Last Thursday (October 3, 2024), the Pennsylvania Department of State’s Board of Medicine submitted to the Independent Regulatory Review Commission (IRRC) a final-omitted regulation that would allow an initial physical examination required for prescribing, administering, and dispensing controlled substances to be conducted via telehealth under certain circumstances under 49 Pa. Code § 16.92. A final-omitted regulation does not require a public comment period and is in essence an expedited process for proposing a regulation change. IRRC will hold a public meeting on November 21 to approve or disapprove the regulation.
This final-omitted regulation would enable the Pennsylvania Department of Drug and Alcohol Programs (DDAP) to grant a statewide exception to 28 Pa. Code § 715.9, which today requires Pennsylvania OTPs (called narcotic treatment programs in DDAP regulations) to conduct a face-to-face determination of whether an individual is currently physiologically dependent on an opioid.
In its Regulatory Analysis Form, the Department of State’s Board of Medicine wrote:
“This final-omitted rulemaking amends the Board’s regulations at § 16.92 by allowing the initial physical examination required for prescribing, administering, and dispensing controlled substances to be conducted by means of telehealth for those patients being admitted into an Opioid Treatment Program (OTP) for treatment of opioid use disorder with either buprenorphine or methadone, provided that the health care provider determines that an adequate evaluation of the patient can be accomplished via telehealth and a full in-person physical examination is completed within 14 days after admission to the OTP. This standard is the same physical examination standard utilized as a result of the Bureau of Professional and Occupational Affairs regulatory waiver issued during the COVID-19 epidemic, which proved to be safe and effective during and after the COVID-19 epidemic. This final-omitted regulation also conforms the Board’s regulations to the Federal opioid use disorder treatment standards as the Board does not wish to unnecessarily maintain a more stringent standard than required by Federal law for OTPs given the continued opioid crisis in this Commonwealth.”
In February 2024, the U.S. Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule amending the federal regulations for the certification of OTPs in 42 CFR Part 8. The changes to the federal rules were used temporarily to improve access to treatment during the COVID-19 federal public health emergency. SAMHSA has now made those changes permanent, and DDAP intends to implement the updated federal rules and reduce barriers to treatment, as described in its latest Licensing Alert 07-2024. This final-omitted regulation is part of the commonwealth’s process for aligning with the final rule on 42 CFR Part 8.