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HHS Issues Buprenorphine Practice Guidelines as Study Confirms Access Barriers

One of the spillover effects of the COVID-19 pandemic has been the increase in opioid-related deaths. These deaths overwhelmingly affect working-class Americans with limited access and resources to lifesaving drugs such as buprenorphine and naloxone. As a result, the Department of Health and Human Services (HHS) issued the Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder (Practice Guidelines) through a waiver of certain certification requirements prescribed by law. The Practice Guidelines remove a longtime prerequisite tied to training and counseling that several practitioners have cited as a barrier to treating patients with Opioid Use Disorder (OUD). The Practice Guidelines could not come soon enough, as a recent study indicates that individuals with OUD experienced decreased access to treatments during the pandemic.

Buprenorphine, a Food and Drug Administration (FDA)-approved medication for OUD, is an opioid partial agonist that manages opioid withdrawal symptoms and cravings. Its effects, such as euphoria or respiratory depression, are weaker than other full opioid agonists such as methadone, making buprenorphine a preferable choice.  When used in combination with naloxone, another FDA-approved medication, OUD sufferers can stay committed to treatment.

Historically, in order for a practitioner to prescribe and dispense buprenorphine for OUD, the practitioner must obtain annually a separate Drug Enforcement Administration (DEA) registration for the purpose of dispensing narcotic drugs to individuals for maintenance treatment or detoxification treatment. Alternatively, a practitioner may seek a waiver by submitting a notice of intent (NOI) to the Substance Abuse and Mental Health Services Administration (SAMHSA) within HHS. Once SAMHSA approves the waiver request and notifies DEA of the approval, DEA issues an X-waiver identification number authorizing the practitioner to treat OUD patients with buprenorphine. To qualify for this waiver, a practitioner must satisfy particular certification requirements related to training, counseling, and other ancillary services such as psychosocial services. For years, these certification requirements have been deemed a barrier to prescribing buprenorphine in the United States.

On April 28, 2021, HHS Secretary Xavier Becerra issued the Practice Guidelines on the Federal Register.  The Practice Guidelines provide eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives, who are state licensed and registered by the DEA to prescribe controlled substances, an exemption from those statutory certification requirements related to training, counseling and other ancillary services. The Practice Guidelines intend to expand access to buprenorphine for OUD. Under certain conditions, the Practice Guidelines exempt practitioners from those certification requirements. For example, the exemption allows practitioners to treat up to 30 patients with OUD using buprenorphine without having to make certain training-related certifications. In addition, the exemption allows practitioners to treat patients with buprenorphine without certifying their capacity to provide counseling and ancillary services.

To qualify for the exemption, practitioners must submit an NOI. However, if a practitioner selects a patient limit of 30 in the NOI, the practitioner will not need to certify as to the training, counseling, and other ancillary services requirements. Practitioners who do not wish to practice under this exemption or those who treat over 30 patients at a time may seek a waiver under the established protocols and submit an NOI that includes all of the certifications required by law.

“The spike [we have] seen in opioid involved deaths during the COVID-19 pandemic requires us to do all we can to make treatment more accessible,” said Acting Assistant Secretary for Mental Health and Substance Use Tom Coderre, who leads HHS’s SAMHSA. “Americans with this chronic disease need and deserve readily available access to life-saving, evidence-based treatment options. These new guidelines are an important step forward in reducing barriers to treatment and will ultimately help more people find recovery.”

A recent study conducted by clinician-researchers from Beth Israel Deaconess Medical Center (BIDMC) was published in JAMA Health Forum in May 2021. The study analyzed U.S. naloxone-specific prescription trends during the pandemic between May 2019 and December 2020. Using data from a national pharmacy insurance claims database that includes claims from national retail, mail-order, and specialty pharmacies, the results showed that the number of naloxone prescriptions filled dropped by more than 25%. The number of individuals with Medicare and commercial coverage filling naloxone prescriptions dropped by nearly a third. While the focus of the study was on naloxone prescriptions, it can be theorized that similar results would be expected for buprenorphine and other OUD treatments.

“Our study identifies an urgent gap in necessary access to lifesaving medications for individuals covered by Medicare and commercial insurance during the pandemic,” said senior author Jennifer P. Stevens, MD, MS, director for the Center for Healthcare Delivery Science at BIDMC. “Continuing to distribute naloxone in densely populated areas and through community-based organizations could help mitigate some of the reductions in naloxone distribution via pharmacies and could also reduce some of the increases in fatal opioid overdoses during the COVID-19 pandemic.”

This study comes at a time when the Biden Administration has made removing barriers to quality treatment, with an emphasis on addiction treatment efforts, a top policy priority. Although some practitioners have called for a complete elimination of the X-waiver, legislative action is required to do so. Instead, per the Practice Guidelines, HHS, in consultation with DEA, SAMHSA, FDA, and the Director of the National Institute on Drug Abuse, will continue to create exemptions from certain certification requirements by issuing practice guidelines. Therefore, additional exemptions may be issued in the near future. For instance, SAMHSA’s FAQs on the matter seem to indicate that the 30-patient limit may be expanded in the next set of practice guidelines.

Aside from the direct impact on practitioners and patients with OUD, pharmacies and the pharmaceutical industry as a whole should be aware that these Practice Guidelines will create an increased demand for buprenorphine and other Schedule III, IV, and V drugs or combinations of such drugs, such as naloxone, for the treatment of OUD. You can find the Practice Guidelines here.

©1994-2021 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume XI, Number 160
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About this Author

Elizabeth K. Conti Associate Mintz DC FDA Regulatory Health Care Enforcement & Investigations Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Consumer Product Safety
Associate

Elizabeth focuses her practice on regulatory compliance and enforcement defense matters for companies in the pharmaceuticals, medical device, dietary supplement, cosmetics, and food industries as well as pharmacies and distributors.

She advises clients on FDA regulations related to labeling, advertising, importing and exporting, and manufacturing practices. Her practice also encompasses administrative matters and civil litigation related to DEA requirements. On the enforcement defense side of her practice, Elizabeth counsels clients on fraud and abuse compliance and litigation...

202-434-7317
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