Federal statutes, regulations, and guidelines govern medication-assisted treatment (MAT) for opioid addiction. SAMHSA’s Division of Pharmacologic Therapies (DPT), part of SAMHSA’s Center for Substance Abuse Treatment (CSAT), manages the day-to-day oversight activates required to implement federal regulations surrounding the use medications approved by the Food and Drug Administration (FDA) such as methadone and buprenorphine for the treatment of opioid use disorder (OUD) for practitioners and opioid treatment programs (OTPs).
Medication-Assisted Treatment (MAT) Statutes
Some medications used in medication-assisted treatment (MAT) are controlled substances governed by the Controlled Substances Act. The Act contains federal drug policy for regulating the manufacture, importation, possession, use, and distribution of controlled substances.
The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities or SUPPORT for Patients and Communities Act of 2018 (SUPPORT Act)
The SUPPORT Act affords practitioners greater flexibility in the provision of medication-assisted treatment (MAT) and extends the privilege of prescribing buprenorphine in office-based settings to qualifying other practitioners (Nurse Practitioners (NPs), Physician Assistants (PAs), Clinical Nurse Specialists (CNSs), Certified Registered Nurse Anesthetist (CRNAs), and Certified Nurse-Midwifes (CNMs) until October 1, 2023.
The SUPPORT Act expands the ability to treat up to 100 patients in the first year of waiver receipt if practitioners satisfy one of the following two conditions:
- The physician holds a board certification in addiction medicine or addiction psychiatry by the American Board of Preventive Medicine or the American Board of Psychiatry and Neurology
- The practitioner provides medication-assisted treatment (MAT) in a "qualified practice setting." A qualified practice setting is a practice setting that:
- provides professional coverage for patient medical emergencies during hours when the practitioner's practice is closed;
- provides access to case-management services for patients including referral and follow-up services for programs that provide, or financially support, the provision of services such as medical, behavioral, social, housing, employment, educational, or other related services;
- uses health information technology systems such as electronic health records;
- is registered for their State prescription drug monitoring program (PDMP) where operational and in accordance with Federal and State law; and
- accepts third-party payment for costs in providing health services, including written billing, credit, and collection policies and procedures, or Federal health benefits.
After one year at the 100-patient limit, physicians and qualifying other practitioners who meet the above criteria can apply to increase their patient limit to 275.
To apply for a 30-, 100-, or 275-patient waiver, go to Become a Buprenorphine Waivered Practitioner.
Comprehensive Addiction and Recovery Act of 2016 (CARA)
CARA signed into law in 2016, addresses the opioid epidemic, encompassing all six pillars necessary for such a coordinated response – prevention, treatment, recovery, law enforcement, criminal justice reform, and overdose reversal. The Act endorses the use of medication-assisted treatment for OUD, and amends the Controlled Substances Act to, under certain conditions and restrictions, raise the total number of patients a prescriber can have for the purposes of dispensing buprenorphine from 30 up to 100 per year.
Drug Addiction Treatment Act of 2000 (DATA 2000)
DATA 2000, part of the Children’s Health Act of 2000, permits physicians who meet certain qualifications to treat opioid dependency with narcotic medications approved by the Food and Drug Administration (FDA)—including buprenorphine—in treatment settings other than OTPs.
The Act permits qualified physicians to obtain a waiver from the separate registration requirements of the Narcotic Addict Treatment Act – 1974 to treat opioid dependency with Schedule III, IV, and V medications or combinations of such medications that have been approved by FDA for that indication. Learn more about buprenorphine to treat substance use disorders.
Find information on buprenorphine waiver training or SAMHSA training and resources.
OTP Regulations
Certification of Opioid Treatment Programs, 42 Code of Federal Regulations (CFR) 8 provides for an accreditation and certification-based system for OTPs, overseen by SAMHSA, and includes regulations for using opioid drugs to treat OUD. The regulation shifted administrative responsibility and oversight of these treatments from FDA to SAMHSA.
The regulations acknowledge that OUD is a medical disorder and that different patients, at different times, could need vastly different treatment services. The regulations also preserve states’ authority to regulate OTPs. Oversight of treatment medications used in MAT remains a multilateral system involving states, SAMHSA, the Department of Health and Human Services (HHS), the Department of Justice (DOJ), and Drug Enforcement Administration (DEA).
Certification of Opioid Treatment Programs, 42 Code of Federal Regulations, Part 2 protects patient confidentiality through restrictions concerning the disclosure and use of patient records pertaining to substance use treatment.
Read the final rule by SAMHSA regarding Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction – 2001.
MAT patients receiving care in OTPs are also required to receive counseling, which includes different forms of behavioral therapy. Learn more about medication and counseling treatment.
Guidelines for Opioid Treatment
The Federal Guidelines for Opioid Treatment Programs – 2015 serve as a guide to accrediting organizations for developing accreditation standards. The guidelines also provide OTPs with information on how programs can achieve and maintain compliance with federal regulations. The 2015 guidelines are an update to the 2007 Guidelines for the Accreditation of Opioid Treatment Programs (PDF | 547 KB). The new document reflects the obligation of OTPs to deliver care consistent with the patient-centered, integrated, and recovery-oriented standards of substance use treatment.
DPT oversees the certification of OTPs and provides guidance to nonprofit organizations and state governmental entities that want to become a SAMHSA-approved accrediting body. Learn more about the accreditation and certification of OTPs and SAMHSA’s oversight of OTP accreditation bodies.
Model Guidelines for State Medical Boards
With input from SAMHSA, the Federation of State Medical Boards in 2013 adopted a revised version of the federation’s office-based opioid treatment policies. The Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office – 2013 (PDF | 279 KB) provides model guidelines for use by state medical boards in regulating office-based opioid treatment.
OTP Guidance
Split Dose Guidance (PDF | 224 KB)
Guidance document on split dosing under the current take-home flexibilities.
Holiday Guidance for Opioid Treatment Programs (PDF | 203 KB)
In response to requests for the upcoming federal holidays and ensuing weekends (December 24th, 25th, and 26th and December 31st, Jan 1st, and Jan 2nd), this letter is to provide guidance regarding requests for unsupervised doses of medication for patients for these dates. View a sample SMA-168 (PDF | 194 KB).
Methadone Take-Home Flexibilities Extension Guidance (November 18, 2021)
Letter to OTP Directors, SOTAs and State Directors on Mobile Component (PDF | 216 KB)
Information regarding the authorization for Opioid Treatment Programs (OTPs) to add a “mobile component” to their existing registration. This is an opportunity to expand access to medications for treatment of Opioid Use Disorders (OUD), especially in remote or underserved areas.
Letter to State Substance Abuse Directors (PDF | 238 KB)
Letter from Miriam E. Delphin-Rittmon, Ph.D, Assistant Secretary for Mental Health and Substance Use, regarding funding for mobile medical units of Opioid Treatment Programs (OTPs).
Special Circumstances for Providing Buprenorphine
Several federal laws and regulations permit physicians and other medical personal to administer buprenorphine to OUD patients without a buprenorphine waiver under special circumstances.
Moreover, recent Practice Guidelines have created two distinct Notification of Intent (NOI) to prescribe Buprenorphine. To receive a practitioner waiver to administer, dispense, and prescribe buprenorphine, practitioners must notify SAMHSA’s Center for Substance Abuse Treatment (CSAT), Division of Pharmacologic Therapies (DPT) of their intent to practice this form of medication-assisted treatment (MAT). The NOI must be submitted to SAMHSA before the initial dispensing or prescribing of OUD treatment medication.
In order to apply for subsequent increases in the number of clients eligible for treatment with Buprenorphine, providers are obliged to undertake required training activities. Completion of required training accompanies the NOI.
To expand access to Buprenorphine, the Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder, exempts eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives from the certification requirements related to training, counseling and other ancillary services (i.e., psychosocial services) under 21 U.S.C. § 823(g)(2)(B)(i)-(ii) of the Controlled Substances Act (CSA).
Practitioners utilizing this exemption are limited to treating no more than 30 patients at any one time (time spent practicing under this exemption will not qualify the practitioner for a higher patient limit). This exemption applies only to the prescription of Schedule III, IV, and V drugs or combinations of such drugs, covered under the CSA, such as buprenorphine.
An eligible provider may choose to undertake training, or forego it prior to prescribing Buprenorphine. As noted above, those who forego training are limited to treating no more than 30 patients at any one time.