SAMHSA’s New OTP Rule Cements Greater Flexibility for Methadone Treatment

The Substance Abuse and Mental Health Services Administration (SAMHSA) has finalized an overhaul of opioid treatment programs (OTPs) that enshrines many flexibilities first implemented during the crisis response to the COVID pandemic.

The final rule represents the first significant change to OTP regulations in over 20 years. In brief, the final rule intends to enable clinicians to provide personalized care. In no small part, this includes loosening OTP providers’ ability to prescribe methadone. It also tweaks and modernizes regulatory language.

SAMHSA and the U.S. Department of Health and Human Services (HHS) released a copy of the final rule on Jan. 31. Preliminary regulatory proposals finalized in the rule date back to December 2022. 


“While this rule change will help anyone needing treatment, it will be particularly impactful for those in rural areas or with low income for whom reliable transportation can be a challenge, if not impossible,” Miriam Delphin-Rittmon, HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA, said in a statement. “In short, this update will help those most in need.”

The rule is effective on April 2, 2024, and compliance is required by Oct. 2, 2024.

Colloquially known as methadone clinics, OTPs presently have a near-total purview of the prescribing and dispensing of methadone for the treatment of opioid use disorder (OUD). Methadone is a long-lasting opioid used to blunt cravings and minimize withdrawal. Historically, fears of abuse have led to regulators mandating that methadone be administered and consumed in person, under the supervision of a clinician.


That comes with barriers to care.

Patients with OUD getting care at OTPs, who may not have stable life circumstances, are stereotypically required to go to a clinic every day to get medication. Those with transportation, work or family challenges often struggle to adhere to treatment.

Further, an analysis shows that statistically the average American has a coin flip’s chance of having geographic access to an OTP. Federal rules and proposed legislation, especially the Modernizing Opioid Treatment Access Act (MOTAA), are meant to increase access to methadone treatment. The same analysis estimates that the passage of MOTAA could increase access to methadone treatment by 14%.

MOTAA proposes waiving certain restrictions on clinicians who can prescribe controlled substances, allowing them to prescribe take-home methadone prescriptions that can be filled in retail pharmacies.

Here’s a short rundown of notable changes presented by the final rule:

— Eliminates the so-called “one-year” history of OUD requirement

— Further encourages and enables mobile treatment units

— Allows greater flexibility with take-home medication

— Makes telehealth induction for buprenorphine permanent without an in-person exam

— Expanding the definition of practitioner to include any approved to dispense and prescribe certain medications

— Final deletion of the so-called “x-waiver” from regulatory language

The rule pairs increased take-home dosage with looser prescribing guidelines. When deciding on take-home doses, clinicians will no longer be subject to length-of-treatment guidelines. It also pares down the requirements for patients to show consistent abstinence in toxicology testing. 

“Toxicology testing is a clinical tool that is used to inform the treatment process, should never be used punitively, and must be conducted in a way that is respectful of the individual and in accordance with clinical and professional standards,” the rule states.

The rule also seeks to clarify and streamline the certification process for OTPs. It increases the time OTPs seeking certification can offer interim care to 180 days from 120 days. It also clarifies administrative language for the certification process and provides guidelines for information sharing among the federal government, state governments and accrediting bodies, “particularly in those circumstances where there have been changes or violations in accreditation.”

SAMHSA data shows that there are about 2,100 OTPs in the U.S. A separate survey released by SAMHSA shows private for-profit entities operated 62% of OTPs, while 31% were nonprofit in 2020. The remainder were operated by federal, state, local or tribal governments. 

Early reactions to the finalized rule highlighted the intent to increase access to care. However, critics of deregulating methadone tempered their praise with concerns over patient safety.

“Cementing these policies is a step in the right direction in the fight against the worsening overdose epidemic to increase equitable access to care, reduce [the] stigma of seeking treatment for OUD, and embrace technology in medicine,” Dr. Bobby Mukkamala, chairman of the American Medical Association’s Substance Use and Pain Care Task Force, said in a statement.

He cheered the increased access to buprenorphine via telehealth.

Advocates for Opioid Addiction Treatment (AOAT), an advocacy organization that represents OTPs and office-based opioid treatment (OBOT) organizations, highlighted that the new final rule keeps the OTP at the center of oversight of methadone treatment.

“While we know that methadone is highly effective when used correctly under appropriate supervision, we also have seen it kill people when misused,” the organization said in a statement. “As such, we support SAMHSA’s rule allowing take-home medication flexibilities, particularly given OTPs’ medication diversion protections to ensure patient safety and prevent misuse and diversion.”

AOAT is a member of the issue-specific coalition Program, Not A Pill, which opposes further methadone deregulation, like that proposed in MOTAA.

Dr. Benjamin Nordstrom found the changes encouraging as a way to increase access to care.

Nordstrom is the chief medical officer of Dallas-based Behavioral Health Group, an outpatient behavioral health provider, and a member of AOAT.

“It is clear that these thoughtful changes were made by people who deeply understand the nuances of opioid addiction treatment and how to safely expand access,” Nordstrom said. “We anticipate these changes will make a real meaningful difference for patients, without the risks that come with proposed legislation to deregulate methadone prescribing and dispensing.”

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