Opioid Treatment Programs and Related Federal Regulations

May 4, 2015 Opioid Treatment Programs and Related Federal Regulations Federally certified opioid treatment programs (OTPs)—also called narcotic treatment programs or, often, methadone clinics—may offer opioid medications, counseling, and other services for individuals addicted to heroin or other opioids. The use of opioid medications to treat opioid addiction is subject to federal regulations beyond those that apply to the same medications used for other purposes (e.g., treating pain). With few exceptions, the use of the opioid medication methadone to treat opioid addiction is limited to OTPs; however, physicians who wish to treat opioid addiction using the opioid medication buprenorphine may obtain a waiver to do so outside an OTP. A non-opioid medication used in the treatment of opioid addiction, naltrexone, may be used by OTPs, physicians with waivers, or anyone with the authority to write prescriptions. To understand how OTPs are regulated, it is helpful to have some background information about the medications used to treat opioid addiction and how each is regulated. Medication-Assisted Treatment (MAT) Medication-assisted treatment (MAT) is the combined use of medication and other services to treat addiction. Three medications are currently used in MAT for opioid addiction: methadone, buprenorphine, and naltrexone. Methadone Methadone is a full opioid agonist, meaning it binds to and activates opioid receptors in the brain. Methadone carries risk of abuse but is less addictive than some other full opioid agonists (e.g., heroin). Methadone suppresses withdrawal symptoms in detoxification therapy and controls the craving for opioids in maintenance therapy. Buprenorphine Buprenorphine is a partial opioid agonist, meaning it binds to opioid receptors in the brain and activates them, but not as much as full opioid agonists. Buprenorphine carries risk of abuse but is less addictive than methadone. Like methadone, buprenorphine is used for detoxification and maintenance therapy. Regulatory Framework Two overlapping systems of federal law apply to MAT for opioid addiction: one regulating pharmaceuticals and the other regulating controlled substances. Federal Food, Drug, and Cosmetic Act (FFDCA) Under the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.), the Food and Drug Administration (FDA) in the Department of Health and Human Services (HHS) has primary responsibility for ensuring the safety and effectiveness of pharmaceuticals, regardless of whether they are controlled substances. See CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness. Methadone, buprenorphine, and naltrexone are subject to the FFDCA. Controlled Substances Act (CSA) Under the Controlled Substances Act (CSA, 21 U.S.C. §§801 et seq.), the Drug Enforcement Administration (DEA) in the Department of Justice (DOJ) has primary responsibility for regulating the use of controlled substances for legitimate medical, scientific, research, and industrial purposes, and for preventing these substances from being diverted for illegal purposes. See CRS Report RL34635, The Controlled Substances Act: Regulatory Requirements. Methadone and buprenorphine are subject to the CSA. Naltrexone, which carries no known risk of abuse, is not. As shown in Table 1, methadone, buprenorphine, and naltrexone are classified differently under the CSA, which assigns various plants, drugs, and chemicals to one of five schedules based on accepted medical use, potential for abuse, and severity of potential psychological or physical dependence. Schedule I contains substances that have no currently accepted medical use and are not available by prescription (such as heroin). Schedules II, III, IV, and V include substances that have recognized medical uses and are progressively less dangerous and addictive. Table 1. FDA-Approved Medications for Opioid MAT Medication Naltrexone Naltrexone is an opioid antagonist, meaning it binds to opioid receptors but does not activate them; it prevents opioid agonists from binding to and activating opioid receptors. Naltrexone carries no known risk of abuse. Naltrexone is used for relapse prevention because an individual on naltrexone who uses opioids will not experience their effects. Class CSA Schedule Methadone Full Opioid Agonist II Buprenorphine Partial Opioid Agonist III Naltrexone Opioid Antagonist none Source: Prepared by the Congressional Research Service based on information publicly available from FDA and DEA. www.crs.gov | 7-5700 Opioid Treatment Programs and Related Federal Regulations Opioid Treatment Programs (OTPs) DATA-Waived Physicians (DWPs) Under the Controlled Substances Act, responsibility for regulating OTPs falls to both DEA in DOJ and the Substance Abuse and Mental Health Services Administration (SAMHSA) in HHS. Opioid treatment programs must obtain Physicians who wish to treat opioid addiction using the opioid medication buprenorphine may obtain a waiver to do so outside an OTP under the Drug Addiction Treatment Act of 2000 (DATA 2000, P.L. 106-310). DATA 2000 waives the statutory requirement for separate DEA registration as an OTP—and the corresponding regulatory requirements for accreditation and certification—if both the practitioner and the medication meet specified conditions. • accreditation from a SAMHSA-approved accreditor, • certification from SAMHSA, and • registration from DEA. Programs meeting all requirements may “administer or dispense directly (but not prescribe)” methadone, buprenorphine, and any other drug approved by FDA for such use. They may also administer a drug being studied for treatment of opioid addiction in compliance with an FDAapproved investigational new drug application. With few exceptions, the use of methadone to treat opioid addiction is limited to OTPs, which may also offer other MAT, including buprenorphine for detoxification or maintenance and naltrexone for relapse prevention. OTP Accreditation Accreditation is based on a peer review process in which SAMHSA-approved accrediting organizations evaluate OTPs by making site visits and reviewing policies, procedures, and practices. Examples of accrediting organizations include the Joint Commission and the Commission on Accreditation of Rehabilitation Facilities. OTP Certification Certification is based on SAMHSA’s determination that an accredited program is qualified to carry out treatment conforming to standards in federal regulation. SAMHSA uses the results of the accreditation process as well as other information to determine whether a program is qualified. SAMHSA promulgates guidelines to help accrediting organizations and OTPs conform to treatment standards. OTP Registration Registration with DEA as an OTP is separate from—and in addition to—the DEA registration required of any “person” (including a hospital, pharmacy, or doctor, among others) who handles controlled substances. Opioid treatment programs must also comply with relevant DEA regulations addressing records maintenance, security controls, and other matters. Most U.S. substance abuse treatment facilities (91%) do not have OTPs. As of March 29, 2013, the 1,282 facilities with OTPs had 330,308 clients in treatment with methadone. Opioid treatment programs generally administer methadone on a daily basis with staff observing as a patient takes an oral dose of liquid methadone; however, a stable patient may receive a few take-home doses (e.g., for a weekend). Practitioner Requirements To qualify for a waiver, a practitioner must notify the HHS Secretary of the intent to use opioid replacement and must certify that he or she is a qualifying physician, has the capacity to refer patients for appropriate counseling and other services, and will comply with a limit on the number of patients. A qualifying physician must be licensed under state law and have expertise as evidenced by certification, training, or experience. The limit is 30 patients during the first year and may increase to 100 after one year, upon submission of a second notice to the Secretary (per the Office of National Drug Control Policy Reauthorization Act of 2006, P.L. 109-469). Nearly 30,000 physicians have DATA waivers. Medication Requirements DATA-waived physicians (DWPs) may administer, dispense, or prescribe opioid replacement therapy using a medication that is a narcotic drug in schedule III–V, that is FDA-approved for use in detoxification or maintenance treatment, and that has not been the subject of an adverse determination (as defined in statute). Buprenorphine is the only medication to meet the conditions for a DATA waiver. DEA assigns each DATA-waived physician a special identification number, which must be included (along with the physician’s regular DEA registration number) on all buprenorphine prescriptions for opioid addiction therapy. Table 2 summarizes who can administer, dispense, or (in some cases) prescribe different types of MAT. Table 2. MAT Used by OTPs, DWPs, and Others Used to Treat Opioid Addiction by OTPs DWPs Other Prescribers Methadone Yes No No Buprenorphine Yes Yes No Naltrexone Yes Yes Yes Medication Source: Prepared by the Congressional Research Service based on 21 U.S.C. §§801 et seq. and information publicly available from FDA. Erin Bagalman, ebagalman@crs.loc.gov, 7-5345 IF10219 www.crs.gov | 7-5700