II Calendar No. 318 118th CONGRESS 2d Session S. 644 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. Luján , 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.

1. Short title This Act may be cited as the Modernizing Opioid Treatment Access Act . 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). 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.

1. Short title This Act may be cited as the Modernizing Opioid Treatment Access Act . 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). .

February 1, 2024 Reported with an amendment