Title: Opioid Treatment Access Act of 2022
Policy area: Health

Summary:
Opioid Treatment Access Act of 2022
This bill expands access to substance use disorder treatment by modifying the regulation of opioid treatment programs and narcotic drugs used for treatment, including with respect to a patient's unsupervised use of such drugs.
Specifically, the Department of Health and Human Services (HHS) must issue regulations to further increase patients' access to unsupervised use or handling of drugs for treatment. The Substance Abuse and Mental Health Services Administration (SAMHSA) must study the effects of these revisions, and HHS must, as appropriate, promulgate additional regulations based on the study's findings.
SAMHSA must also study the impact of certain exemptions from certification requirements for opioid treatment programs that were granted as part of COVID-19 response efforts, including any additional costs or savings that resulted from the exemptions.
The bill also (1) allows specified types of health care providers to prescribe (subject to certain requirements) methadone that is dispensed through pharmacies for a patient's unsupervised use, and (2) provides statutory authority for a regulation that allows registered opioid treatment programs to operate mobile medication units without separately registering the unit.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3629 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  2d Session
                                S. 3629

To authorize a study on certain exemptions for treatment of opioid use 
 disorder through opioid treatment programs during the COVID-19 public 
               health emergency, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 10, 2022

 Mr. Markey (for himself and Mr. Paul) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To authorize a study on certain exemptions for treatment of opioid use 
 disorder through opioid treatment programs during the COVID-19 public 
               health emergency, and for other purposes.

    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 ``Opioid Treatment Access Act of 
2022''.

SEC. 2. STUDY ON EXEMPTIONS FOR TREATMENT OF OPIOID USE DISORDER 
              THROUGH OPIOID TREATMENT PROGRAMS DURING THE COVID-19 
              PUBLIC HEALTH EMERGENCY.

    (a) Study.--The Assistant Secretary for Mental Health and Substance 
Use shall conduct a study, in consultation with patients and other 
stakeholders, on activities carried out pursuant to exemptions 
granted--
            (1) to a State (including the District of Columbia or any 
        territory of the United States) or an opioid treatment program;
            (2) pursuant to section 8.11(h) of title 42, Code of 
        Federal Regulations; and
            (3) during the period--
                    (A) beginning on the declaration of the public 
                health emergency for the COVID-19 pandemic under 
                section 319 of the Public Health Service Act (42 U.S.C. 
                274); and
                    (B) ending on the earlier of--
                            (i) the termination of such public health 
                        emergency, including extensions thereof 
                        pursuant to such section 319; and
                            (ii) the end of calendar year 2022.
    (b) Issues To Be Studied.--The study under subsection (a) shall, 
with respect to exemptions described in such subsection, include 
consideration of each of the following:
            (1) The number of participating patients in each State.
            (2) The percentage of participating patients in each State 
        relative to the total number of patients in the respective 
        State receiving treatment through an opioid treatment program.
            (3) The number of participating patients in each State who 
        cease treatment.
            (4) The number of participating patients in each State who 
        overdose on an opioid and cease treatment.
            (5) The number of participating patients in each State who 
        overdose on an opioid and continue treatment.
            (6) The number of participating opioid treatment programs 
        in each State.
            (7) The percentage of participating opioid treatment 
        programs in each State relative to the total number of opioid 
        treatment programs in the respective State.
            (8) The demographic, socioeconomic, and geographic 
        characteristics of the participating patients and opioid 
        treatment programs.
            (9) Any additional costs or savings from exemptions in each 
        State.
            (10) An analysis of differences in the use of exemptions 
        among States.
            (11) Rates of medication adherence and diversion.
    (c) Privacy.--The section does not authorize the disclosure by the 
Department of Health and Human Services of individually identifiable 
information about patients.
    (d) Feedback.--In conducting the study under subsection (a), the 
Assistant Secretary for Mental Health and Substance Use shall gather 
feedback from the States and opioid treatment programs on their 
experiences in implementing exemptions described in subsection (a).
    (e) Report.--Not later than 180 days after the end of the period 
described in subsection (a)(3)(B), and subject to subsection (c), the 
Assistant Secretary for Mental Health and Substance Use shall publish a 
report on the results of the study under this section.

SEC. 3. CHANGES TO FEDERAL OPIOID TREATMENT STANDARDS.

    (a) Mobile Medication Units.--Section 302(e) of the Controlled 
Substances Act (21 U.S.C. 822(e)) is amended by adding at the end the 
following:
    ``(3) Notwithstanding paragraph (1), a registrant that is 
dispensing pursuant to section 303(g) narcotic drugs to individuals for 
maintenance treatment or detoxification treatment shall not be required 
to have a separate registration to incorporate one or more mobile 
medication units into the registrant's practice to dispense such 
narcotics at locations other than the registrant's principal place of 
business or professional practice described in paragraph (1), so long 
as the registrant meets such standards for operation of a mobile 
medication unit as the Attorney General may establish.''.
    (b) Clarification in Consideration of Patients' Responsibility in 
Handling Opioid Drugs for Unsupervised Use.--Not later than 90 days 
after the date of enactment of this Act, the Secretary of Health and 
Human Services shall promulgate a final regulation, or issue guidance, 
clarifying section 8.12(i)(2)(i) of title 42, Code of Federal 
Regulations (and making such other changes as may be necessary) so that 
a medical director may determine that a patient is sufficiently 
responsible in handling opioid drugs for unsupervised use, as described 
in such section 8.12(i)(2) of such title 42, even if there is evidence 
of recent use of drugs (opioid or nonnarcotic, including alcohol).
    (c) Periods for Take-Home Supply Requirements.--
            (1) First regulation.--Not later than 90 days after the 
        date of enactment of this Act, the Secretary of Health and 
        Human Services shall promulgate a final regulation amending 
        paragraphs (i)(3)(i) through (i)(3)(vi) of section 8.12 of 
        title 42, Code of Federal Regulations (and making such other 
        changes as may be necessary) so that--
                    (A) the references to 90 days in paragraphs 
                (i)(3)(i) through (i)(3)(iii) of such section 8.12 are 
                each reduced to not more than 45 days;
                    (B) the reference to the remaining months of the 
                first year in paragraph (i)(3)(iv) of such section 8.12 
                is reduced to the remaining days of not more than the 
                first six months of treatment;
                    (C) the reference to 1 year in paragraph (i)(3)(v) 
                of such section 8.12 is reduced to not more than 6 
                months; and
                    (D) the reference to 2 years in paragraph 
                (i)(3)(vi) of such section 8.12 is reduced to not more 
                than 1 year.
            (2) Study.--Not later than 18 months after the date of 
        enactment of this Act, the Assistant Secretary for Mental 
        Health and Substance Use shall--
                    (A) complete a study, in consultation with patients 
                and other stakeholders, on the impacts on patient 
                rehabilitation of the changes made by the regulation 
                under paragraph (1) to the periods specified in section 
                8.12(i)(3) of title 42, Code of Federal Regulations;
                    (B) submit a report to the Congress on the results 
                of such study; and
                    (C) include in such report recommendations for 
                policy changes.
            (3) Second regulation.--
                    (A) In general.--Not later than two years after the 
                date of enactment of this Act, the Secretary of Health 
                and Human Services shall promulgate a final regulation 
                amending paragraphs (i)(3)(i) through (i)(3)(vi) of 
                section 8.12 of title 42, Code of Federal Regulations, 
                as appropriate based on the findings of the study under 
                paragraph (2).
                    (B) Limitation.--The regulation under subparagraph 
                (A) shall not amend section 8.12 of title 42, Code of 
                Federal Regulations, so as to--
                            (i) allow the dispensing of more than two 
                        consecutive doses of methadone for take-home 
                        use per week before the patient's 30th day of 
                        treatment; or
                            (ii) prohibit a patient determined to be 
                        responsible in handling opioids from being 
                        given a maximum of a one-month supply of 
                        methadone for take-home use after two years of 
                        continuous treatment.

SEC. 4. EXPANSION OF TAKE-HOME PRESCRIBING OF METHADONE THROUGH 
              PHARMACIES.

    (a) Registration; Other Care by Telehealth.--Section 303(g) of the 
Controlled Substances Act (21 U.S.C. 823(g)) is amended--
            (1) in paragraph (1), by striking ``in paragraph (2)'' and 
        inserting ``in paragraphs (2) and (3)''; and
            (2) by adding at the end the following:
    ``(3)(A) At the request of a State, the Attorney General, in 
consultation with the Secretary, may, pursuant to paragraph (1), 
register persons described in subparagraph (B) to prescribe methadone 
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--
                    ``(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) The prescribing of methadone pursuant to subparagraph (A) 
shall be--
            ``(i) exclusively by electronic prescribing;
            ``(ii) for a supply of not more than 1 month pursuant to 
        each prescription; and
            ``(iii) subject to the restrictions listed in section 
        8.12(i)(3) of title 42, Code of Federal Regulations, including 
        any amendments or exemptions to such section pursuant to 
        section 3(c) of the Opioid Treatment Access Act of 2022, or 
        successor regulations or guidance.
    ``(D) The dispensing of methadone to an individual pursuant to 
subparagraph (A) shall be in addition to the other care which the 
individual continues to have access to through an opioid treatment 
program.
    ``(E) 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) 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 treatment or detoxification treatment provided 
pursuant to subparagraph (A), as well as 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 6 months 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 Agency, acting jointly, shall submit a report to the 
Congress including--
            (1) the number of persons registered pursuant to section 
        303(g)(3) of the Controlled Substances Act, as added by 
        subsection (a);
            (2) the number of patients being prescribed methadone 
        pursuant to such section 303(g)(3); and
            (3) a list of the States in which persons are registered 
        pursuant to such section 303(g)(3).

SEC. 5. SENSE OF CONGRESS ON NEED TO REDUCE BARRIERS TO PATIENT CARE 
              THROUGH OPIOID TREATMENT PROGRAMS.

     It is the sense of the Congress that--
            (1) patients receiving services through opioid treatment 
        programs face barriers to their care; and
            (2) each State should align its regulation of opioid 
        treatment programs in a manner that is consistent with the 
        intent of this Act.
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