An opioid treatment program (OTP) dispenses medications for opioid use disorder under federal certification governed by 42 CFR Part 8. Medicare participation adds enrollment, accreditation and provider-agreement requirements under 42 CFR 410.67, with additional conditions for intensive outpatient services. For new OTPs and acquirers, Integral Healthcare Solutions (IHS) drafts readiness plans and policies for client approval and submission.
Last updated: November 2026
What federal certification and Medicare enrollment require of an opioid treatment program
Under 42 CFR 8.11(a)(1)–(2), an OTP needs current federal certification to qualify to dispense medications for opioid use disorder (MOUD). Certification ordinarily requires section 8.12 treatment standards, current valid accreditation by an Accreditation Body or other Secretary-designated entity, and any other Secretary-established conditions. Section 8.11(d) provides the provisional route described below.
The governing texts are 42 CFR Part 8, 42 CFR 410.67 and 42 CFR 424.67 (current eCFR; pages opened November 5, 2026). Title 42 was last amended October 8, 2026; Part 8 carries the February 23, 2026 correction at 91 FR 8382. Section 424.67 covers the applicable CMS-855A or CMS-855B application and attachments, fees, screening, staff disclosures and continued enrollment compliance. Provisional certification does not satisfy its certification requirement.
| Text | What it asks, in IHS's words | What shows it |
|---|---|---|
| 8.11(a)(3)–(4) | Certification lasts no more than 3 years; renewal during the final year requires an application following paragraph (a)(4). | Certification date and renewal calendar |
| 8.11(b), (b)(7) | The OTP submits the application on form SMA-162, which includes, as the Secretary determines, its accreditation status, structure, responsible persons, medication unit addresses and funding sources. The program sponsor signs and certifies the information is truthful and accurate (8.11(b)(7)). | Completed application file and the sponsor's signed review log |
| 8.11(d) | New OTPs applying for certification and already applying for accreditation may receive provisional certification for up to 1 year. This includes expired OTPs seeking re-certification under (a)(6). Applicants submit paragraph (b) information plus the accreditation body, application date, completed or expected survey dates and completion schedule. After receipt, provisional certification is granted unless the Secretary determines it would adversely affect patient health. | Application file and accreditation timeline |
| 8.11(e)(1) | OTPs comply with pertinent Federal and State laws and regulations. This section’s state-law compliance and state application/report requirements do not apply to OTPs operated directly by the Department of Veterans Affairs, Indian Health Service or another U.S. department or agency. | Applicable-law register |
| 8.11(e)(5) | The OTP notifies the Secretary in writing within 3 weeks of any replacement or other change in the status of the program sponsor or medical director. | Change log and a dated notice file |
| 8.11(e)(6) | The OTP complies with DEA regulations and must be registered by the DEA before administering or dispensing MOUD. | DEA registration record |
| 8.12(b)(1) | At a minimum, each OTP formally designates a program sponsor and a medical director. | Designation letters |
| 8.12(c)(2) | The OTP maintains a current Diversion Control Plan within quality assurance, with measures to reduce diversion of dispensed MOUD and specific responsibility assigned to OTP providers and administrative staff for carrying them out. | Diversion Control Plan and assigned duties |
| 410.67(c) | Medicare participation and payment require enrollment, SAMHSA certification, SAMHSA-approved accreditation and a part 489 provider agreement. OTP intensive outpatient services also require compliance with 424.24(d)(1)–(3) for certification, treatment plans and recertification; recertification may occur any time during an episode of care, and physician requirements may be performed by a non-physician practitioner defined in section 1842(b)(18)(C), as state law and scope of practice permit. | Enrollment, certification, accreditation and agreement records; applicable intensive outpatient documentation |
These are selected requirements, not a complete enrollment checklist. The evidence column is IHS’s suggested documentation. Certification and accreditation constrain the sequence; IHS plans the work around those prerequisites.
State-specific requirements and federal requirements not summarized here need separate review by your program and counsel.
Who needs it and what triggers it?
Any program that treats opioid use disorder as an OTP and wants Medicare payment needs these conditions in place. These triggers are IHS's reading, not a list from the agencies.
- A new OTP needs certification, accreditation and Medicare enrollment, and has to plan the order.
- An acquirer of an existing OTP needs to see the seller's certification and Medicare enrollment status before it relies on them, and a change in the program sponsor or medical director has its own 3-week written notice under section 8.11(e)(5).
- A program in the final year of a certification term of up to 3 years is expected to apply for renewal and needs its documents current first.
How IHS helps
IHS assesses gaps against the governing texts, maps evidence, drafts policies and patient forms for clinical approval, and conducts a mock review with readiness support. Deliverables include a sequence plan, document index, Diversion Control Plan and quality assurance/control plans covering annual policy and procedure reviews and ongoing patient-outcome assessment under section 8.12(c)(1). Integral Healthcare Solutions (IHS) was founded in 2002 by Thomas G. Goddard, JD, PhD, former Chief Operating Officer and General Counsel of URAC, and works across three practice lines: accreditation consulting, compliance services and program development. This build sits in our Compliance Services practice line.
Your program supplies the sponsor and medical director designations, your accreditation status and survey schedule, your structure, the persons responsible, each medication unit address and your funding sources.
The limit: IHS does not submit form SMA-162 and does not contact SAMHSA, the Drug Enforcement Administration, a state, an accrediting body or Medicare for your program. The program sponsor signs the application and your program files it. IHS makes no medical decisions; your medical director makes them and approves all clinical content.
What to have ready
Prepare these records for the gap assessment. Citations refer to the current eCFR opened November 5, 2026.
- Certification term or provisional application file, including the expired-program route (42 CFR 8.11(a)(3)–(6), (d)).
- Accreditation status and survey schedule (42 CFR 8.11(a)(2), (d)).
- Medicare application, attachments, enrollment record, provider agreement and applicable intensive outpatient documentation (42 CFR 424.67; 42 CFR 410.67(c)).
- Sponsor and medical director designations (42 CFR 8.12(b)(1)).
- SMA-162 and supporting information for sponsor review (42 CFR 8.11(b)).
- Current Diversion Control Plan and quality assurance program (42 CFR 8.12(c)(2)).
- DEA registration (42 CFR 8.11(e)(6)).
- Applicable-law register reflecting the federal-operator exception (42 CFR 8.11(e)(1)).
If several of these do not exist yet, book the free introductory call and bring what you have.
How does outside drafting support compare with other routes?
Certification, accreditation and Medicare enrollment are separate approvals under sections 8.11, 410.67 and 424.67. A program can prepare documents internally or use outside drafting support. Compare the work to be done: regulatory research, legal analysis, clinical approval, document preparation and mock review. IHS offers document preparation and readiness support; the client retains clinical and submission responsibilities. See CMS OTP Enrollment (page opened November 5, 2026) and our CARF OTP accreditation page.
What does it cost?
CMS publishes a 2026 Medicare enrollment application fee of 750 USD; OTPs generally pay an application fee, subject to applicable exceptions. Verify current fees with CMS. See Medicare Provider Enrollment (page opened November 5, 2026). Obtain applicable accreditation and state fee information for your program. IHS scopes each engagement after a free introductory call. Scope depends on sites, medication units, accreditation status and documentation gaps.
Your own staff time is a further cost. Your sponsor, medical director and quality staff supply records and review drafts, and that time is yours whichever route you take.
What this is not
This is not legal advice. IHS is a consulting firm, not a law firm. It is not a guarantee that SAMHSA certifies the program, that an accrediting body accredits it or that Medicare enrolls it. IHS does not submit to agencies or accreditors; your program’s authorized personnel handle submissions.
Frequently asked questions
What does federal certification of an opioid treatment program require?
Under section 8.11(a)(2), certification requires section 8.12 treatment standards, current valid accreditation by an Accreditation Body or other Secretary-designated entity, and other Secretary-established conditions; section 8.11(d) provides the provisional route. The OTP applies on SMA-162, signed by the sponsor to certify truthful and accurate information. Section 8.11(e)(1) requires compliance with pertinent Federal and State laws, but its state-law compliance and state application/report provisions exclude OTPs operated directly by U.S. departments or agencies.
What is the order of certification, accreditation and Medicare enrollment for a new OTP?
Accreditation and certification are prerequisites for Medicare enrollment, so the sequence is not freely interchangeable. Section 8.11(d) provides a provisional-certification route, but provisional status does not satisfy section 424.67(b)(4). IHS schedules preparation around these dependencies; your program submits the applications.
What does Medicare require of an OTP to receive payment?
Section 410.67(c)(1)–(4) requires Medicare enrollment, SAMHSA certification in effect, accreditation by a SAMHSA-approved body and a part 489 provider agreement in effect. Paragraph (c)(5) adds certification, treatment-plan and recertification requirements for OTP intensive outpatient services, with the timing and practitioner exceptions described in the table above. Enrollment also requires compliance with section 424.67.
What is provisional certification for a new OTP, and how long does certification last?
New OTPs applying for certification and already applying for accreditation may receive provisional certification for up to 1 year; section 8.11(a)(6) includes expired OTPs seeking re-certification. Applicants must submit the information described in section 8.11(d), and the Secretary must not determine that granting provisional certification would adversely affect patient health. Under section 8.11(a)(3), certification lasts no more than 3 years and may be renewed during the final year through paragraph (a)(4).
What is a Diversion Control Plan, and who must have one?
Section 8.12(c)(2) requires an OTP to maintain a current Diversion Control Plan as part of its quality assurance program, with specific measures to reduce diversion of dispensed MOUD and specific responsibility assigned to providers and administrative staff. IHS drafts the plan, tests it against the full section in the gap assessment, and your medical director approves it.
What does an acquirer of an OTP need to show?
For an acquisition involving Medicare participation, review the program’s status under sections 410.67(c) and 424.67 with counsel. Section 8.11(e)(5) separately requires written notice to the Secretary within 3 weeks of any replacement or other change in the sponsor’s or medical director’s status. That notice does not establish whether an enrollment or certification transfers; counsel should determine the transaction’s requirements.
How is federal OTP certification different from accreditation?
Certification is the Secretary’s determination under section 8.11; accreditation comes from an Accreditation Body or other Secretary-designated entity. Accreditation is ordinarily a condition of certification, with a provisional route under section 8.11(d). For Medicare enrollment, provisional certification is insufficient, and section 410.67(c) separately requires SAMHSA-approved accreditation.
What does OTP certification and enrollment readiness cost?
CMS publishes a 2026 Medicare enrollment application fee of 750 USD; applicable exceptions may affect payment. Verify current fees with CMS and obtain applicable accreditation and state fee information. IHS scopes each engagement after a free introductory call. Budget staff time for supplying records and reviewing drafts.