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Tags Posts tagged with "Regulatory Suspension"

Regulatory Suspension

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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 Bureau of Human Services Licensing (BHSL) within the Office of Long-Term Living (OLTL) has issued the following guidance on the lifting of regulatory suspensions for Personal Care Homes (PCHs) and Assisted Living Residences (ALRs):

On July 1, 2022, the suspension of various regulatory provisions under the state disaster emergency declaration was extended to October 31, 2022. On November 1, 2022, the remaining regulatory suspensions expired, and the full regulatory requirements of 55. PA Code Chapter 2600 (Personal Care Homes) and 55. PA Code Chapter 2800 (Assisted Living Residences) were reinstated.

While most of these regulatory requirements required compliance beginning immediately on November 1, 2022, certain regulatory suspensions included 90-day grace periods designed to allow facilities to fully comply with the regulations. That 90-day period will come to an end on January 30, 2023. Facilities are expected to be able to demonstrate compliance with these regulations beginning January 31, 2023.

A guidance document for Personal Care Homes and Assisted Living Residences includes a list of all applicable regulations that were suspended under the emergency declaration, the dates and details of the suspensions, and clarification on what providers can expect when compliance is being measured in their facilities.

Please note that compliance with annual training requirements is dependent on the 12-month training year for Direct Care Staff and Administrators, as determined by the licensed entity. Training requirements for training years that ended between January 1, 2022, and December 31, 2022, are required to be in compliance by January 31, 2023. If a training year began in 2022 but does not end until 2023, that training year is incomplete and compliance cannot be measured until after the conclusion of the training year.

Please also note that for administrator training years ending in 2023, all 24 hours of administrator training may be completed online, provided that at least 12 of those hours are formatted as a live training (e.g., Zoom, Teams, etc.). A maximum of 12 hours of online asynchronous or pre-recorded trainings are permitted.

Questions about this announcement and the guidance document can be directed via email.

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