Eliminates certain X exemption requirements for doctors registered with the DEA
Today, the United States Department of Health and Human Services announces that it will publish Practical Guidelines for Buprenorphine Administration for the Treatment of Opioid Disorder*, to expand access to medication-assisted treatment (MAT), exempting doctors from certain certification requirements necessary to prescribe buprenorphine for treatment of opioid use disorder (OUD).
More than 83,000 drug overdose deaths occurred in the United States in the 12 months ending June 2020, the highest number of overdose deaths on record in a 12-month period, and an increase of more than 21% compared to the year previous, according to recent provisional data Centers for Disease Control and Prevention (CDC).
The rise in overdose deaths highlights the need for treatment services to be more accessible to people at greater risk of overdose and today’s action will expand access and availability of treatment for opioid use disorder.
“The medical evidence is clear: access to medication-assisted treatment, including buprenorphine, which can be prescribed in doctor’s offices, is the gold standard for treating individuals suffering from opioid use disorder,” said Admiral Brett P. Giroir, MD, assistant health secretary. “Removing some of the certification requirements for an X exemption for doctors is a step towards providing more people struggling with this chronic disease with access to medication-assisted treatment.”
Without MAT, the chances of relapse for a person suffering from OUD are significant; studies have shown that the results for people with OUD are much better with MAT.
THE Practical Guidelines for Buprenorphine Administration for the Treatment of Opioid Disorder issues an exemption from certain certification requirements under 21 U.S.C. § 823 (g) (2) of the Controlled Substances Act (CSA) for physicians licensed under state law and who have a DEA registration. Accordingly:
- The exemption applies only to doctors who can only treat patients located in the states in which they are authorized to practice medicine.
- Doctors using this exemption will be limited to treating no more than 30 patients with buprenorphine for opioid use disorder at any one time (note: the 30 patient limit does not apply to doctors in hospitals, such as doctors in the Emergency Department) .
- The exemption applies only to the prescription of medications or formulations covered by the CSA exemption X, such as buprenorphine, and does not apply to the prescription, dispensing or use of methadone for the treatment of OUD.
- Physicians using this exemption should place an “X” on the prescription and clearly identify that the prescription is being written for opioid use disorders (along with separate maintenance of medical records 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 deviation.
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