Modernizing Opioid Treatment Access Act

Subjects: Health, Congressional oversight, Drug therapy, Drug, alcohol, tobacco use, Prescription drugs

Summary:  <p><b>Modernizing Opioid Treatment Access Act</b></p> <p>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.)</p> <p>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.</p> <p>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.</p> <p>Individuals who receive methadone for unsupervised use must continue to have access to other care through an opioid treatment program.</p> <p>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.</p>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 644 Introduced in Senate (IS)]

&lt;DOC&gt;






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.
                                 &lt;all&gt;
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