Editorial Note on Part 460
Editorial Note: Nomenclature changes to part 460 appear at 67 FR 61504, Oct. 1, 2002.

§ 460.19 Issuance of compliance actions for failure to comply with the terms of the PACE program agreement. ( a ) CMS may take compliance actions as described in paragraph (c)(1) of this section if CMS determines that the PACE organization has not complied with the terms of a current or prior PACE program agreement with CMS and a State administering agency. ( 1 ) CMS may determine that a PACE organization is out of compliance with requirements when the organization fails to meet performance standards articulated in sections 1894 and 1934 of the Act and regulations in this chapter.
( 2 ) If CMS has not already articulated a measure for determining non-compliance, CMS may determine that a PACE organization is out of compliance when its performance in fulfilling requirements represents an outlier relative to the performance of other PACE organizations.
( b ) CMS bases its decision on whether to issue a compliance action and what level of compliance action to take on an assessment of the circumstances surrounding the non-compliance, including all of the following: ( 1 ) The nature of the conduct.
( 2 ) The degree of culpability of the PACE organization.
( 3 ) The actual or potential adverse effect on beneficiaries which resulted or could have resulted from the conduct of the PACE organization.
( 4 ) The history of prior offenses by the PACE organization or its related entities.
( 5 ) Whether the non-compliance was self-reported.
( 6 ) Other factors which relate to the impact of the underlying non-compliance or to the PACE organization's inadequate oversight of the operations that contributed to the non-compliance.
( c ) CMS may take one of three types of compliance actions based on the nature of the non-compliance. ( 1 ) *Notice of non-compliance.* A notice of non-compliance may be issued for any failure to comply with the requirements of the PACE organization's current or prior PACE program agreement with CMS and a State administering agency, as described in paragraph (a) of this section.
( 2 ) *Warning letter.* A warning letter may be issued for serious and/or continued non-compliance with the requirements of the PACE organization's current or prior PACE program agreement with CMS and a State administering agency, as described in paragraph (a) of this section and as assessed in accordance with paragraph (b) of this section.
( 3 ) *Corrective action plan.* ( i ) Corrective action plans are issued for particularly serious or continued non-compliance with the requirements of the PACE organization's current or prior PACE program agreement with CMS and a State administering agency, as described in paragraph (a) of this section and as assessed in accordance with paragraph (b) of this section.
( ii ) CMS issues a corrective action plan if CMS determines that the PACE organization has repeated or not corrected non-compliance identified in prior compliance actions, has substantially impacted beneficiaries or the program with its non-compliance, or must implement a detailed plan to correct the underlying causes of the non-compliance.
[89 FR 30844, Apr. 23, 2024]