Requirements for OTPs

30 – Requirements for OTPs (Rev. 268: Issued; 02-14-20: Effective; 01-01-20: Implementation: 03-16-20) To participate in the Medicare program and receive payment, an opioid treatment program must meet all of the following: A. Be enrolled in the Medicare program. An OTP must be enrolled in Medicare to receive Medicare payment for covered OUD treatment services under section 1861(jjj)(1) of the Act. B. Have in effect a certification by the Substance Abuse and Mental Health Service Administration (SAMHSA) for the opioid treatment program. OTPs must be certified by SAMHSA to furnish Medicare-covered OUD treatment services. SAMHSA has created a system to certify and accredit OTPs, which is governed by 42 CFR part 8, subparts B and C. To be certified by SAMHSA, OTPs must comply with the federal opioid treatment standards as outlined in § 8.12, be accredited by a SAMHSA-approved accreditation body, and comply with any other conditions for certification established by SAMHSA. C. Be accredited by an accrediting body approved by the SAMHSA. OTPs must be accredited by a SAMHSA-approved accrediting body in order to furnish Medicare-covered OUD treatment services. In 2001, the Department of Health and Human Services (HHS) and SAMHSA issued final regulations to establish a new oversight system for the treatment of substance use disorders (SUDs) with Medication Assisted Treatment (MAT) for OUDs (42 CFR part 8). SAMHSA-approved accrediting bodies evaluate OTPs and perform site visits to ensure SAMHSA’s opioid dependency treatment standards are met. SAMHSA also requires OTPs to be accredited by a SAMHSA-approved accrediting body (§ 8.11). The SAMHSA regulations establish procedures for an entity to apply to become a SAMHSA- approved accrediting body (§ 8.3). There are currently six SAMHSA-approved accreditation bodies.1F2 D. Have in effect a provider agreement under 42 CFR 489. All providers of services under section 1866 of the Act must enter into a provider agreement with the Secretary and comply with other requirements specified in that section. These requirements are codified at 42 CFR part 489.