The Substance Abuse and Mental Health Services Administration (SAMHSA) announced today it is extending its opioid treatment program (OTP) exemption for an in-person physical evaluation for buprenorphine treatment for a period of one year from the end of the COVID-19 Public Health Emergency (PHE). The extension goes into effect upon the expiration of the COVID-19 PHE.
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:
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.
This week, SAMHSA announced the availability of $22.6 million to public and private non-profit entities through its Medication-Assisted Treatment – Prescription Drug and Opioid Addiction (MAT-PDOA) grant. Applications are due Friday, April 29. More information about applying for the grant is available on SAMHSA’s website.
The National Council for Mental Wellbeing will host Overdose Prevention Across the Continuum of Care: Strategies from the Field, the first of a two-part series, from 3:30 pm–5:00 pm on Monday, March 21. You can register for the event here.
Presenters will discuss a range of evidence-based strategies that have been successfully implemented across the continuum of care to prevent overdose and improve the health of people who use drugs and have substance use disorders, including those with co-occurring serious mental illness.
American Rescue Plan Funding Will Support State Efforts to Transform Suicide and Mental Health Crisis Care
| Today the Department of Health and Human Services, through its Substance Abuse and Mental Health Services Administration (SAMHSA), will make critical investments in suicide prevention and crisis care services, announcing $282 million to help transition the National Suicide Prevention Lifeline from its current 10-digit number to a three-digit dialing code – 988.
In 2020, Congress designated the new 988 dialing code to be operated through the existing National Suicide Prevention Lifeline. Converting to this easy-to-remember, three-digit number will strengthen and expand the existing Lifeline network, providing the public with easier access to life-saving services. The Lifeline currently helps thousands of people overcome crisis situations every day. The 988 dialing code will be available nationally for call, text, or chat beginning in July 2022. Standing up the 988 dialing code is a key part of the Biden-Harris Administration’s focus on ensuring that those in crisis have someone to call, someone to respond, and somewhere to go. The 988 code is a first step toward transforming crisis care in this country, creating a universal entry point to needed crisis services in line with access to other emergency medical services. With funds from the Biden-Harris Administration’s Fiscal Year (FY) 2022 budget and additional funds from the American Rescue Plan, SAMHSA’s $282 million investment will support 988 efforts across the country to shore up, scale up, and staff up, including:
“As we continue to confront the impact of the pandemic, investing in this critical tool is key to protecting the health and wellbeing of countless Americans – and saving lives. Giving the states a tool to prevent suicide and support people in crisis is essential to our HHS mission of protecting the health and wellbeing of everyone in our nation,” said HHS Secretary Xavier Becerra. “We know that remembering a three-digit number beats a ten-digit number any day, particularly in times of crisis, and I encourage every state to rev up planning to implement 988 for the sake of saving lives.” To support the initial transition to 988, SAMHSA’s investment represents a budget increase of more than 10 times the FY 2021 budget amount of $24 million. A large portion of FY 2022 funding will be distributed to crisis centers across the country. “This investment in states’ crisis call center operations will help strengthen our partnership as SAMHSA works with states to meet the suicide prevention and behavioral health needs of people across our nation,” said Miriam Delphin-Rittmon, Ph.D., the HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA. “Transformation of this scale is never easy – but too many Americans are experiencing suicide and mental health crises without the support and care they need. The federal government cannot do this alone.” Suicide is the second-leading cause of death among young people and was the tenth-leading cause of death in the nation in 2019, according to U.S. Centers for Disease Control and Prevention data. In 2019, one death by suicide happened almost every 11 minutes in the US. More recently, SAMHSA’s 2020 National Survey on Drug Use and Health (NSDUH) data show 4.9 percent of adults aged 18 or older had serious thoughts of suicide, 1.3 percent made a suicide plan, and 0.5 percent attempted suicide in the past year. Among adolescents 12 to 17, 12 percent had serious thoughts of suicide, 5.3 percent made a suicide plan, and 2.5 percent attempted suicide in the past year. The findings vary by race and ethnicity, with people of mixed ethnicity reporting higher rates of serious thoughts of suicide. |
The Substance Abuse and Mental Health Services Administration (SAMHSA) is extending the methadone take-home flexibilities for one year, effective upon the eventual expiration of the COVID-19 Public Health Emergency (PHE). This exemption is a continuation of the take-home medication flexibilities that SAMHSA put in place in March 2020 and is in keeping with the newly announced Health and Human Services (HHS) Overdose Prevention Strategy. SAMHSA is also considering mechanisms to make this flexibility permanent. Visit here for more information.
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