[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 644 Reported in Senate (RS)]
<DOC>
Calendar No. 318
118th CONGRESS
2d 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,
Ms. Hassan, Mr. Lujan, Mr. Welch, Mr. Lee, Ms. Warren, Mr. Casey, and
Mr. Heinrich) introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
February 1, 2024
Reported by Mr. Sanders, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Modernizing Opioid
Treatment Access Act''.</DELETED>
<DELETED>SEC. 2. EXPANSION OF METHADONE FOR OPIOID USE DISORDER THROUGH
PRESCRIBING AND PHARMACIES.</DELETED>
<DELETED> (a) Registration; Other Care by Telehealth.--</DELETED>
<DELETED> (1) Definitions.--In this subsection:</DELETED>
<DELETED> (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).</DELETED>
<DELETED> (B) Secretary.--The term ``Secretary''
means the Secretary of Health and Human
Services.</DELETED>
<DELETED> (2) Waiver.--</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (B) Persons described.--Persons described
in this subparagraph are persons who--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (ii) are--</DELETED>
<DELETED> (I) employees or
contractors of an opioid treatment
program; or</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (C) Requirements for prescribing
methadone.--The prescribing of methadone pursuant to
subparagraph (A) shall be--</DELETED>
<DELETED> (i) exclusively by electronic
prescribing and dispensed to the patient
treated pursuant to subparagraph (A);</DELETED>
<DELETED> (ii) for a supply of not more than
30 days pursuant to each prescription;
and</DELETED>
<DELETED> (iii) subject to the restrictions
listed in section 8.12(i)(3) of title 42, Code
of Federal Regulations, or successor regulation
or guidance.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (E) Registration requirements.--Persons
registered in a State pursuant to subparagraph (A)
shall--</DELETED>
<DELETED> (i) ensure and document, with
respect to each patient treated pursuant to
subparagraph (A), informed consent to
treatment; and</DELETED>
<DELETED> (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).</DELETED>
<DELETED> (F) Cessation and withdrawal of
registration.--At the request of a State, the Attorney
General, in consultation with the Secretary, shall--
</DELETED>
<DELETED> (i) cease registering persons in
the State pursuant to subparagraph (A);
and</DELETED>
<DELETED> (ii) withdraw any such
registration in effect for a person in the
State.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (1) the number of persons registered pursuant to
subsection (a);</DELETED>
<DELETED> (2) the number of patients being prescribed
methadone pursuant to subsection (a); and</DELETED>
<DELETED> (3) a list of the States in which persons are
registered pursuant to such subsection (a).</DELETED>
<DELETED>SEC. 3. SENSE OF CONGRESS ON NEED TO REDUCE BARRIERS TO
PATIENT CARE THROUGH OPIOID TREATMENT PROGRAMS.</DELETED>
<DELETED> It is the sense of Congress that--</DELETED>
<DELETED> (1) patients receiving services through opioid
treatment programs face barriers to their care; and</DELETED>
<DELETED> (2) each State should align the regulation of
opioid treatment programs in a manner that is consistent with
the intent of this Act.</DELETED>
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.
Section 303(h) of the Controlled Substances Act (21 U.S.C. 823(h)),
is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A), in
the first sentence, by inserting ``(other than narcotic
drugs in schedule III, IV, or V)'' after ``drugs''; and
(B) by striking subparagraph (B) and inserting the
following:
``(B) if the Attorney General determines that the applicant
will comply with standards established by the Attorney General
respecting--
``(i) security of stocks of narcotic drugs for such
treatment; and
``(ii) the maintenance of records (in accordance
with section 307) on such drugs; and''; and
(2) by striking paragraph (2) and inserting the following:
``(2)(A) The requirements of paragraph (1) applicable to methadone
medication for opioid use disorder are waived, and the Attorney
General, in consultation with the Secretary, shall separately 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 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 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 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) 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) Persons registered 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 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) and other care provided in conjunction
with such treatment, such as counseling and other ancillary services,
may be provided by means of telehealth.
``(3) Not later than 180 days after the date of enactment of this
paragraph, and annually thereafter, the Assistant Secretary for Mental
Health and Substance Use and the Administrator of the Drug Enforcement
Administration shall jointly submit to Congress a report that
includes--
``(A) the number of persons registered pursuant to
paragraph (2);
``(B) a list of States in which persons are registered
pursuant to paragraph (2).''.
Calendar No. 318
118th CONGRESS
2d Session
S. 644
_______________________________________________________________________
A BILL
To expand the take-home prescribing of methadone through pharmacies.
_______________________________________________________________________
February 1, 2024
Reported with an amendment