The federal government has proposed a new rule that would allow take-home doses of methadone. It would also let authorized physicians treat patients with buprenorphine and methadone-assisted over telehealth.
This comes as the Biden administration continues to prioritize substance use disorder treatment amid the growing rates of drug overdose deaths. The CDC reported a 28% increase in overdose deaths from 2020 to 2021.
The proposed changes, which were released by the U.S. Department of Health and Human Services (HHS) along with the Substance Abuse and Mental Health Services Administration (SAMHSA) on Tuesday, build on some of the treatment flexibilities to come out during the COVID-19 Public Health Emergency (PHE).
“These proposed updates would address longstanding barriers [to] treatment in regulations – most of which have not been revised in more than 20 years,” HHS Assistant Secretary for Mental Health and Substance Use Miriam E. Delphin-Rittmon said in a statement. “I am committed to moving these forward as quickly as possible because we have heard from both providers and patients how urgent the need is for treatment.”
Delphin-Rittmon is also the leader of SAMHSA.
Specifically, during the PHE, SAMHSA flexibilities allowed for the initiation of opioid use disorder (OUD) treatment medication buprenorphine through telehealth. This new proposal would expand on those flexibilities and allow for authorized clinicians to initiate buprenorphine through audio-only or audio-visual technology.
The new proposal would also allow authorized opioid treatment program (OTP) clinicians to provide methadone treatment through audio-visual telehealth.
“I think they’re trying to say is, what are the roadblocks to patients receiving care, and how do we remove them in an appropriate manner, where we factor in any diversion issues, safety quality issues. And how do we provide full [patient-centered] care during an opioid crisis,” Jena Grady, a health care lawyer at Nixon Peabody, told Behavioral Health Business.
The regulations for methadone treatment are still stricter than for buprenorphine.
“The proposed rule allows for the use of audio-visual telehealth for any new patient who will be treated by the OTP with methadone 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, ” the proposal states.
However, this new proposal is a bit of a reversal of SAMHSA’s initial stance on providing methadone via telehealth.
“At the beginning of the COVID 19 pandemic, SAMHSA specifically said we are relaxing prescribing rules, take home medication, etc.,” Grady said. “But we are not going to relax methadone prescribing by telehealth because we just have concerns about diversion, and we just don’t have enough evidence to support that we can do this at this time. And SAMHSA in these proposal rules is saying with audio-visual examination, OTP prescribers can have methadone prescribed.”
The new proposal also aims to make it easier for patients to have take-home methadone treatments.
SAMHSA relaxed methadone regulations during the PHE, allowing OTPs to dispense 28 days of take-home methadone for stable patients and 14 doses for less stable patients. This new proposal appears to be a step towards making some of those flexibilities permanent.
This proposal takes this one step further and gives the clinician the autonomy to prescribe take-home methadone at their discretion, removing the requirement that a patient needs to be in treatment for a certain length of time.
If passed, the proposal would also expand the definition of an OTP practitioner to all providers that are licensed to dispense and prescribe the approved medications. This means that appropriately certified nurse practitioners and physician assistants can be classified as OTP practitioners, whereas historically only physicians could have that designation.
The updates are also aimed at moving towards evidence-based practice and patient engagement. In the release, HHS specifically mentioned adding evidence-based models of care including split doing, telehealth and harm reduction activities.
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