Collapse to view only § 460.196 - Disclosure of review results.

§ 460.190 - Monitoring during trial period.

(a) Trial period review. During the trial period, CMS, in cooperation with the State administering agency, conducts comprehensive annual reviews of the operations of a PACE organization to ensure compliance with the requirements of this part.

(b) Scope of review. The review includes the following:

(1) An onsite visit to the PACE organization, which may include, but is not limited to, observation of program operations;

(2) Detailed analysis of the entity's substantial compliance with all significant requirements of sections 1894 and 1934 of the Act and this part, which may include review of marketing, participant services, enrollment and disenrollment, and grievances and appeals.

(3) A comprehensive assessment of an organization's fiscal soundness.

(4) A comprehensive assessment of the organization's capacity to furnish all PACE services to all participants.

(5) Any other elements that CMS or the State administering agency find necessary.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25677, June 3, 2019]

§ 460.192 - Ongoing monitoring after trial period.

(a) At the conclusion of the trial period, CMS, in cooperation with the State administering agency, continues to conduct reviews of a PACE organization, as appropriate, taking into account the quality of care furnished and the organization's compliance with all of the requirements of this part.

(b) CMS in cooperation with the State administering agency will conduct reviews of the operations of PACE organizations as appropriate, as determined by a risk assessment of each PACE organization which takes into account the PACE organization's performance level and compliance with the significant requirements of sections 1834 and 1934 of the Social Security Act and this part.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25677, June 3, 2019]

§ 460.194 - Corrective action.

Link to an amendment published at 89 FR 30848, Apr. 23, 2024.

(a) A PACE organization must take action to correct deficiencies identified by CMS or the State administering agency through the following:

(1) Ongoing monitoring of the PACE organization.

(2) Reviews and audits of the PACE organization.

(3) Complaints from PACE participants or caregivers.

(4) Any other instance CMS or the State administering agency identifies programmatic deficiencies requiring correction.

(b) CMS or the State administering agency monitors the effectiveness of corrective actions.

(c) Failure to correct deficiencies may result in sanctions or termination, as specified in subpart D of this part.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25677, June 3, 2019]

§ 460.196 - Disclosure of review results.

(a) CMS and the State administering agency promptly report the results of reviews under §§ 460.190 and 460.192 to the PACE organization, along with any recommendations for changes to the organization's program.

(b) CMS and the State administering agency make the results of reviews available to the public upon request.

(c) The PACE organization must post a notice of the availability of the results of the most recent review and any plans of correction or responses related to the most recent review.

(d) The PACE organization must make the review results available for examination in a place readily accessible to participants, their families, their caregivers, and their authorized representatives.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25677, June 3, 2019]

§ 460.198 - xxx

Link to an amendment published at 89 FR 30848, Apr. 23, 2024.