Overview and Summary of PACE Audit Challenges

Overview and Summary of PACE Audit Challenges

July 25, 2014

In recent years,CMS has transferred primary responsibility for PACE audits toits regional offices and has enhanced the use of HPMS data in such audits.As thesechanges have been implemented, members of the National PACE Association(NPA) have expressed increasing concern regarding PACE audit subjectivity and inconsistency.Their observations are that auditors:

• often do not have a full understanding of PACE operations;
• lack interpretive guidelines to support determinations regarding regulatory compliance; and
• demand changes to established and compliant practices based on their preferences or to ease their administrative burden in auditing PACE organizations.

Additionally, largely due to the definitional ambiguity of HPMS “measures,” audit findings regarding PACE compliance and performance that are based on variations from regional and national HPMS “averages” are not reliable.Taken together, these factors have compromised the value and reliability of PACE audits.

After raising these concerns with CMS and in response to its request, NPA sought specific examples from PACE organizations regarding audit challenges and issues stemming from auditor subjectivity or inconsistency.It is our sincere hope that the feedback and recommendations offered in this letter will promote further communication and consultation between CMS and NPA with regard to the future direction and focus of the audit process.

Over the past few years, NPA’s analysis of audit findings indicates that the process results in inconsistency over time and across regions.Inconsistency across PACE regionsresults in practices being deemed compliant, and even exemplary, for a PACE organization in one region and a similar practice, in some cases implemented by the same PACE organization, being found deficient in another region. Reflecting the conversations of NPA with PACE organizations, we provide specific concerns below related to the audit process that we would like to bring to the attention of CMS:

Transparency and Regulatory Compliance

A general area of concern relates to the lack of transparency regarding how PACE organizations are evaluated for compliance with specific regulatory requirements.There is no guidebook orcriteria (interpretive guidelines) on how auditors will assess compliance with the regulatory provisions.These types of guidebooks exist in audits of acute care hospitals by both CMS and the Joint Commission, as well as for use by nursing home surveyors.

The lack of interpretive guidance results in a degree of subjectivity that causes inconsistency in the audit process findings, further exacerbated by auditors with a limited understanding of PACE.For example, as noted earlier,NPA is aware of cases in which a previous “best practice” was cited as deficient in a subsequent audit though there had been no change in the practice.

The lack of specificity in the audit process also invites overreach in the audit process.For example, a PACE organization reported being cited for its on-call tracking process, a process that is not proscribed by regulation.

Clearer guidance is especially needed when auditors do not have a well-developedunderstanding of the PACE program because ofthe current need by CMSto draw PACE auditors from other programs, e.g., Medicare Advantage.As an example, we understand that a PACE organization was instructed to modify its enrollment materials to reflect a definition of grievances that is not applicable to PACE, nor compliant with the PACE regulation.Specifically, the PACE organization was told that a denial of service was a grievance, and written materials, policies and procedures should be modified accordingly.Such a change would deem the PACE organizations as noncompliant with the federal regulation.

Similarly, auditors are applying their background in surveying institutional providers to PACE without understanding the PACE model.For example, a number of sites have indicated that auditors request that a “service request log”be maintained, a practice routinely used in institutional audits.However, there is no current PACE regulation specifying this mandate.There is currently a“practice” that CMS account managers are requesting these service request logs for quarterly calls, as well as audit review.It is felt that these requests are being made for the convenience of the auditor to obviate the review of charts, IDT notes/minutes, etc.While we clearly agree that the HPMS system is not user-friendly or remotely applicableand has limited value to PACE, the burden for overcoming the shortcomings of the system should not solely be borne by PACE organizations.

Another PACE organization observed bias byan auditor due to his/her past employment history and experience.In this instance, a newly hired auditor who had experience with the U.S. Food and Drug Administration spent a significant amount of time inspecting the kitchens of a PACE center at the expense of other equally important practices relating to participant clinical care.The variation in experience may suggest the need for centrally coordinated auditor training and implementation guidance for the audit process across CMS regions.

Lastly, lack of specificity in the audit process is leading to overly broad interpretations of the on-site audits findings.One member expressed concern that an auditor determined that a deficiency on any element was thereby a deficiency of quality (e.g., an error in infection control(IC) resulted in a corrective action plan and a citing for both IC andquality).While we appreciate that quality should be at the helm of improvement and overseeing corrective actions, we did not feel that a PACE program should receive two “dings.”

Regional Variation

Regions are applying different standards with regard to the information they must be provided, their scrutiny of program staffing, and the quality of care plans:

Region IV requires that an entire report on data that was already submitted to HPMS be replicated and submitted for quarterly calls.Given the lack of “user-friendliness” of the HPMS system, this is redundant and significantly time-consuming for the PACE program.These quarterly calls have become more in-depth and akin to a virtualaudit rather than a mutual quest for understanding what constitutes compliant practices and enhancing quality.

Region VII auditors are reported to be quite prescriptive in how they prefer to see PACE programs operate.For example, one auditor was particularly critical of a program’s staff model, stating that the program had “too many physicians.”The auditor also requested several times during the audit to gainremote access to the program’s electronic medical record (EMR) system.

To some degree, similar requests have been made in Region IV.

There is too much variability in the audit process regardingwhat constitutes a compliant care plans, which effectively leads to substantial variation in practice across PACE and compromises the ability to identify and help to replicate best practices.A care plan in Region I should stand in Region II, etc.

Audit Planning and Preparation

The on-site audit process is unavoidably disruptive to the operations of PACE organizationsand should be planned well in advance to minimize the impact on PACE participants.Audit dates in the past year have been changed with less than one month’s notice, and the audit schedule has not been provided to PACE organizations in advance.We recommend a set timeframe for scheduling audit dates in advance and for establishing a preliminary schedule for the on-site review.In preparation for the audit, to minimize the disruption to PACE staff and services, we recommend that provided materials be reviewed in advance by the audit team.We also recommend that the audit team members be familiar with the general reimbursement, program model, regulatory requirements (both shared with Medicare Advantageorganizations and specific to PACE) and services of PACE prior to beginning the audit.

Post-Audit Experience with Corrective Actions Plans

One new PACE program indicated that its post-audit experience lacked effective and consistent communication from CMS, consistency between auditors, and compliance with state administering agency (SAA) requirements.

Regarding communication, the PACE programwas not informed by the Regional Office or Account Manager that once a dispute is received, the Corrective Action Plan (CAP) submission date is on hold until the results of the dispute are received.Thus, the program submitted CAPs in HPMS on the date indicated in the letter and was subsequently informed that they were “null and void” and a resubmission would be necessary.Three submissions were required to achieve compliance.Our understanding is that PACE programs have additional time after the CAP approval to complete the entire plan/documents.In this scenario, the Account Manager required that all documents be submitted (hard copy) on the same day as the CAP submission in HPMS.During the CAP approval process, the Account Manager made a number of conflicting requests (i.e., submit hard copy vs. email per element in a zip file).The Account Manager also frequently modified the submission deadline (e.g., send next day by 11 a.m. following an afternoon call; same-day requests within 10 minutes, 30 minutesand one hour).

In this case, the PACE program also experienced inconsistency between the On-Site Audit Team and the Post-Audit Team.While the On-Site AuditTeam was very positive with continual feedback on the progress made for a new program, the Post-Audit Team, led by the Account Manager, stated that the program was not “on target.”Moreover, the Post-Audit Team continued to change/alter the requirements (documents) for submission, which were unrelated to the original deficiency.

Lastly, the Account Manager required that the PACE program use the CMS Model Letter as is rather than edit the Model Letter in order to comply with thestatemandate that the letter be written at a sixth-grade reading level.

This example highlights the sometimes punitive and inconsistent nature of the audit experience of PACE programs.

On-Site Communications

We recommend that the audit team and PACE team should meet at the outset of the audit to review the schedule and discuss the information and access the audit team will need while onsite.This can help to assure that the audit team develops its findings based on access to necessary information and staff.In some cases, PACE organization staff did not have the opportunity to provide additional information to reviewers that would, at least in some cases, have led to different audit results.We suggest that at the end of each audit day, the audit team and PACE team should meet to review any issues identified related to the conducting of the audit and plan for the audit activities of the following day.This will help to ensure that the audit team has the information it needs and allow PACE team members to plan for the time they will need to be available for the audit.

Communication between the audit team members and the PACE team members should reflect respect for each other’s responsibilities, efforts and professionalism.While audit team members have a responsibility to assure PACE compliance with PACE requirements during their on-site review, the PACE organization staff works diligently to meet the needs of the PACE participants on a daily basis.The perspectives of both the audit team members and the PACE staff must be considered in order to accurately assess the PACE organization.

Medical Record Review

PACE auditors will need to understand how to review and extract information from EMRs if they are to assess accurately the medical record keeping of PACE organizations.We recommend that CMS clarify the relationship between hard copy and EMRs in situations where both are used.Because current EMR systems do not encompass the full range of medical, rehabilitative, social and aging services provided by PACE organizations, these systems often are used in combination with other electronic records or with hard copy records. Auditors should demonstrate a willingness to review EMRs and the level of understanding necessary to assess these records for compliance with PACE requirements.

Audit Team Interaction with Staff and Contractors

The audit team’s interactions with staff and contractors should focus on the compliance issues relevant to the PACE organization.Interactions that relate to personnel management issues should be limited and reported to the PACE program director.Audit team members should not become involved in internal staff or contractor disagreements or issues that do not relate to the compliance of the PACE organization with regulatory requirements.

Lastly, we are also sharing results from a comprehensive analysis of PACE audit data conducted in 2011 that illustrates the degree of variation regarding audit findings.While dated, it fairly reflects the concerns expressed by our PACE organization members regarding intra- and inter-region variation.

Summary and Recommendations

It is our impression that there is no other healthcare delivery system thathas to endure as extensivean audit process as PACE programs.As an example, many PACE sponsors are hospices that often report a five-year or longer interval between on-site CMS audits.NPA strongly encourages CMS to examine the audit process, develop audit guidelines, increase collaboration among CMS regional offices, and enhance auditor training.It is our sense that the PACE regulations are not consistently applied and CMS regions work in silos.Such variation does not aid NPA in its national efforts to identify best practices among PACE programs and thereby improve the delivery of care to PACE participants, nor does it allow for appropriate program operational variations reflecting evolving innovations and improvements.

As an organization with a history of expecting, supporting, and assisting with PACE quality, NPA has a strategic planning goalof supporting and enhancing PACE quality.Not only is it what distinguishes PACE from other models of care for the frail elderly, it is a responsibility embodied in the culture of PACE and NPA.

We appreciate your consideration of our concerns and look forward to continued collaboration with you in support of implementing an effective audit process for PACE.Once you have had the opportunity to review our concerns, please contact me at
703-535-1567 to discuss next steps.

Sincerely,

Shawn M. Bloom

President and CEO

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