New Practice Guidelines Expand Buprenorphine Prescribing

The Department of Health and Human Services (“HHS”) recently released Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder to address the increase in overdose deaths and to expand access to evidence-based treatments in ambulatory settings by removing potential opioid use disorder treatment barriers. The Guidelines are a step towards increasing the number of buprenorphine prescribers in rural and underserved areas.

Prior to 2000, medication-assisted treatment (“MAT”) was available only through federally approved opioid treatment programs, and buprenorphine was not yet approved by the FDA for opioid use disorder treatment. Since enactment of the Drug Addiction and Treatment Act of 2000, physicians outside an opioid treatment program have been able to apply for a Drug Enforcement Administration (“DEA”) X-waiver to prescribe and/or dispense Schedule III, IV, or V medications approved by the FDA for treatment of opioid dependency. Application for the X-waiver has historically required that physicians complete an 8-hour training course and certify their capacity to make counseling and ancillary services available to patients. Over the past 20 years, demand for MAT has outpaced the number of waivered prescribers.  

Research indicates that treatment with either buprenorphine or methadone reduces over-dose related and all-cause mortality risk in opioid use disorder patients by approximately 50%. Yet, according to the National Academy of Medicine, as of 2019 only 35% of these patients receive such treatment, leaving an estimated 2.2 million untreated. Roughly half of all rural counties lack a single waivered prescriber, even though statistics indicate that the 2018 per capita overdose rate was nearly 45% higher in rural areas. As the demand for MAT has increased, a growing number of physicians have criticized the training requirement as an outdated barrier to treatment.

The new HHS Guidelines address the training and certification hurdles. Eligible physicians may now apply for an X-waiver and exemption from the 8-hour training course and certification of the capacity to provide patients with counseling and ancillary services. Practitioners utilizing the new exemptions are limited to prescribing buprenorphine to 30 patients at a time. To obtain a waiver, physicians must have an active state medical license, be registered with the DEA to prescribe controlled substances, and submit a Notice of Intent through the Substance Abuse and Mental Health Services Administration (“SAMHSA”).

If buprenorphine MAT under the Guidelines for an X-waiver is right for you and your patients, you should prepare to apply for the X-waiver and exemption and make the necessary changes to your practice:

·         Earn continuing medical education credit on related topics, such as comprehensive care for patients diagnosed with opioid use disorder.

·         Consult evidence-based guidelines from your specialty organization, SAMHSA, or ASAM.

·         Develop protocols, clinical workflows, diversion policies, consent forms, and treatment agreements with your clinical team.

·         Assess staff training needs and coordinate staff education.

·         Read the Preparations for Treating Opioid Use Disorder in the Office, HHS’s Buprenorphine Quick Start Guide, and ASAM’s and SAMHSA’s templates and resources.

·         Notify your medical professional liability carrier when adding MAT to your practice.

Physicians and practice administration professionals should read the Guidelines and consult an attorney, if necessary, before implementing new buprenorphine MAT processes. Legislative and regulatory summaries and news articles may not contain details needed for compliance.

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*The content of this publication or presentation is intended for educational purposes only; is not an official position statement of Mutual Insurance Company of Arizona (MICA); and should not be considered or relied upon as professional, medical, or legal advice or as a substitute for your professional judgment. Consult your attorney about your individual situation and the applicable laws. The authors, presenters, and editors made a reasonable effort to ensure the accuracy of the information at the time of publication or presentation but do not warrant or guarantee accuracy, completeness, or currency of such information. As medical and legal information is constantly changing and evolving, check for updated information and consult your attorney before making decisions.