Buprenorphine Prescribing to Increase with HHS Removal of X-Waiver

In a stunning move, the U.S. Department of Health and Human Services (HHS) just announced that it is eliminating the need for providers to have a special waiver from the Drug Enforcement Administration (DEA) to prescribe medication-assisted treatment (MAT) for opioid use disorder.

Approved by the Food and Drug Administration (FDA) in 2002, buprenorphine, either with or without naloxone (and marketed as Subuxone and Subutex), is an effective treatment for opioid use disorder when combined with counseling. Prior to this notice, if a provider wanted to prescribe buprenorphine, they had to complete an eight-hour training program and then apply to the DEA for a special addition to their controlled substance prescribing license. Providers were initially limited to 30 patients. These requirements and restrictions for a very effective medication limited its use in primary care, and resulted in a demand that far exceeded the supply.

Buprenorphine is highly effective in treatment, with the medication occupying the Mu-opioid receptors that create the craving for opioids, but without producing the euphoria of opioids. If a patient taking buprenorphine does take an opioid by any mode, they do not get the usual effect, again leading to a reduction in desire. In one controlled trial over one year, buprenorphine was 75 percent effective in preventing relapse, while placebo was 0 percent effective, with 20 percent of the placebo group dying in that year.  

The use of medication-assisted treatment is occasionally viewed as “substituting one opioid for another,” and use of MAT often carries a stigma, with some suggesting that patients simply need to stop using opioids completely. While this is technically correct, it is no different than saying that a type I diabetic should not be given insulin, since it is simply replacing their body’s insulin, and they just need to work harder at making their own instead of relying on an exogenous source. MAT should be combined with counseling and support services, just as diabetics should also receive education about diet and exercise, and be monitored closely. 

This change will be especially welcome by emergency medicine physicians, who often treat patients with opioid overdose or withdrawal, but were previously limited to prescribing only 72 hours’ worth of medication that had to be administered in the emergency department (and then often had difficulty finding providers in the community that had the X-waiver and could continue to provide prescriptions to the patient). These ED physicians can now start buprenorphine treatment, provide a prescription for the medication, and refer the patient to an outpatient provider to continue treatment. This will take close coordination between hospital- and community-based providers – a team effort with involvement of the ED physician, the social worker, the pharmacist, and all the community-based providers – but the efforts should result in a reduction in the morbidity and mortality associated with opioid use disorder.

The HHS notice can be read here: https://www.hhs.gov/about/news/2021/01/14/hhs-expands-access-to-treatment-for-opioid-use-disorder.html

The American College of Emergency Physicians page on buprenorphine in the ED can be found here: https://www.acep.org/patient-care/bupe/

Programming Note: Listen to Dr. Ronald Hirsch every Monday on Monitor Mondays, 10 a.m. Eastern, sponsored by R1-RCM.


Ronald Hirsch, MD, FACP, CHCQM, CHRI

Ronald Hirsch, MD, is vice president of the Regulations and Education Group at R1 Physician Advisory Services. Dr. Hirsch’s career in medicine includes many clinical leadership roles at healthcare organizations ranging from acute-care hospitals and home health agencies to long-term care facilities and group medical practices. In addition to serving as a medical director of case management and medical necessity reviewer throughout his career, Dr. Hirsch has delivered numerous peer lectures on case management best practices and is a published author on the topic. He is a member of the Advisory Board of the American College of Physician Advisors, a member of the American Case Management Association, and a Fellow of the American College of Physicians. Dr. Hirsch is a member of the RACmonitor editorial board and is regular panelist on Monitor Mondays. The opinions expressed are those of the author and do not necessarily reflect the views, policies, or opinions of R1 RCM, Inc. or R1 Physician Advisory Services (R1 PAS).

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