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DEA

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The Drug Enforcement Agency (DEA) is proposing to roll back flexibilities implemented during the public health emergency (PHE) in tele-prescribing buprenorphine. The proposed new regulation would mandate an initial in-person visit with a prescriber in order for a patient to receive more than a 30-day buprenorphine prescription. Since 2020, those with opioid use disorder have been able to receive prescriptions for buprenorphine, including the initial prescription, following a tele-appointment.

Patients who began buprenorphine treatment during the PHE under the expanded flexibilities would have a 180-day grace period but would then need to see a prescriber in person before continuing treatment under the DEA’s proposed rule.

The proposed rule and instructions for providing comments are available online. The public comment period closes March 31, 2023.

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On January 30, the Biden Administration announced that the COVID-19 national emergency and public health emergency (PHE) will both expire on Thursday, May 11, 2023. Under Act 30 of 2022, the Department of Drug and Alcohol Programs’ (DDAP) 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 and what DDAP knows about efforts to make these changes permanent at the federal level.

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 28 Pa. Code § 715.16(e) (prohibiting narcotic treatment programs [NTPs] from permitting a patient to receive more than a two-week take-home supply) is currently suspended under Act 30.

Expiration of the PHE: In November 2021, SAMHSA announced that the methadone take-home flexibilities will be extended for one year after the end of the PHE (now May 11, 2024). DDAP submitted its written concurrence with this exemption in February 2022. Furthermore, SAMHSA issued a notice of proposed rulemaking in December 2022 that proposes modifying regulations related to methadone take-home supply up to 28 days, among other changes.

Buprenorphine Telehealth

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: In March 2022, the DEA announced that it is currently working to make its teleprescribing regulations permanent. 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 and DEA have made clear that support for these flexibilities has been overwhelmingly positive, decreased stigma associated with OUD, and enhanced care for patients. Given the information above, DDAP does not anticipate any lapses in these flexibilities at either the federal or state level but will continue to provide updates and guidance as available.

Resources

If you have any further questions, please contact the Bureau of Program Licensure at (717) 783-8675 or via email.

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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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With Senate Bill 1019 passed into law as Act 14, the Department of Drug and Alcohol’s (DDAP) regulatory suspensions are also extended. These regulatory suspensions are “related to federal exemptions granted under the federal public health emergency declaration” until “the last day federal exemptions granted under the federal public health emergency declaration are authorized.” In addition to three DDAP regulatory suspensions, one additional regulation from the Department of State, also relevant to the field, is included in the chart below and also remains suspended.

Statute/Regulation Statute/Regulation Purpose

Waiver Benefit/Explanation

28 Pa. Code § 715.16(e)

 Prohibits narcotic treatment programs (NTPs — methadone clinics) from permitting a patient to receive more than a 2-week take-home supply of medication In response to COVID-19, SAMHSA is allowing up to 28 days of take-home medications for patients on stable dosages, if the physician deems appropriate.
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 buprenorphine treatment. In response to COVID-19, SAMHSA is allowing initial evaluations for a patient who will be treated with buprenorphine to be completed via telehealth.
28 Pa. Code § 715.6(d) Requires NTPs to have narcotic treatment physician services onsite. In response to COVID-19, SAMHSA is allowing initial evaluations for a patient who will be treated with buprenorphine to be completed via telehealth.
49 Pa. Code § 16.92(b)(1)

(Department of State)

 Before a patient can be prescribed any controlled substance in Pennsylvania, a person licensed to practice medicine and surgery in the commonwealth, or otherwise licensed or regulated by the State Board of Medicine, must take an initial medical history and conduct an initial physical examination, unless emergency circumstances justify otherwise.

In response to COVID-19, the Department of State suspended the initial medical history and physical examination requirement specifically for the treatment of opioid-use disorder with buprenorphine.

 

In November 2021, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced that the methadone take-home flexibilities will be extended for one year after the eventual expiration of the federal COVID-19 Public Health Emergency. DDAP has submitted its written concurrence with this exemption. SAMHSA has also indicated that they are currently considering mechanisms to make this flexibility permanent. Narcotic treatment programs do not need to do anything additional at this time to continue taking advantage of this flexibility.

Similarly, the U.S. Drug Enforcement Administration (DEA) also announced last week that they are currently working to make their teleprescribing regulations permanent. DDAP will continue to provide additional information and guidance as it becomes available.

If you have any further questions, please contact the Bureau of Program Licensure at (717) 783-8675 or via email.

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