Access to buprenorphine, an opioid dependence treatment, could increase under an HHS proposal to allow qualifying practitioners to expand their buprenorphine patient limit from 100 to 200. HHS is hoping to increase patient access to opioid dependence treatments, while, at the same time, reducing opportunities for the medication to be diverted for unlawful uses. The proposal also includes changes that would place increased emphasis on medication-assisted treatment (MAT)—the use of medications alongside counseling to provide a whole-patient approach to substance abuse treatment. The agency announced its plan to increase the patient limit in an advance release of a Proposed rule, which is set to publish in the Federal Register on March 30, 2016.
Current law. Buprenorphine is a schedule III controlled substance under the Controlled Substances Act (CSA). Under Section 303(g)(2) of the CSA, practitioners are permitted to dispense or prescribe buprenorphine for use in maintenance and detoxification treatment without registering as an opioid treatment program (OTP). However, the CSA imposes a patient limit. Under the law, qualified practitioners who file an initial notification of intent (NOI) may treat a maximum of 30 patients at a time. After one year, practitioners can file a new NOI and increase that number to 100. Eligible practitioners must:
- be a physician;
- possess a valid medical license;
- be registered with the Drug Enforcement Administration (DEA);
- be able to refer patients for appropriate counseling and other necessary ancillary services; and
- have completed required training.
Despite patient access measures like the increase in patient limit for prescribers with one year of experience, HSS believes treatment capacity is still too low.
Proposed rule. If finalized, the proposal would allow eligible physicians—those eligible under current rules to treat 100 patients—to request approval to treat up to 200 patients with buprenorphine, if they also (1) possess a subspecialty board certification in addiction medicine or addiction psychiatry; or (2) practice in a qualified practice setting. To obtain the higher limit, physicians would be required to file a Request for Patient Limit Increase, a draft of which is appended to the rule. The rule would also include MAT requirements to ensure that opioid-dependent patients receive a comprehensive array of treatments designed to prevent misuse or diversion of substances. Specifically, qualifying physicians would be required to attest, in the Request for Patient Limit Increase, that they would adhere to evidence-based MAT treatment guidelines and provide patients with or connect patients to necessary behavioral health services. Additionally, the Proposed rule would allow practitioners in good standing with a 100-patient limit, who are not otherwise approved for the 200 patient increase, to treat 200 patients for up to six months, in the case of emergency situations that are likely to worsen due to an untreated substance abuse disorder.
Drug abuse. The announcement comes alongside several other efforts by the Obama Administration to address the prescription opioid abuse and heroin epidemic. In addition to enhancing the buprenorphine patient limit, the White House has also taken steps to improve mental health and substance abuse parity, prevent overdose deaths, enhance policing efforts to combat heroin addiction, develop syringe services programs, and obtain private sector commitments to assist the government efforts. The President spoke in Atlanta on March 29, 2016 to discuss the new actions.
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