Practical Pain Management Jan 2023
DEA Update on Buprenorphine Prescribing Waivers
Clinicians now face one less hurdle in treating patients with opioid use disorder (OUD). As a part of the Consolidation Appropriations Act of 2023, the federal DATA-waiver, or X-waiver, has been removed, making it easier for clinicians to use buprenorphine (marketed under a variety of trade names) to treat individuals with OUD.
In a January 12, 2023 letter to registrants announcing and detailing the changes, the Department of Justice’s DEA stated, “our goal is simple: we want medication for opioid use disorder to be readily and safely available to anyone in the country who needs it. The elimination of the X-Waiver will increase access to buprenorphine for those in need.”
The move is welcomed by pain management and addiction medicine specialists, among including advanced practice providers. “The removal of the DATA-waiver requirement for prescribing buprenorphine for OUD is an essential step forward in fighting the current overdose crisis that is encompassing the United States,” said Jeffrey J. Bettinger, PharmD, clinical pharmacist specialist, pain management, at the Saratoga Medical Group in New York. “By removing the DATA-waiver requirement, clinicians will have more flexibility to prescribe buprenorphine to a greater number of patients with OUD, enhancing availability of it and potentially allowing someone to attain a life-saving medication who otherwise may not have been able to when the DATA-waiver was still standing.”
The X-waiver was established as part of the 2000 Drug Addiction Treatment Act (DATA 2000) so clinicians could use buprenorphine to treat patients in a clinic rather than only in an opioid treatment center. To have the X-waiver appended to their DEA licenses, practitioners were required to complete specialized training and submit a letter of intent to the DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA). Once approved, clinicians were limited in how many patients they could treat with this therapy, although the specific limit varied depending on circumstances. X-waiver restrictions were eased in 2021 including changes to the number of individuals who could be treated but these changes were not enough.
The new rules specify that prescribing buprenorphine will no longer require special certification beyond obtaining a standard DEA registration number for prescribing Schedule III drugs. In addition, there are no longer any caps on the number of individuals a prescriber can treat for OUD using buprenorphine. However, the DOJ does point out that the legislation does not affect existing state laws or regulations.
8-Hour Training Required for Clinicians
The omnibus bill included another provision, which will require all prescribers of controlled substances, not just those treating OUD or using buprenorphine, to take part in a one-time 8-hour training program before they can obtain or renew their DEA registrations. This training is designed to help clinicians learn to recognize and treat OUD. According to the DOJ this provision takes effect June 21, 2023.
Buprenorphine is the first medication approved for medication-assisted treatment for OUD not administered at a methadone clinic, and has been shown to be effective in helping people with the disorder, particularly those who do not have access to or for other reasons cannot get treatment at a methadone clinic. The reduced red-tape resulting from the removal of the X-waiver will allow clinicians to help more people suffering from OUD.
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