SAMHSA Updates

February 1, 2024

We want to update you re:  SAMHSA’s just released final rule  that will (among other things) permanently allow Opioid Treatment Programs (OTPs) to prescribe buprenorphine through telehealth without an in-person visit, if the provider determines adequate evaluation can be done through an audio-visual telehealth platform. 

The NYS Council submitted comments on the proposal last year. Below and at bottom are highlights in the Rule as finalized:

  • As proposed, the final rule expands the definition of “qualifying practitioner” who are able to order and prescribe medications to include the definition of a practitioner as “a health care professional who is appropriately licensed by a State to prescribe and/or dispense medications for opioid use disorders and, as a result, is authorized to practice within an OTP”.
  • The final rule allows more flexibility to offer clients take-home doses of methadone, up to seven days for people who have been in treatment for at least two weeks and up to 14 doses for people who have been in treatment for at least 15 days. 
    SAMHSA also recognized the many pathways to expanding treatment and finalized its proposal to facilitate delivery of comprehensive services in mobile units.
  • The final rule also removes the requirement for people to have had an addiction to opioids for at least one year prior to admission to an OTP for MOUD.
  • Finally, SAMHSA recognized the role that language plays in perpetuating stigma and made updates accordingly and is committed to taking steps to use person-centered and inclusive language. 

The effective date of this final rule is April 2, 2024, and the compliance date is April 2, 2026. Please note that this final rule does not apply more broadly to prescribing outside of OTPs and we expect DEA to issue final regulations relating to virtual prescribing for controlled substances later this year.
(from a SAMHSA Press Release)

The new rule includes the following updates:

  • Expands the definition of practitioner to include, NPs, PAs, and other practitioners.
  • Allows for the use of telehealth.
  • Eliminates stigmatizing language.
  • Eliminates the current criteria for admission where an individual must have had an addiction to opioids for at least one year and replaces it with admission criteria where the person meets diagnostic criteria for a moderate to severe OUD, the individual has an active moderate to severe OUD, or OUD in remission, or is at high risk for recurrence or overdose.
  • Eliminates the requirement that individuals under 18 must have had two documented unsuccessful attempts at treatment within one year to be eligible for MOUD.
  • The current requirement of a medical examination is separated into an initial screening and a comprehensive examination to allow for treatment to begin sooner.
  • Screenings can be undertaken by non-OTP practitioners who work outside of the OTP and telehealth is permitted.
  • Comprehensive examinations can be undertaken by non-OTP practitioners who work outside the OTP and telehealth is permitted.
  • Telehealth screenings and full examinations for methadone must be audio-visual.
  • Telehealth screenings and full examinations for buprenorphine can be audio-visual or audio only.
  • Allows the physician/practitioner to exceed the initial maximum dose of 50 mg when their clinical judgment calls for a higher dose to control withdrawal. This recognizes the impact of fentanyl where higher doses may be appropriate.
  • Take home methadone schedules are significantly increased as follows:
    • Up to 7 days of take home doses for the first 14 days in treatment,
    • Up to 14 days of take home doses from days 15 to 30,
    • Up to 28 days of take home doses after day 31.
  •  Allows medication units to be community pharmacies and allows them to offer take home methadone.
  • Incorporates harm reduction principles and recovery and peer support services into OTP treatment.
  • Allows for split-dosing where such a regimen is indicated.
  • Allows medical directors to delegate responsibilities to other practitioners.
  • Patient refusal of counseling shall not preclude them from receiving MOUD.