[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 644 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
1st Session
S. 644
To expand the take-home prescribing of methadone through pharmacies.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 2, 2023
Mr. Markey (for himself, Mr. Paul, Mr. Sanders, Mr. Braun, Mr. Booker,
and Ms. Hassan) introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
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>