[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