Crosswalk

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Type of Change

Explanation of
Changes

Burden
Impact

All documents

Replaced “Sponsoring organization” with
Medicare Advantage organization (MAO)
throughout all documents.
Retitled the document from “Medicare Part
C Utilization Management (UM)
Annual Data Request” to “Medicare Part C
Utilization Management (UM)
Annual Data Submission” to be consistent
with titling throughout the document.
Starting on page 2, replaced the document
header title words “Utilization
Management Data Request” with “Annual
Data Submission”.
Annual Data Submission Section, Universe
Submission Subsection: Removed the .txt
file format as an allowable file format for
the universe submission.

Modified

Minor wording
change to align
with regulation
Minor word
change

None

Medicare
PartC_UM_AnnualDataSubmission

Annual Data Submission Section, Universe
Submission Subsection: Replaced the words
“record layout” with “field” to clarify that
universe “data must be limited to the
request specified in each field.”

Modified

Medicare
PartC_UM_AnnualDataSubmission

Annual Data Submission Section, Universe
Submission Subsection:

Modified

Medicare
PartC_UM_AnnualDataSubmission

Medicare
PartC_UM_AnnualDataSubmission
Medicare
PartC_UM_AnnualDataSubmission

Modified

Modified

Modified

None

Minor wording
None
change to align
the document title
and header
Modified
None
allowable universe
file format to
ensure proper
formatting of data
Clarified
None
instruction

Modified the
document to
clarify CMS may

Low (increase)

1

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Medicare
PartC_UM_AnnualDataSubmission

Medicare
PartC_UM_AnnualDataSubmission

Medicare
PartC_UM_AnnualDataSubmission

Medicare
PartC_UM_AnnualDataSubmission

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Added additional guidance explaining that
the CMS may validate universe submissions
if errors are noted.
Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)
Record Layout Subsection, Instructions:
Clarified that the universe should include
internal coverage in use during the
applicable calendar year.
Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)
Record Layout Subsection, Instructions:
Defined service using the definition in 42
C.F.R. 400.202 and clarified that the term
“service” includes services, items, and Part
B drugs for the purposes of the record
layout.
Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)
Record Layout Subsection, Instructions:
Clarified that, for the purposes of the
UMAS universe, “service” does not include
step therapy for Part B drugs.
Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)
Record Layout Subsection, Instructions:

Type of Change

Explanation of
Changes

Burden
Impact

validate universe
submissions
Modified

Clarified the
applicable
timeframe

None

Modified

Clarified the
definition of
“service”

None

Modified

Clarified what
constitutes
internal coverage
criteria

None

Modified

Clarified how to
enter internal
coverage criteria
applicable in

None

2

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Medicare
PartC_UM_AnnualDataSubmission

Medicare
PartC_UM_AnnualDataSubmission

Medicare
PartC_UM_AnnualDataSubmission

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Clarified instructions for entering criteria
when there are different versions of criteria
used in different service areas.
Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)
Record Layout Subsection, Instructions:
Clarified instructions for entering
information in comma-separated lists.
Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)
Record Layout Subsection, Instructions:
Added a reference to the Utilization
Management Annual Submission (UMAS)
Record Layout with Examples document.

Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)
Record Layout Subsection, (Original)
Column A:
Moved the original column A to column B,
modified the name of the column, and
modified the instructions. We believe
making the criteria the primary category

Type of Change

Explanation of
Changes

Burden
Impact

different service
areas
Modified

Clarified data
entry instructions

None

Modified

Modified
instructions to
mention the
Utilization
Management
Annual
Submission
(UMAS) Record
Layout with
Examples
document
Modified the
name, the
instructions, and
moved the
column from A to
B

None

Modified

Low
(reduction)

3

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Medicare
PartC_UM_AnnualDataSubmission

Medicare
PartC_UM_AnnualDataSubmission

Medicare
PartC_UM_AnnualDataSubmission

Medicare
PartC_UM_AnnualDataSubmission

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

(rather than service) will reduce burden for
MAOs by more clearly identifying which
information must be reported.
Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)
Record Layout Subsection, (Original)
Column C:
Removed the original column C.
Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)
Record Layout Subsection, (Original)
Column D:
Re-lettered the original column D to column
C due to the removal of the original column
C. Clarified instructions.
Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)
Record Layout Subsection, (Original)
Column E:
Re-lettered the original column E to column
D due to the removal of the original column
C. The column name was revised, and the
instructions were modified.
Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)
Record Layout Subsection, (Original)
Column F:

Type of Change

Explanation of
Changes

Burden
Impact

Remove

Removed CPT and
HCPCS codes from
the information
collection to
reduce burden
Modified column
lettering and
revised
instructions for
clarity

High
(reduction)

Modified

Modified column
lettering, column
name and
instructions

None

Modified

Modified column
lettering and
revised

None

Modified

None

4

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Medicare
PartC_UM_AnnualDataSubmission

Medicare
PartC_UM_AnnualDataSubmission

Medicare
PartC_UM_AnnualDataSubmission

Medicare
PartC_UM_AnnualDataSubmission

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Re-lettered the original column F to column
E due to the removal of the original column
C. Instructions were clarified.
Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)
Record Layout Subsection, (Original)
Column G:
Re-lettered the original column G to column
F due to the removal of the original column
C. Instructions were clarified.
Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)
Record Layout Subsection, (Original)
Column H:
Re-lettered the original column H to column
G due to the removal of the original column
C. The name of the column and the
instructions were modified.
Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)
Record Layout Subsection, (Original)
Column I:
Re-lettered the original column I to column
H due to the removal of the original column
C. Instructions were clarified.
Annual Data Submission Section, Utilization
Management Annual Submission (UMAS)

Type of Change

Explanation of
Changes

Burden
Impact

instructions for
clarity
Modified

Modified column
lettering and
revised
instructions for
clarity

None

Modified

Modified column
lettering, column
name and
instructions

None

Modified

Modified column
lettering and
revised
instructions for
clarity

None

Modified

Modified column
lettering and

None

5

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf
Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf
Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Record Layout Subsection, (Original)
Column J:
Re-lettered the original column J to column
I due to the removal of the original column
C. Instructions were clarified.
Purpose:
Clarified instructions to ensure MAOs were
aware of compliance standards and
requirements that would be applicable to
the data collection.
General:
Clarified the meaning of “service” to
include services, items, and Part B drugs.
Compliance Standards Section, 1.1:
Clarified that auditors would select up to 20
services for review from the Utilization
Management Criteria (UMC) Record Layout.
Compliance Standards Section, 1.5:
Removed the compliance standard.

Type of Change

Explanation of
Changes

Burden
Impact

revised
instructions for
clarity
Modified

Modified
Modified

Modified

Modified
instructions to
identify
requirements that
will apply,
including when
new issues arise.
Clarified the
meaning of the
term service
Clarified how
auditors would
select services

None

Modified the
compliance
standards to
remove the
original standard
1.5.

High
(reduction)

None
None

6

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Type of Change

Explanation of
Changes

Burden
Impact

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Compliance Standards Section, 1.7:
Removed the compliance standard.

Modified

High
(reduction)

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Compliance Standards Section, 1.6 and 1.8
through 1.10:
Renumbered the original compliance
standards 1.6 and 1.8 through 1.10 to 1.5
through 1.8 to account for the removal of
the original compliance standards 1.5 and
1.7.
Compliance Standards Section:
Revised standards to make minor, nonsubstantive wording changes.
UM Audit Data Request Section, Audit
Engagement and Universe Submission
Phase Subsection:
Added additional guidance explaining that
the CMS List of Targeted Services will be
provided with the audit engagement letter.
UM Audit Data Request Section, Audit
Engagement and Universe Submission
Phase Subsection:
Added the due date for the Supplemental
Questions document into the audit protocol

Modified

Modified the
compliance
standards to
remove the
original standard
1.7.
Technical change

Modified

Minor wording
changes

None

Modified

Modified the
document to
clarify when the
CMS List of
Targeted Services
will be provided
Modified the
document to
clarify when the
Supplemental

None

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf
Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Modified

None

None

7

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf
Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

to ensure consistency and transparency.
The due date was previously only included
in the Supplemental Questions document.
UM Audit Data Request Section, Universe
Submission Subsection: Removed the .txt
file format as an allowable file format for
the universe submission.
UM Audit Data Request Section, Universe
Submission Subsection:
Added additional instructions to clarify that
MAOs do not need to submit additional
information at the time of universe
submission. Also added reference to an
optional excel template that MAOs may use
which includes examples of how to
populate instructions.
UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Instructions:
Clarified that information submitted should
be based on the status of the service at the
time of universe submission.
UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column A:

Type of Change

Explanation of
Changes

Burden
Impact

Questions
document is due
Modified

Modified
allowable universe
file format to
ensure proper
formatting of data
Clarified that
additional
documentation
does not have to
be submitted with
the universe

None

Modified

Clarified the
timeframe
associated with
the requested
information

None

Modified

Minor wording
changes

None

Modified

None

8

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf
Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Renamed the column and made minor
wording changes to consistently use
‘service’ rather than ‘service or item.’
UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column B:
Removed the original column B.

Type of Change

Explanation of
Changes

Burden
Impact

Remove

Removed CPT and
HCPCS codes from
the information
collection to
reduce burden
Modified the
column letter and
clarified
instructions

High
(reduction)

Modified the
column letter and
the information
collected

Low
(reduction)

Modified the
column letter and
clarified
instructions

None

UM Audit Data Request Section, Utilization Modified
Management Criteria (UMC) Record Layout,
Column C:
Re-lettered the original column C to column
B due to the removal of column B. Modified
the instructions for clarity.
UM Audit Data Request Section, Utilization Modified
Management Criteria (UMC) Record Layout,
Column D:
Re-lettered the original column D to column
C due to the removal of column B. Modified
the information collected from ‘Locality’ to
‘MAC Jurisdiction’ to reduce burden.
UM Audit Data Request Section, Utilization Modified
Management Criteria (UMC) Record Layout,
Column E:
Re-lettered the original column E to column
D due to the removal of column B. Modified
the instructions for clarity.

None

9

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Type of Change

Explanation of
Changes

Burden
Impact

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column F: Removed the original column F.

Remove

Low
(reduction)

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column G: Removed the original column G.

Remove

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column H: Removed the original column H.

Remove

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column I: Re-lettered the original column I
to column E due to the removal of columns
B and F-H. Modified the instructions for
clarity.
UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column J: Re-lettered the original column J
to column F due to the removal of columns

Modified

Removed
applicable
Medicare
regulations to
reduce burden for
MAOs
Removed national
coverage
determinations to
reduce burden for
MAOs
Removed local
coverage
determinations to
reduce burden for
MAOs
Modified the
column letter and
clarified
instructions
Modified the
column letter and
clarified
instructions

None

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Modified

Low
(reduction)

Low
(reduction)

None

10

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

B and F-H. Modified the instructions for
clarity.
UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column K: Re-lettered the original column K
to column G due to the removal of columns
B and F-H. Renamed the column and
modified the instructions for clarity.
UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column L: Re-lettered the original column L
to column H due to the removal of columns
B and F-H. Renamed the column and
modified the instructions for clarity.
UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column M: Re-lettered the original column
M to column I due to the removal of
columns B and F-H. Modified the
instructions for clarity.
UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column N: Re-lettered the original column
N to column J due to the removal of
columns B and F-H. Renamed the column
and modified the instructions for clarity.

Type of Change

Explanation of
Changes

Burden
Impact

Modified

Modified the
column letter,
column name, and
clarified
instructions

None

Modified

Modified the
column letter,
column name, and
clarified
instructions

None

Modified

Modified the
column letter and
clarified
instructions

None

Modified

Modified the
column letter,
column name, and
clarified
instructions

None

11

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Type of Change

Explanation of
Changes

Burden
Impact

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Modified

Modified the
column letter and
clarified
instructions

None

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column O: Re-lettered the original column
O to column K due to the removal of
columns B and F-H. Modified the
instructions for clarity.
UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column P: Removed the original column P.

Remove

Low
(reduction)

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column Q: Removed the original column Q.

Remove

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

UM Audit Data Request Section, Utilization
Management Criteria (UMC) Record Layout,
Column R: Re-lettered the original column R
to column L due to the removal of columns
B, F-H, and P-Q. Renamed the column and
modified the instructions for clarity.
UM Audit Data Request Section, Supporting
Documentation Submissions:
Renamed the section and clarified that CMS
will select a subset of 20 services from the
UMC universe to review.

Modified

Removed UM
committee
approval to
reduce burden for
MAOs
Removed publicly
accessible to
reduce burden for
MAOs
Modified the
column letter,
column name, and
clarified
instructions
Modified the
subsection name
and clarified the
instructions

None

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Modified

Low
(reduction)
None

12

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Type of Change

Explanation of
Changes

Burden
Impact

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

UM Audit Data Request Section, Supporting
Documentation Submissions:
Created new sub-sections to clarify process
and due dates: including a section for Initial
Submissions, a section for CMS review and
Data Validation, and a section for
“Evidentiary Source Submission”
UM Audit Data Request Section, Supporting
Documentation Submissions:
Under the new Initial Submissions, we
broke out documentation types by the
services that have internal coverage criteria
and the services that do not.
UM Audit Data Request Section, Supporting
Documentation Submissions:
Modified the instructions to clarify that the
Analysis of Internal Coverage Criteria
document must be completed for all
documents that contain internal coverage
criteria. Additionally, clarified that Um
committee notes, and the individual
internal coverage criteria policies must be
submitted in the initial submission
UM Audit Data Request Section, Supporting
Documentation Submissions:
Clarified what documentation must be
submitted for all services (regardless of

Modified

Created new subsections to clarify
audit fieldwork
process

None

Modified

Clarified
documentation
due initially to
CMS

Low
(reduction)

Modified

Clarified the types
of documents that
must be included
in theinitial
submission

None

Modified

Modified
instructions to
better outline
expectations

Low (increase)

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

13

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

whether they have internal coverage
criteria) including any operational tools,
guidelines, or other methods of
disseminating and applying criteria.
Additionally, clarified instructions related to
the identification of denial letters for the
validation review.
UM Audit Data Request Section, Supporting
Documentation Submissions:
Moved information from the data
validation section into the documentation
submission section under a new subsection
titled CMS Review and Data Validation.
UM Audit Data Request Section, Supporting
Documentation Submissions:
Added information into the CMS review
and Data Validation section to clarify how
CMS will identify and review denial letters
and/or validate the submitted internal
coverage criteria
UM Audit Data Request Section, Supporting
Documentation Submissions:
Created a new subsection titled
“Evidentiary Sources Submission” to create
new guidance on a second submission of
data in response to burden concerns. This
section will allow CMS to narrow our

Type of Change

Explanation of
Changes

Burden
Impact

related to
documentation
submissions
during fieldwork

Modified

Modified

Modified

Adjusted
placement of data
validation
information to
better align with
audit process
Clarified how
information would
be gathered and
assessed during
validation

None

Reduced burden
by creating a
secondary
submission of
information on a
smaller subset of
data

High
(decrease)

Low (increase)

14

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

secondary request for information to avoid
over burdening the organization.
UM Audit Data Request Section, Supporting
Documentation Submissions:
Created a new timeframe for evidentiary
sources to be submitted to CMS of 10
business days.

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf
Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf
Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

UM Audit Data Request Section, Supporting
Documentation Submissions:
Made minor edits to improve the clarity of
the instructions.
UM Audit Data Request Section, Data
Validation Subsection:
Removed data validation section and
merged information into the
documentation submission under audit
fieldwork.
UM Audit Data Request Section, Impact
Analysis Submissions Subsection:
Modified the instructions to allow for IA
extensions on a case-by-case basis.
UM Audit Data Request Section, UM
Internal Criteria Impact Analysis (UMIC-IA)
Record Layout Subsection:

Type of Change

Explanation of
Changes

Burden
Impact

Modified

Reduced burden
by creating a
secondary
submission of
information on a
smaller subset of
data
Minor wording
changes

High
(decrease)

Removed section
and shifted
information into a
different section
to clarify audit
process
Modified the
instructions to
allow for
extensions
Clarified
instructions

None

Modified

Modified

Modified

Modified

None

Low
(reduction)
None

15

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf
Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

We revised the UM Internal Criteria
Impact Analysis (UMIC-IA) instructions to
specify that CMS will furnish MAOs with
the UMIC-IA in Microsoft Excel (.xlsx)
format and with columns A-C populated by
CMS. UMIC-IA will no longer be accepted as
a .txt file.
UM Audit Data Request Section, UM
Internal Criteria Impact Analysis (UMIC-IA)
Record Layout Subsection:
We clarified that MAOs must complete
columns D-P.
UM Audit Data Request Section, UM
Internal Criteria Impact Analysis (UMIC-IA)
Record Layout Subsection:
We added instructions stating that we
would limit the IA timeframe based on the
service.
UM Audit Data Request Section, UM
Internal Criteria Impact Analysis (UMIC-IA)
Record Layout Subsection:
We added instructions stating that the IA
should only include Level 1
reconsiderations.
UM Audit Data Request Section, UM
Internal Criteria Impact Analysis (UMIC-IA)
Record Layout Subsection, Column A:

Type of Change

Explanation of
Changes

Burden
Impact

Modified

Clarified
instructions

None

Modified

Clarified
instructions

High
(decrease)

Modified

Clarified
instructions

Medium
(decrease)

Modified

Minor wording
changes

None

16

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf
Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Renamed the column and made minor
wording changes to consistently use
‘service’ rather than ‘service or item.’ Made
minor revision to clarify that CMS will enter
the information in this column.
UM Audit Data Request Section, UM
Internal Criteria Impact Analysis (UMIC-IA)
Record Layout Subsection, Column B:
Made minor revision to clarify that CMS will
enter the information in this column.
UM Audit Data Request Section, UM
Internal Criteria Impact Analysis (UMIC-IA)
Record Layout Subsection, (New) Column C:
We added a new column C to account for a
decreased timeframe for collecting IA data.
UM Audit Data Request Section, UM
Internal Criteria Impact Analysis (UMIC-IA)
Record Layout Subsection, (Original)
Columns C-F:
Original columns C-F were re-lettered due
to the addition of new column C. The
columns were also renamed, and minor
wording changes were made to consistently
use ‘service’ rather than ‘service or item.’

Type of Change

Explanation of
Changes

Burden
Impact

Modified

Minor wording
changes

None

Modified

Modified the IA to
limit the data
collection
timeframe in
order to reduce
burden
Minor wording
changes

High
(reduction)

Modified

None

17

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Type of Change

Explanation of
Changes

Burden
Impact

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

UM Audit Data Request Section, UM
Internal Criteria Impact Analysis (UMIC-IA)
Record Layout Subsection, (Original)
Columns G-I:
Original columns G-I were re-lettered due
to the addition of new column C and minor
wording changes were made to consistently
use ‘service’ rather than ‘service or item.’
UM Audit Data Request Section, UM
Internal Criteria Impact Analysis (UMIC-IA)
Record Layout Subsection, (Original)
Columns J-L:
Original columns J-L were re-lettered due to
the addition of new column C. The columns
were also renamed, and minor wording
changes were made to consistently use
‘service’ rather than ‘service or item.’
UM Audit Data Request Section, UM
Internal Criteria Impact Analysis (UMIC-IA)
Record Layout Subsection, (Original)
Columns M-O:
Original columns M-O were re-lettered due
to the addition of new column C.
UM Audit Data Request Section,
Verification of Information Collected:
Created a new section at the end of the
audit protocol to reiterate that CMS will

Modified

Minor wording
changes

None

Modified

Minor wording
changes

None

Modified

Minor wording
changes

None

Modified

Added a section to None
reiterate intention
to validate

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

Medicare
PartC_UM_AuditProtocolDataReq
uest.pdf

18

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)
Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)
Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)
Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)
Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

validate information submitted and may
require resubmissions when there are
concerns about the accuracy of the
information.
Retitled the “Standardized Formatting of
Internal Criteria “ document to “Analysis of
Internal Coverage Criteria“.

Type of Change

Explanation of
Changes

Burden
Impact

submitted
information
Modified

Minor wording
change

Converted the document from Word to
Excel

File type change

Services Selected by CMS tab:
A ‘Services Selected by CMS’ tab was added
to the Excel version of the document. This
will be completed by CMS and is a
reference for MAOs.
Standardized Formatting Tab, General
Instructions:
This section was added to the document to
clarify how MAOs should complete the
document.
Standardized Formatting Tab, Part 1:
Five rows (Coverage Criteria Unique
Weblink, Coverage Criteria applicable to
Medicare Members, Applicable Medicare
Rules, Medicare Coverage Included or

Modified

Modified format
None
for ease of
readability and
data entry
Modified the
None
document to add
reference material
that will be
completed by CMS
Clarified
None
instructions

Modified

Remove

Modified the table
in Part 1 to
remove rows and
decrease data
entry

None

High
(reduction)

19

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)

Excluded, and Explicit Flexibility for
Additional Coverage) were removed in
order to decrease burden by eliminating
duplicative data entry.
Standardized Formatting Tab, Part 1:
The names and instructions for two
rows/data points (Organization Name and
Applicable Service Area) were modified.

Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)

Standardized Formatting Tab, Part 1:
Added additional instructions to clarify how
the document should be completed by
MAOs.

Modified

Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)

Standardized Formatting Tab, Part 2,
Columns A-B:
Added additional instructions to clarify the
information needed and decrease burden
when completing the document.
Standardized Formatting Tab, Part 2,
Column C:
The information from the original column C
was shifted to column D. CMS requested
additional information in column C that is
necessary to evaluate regulatory
compliance. The additional information

Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)

Type of Change

Explanation of
Changes

Burden
Impact

Modified

Modified the table
in Part 1 to revise
row names and
clarify the types of
data needed
Modified
instructions to
provide additional
clarity

None

Modified

Modified rows A-B
to provide
additional clarity

None

Modified

Modified row C to
collect additional
information
needed to assess
compliance

Low (increase)

None

20

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Type of Change

Explanation of
Changes

Burden
Impact

Modified

Modified the table
to shift the
original column C
to column D, the
original column D
to column E, and
add additional
instructions for
clarity.

None

Modified

Modified the table
to shift the
original column D
to column E and
remove the
information
originally
collected in
column E to
reduce burden.

High
(reduction)
(Related to
the removal of
the
information
originally
requested in
column E.)

requested only requires MAOs to enter “A,”
“B,” or “C.”
Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)

Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)

Internal Coverage Criteria tab, Part 2,
Column D:
The information from the original column C
was shifted to column D and additional
instructions were provided to increase
clarity.
The information originally requested in
column D (Citation associated with
Medicare language) was moved to column
E.
Internal Coverage Criteria tab, Part 2,
Column E:
The information from the original column D
was shifted to column E and additional
instructions were provided to increase
clarity.
The information originally requested in
column E (Provide a statement as to how
this specific clinical criteria provides clinical
benefits that are highly likely to outweigh
any clinical harms) was removed to
decrease burden for MAOs.

21

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Type of Change

Explanation of
Changes

Burden
Impact

Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)

Internal Coverage Criteria tab, Part 2,
Column F:
This column was added to reduce MAO
burden when completing column G. This
column will be completed by CMS.

Modified

High
(reduction)

Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)

Internal Coverage Criteria tab, Part 2,
Column G:
This column was added to incorporate the
information originally requested in Part 3
into Part 2. The instructions were also
modified to provide additional clarity.

Modified

Modified the table
to add column F in
order to reduce
the burden
associated with
column G.
Modified the table
to incorporate the
information
originally
requested in Part
3.

Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)

Internal Coverage Criteria tab, Part 3:
Part 3 was removed, and the requested
information was moved to Part 2, column
G.

Modified

None

Standardized Formatting of
Internal Criteria (now titled
Analysis of Internal Coverage
Criteria)

Internal Coverage Criteria tab, Part 4:
Part 4 was removed in order to decrease
MAO burden.

Modified

Remove Part 3 of
the document and
incorporated the
requested
information in the
table in Part 2.
Removed Part 4

Instructions on Entering and
Submitting Criteria (now merged

Removed instructions from a standalone
document and added them into the

Modified

Merged
instructions into
the document

None

None

Low
(reduction)

22

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

into Analysis of Internal
Coverage Criteria)

Analysis of Internal Coverage Criteria in the
first tab.

Instructions on Entering and
Submitting Criteria (now merged
into Analysis of Internal
Coverage Criteria)

General Header:
This section was added to provide
additional instructions for completing the
Analysis of Internal Coverage Criteria
document.
Services Selected by CMS Tab Header:
This section was added to clarify the
purpose of the ‘Service Selected’ tab in the
Analysis of Internal Coverage Criteria
document.
Internal Coverage Criteria tab, Part 1 Subheader:
Instructions for the rows retained in Part 1
of the Analysis of Internal Coverage Criteria
document were modified to provide
additional clarity.
Internal Coverage Criteria tab, Part 1 Subheader:
Instructions for the rows removed from
Part 1 of the Analysis of Internal Coverage
Criteria document were removed.

Instructions on Entering and
Submitting Criteria (now merged
into Analysis of Internal
Coverage Criteria)
Instructions on Entering and
Submitting Criteria (now merged
into Analysis of Internal
Coverage Criteria)
Instructions on Entering and
Submitting Criteria (now merged
into Analysis of Internal
Coverage Criteria)

Type of Change

Explanation of
Changes

Burden
Impact

they relate to for
ease of MAO
Modified

Clarified
instructions

None

Modified

Clarified
instructions

None

Modified

Modified
instructions for
additional clarity

None

Modified

Removed
instructions for
rows removed
from the Analysis
of Internal
Coverage Criteria
document

None

23

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Instructions on Entering and
Submitting Criteria (now merged
into Analysis of Internal
Coverage Criteria)

Internal Coverage Criteria tab, Part 2 SubModified
header:
Instructions pertaining to the columns in
Part 2 of the Analysis of Internal Coverage
Criteria document were modified to
provide additional clarity (for columns that
were retained in Part 2) or added (for newly
added columns in Part 2).
Internal Coverage Criteria tab, Part 3 SubModified
header:
Instructions were removed because Part 3
of the Analysis of Internal Coverage Criteria
document was incorporated into Part 2.
Internal Coverage Criteria tab, Part 4 SubModified
header: Instructions were removed because
Part 4 of the Analysis of Internal Coverage
Criteria document was removed.

Instructions on Entering and
Submitting Criteria (now merged
into Analysis of Internal
Coverage Criteria)
Instructions on Entering and
Submitting Criteria (now merged
into Analysis of Internal
Coverage Criteria)

CMS List of Targeted Services

Type of Change

Modified the CMS List of Targeted Services’ Modified
Instructions to include the 42 C.F.R. 400.202
definition of “services” and to provide
examples of types of services included per
the cited definition.

Explanation of
Changes

Burden
Impact

Modified
instructions for
additional clarity
and added
instructions as
needed

None

Removed
instructions that
were incorporated
into Part 2

None

Removed
instructions for
Part 4 of the
Analysis of
Internal Coverage
Criteria document
since Part 4 was
removed
Clarified definition
of “services” and
provided
examples of
applicable
“services”

None

None

24

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Type of Change

Explanation of
Changes

Burden
Impact

CMS List of Targeted Services

Modified the CMS List of Targeted Services’
Instructions to clarify that the list could
include Part B drugs.
Modified the CMS List of Targeted Services’
Instructions to clarify that the list may
contain up to 50 unique services, items, or
Part B drugs to be consistent with the Audit
Field Work Phase process described in the
UM Audit Protocol Data Request.
Modified the CMS List of Targeted Services’
Instructions to clarify that MAOs do not
need to submit copies of internal criteria or
other information for the services on the
CMS List of Targeted Services, only the
requested universe of information in the
Part C UM Audit Protocol and Data Request.
Modified the CMS List of Targeted Services’
Instructions to clarify that MAOs can expect
to receive the CMS List of Targeted Services
with the CMS audit engagement letter,
instead of on a calendar year basis.
Modified the Targeted Services Table
column header “Brief Description of
Service” to include “(if applicable)”.
Modified the Targeted Services Table
format to include 50 rows, which is
consistent with the CMS List of Targeted

Modified

Clarified
instructions

None

Modified

Clarified
instructions

None

Modified

Clarified
instructions

Moderate
(reduction)

Modified

Clarified
Instructions

None

Modified

Clarified
instructions

None

Modified

Modified the table
formatting for
consistency

None

CMS List of Targeted Services

CMS List of Targeted Services

CMS List of Targeted Services

CMS List of Targeted Services
CMS List of Targeted Services

25

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

UMSupplementalQuestions

UMSupplementalQuestions

UMSupplementalQuestions

UMSupplementalQuestions

UMSupplementalQuestions
UMSupplementalQuestions

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Services instructions that allow up to 50
unique services, items, or Part B drugs on
the list.
Modified the file name to display
“UMSupplementalQuestions” when opened
to ensure consistency between the
document title and file name.
Modified the Instructions tab to provide a
data collection period example using the
year 2026 instead of 2025 to align with
CMS’ proposed implementation timeframe.
On the UM Supplemental Questions tab, for
the section of questions titled “Questions
on Public Accessibility of Criteria”, we
replaced the term “Accessibility” with
“Availability”.
On the UM Supplemental Questions tab,
replaced the term “beneficiaries” with
“members, non-members” in questions 2,
3, and 4.
On the UM Supplemental Questions tab,
modified question 8 to reference “Part B
drugs” in addition to “items and services”.
On the UM Supplemental Questions tab,
modified question 2 to remove duplicate
terminology.

Type of Change

Explanation of
Changes

Burden
Impact

Modified

Minor wording
change

None

Modified

Minor wording
change

None

Modified

Minor wording
change

None

Modified

Minor wording
change

None

Modified

Clarified
instructions

None

Modified

Minor wording
change

None

26

Proposed CMS-10913 (Prior to 60Day Comment Period) Document

Summary of Changes in Proposed CMS10913 (Following 60-Day Comment Period)

Type of Change

Explanation of
Changes

NA

Created a reference document that
provides example data to guide the
submission of the UM Annual Data
Submission Utilization Management Annual
Submission (UMAS) Record Layout. New
document is titled “Utilization Management
Annual Submission (UMAS) Record Layout
with Examples”
Created a reference document that
provides example data to guide the
submission of the UM Audit Protocol Data
Request Utilization Management Criteria
(UMC) Record Layout. New document is
titled “Utilization Management Criteria
(UMC) Record Layout with Examples”

New

Created a template for the Root Cause
Analysis that is discussed in the UM Audit
Protocol and Data Request. This template
was inadvertently left out of the original
package, however, it was discussed in the
protocol and accounted for in the burden
estimates.

New

Created an excel
None
template that
directly aligns
with data requests
to clarify data
submissions by
providing
examples to MAOs
Created an excel
None
template that
directly aligns
with data requests
to clarify data
submissions by
providing
examples to MAOs
Created a
None
template for the
Root Cause
Analysis

NA

NA

New

Burden
Impact

27