How to become an Accredited and Certified Opioid Treatment Program (OTP)
In the United States, the use medication for opioid use disorder (MOUD) in opioid treatment programs (OTPs) is governed by the Certification of Opioid Treatment Programs, 42 Code of Federal Regulations (CFR) 8. The regulation created a system to certify and accredit OTPs, allowing them to administer and dispense FDA-approved medications. In addition, opioid use disorder (OUD) patients receiving these medications also receive counseling and other behavioral therapies to provide patients with a whole-person approach.
OTPs provide counseling on the prevention of human autoimmune virus (HIV). SAMHSA recommends OTPS also screen and educate high-risk patients on other infectious diseases.
To provide services for OUD patients, OTPs must successfully complete the certification and accreditation process and meet other requirements outlined in 42 CFR 8. Requirements include:
- OTPs must be both certified and accredited;
- Licensed by the state in which they operate; and
- Registered with the Drug Enforcement Administration (DEA), through their local DEA office.
Programs applying for accreditation or certification must also comply with the applicable laws and regulations in their states. Find more information about individual state regulations by contacting your State Opioid Treatment Authority.
To help OTPs achieve regulatory compliance for both certification and accreditation, SAMHSA developed Federal Guidelines for Opioid Treatment Programs – 2015.
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 onsite 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 OTPs. OTP accreditation:
- Enhances community confidence
- Improves medical staff recruitment
- Fulfills most state licensure requirements
- Meets certain Medicare certification requirements
- Influences liability insurance premiums
Learn more about the statutes, regulations, and guidelines that apply to OTPs and MOUD.
Before obtaining SAMHSA certification, OTPs must complete the accreditation process and meet other requirements outlined in the Certification of Opioid Treatment Programs, 42 Code of Federal Regulations (CFR) 8. Learn about the statutes, regulations, and guidelines that apply to OTPs and MOUD.
SAMHSA’s Division of Pharmacologic Therapies (DPT), part of the SAMHSA Center for Substance Abuse Treatment (CSAT), is responsible for certifying that an Opioid Treatment Program (OTP) conforms with federal regulations governing treatment for substance use disorders.
The provisions of 42 CFR 8 enable SAMHSA’s 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 OTPs remains a multilateral system involving states, SAMHSA, the Department of Health and Human Services (HHS), and the DEA.
A program may apply for a provisional (initial) certification as it is working towards becoming accredited by a SAMHSA-approved OTP accrediting body. The provisional certification is a temporary certification granted to a new OTP for up to one year, during which time it must become accredited.
After a provisionally certified program becomes accredited, it must apply to SAMHSA for full certification via the renewal application. Once certified, OTPs must renew certification annually or every three years depending on the accreditation timeframe awarded.
- OTPs may apply to SAMHSA for provisional (initial) certification and are required to apply to a SAMHSA-approved accrediting body for accreditation.
- Provisional certification is temporary, lasting for only one year.
- OTPs may also seek provisional certification while it works to gain state and DEA approvals.
- However, SAMHSA will not grant provisional certification without state and DEA approvals.
- During the one-year provisional certification, an OTP must receive their accreditation.
- After an OTP receives accreditation, they must apply for renewal/recertification of their SAMHSA certification. SAMHSA's OTP Compliance Officers will review all documentation to confirm the OTP is eligible for certification to provide treatment under 42 CFR 8.
Programs seeking provisional certification as an OTP must use the online Form SMA-162: Application for Certification to Use Opioid Drugs in a Treatment Program.
Each application requires different supporting documentation. This documentation can be uploaded along with Form SMA-162. The acceptable file(s) for uploading may be in any of the following formats:
- Text files
- TIFF image files
- PDF files
- Word documents (.doc or .docx)
New applicants should prepare the following supporting documents:
- Copy of the certification application including the date applied for accreditation, dates of any previous held or scheduled accreditation surveys, and the expected schedule for completing the accreditation process.
- Program organizational structure description and chart indicating key OTP personnel including their position and title, and the name and complete address of any central administration or larger organization structure to which the program is responsible.
- Facilities description and diagram and description demonstrating the adequacy of the facilities for drug dispensing and individual and group counseling. The description shall specify how the OTP will provide adequate medical, counseling, vocational, educational, and assessment services at the primary facility, unless the program sponsor has entered into a formal documented agreement with another entity.
- The name, address, and description of each hospital, institution, clinical laboratory, or other facility used by the OTP to provide the necessary medical and rehabilitative services.
- The name and address of any facility other than the primary dispensing site where methadone will be dispensed either on a regular basis or on weekends, and as a service to the treatment program.
- A copy of the medical director’s Drug Enforcement Administration (DEA) registration, state license, and curriculum vitae. If the medical director is also the medical director for another treatment program, enclose a written justification for the feasibility of such an arrangement. This feasibility shall address the portion of the medical director’s time spent in the treatment of unrelated medical patients and memberships on boards and committees that compete for time allocated to the treatment programs.
- The name and state license number of all OTP personnel (other than program physicians) licensed by law to dispense narcotic drugs even if they are not, at present, responsible for administering or dispensing methadone at the program. These would include pharmacists, registered nurses, and licensed practical nurses.
- A tentative schedule showing dispensing hours, counseling hours, and hours to be worked by physicians, nurses, and counselors. Any work to be performed away from the primary dispensing site should also be stated. The program must be open for dispensing at least six days per week. Also, describe how the dispensing hours are adequate and will ensure quality of patient care per 42 CFR 8.12 (b).
- A list of the program’s funding sources, including the name and address of each governmental agency providing funds.
- A description of the number of patients to be treated at operating capacity.
- An affirmative statement that the treatment program will use containers for all take-home medication dispensed to outpatients with safety closures.
- Acknowledgement that the medical director and/or program physician must register for an account on the SAMHSA OTP Extranet website to submit federal patient exception requests (Form SMA-168) online. Applicants may register for an extranet account at the SAMHSA OTP Extranet website. After the request is verified, the applicant will receive an email with a username and password for use of the website.
Certification Renewal and Other Uses for Form SMA-162
OTPs must renew their certification annually or every three years depending on the accreditation timeframe awarded.
For instructions on accessing your program’s account, contact the SAMHSA OTP Extranet helpdesk:
For more information about OTP certification and opening a treatment program, contact your states OTP Compliance Officer.
OTP Services through Medication Units
A medication unit is a component of an OTP that is geographically separated from the OTP. Medication units can be mobile or non-mobile, and they can provide the same services as an OTP, where space allows for quality patient care. Required services not provided in medication units must be conducted at the OTP, including medical, counseling, vocational, educational, and other assessment and treatment services. Medication units allow patients to establish a routine and maintain a productive life. These can be especially helpful for people living in rural areas with limited accessibility. Even in major cities, medication units can be a valuable resource and can help to increase access to treatment.
Medication units must follow the same rules and guidelines for OTPs as outlined by SAMHSA and the state in which they reside and must apply and renew for certification. To receive SAMHSA certification for a medication unit, the OTP program sponsor should use the online application SAMHSA OTP Extranet.
For more information see OTP Guidance.
FAQs about OPTs are available for additional information.