The Physical Evaluation of Patients Who Will Be Treated With Buprenorphine at Opioid Treatment Programs
In April 2020, SAMHSA exempted OTPs from the requirement to perform an in-person physical evaluation (under 42 CFR § 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.”1 In the three years since this exemption was granted, states, OTPs, and other stakeholders report that this flexibility has resulted in improved patient satisfaction with care, and increased patient engagement.2 The support for this flexibility has been overwhelmingly positive, and reports from the State Opioid Treatment Authorities and individual OTPs suggest that this measure has encouraged and enhanced care, while decreasing stigma associated with opioid use disorder (OUD).3
Through this guidance, SAMHSA has made the decision to pre-emptively exercise its regulatory authority under 42 CFR §8.11(h) to extend this flexibility.4 The flexibility extension announced in this Guidance will be effective upon the expiration of the COVID-19 Public Health Emergency, and will remain in effect for the period of one year from the end of the COVID-19 Public Health Emergency, or until such time that the U.S. Department of Health and Human Services publishes final rules revising 42 CFR Part 8 adding this flexibility, whichever occurs sooner. Please note, that a notice of proposed rulemaking has been published that proposes revisions to 42 CFR Part 8 entitled ‘Medications for the Treatment of Opioid Use Disorder’ (87 FR 77330). This extension goes into effect following any end of the COVID-19 PHE declaration, at which time it replaces and supersedes the flexibility announced in SAMHSA’s OTP guidance issued on April 21, 2020.2 This action is also not meant to pre-empt any state law, and for new OTP patients who are treated with methadone, the requirement for an in-person medical evaluation remains in effect.
SAMHSA’s regulatory authority in this particular context is limited to OTPs, and so this extension is applicable only to OTP patients who will be treated with buprenorphine. Treatment of OTP patients with buprenorphine should be undertaken in accordance with applicable evidence-based standards and guidelines.
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 CFR § 8.12(i)(3).
Frequently Asked Questions
No. This extension applies only to OTPs, and providers acting under an OTP’s Drug Enforcement Administration registration. Non-OTP practitioners are covered by the Temporary Rule.
Telehealth includes audio-visual and audio-only devices to the extent allowable under applicable law. While it is preferable to use audio-visual methods of communication, as this allows for direct observation of the individual, this may not be possible at all times. The optimal method of assessment rests with the clinical judgment of the treating provider and should be undertaken in a manner that promotes patient efficacy, safety and confidentiality.
Yes. A provider may continue treating an existing patient of the OTP with buprenorphine via telehealth to the extent allowable under applicable law. This assumes that applicable standards of care are met.
Not necessarily as this is a decision the provider should make on a case-by-case basis. The decision includes consideration of the patient’s comfort with starting a new medication in an unsupervised environment, as well as clinical assessment of the patient’s risk profile for adverse effects. The advantage of an in-person review is that it allows the provider to visualize the patient, and to assess non-opioid use disorder aspects of their medical status, in a manner that may be less challenging than telehealth. In some cases, an in-person review may also promote further engagement in the therapeutic process. In this way, some patients may benefit from being seen in person before initiating buprenorphine. This needs to be weighed against the risks of not starting treatment with buprenorphine.
After an individual has started treatment with buprenorphine, undertaking regular monitoring and evaluation can ensure that the patient is responding as expected, and is using the medication effectively, and not experiencing any adverse side effects. The frequency of follow-up visits, whether in-person or via telehealth, is dependent upon the clinical judgement of the treating provider and integrates knowledge of the individual’s opioid use disorder severity, presence of other substance use disorders, overall medical status, social determinants of health such as transportation and housing stability, comfort with buprenorphine, and individual patient risk profile. The advantage of an in-person review is that it allows the provider to visualize and assess medical needs that may be more challenging to complete via telehealth, and in some cases can promote further engagement in the therapeutic process. In this way, providers should consider an in-person evaluation for those individuals who started buprenorphine via telehealth, particularly through an audio-only platform, within 30 days of the initial telehealth evaluation.
Yes. States, or SOTAs authorized to act on behalf of the state, will need to affirmatively register their concurrence with this specific exemption in order for OTPs within the state to utilize it.
States, or State Opioid Treatment Authorities authorized to act on behalf of the state, may, at any time following the issuance of this guidance, register their concurrence with this exemption by submitting a written concurrence to the Division of Pharmacological Therapies mailbox. To ensure a seamless transition from the flexibility issued during the COVID-19 public health emergency to this guidance, states are encouraged to do this by May 10, 2023.
At the program level, the following activities provide additional safeguards:
- Accreditation Standards
- OTP Diversion Control Plans
- Regular checks of state prescription drug monitoring programs (PDMPs)
- Regular follow-up early in treatment and as needed as treatment progresses
- Dual Enrollment Verification
1See FAQs: Provision of methadone and buprenorphine for the treatment of Opioid Use Disorder in the COVID-19 emergency (PDF | 202 KB)
2Melamed OC, deRuiter WK, Buckley L, Selby P. Coronavirus Disease 2019 and the Impact on Substance Use Disorder Treatments. Psychiatr Clin North Am. 2022;45(1):95-107.
3Nunes, E. V., Levin, F. R., Reilly, M. P., & El-Bassel, N. (2021). Medication treatment for opioid use disorder in the age of COVID-19: Can new regulations modify the opioid cascade?. Journal of substance abuse treatment, 122, 108196.
4The flexibility being extended by this document is the exemption from the requirement to perform an in-person physical evaluation (under 42 CFR § 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 an audio-visual or audio-only telehealth platform.