'X-waiver' Obstacle Removed to Prescribing Buprenorphine for OUD Patients
UPDATE (JANUARY 30, 2021): ACEP is one of 16 organizations that signed on to a letter to HHS strongly requesting to finalize the Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorders initially issued Jan. 14. Unfortunately, the letter does not seem to have worked (at least for now). In late breaking news, HHS and the Office of National Drug Control Policy (ONDCP) announced this week that the guidelines were released prematurely and "cannot be issued at this time." Read more in ACEP’S Regs & Eggs post: Xing the X-Waiver: The Fight Continues!
ORIGINAL POST (JANUARY 16, 2021): This week, the “X-waiver” requirement for physicians was effectively removed by the U.S. Department of Health and Human Services (HHS). The decision expands physicians' ability to use medication-assisted treatment (MAT) for patients struggling with opioid use disorder (OUD).
The exemption to the X-waiver requirement was given on January 14 to physicians registered with the Drug Enforcement Administration (DEA) who wish to prescribe buprenorphine and other MAT. Of note:
The exemption only applies to physicians treating patients located in states in which the physician is authorized to practice medicine.
Physicians using the exemption are limited to treating no more than 30 patients with buprenorphine at any one time (the 30-patient cap does not apply to hospital-based physicians, such as Emergency Physicians, so long as they are not engaged in a long-term treatment relationship with the patient).
The exemption applies only to the prescription of drugs or formulations covered under the X-waiver of the DEA's Controlled Substances Act, such as buprenorphine; it does not apply to the prescription, dispensation, or use of methadone.
Physicians using the exemption must place an "X" on the prescription and clearly identify that the prescription is being written for OUDs (along with the separate maintaining of charts for patients being treated for OUD).
An interagency working group will be established to monitor the implementation and results of these practice guidelines, as well as the impact on diversion.
The exception does not apply to non-physicians; they will still need to get an X-waiver as before.
Before today’s announcement, physicians wishing to prescribe buprenorphine outside of opioid treatment programs had to take an eight-hour course and often waited 60 to 90 days to receive the waiver once the course was completed and license application was submitted. The presence of this X-waiver requirement has also led to misperception about MAT and has increased negative pre-conceived notions about OUD and the treatment of this disease. As a result, some clinicians are hesitant to pursue this DEA license or even engage in treatment of patients with OUD.
ACEP, and by extension VACEP, applaud the decision. More details at the buttons below.