HHS is waiving certification requirements for physicians to prescribe the drug buprenorphine in an effort to expand access to medical-assisted treatment to stem a stark rise in opioid overdose deaths over the past year.
New practice guidelines released by HHS on Thursday will allow any physician licensed by the Drug Enforcement Agency can prescribe buprenorphine to up to 30 patients without having to go through the standard process to become authorized, which requires clinicians to undergo eight hours of training.
Only physicians can qualify for the exemption, and the 30 patient cap will not apply to hospital-based physicians, such as those who work in emergency departments. Physicians will be limited to treating patients located in states in which they are authorized to practice medicine, and it will not include the prescribing of methadone.
HHS said the certifications "represent a significant perceived barrier to prescribing buprenorphine."
The guideline change leaves out a whole array of other clinicians that can certify to prescribe buprenorphine under the standard rules, including nurse practitioners, physician assistants, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse-midwifes.
Adm. Dr. Brett Giroir, HHS assistant secretary of health, acknowledged implementation of the rule change is starting on a smaller scale than some would have hoped, but said it was to give regulators the opportunity to monitor its results.
HHS will establish a working group to monitor the implementation and impact of the exemption. The group will include representatives from several agencies including the Centers for Disease Control and Prevention and the Food and Drug Administration.
"Many people will say this has gone too far, but I believe more people will say this has not gone far enough," Giroir said. "We think this is a measured, logical, appropriate, evidence-based and patient-centered interaction that may save tens of thousands of lives over the next coming months and years."
Giroir said the decision to change the practice guidelines was in response to an increasing number of opioid-related deaths that have occurred since the beginning of the pandemic. The U.S. saw a 21% increase in opioid-related deaths in 2020 compared to 2019. The country recorded its highest ever number of drug overdose deaths within a 12-month span last June, totaling more than 83,000 deaths over that period.
Many addiction medicine advocates for years have supported an elimination of the federal requirements around clinicians prescribing buprenorphine, contending that the rules make it harder to prescribe the treatment for opioid use disorder than to prescribe opioids.
Of the more than 1 million physicians currently practicing medicine in the U.S., only around 66,000 are certified to prescribe buprenorphine, which coupled with behavioral health counseling is considered by many experts to be the gold standard therapy for substance use disorder.