60 Day Public Comment Response

Centers for Medicare and Medicaid Services Response to Public Comments
Received for CMS-10630
The Centers for Medicare and Medicaid Services (CMS) received 52 public submissions from
Program of All-Inclusive Care for the Elderly (PACE) organizations (POs) and an association
on The PACE Organization (PO) Monitoring and Audit Process in 42 CFR Part 460 (CMS10630) proposed information collection issued December 21, 2021. We combined the public
submissions into 38 unique comments and provided responses in the document below.
Comments are categorized first by those that are general in nature, next, those that pertain to
the audit protocol and other attachments, then, those that pertain to Root Cause Analyses
(RCAs) and Impact Analyses (IAs), and finally, those that pertain to burden.
General Comment:
Comment: One commenter asked that CMS allow enough time for POs to make updates to
their systems to adjust to the new audit protocol before implementing it for audits and
commented that proposed changes to the audit protocol would take a year or more to
implement through IT changes and training.
Response: CMS understands the importance of allowing sufficient time to implement
changes. We will continue to work toward the goal of finalizing this collection to afford POs
the maximum amount of time possible to update their systems and processes, while still
allowing CMS to conduct the audits that are statutorily required.
Attachment I- PACE Audit Process and Data Request (Audit Protocol) Comments
Audit Protocol – General:
Comment: Multiple commenters expressed concern regarding CMS’ removal of audit
process information from the audit protocol. Specifically, one commenter was concerned
about CMS' intent with responding to draft audit report comments and scoring since the
audit process is no longer included in the audit protocol. Another commenter was concerned
that the audit protocol no longer mentioned immediate corrective action required (ICAR)
mitigation for pre-audit issue summary (PAIS) disclosures and sought clarification on CMS’
intentions for the PAIS and condition classification.
Response: The purpose of the audit protocol is to provide information on CMS’ data and
documentation collection for PACE audits. We streamlined the PACE audit protocol by
removing information that does not impact data collection or application of the compliance
standards. However, we will continue to provide audit process related information separately
and remain committed to transparency in our audit process.
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Audit Protocol - Initial Documentation and Data Submissions:
Comment: Multiple commenters expressed concern over the additional burden of the proposed
monitoring 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.
Commenters stated that generating the report as proposed would be burdensome because of the
volume of services that would need to be provided and because it would require a high degree
of manual data collection from different sources. Commenters suggested eliminating the
monitoring reports and alternative ways CMS could gather the information they need to assess
compliance. This included requiring POs to provide their policies and procedures for
monitoring and tracking of services followed by in-depth review of the cases evaluated during
the provision of services and service determination requests, appeals, and grievances (SDAG)
element reviews, or collecting a monitoring report for only 10-15 randomly selected
participants rather than all participants. Additionally, commenters asked for clarification on
what level of services CMS expects to be included in the monitoring reports.
Response: CMS considered these concerns and will not require monitoring reports for all
participants. Instead, we will limit the request to 30 participants that CMS will select from
enrollment data already collected by CMS, and for which the PO would submit all services
across all care settings that were ordered, approved, or care planned during the data collection
period. The PO will receive the list of 30 participants at the time the audit engagement letter is
issued. The PO will then submit the monitoring of services for those individuals as part of the
initial documentation and data submissions for the audit within 20 business days following
issuance of the engagement letter. We will then use that information, in conjunction with the
universes, to determine the samples selected for audit. We have updated the audit protocol to
reflect this change.
Comment: Multiple commenters asked CMS to clarify its intent for the Compliance and
Quality Improvement element request for documentation of all self-evaluations and audits
conducted in the PO’s compliance oversight program, which we proposed collecting up front
as part of Initial Documentation and Data Submissions monitoring reports. More specifically,
the commenters asked to confirm that there is no expectation inherent in this documentation
request that POs must submit the results of routine auditing and monitoring activities for Part
D required under 42 CFR 423.504(b)(4)(vi)(F) or that CMS requires POs to undertake routine
monitoring and auditing for their operations as a whole.
Response: Section 460.63 requires that POs must investigate potential compliance problems
as identified in the course of self-evaluations and audits. While we are removing this from the
paperwork reduction act (PRA) package, during review of the Compliance and Quality
Improvement element review, POs may choose to show self-evaluations and audits as
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evidence of their efforts in developing an effective compliance oversight program. POs may
also choose to show their monitoring and auditing of their Part D program in order to help
demonstrate their compliance program oversight efforts.
Audit Protocol - Audit Element Review Comments
Provision of Services Element:
Comment: For the Provision of Services element sample case documentation, multiple
commenters requested clarification on why CMS would request "Documentation of
recommendations for care or services by IDT team members, participants, caregivers, PO
employees, contractors, specialists, and designated representatives", because the commenters
expected that participants, caregivers, and designated representatives would make a service
determination request rather than a recommendation.
Response: We agree with the commenter and have updated the Provision of Services
element sample case documentation request to “Documentation of recommendations or
requests for care or services by IDT members, participants, caregivers, PO employees,
contractors, specialists, and designated representatives".
Compliance and Quality Improvement Element:
Comment: Multiple commenters asked CMS to clarify what types of documentation CMS
would collect for the Compliance and Quality Improvement element 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. Commenters asked that CMS keep this request broad so that a variety of materials
would be accepted to meet the documentation request.
Response: We appreciate the opportunity to clarify our expectations and understand that POs
may have a wide range of materials in response to this documentation request. CMS will
accept documentation of any kind and in any format that POs have available to demonstrate
the measures they have developed as part of their compliance oversight program.
Audit Protocol – Record Layouts
Record Layouts – General:
Comment: Multiple commenters asked that CMS provide updated record layout templates at
least three months before CMS intends to implement the new audit protocol.
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Response: We will provide updated record layout templates as soon as possible once the audit
protocol has been approved by the Office of Management and Budget (OMB) through the
PRA process.
Record Layouts - Table 1 - Service Determination Requests (SDR):
Comment: One commenter recommended the removal of the fields: “Date of the first
assessment completed in response to the service determination request” (column M), “Date of
the last assessment completed in response to the service determination request” (column N),
and “How many assessments were completed in response to the service determination
request?” (column O). The commenter suggested that these fields add unnecessary burden
since the data would already be captured in the current audit protocol SDR record layout field
“Date(s) assessment(s) performed”, which would include all assessment dates in one field. The
commenter also noted there is no regulatory requirement to complete an assessment except for
any denied or partially denied service determination request.
Response: While CMS agrees that the proposed audit protocol increases the number of data
fields related to service determination request assessments, we do not believe this is a
significant burden increase. The data is already being requested in the current audit protocol,
we are merely separating that data into different columns in this version. Additionally, as one
commenter pointed out, assessments are no longer required for approvals, which will limit
how often the PO may need to populate data into these columns. No changes were made to the
audit protocol in response to these comments.
Comment: Multiple commenters requested clarification on whether POs should enter “N” for
the field “Immediate Approval” (column R), if the service determination request was
approved in full by the entire interdisciplinary team (IDT). They suggested that it would be
clearer to require “N” if a member of the IDT was not able to approve the service
determination request in full at the time the request is made, as the preceding column provides
information on the request disposition.
Response: CMS agrees with commenters that the description for “Immediate Approval” does
not need to repeat dispositions that were included in the prior column. We modified the
description of “Immediate Approval” to read “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.”
Record Layouts - Table 2 - Appeals Requests (AR):
Comment: Multiple commenters requested clarification on whether, for the field “Third-party
reviewer or committee credentials” (column M), POs may enter IDT members employed by
other POs as third-party reviewers, and if yes, when an individual IDT member (as opposed to
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multiple IDT members) is the third-party reviewer, should POs provide the individual-specific
credentials or should this individual be identified as “Another PO’s IDT”?
Response: We appreciate the opportunity to provide clarification. As specified in the “Thirdparty reviewer or committee credentials” description, POs may indicate that the third-party
committee is another PO’s IDT. This response should be entered when the committee consists
of another PO’s full IDT representing every required IDT discipline. When the third-party
reviewer is a single IDT member or consists of multiple members, but not the full IDT from
another PO, this field should be populated with the individual-specific credentials only (e.g.,
primary care physician or PCP). We updated the “Third-party reviewer or committee
credentials” description with this clarification.
Record Layouts - Table 3 - Grievance (GR):
Comment: One commenter requested that CMS align the grievance record layout with
quarterly grievance reporting requirements to reduce burden.
Response: CMS has already aligned the grievance record layout data fields with quarterly
reporting requirements where possible and no further modifications are applicable.
Record Layouts - Table 4 - List of Personnel (LOP):
Comment: Multiple commenters asked CMS not to replace the field for “Direct
Participant Contact” in the current protocol with the proposed “Date of Initial Participant
Contact” (column E) and “Date Individual Began Providing Care Independently” (column
F) fields, because populating these fields would be time consuming. The commenters
noted that, if a Personnel related IA is required, the PO would have to provide “Date of
Initial Participant Contact” and “Date Individual Began Providing Care Independently”, so
CMS has a method for looking into this further if non-compliance is identified.
Response: CMS agrees with the commenters and will maintain the “Direct Participant
Contact” field and remove the proposed new fields “Date of Initial Participant Contact”
(column E) and “Date Individual Began Providing Care Independently” (column F).
Record Layouts - Table 5 - List of Participant Medical Records (LOPMR):
Comment: Multiple commenters recommended that POs report LOPMR data for a random
sampling of participants enrolled during the data collection period with a "statistically valid
sample" size, instead of reporting data for all enrolled participants. This would significantly
decrease burden.
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Response: The data CMS requests in the LOPMR record layout is used to ensure we can select
an appropriate sample for the Provision of Services review rather than conducting a full review of
all participants, thus limiting burden. No changes were made to the audit protocol in response to
this comment.
Comment: Multiple commenters recommended removing "Change in Living Situation”
(column L), because information requested for this field would not be available in the
participant medical record and care need changes related to a change in living situation could be
identified through other fields.
Response: In response to comments, we have revised the "Change in Living Situation" field
description to clarify that we are asking whether the participant’s living situation changed
significantly, for example, if the participant went from the community or home to a facility,
such as an Assisted Living Facility, or if the participant went from living with family to living
alone.
Comment: Multiple commenters asked CMS to clarify how CMS defines “medication
overdose” for “Hospitalization/Emergency Room Reason” (column P). Commenters also
requested that CMS include ICD-10 codes in column P to ensure POs uniformly reported this
information.
Response: This field is intended to capture intentional and unintentional drug overdoses
resulting in an Emergency Room (ER) visit and/or a hospital admission, regardless of cause.
While we are not requiring ICD-10 codes in the field description, POs may create a list of ICD10 codes to assist with compiling this information.
Comment: Multiple commenters requested that CMS reconsider “Diagnoses” (column T), and
how POs may submit that information that would reduce burden. These commenters indicated
that typing the individual diagnoses into the field would take too long.
Response: Diagnosis information should be readily available to POs. CMS already limits the
“Diagnoses” field to collecting only 20 diagnoses out of many possible diagnoses. We
encourage POs to create and operationalize their own internal tools to assist them with
compiling this information. POs are further encouraged to maintain this information in a readily
accessible form to be prepared for audits.
Comment: Multiple commenters requested that CMS remove “CHF Exacerbation” (column U)
and “COPD Exacerbation” (column V), as they believe that they are overly burdensome and the
information could be gleaned from other data already submitted (for example, under
“Diagnoses” (column T) and columns on hospitalizations and ER visits).
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Response: We disagree with commenters that the information in “CHF Exacerbation” and
“COPD Exacerbation” can be identified through other fields, and therefore we are not
eliminating those fields. These fields allow us to maintain the proposed sample size rather than
increase it, which reduces burden.
Comment: Multiple commenters requested clarification of the term “comfort care” for
“Received Comfort Care” (column X) and recommended that this field focus exclusively on
end-of-life care as defined by the PO with the name of the field changed to reference “end-oflife care” instead of “comfort care”.
Response: We have modified the field description to offer further clarification on our intention.
During audits we have seen a wide interpretation of what the terms “comfort care” and/or
“palliative care” mean to different POs. For purposes of the audit protocol, POs should enter
“Y” for this field when a participant is receiving comfort care that is considered end-of-life care
and they are therefore no longer receiving curative or maintenance care for one or more of their
health conditions. POs should enter “N” for this field when a participant is receiving comfort
care in addition to other services meant to treat a condition or maintain health and no services
were stopped or eliminated as a result of the comfort care, or when the participant is not
receiving any form of comfort care. We maintained the field name of “Received Comfort
Care”, but have updated the description to include this clarification.
Comment: Multiple commenters recommended that we remove “Date Comfort Care Began”
(column Y) and “Date Comfort Care Ended” (formerly column Z). They asked CMS to focus
on end-of-life care for comfort care and expressed that including this data in the LOPMR
universe would be burdensome.
Response: CMS has removed “Date Comfort Care Ended” and revised “Date Comfort Care
Began” to allow for multiple start dates. Additionally, as mentioned in the previous comment
response, the comfort care fields will focus on when comfort care is provided as end-of-life care
in place of the participant receiving curative or maintenance care.
Comment: Multiple commenters asked CMS to modify the “Current Center Attendance”
(formerly column AC, now column AB) field description to report PACE center attendance in
terms of days per week rather than days per month, as that format is more consistent with PO
tracking of center days.
Response: We appreciate the comment. The suggested modification will not allow the PO to
account for weekly variations in participant center attendance during a given month, including
those participants who attend the PACE center less than once every week. No changes to the
audit protocol were made in response to this comment.
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Record Layouts - Table 6 - On-Call (OC):
Comment: Multiple commenters suggested that CMS remove “Call Category” (column H),
because they considered the information CMS intends to collect in this field to be covered by
the "Call Description/ Reason for Call" field.
Response: CMS agrees with the commenters and has removed the “Call Category” field from
the OC record layout.
Record Layouts - Table 7 - Contracted Entities and Providers (CEP):
Comment: Multiple commenters requested clarification whether CMS’ intent with the CEP
record layout is to obtain information on the PO’s contracted entities, both individual
providers and group practices in which multiple providers practice. Additionally, some
commenters requested that CMS change the CEP record layout field name of
“Provider/Facility Name” (column A) to “Provider/Practice/Facility Name” and allow for
POs to provide the practice name if that is the contracted entity. Similarly, commenters
suggested the field “Specialty or Facility Types” (formerly column C, now column B) should
allow for multiple specialty types to accommodate a multi-specialty group practice.
Response: The intent of the CEP record layout is to collect contracted entity information for
both individual or single practice providers and group practices with multiple providers. CMS
agrees with the commenters on their recommendations for the fields. We updated the
“Provider/Facility Name” (column A) to “Provider, Practice, Facility Name” to allow POs to
provide the practice name if that is the contracted entity, removed the field “Practice Name”,
as it is no longer applicable, and modified the field “Specialty or Facility Types” to
accommodate a multi-specialty group practice.
Comment: Multiple commenters requested clarification regarding what CMS means by “any
limitations” in the description for the field “Limitations/Restrictions” (formerly column G,
now column F), which could encompass a wide scope of factors.
Response: CMS has revised the “Limitations/Restrictions” description to clarify our
expectations for this field and narrow its scope. POs would enter “Y” when 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 a limitation
include, but are not limited to: the provider had a cap or quota on the number of PACE
participants it could serve, or the provider did not accept new PACE participants as patients
for a period of time during the data collection period.
Comment: One commenter wanted to eliminate the CEP record layout and recommended
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that POs instead provide a list of the PO's provider network.
Response: We appreciate the comment and recommendation; however, the CEP record layout
requests data that may not be included in a PO’s provider network lists, and based on what we
have learned on audit, this information is necessary for CMS’ review. No changes were made
to the protocol in response to this comment.
Root Cause Analyses (RCAs) and Impact Analyses (IAs) - General:
Comment: Multiple commenters recommend a sampling approach for IAs which takes into
account the PO’s census in determining the scope of the IAs. While they appreciated CMS’
decision in 2020 to reduce the scope of numerous IAs from 100 percent to 50 percent of
participants and personnel, they remain concerned about the burden of completing IAs,
particularly for POs with medium and large enrollment sizes. One commenter suggested that
30 percent of the PO census would be a more reasonable threshold. The commenters
expressed that if the results of an IA identify a widespread or systemic issue of significant
concern, auditors could then ask the PO to expand its focus to a larger scope of records and a
more comprehensive review could be saved for the PO’s corrective action plan. Additionally,
commenters want the participant samples chosen for the IAs to overlap to the greatest extent
possible to limit the total number of records to be reviewed.
Response: We appreciate the comments and recognition of the significant reduction in scope
for IAs beginning in 2020. IAs continue to be an effective mechanism to determine the cause
and magnitude of an issue, and based on our experience, we believe the current threshold of up
to 50 percent is appropriate. As we stated for our 2020 package, the 50 percent threshold
represents an upper limit that is reduced depending on the nature of the issue of
noncompliance and in consideration of the PO’s enrollment size. Further, these analyses are
not routinely requested as part of all audits, and are only requested when a PO is noncompliant with regulatory requirements. Lastly, when selecting the participant samples for the
IAs, CMS will continue to select participants based on factors that allow us to determine
compliance with program requirements, with overlapping samples across IAs whenever
possible, as we have been doing since the approval of the 2020 audit protocol.
Comment: Multiple commenters suggested other ways that CMS could reduce the burden of
IAs. Commenters suggested that CMS have more dialogue with POs during audits to avoid
potentially unnecessary IAs through discussion and a thorough understanding of the identified
issue. Additionally, commenters suggested that thresholds for IAs related to medical record
documentation should consider the comprehensiveness of POs’ documentation requirements
and the threshold for an IA should be adjusted accordingly so that minor omissions without
consequences for participant care do not lead to IAs consuming significant PO staff time.
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Response: The current framework of audit fieldwork provides POs with multiple
opportunities to demonstrate compliance and ensure that CMS and the PO have a thorough
understanding of potential issues, before IAs are determined necessary. This is accomplished
through various modalities including discussions between the PO and CMS about potential
issues, joint review of electronic medical records via webinar when requested, and
documentation requests for additional information. CMS carefully considers all information
received from the PO prior to deciding whether to request an IA, and starting in 2020, we have
eliminated multiple IA templates where the non-compliance was less likely to result in
participant harm.
Comment: One commenter asked that CMS raise its threshold for requesting RCAs.
Response: RCAs are critical to understanding the cause and potential impact of noncompliance identified during an audit and they provide the PO additional opportunities to
submit documentation that may address or mitigate the non-compliance. CMS will continue
requesting RCAs based on the specifics of each issue and the information provided by the PO.
Impact Analyses (IAs) - Specific:
Comment: Multiple commenters would like further clarification of CMS’ expectations of
POs in completing the CoordinationofCare1P95 IA, in particular for participants receiving
care in acute settings. They noted that in acute settings (e.g., a hospital), the IDT is limited in
their authority to direct or approve the care provided. Commenters recommended modifying
this IA to focus on whether the IDT ensured that care provided in the acute setting was
consistent with the participant’s care plan and the participant’s wishes/goals for care.
Response: We thank the commenters for their recommendation and have modified column H
of the IA to remove the focus from acute care and to be specific to long-term and short-term
residential facilities, as noted in the facility definition provided on the Instructions tab of the
IA.
Comment: For the RequiredServices1P93 IA, multiple commenters would like columns I
and J to be changed to yes/no questions and suggested that the information requested in
columns L, M, O, P and Q could be limited to situations in which the PO did not provide the
services in full if a participant’s caregiver expressed unwillingness or the IDT determined
caregivers were unsafe. Some commenters also asked CMS to clarify if the PO would need
to complete columns K through T if responses in columns I and J are “No”. Commenters
also requested that CMS clarify its intent with this IA.
Response: When needed, we will use this IA to assess whether POs are providing required
services appropriately and not inappropriately utilizing individuals that are not an employee
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or a contractor to provide required care. We have reviewed and modified the
RequiredServices1P93 IA, and have added the option of “NA” for columns that do not apply
when the PO is providing all care and services through their own employees or contractors.
As for columns I and J, we do not believe a yes/no response is appropriate, as the information
in those columns is necessary to understand what services caregivers may have been
providing.
Comment: For the SpecialistRecommendations1P14 IA, most commenters asked for
clarification on CMS’ expectations regarding “all services recommended or ordered by the
specialist, ER provider, or hospital provider” in column J. Specifically, they asked whether
column J would include recommendations made by ER or hospital providers included in
discharge summaries for ER visits and hospitalizations.
Response: We appreciate the opportunity to clarify the types or sources of documentation
POs should consider when completing column J. At a minimum, the PO should identify all
services (including items and/or drugs) included in any specialist consult notes, any ER or
hospital discharge summaries and any other documentation the PO may have received from
the hospital or ER. Additionally, we are changing the title for this IA to
“SpecialistRecommendations1P94”.
Comment: For the SpecialistRecommendations1P14 IA, multiple commenters noted that the
use of “NA” appeared inconsistent, e.g., in column L, and asked whether “NA” should also
be an option consistent with instructions for column K and others?
Response: We thank the commenters for their recommendation and have updated
SpecialistRecommendations1P14 IA to include an “NA” response for column L if it does not
apply to the record.
Comment: Multiple commenters noted that some of the columns in
SpecialistRecommendations1P14 seemed to be related to the provision of services, and not
remaining alert to information from specialists. Specifically, commenters noted columns N,
O, and P, and recommended those columns be deleted.
Response: We disagree with commenters that these columns should be removed. These
columns are meant to assess whether a specialist recommended service was actually ordered
and/or provided to the participant, which is vital in understanding the participant’s care and
access to services.
Attachment IV - Observation Participant List Comments:
Comment: Multiple commenters requested that CMS eliminate Attachment IV, the
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Observation Participant List. Commenters suggested that the participant information included
in the LOPMR record layout and sample cases would be adequate for CMS to select five
participants for the Provision of Services observations, as CMS has done for the past couple
audit years. As an alternative, multiple commenters suggested allowing POs to provide a list
of participants assigned to an IDT at a specific center who receive wound care, medication
administration, home care and/or a specialized diet during the week of the participant
observation review, rather than complete the full data request proposed in Attachment IV.
Response: CMS agrees with commenters and has eliminated Attachment IV from the audit
protocol. In doing so, we have also reordered the audit survey as the new Attachment IV, and
the Corrective Action Plan Process as the new Attachment V.
Attachment VI - Corrective Action Plan Process Comments:
Comment: Multiple commenters expressed appreciation for the information provided in
Attachment VI, the Corrective Action Plan (CAP) Process, particularly for how it explains the
role of the Account Manager during the CAP process.
Response: Thank you for this comment.
Burden Estimate:
Comment: Multiple commenters expressed that CMS audit data requirements are extensive,
burdensome, and the amount of documentation requested demonstrates the intent to identify
all possible non-compliance and human error, rather than creating focused audit samples to
identify significant and recurring system failures. One commenter indicated that audits have
shifted since 2017 and have started asking for more documentation, including at times, full
participant medical records.
Response: We appreciate the commenters’ concerns. The audit protocol was developed to
assess compliance with statutory and regulatory requirements and ensure that enrollees
receive the benefits they are entitled to under the PACE program. Since 2017, we have made
numerous and significant changes to the documentation requests in response to comments,
and with each protocol update, we have sought to strike a balance between ensuring
participants are receiving appropriate and timely care and services, while not overwhelming
POs with intensive data requests over the course of the audit. The current audit protocol has
helped CMS improve the PACE program by identifying non-compliance and ensuring POs
understand the actions that are needed to correct deficiencies. This includes identification of
significant concerns with ensuring access to services, and inadequate processes and
infrastructure. CMS will continue to request any and all documentation that is necessary to
investigate and document potential non-compliance, including full participant medical records
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when needed. We will also continue to identify opportunities to streamline the audit process
while still ensuring CMS’ ability to effectively monitor POs for compliance with regulatory
requirements.
Comment: Multiple commenters suggested that POs should not be expected to retrieve data
from their electronic medical record systems in the same manner CMS expects Medicare
Advantage Organizations (MAOs)/ Part D plans to access their administrative databases,
because electronic medical records (EMRs) are not designed to produce data reports
representing all the information documented in the EMR. The commenters expressed that
CMS’ audit process creates excessive burden, because the narrative nature of EMRs require
POs to perform manual reviews of audit data requests and diverts staff from participant care.
Response: POs have unique responsibilities as both an insurer for purposes of implementing
the Medicare program and a direct care provider that is responsible for ensuring the health
and safety of the participants enrolled in their programs. We understand that some POs do not
have systems that are capable of efficiently tracking the provision of care and services for
participants or compiling audit relevant information, which may hinder a PO’s ability to
respond to oversight requests. However, because PACE is a direct care provider, it is even
more critical that POs have the ability to maintain information on requested and approved
services to ensure services are being provided to participants. When a PO is unable to easily
understand or track the services a participant should be receiving, we have found on audit that
they are unable to effectively manage a participant’s condition and ensure the participant is
receiving the care they need. Therefore, we strongly encourage POs to develop and maintain
an appropriate infrastructure to ensure the needs of participants are met in accordance with
program requirements.
Comment: The majority of commenters who commented on the burden estimates indicated
CMS underestimated almost every aspect of the PACE audit, including the number and types
of staff involved in each phase of the audit, and particularly for medium and large enrollment
POs. Their concerns for burden included the amount of time and resources involved in the
pre-audit work, the amount of time and resources that were involved in the audit fieldwork
phase, compiling and submitting RCAs and IAs, and responding to draft audit reports.
Commenters did concur with the burden estimate for corrective action and close out activities.
Furthermore, commenters recommended that CMS carefully consider how it integrates
lessons learned from audit experiences during the 2020 and 2021 PACE audit years and
COVID-19 public health emergency (PHE) so that the audit protocol takes into account
burden for medium and large enrollment POs, as they believed the 2020 and 2021 audit years
were not representative of POs with medium to large enrollments.
Response: We appreciate the opportunity to respond to these comments. The burden estimates
for this package are based on our audit experience of small, medium and large enrollment POs
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over the last two years, as well as survey feedback from audited POs on the average amount of
time it has taken POs to complete certain audit-related requests and the staff that were
involved in completing them. These lessons learned are reflected in the proposed changes.
Additionally, changes proposed for the updated audit protocol, including those specified in
this document, will further reduce PO burden while still ensuring CMS’ ability to effectively
monitor POs for compliance with regulatory requirements. For example, we have streamlined
data fields, clarified instructions related to the collection tools for analysis of potential noncompliance, and developed a more efficient CAP process. Furthermore, CMS will use other
data or information collected before or during the fieldwork stage of the audit for the
participant observation review, and we are eliminating our request for Attachment IV
(Observation Participant List) from this collection. With these updates, we believe the current
burden estimates are accurate. We continue to be committed to trying to streamline the process
when feasible in order to reduce burden and we will continue to use our survey at the end of
audits to assess burden for POs in future PRA packages.
Comment: Multiple commenters states that the burden estimate of a total of 100 hours, or a 20
hour increase, for the pre-audit period is substantially underestimated because of the increase
of information required of POs, particularly: reports logging the provision of all services
ordered, approved, or care planned for the six-month data collection period, additional fields in
the LOPMR record layout; the new CEP record layout, and new documentation and report
requirements related to the PO’s compliance oversight program.
Response: We have made a number of changes in response to comments that will significantly
reduce PO burden during the pre-audit period including eliminating Attachment IV and
reducing the monitoring report to just 30 participants. We have also clarified that we will
accept documentation related to the PO’s compliance oversight program in any format to
demonstrate they are meeting the requirements established in 2019 at 42 CFR 460.63. As a
result, we believe the original estimates for pre-audit activities now more accurately reflect the
burden associated with a PACE audit.

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