In conjunction with the Presidentâ€™s visit to the National Rx Drug Abuse and Heroin Summit, U.S. Department of Health and Human Services (HHS) today announced a proposal to allow qualified physicians to prescribe the opioid use disorder treatment medication buprenorphine to an increased number of patients.Â The proposed change is designed to strike an appropriate balance between expanding access to this important treatment, encouraging use of evidence-based medication-assisted treatment (MAT), and minimizing the risk of drug diversion.
â€œThis proposal is an important step to increasing access to evidence-based treatment to help more people get the treatment necessary for their recovery and is critical in our comprehensive approach to addressing the serious opioid epidemic facing our nation,â€ said HHS Secretary Sylvia M. Burwell.
Buprenorphine is an FDA-approved drug used as part of MAT, a comprehensive way to address the recovery needs of individuals that combines the use of medication with counseling and behavioral therapies to treat substance use disorders. Buprenorphine — because of its lower potential for abuse — is permitted to be prescribed or dispensed in physician offices, significantly increasing its availability to many patients.Â When taken as prescribed, buprenorphine is safe and effective.
Existing evidence shows that this lifesaving, evidence-based treatment is under-utilized. Updating the regulations around the prescribing of buprenorphine-containing products, as proposed today, would help close this treatment gap.
Under current regulations, physicians that are certified to prescribe buprenorphine for MAT are allowed to prescribe up to 30 patients initially and then after one year can request authorization to prescribe up to a maximum of 100 patients. This cap on prescribing limits the ability of some physicians to prescribe to patients with opioid use disorder.Â If adopted, todayâ€™s proposal would allow for a qualified and currently waivered physician to prescribe buprenorphine for up to 200 patients.
â€œThis proposed expansion is especially important to people who are seeking help for an untreated opioid use disorder,â€ said SAMHSA Principal Deputy Administrator Kana Enomoto.Â â€œIn many cases there are long patient waiting lists for prescribers who have reached the 100 patient limit.Â Easing barriers to treatment is a major step to reducing prescription opioid and heroin related overdose, death, and dependence.â€
HHS welcomes public comment on this proposed rule, which will be open for comment for 60 days starting Wednesday, March 30, 2016.
HHS Secretary Sylvia Burwell has made addressing opioid misuse, dependence, and overdose a priority. Other work on this important issue is underway within HHS. The evidence-based HHS-wide opioid initiative focuses on three priority areas: informing opioid prescribing practices, increasing the use of naloxone (a rescue medication that can prevent death from overdose), and expanding access to and the use of Medication-Assisted Treatment to treat opioid use disorder.
These efforts build on work that began in 2010, when the President released his first National Drug Control Strategy, which emphasized the need for action to address opioid misuse and overdose, while ensuring that individuals with pain receive safe, effective treatment. Also in 2010, the Affordable Care Act improved access to substance use disorder treatment options by requiring coverage of substance use disorder services in the Health Insurance Marketplace and establishing important parity protections to ensure that substance use disorderÂ coverage is comparable to medical and surgical care coverage. The Presidentâ€™s FY 2017 Budget includes $1 billion in new mandatory funding over two years to expand access to treatment for prescription drug abuse and heroin use, helping to ensure that every American who wants to get treatment for opioid use disorder will have access. It also includes approximately $500 million — an increase of more than $90 million — to continue and build on current efforts across the Departments of Justice and HHS to expand state-level prescription drug overdose prevention strategies, increase the availability of MAT programs, improve access to the overdose-reversal drug naloxone, and support targeted enforcement activities.