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pdfPrograms of All-Inclusive
Care for the Elderly (PACE)
Audit Protocol
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 ......................................................................................................................... 12
III. Personnel Records ............................................................................................................................. 17
IV. Compliance and Quality Improvement.............................................................................................. 18
Analysis of Potential Non-Compliance......................................................................................................... 20
I.
Root Cause Analysis.......................................................................................................................... 20
II.
Impact Analysis ................................................................................................................................. 20
III. Additional Records Review............................................................................................................... 20
Appendix....................................................................................................................................................... 21
Appendix A - Programs of All-Inclusive Care for the Elderly (PACE) Record Layouts .......................... 21
Table 1: Service Determination Requests (SDR) Record Layout ......................................................... 21
Table 2: Appeal Requests (AR) Record Layout .................................................................................... 27
Table 3: Grievance (GR) Record Layout .............................................................................................. 31
Table 4: List of Personnel (LOP) Record Layout.................................................................................. 33
Table 5: List of Participant Medical Records (LOPMR) Record Layout.............................................. 35
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
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’ remote
review includes, but is not limited to, CMS accessing and obtaining information from the PO’s
electronic medical records 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 noncompliance 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 demonstrating the measures developed as part of the PO’s
compliance oversight program to prevent, detect, and correct noncompliance
with regulatory requirements and fraud, waste, and abuse
2.2.2. Monitoring Reports:
• For 30 participants selected by CMS at the time the engagement letter is
issued: Reports that detail the PO’s monitoring and tracking of all services
across all care settings that were ordered, approved, or care planned during
the data collection period. At a minimum, reports should be arranged in
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alphabetical order by participant last name and include:
• Participant first and last name (provided by CMS)
• Medicare Beneficiary Identifier (MBI) (if applicable)
• Participant ID
• Date the service was ordered, approved, or care planned
• Description of the service ordered, approved or care planned
• Date the service was provided
2.2.3. 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)
• 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. 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
two business days before the SDAG 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: identifying the
request, processing the request, notifying participants of the IDT decision, and providing any
approved services. 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 should comprehensively address the applicable
documentation requests below with documentation that is either (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]”). For any required documentation that is
unavailable, the PO must include a note in the case file that states the required documentation
does not exist. For example, if the PO does not have documentation to support what was
communicated to a participant during oral notification of a denied service determination request,
then the PO would include a page in the case file that states the PO does not have a record of the
oral notification conversation.
2.1. For service determination requests:
Documentation of the initial request
• Documentation of the initial request (received in writing, orally, etc.), including all
system notes, progress notes, logs, written communication from the participant,
designated representative, and/or caregiver, and any other data, such as the date the
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request was made and who made the request, related to the receipt of the service
determination request
Documentation of reassessments conducted in response to the service determination
request
• All assessments conducted in response to the service determination request and all IDT
notes and discussions regarding the assessments, including:
Documentation of the date(s) of the assessment(s)
Documentation of which IDT member(s) were selected by the IDT to perform the
assessment(s) and which IDT member(s) performed the assessment(s)
Documentation showing that the assessment(s) was/were conducted in-person, if
applicable
Documentation of the contents of the assessment(s), such as the evaluation of the
participant's medical, physical, emotional, and social needs
Documentation of full IDT involvement in the service determination request review
(not applicable to immediate approvals by IDT member)
• Documentation of the IDT’s review of the service determination request, including:
Documentation of all IDT members involved in the review of the service
determination request
Documentation identifying the date(s) the request was reviewed by the IDT
Documentation that the IDT considered all relevant information when evaluating the
service determination request
Documentation of the IDT’s decision to approve, deny, or partially deny the request
Documentation for service determination requests with extended processing
timeframes
• If the extension was requested by the participant, the participant’s designated
representative, or the participant’s caregiver, documentation of their request for an
extension
• If the extension was taken because the IDT needed additional information, provide
documentation of the circumstances that led to the extension and how the extension
was in the participant's best interest
• Documentation demonstrating when the IDT extended the review/notification
timeframe
• A copy of the written notice of extension provided to the participant, the participant’s
designated representative, or caregiver
Documentation of service determination request notifications based on request
disposition
• Denied and partially denied service determination requests:
Documentation of the oral and written notification provided to the participant or
designated representative, including the specific reason for the denial and the
participant’s appeal rights
• Approved service determination requests:
Documentation of oral and/or written notification provided to the participant or
designated representative, including an explanation of the conditions of the
approval and when the participant may expect to receive the approved service(s)
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•
Any other reports, system notes, or logs that document denial or approval of the request
and participant notification
Documentation of the provision of services
• For all approved and partially denied service determination requests, documentation
showing that all approved services were provided as expeditiously as the participant's
health condition requires, considering the participant's medical, physical, emotional,
and social needs (e.g., an annotation in the participant’s medical record, assessments,
progress notes)
2.2. For appeals:
• Documentation of the initial appeal request (received in writing, orally, etc.), including
any system notes, progress notes, logs, or other data related to the appeal request
• All case notes, progress notes and assessments related to the appeal, including
the underlying service determination request denial
• Documentation that the participant was given an opportunity to present evidence inperson as well as in writing
• Documentation indicating why an appeal was expedited (if applicable)
• Documentation indicating why an expedited appeal was extended, including the
participant’s request for an extension or documentation the PO justified the extension to
the SAA (if applicable)
• Documentation identifying the third-party reviewers and their credentials
• Documentation of the third-party reviewer decision
• Note: Upon request by CMS, POs may be asked for the documentation provided to the
third-party reviewer or committee reviewer that explained the PACE benefit structure,
including services that must be provided and how determinations must be consistent
with relevant laws and regulations. This information does not need to be routinely
included in appeal case files.
Documentation of appeal notifications based on the appeal disposition
• Partially and fully adverse appeal decisions:
Documentation of the written notification provided to all parties involved in the
appeal, including the specific reason(s) for the denial, and their external appeal
rights available through Medicare and/or Medicaid
• Favorable appeal decisions:
Documentation of written notification of the decision, including explanation of the
conditions of approval in understandable language
If oral notification was provided, documentation of the oral notification
• Any other reports, system notes, or logs that document denial or approval of the request
and participant notification
Documentation of the provision of services
• Documentation showing that all approved services were provided as expeditiously as
the participant's health condition required (e.g., an annotation in the participant’s
medical record, assessments, progress notes)
• 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
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2.3. For grievances:
• Documentation of the initial complaint including system notes, progress notes, logs, or
other data related to the complaint classified by the PO as a grievance
• Documentation detailing each issue in the grievance
• Documentation of all supplemental information submitted by the participant and/or
their caregiver
• Documentation showing the steps the PO took to resolve each issue identified in the
grievance, such as documentation of communication with other individuals and
organizations internal and external to the PO that the PO contacted in order to resolve
the grievance
• Documentation describing the final resolution for each grievance issue
• Documentation showing resolution notification of each issue identified in the grievance
to the participant and/or their representative
If written notification was provided, a copy of the written resolution letter and
documentation of the date/time the letter was mailed
If oral notification was provided, a copy of progress notes and/or other
documentation of the notification including the date the notification was
provided
• Documentation to demonstrate that any necessary follow-up actions identified by the PO
when processing the grievance were followed up as appropriate.
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.
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 full IDT review the service determination request, if applicable?
3.1.3. Did the PO ensure that the appeal was reviewed by an impartial and
appropriately credentialed third-party reviewer or committee?
3.1.4. 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?
3.1.5. Did the PO conduct in-person assessments in response to a service determination
request the IDT expected to deny or partially deny?
3.1.6. Did the in-person assessment evaluate whether the requested service was
necessary to meet the participant’s medical, physical, emotional, and social
needs?
3.1.7. 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?
3.1.8. Did the PO automatically process as an appeal any service determination request
that was not processed within the required timeframe?
3.1.9. Did the PO give all parties involved in an appeal a reasonable opportunity to
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present evidence in-person, as well as in writing?
3.1.10. Did the PO continue providing services to a Medicaid participant, during an
appeal, if the participant requested to continue the services?
3.1.11. Did the PO properly identify and address all issues in a grievance?
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?
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. Did the PO notify the participant of the grievance resolution(s)?
3.3. Did the PO process service determination requests and appeals within required
timeframes and take appropriate extensions?
3.3.1. Did the PO notify the participant or designated representative of the approval, at
the time the request was made for a service that could be immediately approved
by a member of the IDT?
3.3.2. 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?
3.3.3. 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?
3.3.4. Did the PO appropriately extend the timeframe for approving or denying a
service determination request, if applicable?
3.3.5. If the IDT extended the service determination request processing timeframe, did
the IDT provide notice of the extension to the participant or designated
representative in writing no later than 24 hours after the IDT decided to extend
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3.3.6.
3.3.7.
3.3.8.
3.3.9.
the timeframe?
If the IDT extended the service determination request processing timeframe, did
the IDT notify the participant or designated representative 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?
3.4. Did the PO effectuate/provide approved services as expeditiously as the participant’s
condition required?
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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 30 targeted medical records 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 identify the participants selected for observation on the first day of the week of the
participant observations review. 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 if services are being
provided appropriately.
2. Review Sample Case Documentation: CMS will review participant medical records and
conduct participant observations to determine compliance with regulatory requirements
including: provision of required services, coordination and management of participant care,
completion of required assessments, and the development and review of participant care plans.
CMS may also conduct interviews with participants, personnel, and caregivers as determined
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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.
Medical Record Review:
• All documentation related to participant assessments:
Initial comprehensive assessments
Semi-annual and unscheduled assessments
Documentation that assessments were completed as required
IDT progress notes, evaluations, or other documentation related to initial,
semiannual, and unscheduled assessments
Documentation related to assessment outcomes, changes in care plans, participant
outcomes, etc.
• All documentation related to participant care plans:
Documentation showing when and how the care plan was developed/reevaluated including documentation of IDT members involved in the development
and re- evaluation
Changes made to the care plan at any point
IDT recommendations and notes related to the care plan
Assessments that were used in constructing or revising the care plan
Documentation that the participant and/or caregiver was appropriately involved in
the development and revision of the care plan
Documentation showing that services and care indicated in a participant’s care plan
were provided appropriately
Documentation that initial care plans include the rationale for not providing services
identified in initial assessments (if the IDT determined the services are not
necessary)
• All documentation related to service delivery and emergency care:
Documentation that the PO is providing all necessary services and care as
determined by the IDT
Documentation that the PO is tracking and monitoring the provision of services
across all care settings
Documentation that the PO provided services as expeditiously as the participant's
health condition requires, taking into account the participant's medical, physical,
emotional, and social needs
Documentation that the PO provides Medicare and Medicaid covered services, as
appropriate and necessary
Documentation that the PO provides comprehensive PACE services to meet
participants’ medical, physical, emotional, and social needs
Documentation that an on-call provider is available to participants 24 hours a day
Documentation the PO provides immediate access to emergency care
Documentation of emergency care, including documentation that the participant was
held harmless
Documentation relating to the use of restraints, if applicable
• Documentation that the PO provided Medicare and Medicaid benefits without any
limitations or conditions related to amount, duration, scope of services, deductibles,
copayments, coinsurance, or other cost-sharing
• Documentation relating to the IDT including:
Documentation that the IDT consists of all required members
Documentation showing appropriate members were involved in assessments and
care planning as required
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•
•
•
•
•
•
•
•
•
•
•
Documentation of all IDT communications
Documentation of recommendations or requests for care or services by IDT
members, participants, caregivers, PO employees, contractors, specialists, and
designated representatives
In the case of recommended services that were not approved and/or not provided by the
IDT, the documented reason(s) the service(s) were not approved and/or provided
Documentation of communications from the participant, their designated
representative, a family member, a caregiver, or any other individual who provides
information pertinent to a participant's health or safety or both, including access to
original written communication
Documentation of communications from an advocacy or governmental agency such as
Adult Protective Services, including access to original written communication
All other documentation related to participant experience and care at the PO
Documentation related to visits or consults with specialists
Documentation from outside provider including hospital records, SNF/NF records,
respite care
Documentation related to medication administration and orders
Any documentation relating to the participants dietary needs
Any documentation relating to participant attendance at the PACE center
Documentation that treatment options were explained in a culturally competent manner
Participant observations:
• A private area (can be the clinic) to view a willing participant receiving care
• Home visit(s) to view a willing participant receiving care
• Visit(s) to an outside facility (such as a SNF), if applicable
Equipment:
• Emergency equipment available at the center
• At least one vehicle used to transport participants
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.
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
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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 document all recommendations for care or services?
3.2.7. 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
documented in accordance with medical records maintenance requirements?
3.2.8. Did the IDT implement, coordinate, and monitor the plan of care whether the
services were furnished by PACE employees or contractors?
3.2.9. Did the PO continuously monitor the participant's health and psychosocial status,
as well as the effectiveness of the plan of care, through the provision of services,
informal observation, input from participants or representatives, and
communications among members of the IDT and other providers?
3.3. Did the PO perform assessments as required?
3.3.1. Did the PO 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 reevaluate the participant care plans as required?
3.5.2. Did the PO ensure that the appropriate IDT members were 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, did the IDT document the reasoning behind the determination in the
care plan?
3.5.5. Did the IDT identify how each intervention in the participant’s initial plan of care
would be implemented and evaluated to determine progress in reaching specified
goals and desired outcomes?
3.5.6. 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?
3.7. Did the PO follow appropriate infection control standards when providing care?
3.7.1. Did personnel wash/sanitize hands as appropriate?
3.7.2. Did personnel don and doff personal protective equipment as appropriate?
3.8. Did the PO have emergency equipment immediately available (suction, oxygen,
medications, etc.)?
3.9. Did the PO have a method of providing safe transportation to participants?
3.9.1. Did the PO have a demonstrated method for securing participants (i.e., seat belts)
and securing DME (e.g., wheelchairs, oxygen, walkers)?
3.9.2. Did the PO have a method for communicating between the vehicle and the PACE
center?
3.9.3. 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. 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. 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 personnel were determined to be free of communicable disease
Documentation of completed competencies
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.
3.1. Did the PO conduct a background check on all personnel 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 licensed, 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?
3.5. 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. 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 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.
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
noncompliance with regulatory requirements and fraud, waste, and abuse?
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?
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3.2. Did the PO develop and implement an effective, data-driven quality improvement
program?
3.2.1. 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?
3.2.2. 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?
3.3. 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?
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Analysis of Potential Non-Compliance
I. Root Cause Analysis
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.
II. Impact Analysis
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.
III. 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 place 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.
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 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 PO’s decision was rendered or should have been
rendered (the date the request was initiated may fall outside of the data collection period).
Column
ID
A
B
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. Options
include: participant, designated representative,
or caregiver.
Date the Service Determination Request was
made by the participant, designated
representative, or caregiver.
12345
Participant
02/01/2023
Submit in MM/DD/YYYY format (e.g.,
01/01/2023).
G
H
Date Service
Determination
Request
Brought to the
full IDT
Extension
Date the service determination request was
brought to the full IDT.
02/02/2023
Submit in MM/DD/YYYY format (e.g.,
01/01/2023).
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.
02/03/2023
Submit in MM/DD/YYYY format (e.g.,
01/01/2023).
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, in
writing, of the IDT’s decision to extend the
service determination request timeframe.
02/03/2023
Submit in MM/DD/YYYY format (e.g.,
01/01/2023).
K
Category of
the Request
L
Description of
the Request
Page 23 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.
v. 04292022
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.
02/01/2023
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.,
01/01/2023).
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 02/03/2023
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.,
01/01/2023).
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?
For Immediate Approvals, which IDT member
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.
Reason for
Denial
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 not immediately
approved.
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.
v. 04292022
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).
02/03/2023
Submit in MM/DD/YYYY format (e.g.,
01/01/2023).
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).
02/03/2023
Submit in MM/DD/YYYY format (e.g.,
01/01/2023).
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).
02/04/2023
Submit in MM/DD/YYYY format (e.g.,
01/01/2023).
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 PO’s decision was rendered or should have been
rendered (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
D
Participant ID
E
Enrollment Type
F
Person who
Submitted the
Appeal
Date Appeal
Received
G
H
Time Appeal
Received
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.
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 if the appeal was submitted by the
participant or the participant’s designated
representative.
Date the appeal was received by the PO.
Submit in MM/DD/YYYY format (e.g.,
01/01/2023).
Enter the time the expedited appeal was
received by the PO.
12345
Dual Eligible
Participant
03/01/2023
NA
Submit in HH:MM format (e.g., 23:54).
Enter NA for standard appeals (i.e., if the
appeal was not expedited).
Page 27 of 46
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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.
03/10/2023
Submit in MM/DD/YYYY format (e.g.,
01/01/2023).
Q
Time of Written
Notification
Enter NA if written notification was not provided
or not documented.
NA
Enter the time 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
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
Enter the date that the approved service was
05/01/2023
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.,
01/01/2023).
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
D
Participant ID
E
Person who
submitted the
Grievance
Date
Grievance
Received
F
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.
Enter NA if the participant is not a Medicare
beneficiary.
The identification number the PO uses to
identify the participant.
Indicate if the grievance was submitted by the
participant, caregiver or family.
123456
Participant
Date the grievance was received by the
PO. Submit in MM/DD/YYYY format
(e.g., 01/01/2023).
04/01/2023
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
J
Field Name
Description
Example
Grievance
Resolution
Enter Y if the grievance was fully resolved (i.e.,
all issues within the grievance were resolved).
Y
Date of Resolution
Notification, Oral
and/or Written
Enter N if all issues in the grievance were not
resolved or none of the issues were resolved.
Date notification of the grievance resolution
was provided by the PO to the participant,
family, and/or caregiver. If both oral and
written notification was provided, enter the
first notification date. Submit in
MM/DD/YYYY format.
04/05/2023
Enter NA if the grievance was not resolved or if
no notification of the grievance resolution was
made.
Enter NNR if the participant, family, or
caregiver specifically requested not to receive
notification about the grievance resolution.
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Table 4: List of Personnel (LOP) Record Layout
• Include all personnel employed during the data collection period (i.e., volunteer, parttime, full time, and contracted staff).
• Include any personnel hired during the data collection period.
• 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 (i.e.,
drivers).
• 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., 01/01/2023).
Date the employee was terminated or resigned
from the PO. Submit in MM/DD/YYYY
format (e.g., 01/01/2023).
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.
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
12/01/2023
NA
Full-time
Y
Y
Enter N if the employee does not require a
license in order to perform their duties with the
PO.
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Column
ID
I
J
Field Name
Description
Example
IDT
Member
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.
Y
IDT Role
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.
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
D
Participant ID
E
PACE Center
F
G
H
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.
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.,
01/01/2023).
Date of
Date the participant disenrolled from the PO.
Disenrollment
Submit in MM/DD/YYYY format (e.g.,
01/01/2023).
Reason for
Disenrollment
I
Enrollment
Type
J
Participant’s
Preferred
Language
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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
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
L
Change in
Living Situation
Identify whether the participant’s living
N
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
N
O
Number of
Hospital
Admissions/
Observations
30-Day Hospital
Readmissions
Number of
Emergency Room
Visits
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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
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
Direct SNF
Admission
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.
At any point during the data collection period,
was the participant admitted directly to the SNF
from the PACE center or participant’s home for
a service other than respite care?
1
Y
Enter Y if the participant had a direct SNF
admission during the data collection period.
Enter N if the participant did not have a direct
SNF admission during the data collection period
or if the direct SNF admission was for respite
care.
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Column
ID
S
Field Name
Description
Example
Specialist
Consultations/
Visits
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?
Cardiology, Oncology,
Rheumatology
•
•
•
•
•
•
•
Cardiology
Endocrinology
Gastroenterology
Oncology
Ophthalmology
Pulmonary Medicine
Rheumatology
If Yes, enter each type of specialty.
If No, enter N.
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Column
ID
T
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)
Dementia
Diabetes Mellitus
Hemolytic Uremic Syndrome
Hepatitis C
Hereditary Angioedema
Human immunodeficiency virus (HIV)
Mental Illness (any type- specify
the type in the response)
Multiple Sclerosis
Myasthenia Gravis
Paroxysmal Nocturnal Hemoglobinuria
Pneumonia
Sepsis
If Yes, enter each diagnosis and where
applicable specify the type.
If No, enter N.
U
CHF Exacerbation
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
V
Field Name
Description
Example
COPD
Exacerbation
Enter Y if the participant was diagnosed with a
COPD exacerbation during the data collection
period.
N
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.
W
Transplant
Enter Y if the participant has ever undergone a
transplant (this is not limited to the time the
participant was enrolled in the PO and applies to
any type of transplant).
N
Enter N if the participant has never undergone a
transplant.
X
Y
Received Comfort
Care
Enter Y if the participant received comfort care
during the data collection period that is
considered end-of-life care, and as a result, they
are no longer receiving curative or maintenance
care for one or more of their health conditions.
N
Enter N if the participant received comfort care
during the data collection period meant to treat a
condition or maintain health and no services
were stopped or eliminated as a result of the
comfort care, or if the participant did not receive
any form of comfort care.
Date Comfort Care Enter the date comfort care began. Enter multiple NA
dates, if applicable.
Began
Submit in MM/DD/YYYY format (e.g.,
01/01/2023).
Enter NA if the response to the previous field
“Received Comfort Care” was N.
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Column
ID
Z
Field Name
Description
Example
Received Home
Care
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.
AA
Assistance with
Administering
Medications
AB
Current Center
Attendance
AC
Number of Falls
with Injury
AD
Number of
Pressure Ulcers
AE
Number of
Confirmed
Abuse Reports
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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.
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.
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.
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.
Y
2
1
1
0
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Column
ID
AF
AG
Field Name
Description
Example
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
Functional
Decline
AH
Number of
Infections
AI
Incontinent
AJ
AK
Indwelling
Catheter
Significant
Weight Loss
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 the number of infections the participant
had during the data collection period. This
includes all types of infections as defined by the
PO’s infection control plan.
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.
Enter N if the participant did not have an
indwelling catheter during the data collection
period.
Enter Y if the participant had a weight loss of
more than 5% within a 30 day period or 10%
within a 180 day period.
N
2
Y
N
N
Enter N if the participant did not have a weight
loss of more than 5% within a 30 day period or
10% within a 180 day period.
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Column
ID
AL
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
Enter N if physical or chemical restraints
were not used on the participant at any point
during the data collection period.
AM
AN
AO
Oxygen Use
Dialysis
Impaired Vision
Enter Y if the participant required oxygen on a
regular basis at any point during the data
collection period.
Enter N if the participant did not require oxygen
on a regular basis at any point during the data
collection period.
Enter Y if the participant received dialysis
during the data collection period.
Enter N if the participant did not receive
dialysis during the data collection period.
Enter Y if the participant had impaired vision
(i.e., blindness or severely impaired vision
without corrective lenses) during the data
collection period.
N
N
Y
Enter N if the participant did not have
impaired vision during the data collection
period.
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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.
D
Participant ID
E
Caller Information
F
Date of Call
G
Time of Call
H
Call
Description/
Reason For
Call
I
Response to Call
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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., 01/01/2023).
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
02/01/2023
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, such as dentist, podiatrist, cardiologist,
dermatologist, neurologist, oncologist, chiropractors, massage therapists, etc.;
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.
• Do not include any entities whose contracts were terminated prior to the start of the data
collection period.
Column
ID
A
Field Name
Description
Example
Provider/
Practice/ Facility
Name
Name of the provider, practice or facility.
Dr. Jane Smith, MD
B
Specialty or
Facility Types
C
Contract Status
Description of the specialty type or facility type. Oncology
For practices that may handle multiple specialties,
please include all specialties that they provide on
behalf of the PACE organization.
Enter Active if a contract is in effect with the
Active
provider / facility at the time of the universe
submission.
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.
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.
D
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.
Contract Start Date Enter the date the contract became effective.
11/01/2019
E
Enter NA if the contract status is currently
pending.
Enter the date the contract was terminated.
Contract
Termination Date
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NA
Enter NA if the contract status is currently active
or pending.
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Column
ID
F
Field Name
Description
Example
Limitations /
Restrictions
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.
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. 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.
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| File Type | application/pdf |
| File Title | Programs of All-Inclusive Care for the Elderly (PACE) |
| Subject | PACE, Protocols |
| Author | CMS |
| File Modified | 2022-04-25 |
| File Created | 2022-04-25 |