';
Tags Posts tagged with "Regulatory Suspensions"

Regulatory Suspensions

The Office of Long-Term Living (OLTL) has issued a notice announcing the extension of various regulatory provisions under the state disaster emergency declaration that are currently in effect and which were set to expire on September 30, 2021. These are now extended until further notice. A list of the regulations that were suspended in whole or in part and their current status is available here.

The Department of Drug and Alcohol Programs (DDAP) sent out guidance on June 14, 2021 regarding three temporary regulatory suspensions granted by the governor’s declaration of a disaster emergency due to the coronavirus pandemic. House Bill 1861, which was signed into law today by Governor Wolf, further extends those regulatory suspensions from September 30, 2021 until March 31, 2022 unless terminated sooner. In addition to the suspensions noted in DDAP’s previous communication, one additional regulatory suspension from the Department of State, also relevant to the field, is added to the chart below and also suspended until March 31, 2022.

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.

Please email the Bureau of Program Licensure or call (717) 783-8675 with questions.

As you may know, the Pennsylvania Department of Drug and Alcohol Programs (DDAP) has issued three temporary regulatory suspensions under authority granted by the Governor’s declaration of a disaster emergency due to the coronavirus pandemic. Based on flexibilities granted by the Substance Abuse and Mental Health Services Administration (SAMHSA), DDAP’s goal with these suspensions was to respond to the extraordinary circumstances of the last year by allowing entities regulated by DDAP to continue operating throughout the uncertainty of the pandemic.

On June 10, 2021, the General Assembly passed House Resolution 106, which terminated the Disaster Declaration in whole, effective immediately. However, Governor Wolf signed Act 21 of 2021 on June 11, 2021 to ensure regulatory and statutory suspensions enacted under the Disaster Declaration would continue. Act 21 extends all of the regulatory and statutory suspensions authorized under the Disaster Declaration until September 30, 2021. More information on Act 21 is outlined in this press release from the Governor.

In the table below, you will find the three regulations in which DDAP suspended utilizing the Disaster Declaration. DDAP would like to reiterate that these suspended regulations will continue to be in place until September 30, 2021.

 

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.

 

In the coming weeks, DDAP will continue to work with SAMHSA and solicit feedback on the best way to move forward with these suspended regulations to ensure that the drug and alcohol treatment field is able to provide necessary services to patients in the safest, most effective way possible.

Thank you all for your continued work to help better the lives of Pennsylvanians with substance use disorder. If you have any further questions, please do not hesitate to reach out to the Bureau of Program Licensure, Division of Licensing Inspection at (717) 783-8675 or via email.