Opioid Treatment Access Act of 2022
This bill expands access to substance use disorder treatment by modifying the regulation of opioid treatment programs and narcotic drugs used for treatment, including with respect to a patient's unsupervised use of such drugs.
Specifically, the Department of Health and Human Services (HHS) must issue regulations to further increase patients' access to unsupervised use or handling of drugs for treatment. The Substance Abuse and Mental Health Services Administration (SAMHSA) must study the effects of these revisions, and HHS must, as appropriate, promulgate additional regulations based on the study's findings.
SAMHSA must also study the impact of certain exemptions from certification requirements for opioid treatment programs that were granted as part of COVID-19 response efforts, including any additional costs or savings that resulted from the exemptions.
The bill also (1) allows specified types of health care providers to prescribe (subject to certain requirements) methadone that is dispensed through pharmacies for a patient's unsupervised use, and (2) provides statutory authority for a regulation that allows registered opioid treatment programs to operate mobile medication units without separately registering the unit.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6279 Introduced in House (IH)]
<DOC>
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Opioid Treatment Access Act of
2022''.
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 consultation with patients and other
stakeholders, on activities carried out pursuant to exemptions
granted--
(1) to a State (including the District of Columbia 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 subsection (a) shall,
with respect to exemptions described in such subsection, include
consideration of each of the following:
(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 treatment programs
in each State.
(7) The percentage of participating opioid treatment
programs in each State relative to the total number of opioid
treatment programs in the respective State.
(8) The demographic, socioeconomic, and geographic
characteristics of the participating patients and opioid
treatment programs.
(9) Any additional costs or savings from exemptions in each
State.
(10) An analysis of differences in the use of exemptions
among States.
(11) Rates of medication adherence and diversion.
(c) Privacy.--The section does not authorize the disclosure by the
Department of Health and Human Services of individually identifiable
information about patients.
(d) Feedback.--In conducting the study under subsection (a), the
Assistant Secretary for Mental Health and Substance Use shall gather
feedback from the States and opioid treatment programs on their
experiences in implementing 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 subject 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 STANDARDS.
(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:
``(3) Notwithstanding paragraph (1), a registrant that is
dispensing pursuant to section 303(g) narcotic drugs to individuals for
maintenance treatment or detoxification 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
narcotics 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 standards for operation of a mobile
medication unit as the Attorney General may establish.''.
(b) Clarification in Consideration of Patients' 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 described
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 is sufficiently responsible in handling
opioid drugs for unsupervised use, as described in such section
8.12(i)(2).
(c) Periods for Take-Home Supply Requirements.--
(1) First regulation.--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 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 paragraphs
(i)(3)(i) through (i)(3)(iii) of such section 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 treatment;
(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
(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 Secretary 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 recommendations 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).
(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 patient'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 Telehealth.--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 General, in
consultation with the Secretary, may, pursuant to paragraph (1),
register persons described in subparagraph (B) to prescribe methadone
to be dispensed through a pharmacy for individuals for unsupervised
use.
``(B) Persons described in this subparagraph are persons who--
``(i) are licensed, registered, or otherwise permitted, by
the United States or the jurisdiction in which they practice,
to prescribe controlled substances in the course of
professional practice; and
``(ii) are--
``(I) employees or contractors of an opioid
treatment program; or
``(II) addiction medicine physicians or addiction
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
Psychiatry and Neurology, or a subspecialty board
certification in addiction medicine from the American
Osteopathic Association.
``(C) The prescribing of methadone pursuant to subparagraph (A)
shall be--
``(i) exclusively by electronic prescribing;
``(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 Treatment 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 subparagraph (A)
shall--
``(i) ensure and document, with respect to each patient
treated pursuant to subparagraph (A), informed consent to
treatment; and
``(ii) include in such informed consent, specific informed
consent regarding differences in confidentiality protections
applicable when dispensing through an opioid treatment program
versus dispensing through a pharmacy pursuant to subparagraph
(A).
``(F) At the request of a State, the Attorney General, in
consultation with the Secretary, shall--
``(i) cease registering persons in the State pursuant to
subparagraph (A); and
``(ii) withdraw any such registration in effect for a
person in the State.
``(G) Maintenance treatment or detoxification treatment 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 appropriate.''.
(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
Enforcement 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).
SEC. 5. SENSE OF CONGRESS ON NEED TO REDUCE BARRIERS 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 consistent with the
intent of this Act.
<all>
Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Crime, Terrorism, and Homeland Security.
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