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R PACE Audit Preparation Guide

AUGUST 2017

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

https://www.cms.gov/Medicare/Compliance-and-Audits/Part-C-and-Part-D-Compliance-and-Audits/PACE_Audits.html

2 PACE AUDIT PREPARATION GUIDE

BackgroundThe Centers for Medicare & Medicaid Services (CMS), in concert with State Administering

Agencies (SAAs), has been conducting regular audits of PACE organizations for over a

decade. PACE organizations, viewed as variants of Medicare Part C managed care orga-

nizations (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 Medi-

care/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 resourc-

es expended on their behalf, CMS historically has conducted comprehensive on-site

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, gover-

nance, 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 operations 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 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 opera-

tions team would review grievances and appeals, conduct van inspections, review orga-

nizational 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 com-

pliant 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. The new PACE audit protocol focuses on clinical and

operations outcomes rather than on processes.

Features of the 2017 PACE AuditImplementation of the 2017 audit protocol has affected every aspect of the PACE audit,

reducing the number of audited elements, eliminating some elements that were re-

viewed in the past, replacing the Met/Not Met/Met with Note designations, and chang-

ing the PACE organization requirements for document submission prior to and after the

audit.

2017 Audit ElementsTable 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 compo-

nents 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, operations 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” ele-

ments required for their state audit protocols.


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

Pre-2017 Element Code Pre-2017 Element Name 2017 Elements

CLINICAL ELEMENTS*PRS 24 Personnel Training and Oversight of Direct

Participant CarePersonnel

ENV 02 Infection Control

Onsite

DTY 01 Dietary Services

SDY 12 Service Delivery and Emergency Care

TRS 01 Transportation Services (previously an operational element)

SDY 03 Interdisciplinary TeamClinical Appropriateness and Care Plans

SDY 04 Participant Assessment

SDY 05 Plan of Care

MR 01 Medical Records

QAP 06 Internal Quality Assessment and Performance Improvement Program Activities

Quality

ENV 01 Physical Environment Deleted for 2017*

OPERATIONS ELEMENTS*PRT 06 Grievance Process

SDAG (Service Delivery, Appeals and Grievances)

PRT 07 PACE Organization Appeals Process

PRT 08 Additional Appeal Rights Under Medicare or Medicaid

GOV 01 Governing Body Deleted for 2017*

CTS 01 Contracted Services Deleted for 2017*

PRT 04 Explanation of Rights Deleted for 2017*

MKT 03 Enrollment Process Deleted for 2017*

MKT 08 Voluntary Disenrollment Deleted for 2017*

MKT 09 Involuntary Disenrollment 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 au-

dit 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 request-

ed universes are as follows:


• 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 VisitThe 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, po-

tentially 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 poli-

cies 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, organi-

zational 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 clin-

ical observations (e.g., home visit, clinic visits and emergency care) to better understand

and observe how the PACE clinical staff translates its care plans into providing actual

care and services to participants.

The audit team also will use the Personnel Records Universe to select a sample of em-


ployed and contracted staff files for review, which is very similar to reviews prior to

2017. As in the past, auditors will review job descriptions, licensure and/or certifications,

training and orientation materials, competencies and required immunizations per organi-

zational 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

fall 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 OutcomesAs 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 non-compliant

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 as-

sessment 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 poten-

tially 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 enti-

ty 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.


Compliance DeterminationsIn 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.

ObservationAnalogous to “Met with Note” designations under the prior audit protocol, observa-

tions reflect occasional, immaterial, non-systemic or low-impact issues whose correction

would enhance compliance with PACE regulations.

Condition of Non-ComplianceComparable 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 ele-

ment 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): Comparable to the Corrective Action Plan (CAP) requirement in prior audits, a CAR may be requested when an element is found to be out of compliance with PACE regulations. Commonly, these involve deficiencies in training and orientation, internal oversight, or deficiencies that do not affect participant care 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 OrganizationAlthough 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 organiza-

tion 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.


Exhibit 1: Audit Milestones

See Corresponding PACE Audit Timeline [Appendix 2]

PACE Organization Responsibilities

• Pre-Audit Period (60 Days Prior to Audit)

f Receipt of engagement letter

f Attestation of receipt

f Conference call with CMS/SAA audit team

f Submission of Attachments II and III

• 30 Days Prior to Audit

f Submission of audit “universes” through HPMS

f Initiation of on-site (and/or desk audit/webinar) logistics

• CMS/SAA Site Visit

f On-site logistics

f Document request log

f Preparation of root cause analyses and impact analyses, if requested

f Exit Conference logistics

• Post-Site Visit

f Preparation of RCAs, IAs, if requested

f Preparation of CAP, if requested


Pre-Audit PeriodThe 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 desig-

nee 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., exec-

utive 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 organi-

zation 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).

Attachment II (“Supplemental Questions”) must be completed within five business days

of the engagement letter. The short questionnaire requests additional information about

grievance policies, emergency medications and emergency preparedness training, the

PACE organization EHR, communication capabilities available to drivers, and the service

request policies of the organization. (See Appendix 1, Exhibit 2: Engagement Letter

Attachment II.) Because PACE organizations are no longer tasked with submitting com-

prehensive organizational policies and procedures in advance of the audit, CMS will use

responses to Attachment II (and the corresponding policies) to determine the standards

that should be applied throughout the audit. For example, in their review of personnel

samples, auditors would expect to find evidence that immunizations required in the poli-

cies of the PACE organization were made available to personnel.

Though remote access to PACE organization medical records is not required, some orga-

nizations have IT capabilities for, and organizational policies permitting, remote electron-

ic record review. Question No. 8 references this issue to assist CMS in audit scheduling

and staffing. Some auditors may choose to begin record review remotely in advance of

the site visit, if that option is available.

Attachment III (“Pre-Audit Issue Summary), due within five business days of the engage-

ment letter, is an Excel spreadsheet that affords PACE organizations the opportunity

to document issues of potential non-compliance that previously were self-disclosed to

CMS. The spreadsheet, which has self-explanatory data fields, is not intended to cap-

ture Level I or II data already reported through other avenues. Rather, it is intended to

encompass self-discovered issues identified by the PACE organization and reported to

CMS previously, even if remediation efforts are not yet completed (e.g., a non-compliant

service delivery timeline or failure to conduct OIG checks on employees or contractors).


Attachments II and III, when completed, are uploaded to HPMS (along with any policy,

medication list or other companion documents) via the Data Upload tab into the Supple-

mental Files.

After the completion of these four deliverables, the next major milestone for the PACE

organization is to prepare and submit the seven required universes: service delivery re-

quests, appeals, grievances, personnel, participant medical records, quality and on-call.

The zip file containing these templates can be downloaded from HPMS (Audit Materials

Repository/Universe Templates for PACE Organizations). Though instructions for com-

pleting these documents are mostly self-explanatory, sample illustrations are included

in Appendix 1 (Exhibit 3: Service Delivery Request Universe and Exhibit 4: Quality As-

sessment Initiatives Template). PACE organizations instead may choose to use the NPA

Audit Data Universe Templates and the corresponding Operational Guide developed by

the NPA PACE Audit Task Force for assistance in completing the requested universes, or

they may contact their account manager for additional assistance.

The due date for these documents is 30 days prior to the on-site audit.

30 Days Prior to Audit The PACE executive director, quality director or other delegated staff member can sub-

mit these universes through HPMS via the Data Upload tab into the “Universe File” fold-

er. CMS will conduct data validation and integrity checks and, if necessary, request that

the PACE organization resubmit one or more of the universes with corrected data fields.

In audits prior to 2017, the executive director, quality director or site manager commonly

assumed the role of coordinating audit activities in advance of the site visit. That role re-

mains largely unchanged for 2017 audits. The PACE organization point of contact (POC)

will collaborate with the audit lead in designing a tentative audit schedule. In addition,

the POC will be responsible for coordinating logistical efforts in order to provide the

following:

• laptop computers or work stations for auditors’ medical record review, including arrangements for auditors’ system access, passwords, training and available IT support;

• conference room(s) for auditor document reviews and discussions;

• security, including badges, parking and auditor accessibility to the day room, clinic and other adult day center facilities;

• schedules for personnel or participant interviews, if requested, and care observation (including one or more home care visits), if requested; and

• scheduling for morning meetings and care plan meetings, as requested.

If auditors opt to review medical records or other documents remotely, the PACE organi-

zation POC may be requested to assist in scheduling webinars or desk reviews with the

audit team.


CMS/SAA Site VisitAs in past years, the PACE organization POC will retain the responsibility to assist in

scheduling changes while the audit is proceeding, based around staff and participant

availability, clinic hours, availability of participants receiving home care services, and

auditor requests.

At the entrance conference, the executive director or designee may choose to provide a

PowerPoint (or other) presentation of the history of the PACE organization and any signif-

icant changes that occurred since the previous audit [e.g., census changes, new alterna-

tive care settings (ACSs), or expansion]. Rather than handing in attendance sheets to the

audit lead, the executive director will be asked to upload attendance sheets to HPMS for

the entrance and exit conferences and all other meetings/interviews that involve CMS

audit staff.

There are two other differences in the audit responsibilities of PACE organizations in

2017 compared to prior years:

• To better track documents that auditors request for review, they will upload all requests to the Document Request Log (DRL) in HPMS. The PACE organization will be responsible for uploading the requested documents to HPMS (Data Upload tab), rather than producing hard copy documents for the audit team members.

• As noted above, auditors may request PACE organization to undertake an RCA and/or IA for issues of concern raised by CMS. The RCA/IA templates can be downloaded from HPMS (Submission Materials, Attachment IV Impact Analysis.zip), completed by the PACE organization using the process noted in Appendix 1, Exhibit 5. The completed templates then are uploaded to HPMS (Data Upload tab).

Post-Site VisitThe audit lead will present information about next steps at the exit conference. This con-

ference may include a discussion about areas of concern, but final decisions regarding

specific observations and conditions of non-compliance will be made by the CMS PACT

team, in collaboration with the audit team, in the weeks after the site visit. The PACT

could request additional RCAs or IAs, even after the site visit has been completed. If ei-

ther or both of these analyses are requested, the POC will be responsible for completing

the relevant templates, as described above, within the requested timeframes.

The PACE organization will receive a draft audit report from CMS approximately 30 days

after the date of the exit conference and will have 10 business days to offer comments,

request clarifications, or dispute audit findings.

CMS will issue the final audit report approximately two to four weeks after reviewing

comments in the draft report. If a condition of non-compliance is deemed to exist, the

PACE organization POC will be requested to complete and submit a CAP. As in previous

years, the CAP takes the form of a narrative that describes remedial steps and includes

files, copies or screen shots of supporting documentation, new policies or other files

consistent with the request by CMS. At present, CMS does not prescribe a specific


format or template for CAP completion. An immediate CAR (ICAR), which is requested

because of a concern for participant safety, requires the same information but with a 72-

hour turn-around time. Given that CMS has adopted a new audit protocol for 2017, the

PACE organization POC will be best served by seeking explicit direction from their audit

lead and/or account manager to ensure full compliance with the requirements.

Finally, having experienced the audit preparation process and the audit itself, the PACE

organization may wish to consider adopting (or adapting) the Audit Universe Excel tem-

plates on an ongoing basis (i.e., using the CMS templates or NPA Task Force templates

as real-time tools for PACE documentation). Populating the templates on an ongoing

basis may provide the PACE organization with the benefit of the following:

• maintaining a compliant process for capturing required data and information (e.g., for SDAG and On-Call documentation);

• capturing hire and termination dates and license and certification changes for Personnel;

• maintaining a current inventory of services being provided to participants in the Participant Universe; and

• expediting preparation for subsequent CMS and SAA audits.


Appendix 1: Sample Submissions and Audit UniversesAudit Engagement Letter – Attachment II: Supplemental QuestionsThe Audit Engagement Letter includes two attachments, one of which is a list of supple-

mental questions. CMS expects responses to be submitted via HPMS within five business

days of the letter date. The questions are designed to assist CMS in understanding the

policies of the PACE organization (since the comprehensive pre-audit policy and docu-

ment review have been eliminated from the audit) and in audit staffing and assignments.

Responses to the supplemental questions should reflect an accurate description of cur-

rent policies and practices.

Exhibit 2: Attachment II: Supplemental Questions

Question Explanation

1: What time frame does your organization adhere to when processing grievances? Please include the page (or screen shot of the page) of your policies and procedures that is relevant.

Since PACE organizations are responsible for determining their own timelines for grievance resolution, organizational P&Ps provide the timelines used during the audit to determine internal compliance.

2: How does your organization communicate the resolution of grievances to participants?

Given variations in resolving grievances among PACE organizations, CMS is inquiring whether your organization uses oral, written or both types of notifications to participants.


Question Explanation

3: List the emergency medications (name, dosage and quantity) that your organization keeps readily available on-site at all times. (Note: List drug name as written on the product label.)

Auditors may review emergency medications on site as part of the Onsite element.

4: What emergency or disaster preparedness trainings must staff receive? How frequently are these trainings administered?

Though auditors expect the existence of emergency/disaster training, CMS mandates only that PACE organizations include training relevant to their geographic region and regional history (e.g., earthquake, tornado, snowstorm).

5: What vaccinations do you require your personnel with direct participant contact to receive?

CMS does not mandate specific immunizations for personnel and contracted staff but does require PACE organizations to address them per organizational policy.

6: How do drivers communicate with your organization while transporting participants?

Indicate if drivers have a method of communicating and which method the organization uses (e.g., organization-provided cell phones, radio, etc.)

7: Include the name(s) of your organization’s electronic medical record system, if applicable.

This is self-explanatory.

8: Can we access your medical records remotely?

Notify the audit team if participant records can be reviewed as a desk audit prior to or during the site visit.

9: Please describe when your organization deems a service delivery request as received by the IDT. Attach the portion of the policy or procedure that discusses receipt of a service delivery request.

Another request for organizational policy, this question asks whether the PACE organization considers a service request as being received by the IDT when an IDT member receives the request or when that request is presented to the full IDT.

Service Delivery Request Universe§460.104 Participant Assessment

(d) Unscheduled reassessments. In addition to annual and semiannual reassessments, unsched-uled reassessments may be required based on the following:

(2) At the request of the participant or designated representative. If a participant (or his or her designated

representative) believes that the participant needs to initiate, eliminate, or continue a particular service, the appropriate members of the interdisciplinary team, as identified by the interdisciplin-ary team, must conduct an in-person reassessment.

(i) The PACE organization must have explicit procedures for timely resolution of requests by a participant or his or her designated representative to initiate, eliminate, or continue a particular service.

(ii) Except as provided in paragraph (d)(2)(iii) of this section, the interdisciplinary team must notify the participant or designated representative of its decision to approve or deny the request from the participant or designated representative as expeditiously as the participant’s condition requires, but no later than 72 hours after the date the interdisciplinary team receives the request for reassessment.


(iii) The interdisciplinary team may extend the 72-hour timeframe for notifying the participant or designated representative of its decision to approve or deny the request by no more than 5 additional days for either of the following reasons:

(A) The participant or designated representative requests the extension.

(B) The team documents its need for additional information and how the delay is in the interest of the participant….

(iv) The PACE organization must explain any denial of a request to the participant or the partici-pant’s designated representative orally and in writing. The PACE organization must provide the specific reasons for the denial in understandable language. The PACE organization is responsible for the following:

(A) Informing the participant or designated representative of his or her right to appeal the deci-sion as specified in §460.122….

Section §460.104 of the PACE regulations spells out expectations and requirements of

the PACE organization when a participant or designated representative requests a

service from the organization. The PACE organization is required to consider the request

and conduct an in-person assessment by relevant disciplines as a result of a service

request. Except under either of two circumstances defined in §460.104(d)(2)(iii), the PACE

organization also must provide a response to the participant within 72 hours after the

IDT receives the request, including the participant’s appeal rights.

The Service Delivery Request Universe is used to determine compliance by the PACE

organization with the service request components of §460.104. PACE organizations may

choose to use their own roster or spreadsheet that contains the required fields or opt to

complete the Microsoft Excel universe template provided by CMS because it includes

all of the required data elements. Alternatively, PACE organizations may want to use the

NPA Audit Data Universe Templates and the corresponding Operational Guide devel-

oped by the NPA PACE Audit Task Force for assistance in completing the requested

universes.

Exhibit 3 below contains all columns of the Service Delivery Excel template and contains

a narrative that is relevant to populating the Service Delivery, Grievances and Appeals

universes. The first three rows of the spreadsheet contain the Excel column letters, the

requested data to be entered into each column, and CMS formatting instructions for

each cell or field. (Note: Use drop-down menus if they appear on the screen since this

will reduce the possibility of an incorrect universe submission.)


Exhibit 3: Service Delivery Request Universe

A B C D E F

Participant First Name

Participant Last Name

Participant ID

Person Who Submitted

Service Request

Date Service Delivery Request Received

Category of Request

50 Characters

50 Characters

25 Characters

50 Characters

CC YY/MM/DD

50 Characters

1

2

Data requested for completion of columns A through D are self-explanatory.

Column E requests the date that the PACE organization documents the request as being received by the IDT, as defined by the PACE organization’s policy.

The required information for Column F is also self-evident, as the options in the dropdown menu (e.g., Trans-portation, Dietary, Home Care, DME, etc.) are designed primarily to help stratify the data by disciplines from which the service requests are received.

G H I J K

Description of the

Request

Date(s) Assessment(s)

Performed

Discipline(s) Performing

Assessment(s)Assessment(s)

in PersonRequest

Disposition1,000

CharactersCCYY/MM/DD

format. Enter NA if an assessment

was not conducted. Separate multiple dates by commas.

Separate multiple disciplines by commas.

Enter NA if an assessment was not

conducted.

Y/N/NA Approved, Denied,

or Partially Denied

Instructions for columns H, J and K are self-explanatory.

Entries for Column G should reflect the information documented in the PACE organi-

zation service request log. Typically, it is a simple statement of the requested service,

possibly supported by the reason for the request. For example, the entry might read

“participant requested a rollator from physical therapy because she occasionally feels

unsteady when walking at home,” or “participant’s family requests respite care for the

weekend of April 21-24 so they can attend an out-of-town funeral.” This column allows

for a 1,000-character description. Since the template does not offer other columns for

entries related to the rationale for denials, PACE organizations may wish to add that de-

scription here to avoid ambiguity.

In general, per §460.104(d)(2), assessments triggered by a service request need be

conducted only by relevant disciplines and not the full IDT. In the above examples, the

request for a rollator may require assessments only from physical and/or occupational

therapy, and the request for respite care may only require a social worker and/or home

care nurse. Regardless, Column I requires a list of all disciplines that, per PACE organiza-

tion records, actually performed assessments in response to the specific service request.


L M N O

ExtensionDate of Oral Notification

Date of Written Notification

Date Service Provided

Y/N CCYY/MM/DD format. Enter NA if no oral

notification was provided.

CCYY/MM/DD format. Enter NA if no written notification

was provided.

CCYY/MM/DD format. Enter NA if request was

denied.

Column L asks if the IDT took an extension for the time to notify the participant of the

decision, under either of the exceptions in §460.104(d)(2)(iii) – “(A) The participant or des-

ignated representative requests the extension, or (B) The team documents its need for

additional information and how the delay is in the interest of the participant.”

Columns M through O should be self-explanatory, and simply request the dates of oral

notification to the participant (if performed), written notification to the participant (if

performed), and initiation of the service (if approved).

Quality Assessment Initiatives UniverseThe Service Delivery, Grievances, Appeals, Personnel, Participant Medical Records and

On-Call universes are similar in that each requires transcription of data elements likely

already recorded in PACE organization rosters and logs. The Quality Initiatives Universe,

on the other hand, may require the entry of information abstracted from multiple sourc-

es – the Annual Quality Report, Quality Work Plan, PACE Advisory Committee (PAC)

minutes, or other sources available to the quality director. For example, a PACE organiza-

tion may classify responses to Level 2 events, quality improvement activities, participant

satisfaction surveys, disenrollment tracking, trending of grievances, handwashing audits,

etc., as “quality initiatives.” Therefore, completion of the Quality Assessment Initiatives

Universe may require the quality director to aggregate information from the Quality Plan

and other internal sources and reframe other quality activities to meet the requirements

of the universe submission.

Most of the universe fields are self-explanatory, requesting start and end dates of quality

initiatives and corrective actions or Y/N/NA characterizations of entries as to how the

initiatives were generated (e.g., in response to an incident, as a product of a root cause

analysis, due to recognition of potential for participant harm). Other fields require entries

that may not be available in current organizational documents.


Exhibit 4: Quality Assessment Initiatives Universe

A B C D E F

Data Identifier

Quality Initiative

NameQuality

Initiative GoalQAPI Plan Incident

Type of Data Collected

Unique Numeric Identifier

100 Characters

100 Characters Y/N Y/N

200 Characters

1 Reduction in Fall Risks for Participants

Reduce the risks for falls and number

of falls among participants.

Y N Baseline falls data and medications, neurological conditions, environmental, behavioral and related fall

causes.

2

For example, each initiative requires a name, illustrated in Column B above. Additionally,

Column C calls for a brief explanation of the goal of each initiative entered, and Column

F requires an inventory of the types of data collected in support of the initiative.

G H I J K L M N

Start Date of Quality Initiative

End Date of Quality Initiative

Root Cause

Corrective Action

Required

Corrective Action

Implemented

Start Date of

Corrective Action

Potential Participant

Harm

Actual Participant

HarmCCYY/MM/DD format

CCYY/MM/DD format. Enter NA if the quality initiative is ongoing.

Y/N Y/N Y/N/NA CCYY/MM/DD format. Enter

NA if no corrective action was necessary.

Y/N Y/N

2017/02/17 NA N N NA NA N N

Columns G through N are straightforward, requesting dates or characteristics for each

initiative in the Quality universe.


O P Q R

Quality Improvements

Quality Improvements Description

Ongoing Review or

Monitoring

Frequency of Review/ Monitoring

Y/N 1,000 Characters Y/N Daily, weekly, monthly, random. Enter NA if

no ongoing review or monitoring is done.

Y Though the falls initiative is not yet completed, our IDT

already has learned that more frequent polypharmacy reviews

of participant medications seem to be correlated with

fewer fall incidents. Pending the completion of the initiative, our

pharmacy consultant will conduct medication reviews quarterly instead of semi-annually and

each time a medication is added to a participant’s regimen.

Y Quarterly

Finally, Column P offers 1,000 characters to describe the impacts or outcomes of the

Quality Assessment Initiative on care and service to or safety of participants, organiza-

tional processes and practices, responses to aggregated grievances and appeals, time-

liness of home care services, oversight of contracted services, organizational efficiency

and finances, or other relevant metrics.


Root Cause Analysis and Impact AnalysisDuring or after the site visit, CMS may request that the PACE organization complete a

Root Cause Analysis (RCA) and/or Impact Analysis (IA) for variances that reflect poten-

tial non-compliance with PACE regulations. Concerns noted about any of the five audit

elements can engender requests for RCAs, and CMS supplies a template for completion

by the PACE organization. This Excel template affords the PACE organization opportuni-

ties to explain to CMS the background of the issue, undertake an effort to identify lapses

or deficiencies in the systems and processes of the PACE organization, and serve as a

skeleton for future corrective actions if requested by CMS.

The RCA/IA templates are available for download from HPMS (Submission Materials,

Attachment IV Impact Analysis.zip). The zip file contains multiple IA Excel templates, one

each for Service Delivery, Grievances, Appeals and Personnel, and multiple templates for

the Clinical Appropriateness element. While these templates appear to be identical at

first glance, please note that they may contain a second tab with columns seeking infor-

mation specific to the audit element under consideration.

• Appeals IA Template

• Clinical Appropriateness IA Template_Assessments

• Clinical Appropriateness IA Template_Care Plan

• Clinical Appropriateness IA Template_Comp.Care

• Clinical Appropriateness IA Template_Emergency

• Clinical Appropriateness IA Template_IDT Documentation

• Clinical Appropriateness IA Template_Infections

• Clinical Appropriateness IA Template_Med Rec Documentation

• Clinical Appropriateness IA Template_Providers

• Clinical Appropriateness IA Template_Restraints

• Clinical Appropriateness IA Template_Transportation

• Grievance IA Template

• Personnel IA Template

• Root Cause Template

• Service Delivery IA_Template.

Given the multiple available templates, Exhibit 5 below furnishes generic guidance for

completing the RCA and IA templates.


Exhibit 5: Root Cause Analysis and Impact Analysis Template

To Be Completed by CMS (When RCA and/or IA Is Requested)

A B C

Date Identified

Brief Description of Issue (Per CMS Audit Lead)

Condition Language (Per CMS Audit Lead)

1 03/15/17 IDT members were unaware of the results of the efforts made to reduce participant injuries resulting from falls and the incidents of foot infections in participants with diabetes.

2 03/15/17 Four cases did not state specific reasons for the denial of services. The reason noted was a general statement of medical necessity.

When an RCA is requested, the audit lead will complete the first three columns, stating

the observed issue(s) and the potential condition of non-compliance that could result,

and then upload the file to HPMS for the PACE organization to complete. Exhibit 5

provides examples of two root cause analyses, with sample responses to the information

requested.

To Be Completed by PACE Organization (When an RCA Is Requested)

D E

Detailed Description of the IssueRoot Cause Analysis for the Issue

(Explain Why It Happened)1 The organization undertook two quality initiatives

aimed at reducing injuries resulting from participant falls and the incidents of foot infections in participants with diabetes. All IDT disciplines participated in these initiatives, and process improvements have been implemented, but they did not understand that these two initiatives were explicitly deemed quality improvement projects.

Our organization failed to call out efforts at improving care and services as QAPI initiatives

2 The organization did not interpret this PACE regulation in a way that would have mandated specific reasons, thinking that “medical necessity” was a sufficient explanation.

Incorrect organizational interpretation of the information required in the denial language

For a root cause analysis the PACE organization needs to complete only columns D and E.

Column D solicits a brief narrative description of the issue from the PACE organization,

seeking to determine if the variance observed by auditors was a result of miscommuni-

cation, systemic issues, misinterpretation of the relevant regulation(s), or other issues.

Column E asks the PACE organization to explain the cause of the variance or deficiency


as determined by the RCA of the organization. As in the example above, the root cause

statement should be specific, but a lengthy explanation is not required.

To Be Completed by PACE Organization (When an IA Is Requested)

F G H I

Methodology: Describe

the process undertaken

to determine the number of

individuals (e.g., participants)

impacted

Number of Individuals Impacted

Action Taken to Resolve System/ Operational Issues

Date System/ Operational Remediation

Initiated (MM/DD/YY)

1 NA None Plan to have monthly quality meeting with full IDT to address opportunities for quality improvement and present recommendations from existing quality initiatives.

03/17/17

2 Reviewed all denial letters issued over the last 12 months to determine the number of participants who received denial letters with insufficient explanations.

29 of 60 Plan to invoke a three-pronged effort to bring this issue into compliance:

1. Educate full IDT and clinical staff about the requirement to note a specific reason for each denial.

2. Change P&Ps to mandate inclusion of a specific denial reason.

3. Implement, for at least six months, a quality control process ensuring denial letters are fully compliant before mailed to participants.

03/17/17

If the PACE organization is asked to conduct a full Impact Analysis, columns F through M

will need to be populated as well.

Columns F and G request a brief description of the methodology used by the PACE

organization to determine the number of participants affected by the organizational mis-

understanding, oversight or systems error. Column H requires an explanation of the plan

implemented by the organization to bring the systemic or operational issue back into

compliance, and Column I requests the date that remediation efforts began.


To Be Completed by PACE Organization (When an IA Is Requested)

J K L M

Date System/

Operational Remediation Completed

(MM/DD/YY)

Actions Taken to Resolve Negatively

Impacted Individuals, Including

Outreach Description and Status

Date Individual Outreach

and Remediation

Initiated

(MM/DD/YY)

Date Individual Outreach

and Remediation Completed

(MM/DD/YY)1 03/25/17 NA NA NA

2 3/26/17 Reviewed the denial letters and records of the 29 affected individuals and contacted them directly to determine if their service requests are still applicable in order to:

1. explain the omitted rationale for denial,

2. determine if the participant wishes to pursue the request,

3. determine if any participants were harmed by the non-specific denial, and

4 remind participants of their appeal rights.

03/17/17 03/24/17

Column K asks the PACE organization to explain the plans and actions that were institut-

ed to identify participants who may have experienced harm or foreclosed on the oppor-

tunity to request an appeal as a result of the deficient practice of the PACE organization.

Some events may be “one-off” isolated events or administrative errors with a low like-

lihood of impacting participant safety or rights. Others may reflect systemic issues that

could potentially jeopardize participant rights, care or safety.

Columns J, L and M request dates that the PACE organization conducted or will conduct

its remediation of the observed issue and its outreach to potentially affected participants.


Appendix 2: PACE Audit Timeline for PACE OrganizationsThis section provides a typical PACE audit timeline based on the 2017 revised PACE

Audit Protocol. The timeline identifies preparation activities before, during and after

the audit, as well as required deliverables (in boldface) and key milestones. This

appendix is designed to be used as an audit preparation tracker in the event that a

PACE organization chooses to print the document to view the key responsibilities and

milestones as a real-time progress tracking tool.

Pre-Audit Activities Start Date Due Date

PACE Organization Point of Contact (POC) for Audit

Enters Actual Due Dates

Responsible Person

Completed Date

Receipt of Engagement Letter

(Activities in bold face are actionable items due to CMS/)

60 days prior to start of

onsite audit

Upload in HPMS

attestation of receipt of letter within

two days

CEO or other individual with HPMS attestation

rights

Follow-Up Conference Call with CMS

CMS will send POC a call

appointment two to three

days after engagement letter is sent

N/A POC sends invite to other

key PACE organization

staff responsible

for preparatory actions for

audit

Upload Follow-Up Conference Call Attendance Sheet Sent by CMS

CMS will send POC attendance

sheet

After follow-up call

completed

PACE organization

POC

Upload Attachment II : Supplemental Questions

Date on engagement letter is Day 1

Five business days from

issuance of engagement

letter

PACE organization

POC

Upload Attachment III : Pre-Audit Issue Summary

Date on engagement letter is Day 1

Five business days from


letter

PACE organization

POC


Pre-Audit Activities Start Date Due Date

PACE Organization Point of Contact (POC) for Audit

Enters Actual Due Dates

Responsible Person

Completed Date

Upload Universes Per Naming Conventions (Begin filling out universes as soon after the follow-up call as possible.)

Date on engagement

letter is Day 1

30 calendar days from


letter

PACE organization

POC and/or delegated individuals

Upload Onsite Agenda After Collaborating and Finalizing Schedule with CMS

As requested by CMS

As requested

by CMS

PACE organization

POC

Other Pre-Audit Tasks Start Date Due Date

PACE Organization

Point of Contact

(POC) for Audit Enters Actual Due

DatesResponsible

PersonCompleted

Date

Reserve space for auditors for onsite audit

N/A Day 1 of site visit

PACE organization POC

Secure a telephone in the reserved audit space if not already present



Ensure access to a copier



Obtain passwords for auditors to gain EHR access for MR review


IT Director


Other Pre-Audit Tasks Start Date Due Date

PACE Organization

Point of Contact


DatesResponsible

PersonCompleted

Date

Arrange for personnel, health and education records for selected sample to be available to auditors per agenda date and time


HR Director

Arrange transportation for home visit and NH visit if requested

N/A Per audit team

request

Home Care Coordinator

Have a schedule of clinic visits, wound care, medication pass and any other activities auditors may request available on Day 1 of onsite audit


Clinic Director

Create a presentation about the PACE organization (in PowerPoint, Word or other format)

N/A Entrance conference



Onsite Audit Activities Start Date Due Date

PACE organization

Point of Contact


DatesResponsible

PersonCompleted

Date

Assign personnel to be available to auditors for troubleshooting and schedule modifications, EHR navigation, and remediation of IT issues


through exit conference

As delegated by PACE organization

POC

Upload Entrance Conference Attendance Sheet

N/A After entrance

conference


Upload Documents Noted on Document Request Logs in HPMS

As requested by CMS

As requested

by CMS


Upload Attendance Sheets (Debriefs, Meetings)

As requested by CMS

As requested

by CMS


Complete and Upload Any Root Cause Analyses (RCAs) Per CMS Direction

As requested by CMS

As requested

by CMS



Complete and Upload Any Impact Analyses (IAs)

Request for IA is Day 1

10 business days from

date of request


Upload Exit Conference Attendance Sheet

N/A After exit conference


Post-Audit Activities Start Date Due

Date

PACE organization

Point of Contact (POC) for Audit Enters Actual

Due Dates

Responsible Person

Completed Date

Complete and Upload Any RCAs per CMS Direction

As requested by CMS

As requested

by CMS

PACE organization

POC

Complete and Upload Any IAs per CMS Direction

As requested by CMS

As requested

by CMS

PACE organization

POC

Upload CAR and/or ICAR As Directed by CMS

As requested by CMS

As requested

by CMS

PACE organization

POC

CMS Issuance of Draft Audit Report

Approximately 30 days

after exit conference

N/A CMS

Upload Draft Audit Report Comments of PACE Organization

N/A Within 10 business days of draft

report released by CMS

PACE organization

POC

Final Audit Report

Approximately two weeks

after receipt of PACE

organization’s response to Draft Audit

Report

N/A CMS

Upload Corrective Action Plans Per Audit Report

Per CMS direction

Per CMS direction

PACE organization

POC