Modernizing Opioid Treatment Access Act
This bill expands access to methadone for an individual's unsupervised use to treat opioid use disorder (OUD). (Typically, methadone must be dispensed to individuals in person through opioid treatment programs.)
The bill (1) waives provisions of the Controlled Substances Act that require qualified practitioners to obtain a separate registration from the Drug Enforcement Administration (DEA) to prescribe and dispense methadone to treat OUD, and (2) requires the Substance Abuse and Mental Health Services Administration and the DEA to jointly report on the waiver.
Additionally, the bill directs the DEA to register certain practitioners to prescribe methadone that is dispensed through a pharmacy for an individual's unsupervised use. Qualified practitioners must be licensed or authorized to prescribe controlled substances, and they must either work for an opioid treatment program or be a physician or psychiatrist with a specialty certification in addiction medicine. A state may request that the DEA stop registering such practitioners in its jurisdiction.
Individuals who receive methadone for unsupervised use must continue to have access to other care through an opioid treatment program.
For purposes of the waiver, the bill also requires the exclusive use of electronic prescribing, establishes prescription limits, and sets out requirements for informed consent. Further, the bill permits the use of telehealth to provide methadone treatment and related services if the state and the Department of Health and Human Services jointly determine the use is feasible and appropriate.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1359 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 1359
To expand the take-home prescribing of methadone through pharmacies.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 3, 2023
Mr. Norcross (for himself, Mr. Bacon, Ms. Kuster, Mr. Trone, Mr.
Fitzpatrick, Mr. Tonko, Ms. Pettersen, and Mr. Kim of New Jersey)
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 expand the take-home prescribing of methadone through pharmacies.
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 ``Modernizing Opioid Treatment Access
Act''.
SEC. 2. EXPANSION OF METHADONE FOR OPIOID USE DISORDER THROUGH
PRESCRIBING AND PHARMACIES.
(a) Registration; Other Care by Telehealth.--
(1) Definitions.--In this subsection:
(A) Controlled substance; detoxification treatment;
dispense; maintenance treatment; opioid.--The terms
``controlled substance'', ``detoxification treatment'',
``dispense'', ``maintenance treatment'', and ``opioid''
have the meanings given the terms in section 102 of the
Controlled Substances Act (21 U.S.C. 802).
(B) Secretary.--The term ``Secretary'' means the
Secretary of Health and Human Services.
(2) Waiver.--
(A) In general.--The requirements of section 303(h)
of Controlled Substances Act (21 U.S.C. 823(h))
applicable to methadone medication for opioid use
disorder are waived, and the Attorney General, in
consultation with the Secretary, shall register persons
described in subparagraph (B) to prescribe methadone
for opioid use disorder to be dispensed through a
pharmacy for individuals for unsupervised use.
(B) Persons described.--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) Requirements for prescribing methadone.--The
prescribing of methadone pursuant to subparagraph (A)
shall be--
(i) exclusively by electronic prescribing
and dispensed to the patient treated pursuant
to subparagraph (A);
(ii) for a supply of not more than 30 days
pursuant to each prescription; and
(iii) subject to the restrictions listed in
section 8.12(i)(3) of title 42, Code of Federal
Regulations, or successor regulation or
guidance.
(D) Requirements for dispensing methadone.--The
dispensing of methadone to an individual pursuant to
subparagraph (A) shall be in addition to the other care
that the individual continues to have access to through
an opioid treatment program.
(E) Registration requirements.--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) Cessation and withdrawal of registration.--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 and detoxification treatment.--
Maintenance treatment or detoxification treatment
provided pursuant to subparagraph (A) and 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 180 days 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 Administration shall jointly submit a report to Congress
that includes--
(1) the number of persons registered pursuant to subsection
(a);
(2) the number of patients being prescribed methadone
pursuant to subsection (a); and
(3) a list of the States in which persons are registered
pursuant to such subsection (a).
SEC. 3. SENSE OF CONGRESS ON NEED TO REDUCE BARRIERS TO PATIENT CARE
THROUGH OPIOID TREATMENT PROGRAMS.
It is the sense of Congress that--
(1) patients receiving services through opioid treatment
programs face barriers to their care; and
(2) each State should align the 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.
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