I 
★
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 subse-
quently 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Opioid Treatment Ac-
cess Act of 2022’’. 
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SEC. 2. STUDY ON EXEMPTIONS FOR TREATMENT OF 
OPIOID USE DISORDER THROUGH OPIOID 
TREATMENT PROGRAMS DURING THE COVID– 
19 PUBLIC HEALTH EMERGENCY. 
(a) STUDY.—The Assistant Secretary for Mental 
Health and Substance Use shall conduct a study, in con-
sultation with patients and other stakeholders, on activi-
ties carried out pursuant to exemptions granted— 
(1) to a State (including the District of Colum-
bia or any territory of the United States) or an 
opioid treatment program; 
(2) pursuant to section 8.11(h) of title 42, Code 
of Federal Regulations; and 
(3) during the period— 
(A) beginning on the declaration of the 
public health emergency for the COVID–19 
pandemic under section 319 of the Public 
Health Service Act (42 U.S.C. 274); and 
(B) ending on the earlier of— 
(i) the termination of such public 
health emergency, including extensions 
thereof pursuant to such section 319; and 
(ii) the end of calendar year 2022. 
(b) ISSUES TO BE STUDIED.—The study under sub-
section (a) shall, with respect to exemptions described in 
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such subsection, include consideration of each of the fol-
lowing: 
(1) The number of participating patients in 
each State. 
(2) The percentage of participating patients in 
each State relative to the total number of patients 
in the respective State receiving treatment through 
an opioid treatment program. 
(3) The number of participating patients in 
each State who cease treatment. 
(4) The number of participating patients in 
each State who overdose on an opioid and cease 
treatment. 
(5) The number of participating patients in 
each State who overdose on an opioid and continue 
treatment. 
(6) The number of participating opioid treat-
ment programs in each State. 
(7) The percentage of participating opioid treat-
ment programs in each State relative to the total 
number of opioid treatment programs in the respec-
tive State. 
(8) The demographic, socioeconomic, and geo-
graphic characteristics of the participating patients 
and opioid treatment programs. 
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(9) Any additional costs or savings from exemp-
tions in each State. 
(10) An analysis of differences in the use of ex-
emptions among States. 
(11) Rates of medication adherence and diver-
sion. 
(c) PRIVACY.—The section does not authorize the dis-
closure by the Department of Health and Human Services 
of individually identifiable information about patients. 
(d) FEEDBACK.—In conducting the study under sub-
section (a), the Assistant Secretary for Mental Health and 
Substance Use shall gather feedback from the States and 
opioid treatment programs on their experiences in imple-
menting exemptions described in subsection (a). 
(e) REPORT.—Not later than 180 days after the end 
of the period described in subsection (a)(3)(B), and sub-
ject to subsection (c), the Assistant Secretary for Mental 
Health and Substance Use shall publish a report on the 
results of the study under this section. 
SEC. 3. CHANGES TO FEDERAL OPIOID TREATMENT STAND-
ARDS. 
(a) MOBILE MEDICATION UNITS.—Section 302(e) of 
the Controlled Substances Act (21 U.S.C. 822(e)) is 
amended by adding at the end the following: 
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‘‘(3) Notwithstanding paragraph (1), a registrant 
that is dispensing pursuant to section 303(g) narcotic 
drugs to individuals for maintenance treatment or detoxi-
fication treatment shall not be required to have a separate 
registration to incorporate one or more mobile medication 
units into the registrant’s practice to dispense such nar-
cotics at locations other than the registrant’s principal 
place of business or professional practice described in 
paragraph (1), so long as the registrant meets such stand-
ards for operation of a mobile medication unit as the At-
torney General may establish.’’. 
(b) CLARIFICATION
IN
CONSIDERATION
OF
PA-
TIENTS’ RESPONSIBILITY IN HANDLING OPIOID DRUGS 
FOR UNSUPERVISED USE.—Not later than 90 days after 
the date of enactment of this Act, the Secretary of Health 
and Human Services shall promulgate a final regulation, 
or issue guidance, clarifying section 8.12(i)(2)(i) of title 
42, Code of Federal Regulations (and making such other 
changes as may be necessary) so that a medical director, 
in determining whether a patient is sufficiently responsible 
in handling opioid drugs for unsupervised use, as de-
scribed in such section 8.12(i)(2) of such title 42, shall 
not consider whether the patient has an absence of recent 
abuse of drugs (opioid or nonnarcotic), including alcohol, 
as the sole consideration in determining whether a patient 
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is sufficiently responsible in handling opioid drugs for un-
supervised use, as described in such section 8.12(i)(2). 
(c) PERIODS FOR TAKE-HOME SUPPLY REQUIRE-
MENTS.— 
(1) FIRST
REGULATION.—Not later than 90 
days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall pro-
mulgate a final regulation amending paragraphs 
(i)(3)(i) through (i)(3)(vi) of section 8.12 of title 42, 
Code of Federal Regulations (and making such other 
changes as may be necessary) so that— 
(A) the references to 90 days in para-
graphs (i)(3)(i) through (i)(3)(iii) of such sec-
tion 8.12 are each reduced to not more than 45 
days; 
(B) the reference to the remaining months 
of the first year in paragraph (i)(3)(iv) of such 
section 8.12 is reduced to the remaining days of 
not more than the first six months of treat-
ment; 
(C) the reference to 1 year in paragraph 
(i)(3)(v) of such section 8.12 is reduced to not 
more than 6 months; and 
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(D) the reference to 2 years in paragraph 
(i)(3)(vi) of such section 8.12 is reduced to not 
more than 1 year. 
(2) STUDY.—Not later than 18 months after 
the date of enactment of this Act, the Assistant Sec-
retary for Mental Health and Substance Use shall— 
(A) complete a study, in consultation with 
patients and other stakeholders, on the impacts 
on patient rehabilitation of the changes made 
by the regulation under paragraph (1) to the 
periods specified in section 8.12(i)(3) of title 
42, Code of Federal Regulations; 
(B) submit a report to the Congress on the 
results of such study; and 
(C) include in such report recommenda-
tions for policy changes. 
(3) SECOND REGULATION.— 
(A) IN
GENERAL.—Not later than two 
years after the date of enactment of this Act, 
the Secretary of Health and Human Services 
shall promulgate a final regulation amending 
paragraphs (i)(3)(i) through (i)(3)(vi) of section 
8.12 of title 42, Code of Federal Regulations, 
as appropriate based on the findings of the 
study under paragraph (2). 
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(B) LIMITATION.—The regulation under 
subparagraph (A) shall not amend section 8.12 
of title 42, Code of Federal Regulations, so as 
to— 
(i) allow the dispensing of more than 
two consecutive doses of methadone for 
take-home use per week before the pa-
tient’s 30th day of treatment; or 
(ii) prohibit a patient determined to 
be responsible in handling opioids from 
being given a maximum of a one-month 
supply of methadone for take-home use 
after two years of continuous treatment. 
SEC. 4. EXPANSION OF TAKE-HOME PRESCRIBING OF 
METHADONE THROUGH PHARMACIES. 
(a) 
REGISTRATION; 
OTHER
CARE
BY
TELE-
HEALTH.—Section 303(g) of the Controlled Substances 
Act (21 U.S.C. 823(g)) is amended— 
(1) in paragraph (1), by striking ‘‘in paragraph 
(2)’’ and inserting ‘‘in paragraphs (2) and (3)’’; and 
(2) by adding at the end the following: 
‘‘(3)(A) At the request of a State, the Attorney Gen-
eral, in consultation with the Secretary, may, pursuant to 
paragraph (1), register persons described in subparagraph 
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(B) to prescribe methadone to be dispensed through a 
pharmacy for individuals for unsupervised use. 
‘‘(B) Persons described in this subparagraph are per-
sons who— 
‘‘(i) are licensed, registered, or otherwise per-
mitted, by the United States or the jurisdiction in 
which they practice, to prescribe controlled sub-
stances in the course of professional practice; and 
‘‘(ii) are— 
‘‘(I) employees or contractors of an opioid 
treatment program; or 
‘‘(II) addiction medicine physicians or ad-
diction psychiatrists who hold a subspecialty 
board certification in addiction medicine from 
the American Board of Preventive Medicine, a 
board certification in addiction medicine from 
the American Board of Addiction Medicine, a 
subspecialty board certification in addiction 
psychiatry from the American Board of Psychi-
atry and Neurology, or a subspecialty board 
certification in addiction medicine from the 
American Osteopathic Association. 
‘‘(C) The prescribing of methadone pursuant to sub-
paragraph (A) shall be— 
‘‘(i) exclusively by electronic prescribing; 
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‘‘(ii) for a supply of not more than 1 month 
pursuant to each prescription; and 
‘‘(iii) subject to the restrictions listed in section 
8.12(i)(3) of title 42, Code of Federal Regulations, 
including any amendments or exemptions to such 
section pursuant to section 3(c) of the Opioid Treat-
ment Access Act of 2022, or successor regulations or 
guidance. 
‘‘(D) The dispensing of methadone to an individual 
pursuant to subparagraph (A) shall be in addition to the 
other care which the individual continues to have access 
to through an opioid treatment program. 
‘‘(E) Persons registered in a State pursuant to sub-
paragraph (A) shall— 
‘‘(i) ensure and document, with respect to each 
patient treated pursuant to subparagraph (A), in-
formed consent to treatment; and 
‘‘(ii) include in such informed consent, specific 
informed consent regarding differences in confiden-
tiality 
protections 
applicable 
when 
dispensing 
through an opioid treatment program versus dis-
pensing through a pharmacy pursuant to subpara-
graph (A). 
‘‘(F) At the request of a State, the Attorney General, 
in consultation with the Secretary, shall— 
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‘‘(i) cease registering persons in the State pur-
suant to subparagraph (A); and 
‘‘(ii) withdraw any such registration in effect 
for a person in the State. 
‘‘(G) Maintenance treatment or detoxification treat-
ment provided pursuant to subparagraph (A), as well as 
other care provided in conjunction with such treatment, 
such as counseling and other ancillary services, may be 
provided by means of telehealth as determined jointly by 
the State and the Secretary to be feasible and appro-
priate.’’. 
(b) ANNUAL REPORTING.—Not later than 6 months 
after the date of enactment of this Act, and annually 
thereafter, the Assistant Secretary for Mental Health and 
Substance Use and the Administrator of the Drug En-
forcement Agency, acting jointly, shall submit a report to 
the Congress including— 
(1) the number of persons registered pursuant 
to section 303(g)(3) of the Controlled Substances 
Act, as added by subsection (a); 
(2) the number of patients being prescribed 
methadone pursuant to such section 303(g)(3); and 
(3) a list of the States in which persons are 
registered pursuant to such section 303(g)(3). 
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SEC. 5. SENSE OF CONGRESS ON NEED TO REDUCE BAR-
RIERS TO PATIENT CARE THROUGH OPIOID 
TREATMENT PROGRAMS. 
It is the sense of the Congress that— 
(1) patients receiving services through opioid 
treatment programs face barriers to their care; and 
(2) each State should align its regulation of 
opioid treatment programs in a manner that is con-
sistent with the intent of this Act. 
Æ 
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