Provisional certification is a temporary SAMHSA certification of up to one year for a new opioid treatment program that has applied for OTP accreditation. The program files Form SMA-162 naming its accrediting body and survey schedule. SAMHSA will not grant it without state and DEA approvals, and the program must be accredited and move to full certification within the year.
A new opioid treatment program (OTP) faces a timing problem. SAMHSA certification requires current accreditation from a SAMHSA-approved body (42 CFR 8.11(a)(2)), but an accrediting body needs to see a program operating before it can accredit it. Provisional certification is the bridge. Part 8 lets a new program that "ha[s] applied for accreditation with an Accreditation Body" receive "provisional certification for up to 1 year" (42 CFR 8.11(d)), and SAMHSA describes it as "a temporary certification granted to a new OTP for up to one year, during which time it must become accredited."
Who is eligible for provisional certification?
New OTPs that have not been certified by SAMHSA before, plus programs whose certification expired and that must therefore start over as "new" (8.11(a)(6), (d)). The one firm condition is that the program has already applied to an accrediting body. An OTP that has not applied for accreditation cannot get provisional certification, however complete the rest of its packet is.
The accreditation application must be specific to OTP services. SAMHSA's FAQ answers the question existing treatment centers ask most often: a behavioral health organization cannot use its existing accreditation for provisional certification and "must provide evidence of a separate application for accreditation as an OTP." See why a new OTP needs its own accreditation application.
What does the application need to show?
The program files Form SMA-162 with the Provisional Certification box checked, together with everything an initial application requires under 8.11(b) and "a statement identifying the Accreditation Body to which the OTP has applied for accreditation, the date on which the OTP applied for accreditation, the dates of any accreditation surveys that have taken place or are expected to take place, and the expected schedule for completing the accreditation process" (8.11(d)). The supporting documents SAMHSA lists, from the facility diagram to the medical director's DEA registration, are covered in SAMHSA's Form SMA-162.
Why do state and DEA approvals have to come first?
The regulation says provisional certification "will be granted, following receipt of the information described in this paragraph (d), unless the Secretary determines that patient health would be adversely affected." SAMHSA's practice adds a condition the text alone does not show. Its "Become an OTP" page says: "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."
Its FAQ describes the mechanics. While SAMHSA reviews the SMA-162, the program completes its applications for "the respective DEA and State Inspections." A SAMHSA compliance officer "will seek approvals from each entity, utilizing an internal approval form," and only once the state and DEA approvals are in does the officer seek leadership approval. SAMHSA calls this "a triplicate process" and "requests 45 days from the receipt of the provisional application to render a decision." The 45 days is SAMHSA's request for itself, not a promise to the program, and it does not count the state's or DEA's time.
Can the program bill Medicare during the provisional year?
No. Medicare's OTP enrollment rule requires "a current, valid certification by SAMHSA," and states that "a provisional certification under § 8.11(e) of this title does not meet the requirements" (42 CFR 424.67(b)(4)). The cross-reference to 8.11(e) predates the 2024 renumbering that put provisional certification in 8.11(d), but CMS's own OTP enrollment page says the same thing in plain words: programs "that are fully-certified by SAMHSA and accredited by a SAMHSA-approved accrediting body can enroll." Budget the provisional year without Medicare revenue. Our post on Medicare enrollment for OTPs covers the timing.
What has to happen before the year runs out?
- The accreditation survey. The accrediting body surveys the operating program. Under 8.4(b), a body that finds noncompliance gives written notice within 60 days and a correction schedule of up to 180 days.
- The accreditation decision. A program with only minor conditions to fix is granted three years; one with significant conditions is granted one year (8.4(b)(3)-(4)).
- The move to full certification. SAMHSA's page says that "after a provisionally certified program becomes accredited, it must apply to SAMHSA for full certification via the renewal application." That is another SMA-162, and SAMHSA's FAQ says a renewal stays "in processing" until the program sends a copy of the full accreditation survey report.
If accreditation is not finished in time, the provisional certification simply ends. A program in that position should contact its SAMHSA compliance officer before the expiration date; SAMHSA's FAQ describes an extension request process for certification that is about to expire because of an upcoming accreditation survey, with documentation from the accrediting body.
How should a new program use the provisional year?
- Book the survey early. Ask the accrediting body for its survey window when you apply, and put it in the SMA-162 schedule.
- Run to the accreditor's standards from the first day. Policies, diversion control, take-home procedures and chart documentation are what the survey will read. A SAMHSA-approved body surveys against the federal standards in 42 CFR 8.12 as well as its own.
- Keep the state and DEA current. DEA registration for a narcotic treatment program lasts one year and is renewed on Form 363a (21 CFR 1301.13(e)(1)(viii)).
- Prepare the Medicare application in advance so it can go in as soon as full certification arrives.
- Report changes on time. A new sponsor or medical director during the provisional year still goes to SAMHSA within three weeks (8.11(e)(5)).
Where do we fit in?
The provisional packet is the center of our Opioid Treatment Program Approval Package ($6,995 plus the state license package): the OTP accreditation application, the SMA-162 attachments, the DEA Form 363 information and the state file, sequenced so each agency has what the others need. During the provisional year, our Mock Survey ($1,495) tests the program against the accreditor's standards before the real survey. Your program sponsor signs and submits the SMA-162 from the sponsor's own Extranet account, and you pay the state, DEA and the accrediting body directly. See pricing and the OTP approval hub.
Common questions
- How long does OTP provisional certification last?
- Up to one year. During that year the program must be surveyed and accredited by a SAMHSA-approved body, then apply for full certification through the renewal application.
- Can I get provisional certification before applying for accreditation?
- No. Part 8 makes provisional certification available only to a new program that has already applied to an accrediting body, and the SMA-162 must name the body and the date you applied.
- Does provisional certification let an OTP bill Medicare?
- No. Medicare's OTP enrollment rule says a provisional certification does not meet its certification requirement, and CMS says fully certified and accredited programs can enroll.
- What happens if accreditation is not finished within the year?
- The provisional certification ends. Contact your SAMHSA compliance officer before expiration; SAMHSA describes an extension request process when an accreditation survey is pending, supported by documentation from the accrediting body.
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