PACE Audit Preparation Guide

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PACE Audit

Preparation Guide

SEPTEMBER 2017

Disclaimer: CMS guidance is always the authoritative source of PACE audit information. This guide is based on NPA's best understanding of the 2017 audit protocol as of September 2017. It is not intended to substitute for CMS guidance but to provide additional information to PACE organizations preparing for audit.

Background

The Centers for Medicare & Medicaid Services (CMS), in concert with State Administering Agencies (SAAs), conducts regular audits of PACE organizations. PACE organizations, viewed as variants of Medicare Part C managed care organizations (MCOs), share a unique profile compared with conventional MCOs in that they manage care, on a capitated basis, for the frailest and most complex subset of the Medicare/Medicaid population; provide care and services to a population that might otherwise require nursing home care; and receive substantial per-beneficiary reimbursements for doing so.

Mindful of both the severity of illness of PACE participants and the considerable resources expended on their behalf, CMS historically has conducted comprehensive onsite biennial audits of PACE organizations. These audits have been designed to evaluate their compliance with the PACE regulations, including the quality, appropriateness and safety of clinical and non-clinical care and services, as well as the administrative (or operational) oversight of the PACE program (e.g., enrollment and disenrollment practices, governance, and participants' rights to services). In the past these audits have been conducted through an assessment of 10 clinical "elements" ? components of the PACE organization environment, staffing, care planning and service delivery ? and 10 operational elements. (See Table 1.)

Structurally, these pre-2017 audits required the PACE organization to submit its policies and procedures, committee minutes, temperature and maintenance logs, Quality Plan and Annual Quality Reports, and other plan documents for auditor review prior to the site visit. While on site, the clinical audit team would review further documents, including personnel records and participant medical records; survey the day center environment for safety concerns; observe the delivery of care and services (e.g., clinical care, meal service and transportation); observe interdisciplinary team (IDT) and care planning

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PACE AUDIT PREPAR ATION GUIDE

meetings; conduct extensive interviews with staff and leadership; visit alternative care settings; and perform home and nursing home visits. Under the pre-2017 audit protocol, the operations team would review grievances and appeals, conduct van inspections, review organizational contracts, and examine marketing, enrollment and disenrollment practices and documentation.

Within a month of completing the audit, CMS issued a report focused on deficiencies noted during the on-site review. Elements judged to be "Met" were considered compliant with PACE regulations. "Met with Note" elements also were deemed compliant, though CMS auditors typically provided recommendations to enhance compliance or improve organizational performance. Elements considered "Not Met" were deemed by auditors to be not compliant with regulations, and the PACE organization was expected to submit a Corrective Action Plan (CAP), i.e., a plan to bring the PACE organization back into compliance with regulations.

More recently, in response to requests from both internal and external stakeholders, CMS has examined its prevailing audit process and implemented a significant overhaul of the process beginning in 2017.

Features of the 2017 PACE Audit

Implementation of the 2017 audit protocol has affected every aspect of the PACE audit, reducing the number of audited elements, eliminating some elements that were reviewed in the past, replacing the Met/Not Met/Met with Note designations, and changing the PACE organization requirements for document submission prior to and after the audit.

2017 Audit Elements

Table 1 depicts the evolution of the pre-2017 audit elements to five elements in the 2017 protocol. Reviews of Personnel Records and Quality Management remain, though with changes in the scope and process of reviews. The Onsite element aggregates components formerly audited under Infection Control, Dietary Services, Service Delivery and Emergency Care, and Transportation Services elements. The Clinical Appropriateness and Care Plans element consolidates pre-2017 IDT, Participant Assessment, Plan of Care, and Medical Records elements. Finally, operational elements are directed to Service Delivery, Appeals and Grievances (SDAG), reflecting an emphasis on the approach of the PACE organization to managing grievances and participant/ caregiver requests for services. Although CMS is reviewing fewer elements, there are two caveats. As before, CMS reserves the right to evaluate other services and components of PACE operations if auditor observations warrant, and the SAA may review any of the applicable "old" elements required for their state audit protocols.

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PACE AUDIT PREPAR ATION GUIDE

Table 1: Summary of Pre-2017 and Current CMS Audit Elements

Pre-2017 Element Code

PRS 24

ENV 02 DTY 01 SDY 12 TRS 01

SDY 03 SDY 04 SDY 05 MR 01 QAP 06

ENV 01

Pre-2017 Element Name

CLINICAL ELEMENTS* Personnel Training and Oversight of Direct Participant Care Infection Control Dietary Services Service Delivery and Emergency Care Transportation Services (previously an operational element) Interdisciplinary Team Participant Assessment Plan of Care Medical Records Internal Quality Assessment and Performance Improvement Program Activities Physical Environment

2017 Elements Personnel

Onsite

Clinical Appropriateness and Care Plans Quality Deleted for 2017*

PRT 06 PRT 07 PRT 08

GOV 01 CTS 01 PRT 04 MKT 03 MKT 08 MKT 09

OPERATIONAL ELEMENTS* Grievance Process PACE Organization's Appeals Process Additional Appeal Rights Under Medicare or Medicaid Governing Body Contracted Services Explanation of Rights Enrollment Process Voluntary Disenrollment Involuntary Disenrollment

SDAG (Service Delivery, Appeals and Grievances)

Deleted for 2017* Deleted for 2017* Deleted for 2017* Deleted for 2017* Deleted for 2017* Deleted for 2017*

* PACE auditors maintain the right to evaluate any or all aspects of the deleted elements if there is evidence of concern noted during the on-site visit.

Pre-Audit Data "Universes"

The pre-audit requests by CMS for PACE organization policies and procedures, related documents, and participant and personnel rosters largely have been replaced in 2017 by requests for data "universes" (i.e., rosters or inventories) from various PACE organization disciplines or departments, enabling the CMS audit team to select samples over the audit period for on-site review. The "audit period" ? formerly dating back to the conclusion of the previous audit, generally up to two years ? has been modified to the 12-month period preceding the date of the Audit Engagement Letter. Currently, the seven requested universes are as follows:

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PACE AUDIT PREPAR ATION GUIDE

? Service Delivery Requests Record, documenting the disposition and timelines of all service requests made by participants and their caregivers;

? Appeal Requests Record, also listing the outcome and process timelines of all participant and caregiver appeals;

? Grievance Requests Record, listing the outcome and process timelines of all participant and caregiver grievances;

? Personnel Records, encompassing all personnel employed during the audit period (i.e., full-time, part-time, contract and volunteer) including personnel terminated during the audit period;

? Participant Medical Records, including all enrolled and disenrolled participants who received care during the audit period;

? Quality Assessment Initiatives Record, comprised of all quality projects and initiatives conducted by the PACE organization during the audit period; and

? On-Call Universe, encompassing after-hours clinical and administrative calls.

PACE organizations are expected to submit these universes via the CMS Health Plan Management System (HPMS) 30 days after receipt of the Audit Engagement Letter (i.e., 30 days before the start of the CMS site visit).

Site Visit

The CMS site visit will look very much like visits in prior PACE audits, using the same audit team composition, except the "Deleted for 2017" elements in Table 1 will not be reviewed. Further, some auditors may choose to perform medical record review and/ or review of other elements as a desk audit or webinar prior to or during the site visit, potentially affecting the duration and staffing of the on-site portion of their audit. Auditors still will review samples selected from the submitted universes and observe clinical care, representative food service, transportation and emergency services; but reviews of policies and procedures and other internal documents will be de-emphasized, unless auditor questions, needs for explanations, or concerns arise during the audit.

In the 2017 audit protocol a review of participant medical records becomes a main focal point of the clinical audit team because the records fall at the intersection of participant assessment, IDT collaboration, care planning, performance of the clinical team, organizational responses to emergency care needs, infection control, and activities by related disciplines.

As a complement to medical record review, clinical auditors will be making multiple clinical observations (e.g., home visit, clinic visits and emergency medications and equipment) to better understand and observe how the PACE clinical staff translates its care plans into providing actual care and services to participants.

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PACE AUDIT PREPAR ATION GUIDE

The audit team also will use the Personnel Records Universe to select a sample of employed and contracted staff files for review, which is very similar to reviews prior to 2017. As in the past, auditors will review the presence of OIG and background checks, licensure and/or certifications, completion of training, orientation, and competencies and required immunizations per organizational policies.

Finally, the clinical audit team will review the quality program of the PACE organization, using a somewhat different review process than what was used in prior audits. Primarily using a "tracer" methodology, auditors review a sample of the quality initiatives of a PACE organization from inception to completion, including the genesis of the initiatives, the process by which the PACE organization evaluated its data, the comprehensiveness of staff involvement, conclusions, actions taken to improve organizational outcomes, and the overall effectiveness of the quality program.

Review of the Service Delivery Requests, Grievances and Appeals Universes generally falls under the purview of operations audit team members. These universes reflect the effectiveness of the IDT in overseeing care, responsiveness of the PACE organization to participant/caregiver requests, suggestions and grievances, timeliness of approvals and denials, and compliance with requirements regarding appeals and appeal rights for organizational decisions.

Audit Outcomes

As a result of auditor observations, concerns or issues with potential for non-compliance with regulations, the PACE organization may be requested to provide a Root Cause Analysis (RCA) or Impact Analysis (IA) during or after the site visit. The intent of an RCA ? which generally requires a brief, accurate explanation of why a potentially noncompliant event occurred ? is to determine whether an irregularity noted during the audit reflects a "one-off" lapse or a systemic failure. For example, a single missing social work assessment attributable to a participant's inability to keep an appointment may be viewed differently than multiple missing assessments in several disciplines.

Similarly, an IA attempts to determine the extent to which an observed lapse or potentially non-compliant practice impacts the participant population of a PACE organization. For example, a systemic issue affecting any of the five elements might prompt auditors to request an IA to determine how extensively, if at all, the deficient PACE organization system compromises access to care and services or the exercise of participant rights.

In its efforts to enhance consistency in the PACE audit process, CMS has created an entity called the PACE Audit Consistency Team (PACT), a group comprised of PACE auditors and PACE audit subject matter experts charged with making final determinations about concerns or areas of non-compliance noted during the site visit. As a result, auditors in 2017 will not define conclusions about their audit observations nor any corrective action required of the PACE organization at a debrief or exit conference. Rather, the PACT will review auditor documents and, in concert with the CMS audit team, render the decision about PACE organization responsibilities for audit follow-up, generally within four weeks of the exit conference.

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PACE AUDIT PREPAR ATION GUIDE

Compliance Determinations

In contrast to the Met/Not Met/Met with Note designations previously determined by the PACE audit team, CMS has revised the designation for audited elements in 2017, depending on the degree of observed compliance with the PACE regulations.

OBSERVATION

Somewhat analogous to "Met with Note" designations under the prior audit protocol, observations reflect occasional, immaterial, non-systemic or low-impact issues of noncompliance whose correction would enhance compliance with PACE regulations.

CONDITION OF NON-COMPLIANCE

Comparable to a "Not Met" in pre-2017 audits, a condition reflects non-compliance with one or more PACE regulations. Unlike a "Not Met" in previous years, where an entire element may have "failed" the audit, a condition generally refers to an aspect of an element that is found to be out of compliance. A condition of non-compliance will result in one of two requests from CMS:

? Corrective Action Required (CAR): A CAR may be requested when an element is found to be out of compliance with PACE regulations. Commonly, these involve systemic deficiencies in training and orientation, internal oversight, or deficiencies that do not affect participant health or safety.

? Immediate Corrective Action Required (ICAR): This designation is invoked when deficient practices or processes, left uncorrected, are deemed to imperil the care, safety or rights of participants. Deficient safety and security practices, lax medication administration processes, unresponsiveness to falls, and failure to implement PCP/NP orders may be grounds for an ICAR designation, requiring an emergent corrective action by the PACE organization.

Audit Milestones for the PACE Organization

Although the responsibilities for audit preparation are similar to those of audits prior to 2017, the pre-audit, audit and post-audit document submissions of the PACE organization to CMS are substantially different in 2017. The executive director, quality director or other designated point of contact can organize the audit phases under four major milestones and associated activities.

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PACE AUDIT PREPAR ATION GUIDE

Pre-Audit Period-- 60 Days

Prior to Audit

30 Days Prior

to Audit

Audit

Post-Audit

Exhibit 1: Audit Milestones

? Engagement Letter ? Conference Call ? Attachments II and III

? Universe Submissions ? Audit Logistics

? On-site Logistics ? Potential RCAs, IAs ? Exit Conference

? Potential RCAs, IAs ? Potential CARs, ICARs ? Draft Audit Report ? Final Audit Report

PACE Organization Responsibilities ? Pre-Audit Period (60 Days Prior to Audit)

ff Receipt of engagement letter ff Attestation of receipt ff Conference call with CMS/SAA audit team ff Submission of Attachments II and III

? 30 Days Prior to Audit ff Submission of audit "universes" through HPMS ff Initiation of on-site (and/or desk audit/webinar) logistics

? CMS/SAA Site Visit ff On-site logistics ff Document request log ff Preparation of root cause analyses and impact analyses, if requested ff Exit Conference logistics

? Post-Site Visit ff Preparation of RCAs, IAs, if requested ff Response to Draft Audit Report ff Preparation of CAP, if requested

See Corresponding PACE Audit Timeline [Appendix 2] for more detail.

Pre-Audit Period

The first audit milestone is the receipt of the Audit Engagement Letter, sent by the Audit Lead to the PACE organization 60 days before the scheduled site visit. This letter triggers four immediate "deliverables" for the executive director, quality director or audit designee of the PACE organization.

Within two business days the PACE organization is obligated to submit an attestation to the engagement letter through HPMS. The attestation is simply an acknowledgement that the organization has received the letter and is aware of the scheduled audit date.

Many PACE organizations may have a single individual with attestation rights (e.g., executive director, compliance office, chief financial officer), so this attestation step may need to be delegated to the individual with those rights.

A conference call with the PACE organization will be scheduled by the Audit Lead within two to three business days after distribution of the engagement letter. The PACE organization may choose to include only the audit point of contact (POC) or any additional key personnel who are expected to have roles in preparation for and during the audit.

Finally, the engagement letter references Attachments II and III, both of which can be downloaded from HPMS (under Submission Materials).

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