---
kind: "section"
citation: "42 C.F.R. § 460.19"
title: "42"
number: "460.19"
heading: "Issuance of compliance actions for failure to comply with the terms of the PACE program agreement."
url: "https://uscodex.org/cfr/42/460.19"
---

# §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)](#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)](#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)](#a) of this section and as assessed in accordance with [paragraph (b)](#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)](#a) of this section and as assessed in accordance with [paragraph (b)](#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.

## Notes

### Amendments

[89 FR 30844, Apr. 23, 2024]

### Authority

Authority: 42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f).

### Source

Source: 64 FR 66279, Nov. 24, 1999, unless otherwise noted.

### Amendments

[89 FR 30844, Apr. 23, 2024]