(a) General enrollment requirement. In order for a program or eligible professional (as that term is defined in section 1848(k)(3)(B) of the Act) to receive Medicare payment for the provision of opioid use disorder treatment services, the provider must qualify as an OTP (as that term is defined in §8.2 of this title) and enroll in the Medicare program under the provisions of this section and of subpart P of this part.

(b) Specific requirements and standards for enrollment. To enroll in the Medicare program, an OTP must meet all of the following requirements and standards:

(1) Fully complete and submit the Form CMS-855B application (or its successor application) and any applicable supplement or attachment thereto to its applicable Medicare contractor. This includes, but is not limited to, the following:

(i) Maintain and submit to CMS (via the applicable supplement or attachment) a list of all physicians, other eligible professionals, and pharmacists (regardless of whether the individual is a W-2 employee of the OTP) who are legally authorized to prescribe, order, or dispense controlled substances on behalf of the OTP. The list must include the physician's, other eligible professional's, or pharmacist's:

(A) First and last name, and middle initial.

(B) Social Security Number.

(C) National Provider Identifier.

(D) License number (if applicable).

(ii) Certifying via the Form CMS-855B and/or the applicable supplement or attachment thereto that the OTP meets and will continue to meet the specific requirements and standards for enrollment described in paragraphs (b) and (d) of this section.

(2) Comply with the application fee requirements in §424.514.

(3) Successfully complete the assigned categorical risk level screening required under, as applicable, §424.518(b) and (c).

(4)

(i) Have a current, valid certification by SAMHSA for an opioid treatment program consistent with the provisions and requirements of §8.11 of this title.

(ii) A provisional certification under §8.11(e) of this title does not meet the requirements of paragraph (b)(4)(i) of this section.

(5) Report on the Form CMS-855B and/or any applicable supplement all OTP staff who meet the definition of “managing employee” in §424.502. Such individuals include, but are not limited to, the following:

(i) Medical director (as described in §8.2 of this title).

(ii) Program sponsor (as described in §8.2 of this title).

(6)

(i)

(A) Must not employ or contract with a prescribing or ordering physician or eligible professional or with any individual legally authorized to dispense narcotics who, within the preceding 10 years, has been convicted (as that term is defined in 42 CFR 1001.2) of a Federal or State felony that CMS deems detrimental to the best interests of the Medicare program and its beneficiaries based on the same categories of detrimental felonies, as well as case by case detrimental determinations, found at §424.535(a)(3).

(B) Paragraph (b)(6)(i)(A) of this section applies regardless of whether the individual in question is:

(1) Currently dispensing narcotics at or on behalf of the OTP; or

(2) A W-2 employee of the OTP.

(ii) Must not employ or contract with any personnel (regardless of whether the individual is a W-2 employee of the OTP) who is revoked from Medicare under §424.535 or any other applicable section in Title 42, or who is on the preclusion list under §422.222 or §423.120(c)(6) of this chapter.

(iii) Must not employ or contract with any personnel (regardless of whether the individual is a W-2 employee of the OTP) who has a prior adverse action by a State oversight board, including, but not limited to, a reprimand, fine, or restriction, for a case or situation involving patient harm that CMS deems detrimental to the best interests of the Medicare program and its beneficiaries. CMS will consider the factors enumerated at §424.535(a)(22) in each case of patient harm that potentially applies to this paragraph.

(7)

(i) Sign (and adhere to the term of) a provider agreement in accordance with the provisions of part 489 of this chapter.

(ii) An OTP's appeals under part 498 of a Medicare revocation (under §424.535) and a provider agreement termination (under §489.53 of this chapter) must be filed jointly and, as applicable, considered jointly by CMS under part 498 of this chapter.

(8) Comply with all other applicable requirements for enrollment specified in this section and in subpart P of this part.

(c) Denial of enrollment. CMS may deny an OTP's enrollment application on any of the following grounds:

(1)

(i) The provider does not have a current, valid certification by SAMHSA as required under paragraph (b)(4)(i) of this section or fails to meet any other applicable requirement in this section.

(ii) Any of the denial reasons in §424.530 applies.

(2) An OTP may appeal the denial of its enrollment application under part 498 of this chapter.

(d) Continued compliance, standards, and reasons for revocation.

(1) Upon and after enrollment, an OTP—

(i) Must remain validly certified by SAMHSA as required under §8.11 of this title.

(ii) Remains subject to, and must remain in full compliance with, the provisions of this section and of subpart P of this part. This includes, but is not limited to, the provisions of paragraph (b)(6) of this section, the revalidation provisions in §424.515, and the deactivation and reactivation provisions in §424.540.

(iii) Upon revalidation, successfully complete the moderate categorical risk level screening required under §424.518(b).

(2) CMS may revoke an OTP's enrollment on any of the following grounds:

(i) The provider does not have a current, valid certification by SAMHSA as required under paragraph (b)(4)(i) or fails to meet any other applicable requirement or standard in this section, including, but not limited to, the OTP standards in paragraphs (b)(6) and (d)(1) of this section.

(ii) Any of the revocation reasons in §424.535 applies.

(3) An OTP may appeal the revocation of its enrollment under part 498 of this title.

(e) Claim payment. For an OTP to receive payment for furnished drugs:

(1) The prescribing or medication ordering physician's or other eligible professional's National Provider Identifier must be listed on Field 17 of the Form CMS-1500; and

(2) All other applicable requirements of this section, this part, and part 8 of this title must be met.

(f) Relation to part 8 of this title. Nothing in this section shall be construed as:

(1) Supplanting any of the provisions in part 8 of this title; or

(2) Eliminating an OTP's obligation to maintain compliance with all applicable provisions in part 8 of this title.

[84 FR 63202, Nov. 15, 2019]