Learn about SAMHSA’s oversight of opioid treatment programs (OTPs) and the steps OTP sponsors must take to become certified.
Opioids are medications that relieve pain. In the United States, the treatment of opioid dependence with medications is governed by the Certification of Opioid Treatment Programs, 42 Code of Federal Regulations (CFR) 8. This regulation created a system to accredit and certify opioid treatment programs (OTPs). OTPs provide medication-assisted treatment (MAT) for people diagnosed with an opioid-use disorder. MAT patients also must receive counseling, which can include different forms of behavioral therapy. Learn more about medication and counseling treatment for substance use disorders.
SAMHSA’s Division of Pharmacologic Therapies (DPT), part of the SAMHSA Center for Substance Abuse Treatment (CSAT), oversees the certification of OTPs. OTPs must be certified by SAMHSA and accredited by an independent, SAMHSA-approved accrediting body to dispense opioid treatment medications. All OTPs also must be licensed by the state in which they operate and must register with the Drug Enforcement Administration (DEA), through a local DEA office.
The provisions of 42 CFR 8 enable DPT to focus its oversight efforts on improving treatment rather than solely ensuring that OTPs are meeting regulatory criteria. The regulation also preserves 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), and DEA. Learn more about the federal legislation, regulations, and guidelines that apply to OTPs and MAT.
To become certified, an OTP must successfully complete the certification and accreditation process and meet other requirements outlined in 42 CFR 8. A program may apply to SAMHSA for provisional (initial) certification while it is working towards accreditation with a SAMHSA-approved accrediting body. Provisional certification is temporary, lasting for only one year. An OTP must become accredited during this one-year timeframe.
A program may also seek provisional certification while it works to gain state and DEA approvals. However, provisional certification will not be granted until state and DEA approvals have been obtained.
After an OTP receives accreditation, SAMHSA determines if the program can be certified to provide treatment under 42 CFR 8. This work is carried out by SAMHSA's regional OTP Compliance Officers.
Once an OTP is certified, its certification must be renewed annually or every three years depending on the accreditation timeframe awarded.
Accreditation is a peer-review process that evaluates an OTP against SAMHSA’s opioid treatment standards and the accreditation standards of SAMHSA-approved accrediting bodies. The accreditation process includes site visits by specialists with experience in opioid treatment medications and related treatment activities. The purpose of site visits is to ensure that OTPs meet specific, nationally accepted standards for MAT.
- Enhances community confidence
- Improves medical staff recruitment
- Fulfills most state licensure requirements
- Meets certain Medicare certification requirements
- Influences liability insurance premiums
OTP Accreditation Technical Assistance
SAMHSA offers technical assistance to help programs meet accreditation standards. Support services include identifying potential deficiencies and providing the resources to help make the necessary adjustments. If your OTP needs technical assistance, or you would like to learn more about resources available to help you through the accreditation process, contact DPT at 240-276-2700 or email@example.com.
To help OTPs achieve regulatory compliance, SAMHSA also has developed Federal Guidelines for Opioid Treatment Programs – 2015.
OTPs applying for accreditation must comply with any applicable state laws and regulations. Contact your local opioid treatment authority using the State Opioid Treatment Authorities Directory.
Patient Exception Requests
Sometimes patients taking medications for opioid treatment may need exceptions from federal opioid treatment standards. Common reasons include transportation hardships, conflicts with employment or vacation, and medical disabilities. In these instances, the physician must submit an “exception request” to SAMHSA and (where applicable) the state opioid treatment authority for approval to change the patient care regimen from federal opioid standards.
Learn more about submitting patient exception requests.
SAMHSA is also responsible for implementing the Drug Addiction Treatment Act of 2000 (DATA 2000), which expanded the clinical context of medication-assisted opioid addiction treatment. DATA 2000 allows physicians to dispense or prescribe buprenorphine (a medication with a lower risk for abuse than some medications used in MAT) along with other medications approved by the Food and Drug Administration (FDA) to treat opioid use disorders in treatment settings other than OTPs. Buprenorphine also can be dispensed through OTPs. Learn more about buprenorphine.
In addition, DATA 2000 reduces the regulatory burden on physicians who choose to prescribe or dispense buprenorphine. It permits qualified physicians to apply for and receive waivers for the special registration requirements defined in the Controlled Substances Act. OTPs are not required to apply for a waiver, but they must be SAMHSA-certified. They also are not subject to patient limits as physicians. Learn more about SAMHSA’s buprenorphine waiver management program.
To provide approved buprenorphine products, OTPs should modify their registration with DEA to add Schedule III narcotics to their registration certificates. OTPs providing approved buprenorphine products for opioid maintenance or detoxification treatment must conform to the federal opioid treatment standards under the Federal Opioid Treatment Standards, 42 CFR 8.12. These regulations require that OTPs provide medical services, counseling, drug abuse testing, and other services to patients admitted to treatment.