CMS Pub. 100-11, ch. 15, § 30.4

Every PACE organization must have, as required by Sections 1894(a)(9) and (e)(4) and

1934(a)(9) and (e)(4), an annual audit during the PACE organization’s trial period -

the first three contract years following the PACE organization program’s effective date.

Routine or Biennial audits are conducted at least every two years following a PACE

organization’s successful completion of the trial period audits. A Focused audit may be

performed if CMS or the State Administering Agency determines that additional

monitoring or auditing is required due to identified issues of non-compliance, operational

deficiencies or significant audit findings. Focused audits may occur during the trial

period or thereafter.

CMS does not share its method of evaluation or protocols with PACE organizations.

PACE organizations must comply with all PACE regulations and preparations for audits

should focus on a self-evaluation of the organization’s compliance with PACE

regulations. The PACE organizations must comply with local policies and procedures and

performance on monitoring requirements such as quarterly HPMS reporting elements.

The elements covered include, but are not limited to, the following:

Element Title

Section 1 – Clinical PACE Elements

PRS 02 Personnel Training

PRS 04 Oversight of Direct Patient Care

ENV 01 Physical Environment

ENV 02 Infection Control

TRS 01 Transportation Services

DTY 01 Dietary Services

SDY 01 Service Delivery

SDY 02 Emergency Care

SDY 03 Interdisciplinary Team

SDY 04 Participant Assessment

SDY 05 Plan of Care

QAP 04 Internal Quality Assessment and Performance Improvement

Activities

Section 2 A – Administrative PACE Elements

CTS 01 Contracted Services

FIN 01 Fiscal Soundness

PRT 04 Explanation of rights

PRT 06 Grievance Process

PRT 07 PACE Organization’s Appeals Process

PRT 08 Additional Appeal Rights Under Medicare or Medicaid

MKT 03 Enrollment Process

MKT 08 Voluntary Disenrollment

MKT 09 Involuntary Disenrollment

Section 2B – Operational Part D Elements

ER 13 Confirmation of Enrollment for Members of Employer

Group/Union

PR 02 Use of SSN/HICN

EP01

CB 01

Electronic Prescribing

Collecting/Updating Enrollees’ Other health Insurance

Information

CB03 TrOOP Status at Disenrollment

CP06 Internal Monitoring and Auditing Procedures

CP07 Response to Detected Offenses and Corrective Action Plan

CP08 Comprehensive Fraud and Abuse Plan

Element Title

CL01

CL02

Online Claims Processing System

Data Elements Needed to Link Medicare Parts A, B and D

Data

CL03 Processing Systems

CL04 Disputed Claims

CL06

PA 01

Certification of Claims Data

Certification of Monthly Enrollment and Payment Data

Relating to CMS Payment

PA02 Submission of Prescription Drug Event Data

PA03 Overpayment and Underpayment Requirements