Section 1 Short title
This Act may be cited as the “Modernizing Opioid Treatment Access Act”.
Modernizing Opioid Treatment Access Act
A BILL
To expand the take-home prescribing of methadone through pharmacies.
Sec. 2 Expansion of methadone for opioid use disorder through prescribing and pharmacies
Registration; other care by telehealth—
Definitions— In this subsection:
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).
Secretary— The term Secretary means the Secretary of Health and Human Services.
Waiver—
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.
Persons described— Persons described in this subparagraph are persons who—
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
are—
employees or contractors of an opioid treatment program; or
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.
Requirements for prescribing methadone— The prescribing of methadone pursuant to subparagraph (A) shall be—
exclusively by electronic prescribing and dispensed to the patient treated pursuant to subparagraph (A);
for a supply of not more than 30 days pursuant to each prescription; and
subject to the restrictions listed in section 8.12(i)(3) of title 42, Code of Federal Regulations, or successor regulation or guidance.
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.
Registration requirements— Persons registered in a State pursuant to subparagraph (A) shall—
ensure and document, with respect to each patient treated pursuant to subparagraph (A), informed consent to treatment; and
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).
Cessation and withdrawal of registration— At the request of a State, the Attorney General, in consultation with the Secretary, shall—
cease registering persons in the State pursuant to subparagraph (A); and
withdraw any such registration in effect for a person in the State.
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.
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—
the number of persons registered pursuant to subsection (a);
the number of patients being prescribed methadone pursuant to subsection (a); and
a list of the States in which persons are registered pursuant to such subsection (a).