The Treatment of Opioid Use Disorders since the Expiration of the COVID-19 Public Health Emergency

Last Updated: May 17, 2023

The Pennsylvania Department of Drug and Alcohol Programs (DDAP) issued the following reminder regarding the expiration of the COVID-19 Public Health Emergency (PHE).

Under Act 30 of 2022, DDAP’s regulatory suspensions that are “related to federal exemptions granted under the federal public health emergency declaration” were extended until “the last day federal exemptions granted under the federal public health emergency declaration are authorized.” In other words, Act 30 aligned the timing for DDAP’s regulatory suspensions with the deadline for flexibilities granted by the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Drug Enforcement Administration (DEA) – not with the deadline of the PHE itself. 

Below is a description of each currently suspended regulation, how these flexibilities are being extended, and efforts to make these changes permanent at the federal level.  

 

Buprenorphine telehealth – for office-based providers 

Current regulatory suspension: Under the federal PHE, the DEA is currently allowing initial evaluations for a patient who will be treated with buprenorphine to be completed via telehealth. The Pennsylvania Department of State’s (DOS’) regulation at 49 Pa. Code § 16.92(b)(1) (requiring an initial physical examination of a patient prior to prescribing buprenorphine for the treatment of OUD) is currently suspended under Act 30. 

Expiration of the PHE: On May 9, 2023, DEA released a temporary rule to extend COVID-19 telemedicine flexibilities for controlled substance prescriptions for 6 months. Current flexibilities are in place until November 11, 2023. DOS has indicated that their regulation at 49 Pa. Code § 16.92(b)(1) will remain suspended accordingly. Clinicians may treat new patients with buprenorphine following a telehealth evaluation through November 11, 2023. For any practitioner-patient relationship established on or before November 11, 2023, a one-year grace period will continue through November 11, 2024. This grace period not only allows clinicians the ability to continue their established telemedicine relationships with patients under the flexibilities that were in place under the COVID-19 PHE but also allows clinicians a period of time to prepare patients for upcoming changes in federal regulations. In the meantime, DEA is continuing to carefully evaluate comments received on its proposed rulemaking to make a form of this flexibility permanent. 

 

Methadone take-home supply 

Current regulatory suspension: Under the federal PHE, SAMHSA is currently allowing up to 28 days of take-home medications for patients on stable dosages, as deemed appropriate by their physician. DDAP’s regulation at 28 Pa. Code § 715.16(e) (prohibiting narcotic treatment programs [NTPs] from permitting a patient to receive more than a 2-week take-home supply) is currently suspended under Act 30. 

Expiration of the PHE: SAMHSA issued a notice of proposed rulemaking in December 2022 that proposed modifying regulations related to methadone take-home supply up to 28 days, among other changes. In April 2023, SAMHSA issued updated guidance on the extension of methadone take-home flexibilities. This revised guidance will be effective upon the expiration of the PHE and will remain in effect for one year after the end of the PHE, or until the final regulations are published, whichever occurs sooner. DDAP submitted our written concurrence with this exemption on April 20, 2023.The written concurrence is our agreement with SAMSHA that NTPs in Pennsylvania may continue to exercise these flexibilities during this time period.  

Buprenorphine telehealth – for Narcotic Treatment Programs 

Current regulatory suspension: Under the federal PHE, SAMHSA and the DEA are currently allowing initial evaluations for a patient who will be treated with buprenorphine to be completed via telehealth. DDAP has two related regulations that are currently suspended under Act 30: 

  • 28 Pa. Code § 715.9(a)(4): requires NTPs to make a face-to-face determination before admission to treatment, for those clients who will receive medication to treat opioid use disorder (OUD). 
  • 28 Pa. Code § 715.6(d): requires NTPs to have narcotic treatment physician services onsite. 

Expiration of the PHE: SAMHSA issued a notice of proposed rulemaking in December 2022 that proposed the use of telehealth in initiating buprenorphine, among other changes. In June 2022, SAMHSA announced to State Opioid Treatment Authorities that flexibilities around telehealth evaluations before buprenorphine treatment at NTPs, specifically, will be extended for one year after the end of the PHE (now May 11, 2024). SAMHSA reaffirmed this extension on May 10, 2023, and DDAP submitted our written concurrence on the same day that NTPs in Pennsylvania may continue to exercise these flexibilities during this time period. 

SAMHSA and DEA have made clear that support for these flexibilities have been overwhelmingly positive, decreased stigma associated with OUD, and enhanced care for patients. DDAP has also recognized the benefits to these flexibilities and looks forward to seeing them made permanent in forthcoming regulatory updates. 

Resources: 

If you have any further questions, please contact the Bureau of Program Licensure at (717) 783-8675 or RA-licensuredivision@pa.gov

Login to be able to comment

Leave a comment