On February 2, 2024, the Department of Health and Human Services (HHS) issued a Final Rule that expands access to medications for the treatment of opioid use disorder (OUD) via telehealth modalities and “take-home” doses. The Final Rule is part of the current administration’s “Overdose Prevention Strategy” first announced in 2021 that updates for the first time in two decades certain provisions of regulations related to Opioid Treatment Program (OTP) accreditations, certification, and standards for the medication assisted treatment (“MAT”) of OUD patients. The Final Rule codifies certain flexibilities already granted during the COVID-19 pandemic. Providers have until October 2, 2024 to comply with the Final Rule. 

Prior Flexibilities Codified and Expanded

In March 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) published guidance on flexibilities amid the COVID-19 pandemic, including the prescription of buprenorphine via telehealth and the provision of unsupervised methadone doses. Under the SAMSHA exemption, OTPs could dispense up to 28 days of methadone take-home doses to “stable” patients and up to 14 days of take-home methadone doses for “less stable” patients that were being treated for an OUD. Additionally, SAMSHA granted certain flexibilities in April 2020 which exempted OTPs from the requirement to perform an in-person evaluation before treating patients with buprenorphine, a flexibility that did not cover treatment with methadone. 

This Final Rule makes certain of the above mentioned flexibilities permanent which were otherwise due to sunset on May 11, 2024 and expands access to patients with an OUD in several important ways: 

• Take-home doses. Patients can receive take-home doses of methadone, buprenorphine, buprenorphine combination productions, and Naltrexone. The Final Rule allows patients to receive doses for days when the OTP is closed and vests practitioners with discretion to provide take-home doses at various stages of treatment that gradually increase the longer the patient has been receiving MAT.
• Telehealth. OTPs may initiate treatment using buprenorphine via audio-only or audio-visual telehealth — and methadone via audio-visual telehealth — without an in-person examination if the proper healthcare professionals (whether directly or under supervision) determine that such telehealth modality can support an adequate patient evaluation.
• Expansion of eligible practitioners. The Final Rule expanded the eligible practitioners who can prescribe medications for treatment of an OUD through an OTP (subject to state law on prescriptive authority). Now, nurse practitioners and physicians can initiate MAT.
• OTP patient eligibility requirements. The Final Rule removed the requirement that OUD patients have a history of addiction lasting one year to qualify for treatment in an OTP and struck the need for patients under 18 to have two unsuccessful attempts at treatment before receiving care at an OTP. 

Why the Final Rule Matters 

Flexibilities may drive patient volumes and investment interest. The Final Rule will have a significant impact on rural communities with low access to transportation, as previous rules required the administration of methadone to occur in only certain settings, and never at home. Additionally, the expanded class of patients who can receive treatment in OTPs following elimination of the one-year history of addiction requirement will enable higher admissions volumes. These factors may fuel renewed interest by strategics and private equity investors to pursue the acquisition of OTP providers.

The Final Rule is important but narrow in scope. While the flexibilities afforded under the Final Rule are meaningful, its scope is limited to OTPs and does not apply to other types of addiction treatment programs that are not subject to the more stringent accreditation, licensure, and operational standards that fall on OTPs.

Waiting for the next shoe to drop. The Final Rule also leaves open, broader questions about federal requirements for prescribing controlled substances via telehealth—outside the OTP context—which The Drug Enforcement Administration (DEA) is expected address through its own final rule later this year. Current COVID-19 era flexibilities allow telehealth providers to remotely prescribe specific controlled substances, including buprenorphine, without an in-person visit and also allowed prescribing certain Schedule III-V substances via telehealth for the initial 30-day dose. Existing providers or investors conducting diligence and looking to pursue acquisitions will need to ensure that go-forward practices square with any new or different requirements in the DEA’s final rule that may depart from past flexibilities. 

Data privacy and security loom large. As the healthcare industry transitions to an increasingly tech-based services model, enabled by the type of telehealth flexibilities provided by the Final Rule, dangers related to data leakage, breaches, and the failure to comply with HIPAA, 42 CFR Part 2, and state privacy laws, are at an all-time high. Industry participants and investors would be wise to consider cybersecurity insurance, proper privacy and security policy maintenance, overall enhanced due diligence during acquisitions, and closer inspection of vendor relationships to ensure protection from liabilities that come from the use of telehealth modalities. 

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