study; and 

15 (C) include in such report recommenda16 tions for policy changes. 

17 (3) SECOND REGULATION.— 

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

19 years after the date of enactment of this Act, 

20 the Secretary of Health and Human Services 

21 shall promulgate a final regulation amending 

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

23 8.12 of title 42, Code of Federal Regulations, 

24 as appropriate based on the findings of the 

25 study under paragraph (2). 


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1 (B) LIMITATION.—The regulation under 

2 subparagraph (A) shall not amend section 8.12 

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

4 to— 

5 (i) allow the dispensing of more than 

6 two consecutive doses of methadone for 

7 take-home use per week before the pa8 tient’s 30th day of treatment; or 

9 (ii) prohibit a patient determined to 

10 be responsible in handling opioids from 

11 being given a maximum of a one-month 

12 supply of methadone for take-home use 

13 after two years of continuous treatment. 

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

15 METHADONE THROUGH PHARMACIES. 

16 (a) REGISTRATION; OTHER CARE BY TELE17 HEALTH.—Section 303(g) of the Controlled Substances 

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

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

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

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

22 ‘‘(3)(A) At the request of a State, the Attorney Gen23 eral, in consultation with the Secretary, may, pursuant to 

24 paragraph (1), register persons described in subparagraph 


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

2 pharmacy for individuals for unsupervised use. 

3 ‘‘(B) Persons described in this subparagraph are per4 sons who— 

5 ‘‘(i) are licensed, registered, or otherwise per6 mitted, by the United States or the jurisdiction in 

7 which they practice, to prescribe controlled sub8 stances in the course of professional practice; and 

9 ‘‘(ii) are— 

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

11 treatment program; or 

12 ‘‘(II) addiction medicine physicians or ad13 diction psychiatrists who hold a subspecialty 

14 board certification in addiction medicine from 

15 the American Board of Preventive Medicine, a 

16 board certification in addiction medicine from 

17 the American Board of Addiction Medicine, a 

18 subspecialty board certification in addiction 

19 psychiatry from the American Board of Psychi20 atry and Neurology, or a subspecialty board 

21 certification in addiction medicine from the 

22 American Osteopathic Association. 

23 ‘‘(C) The prescribing of methadone pursuant to sub24 paragraph (A) shall be— 

25 ‘‘(i) exclusively by electronic prescribing; 


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

2 pursuant to each prescription; and 

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

4 8.12(i)(3) of title 42, Code of Federal Regulations, 

5 including any amendments or exemptions to such 

6 section pursuant to section 3(c) of the Opioid Treat7 ment Access Act of 2022, or successor regulations or 

8 guidance. 

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

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

11 other care which the individual continues to have access 

12 to through an opioid treatment program. 

13 ‘‘(E) Persons registered in a State pursuant to sub14 paragraph (A) shall— 

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

16 patient treated pursuant to subparagraph (A), in17 formed consent to treatment; and 

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

19 informed consent regarding differences in confiden20 tiality protections applicable when dispensing 

21 through an opioid treatment program versus dis22 pensing through a pharmacy pursuant to subpara23 graph (A). 

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

25 in consultation with the Secretary, shall— 


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1 ‘‘(i) cease registering persons in the State pur2 suant to subparagraph (A); and 

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

4 for a person in the State. 

5 ‘‘(G) Maintenance treatment or detoxification treat6 ment provided pursuant to subparagraph (A), as well as 

7 other care provided in conjunction with such treatment, 

8 such as counseling and other ancillary services, may be 

9 provided by means of telehealth as determined jointly by 

10 the State and the Secretary to be feasible and appro11 priate.’’. 

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

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

14 thereafter, the Assistant Secretary for Mental Health and 

15 Substance Use and the Administrator of the Drug En16 forcement Agency, acting jointly, shall submit a report to 

17 the Congress including— 

18 (1) the number of persons registered pursuant 

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

20 Act, as added by subsection (a); 

21 (2) the number of patients being prescribed 

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

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

24 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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