CMS-10630 Corrective Action Plan (CAP) Process

The PACE Organization (PO) Monitoring and Audit Process in Part 460 of 42 CFR (CMS-10630)

AttachmentVCorrectiveActionPlanProcess

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Programs of All-Inclusive
Care for the Elderly (PACE)
Corrective Action Plan (CAP)
Process

Corrective Action of Audit Findings
1. Corrective Action Plan Submission: The PACE organization (PO) must submit corrective action
plans (CAPs) for any issue of non-compliance identified during a PACE audit as requiring
correction, unless otherwise specified by CMS.
2. Corrective Action Plan Requirements: For each issue of non-compliance requiring correction, the
PACE organization must submit a detailed plan of correction that outlines how they will correct
non-compliance. Corrective action plans must fully address how the PO will remediate all identified
non-compliance and prevent future non-compliance. To ensure the PO comes into compliance with
CMS requirements, all corrective action plans must address, at a minimum, the following:
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The PO’s understanding of the regulatory requirement(s).
The cause(s) that led to the non-compliance and what specific actions will be taken to address
each cause.
The specific actions that will be taken to remediate any impacted participants, if remediation
is possible.
The specific actions and changes that will be implemented to prevent future non-compliance.
The specific, objective, and measurable monitoring activities the PO will undertake to
evaluate the effectiveness of the changes implemented to mitigate future non-compliance.
The staff responsible for the implementation of the corrective action plan.
The staff responsible for monitoring and evaluating the effectiveness of the CAP (if different
from the staff responsible for implementing the CAP).
How the CAP will be integrated into the PO’s compliance program in order to ensure
compliance with CMS requirements.

3. Corrective Action Plan Implementation Timeframes: Corrective action plan submission is only
required when regulatory non-compliance has been identified; therefore, it is imperative that the PO
implement corrective actions and achieve regulatory compliance as quickly as possible. PO’s are
expected to begin implementing each CAP immediately following CMS’s acceptance of the CAP(s)
and must plan to achieve regulatory compliance within 60 days of CAP acceptance.
4. Account Management Technical Assistance and Documentation Submission: Your Account
Manager (AM) will provide technical assistance and education to assist you with successfully
implementing your CAP. Technical assistance and education may include the review of CAPs,
routine technical calls to discuss implementation, and a review of specific documentation collected
during the implementation efforts. Documentation may be requested through HPMS or shared
through webinar capabilities in order for the AM to provide ongoing technical and educational
assistance. Since each corrective action plan is individualized to address the non-compliance
identified during a given audit, documentation reviewed by the PO and the AM may differ
depending on the CAP. Documentation may include, but is not limited to:
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Documentation of the content of trainings
Documentation that staff and/or contractors completed training, including when trainings
were completed
Documentation of revisions made to policies, procedures, and other work papers
Documentation of internal audits and monitoring conducted as part of the CAP
Tools or processes developed or used by the PACE organizations to assess or prevent future
non-compliance
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Additionally, AMs may ask to see documentation specific to issues of non-compliance in order to
provide tailored education on correction. This may include collecting data or records identified in
the Attachment I PACE Audit Process and Data Request document. Any data or records collected
for CAP monitoring purposes will be limited to those generated after the acceptance of the CAP and
prior to the CAP release. Examples including the following: if an issue of non-compliance was cited
because the PO was not providing the specific reason for the service determination request denial
decision, the AM may request to see denial letters in order to provide continued education on CMS
expectations. The AM may ask for a universe of service determination requests, appeals and
grievances to determine if additional education is needed on notification timeframes or processing of
appeals. The AM may review portions of medical records to assess whether education is needed
with respect to correcting non-compliance cited during the audit. For example, the AM may review
portions of medication records to determine whether the PO is providing IDT approved services or
managing specialists.
5. CAP Release: CMS expects that PACE organizations correct non-compliance as expeditiously as
possible. Corrective action plans will be released 60 days after the CAP acceptance with the
expectation that PACE organizations will have fully implemented those corrective action plans by
that time. Failure to correct non-compliance identified during an audit by the CAP release date may
result in a compliance or enforcement action referral.

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File Typeapplication/pdf
File TitlePrograms of All-Inclusive Care for the Elderly Corrective Action Plan Process
SubjectPACE, CAP, Corrective Action Plan Process
AuthorCMS
File Modified2021-12-02
File Created2021-12-02

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