SAMHSA: In-Person Physical Evaluation Flexibility Extension Guidance for OTPs

June 28, 2022

In April 2020, during the COVID-19 Public Health Emergency, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued an exemption to Opioid Treatment Programs (OTP) from the requirement to perform an in-person physical evaluation (under 42 C.F.R. § 8.12(f)(2)) for any patient who will be treated by the OTP with buprenorphine if a program physician, primary care 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 telehealth. The duration of this exemption was specifically tied to the “period of the national emergency declared in response to the COVID-19 pandemic.”

The support for this flexibility has been overwhelmingly positive, and early reporting from the state Opioid Treatment Authorities and individual OTPs suggest that these measures have encouraged and enhanced care, while decreasing stigma associated with opioid use disorder.

Therefore, SAMHSA is extending this flexibility for a period of one year from the end of the COVID-19 Public Health Emergency. The extension goes into effect upon the expiration of the COVID-19 Public Health Emergency, and once in effect, this document will replace and supersede the flexibility announced in SAMHSA’s OTP guidance issued on April 21, 2020.

This extension is issued pursuant to SAMHSA’s regulatory authority under 42 C.F. R. §8.11(h), and it will provide time for SAMHSA to promulgate regulations to permanently continue this flexibility. This action is not meant to pre-empt any state law. This extension is applicable only to patients who will be treated with buprenorphine in an OTP. Treatment of patients with buprenorphine in OTPs should be undertaken in accordance with applicable evidence-based standards and guidelines. For new patients who are treated with methadone in OTPs, the requirement for an in-person medical evaluation remains in effect.

When determining whether to perform an in-person or telehealth evaluation for any patient who will be treated by the OTP with buprenorphine, SAMHSA recommends that the best interests of each patient and the diversion risk to the community be taken into consideration. Although the flexibility allows for the use of telehealth or an in-person visit, the choice remains subject to the clinical judgment of the treating provider. The flexibility is meant to support entry into treatment and reduce a significant barrier to care. Therefore, it is expected that OTP providers use clinical judgment in determining how to best assess the patient and to engage them in treatment planning. Such decision-making must be documented in the individual’s medical record consistent with 42 C.F.R. § 8.12(i)(3).

Read the SAMHSA guidelines.