Medicare Claims Processing Manual (Pub. 100-04), Ch. 39 § 20
Statutory authority for OTPs billing Medicare
20 - Statutory authority for OTPs billing Medicare
(Rev. 13147; Issued: 03-28-25; Effective: 01-01-25; Implementation: 03-25-25)
Section 2005 of the SUPPORT Act amended section 1861 of the Act by adding a new subsection (jjj)(2) to
define an OTP as an entity meeting the definition of OTP in 42 CFR 8.2 or any successor regulation (that is,
a program or practitioner engaged in opioid treatment of individuals with an opioid agonist treatment
medication registered under 21 U.S.C. 823(g)(1)), that meets the additional requirements set forth in
subparagraphs (A) through (D) of section 1861(jjj)(2) of the Act. Specifically that the OTP: is enrolled
under section 1866(j) of the Act; has in effect a certification by the Substance Abuse and Mental Health
Services Administration (SAMHSA) for such a program; is accredited by an accrediting body approved by
SAMHSA; and meets such additional conditions as the Secretary may find necessary to ensure the health
and safety of individuals being furnished services under such program and the effective and efficient
furnishing of such services.
We defined “opioid treatment program” at § 410.67(b) as an entity that is an OTP as defined in § 8.2 (or any
successor regulation) that meets the applicable requirements for an OTP. For an OTP to participate and
receive payment under the Medicare program, the OTP must be enrolled under section 1866(j) of the Act,
have in effect a certification by SAMHSA for such a program, and be accredited by an accrediting body
approved by SAMHSA. Additionally, payments made to OTPs under the Medicare OTP benefit must be for
the treatment of an opioid use disorder (OUD).