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SAMHSA Proposed Rule Permits Methadone Prescribing for New Patients via Telemedicine

The Substance Abuse and Mental Health Services Administration (SAMHSA) on Tuesday proposed updating federal regulations to permit using audio-visual telehealth services for any new patient treated with methadone in an Opioid Treatment Program (OTP) under specific conditions.

In a proposed rule, SAMHSA said federal regulations should be updated to allow using audio-visual telehealth services for patients treated with methadone in OTPs only if a program physician, or an authorized healthcare professional under the supervision of a program physician, determines that an adequate evaluation of the patient can be accomplished via an audio-visual telehealth platform.

This change is not extended to using audio-only telehealth platforms and applies only to ordering methadone that an OTP dispenses under existing OTP procedures.

In addition, SAMHSA’s proposed changes would update 42 CFR Part 8 by removing stigmatizing or outdated language; supporting a more patient-centered approach to treatment; and reducing barriers to receiving care.

SAMHSA’s proposed changes also would revise standards to reflect an OTP accreditation and treatment environment that has evolved since Part 8 became effective in 2001. Consequently, SAMHSA said its proposed revisions reflect evidence-based practice, language that aligns with current medical terminology, effective patient engagement approaches, and the workforce providing services in OTPs, including:

  • expanding the definition of an OTP treatment practitioner to include any provider who is appropriately licensed to dispense and/or prescribe approved medications. The current Part 8 rule defines a practitioner as being: “a physician who is appropriately licensed by the State to dispense covered medications and who possesses a waiver under 21 U.S.C.823(g)(2).” During the Covid-19 public health emergency, this has been formally expanded to align with broader definitions of a practitioner (nurse practitioners, physician assistants, etc.), and OTPs reported that this change was essential in supporting workflow and access;
  • adding evidence-based delivery models of care, such as split dosing, telehealth, and harm-reduction activities;
  • removing such outdated terms as “detoxification”;
  • updating criteria for provision of take-home doses of methadone;
  • strengthening the patient-practitioner relationship through promoting shared and evidence-based decision-making;
  • allowing for early access to take-home doses of methadone for all patients, to promote flexibility in creating plans of care that facilitate such every-day needs as employment, while also affording people with unstable access to reliable transportation the opportunity to also receive treatment; likewise, promoting mobile medication units to expand an OTPs geographic reach; and
  • reviewing OTP accreditation standards.

According to SAMHSA, the changes– which are part of President Biden’s National Drug Control Strategy – come at a time when fewer than one out of 10 Americans can access treatment for substance use disorder.

SAMHSA will accept public comments on the proposed rule until Feb. 14, 2023.