March 29, 2016
Fact Sheet: Medication Assisted Treatment for Opioid Use Disorders: Increasing the Buprenorphine Patient Limit
The U.S. Department of Health and Human Services (HHS) published a proposed rule to expand access to buprenorphine, one of three medications currently approved by the Food and Drug Administration (FDA) for treatment of opioid dependence through medication-assisted treatment (MAT). The Notice of Proposed Rulemaking (NPRM), entitled Medication-Assisted Treatment for Opioid Use Disorders: Increasing the Buprenorphine Patient Limit, will be open for comment for 60 days starting Wednesday, March 30, 2016.
In September of 2015, Secretary Burwell announced that the Department would begin the rulemaking process to increase access to MAT by developing a rule related to the prescribing of buprenorphine-containing products approved by the FDA for treatment of opioid dependence. The proposed rule would increase access to MAT by increasing the highest limit on the number of patients waivered practitioners can treat from 100 per practitioner to 200, if waivered practitioners request approval for the higher patient limit and fulfill several additional requirements.
Ending the opioid epidemic is a top priority for the Administration, and of the Department.
In March 2015, the Department announced a targeted initiative aimed at reducing prescription opioid and heroin-related overdose, death, and dependence. This initiative focuses on three priority areas: (1) increasing access to MAT; (2) improving prescribing practices; and (3) expanding the use of naloxone, a life-saving drug that can reverse the effects of overdose. The President’s FY 2017 Budget proposes significant new discretionary and mandatory funding totaling nearly $1.1 billion to expand access to treatment for prescription drug abuse and heroin use, and to execute on the Department’s three-pronged evidence-based approach to combat the opioids crisis. Increasing the patient limit for practitioners who prescribe buprenorphine through this regulation is one aspect of the overall Department effort to increase access to MAT.
HHS welcomes public comment on this proposed rule.
The abuse of and addiction to opioids, such as heroin and prescription pain medication, is a serious and increasing public health problem. Approximately 4.5 million people in the United States were non-medical prescription pain reliever users in 2013, and an estimated 289,000 were current heroin users. HHS also estimates the number of unintentional overdose deaths from prescription pain medications has nearly quadrupled from 1999 to 2013, and deaths related to heroin increased 39 percent between 2012 and 2013.
MAT is the use of medications in combination with counseling and behavioral therapies to provide a whole-patient approach to the treatment of substance use disorders, including opioid use disorders. It is a safe and effective strategy for reducing opioid use and the risk of overdose. Currently, there are three MAT medications approved by the FDA for the treatment of opioid dependence: methadone, buprenorphine and naltrexone.
Buprenorphine-based MAT is governed by the Controlled Substances Act (CSA), as amended by the Drug Addiction Treatment Act of 2000 (DATA 2000). Pursuant to DATA 2000, practitioners may obtain a waiver to prescribe buprenorphine for treatment of opioid use disorder. Initially, they may treat up to 30 patients at a time and, after one year they may file a request to treat up to 100 patients at a time. Only physicians may be authorized to prescribe buprenorphine for the treatment of opioid use disorder.
Existing evidence shows that evidence-based MAT is under-utilized. In the midst of this crisis, many practitioners have been limited in their ability to help patients in need of MAT because of this patient limit. Updating the regulations around the prescribing of buprenorphine-containing products, as proposed today, would help close this treatment gap.
Major proposed changes include:
- The proposed rule would revise the existing patient limit of 100 patients to allow qualified practitioners to treat up to 200 patients. To be eligible, practitioners must have an active waiver to treat up to 100 patients for one year and either: 1) possess subspecialty board certification in addiction medicine or addiction psychiatry or 2) practice in a qualified practice setting, as defined in the NPRM.
- Practitioners seeking the higher patient limit must attest that they will: adhere to evidence-based treatment guidelines, provide patients with or connect patients to necessary behavioral health services, provide appropriate releases of information to permit care coordination, use patient data to inform the improvement of outcomes, adhere to a diversion control plan, consider how to assure continuous access to care in the event of practitioner incapacity or an emergency situation, and notify patients in the event that a request for the higher limit is not renewed. Practitioners must also reaffirm their eligibility every three years.
- Additionally, during emergency situations likely to exacerbate or be exacerbated by untreated substance use disorder, (e.g., natural or human-caused disaster, practitioner incapacity, or a local disease outbreak associated with drug use), practitioners with a 100-patient limit in good standing may be allowed the higher limit for up to six months.
DEADLINE FOR SUBMITTING COMMENTS: HHS welcomes public comment on this proposed rule for 60 days after it publishes in the Federal Register on Wednesday, March 30, 2016.