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 (2)—(A)by striking (A) and inserting (i); and(B)by striking (B) and inserting (ii);(2)by redesignating paragraphs (1), (2), and (3) as subparagraphs (A), (B), and (C), respectively;(3)by striking (h) Practitioners and inserting (h)(1) Practitioners; and(4)by adding at the end 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 practitioners described in subparagraph (B) of this paragraph to prescribe methadone for opioid use disorder to be dispensed through a pharmacy to individuals for their own supervised or unsupervised use.(B)Practitioners 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)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; or(II)otherwise determined by the Secretary, under standards established by the Secretary, to be qualified to prescribe methadone for opioid use disorder.(C)The prescribing of methadone pursuant to subparagraph (A) shall be—(i)exclusively by electronic prescribing and dispensed to the individual treated pursuant to subparagraph (A);(ii)in compliance with applicable Federal and State law respecting the quantities of methadone for opioid use disorder that may be dispensed to individuals pursuant to subparagraph (A); and(iii)for a liquid or dispersible tablet formulation.(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 use disorder treatment program.(E)Practitioners registered pursuant to subparagraph (A) shall—(i)ensure and document, with respect to each individual 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);(ii)revoke any such registration in effect for a person in the State pursuant to section 304; and(iii)deny any pending application for such registration from a practitioner in the State pursuant to section 304.(G)Maintenance treatment or detoxification treatment provided pursuant to subparagraph (A) may be provided through the practice of telemedicine.(H)A pharmacy shall not be required to obtain a separate registration to dispense methadone medication for opioid use disorder to an individual who has been prescribed that medication by a practitioner registered pursuant to subparagraph (A).(3)Not later than 180 days after the date of enactment of this paragraph, and annually thereafter, the Administrator of the Drug Enforcement Administration shall submit to Congress a report that includes, for the reporting period—(A)the number of practitioners registered pursuant to paragraph (2)(A) in each State;(B)a list of States for which the Attorney General received a request pursuant to paragraph (2)(F);(C)the number of revocations or suspensions of registration issued pursuant to section 304, based on violations related to the prescribing of methadone for opioid use disorder by practitioners who are registered pursuant to paragraph (2)(A); and(D)the number of pharmacies that ordered methadone in liquid or dispersible tablet formulations.