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pdfPrograms of All-Inclusive
Care for the Elderly (PACE)
Audit Protocol
v.1115202406162025
Table of Contents
Audit Purpose and Scope ................................................................................................................................ 3
Initial Documentation and Data Submissions ................................................................................................. 4
Audit Element Review .................................................................................................................................... 6
I.
Service Determination Requests, Appeals and Grievances (SDAG) ................................................... 6
II.
Provision of Services ......................................................................................................................... 11
III. Personnel Records ............................................................................................................................. 17
IV. Compliance and Quality Improvement .............................................................................................. 19
Analysis of Potential Non-Compliance ......................................................................................................... 21
I.
Request for Additional Information (RAI) ........................................................................................ 21
II. Root Cause Analysis (RCA) .............................................................................................................. 21
III. Impact Analysis (IA).......................................................................................................................... 21
IV. Additional Records Review ............................................................................................................... 21
Appendix ....................................................................................................................................................... 22
Appendix A - Programs of All-Inclusive Care for the Elderly (PACE) Record Layouts .......................... 22
Table 1: Service Determination Requests (SDR) Record Layout ......................................................... 22
Table 2: Appeal Requests (AR) Record Layout .................................................................................... 28
Table 3: Grievance (GR) Record Layout .............................................................................................. 32
Table 4: List of Personnel (LOP) Record Layout.................................................................................. 35
Table 5: List of Participant Medical Records (LOPMR) Record Layout .............................................. 37
Table 6: On-Call (OC) Record Layout .................................................................................................. 44
Table 7: Contracted Entities and Providers (CEP) Record Layout ....................................................... 45
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Audit Purpose and Scope
1. Purpose: To evaluate PACE organizations’ (POs’) compliance with regulatory requirements in
any or all of the following four areas related to the Programs of All-Inclusive Care for the
Elderly (PACE). The Centers for Medicare and Medicaid Services (CMS) will perform its
audit activities based on these instructions (unless otherwise noted).
Service Determination Requests, Appeals and Grievances (SDAG);
Provision of Services (care planning, participant assessments, interdisciplinary team
(IDT) requirements, medical records, participant observations, etc.);
Personnel Records; and
Compliance and Quality Improvement
2. Scope of Review: CMS will review data and documentation collected prior to, during, and after
the audit fieldwork, as well as conduct real-time observations of participants and equipment.
CMS will conduct audits remotely, onsite or a combination of the two and the PO will grant
CMS access to all relevant documentation or information related to the audit. CMS’s remote
review includes, but is not limited to, CMS accessing and obtaining information from the PO’s
electronic medical record system(s) as well as examination of case files uploaded by the PO.
The initial data/document collection period for this protocol will be at least 6 months prior to,
and including, the date of the audit engagement letter unless otherwise specified. CMS reserves
the right to expand the data/document collection period to ensure sufficient universe size,
evaluate participant impact or outcomes, and/or investigate quality of care concerns.
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Initial Documentation and Data Submissions
1. Responding to Initial Documentation and Data Submissions: The PO must submit accurate
and timely documentation and universes in accordance with the instructions provided in this
PACE audit protocol. See Appendix A for additional instructions on universe submissions.
To fulfill audit related documentation requests, the PO is expected to upload any and all
requested documentation to the Health Plan Management System (HPMS) and when applicable,
use the designated file names as indicated in the Document Request Log (DRL) tab of HPMS.
See the element sections for further information on documentation requirements.
2. Initial Documentation and Data Submission Timeframes: The following documentation and
universes must be submitted in the timeframes indicated below.
2.1. Documentation due within 5 business days of the audit engagement letter: POs must
submit the following documentation in Microsoft Word (.docs), Microsoft Excel (.xlsx) or
Portable Document File (PDF):
Completed PACE Supplemental Questions (Audit Engagement Letter, Attachment II)
Completed Pre-Audit Issue Summary (Audit Engagement Letter, Attachment III)
NOTE: POs will be asked to provide a list of all issues of non-compliance disclosed to
CMS prior to the date the audit engagement letter is issued, using the Pre-Audit Issue
Summary template (Attachment III). This submission will include a description of each
disclosed issue and the status of correction. The PO’s Account Manager will review
Attachment III to validate that disclosed issues were reported to CMS prior to receipt of
the audit engagement letter. If issues were reported to someone in CMS other than the
AM, the PO should indicate that in the attachment.
Issues identified by CMS or the State administering agency (SAA) through ongoing
monitoring or other account management and oversight activities during the audit year
are not considered disclosed. POs should exclude PACE Quality data already reported
to CMS, unless otherwise specified, and any data that is not relevant to the audit
elements included in this document.
2.2. Documentation and universes due within 20 business days of the audit engagement
letter
2.2.1. Documentation:
• The PO’s Quality Improvement (QI) plan(s) that were in use during the data
collection period.
• Participant Advisory Committee (PAC) minutes for the data collection period
• Documentation that the PO implemented measures to prevent, detect, and
correct noncompliance with PACE regulatory requirements, Part D
regulatory requirements, and fraud, waste, and abuse.
2.2.2. Data Universes described in Appendix A:
• Table 1: Service Determination Requests (SDR)
• Table 2: Appeal Requests (AR)
• Table 3: Grievances (GR)
• Table 4: List of Personnel (LOP)
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•
•
•
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Table 5: List of Participant Medical Records (LOPMR)
Table 6: On-call (OC)
Table 7: Contracted Entities and Providers (CEP)
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Audit Element Review
I. Service Determination Requests, Appeals and Grievances (SDAG)
1. Select Sample Cases: CMS will initially select up to 40 targeted sample cases from the
Service Determination (SDR), Appeal Requests (AR), and Grievances (GR) universes (Tables
1-3 of Appendix B). When selecting sample cases, CMS will attempt to ensure that the sample
set is representative of various types of service determination requests, appeals and grievances.
CMS will use all universes, documentation, and available information in order to target
samples for review. The SDAG sample set will include:
10 denied service determination requests
10 approved service determination requests
5 denied appeals
5 approved appeals
10 grievances
CMS reserves the right to adjust the number of service determination requests, appeals or
grievance samples if the number of entries in a given universe is less than the number of
required samples. For example, if a PO does not have five approved appeals, CMS may select
additional denied appeals or additional service determination requests to make up the total
number of samples. Additionally, CMS may add samples in order to further investigate
potential noncompliance or participant impact. CMS will provide sample selections to the PO
no less than two business days before the SDAG review starts.
2. Review Sample Case Documentation and Evaluate Universes: CMS will review all sample
case file documentation and evaluate SDR, AR, and GR universes to determine compliance with
regulatory requirements including, but not limited to 42 CFR §§ 460.120, 460.121, 460.122 and
460.124. During the audit, the PO will need to submit the documentation listed in section 2 for
each service determination request, appeal, and grievance sample selected. Documentation will
be submitted through HPMS.
Each sample case file submitted to CMS must comprehensively address the applicable
documentation requests below. The documentation for each sample case file must either be (1)
combined into one file that is ordered according to the sequence in which the service
determination request, appeal, or grievance was processed, or (2) zipped into a single file in
which individual files within the zipped file are titled in accordance with their contents for easy
identification (e.g., a document demonstrating IDT attendance for the review of a service
determination request could be titled “IDT attendance during morning meeting on [date]”).
Additionally, each sample case file must include a cover sheet which includes all the requested
documentation, whether the documentation is included in the case file, and if so, the page
number where that documentation can be found. If any required documentation is unavailable,
the PO must specify in the cover sheet that the required documentation does not exist. For
example, if the PO does not have documentation that a participant received oral notification of a
service determination request decision, the PO would indicate that documentation of oral
notification was not available in the cover sheet. For any case file documentation in a language
other than English, CMS will request the original documentation as well as a version translated
into English.
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2.1 Service Determination Request Review:
All documentation related to the initial service determination request
All documentation related to assessments conducted in response the service
determination request and all IDT notes
All documentation of the IDT’s review of the service determination request
For service determination requests with extensions, documentation identifying when the
extension was initiated, why the extension was initiated, and all notification(s)
Service determination request decision notification(s)
All documentation related to the provision of approved services, including arranging or
scheduling the delivery of services, timeframes for service delivery, and tracking and
monitoring the provision of approved services
Any other reports, system notes, or logs that document denial, partial denial, or approval
of the request and participant notification
2.2 Appeal Review:
All documentation related to the initial appeal request
All documentation related to the underlying service determination request
Documentation that the participant was given an opportunity to present evidence inperson as well as in writing
All documentation related to expedited appeals and expedited appeals extensions (if
applicable).
All documentation provided to the third-party reviewers or committee related to the
disputed service(s)
All documentation related to the third-party reviewers or committee members, including
their credentials
All documentation related to the third-party reviewer or committee members appeal
decision
Appeal decision notification(s)
Documentation that the PO continued to furnish the appealed service to Medicaid
participants who requested to continue receiving disputed services under appeal until
issuance of the final determination, if applicable
All documentation related to the provision of approved services, including arranging or
scheduling the delivery of services, timeframes for service delivery, and tracking and
monitoring the provision of approved services
Any other reports, system notes, or logs that document denial or approval of the request
and participant notification
Upon request from CMS, all materials provided by the PO explaining the PACE
regulatory requirements
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2.3 Grievance Review:
All documentation related to the initial complaint, including each distinct issue identified
by the participant and/or their representative
All supplemental information submitted by the participant and/or their representative,
including any written documentation
Documentation of the distinct issues that required an investigation and the PO’s
investigations into each distinct issue
All documentation related to the final resolution for each grievance issue, including the
steps and actions taken by the PO to resolve each distinct issue
All documentation related to resolution notification(s)
All documentation related to quality of care issues and the PO’s cooperation with Quality
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Improvement Organizations (QIOs) (if applicable)
Corrective action(s) taken by the PO in response to the grievance (if applicable)
Any other system notes, progress notes, logs, or other data related to the complaint
classified by the PO as a grievance
Documentation of the grievance process information provided to the participant
3. Apply Compliance Standard: The criteria used to evaluate cases include, but are not limited to,
the compliance standards in this section. CMS may review requirements not specifically addressed in
these questions, including compliance standards noted in other elements if it is determined that there
are other requirements not being met. In applying these standards, auditors may request written
responses to questions and additional documentation to be submitted by the organization to
demonstrate compliance with a particular requirement. Written responses to auditor questions must be
submitted using the Request for Additional Information (RAI) template developed by CMS.
3.1. Did the PO appropriately process service determination requests, appeals and
grievances?
3.1.1. Did the PO appropriately identify, classify, and process service determination
requests, appeals, and grievances?
3.1.2. Did the PO appropriately process immediately approved service determination requests?
3.1.3. Did the full IDT review the service determination request, if applicable?
3.1.4. Did the PO ensure that the appeal was reviewed by an impartial and
appropriately credentialed third-party reviewer or committee?
3.1.5. Did the PO distribute written or electronic materials to the third party reviewer or
committee that meet the requirements in § 460.122(c)(5) necessary to understand the
PACE benefit?
3.1.6. Did the PO conduct in-person assessments in response to a service determination
request the IDT expected to deny or partially deny?
3.1.7. Did the in-person assessment evaluate whether the requested service was
necessary to meet the participant’s medical, physical, emotional, and social
needs?
3.1.8. Did the IDT consider all relevant information when evaluating a service
determination request, including, but not limited to: the findings and results of
any reassessments, the participant’s current medical, physical, emotional, and
social needs, and current clinical practice guidelines and professional standards
of care applicable to the particular service?
3.1.9. Did the PO automatically process as an appeal any service determination request
that was not processed within the required timeframe?
3.1.10. Did the PO give all parties involved in an appeal a reasonable opportunity to present
evidence in-person, as well as in writing?
3.1.11. Did the PO continue providing services to a Medicaid participant, during an
appeal, if the participant requested to continue the services?
3.1.12. Did the PO conduct a thorough investigation of all distinct issues within the grievance
when the cause of the issue is not already known?
3.1.13. Did the PO cooperate with the QIO in resolving participant complaints, when applicable?
3.1.14. Did the PO take corrective action(s) taken as a result of the grievance, when applicable?
3.1.15. Did the PO give the participant written information on the grievance process, upon
enrollment and at least annually thereafter, that includes all of the required information
specified in § 460.120(c)?
3.2. Did the PO appropriately notify participants and/or their designated representatives of
any decision relating to a service determination request, appeal or grievance?
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3.2.1.
Did the PO provide oral and written notification of service determination request
denials and partial denials that included the specific reason for the denial,
including why the service was not necessary to maintain or improve the
participant’s overall health status and considering the participant’s medical,
physical, emotional, and social needs, and the results of the reassessment(s), in
understandable language?
3.2.2. Did the PO provide oral and written notification of service determination request
denials and partial denials that included the participant or designated
representative’s right to appeal, including the right to an expedited appeal?
3.2.3. Did the PO inform Medicaid participants of their right to continue receiving
disputed services during the appeals process and the conditions for continuing to
receive disputed services?
3.2.4. Did the PO provide oral or written notification of service determination request
approvals, including an explanation of the conditions of approval in
understandable language and when the participant may expect to receive the
approved service?
3.2.5. Did the PO provide appropriate written notification for favorable appeal
decisions, including an explanation of the conditions of approval in
understandable language?
3.2.6. Did the PO provide appropriate written notification for partially or fully adverse
appeal decisions, including the specific reason(s) for the adverse decision, why the
service would not improve or maintain the participant’s overall health status, and a
description of the participant’s external appeal rights?
3.2.7. If a grievance was not related to quality of care, did the PO provide oral or written
notification of the grievance resolution, based on the preference of the individual who
submitted the grievance, except when the individual specifically requested not to receive
notification?
3.2.8. If a grievance was not related to quality of care, did oral or written notification of the
grievance resolution include a summary of all distinct issues, a summary of the pertinent
findings or conclusions for each distinct issue that required investigation, and for
grievances that required corrective action, the corrective action(s) taken or to be taken by
the PACE organization, and when the participant may expect corrective action(s) to
occur?
3.2.9. If a grievance was related to quality of care, did the PO provide written notification of the
grievance resolution, except when the individual specifically requested not to receive
notification?
3.2.10. If a grievance was related to quality of care, did written notification of the grievance
resolution include a summary of all distinct issues, a summary of the pertinent findings or
conclusions for each distinct issue that required investigation, and for grievances that
required corrective action, the corrective action(s) taken or to be taken by the PACE
organization, and when the participant may expect corrective action(s) to occur?
3.2.11. If a grievance was related to quality of care, did written notification of the grievance
resolution inform Medicare participants or their representatives of the right to file a
written complaint with the QIO with regard to Medicare covered services?
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3.3. Did the PO process service determination requests, appeals, and grievances within required
timeframes and take appropriate extensions?
3.3.1. For requests that were immediately approved by a member of the IDT, did the IDT
member notify the participant or designated representative of the approval, at the
time the request was made?
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3.3.2.
3.3.3.
3.3.4.
3.3.5.
3.3.6.
3.3.7.
For requests that were not immediately approved:
3.3.2.1 Did the PO ensure the service determination request was brought to the
IDT as expeditiously as the participant’s condition required, but no later
than 3 calendar days from the time the request was made?
3.3.2.2 Did the PO notify the participant or designated representative of the
IDT decision to approve, deny, or partially deny a service
determination request no later than 3 calendar days after the date the
IDT received the request?
3.3.2.3 Did the PO appropriately extend the timeframe for approving or
denying a service determination request, if applicable?
3.3.2.4 If the IDT extended the service determination request processing
timeframe, did the IDT provide notice of the extension to the
participant or designated representative orally or in writing no
later than 24 hours after the IDT decided to extend the timeframe?
3.3.2.5 If the IDT extended the service determination request processing
timeframe, did the IDT notify the participant or designated
representative of their decision no later than 8 days following the
date the request was received by the IDT?
Did the PO notify all parties involved in the appeal of the standard appeal
decision within 30 days of the appeal receipt date or, for expedited appeals,
within 72 hours after the PO receives the appeal?
Did the PO appropriately extend the timeframe for responding to an
expedited appeal, if applicable?
If the PO extended the appeals processing timeframe, did the PO provide
notification to all parties involved in the appeal no later than 17 days after
receipt of an expedited appeal for which an extension was taken?
Did the PO resolve the grievance as expeditiously as the case requires, but no later than
30 calendar days after the date the PACE organization receives the oral or written
grievance?
Did the PO notify the individual who submitted the grievance of the
grievance resolution as expeditiously as the case requires, but no later than 3
calendar days after the date the PACE organization resolved the grievance?
3.4. Did the PO effectuate/provide approved services as expeditiously as the participant’s
condition required?
3.4.2. Did the PO arrange and/or schedule the delivery of approved services within the
required timeframe?
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II. Provision of Services
1. Select Sample Cases: This element will be tested using, at a minimum, medical record review
and observations/inspections.
Medical Record Review: CMS will initially select up to 25 targeted medical records from the
List of Participant Medical Records (LOPMR) universe (Table 5 of Appendix B) that appear
clinically significant. When selecting sample cases, CMS will attempt to ensure that the sample
set is representative of various types of medical, functional, and social needs (e.g.,
hospitalizations, wound care, dialysis, social needs, home bound, skilled nursing care). CMS
will use all universes, documentation, and available information in order to target participant
samples for review. CMS will provide sample selections to the PO 1 hour prior to the start of
the review of medical records.
CMS may expand the scope of review, which includes, but is not limited to, adding medical
records or reviewing relevant records beyond the universe collection periods, in order to
appropriately investigate potential compliance issues discovered during the review of audit
elements.
Participant Observations: CMS will also conduct up to 5 participant observations during audit
fieldwork in order to ensure participants are receiving appropriate care and services that were
indicated to be necessary. Observations will also ensure care is being provided following CDC
standard precautions. Observations may include but are not limited to:
Skilled care provided in participants’ homes, including wound care and medication
administration;
Skilled care provided at the center, or Alternative Care Setting, including wound care
and medication administration; and
Dietary/meal services
CMS will work with the PO prior to and during audit fieldwork to determine if participants
are available for observations. If participants are available for observations, CMS may select
participants and conduct observations. CMS will notify the PO of participant observation
selections before conducting each observation. CMS may observe more participants if issues
are noted that warrant additional observations.
Emergency Equipment: CMS will conduct an inspection of specific emergency equipment and
emergency medications in order to ensure the PO is properly equipped to handle an emergency
situation.
Vehicle Inspection: CMS will conduct an observation of at least one vehicle that the PO utilizes
to transport participants in order to ensure that the PO is equipped to provide safe and
appropriate transportation services.
Participant/Caregiver/ Staff Interviews: CMS may conduct interviews with participants,
caregivers, and/or staff to investigate potential concerns and/or determine compliance with
regulatory requirements.
2. Review Sample Case Documentation: CMS will review participant medical records and
conduct participant observations to determine compliance with regulatory requirements
including but not limited to 42 CFR §§ 460.64, 460.70, 460.74, 460.76, 460.78, 460.84,
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460.90, 460.92, 460.94, 460.96, 460.98, 460.100, 460.102, 460.104, 460.106, 460.112,
460.114, 460.120, 460.121, 460.122, 460.200, 460.210. CMS may also conduct interviews
with participants, personnel, and caregivers as determined necessary. The PO must provide
CMS auditors unrestricted access to these records and may be required to upload copies
and/or screenshots of the following documents during and/or after the audit.
2.1 Medical Record Review:
All enrollment/disenrollment information
Advanced directives, if applicable
All participant assessments
All participant care plans
o All information related to the development, creation, evaluation, or revision of participant
care plans, including care plan meeting minutes
All information related to the provision of services, the delivery of participant care, the coordination
of care between IDT members, the coordination of care between the IDT and other PACE
employees, and the coordination of care between the IDT and contracted individuals and entities,
including but not limited to:
o IDT progress notes
o All notes from other employees and contractors related to the provision services and
participant care
o IDT meeting minutes
o Specialist records
o Hospital discharge summaries
o Summaries of other inpatient and long-term care services, including documentation of
coordination of care with nursing facilities, assisted living facilities, and other sub-acute
facilities
o Medication records
o Wound care records
o Other treatment records
o Laboratory results
o Diagnostic testing results
o Home care records
o On-call records
o Service determination request information
o Appeals information
o Grievance information
o Incident reports, including information not contained within the medical record
o All information related to coordination of participant care including communication between
the PO and the participant, their designated representatives, their caregivers, hospitals,
nursing facilities, assisted living facilities, other sub-acute facilities, specialists, other
contractors, CMS, state and local agencies, any other individual who provides information
pertinent to a participant's, care, health, or safety, etc.
All information provided to the participant or designated representative regarding palliative care,
comfort care, or end-of-life care
3. Apply Compliance Standards: The criteria used to evaluate cases include, but are not limited
to, the compliance standards in this section. CMS may review requirements not specifically
addressed in these questions, including compliance standards noted in other elements if it is
determined that there are other requirements not being met. In applying these standards, auditors
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may request written responses to questions and additional documentation to be submitted by the
organization to demonstrate compliance with a particular requirement. Written responses to
auditor questions must be submitted using the Request for Additional Information (RAI)
template developed by CMS.
3.1. Did the PO furnish comprehensive services necessary to meet the needs of all
participants?
3.1.1. Did the PO furnish mandatory services at the PACE center?
3.1.2. Did the PO provide all Medicare covered services, Medicaid covered services,
and other services determined necessary by the IDT?
3.1.3. Did the PO provide Medicare and Medicaid covered services without limitations
or conditions relating to amount, duration, scope of services, deductibles,
copayments, coinsurance, and other cost-sharing?
3.1.4. Did the PO provide immediate access to emergency services without prior
authorization?
3.1.5. Did the PO furnish comprehensive medical, health, and social services that
integrate acute and long-term care and in accordance with contracted services
requirements, as applicable?
3.1.6. Did the PO ensure accessible and adequate services to meet the needs of its
participants and, if necessary, increase the number of PACE centers, personnel,
or other PACE services?
3.2. Did the PO ensure that the IDT was appropriately involved in participant care?
3.2.1. Did the PO establish an IDT composed of the required members at each PACE
center?
3.2.2. Did the IDT conduct initial and periodic assessments, develop plans of care, and
coordinate 24-hour care delivery?
3.2.3. Did the PO ensure that decisions by the IDT to provide or deny services were
based on an evaluation of the participant that considers the participant's current
medical, physical, emotional, and social needs?
3.2.4. Did the PO ensure that decisions by the IDT to provide or deny services were
based on current clinical practice guidelines and professional standards of care
applicable to the particular service?
3.2.5. Did the IDT remain alert to pertinent input from other team members,
participants, caregivers, employees, contractors, specialists, and
designated representatives?
3.2.6. Did the IDT order, approve, or authorize all necessary care, across all care settings?
3.2.7. Did the IDT communicate all necessary care and relevant instructions for care, across
all care settings?
3.2.8. Did the IDT ensure care was implemented as it was ordered, approved, or authorized,
across all care settings?
3.2.9. Did the IDT monitor and evaluate the participant’s condition to ensure that the care
provided was effective and met the participant’s needs, across all care settings?
3.2.10. Did the IDT promptly modify care when it determined the participant's needs were not
met in order to provide safe, appropriate, and effective care to the participant?
3.2.11. Did the IDT document all recommendations for care or services?
3.2.12. If the IDT did not approve or provide the recommended care or services, were
the reasons for not approving or providing recommended care or services
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documented in accordance with medical records maintenance requirements?
3.2.13. Did the appropriate member(s) of the IDT review all recommendations from
hospitals, emergency departments, and urgent care providers and determine if
the recommended services were necessary to meet the participant’s medical,
physical, social, or emotional needs as expeditiously as the participant’s
health condition requires, but no later than 48 hours from the time of the
participant’s discharge?
3.2.14. Did the appropriate member(s) of the IDT review all recommendations from
other employees and contractors and determine if the recommended services
were necessary to meet the participant’s medical, physical, social, or
emotional needs as expeditiously as the participant’s health condition
requires, but no later than 7 calendar days from the date the recommendation
was made?
3.2.15. Did the IDT implement, coordinate, and monitor the plan of care whether the
services were furnished by PACE employees or contractors, across all care
settings?
3.2.16. Did the IDT evaluate and monitor the participant's medical, physical, emotional,
and social needs, as well as the effectiveness of the plan of care, through the
provision of services, informal observation, input from participants or
caregivers, and communications among members of the IDT and other
employees or contractors?
3.3. Did the PO perform assessments as required?
3.3.1. Did the IDT perform assessments as required (initial, semi-annual, or
more frequently when necessary)?
3.3.2. Did the PO ensure the required IDT members performed assessments?
3.4. Did the PO maintain a complete, accurate, and accessible medical record?
3.4.1. Did the PO ensure the participant medical record was available to all personnel?
3.4.2. Did the PO maintain the required content in each participant medical record?
3.4.3. Did the PO safeguard records and data against loss, destruction, or inappropriate
alteration, and ensure the medical records were appropriately authenticated and
dated?
3.5. Did the PO develop and document an appropriate care plan for the participants?
3.5.1. Did the IDT develop and evaluate participant care plans within the required
timeframes?
3.5.2. Did the PO ensure the full IDT was involved in creating and evaluating care
plans?
3.5.3. Did the IDT consolidate initial, discipline-specific assessments into a
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comprehensive care plan, including all necessary services?
3.5.4. If the IDT determined that certain services were not necessary for the care of the
participant during the development of the initial plan of care, did the IDT
document the reasoning behind the determination in the care plan?
3.5.5. Did each plan of care identify all of the participant’s current medical, physical,
emotional, and social needs, including all needs associated with chronic diseases,
behavioral disorders, and psychiatric disorders that required treatment or routine
monitoring, taking into consideration the most current assessment findings?
3.5.6. Did each plan of care address vision, hearing, dentition, skin integrity, mobility,
physical functioning, including activities of daily living, pain management,
nutrition, including access to meals that meet the participant’s daily nutritional
and special dietary needs, the participant’s ability to live safely in the community,
including the safety of their home environment, home care, center attendance,
transportation, and communication, including any identified language barriers?
3.5.7. Did each plan of care identify each intervention needed to meet each medical,
physical, emotional, and social need?
3.5.8. Did each plan of care identify how each intervention would be implemented,
including a timeframe for implementation?
3.5.9. Did each plan of care identify a measurable goal for each intervention and how
the goal for each intervention would be evaluated to determine whether the
intervention should be continued, discontinued, or modified?
3.5.10. Did each plan of care identify the participant’s preferences and goals of care?
3.5.11. Did the PO document participant and/or representative involvement in the
development, review, and evaluation of care plans?
3.6. Did the PO provide care and services necessary to meet the medical, physical,
emotional, and social needs of each participant?
3.6.1. Did the PO provide all necessary services, including all care planned, ordered,
and IDT-approved services?
3.6.2. Did the PO document, track, and monitor the provision of all services to ensure
services were provided as expeditiously as the participant’s health condition
required, considering the participant’s medical, physical, emotional, and social
needs?
3.6.3. Did the PO arrange and schedule the dispensing of medications as
expeditiously as the participant’s condition requires, but no later than 24 hours
after a primary care provider ordered the medications?
3.6.4. Did the PO arrange or schedule the delivery of interdisciplinary team approved
services, other than medications, as expeditiously as the participant’s health
condition required, but no later than 7 calendar days after the date the
interdisciplinary team or member of the interdisciplinary team first approved
the service, except for routine and preventative services as permitted in §
460.98(c)(3)?
2
3.7. Did the PO protect and provide for the exercise of the participant's rights?
3.7.1. Did the PO inform the participant in writing before implementing palliative care,
comfort care, or end-of-life care services?
3.7.2. Did written notification inform the participant of how the PACE organization’s
palliative care, comfort care, or end-of-life care services differ from the care the
participant is currently receiving and whether the services would be provided in
addition to or in lieu of the care the participant is currently receiving?
3.7.3. Did written notification inform the participant of all services that are impacted and
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provide a detailed explanation of how the services will be impacted if the participant or
designated representative elects to initiate palliative care, comfort care, or end-of-life
care?
3.7.4. Did written notification inform the participant of the right to revoke or withdraw their
consent to receive palliative, comfort, or end-of-life care at any time and for any reason,
either verbally or in writing?
3.7.5. Did the PO fully explain the palliative care, comfort care, or end-of- life treatment
options before initiating palliative care, comfort care, or end-of- life care?
3.7.6. Did the PO obtain written consent before initiating palliative care, comfort care, or endof-life care?
3.8. Did the PO follow appropriate infection control standards when providing care?
3.8.1. Did personnel wash/sanitize hands as appropriate?
3.8.2. Did personnel don and doff personal protective equipment as appropriate?
3.9. Did the PO have emergency equipment immediately available (suction, oxygen,
medications, etc.)?
3.10.
7
Did the PO have a method of providing safe transportation to participants?
3.10.1. Did the PO have a demonstrated method for securing participants (i.e., seat belts)
and securing DME (e.g., wheelchairs, oxygen, walkers)?
3.10.2. Did the PO have a method for communicating between the vehicle and the PACE
center?
3.10.3. Did the PO provide training to drivers on managing the special needs of the
participants and handling emergency situations?
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III. Personnel Records
1.
Select Sample Cases: CMS will initially select up to 10 targeted personnel records from the
List of Personnel (LOP) universe (Table 4 of Appendix B). CMS will attempt to ensure that
the sample set is representative of various types of employees, including part-time, full-time,
and contracted staff. Additionally, CMS may add additional samples or case review in order to
further investigate potential noncompliance or participant impact. CMS will provide sample
selections to the PO two business days before the Personnel review starts.
2.
Review Sample Case Documentation: CMS will review all sample case file documentation to
determine compliance with regulatory requirements including, but not limited to 42 CFR §
460.64, 460.68, 460.71, 460.86, and 460.102. The PO must provide CMS auditors unrestricted
access to these records and may be required to upload copies and/or screenshots of the
following documents during and/or after the audit.
3.
Documentation of any and all background checks conducted
Documentation of any and all OIG excluded provider checks conducted
Documentation that personnel have current and active licensure, if licensure is required
for their position
Documentation that staff filling the social worker role on the IDT is a Master’s-level social
worker
Documentation that personnel were cleared for communicable diseases based on a physical
examination and/or that a risk assessment was conducted to determine if a physical
examination was required
Documentation that staff were determined to be free of active Tuberculosis
Documentation of completed competencies
Documentation of the date staff had direct participant contact
Documentation of the date staff began providing participant care independently
Apply Compliance Standards: The criteria used to evaluate cases include, but are not limited
to, the compliance standards in this section. CMS may review requirements not specifically
addressed in these questions, including compliance standards noted in other elements if it is
determined that there are other requirements not being met. In applying these standards, auditors
may request written responses to questions and additional documentation to be submitted by the
organization to demonstrate compliance with a particular requirement. Written responses to
auditor questions must be submitted using the Request for Additional Information (RAI)
template developed by CMS.
3.1. Did the PO ensure all personnel were free of criminal convictions that would exclude them
from employment, prior to their date of hire?
3.2. Did the PO conduct an OIG exclusion check for all personnel prior to their date of
hire?
3.3. Did the PO ensure that personnel were appropriately legally authorized and/or
appropriately credentialed, if applicable?
3.4. Did the PO ensure that all personnel with direct participant contact were medically
cleared of communicable diseases before engaging in direct participant contact?
3.4.1. If the PO conducted a physical examination, was the examination completed
before personnel engaged in direct participant contact?
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3.4.2. If the PO conducted a physical examination, was the examination performed by a
licensed physician, nurse practitioner, or physician assistant acting within the
scope of their authority to practice?
3.4.3. If the PO conducted a risk assessment, was the risk assessment completed before
personnel engaged in direct participant contact?
3.4.4. If the PO conducted a risk assessment, did the risk assessment identify when a physical
examination was required?
3.4.5. If the PO conducted a risk assessment, did the risk assessment assess whether the
individual was exposed to or had any symptoms of COVID–19, Diphtheria,
Influenza, Measles, Meningitis, Meningococcal Disease, Mumps, Pertussis,
Pneumococcal Disease, Rubella, Streptococcal Infection, and Varicella Zoster
Virus?
3.4.6. If the PO conducted a risk assessment, were the results of the risk assessment reviewed by a
registered nurse, physician, nurse practitioner, or physician assistant?
3.4.7. If the PO conducted a risk assessment and the results of a risk assessment
indicated a physical examination was required, was a physical examination
completed as required, before personnel engaged in direct participant contact?
3.4.8. Did the PO determine that all personnel with direct participant contact were free
of active Tuberculosis before engaging in direct participant contact?
3.5. Did the PO ensure that personnel completed competencies before working
independently?
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IV. Compliance and Quality Improvement
1. Compliance and Quality Improvement Review: CMS will conduct an interview and review
data/documentation with the PO’s personnel responsible for the compliance oversight program
and development and implementation of the quality improvement program.
2. Review Documentation: CMS will review relevant documentation and information related to
the PO’s compliance oversight and quality improvement programs to determine compliance
with regulatory requirements including, but not limited to 42 CFR §§ 460.3, 460.60, 460.62,
460.63, 460.120, 460.122, 460.130, 460.132, 460.134, and 460.136. Upon request, the PO must
produce the following documents.
Documentation of the measures developed as part of the PO’s compliance oversight
program that prevent, detect, and correct noncompliance with regulatory requirements
and fraud, waste, and abuse.
Documentation of investigations into any compliance issues (if applicable), and any results of
those investigations.
Documentation of any corrective action taken in response to compliance issues (if
applicable).
Documentation of compliance issues that were self-reported to CMS, the SAA, or both
(if applicable).
Documentation that the PO’s governing body reviews the quality improvement plan
on at least an annual basis
Documentation that the PO collected, analyzed, and used data as a part of their Quality
Improvement program to improve performance in the following areas:
Utilization of PACE services
Participant and caregiver satisfaction
Participant assessment data including physiological well-being, functional status,
cognitive ability, social and behavioral functioning, and quality of life
The effectiveness and safety of personnel, including competency of clinical
personnel, promptness of service delivery, and achievement of treatment goals
Nonclinical areas such as: grievances, appeals, transportation services, meals, and
environmental issues
Specific actions taken in response to the detected quality issue(s), if applicable
Documentation that personnel were involved in the development and implementation
of the Quality Improvement program
Documentation that the results of quality initiatives were communicated to personnel
3. Apply Compliance Standards: The criteria used to evaluate cases include, but are not limited
to, the compliance standards in this section. CMS may review requirements not specifically
addressed in these questions, including compliance standards noted in other elements if it is
determined that there are other requirements not being met. In applying these standards, auditors
may request written responses to questions and additional documentation to be submitted by the
organization to demonstrate compliance with a particular requirement. Written responses to
auditor questions must be submitted using the Request for Additional Information (RAI)
template developed by CMS.
3.1. Did the PO adopt and implement an effective compliance oversight program?
3.1.1. Did the PO develop and implement measures to prevent, detect and correct
non-compliance with regulatory requirements and fraud, waste, and
abuse?
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3.1.2. Did the PO establish and implement procedures and a system for promptly
responding to compliance issues?
3.1.3. Did the PO investigate and correct compliance issues promptly?
3.2. Did the PO develop and implement an effective, data-driven quality improvement
program?
3.2.1. Did the PO maintain, aggregate, and analyze information on grievance proceedings
and use this information in the organization's internal quality improvement
program?
3.2.2. Did the PO maintain, aggregate, and analyze information on appeals proceedings
and use this information in the organization's internal quality improvement
program?
3.2.3. Did the PO collect and analyze the minimum required data including: utilization of
PACE services, participant and caregiver satisfaction, participant assessment data,
the effectiveness and safety of personnel, and nonclinical areas, such as grievances,
appeals, transportation services, meals, and environmental issues?
3.2.4. Did the PO use the minimum required data (utilization, participant and caregiver
satisfaction, participant assessments, effectiveness and safety of personnel, and
nonclinical data) to improve the delivery of PACE services?
3.2.5. Did the PO immediately correct any identified problem that directly or
potentially threatens the health and safety of a PACE participant?
3.3. Did the PO ensure that the appropriate personnel were involved in the development
and implementation of Quality Improvement activities and did the PO appropriately
disseminate information related to the Quality Improvement activities?
3.3.1. Did the PO’s governing body review the quality improvement plan on at least an
annual basis?
3.3.2. Did the PO ensure the medical director was involved in the implementation and
oversight of the quality improvement program?
3.3.3. Did the PO designate an individual to coordinate and oversee implementation of quality
assessment and performance improvement activities?
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Analysis of Potential Non-Compliance
I. Request for Additional Information (RAI)
If auditors require additional information to determine compliance with regulatory requirements,
auditors may submit Requests for Additional Information (RAIs). RAIs are documents that may
include questions, requests for documentation (evidence), or both. POs must provide a written response
for each question in an RAI. The written response to each question must be entered directly into the
RAI document and the completed document must be uploaded to HPMS in Microsoft Word (.docx)
format (unless otherwise specified). POs must submit documentation to corroborate each RAI response
or must indicate that documentation is not available to corroborate the response. All supporting
documentation provided in response to an RAI, including documentation to corroborate RAI responses
and documentation specifically requested by CMS, must be uploaded to HPMS. Documentation must
be labeled in accordance with the RAI instructions. Each RAI response, including the written responses
to RAI questions and all supporting documentation, is due within 24 hours of the original request
unless otherwise noted. All documents associated with each RAI must be uploaded to HPMS in a
single ZIP file, whenever possible.
II. Root Cause Analysis (RCA)
Root Cause Analyses and/or Impact Analyses must be submitted by the PO when they are requested
by the CMS audit team. Auditors request a Root Cause Analysis for each potential issue of
noncompliance identified during the review. A Root Cause Analysis describes the nature of the issue
and addresses why the noncompliance occurred. In order to adequately address why the
noncompliance occurred and complete the Root Cause Analysis to the satisfaction of CMS, the PO
must conduct a thorough investigation of the issue to determine all contributing factors, both
individual and organizational, that led to the noncompliance. The factors that led to the
noncompliance must be identified and explained in any Root Cause Analysis submitted to CMS.
Root Cause Analyses that restate the circumstances of the noncompliance without analysis of why
the noncompliance occurred will not be accepted. POs will have up to 2 business days to complete
the requested Root Cause Analysis templates.
III. Impact Analysis (IA)
When necessary, CMS will also request an Impact Analysis. For each Impact Analysis, CMS will
identify the participants that must be reviewed by the organization. The PO must then identify which
of those participants were subject to or impacted by the issues of noncompliance generally from the
beginning of the data collection period through the audit exit conference. However, in some
circumstances, CMS may modify the review scope as determined necessary. POs will have up to 10
business days to complete the requested Impact Analysis templates. CMS may validate the accuracy
of the Impact Analysis submission(s). In the event an Impact Analysis cannot be produced, is
incomplete, or is determined to be inaccurate, CMS will report that the scope of noncompliance
cannot be determined and impacted an unknown number of participants within the PO.
IV. Additional Records Review
The PO may be required to submit additional case files, documentation, data or provide access
to participant medical records after CMS concludes audit fieldwork if CMS determines there is a
need to validate the accuracy of information the PO submitted, such as the participant impact
reported on an Impact Analysis, or to further investigate quality of care issues or follow-up on
other potential noncompliance.
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Appendix
Appendix A - Programs of All-Inclusive Care for the Elderly (PACE) Record Layouts
Unless otherwise specified by CMS, POs must ensure each universe in the Microsoft Excel (.xlsx)
file format with a header row that corresponds to the record layouts shown in Appendix A, Tables 1-7
and the initial collection periods noted below. Excel documents must be placed into a zip file in order
to be uploaded into HPMS. CMS may expand the data collection period to ensure sufficient universe
size and/or evaluate participant impact or request data in alternatives formats such as Microsoft Text
(.txt) files.
Universe Record
Layout
Table 1
Table 2
Table 3
Table 4
Table 5
Table 7
Table 6
Universe Data Collection
Start Date
6 months prior to the date of the
audit engagement letter
Universe Data Collection
End Date
Date of the audit engagement
letter
3 months prior to the date of the
audit engagement letter
Date of the audit engagement
letter
Descriptions and clarifications of what must be included in each submission and data field are
outlined in the individual universe record layouts below. Characters are required in all requested
fields, unless otherwise specified, and data must be limited to the request specified in each record
layout. Use a comma (,) with no spaces to separate multiple values within one field if there is more
than one piece of information for a specific field (e.g., PCP, RN, MSW). Do not include any leading
or trailing spaces and do not leave any fields blank. CMS will complete data entry tests on all of the
universes to ensure there are no blank entries, no merged cells, and data is properly formatted.
Submissions that do not strictly adhere to the record layout specifications will be rejected. If CMS
rejects a universe, resubmission of the universe may be requested before and/or after the entrance
conference depending on when the data issue was identified.
Table 1: Service Determination Requests (SDR) Record Layout
Include all requests processed by the PO as service determination requests during the
data collection period, including requests immediately approved by a member of the IDT.
Submit cases based on the date the notification of the decision to approve or deny the
request was first provided or should have been provided (the date the request was
initiated may fall outside of the data collection period).
Column
ID
A
B
7
Field Name
Description
Example
Participant First
Name
Participant Last
Name
First name of the participant.
Jane
Last name of the participant.
Doe
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Column
ID
C
Field Name
Description
Example
Medicare
Beneficiary
Identifier
If the participant has Medicare, enter the
Medicare Beneficiary Identifier. The MBI should
only include uppercase alphabetic and numeric
characters throughout the 11-digit identifier and
is unique to each Medicare enrollee. This number
must be submitted excluding hyphens or dashes.
6M52L458T10
D
Participant ID
E
Person who
Submitted the
Service
Determination
Request
Date Service
Determination
Request Made
F
Enter NA if the participant is not a Medicare
beneficiary.
The identification number the PO uses to
identify the participant.
Indicate who submitted the request. Valid
entries include: participant, designated
representative, or caregiver.
Date the Service Determination Request was
made by the participant, designated
representative, or caregiver.
12345
Participant
02/01/2026
Submit in MM/DD/YYYY format (e.g.,
01/01/2026).
G
H
Date Service
Determination
Request
Brought to the
full IDT
Extension
Date the service determination request was
brought to the full IDT.
02/02/2026
Submit in MM/DD/YYYY format (e.g.,
01/01/2026).
Enter NA if the service determination request
was immediately approved by a member of the
IDT, or if the service determination request was
never brought to the full IDT.
Enter Y if the PO took an extension when
processing the service determination
request.
Y
Enter N if the PO did not take an extension.
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Column
ID
I
Field Name
Description
Example
Extension
Date
Enter the date the IDT made the decision to
extend the service determination request
notification timeframe.
02/03/2026
Submit in MM/DD/YYYY format (e.g.,
01/01/2026).
Enter NA if the service determination request
was not extended.
J
Extension
Notification
Date
Enter the date the IDT notified the participant
and/or the designated representative, orally or
in writing, of the IDT’s decision to extend the
service determination request timeframe.
02/03/2026
Submit in MM/DD/YYYY format (e.g.,
01/01/2026).
7
K
Category of
the Request
L
Description of
the Request
Page 24 of 46
Enter NA if the service determination request
was not extended or if the participant and/or
designated representative was not notified of
the extension in writing.
Provide the category or type of service delivery
request. Examples include: Center Days, Eye
Wear, Dental, Home Care, Medications, etc.
Provide a description of the service
determination request.
Home Care
The participant requested
an increase in home care
from 1x per day, 5 days
per week to 2x per day, 5
days per week.
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Column
ID
M
N
O
P
Field Name
Description
Example
Date of the
first
assessment
completed in
response to
the service
determination
request
Enter the date the first assessment was completed
in response to the service determination request.
02/01/2026
Date of the
last
assessment
completed in
response to
the service
determination
request
How many
assessments
were
completed in
response to
the service
determination
request?
Assessment(s)
In-person
Submit in MM/DD/YYYY format (e.g.,
01/01/2026).
Enter NA if no assessment was completed in
response to the service determination request
(e.g., do not include the date of the participant’s
latest semi-annual assessments if they were not
done in response to the requested services).
Enter the date of the last assessment completed in 02/03/2026
response to the service determination request. The
date of the first and last assessment will be the
same if there was only one assessment completed
in response to the service determination request.
Submit in MM/DD/YYYY format (e.g.,
01/01/2026).
Enter NA if no assessment was completed in
response to the service determination request (e.g.,
do not include the date of the participant’s latest
semi-annual assessments if they were not done in
response to the requested services).
Enter the total number of assessments completed 3
in response to the service determination request.
Enter NA if no assessment(s) were completed in
response to the service determination request (e.g.,
do not include the date of the participant’s latest
semi-annual assessments if they were not done in
response to the requested services).
Enter Y if all assessments that were completed
were conducted in-person.
Y
Enter N if any assessments that were completed
were not conducted in-person.
Enter NA if no assessment was completed in
response to the service determination request.
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Column
ID
Q
Field Name
Description
Example
Request
Disposition
Valid entries include: Approved, Denied,
Partially Denied, or Withdrawn.
Partially Denied
Enter Approved if the request was approved, in
full, as requested.
Enter Denied if all of the requested services were
denied.
Enter Partially Denied if the request was not fully
approved as requested and/or the PO provided a
modified or alternative service to the participant.
R
Immediate
Approval
Enter Withdrawn if the participant and/or the
designated representative requested to withdraw
the service determination request prior to the
organization rendering a decision.
Enter Y if a member of the IDT was able to
approve the service determination request
in full at the time the request was made.
N
Enter N if a member of the IDT was not able to
approve the service determination request in full
at the time the request was made.
S
T
For
Immediate
Approvals,
which IDT
member
approved the
request?
Reason for
Denial
For Immediate Approvals, which IDT member
received and immediately approved the
request? Valid entries include: PCP, RN, MSW,
Home Care Coordinator, OT, PT, Dietitian,
Recreational Therapist/Activities Coordinator,
Personal Care Attendant, Transportation, Center
Manager, Other.
Enter NA if the request was not immediately
approved.
If the request was denied or partially
denied, please enter a brief explanation of
why the request was denied.
Enter NA if the request was approved or
withdrawn.
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NA
Participant needed
assistance with chore
services, which the IDT
assessed could be
completely with 4
additional hours of
homecare per week.
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Column
ID
U
Field Name
Description
Example
Date of Oral
Notification
Enter the date the PO provided oral
notification, to the participant and/or the
designated representative, of the decision (e.g.,
approve or deny the request).
02/03/2026
Submit in MM/DD/YYYY format (e.g.,
01/01/2026).
V
Date of
Written
Notification
Enter NA if oral notification was not provided or
not documented.
Enter the date the PO provided written
notification, to the participant and/or
designated representative, of the decision (e.g.,
approve or deny the request).
02/03/2026
Submit in MM/DD/YYYY format (e.g.,
01/01/2026).
Enter NA if written notification was not provided
or not documented.
W
Date Service
Provided
Enter the date that the approved service was
provided to the participant. Please enter a date for
any request that was fully approved or partially
approved (partially denied).
02/04/2026
Submit in MM/DD/YYYY format (e.g.,
01/01/2026).
Enter NA if the request was denied, withdrawn
or if there was no documentation of the
effectuation (provision) of the service.
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Table 2: Appeal Requests (AR) Record Layout
Include all requests processed as standard or expedited appeals received by the PO during
the data collection period.
Exclude appeals from external reviewers (i.e., Medicaid appeals).
Submit cases based on the date the notification of the decision was first provided or
should have been provided (the date the request was initiated may fall outside of
the data collection period).
Column
ID
A
B
C
Field Name
Description
Example
Participant First
Name
Participant Last
Name
Medicare
Beneficiary
Identifier
First name of the participant.
John
Last name of the participant.
Smith
If the participant has Medicare, enter the
Medicare Beneficiary Identifier.
6M52L458T10
The MBI contains uppercase alphabetic and
numeric characters throughout the 11-digit
identifier and is unique to each Medicare
enrollee. This number must be submitted
excluding hyphens or dashes.
D
Participant ID
E
Enrollment Type
F
Person who
Submitted the
Appeal
Date Appeal
Received
G
H
Time Appeal
Received
Enter NA if the participant is not a Medicare
beneficiary.
The identification number the PO uses to
identify the participant.
Enter the participant’s current enrollment type.
Valid entries include: Medicare only, Medicaid
only, Dual Eligible, and Private Pay.
Indicate who submitted the appeal. Valid
entries include: participant or designated
representative.
Date the appeal was received by the PO.
Submit in MM/DD/YYYY format (e.g.,
01/01/2026).
Enter the time the expedited appeal was
received by the PO.
12345
Dual Eligible
Participant
03/01/2026
NA
Submit in HH:MM format (e.g., 23:54).
Enter NA for standard appeals (i.e., if the
appeal was not expedited).
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Column
ID
I
J
Field Name
Description
Expedited
Enter Y if the appeal was processed as expedited. N
Extension
Enter N if the appeal was not expedited (i.e., was
processed as a standard appeal).
Enter Y if the PO took an extension when
processing an expedited appeal.
Example
NA
Enter N if the PO did not take an extension on an
expedited appeal.
K
Category of the
Appeal/ Appeal
Type
L
Description of the
Appeal/ Specific
Issue
Third-party
reviewer or
committee
credentials
M
Enter NA if the appeal was not expedited (i.e.,
was processed as a standard appeal).
Provide the category or type of appeal request.
Valid entries include: Decreased Center
Attendance, Denial of Enrollment, Dentures,
Durable Medical Equipment, Glasses, Hearing
Aid, Home Modification(s), Increased Center
Attendance, Increased Home Care, Involuntary
Disenrollment, Medical Procedure, Medical
Supplies, Nursing Facility Placement - Long
Term, Nursing Facility Placement – Respite,
Nursing Facility Placement - Short Term,
Specialist Consultation or Visit, Surgical
Procedure, Transportation, or Other
Provide a description of the appeal.
Glasses
The participant requested
prescription bifocals.
Enter the credentials of the third-party reviewer or Another PO’s IDT
committee that was involved in the review of this
appeal. For a committee review, list all committee
members’ credentials. If the committee reviewing
the appeal was another PO’s full IDT, enter
“Another PO’s IDT”.
Note: If the committee was another PO’s IDT, but
was not the full IDT, identify the credentials of all
individuals that were involved as third-party
reviewers.
Enter NA if the appeal was not reviewed by a
third-party reviewer or committee.
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Column
ID
N
Field Name
Description
Example
Request
Disposition
Valid entries include: Approved, Denied, Partially Approved
Denied or Withdrawn.
Enter Approved if all of the requested services
were approved as requested.
Enter Denied if all of the requested services were
denied.
Enter Partially Denied if the request was not fully
approved as requested and/or the PO provided a
modified or alternative service to the participant.
O
P
Reason for Denial
Date of Written
Notification
Enter Withdrawn if the participant and/or
designated representative requested to withdraw
the appeal prior to a decision being rendered.
If the appeal was denied or partially denied,
please enter a brief explanation of why the
request was denied.
Enter NA if the appeal was approved or
withdrawn.
Enter the date the PO provided written
notification to the participant or other
representative (e.g. family or caregiver) of
the third-party’s decision to approve or deny
the appeal.
Glasses were denied because
the participant was assessed
to have 20/20 vision.
03/10/2026
Submit in MM/DD/YYYY format (e.g.,
01/01/2026).
Q
Time of Written
Notification
Enter NA if written notification was not provided
or not documented.
Enter the time the PO provided written
NA
notification to the participant or other
representative (e.g. family or caregiver) of the
third-party’s decision to approve or deny the
expedited appeal.
Submit in HH:MM format (e.g., 23:59).
Enter NA if the appeal was not expedited (i.e.,
was processed as a standard appeal) or if written
notification was not provided.
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Column
ID
R
Field Name
Description
Example
Date Service
Provided
05/01/2026
Enter the date that the approved service was
provided to the participant. Please enter a date for
any appeal that was fully approved or partially
approved (partially denied).
Submit in MM/DD/YYYY format (e.g.,
01/01/2026).
Enter NA if the appeal was not approved (i.e.,
denied) or if the service was not provided or if
there was no documentation of the effectuation
(provision) of the service.
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Table 3: Grievance (GR) Record Layout
Include all complaints processed as grievances during the data collection period.
Submit grievances based on the date the PO resolved or should have resolved the grievance
(the date the complaint was initiated may fall outside of the data collection period).
Column
ID
A
B
C
Field Name
Description
Example
Participant First
Name
Participant Last
Name
Medicare
Beneficiary
Identifier
First name of the participant.
Jane
Last name of the participant.
Doe
If the participant has Medicare, enter the
Medicare Beneficiary Identifier.
6M52L458T10
The MBI contains uppercase alphabetic and
numeric characters throughout the 11-digit
identifier and is unique to each Medicare
enrollee. This number must be submitted
excluding hyphens or dashes.
D
Participant ID
E
Person who
submitted the
Grievance
Date
Grievance
Received
F
Enter NA if the participant is not a Medicare
beneficiary.
The identification number the PO uses to
identify the participant.
Indicate who submitted the complaint. Valid
entries include: participant, family member,
designated representative, or caregiver.
Date the grievance was received by the
PO. Submit in MM/DD/YYYY format
(e.g., 01/01/2026).
123456
Participant
04/01/2026
G
Category of the
Grievance/
Grievance Type
Provide the category or type of grievance.
Valid entries include: Activities,
Communication, Contracted Specialist,
Contracted Facility (Hospital, SNF, etc.),
Dietary, Disenrollment, Enrollment, Home
Care, Marketing, Medical Care, Medication,
PACE Services, Supplies, Transportation, or
Other.
Contracted Specialist
H
Description of the
Grievance/
Specific Issue
Provide a description of the grievance. If
multiple issues were included in the complaint,
please provide a brief description of each issue in
the grievance.
The participant was
dissatisfied with the time it
took to arrange a cardiology
appointment.
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Column
ID
I
Field Name
Description
Example
Quality of Care
Were any of the issues within the grievance
related to quality of care concerns?
N
A quality of care concern means a concern that
care provided did not meet a professionally
recognized standard of health care.
Enter Y if any of the issues in the grievance
related to quality of care concerns.
J
Investigation
Required
Enter N if none of the issues in the grievance
related to quality of care concerns.
Was an investigation of one or more issues
within the grievance required?
Y
Enter Y if any issues in the grievance required
an investigation.
K
Corrective Action
Required
Enter N if no issues in the grievance required
an investigation.
Was corrective action taken as a result of the
grievance?
N
Enter Y if corrective action was required and
taken.
Enter N if corrective action was required and
not taken.
L
QIO
Enter NA if corrective action was not required.
Did the participant, family member, designated
representative, or caregiver file a complaint
with the QIO related to this grievance or any
portion of this grievance?
N
Enter Y if a complaint was filed with the QIO
related to this grievance.
M
Date of Grievance
Resolution
Enter N if no complaints were filed with the
QIO related to this grievance.
Date the PO resolved the grievance. Submit in
MM/DD/YYYY format.
04/08/2026
Enter NA if the grievance was not resolved.
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Column
ID
N
Field Name
Description
Example
Notification
Preference
oral
O
Date of Oral
Notification
Did the individual who submitted the grievance
have a preference for how notification was
provided? Valid entries include: oral, written,
both, withhold, no preference.
Enter the date the PO provided oral
notification (if applicable) to the individual
who submitted the grievance.
04/11/2026
Submit in MM/DD/YYYY format
(e.g., 01/01/2026).
Enter NA if oral notification was not provided
or not documented.
P
Date of Written
Notification
Enter the date the PO provided written
notification (if applicable) to the individual
who submitted the grievance.
NA
Submit in MM/DD/YYYY format
(e.g., 01/01/2026).
Enter NA if written notification was not
provided or not documented.
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Table 4: List of Personnel (LOP) Record Layout
Include all personnel hired or employed during the data collection period (i.e.,
volunteer, part- time, full time, and contracted staff).
Include only those contracted employees that provide care/services to participants in the
participant’s home, at the PACE center (or ACS) or when transporting participants. This
includes all individuals who transported participants and all individuals who provided
home care to participants.
Exclude employees of institutional contracted providers such as nursing facilities and hospitals.
Exclude all personnel terminated prior to the data collection period.
Column
ID
A
Field Name
Description
Example
First Name
John
B
Last Name
C
Job Title
D
Date of Hire
E
Date of
Termination
First name of the employee or contracted
individual.
Last name of the employee or contracted
individual.
Provide the job title of the employee. Examples:
Home Health Aide, Physical Therapist, etc.
Date the employee or contracted individual was
hired by the PO. Submit in MM/DD/YYYY
format (e.g., 01/01/2026).
Date the employee was terminated or resigned
from the PO. Submit in MM/DD/YYYY
format (e.g., 01/01/2026).
F
Type of
Employment
G
Direct
Participant
Contact
H
License
Enter NA if the employee is still working for
the PO.
Provide the type of employment for the
employee. Valid entries include: Contract, Fulltime, Part-time, Volunteer, or Other.
Enter Y if the employee had direct
participant contact during the data collection
period. For audit purposes, an employee or
contractor is considered to have had direct
contact with a participant if the employee or
contractor had the ability to transmit any
type of infectious disease to the participant.
Enter N if the employee did not have direct
participant contact during the data collection
period.
Enter Y if the employee requires a license in
order to perform their duties with the PO.
Smith
Physical Therapist
12/01/2026
NA
Full-time
Y
Y
Enter N if the employee does not require a
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Column
ID
Field Name
Description
Example
license in order to perform their duties with the
PO.
I
J
IDT
Member
IDT Role
Enter Y if the employee is a part of the PO’s
IDT. If a PO has multiple IDTs, the PO should
enter Y if this individual is a member of any
IDT.
Enter N if the employee is not a member of any
of the PO’s IDTs.
Enter the discipline(s) the individual represents
on the IDT. Valid entries include: PCP, RN,
MSW, Home Care Coordinator, OT, PT,
Dietitian, Recreational Therapist/Activities
Coordinator, Personal Care Attendant,
Transportation, Center Manager, Other.
Y
PT
Enter NA if the individual is not a part of an IDT.
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Table 5: List of Participant Medical Records (LOPMR) Record Layout
Include all participants enrolled in the PO at some point during the data collection period.
Exclude all participants disenrolled prior to the start of the data collection period.
POs may use any and all information available to them when populating these fields, including
participant medical records, claims data, and any other participant-specific information the PO
may maintain.
Column
ID
A
B
C
Field Name
Description
Example
Participant First
Name
Participant Last
Name
Medicare
Beneficiary
Identifier
First name of the participant.
Juan
Last name of the participant.
Doe
If the participant has Medicare, enter the
Medicare Beneficiary Identifier.
6M52L458T10
The MBI contains uppercase alphabetic and
numeric characters throughout the 11-digit
identifier and is unique to each Medicare
enrollee. This number must be submitted
excluding hyphens or dashes.
D
Participant ID
E
PACE Center
F
G
H
7
Enter NA if the participant is not a Medicare
beneficiary.
The identification number the PO uses to
identify the participant.
If the PO has more than one center, enter the
name of the participant’s assigned center.
If there is only one center, enter NA.
Date of Enrollment Date the participant was enrolled in the PO.
Submit in MM/DD/YYYY format (e.g.,
01/01/2026).
Date of
Date the participant disenrolled from the PO.
Disenrollment
Submit in MM/DD/YYYY format (e.g.,
01/01/2026).
Reason for
Disenrollment
I
Enrollment
Type
J
Participant’s
Preferred
Language
Page 37 of 46
Enter NA if the participant is still enrolled.
Provide the reason for the disenrollment.
Enter NA if the participant is still enrolled.
Enter the participant’s current enrollment type.
Valid entries include: Medicare only, Medicaid
only, Dual Eligible, Private Pay.
Enter the participant’s preferred language to
receive communications from the PO.
1234
Center 1
05/01/2018
NA
Participant wanted to
receive cardiac care from a
non-contract provider.
Dual Eligible
Spanish
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Column
ID
K
L
Field Name
Description
Example
Participant’s
Current Living
Situation
Describe the participant’s current living
arrangement. Valid entries may include, but are
not limited to: home with family member/
caregivers, home without family member/
caregiver, SNF/NF, ALF, etc.
Resides in home with a
family member caregiver
Change in
Living Situation
N
Identify whether the participant’s living
arrangement changed significantly during the data
collection period. For example: the participant
went from living in the community to living in a
facility (ALF, NH, etc.), or vice versa; or if the
participant went from living with family to living
alone.
Enter Y if the participant’s living arrangement
changed significantly during the data collection
period.
M
Number of
Hospital
Admissions/
Observations
Enter N if the participant’s living arrangement
did not change significantly during the data
collection period.
Enter the number of hospital admissions and/or
observations that occurred during the data
collection period.
2
This includes:
Admissions/observations from an
emergency room
Direct admissions
N
O
7
30-Day Hospital
Readmissions
Number of
Emergency Room
Visits
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Enter Y if the participant had an unplanned
hospital readmission, for any cause, within 30
days of discharge from the previous admission,
during the data collection period.
Enter N if the participant did not have an
unplanned hospital readmission, for any cause,
within 30 days of discharge from the previous
admission during the data collection period.
Enter the number of emergency room visits that
occurred during the data collection period.
Include ER visits that resulted in a hospital
admission or observation.
Y
3
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Column
ID
P
Field Name
Description
Example
Hospitalization
/ Emergency
Room Reason
Was the participant diagnosed with
hypoglycemia, hyperglycemia, internal
bleeding, sepsis, medication overdose, or
decreased oxygen saturation in the
emergency room or on admission to the
hospital?
Y
Enter Y if the participant went to the ER or
was admitted to the hospital (or observed at
the hospital) with a primary or secondary
diagnosis of hypoglycemia, hyperglycemia,
internal bleeding, sepsis, medication overdose,
or decreased oxygen saturation.
Q
Number of
SNF/NF
Admissions
R
Specialist
Consultations/
Visits
Enter N if the participant did not go to the ER
or was not admitted to the hospital (or
observed at the hospital with a primary or
secondary diagnosis of hypoglycemia,
hyperglycemia, internal bleeding, sepsis,
medication overdose,
or decreased oxygen saturation).
Enter the number of skilled nursing
facility/nursing facility admissions that
occurred during the data collection period.
This should include all SNF/NF admissions
for any cause, including admission as a result
of a request for services.
Was a consultation/visit with any of the
following types of specialties approved by
the IDT and/or ordered by a PCP during the
data collection period?
1
Cardiology, Oncology,
Rheumatology
Cardiology
Endocrinology
Gastroenterology
Infectious Disease
Mental Health
Oncology
Ophthalmology
Oral Maxillofacial Surgery
Pulmonary Medicine
Rheumatology
If Yes, enter each type of specialty. If No,
enter N.
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Column
ID
S
Field Name
Description
Example
Diagnoses
Did the participant have any of the following
diagnoses/conditions during the data
collection period?
AIDS, Hepatitis C, Cancer
- lung
AIDS
Anemia
Auto-immune disorder (any type
– specify the type in the
response)
Cancer (any type – specify the type
in the response)
Cellulitis
Cerebrovascular Accident (CVA)
Chronic Obstructing
Pulmonary Disease (COPD)
Congestive Heart Failure (CHF)
Current Drug Abuse
Dementia
Diabetes Mellitus
Hepatitis C
Human immunodeficiency virus (HIV)
Mental Illness (any type- specify
the type in the response)
Multiple Sclerosis
Myasthenia Gravis
Necrotizing Fasciitis
Pneumonia
Psychosis
Sepsis
If Yes, enter each diagnosis and
where applicable specify the type.
T
CHF
Exacerbation
If No, enter N.
Enter Y if the participant was diagnosed with a
CHF exacerbation during the data collection
period.
Y
Enter N if the participant was not diagnosed
with a CHF exacerbation or the participant
did not have a diagnosis of CHF during the
data collection period.
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Column
ID
U
V
Field Name
Description
Example
COPD
Exacerbation
Enter Y if the participant was diagnosed with a
COPD exacerbation during the data collection
period.
N
Received
Home Care
Enter N if the participant was not diagnosed
with a COPD exacerbation or the participant
did not have a diagnosis of COPD during the
data collection period.
Enter Skilled if the participant ever received
either skilled home care or a combination of
skilled and unskilled home care during the data
collection period.
Skilled
Enter Unskilled if the participant only received
unskilled home care during the data collection
period.
W
7
Assistance
with
Administering
Medications
X
Current Center
Attendance
Y
Number of
Falls with
Injury
Page 41 of 46
Enter NA if the participant did not receive
home care during the data collection period.
Enter Y if an employee/contracted employee
administered medication to the participant in
the participant’s home and/or the PACE
center at any time during the data collection
period.
Enter N if an employee/contracted employee
did not administer medication to the
participant in the participant’s home and/or
the PACE center at any time during the data
collection period. Prompting/medication
reminders are not considered medication
administration assistance.
Enter the number of days per month the
participant is scheduled to attend the PACE
center at the time the universe is completed.
Enter 0 if the participant is not scheduled to
attend the PACE center or had disenrolled
(voluntarily, involuntarily or deceased) at the
time the universe is completed. Do not
include attendance at an Alternative Care
Setting (ACS) in this field.
Enter the number of falls with injury the
participant had that met the criteria for a
root cause analysis per the PACE Quality
Monitoring requirements during the data
collection period.
Y
2
1
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Column
ID
Z
Field Name
Description
Example
Number of
Pressure
Ulcers
Enter the number of pressure ulcers the
participant had that met the criteria for a root
cause analysis per the PACE Quality
Monitoring requirements during the data
collection period.
1
AA
Number of
Confirmed
Abuse Reports
Enter the number of confirmed abuse
reports that met the criteria for a root cause
analysis per the PACE Quality Monitoring
requirements during the data collection
period.
0
AB
Unexpected
Death
Enter Y if the participant experienced an
unexpected death that met the criteria for
a root cause analysis per the PACE
Quality Monitoring requirements during
the data collection period.
N
AC
AD
AE
Functional
Decline
Incontinence
Indwelling
Catheter
Enter N if the participant did not experience
an unexpected death that met the criteria for a
root cause analysis per the PACE Quality
Monitoring requirements during the data
collection period.
Enter Y if the participant experienced a
functional decline, as defined by the
PO, during the data collection period.
Enter N if the participant did not experience
a functional decline during the data
collection period.
Enter Y if the participant was routinely
incontinent during the data collection period.
Enter N if the participant was not routinely
incontinent or had acute/transient incontinence
during the data collection period.
Enter Y if the participant had an indwelling
catheter during the data collection period.
N
Y
N
Enter N if the participant did not have an
indwelling catheter during the data collection
period.
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Column
ID
AF
AG
Field Name
Description
Example
Restraints
Enter Y if physical or chemical
restraints were used on the participant at
any point during the data collection
period,
N
Dialysis
Enter N if physical or chemical restraints
were not used on the participant at any point
during the data collection period.
Enter Y if the participant received
dialysis during the data collection period.
N
Enter N if the participant did not receive
dialysis during the data collection period.
AH
AI
AJ
7
Palliative
Care, Comfort
Care, or Endof-Life
Services
Initiated
Wound Care
Type of
Disenrollment
Page 43 of 46
Enter Y if palliative care, comfort care,
or end-of-life care services were initiated
during the data collection period.
Enter N if palliative care, comfort care,
or end-of-life care services were not
initiated during the data collection
period.
Enter Y if the participant received
regularly scheduled wound care during
the audit review period. Do not include
one time instances of wound care.
Enter N if the participant did not receive
regularly scheduled wound care.
Valid entries include: Voluntary,
Involuntary, and Deceased. Enter NA if the
participant is still enrolled.
Y
Y
Voluntary
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Table 6: On-Call (OC) Record Layout
Include all after hour calls received by the PO during the data collection period.
Exclude all calls received during normal business hours.
Column ID
A
B
C
Field Name
Participant First Name
Participant Last Name
Medicare Beneficiary
Identifier
Description
First name of the participant.
Last name of the participant.
If the participant has Medicare, enter the
Medicare Beneficiary Identifier.
Example
Jane
Doe
6M52L458T10
The MBI contains uppercase alphabetic and
numeric characters throughout the 11-digit
identifier and is unique to each Medicare
enrollee. This number must be submitted
excluding hyphens or dashes.
7
D
Participant ID
E
Caller Information
F
Date of Call
G
Time of Call
H
Call
Description/
Reason For
Call
I
Response to Call
Page 44 of 46
Enter NA if the participant is not a Medicare
beneficiary.
The identification number the PO uses to
identify the participant.
Identify who made the call (e.g., participant,
daughter, spouse, caregiver).
Date the call was received. Submit in
MM/DD/YYYY format (e.g., 01/01/2026).
Time the call was received. Submit in
HH:MM format (e.g., 23:54).
Provide a description of the reason for
the call.
Provide a description of the response to the
call as it relates to the participant (e.g., did
the PO send someone to the participant’s
home, did the participant go to the hospital).
1234
Daughter
02/01/2026
20:15
The participant called to
report chest pain.
Described the pain as
persistent and radiating
down left arm.
Called EMS for transport
to hospital.
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Table 7: Contracted Entities and Providers (CEP) Record Layout
Include all entities contracted to provide services to PACE participants during the data collection
period. This includes, but is not limited to:
o All specialists, both medical and non-medical, including at a minimum all medical
specialists listed under 460.70(a);
o Home care providers, both skilled and non-skilled (name of home care companies, not
individual employees);
o Nursing facilities, short and long-term;
o Hospitals and urgent care facilities
o Other contracted residential facilities such as assisted living facilities, boarding homes,
etc.
Include all entities with pending contracts at the time the universe is completed.
Include each distinct specialty or facility types (column B) for a given practice or facility (column
A) on a separate row.
Do not include any entities whose contracts were terminated prior to the start of the data
collection period.
Column
ID
A
B
Field Name
Description
Example
Provider/
Practice/ Facility
Name
Name of the provider, practice or facility.
Dr. Jane Smith, MD
Specialty or
Facility Types
Description of the specialty type or facility type
associated with the provider/practice or facility
name in column A.
For the purposes of this field, provider includes
specialists, home care companies, hospitals,
urgent care, and facility includes contracted
nursing facilities and other contracted residential
facilities.
Oncology
If the PACE organization has a contract with one
provider, practice, or facility to provide multiple
types of specialist services or other services, enter
each specialty or service in a new row.
C
Contract Status
For example, if the PACE organization is
contracted with a hospital system to provide
oncology, gastroenterology, and pulmonology,
enter each of these specialties in a separate row
with the same facility listed in column A.
Enter Active if a contract is in effect with the
provider / facility at the time of the universe
submission.
Active
Enter Terminated if a contract was in effect for
some portion of the data collection period but is
terminated at the time of universe submission.
Enter Pending if the PO is currently attempting to
establish a contract with the provider / facility but
the contract is not in effect at the time of universe
submission.
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Column
ID
D
E
F
Field Name
Description
Contract Start Date Enter the date the contract became effective.
Contract
Termination Date
Limitations /
Restrictions
Enter NA if the contract status is currently
pending.
Enter the date the contract was terminated.
Enter NA if the contract status is currently active
or pending.
Enter Y if the contracted entity or provider
implemented or imposed any blanket restrictions
or limitations on services that impacted
participants at any point during the data review
period. Examples of limitations include: The
provider placed a cap on the number of PACE
participants they will accept, or the provider did
not accept new PACE participants.
Example
11/01/2019
NA
Y
If there were no limitations or restrictions on the
availability of services from contracted entities or
providers, at any point during the data collection
period, enter N.
Enter NA if the contract status is currently
pending.
PRA Disclosure Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid
OMB control number. The valid OMB control number for this information collection is 0938-1327. This information collection will allow CMS to
conduct comprehensive reviews of PACE organizations to ensure compliance with regulatory requirements. The time required to complete this
information collection is estimated at 780 per response, including the time to review instructions, search existing data resources, gather the data
needed, to review and complete the information collection. This information collection is mandatory per CMS’s authority under Section 1894 and
1934 of the Social Security Act and implementing regulations at 42 CFR § 460.190 and 460.194, which state that CMS, in conjunction with the
State Administering Agency (SAA), audit PACE organizations (POs) annually for the first 3 contract years (during the trial period), and then on an
ongoing basis following the trial period. Additionally, per § 460.200(a) PACE organizations are required to collect data, maintain records, and
submit reports as required by CMS and the State administering agency. If you have comments concerning the accuracy of the time estimate(s) or
suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05,
Baltimore, Maryland 21244-1850.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0938-1327. The time required to complete this
information collection is estimated to average 780 hours per response, including the time to review instructions, search existing data
resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the
time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance
Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.
7
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| File Type | application/pdf |
| File Title | Microsoft Word - Document1 |
| Author | MMV6 |
| File Modified | 2025-07-07 |
| File Created | 2025-07-07 |