An opioid treatment program (OTP) accrediting body is an organization approved by the Substance Abuse and Mental Health Services Administration (SAMHSA) under 42 CFR Part 8, Subpart B, to accredit opioid treatment programs. This page is for private nonprofit organizations, state or territorial governmental entities and Indian Tribes applying for that approval or renewing it. Integral Healthcare Solutions (IHS) builds the survey and decision procedures and the federal crosswalk for the application; your addiction-treatment experts own the standards, and your organization applies.

Last reviewed: October 2026.

What is an OTP accrediting body?

An accrediting body surveys opioid treatment programs and, under section 8.4, sends the Secretary a copy of each noncompliance notice it issues. SAMHSA's summary is short: "Nonprofit groups or state governmental entities can apply for approval to accredit opioid treatment programs (OTPs)" (SAMHSA, Become an Accrediting Body, last updated 01/02/2026).

The governing text is 42 CFR Part 8, Subpart B, "Accreditation of Opioid Treatment Programs." It contains section 8.3, "Application for approval as an Accreditation Body"; section 8.4, "Accreditation Body responsibilities"; section 8.5, "Periodic evaluation of Accreditation Bodies"; and section 8.6, "Withdrawal of approval of Accreditation Bodies." We read the current eCFR text on 2 October 2026; the source note for section 8.3 reads "[89 FR 7549, Feb. 2, 2024, as amended at 91 FR 8382, Feb. 23, 2026]" (eCFR).

The application itself is Form SMA-163. SAMHSA states: "All new and renewal applicants must submit Form SMA-163: Application for Approval as Accreditation Body. New applicants can submit their SMA-163 online." It adds that "Form SMA-163 includes a list of documents required for submission with the application" and that "No applications will be reviewed until all required documentation is submitted" (SAMHSA).

Who needs it and what triggers it

Eligibility is set in the regulation: "Private nonprofit organizations, State or territorial governmental entities, or political subdivisions thereof, and Indian Tribes as defined by the Federally Recognized Indian Tribe List Act of 1994, that are capable of meeting the requirements of this part may apply for approval as an Accreditation Body" (42 CFR 8.3(a)). The buyer for this work is the would-be accrediting body, not an OTP.

• A first application. A new applicant files Form SMA-163 with the documents it lists.
• Renewal. "Renewal of SAMHSA approval is required every five years" (SAMHSA), and the regulation sets the term at "a period not to exceed 5 years" (42 CFR 8.3(g)). The body must tell SAMHSA of its intent to renew "At least 9 months before the date of expiration," and file the renewal application "At least 3 months before the date of expiration" (42 CFR 8.3(c)(1), (3)).
• A deficiency notice. If SAMHSA finds deficiencies, it will "request that the applicant resolve such deficiencies within 90 days of receipt of the notice." Unresolved, "the application for approval as an Accreditation Body will be denied" (42 CFR 8.3(d)(2)).

How IHS helps

IHS builds the application package and the procedures an approved body has to operate under section 8.4. The process:

1. Gap assessment. Your standards, survey process and governance are read against 42 CFR Part 8, Subpart B and the SMA-163 document list, and each gap is tied to its source paragraph.
2. Crosswalk. IHS builds a table from each federal OTP requirement to the standard in your manual that addresses it, with gaps marked.
3. Drafting. IHS drafts the survey, reviewer qualification, conflict-of-interest, noncompliance-notice and reporting, fee-setting and accreditation-decision procedures for your experts to review and approve.
4. Evidence mapping. Each required document is tied to the file in your package that supplies it.
5. Mock review. IHS reviews the full package against the regulation and the form's document list and reports what is missing.
6. Readiness support. IHS drafts the application text for your organization to submit through SAMHSA's system, and helps you prepare a response if a deficiency notice arrives.

What you supply: your standards, the addiction-treatment experts who own and approve them, reviewer files, governance documents and counsel.

The limit: IHS drafts no clinical standard on its own authority; your experts approve each one. Your organization, not IHS, submits to and corresponds with SAMHSA.

What to have ready

Each item comes from 42 CFR Part 8, Subpart B (eCFR current text read 2 October 2026) or SAMHSA's application page.

• Documentation that your organization fits an eligible category under 42 CFR 8.3(a): private nonprofit, state or territorial governmental entity or political subdivision, or Indian Tribe.
• Form SMA-163 and the "list of documents required for submission with the application" that the form contains (SAMHSA). Assemble every document before filing, since "No applications will be reviewed until all required documentation is submitted."
• A survey schedule that meets section 8.4(a)(1): "routine accreditation surveys for initial accreditation, and then at least every three years to allow for renewal of certification."
• A noncompliance procedure that issues written notice "within 60 days following discovery," "categorizes each non-compliant condition as either 'minor' or 'significant'," sets a corrective schedule "not to exceed 180 days," and provides the Secretary a copy (42 CFR 8.4(b)(1)).
• A fee policy and cost basis for what you will charge OTPs, since the Secretary "generally will find fees to be reasonable if the fees are limited to recovering costs to the Accreditation Body, including overhead incurred" (42 CFR 8.4(i)). Section 8.4(i)(1) also requires the Accreditation Body to make its fee structure public.
• For a state, territorial or Tribal unit: the measures you have taken "to prevent actual or apparent conflicts of interest" (42 CFR 8.3(h)).
• Staff capacity to answer a deficiency notice within 90 days (42 CFR 8.3(d)(2)).
• A renewal calendar with the 9-month notice of intent and the 3-month renewal filing (42 CFR 8.3(c)).

The introductory call is the place to go through this list against your organization's current documents.

How it compares

SAMHSA's list of approved accrediting bodies, last updated 04/24/2026, names five: CARF International; Social Current (Previously Council on Accreditation); The Joint Commission; National Commission on Correctional Health Care; and Washington State Department of Health (SAMHSA, Accreditation Bodies). For an OTP these are the available accreditors. For an organization applying to join the list, they are the bodies already approved.

Other federal approval routes for assurance bodies run under different authorities: CMS deeming authority for accrediting organizations, ONC authorization of health IT certification bodies and ONC authorization of health IT testing laboratories.

What it costs

An application has two cost parts: any fee SAMHSA charges the applicant, and your staff and expert time. SAMHSA does not publish a fee schedule on the pages we reviewed. IHS's fee depends on scope. The regulation does govern what an approved body charges OTPs: "Fees charged to OTPs for accreditation shall be reasonable" (42 CFR 8.4(i)). It sets no dollar amount. IHS scopes each engagement after a free introductory call.

What this is not

• IHS is not an accrediting body and does not grant, influence or predict SAMHSA's decision.
• IHS does not submit to SAMHSA or act for your organization before it. Your organization files and corresponds.
• IHS does not set addiction-treatment clinical standards, and this page is not legal advice.

Frequently asked questions

Who is eligible to become a SAMHSA-approved opioid treatment program accrediting body?

Under 42 CFR 8.3(a), "Private nonprofit organizations, State or territorial governmental entities, or political subdivisions thereof, and Indian Tribes" that can meet Part 8 may apply (eCFR). SAMHSA summarizes it as "Nonprofit groups or state governmental entities."

What is Form SMA-163 and what documents must go with it?

Form SMA-163 is the "Application for Approval as Accreditation Body," required of all new and renewal applicants. SAMHSA says the form "includes a list of documents required for submission with the application," and that "No applications will be reviewed until all required documentation is submitted" (SAMHSA).

What does 42 CFR Part 8 require of an OTP accrediting body after approval?

Section 8.4 sets the duties. They include routine surveys at least every three years, written noncompliance notices within 60 days of discovery with a copy to the Secretary, and reasonable fees to OTPs. Sections 8.5 and 8.6 cover periodic evaluation of accrediting bodies and withdrawal of approval.

How long does SAMHSA approval last and when must we start renewal?

The term is "a period not to exceed 5 years" (42 CFR 8.3(g)), and SAMHSA states that "Renewal of SAMHSA approval is required every five years." Notice of intent to renew is due "At least 9 months before the date of expiration," and the renewal application "At least 3 months before" it (42 CFR 8.3(c)).

Can a state agency or Tribe act as an OTP accrediting body?

Yes. State or territorial governmental entities, their political subdivisions and Indian Tribes are eligible under 42 CFR 8.3(a). Section 8.3(h) lets State, territorial and Indian Tribe entities, including political subdivisions, establish organizational units that act as Accreditation Bodies, provided the unit meets section 8.3, is approved by the Secretary, and has "taken appropriate measures to prevent actual or apparent conflicts of interest" (42 CFR 8.3(h)).

How often must an approved body survey each OTP, and what happens when it finds noncompliance?

Accrediting bodies "shall conduct routine accreditation surveys for initial accreditation, and then at least every three years" (42 CFR 8.4(a)(1)). On noncompliance, the body gives the OTP written notice within 60 days that categorizes each condition as "minor" or "significant," with a corrective schedule "not to exceed 180 days," and sends the Secretary a copy (42 CFR 8.4(b)(1)).

What happens if SAMHSA finds deficiencies in our application?

SAMHSA will "request that the applicant resolve such deficiencies within 90 days of receipt of the notice." If they are not resolved in that time, "the application for approval as an Accreditation Body will be denied" (42 CFR 8.3(d)(2)).

How are accreditation fees charged to OTPs judged reasonable?

"Fees charged to OTPs for accreditation shall be reasonable." The Secretary "generally will find fees to be reasonable if the fees are limited to recovering costs to the Accreditation Body, including overhead incurred" (42 CFR 8.4(i)). The regulation sets no dollar amount.

Which organizations are currently approved to accredit OTPs?

SAMHSA's list, last updated 04/24/2026, names CARF International; Social Current (Previously Council on Accreditation); The Joint Commission; National Commission on Correctional Health Care; and Washington State Department of Health (SAMHSA).