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Tags Posts tagged with "DOS"

DOS

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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(a)(4), 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.

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The Pennsylvania Department of State (DOS) has reversed course and extended its waiver allowing for an initial prescription of buprenorphine without an in-person physical exam. DOS had announced previously that the waiver would expire on June 30, 2022; however, DOS’s waiver will now continue until the last day of the federal public health emergency declaration, unless the exemptions are ended sooner by the Substance Abuse and Mental Health Services Administration (SAMHSA) or the US Drug Enforcement Administration (DEA).

On Sept. 4, 2020, DOS issued a waiver suspending the State Board of Medicine’s regulation at 49 Pa. Code § 16.92(b)(1), which requires an initial physical examination of a patient prior to prescribing buprenorphine for the treatment of opioid use disorder. This waiver was sought specifically to complement the Department of Drug and Alcohol Programs’ (DDAP) suspension of 28 Pa. Code § 715.9(a)(4) and “relates to Federal exemptions granted under the Federal public health emergency (PHE) declaration,” specifically the exemptions granted by the federal Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Drug Enforcement Agency (DEA).

Therefore, in accordance with section 2102-F(a.3) of the Pennsylvania Administrative Code of 1929 (amended by Act 14 of 2022), the Department of State’s waiver will continue until the last day of the federal public health emergency declaration, unless the exemptions are ended sooner by SAMHSA or the DEA. This waiver will not expire on June 30, 2022. More information about the federal public health emergency can be found here.

It is important to note that, to be considered within the acceptable and prevailing standard of care, the physician/prescriber must be following the applicable SAMHSA/DEA guidelines.

Pennsylvania has not received notification that the PHE will be terminated on July 15. The commonwealth expects the PHE to be extended again. If this occurs, this waiver and others tied to or related to the PHE will be extended until mid-October 2022.

Additional information:

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