On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA), U.S. Department of Health and Human Services, announced a final rule updating the regulations regarding Opioid Treatment Programs (OTPs) as part of the Biden Administration’s Overdose Prevention Strategy. These announced changes are the first update to the OTP regulations in over 20 years and significantly increase access to medications like methadone and buprenorphine that treat opioid use disorder by, among other things, making permanent prescribing of “take-home” doses and enabling use of telemedicine to extend OTPs to a patient’s home.
What are OTPs?
OTPs provide medication assisted treatment (MAT) for people diagnosed with opioid use disorder (OUD). MAT utilizes medications (typically methadone or buprenorphine) with psychosocial counseling and other behavioral health services to treat patients. OTPs are sometimes called methadone clinics because these clinics are the only way people can access methadone treatment for opioid use disorder. OTPs may exist in a variety of settings including intensive outpatient programs, residential programs, and hospitals, but all OTPs require a specific license certification by SAMHSA, and accreditation by an independent, SAMHSA-approved accrediting body. The OTP model has been criticized as too burdensome in restricting a patient’s ability to easily access life-saving medication and treatments for OUD. The prior requirement that methadone only be prescribed at these clinics and the prior restriction on unsupervised or take-home doses of medications used to treat OUD have historically required patients to make daily visits to an OTP, even in the outpatient setting.
What did the Final Rule change?
The final rule updates OTP certificate and accreditation standards, treatment standards related to medications dispensed by an OTP and removed language regarding the DATA Waiver. The DATA Waiver requirement was removed in January 2023. SAMHSA also released a table summarizing key changes along with the rationale for these changes.
Flexibility of Methadone Medication Take-Home Doses in OTPs
In March 2020, due to the COVID-19 Pandemic, SAMHSA issued exemptions allowing OTPs to dispense up to 28 days of “take-home methadone doses for stable patients being treated for OUD and up to 14 doses of “take-home” methadone for “less stable” patients. Originally meant to reduce the risk of spreading COVID-19, OTPs and patients widely supported these changes. These flexibilities were scheduled to sunset one year past the end of the COVID-19 Public Health Emergency (PHE) (May 11, 2024) or until a final rule was published.
This final rule created a permanent option allowing take-home medication including methadone, buprenorphine, buprenorphine combination productions, and Naltrexone. First, the rule allows patients to be able to access take-home medication doses for days when the clinic is closed. Beyond those doses, the OTP practitioner may use their discretion to dispense medications to patients for OUD subject to certain maximums. Within the first 14 days of treatment, the take-home supply is limited to maximum supply of seven days’ worth of take-home medication. Between 15-30 days of treatment, the take-home supply maximum is increased to 14 days. Finally, after 31 days, the patient may have a take-home supply up to 28 days.
Flexibility to Prescribe Medication for OUD via Telehealth without an Initial In-person Physical Evaluation
In April 2020, SAMHSA implemented regulatory flexibilities to address the impact of the COVID-19 pandemic including exempting OTPs from the requirement to perform an in-person physical evaluation for patients being treated with buprenorphine in an OTP. Notably, this flexibility did not apply to methadone. On May 9, 2023, SAMHSA extended this telehealth flexibility until one year past the end of the COVID-19 PHE, or until such time that SAMHSA published a final rule.
This final rule allows an OTP practitioner to initiate treatment of methadone or buprenorphine via telehealth without an initial in-person exam. The final rule states that if certain practitioners, including the OTP physician, primary care physician, or other authorized health care professional under the supervision of program physician determines that an evaluation of the patient can be accomplished via audio visual technology, then a licensed OTP practitioner may prescribe and dispense methadone or buprenorphine to the patient. Importantly, in the rule commentary, SAMHSA notes it is not extending the use of audio-only telehealth technology to methadone because methadone holds a higher risk profile for sedation. If audio-visual technology is not available, an audio-only device may be used to prescribe methadone but only when patient is in the presence of a licensed practitioner who is registered to prescribe and dispense controlled medications. These additional requirements significantly limit the usefulness of audio-only technology for the prescription of methadone.
SAMHSA notes that this final rule does not authorize the prescription of methadone via telehealth outside the OTP context Methadone must still be prescribed and dispensed by appropriately licensed OTP practitioners. Additionally, any medication must still be dispensed to the patient under existing OTP procedures.
Admission Criteria Changes
Additionally, the final rule removed stringent admission criteria that prevented patients from initially accessing treatment. First, the final rule removed the requirement that patients have a full year history of OUD before being able to access treatment at an OTP. Second, this final rule removes the requirement that patients under the age of 18 have two unsuccessful attempts at treatment before entering treatment at an OTP.
Scope of Practice Expansion
On the federal level, the definition of practitioner was modified to include any “health care professional who is appropriately licensed by the state to prescribe and/or dispense medications for opioid use disorder.” This means, subject to state laws, many more types of non-physician practitioners such as nurse practitioners or physician assistant may prescribe or order medication. However, some states may not allow non-physician practitioners such as certified nurse-midwives, nurse practitioner, physician assistants, or pharmacists to prescribe these medications.
Impact of the Final Rule
These increased flexibilities will vastly improve patient’s access to life-saving OTP services. Specifically, the changes regarding methadone prescribing are a crucial step forward in allowing patients access to this important medication. While these changes only apply to the OTP regulatory scheme, the introduction of take-home medications, the ability to prescribe medication through telehealth, changes to admission criteria, and expanding the scope of practitioners will allow OTPs to access more patients in a field that desperately needs more providers.
Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group with any questions.