Crosswalk

Crosswalk_of_Revisions.pdf

Medicare Parts C and D Program Audit Protocols and Data Requests (CMS-10191)

Crosswalk

OMB: 0938-1000

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0938-1000 can be found here:

2020-01-07 - Revision of a currently approved collection

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Current Section
in CMS-10191
Attachments I, II, III, IV,
V, and VI (CPE, FA,
CDAG, ODAG, SNPMOC, and MTM) Audit
Process and Data Request
Audit Purpose and General
Guidelines
Disclosed and SelfIdentified Issues

Original Language

Clarification or Change

Sponsor Disclosed and Self-Identified Issues: Sponsors will be
asked to provide a list of all previously disclosed and selfidentified issues of non-compliance, from January 1, 2015 through
the date of the audit start notice, which CMS may find in your data
universes. For 2016: the period will be from January 1, 2016
through the date of the audit start notice. A disclosed issue is one
that has been reported to CMS prior to the date of the audit start
notice (which is also known as the “engagement letter”). A selfidentified issue is one that has been discovered by the sponsor for
which no prior notification has been provided to CMS. If CMS
identifies an issue through on-going monitoring or other account
management/oversight activities during the plan year and reported
that issue to the sponsor, the sponsor should list that issue as selfidentified. Please do not include all issues identified by your
organization, just those that are relevant to the areas being audited.
Please identify if the issue is corrected, uncorrected and the date
when correction occurred.

Modified the Disclosed and
Self-Identified issues section
in every protocol. We are no
longer asking for selfidentified issues- only issues
that have been previously
reported (disclosed) to CMS.
Those issues will be reported
on the Pre-Audit Issue
Summary and will be due 5
days from the date of the
audit start notice. The PreAudit Issue Summary will
no longer be called
Attachment VIII. All
references to Attachment
VIII has been removed.
Included new language
relating to downgrading
conditions based on issues
that were disclosed,
promptly identified, and
corrected.

Within 5 business days after receipt of the engagement letter,
sponsors must provide a description of each issue as well as the
remediation status using the Pre-Audit Issue Summary template
(Attachment VIII). The sponsor’s Account Manager will review
the summary for accuracy and completeness. Account Managers
(AMs) will be expected to validate that issues identified as
“disclosed” were known to CMS prior to the date of the audit start
notice. The AMs will also validate the “disclosed” issue status of
“corrected” and may also be asked to validate that issues have not
been omitted from the “disclosed” summary.
CMS will consider an issue corrected if there is evidence of
appropriate and adequate remediation in the sponsor’s systems and
for its beneficiaries either prior to or during the “audit review
period”, but before receipt of the audit start notice. The “audit
review period” refers to the period covered by the related universe
request.

Page 1 of 112

Revised Language

Sponsor Disclosed Issues: Sponsors will be asked to provide a list
of all disclosed issues of non-compliance that are relevant to the
program areas being audited and may impact the submitted
universes. A disclosed issue is one that has been reported to CMS
prior to the receipt of the audit start notice (which is also known as
the “engagement letter”). Issues identified by CMS through ongoing monitoring or other account management/oversight activities
during the plan year are not considered disclosed.
Sponsors must provide a description of each disclosed issue as well
as the status of correction and remediation using the Pre-Audit Issue
Summary template. This template is due within 5 business days
after the receipt of the audit start notice. The sponsor’s Account
Manager will review the summary to validate that
“disclosed” issues were known to CMS prior to receipt of the audit
start notice.
When CMS determines that a disclosed issue was promptly
identified, corrected (or is actively undergoing correction), and the
risk to beneficiaries has been mitigated, CMS will not apply the
ICAR condition classification to that condition.

Current Section
in CMS-10191

Original Language

Issues that are reported as uncorrected will automatically be
cited as conditions in the CMS audit report. Issues reported
as corrected after the date of the audit start notice will be
treated as uncorrected issues.
Issues that are reported as corrected prior to the audit
universe review period will be assumed to be corrected.
However, if the issue is identified during the course of the
audit, CMS will cite the applicable conditions in the audit
report. CMS will not otherwise validate correction of issues
identified as corrected.
Issues that are reported as corrected during the universe review
period will either be validated for correction during the audit or
during the validation of correction of audit findings, based on the
type of issue identified. Auditors will validate correction if it can
be accomplished simply (e.g., running a test claim through the
sponsor’s system to ensure edits were properly reprogrammed or
confirming a change was made in the system to a letter template,
ensuring required language was included).
When correction is validated the issue will be noted as an
observation in the organization’s audit report. If validation of
correction is not feasible during the audit (e.g., would be time
consuming or insufficient data exists) then the organization will be
cited the applicable conditions related to the disclosed/selfidentified issue in their audit report and CMS will validate
correction during audit validation.
NOTE: For timeliness tests, CMS will make allowances for
corrected issues provided that after the reported correction date, at
least 6 consecutive weeks of data remain in the audit review
period. If at least 6 weeks are not available, the usual timeliness
tests will be conducted on the entire universe and conditions will
be cited based on the results. CMS will ensure correction of those
timeliness conditions during audit validation.

Page 2 of 112

Clarification or Change

Revised Language

Current Section
in CMS-10191
Attachments I, II, III, IV,
V, and VI (CPE, FA,
CDAG, ODAG, SNPMOC, and MTM) Audit
Process and Data Request
Attachment I CPE
Audit Process and Data
request

Original Language

Clarification or Change

Revised Language

2017

Removed year specific
reference

None

Completed CPE Self-Assessment Questionnaire

Added language to specify the
corresponding attachment of
the protocol.

Completed CPE Self-Assessment Questionnaire (Attachment I-A)

Completed Compliance Officer Questionnaire

Added language to specify the
corresponding attachment of
the protocol.

Completed Compliance Officer Questionnaire (Attachment I-B)

Organizational Structure and Governance PowerPoint Presentation

Added language to specify the
corresponding attachment of
the protocol.

Customized Organizational Structure and Governance PowerPoint
Presentation (Attachment I-C)

Completed First-Tier Downstream and Related Entities (FDR)
Operations Questionnaire

Added language to specify the
corresponding attachment of
the protocol.

Completed First-Tier Downstream and Related Entities (FDR)
Operations Questionnaire (Attachment I-D)

Universe Preparation &
Submission
Documentation
Attachment I CPE
Audit Process and Data
request
Universe Preparation &
Submission
Documentation
Attachment I CPE
Audit Process and Data
request
Universe Preparation &
Submission
Documentation
Attachment I CPE
Audit Process and Data
request
Universe Preparation &
Submission
Documentation

Page 3 of 112

Current Section
in CMS-10191
Attachment I CPE
Audit Process and Data
request

Original Language

Clarification or Change

Revised Language

Completed Special Investigation Unit (SIU)/FWA Prevention and
Detection Questionnaire

Added language to specify the
corresponding attachment of
the protocol.

Completed Special Investigation Unit (SIU)/FWA Prevention and
Detection Questionnaire
(Attachment I-E)

Standards of Conduct/Code of Conduct document
(distributed to employees and FDRs during the audit
period)

Changed “audit period” to
“audit review period” to
reflect consistency with the
protocol.

Standards of Conduct/Code of Conduct document
(distributed to employees and FDRs during the audit
review period)

Corporate Compliance/Medicare Compliance/Fraud,
Waste and Abuse Plan (or similar document in effect
during the audit period)

Changed “audit period” to
“audit review period” to
reflect consistency with the
protocol.

Corporate Compliance/Medicare Compliance/Fraud,
Waste and Abuse Plan (or similar document in effect
during the audit review period)

Formal Risk Assessments and Compliance
Performance Mechanisms that show the extent to
which Medicare Parts C and/or D operational areas
and FWA risks were identified and compliance goals
were monitored during the audit period

Changed “audit period” to
“audit review period” to
reflect consistency with the
protocol.

Formal Risk Assessments and Compliance
Performance Mechanisms that show the extent to which
Medicare Parts C and/or D operational areas and FWA
risks were identified and compliance goals were
monitored during the audit review period

Page 4 of 112

Current Section
in CMS-10191
Attachment I CPE
Audit Process and Data
request

Original Language

Changed “audit period” to
“audit review period” to
reflect consistency with the
protocol.

Audit and Monitoring Work Plans (for internal operations and
FDRs, in effect at any time during the audit review period)

None

Added clarification regarding
sponsors to include both
compliance and FWA
activities in the data
universes.

For each respective universe, the sponsor should include compliance
and FWA activities.

None

Added clarification regarding
policy guidance for fraud,
waste and abuse monitoring
and SIU operations.

Please refer to Sections 50.6.9 and 50.6.10 for guidance on fraud,
waste and abuse monitoring activities and SIU operations.

Universe Preparation &
Submission
Data Universes
Attachment I CPE
Audit Process and Data
request
Universe Preparation &
Submission
Data Universes

Page 5 of 112

Revised Language

Audit and Monitoring Work Plans (for internal operations
and FDRs, in effect at any time during the audit period)

Universe Preparation &
Submission
Documentation
Attachment I CPE
Audit Process and Data
request

Clarification or Change

Current Section
in CMS-10191
Attachment I CPE
Audit Process and Data
request
Tracer Evaluation
Tracer Case Summary

Original Language

For each selected case, sponsors should prepare a written
document that provides the specific facts, rationales, and
decisions and describe how suspected, detected or reported
compliance issues are investigated and resolved by the sponsor
in chronological order. The sponsor should ensure each tracer
summary, at a minimum, addresses the following points:
•
Overview of the issue

•

•
•
•
•

•
•

Detailed explanation of the issue(s) (e.g., what the
sponsor found, when the sponsor first learned about
the issue, the root cause, and who or which
personnel/operational area(s) were involved.)
Root cause analysis that determined what caused or
allowed the compliance issue, problem or deficiency
to occur
Specific actions taken in response to the
detected issue(s)
Processes and procedures affected and revised in
response to becoming aware of the issue(s)
Steps taken to correct the issues/deficiencies at the
sponsor or FDR levels, including a timeline indicating
the corrective actions fully implemented or, if not
implemented, when the sponsor expects the corrective
action to be completed.
Communication within the sponsor and with
its FDRs
Prevention controls and safeguards
implemented in response to the issue(s)

Sponsors may document the facts of each tracer summary using
the most effective and efficient method for their business
including but not limited to MS Word, MS Excel, and MS
PowerPoint, story boards, and/or dashboards.

Page 6 of 112

Clarification or Change

Modified language to reflect
additional details that should
be included in the tracer case
summaries and specified the
number of summaries that
must be submitted to CMS.

Revised Language
For each selected case, sponsors should prepare a written document
that provides the specific facts, rationales, and decisions and describe
how suspected, detected or reported compliance issues are
investigated and resolved by the sponsor in chronological order. The
sponsor should ensure each tracer summary, at a minimum,
addresses the following points:
•
Overview of the issue(s) or activity
•
Indicate which compliance and business operations units
were involved in detecting and correcting the issue(s)
•
Detailed explanation of the issue(s)/ activity (e.g., what
the sponsor found, when the sponsor first learned about
the issue, and who or which personnel/operational area(s)
were involved.)
•
Root cause analysis that determined what caused or
allowed the compliance issue, problem or deficiency to
occur
•
Specific actions taken in response to the detected
issue(s)/activity
•
Processes and procedures affected and revised in response
to becoming aware of the issue(s)/activity
•
Steps taken to correct the issues/deficiencies at the sponsor
or FDR levels, including a timeline indicating the
corrective actions fully implemented or, if not
implemented, when the sponsor expects the corrective
action to be completed.
•
Issue escalation (e.g. senior management, compliance
oversight committees, governing body, etc.)
•
Communication within the sponsor and with its FDRs

Current Section
in CMS-10191

Original Language

Clarification or Change

Revised Language
•

Attachment I CPE
Audit Process and Data
request
Tracer Evaluation

During the onsite portion of the audit, CMS will review
documentation in support of tracer summaries to determine if
applicable audit elements were effectively met. The sponsor will
need access and provide screenshots only for the documents and
data that are relevant to a particular case.

Modified language to reflect
the types of documentation
that will be reviewed during
the tracer reviews.

Sponsors should be prepared to provide only the
supporting documentation that is specific for each tracer
either by uploading to the Health Plan Management
System (HPMS) or onsite.

Changed “onsite” to
“providing onsite”.

Prevention controls and safeguards implemented in
response to the issue(s)/activity

Sponsors must document the facts of each tracer case summary using
the most effective and efficient method for their business. While the
method used frequently by sponsors for tracer summaries are
PowerPoint presentations (PPTs), sponsors may use other
communication tools such as MS Word, story boards, and/or
dashboards. A total of 6 tracer case summaries must be submitted to
CMS.
During the onsite portion of the audit, CMS will review the
summaries and supporting documentation during the tracer reviews
with the sponsor to determine if applicable audit elements were
effectively met. The sponsor will need access and provide
screenshots only for the documents and data that are relevant to a
particular case.

Supporting Documentation
Attachment I CPE
Audit Process and Data
request
Tracer Evaluation
Submit Tracer
Documentation to CMS

Page 7 of 112

Sponsors should be prepared to provide only the supporting
documentation that is specific for each tracer either by
uploading to the Health Plan Management System (HPMS)
or onsite.

Current Section
in CMS-10191
Attachment I CPE
Audit Process and Data
request
Table 1 - Introductory Text

Page 8 of 112

Original Language

Bullet 1: Include: First-tier entities (FTEs) that are truly
delegated a function on behalf of the sponsor (e.g., PBM,
claims processors, enrollment processes, fulfillment, call
centers, credentialing, independent provider groups that
manage/oversee a network of physicians). Audit and
monitoring activities of first-tier entities that were conducted
by the compliance department and operational areas to evaluate
the compliance performance of first-tier entities. Audit and
monitoring activities initiated, started, re-opened or completed
during the audit review period. This includes auditing and
monitoring activities that may have started outside the audit
review period, but were completed within the audit review
period. Audit and monitoring activities that are performed on
a scheduled basis (e.g., daily, monthly, quarterly, annually),
should be included in the universe each time it was performed.
If an activity is conducted daily, only include it once in the
universe, but identify all deficiencies, corrective actions, etc.
for all monitoring performed throughout the audit review
period. Related entities acting as a first-tier entity to provide
administrative or health care services. Other audit or
monitoring activities of downstream entities performed by the
sponsor during the audit review period.

Clarification or Change

Modified instructions to
reflect the inclusion of FWA
and compliance monitoring
and auditing activities in the
FTEAM universe. Removed
references to daily activities
and added clarification
regarding sponsors who have
been in operation for less than
one year

Revised Language

Bullet 1: Include: First-tier entities (FTEs) that have entered into a
written agreement with a sponsor to provide administrative or health
care services to Medicare enrollees under the Part C and/or D
program (e.g., PBM, claims processors, enrollment processes,
fulfillment, call centers, credentialing, independent provider groups
that manage/oversee a network of physicians). Compliance and
FWA audit and monitoring activities of first-tier entities that were
conducted by the compliance department, operational areas and SIU
to evaluate the compliance performance of first-tier entities.
Audit and monitoring activities performed during the audit review
period to identify and address potential or suspected non-compliance
and FWA at the FDR level in the delivery of Medicare Part C and/or
D benefits. Audit and monitoring activities that reviewed reports
from FDRs to detect non-compliance and FWA trends and
abnormalities. Audit and monitoring activities to investigate
allegations of non-compliance and fraudulent , wasteful, abusive or
questionable behavior performed by FTEs (e.g. employee
misconduct, fraudulent provider or pharmacy claims, fraudulent FTE
invoices, misuse of Medicare beneficiary information, overpayments,
complaints or tips received through hotlines, referrals, members,
MEDIC, law enforcement, etc.) Audit and monitoring activities
initiated, started, re-opened or completed during the audit review
period. This includes auditing and monitoring activities that may
have started outside the audit review period, but were completed
within the audit review period.
Audit and monitoring activities that are performed on a scheduled
basis (e.g., weekly, monthly, quarterly, annually, ad-hoc), should be
included in the universe each time it was performed.
Related entities acting as a first-tier entity to provide administrative
or health care services.
Other audit or monitoring activities of downstream entities
performed by the sponsor during the audit review period.

Current Section
in CMS-10191
Attachment I CPE
Audit Process and Data
request
Table 1 - Introductory Text

Attachment I CPE
Audit Process and Data
request

Original Language

Clarification or Change

Revised Language

Bullet 2: Exclude: First-tier entities that do not provide an
administrative or health care service function related to the
sponsor’s Medicare Parts C and/or D contracts. First-tier
entities that were not audited or monitored within the audit
review period. Downstream entities that were not
audited/monitored by the sponsor during the audit review
period.

Modified instructions to
clarify that daily audit and
monitoring activities and
related entities not audited or
monitored should be excluded
from the universe.

Bullet 2: Exclude: First-tier entities that do not provide an
administrative or health care service function related to the sponsor’s
Medicare Parts C and/or D contracts. Audit and monitoring
activities that are performed on a daily basis. First-tier entities that
were not audited or monitored within the audit review period.
Downstream or related entities that were not audited/monitored by
the sponsor during the audit review period

Field Name: Activity Frequency

Added a new field to indicate
whether the monitoring or
audit activity is compliance or
FWA related. Shifted all
letters down one beginning
with Column F.

Field Name: Compliance or FWA?

Field Name: Activity Rationale

Column F in the previous
version is now Column G.

Field Name: Activity Frequency

Field Name: Activity Description

Column G in the previous
version is now Column H.

Field Name: Activity Rationale

Field Name: Activity Start Date

Column H in the previous
version is now Column I.

Field Name: Activity Description

Table 1 - Column F

Attachment I CPE
Audit Process and Data
request
Table 1 - Column G

Attachment I CPE
Audit Process and Data
request
Table 1 - Column H

Attachment I CPE
Audit Process and Data
request
Table 1 - Column I

Page 9 of 112

Current Section
in CMS-10191
Attachment I CPE
Audit Process and Data
request
Table 1 - Column J

Attachment I CPE
Audit Process and Data
request
Table 1 - Column K

Attachment I CPE
Audit Process and Data
request

Original Language

Clarification or Change

Revised Language

Column I Field Name: Activity Start Date
Description: Date that the specific audit or monitoring activity
was initiated, started or reopened by the sponsor. For example, if
the sponsor started monitoring a function of the PBM to ensure it
properly implemented its transition policy for new beneficiaries on
January 1, 2017, that is the date that would be used for the date the
audit or monitoring started. For an audit or monitoring activity
conducted on a daily basis, only include the most recent start date.
Column J Field Name: Activity Completion Date
Description: Date that the audit or monitoring activity ended.
For example, if the sponsor completed monitoring a function of
the PBM to ensure it properly implemented its transition policy
for new beneficiaries on January 31, 2017, that is the date that
would be used for the date the audit or monitoring completed.
For an audit or monitoring activity conducted on a daily basis,
only include the completion date for the previously indicated
most recent start date.
Field Name: Number of Deficiencies

Column I in the previous
version is now Column J.
Removed all references to
daily monitoring/audit
activities from the Activity
Start Date description.

Column J Field Name: Activity Start Date
Description: Date that the specific audit or monitoring activity was
initiated, started or reopened by the sponsor. For example, if the
sponsor started monitoring a function of the PBM to ensure it
properly implemented its transition policy for new beneficiaries on
January 1, 2017, that is the date that would be used for the date the
audit or monitoring started.

Column J in the previous
version is now Column K.
Removed all references to
daily monitoring/audit
activities from the Activity
Completion Date description.

Column K Field Name: Activity Completion Date
Description: Date that the audit or monitoring activity ended. For
example, if the sponsor completed monitoring a function of the PBM
to ensure it properly implemented its transition policy for new
beneficiaries on January 31, 2017, that is the date that would be used
for the date the audit or monitoring completed.

Column K in the previous
versions is now Column L.

Field Name: Identified Deficiencies

Column L Field Name: Number of Deficiencies
Description: Provide the number of deficiencies, findings or
issues identified. For an audit or monitoring activity conducted on
a daily basis, include the total number of deficiencies identified in
all of the daily or monitoring activities during the audit review
period.

Column L in the previous
version is now Column M.
Modified language to instruct
sponsors to provide a
summary in the field and
remove root cause and all
references to daily
monitoring/audit activities
from the Number of
Deficiencies description.

Column M Field Name: Number of Deficiencies
Description: Provide the number of deficiencies, findings or issues
identified.

Table 1 - Column L

Attachment I CPE
Audit Process and Data
request
Table 1 - Column M

Page 10 of 112

Current Section in
CMS-10191
Attachment I CPE
Audit Process and Data
request
Table 1 - Column N

Attachment I CPE
Audit Process and Data
request
Table 1 - Column O
Attachment I CPE
Audit Process and Data
request
Table 1 - Column P

Page 11 of 112

Original Language

Clarification or Change

Revised Language

Column M Field Name: Description of Deficiencies
Description: Provide a description of all deficiencies, findings or
issues identified during the audit or monitoring activity, including
the root cause. If the audit or monitoring activity was identified in
the pre-audit issue summary submitted to CMS, provide the issue
number in the description. For an audit or monitoring activity
conducted on a daily basis, include all deficiencies identified in all
audit or monitoring activities during the audit review period.
Separate by a number as needed (e.g., 1. 2017/01/01 monitoring of
sponsor’s pharmacy network mail order identified incorrect
dosage for 200 members, 2. 2017/01/02 monitoring of sponsor’s
pharmacy network mail order identified no issues). Answer TBD
if deficiencies have yet to be identified for an ongoing activity.
Field Name: Corrective Action Description

Column M in the previous
version is now Column N.

Column N Field Name: Description of Deficiencies
Description: Provide a summary of deficiencies, findings or issues
identified during the audit or monitoring activity. If the audit or
monitoring activity was identified in the pre-audit issue summary
submitted to CMS, provide the issue number in the description.
Answer TBD if deficiencies have yet to be identified for an ongoing
activity

Column N in the previous
version is now Column O.

Field Name: Corrective Action Required

Column O Field Name: Corrective Action Description:
Description: Provide a full description of the corrective
action(s) implemented by the sponsor and FTE in response to the
noncompliance or potential FWA, including any root cause
analysis, timeframes for specific achievements and any
ramifications for failing to implement the corrective action
satisfactorily.

Column O in the previous
version is now Column P.
Modified Corrective Action
Description language to
instruct sponsors to provide a
summary instead of full
description.

Column P Field Name: Corrective Action Description
Description: Provide a summary of the corrective action(s)
implemented by the sponsor and FTE in response to the
noncompliance or potential FWA, including any root cause,
timeframes for specific achievements and any ramifications for
failing to implement the corrective action satisfactorily.

Current Section in
CMS-10191
Attachment I CPE
Audit Process and Data
request
Table 1 - Column Q

Attachment I CPE
Audit Process and Data
request

Original Language

Clarification or Change

Revised Language

Column P Field Name: Activity Results Shared?
Description: Describe how the results of the audit or monitoring
activity were communicated or shared with sponsor’s affected
components,
compliance department, senior management,
and/or the FTE. For an audit or monitoring activity that
identified multiple issues, separate how the results of each issue
were communicated with internal and external stakeholders by a
number as needed (e.g., 1. the compliance department sent the
pharmacy services department a formal report of the billing
errors and member impact identified during the pharmacy mail
order monitoring and is responsible for the ongoing tracking and
trending of the pharmacy’s performance with the mail order
benefit, 2. the members impacted by the pharmacy errors were
communicated to the Medicare Pharmacy Officer and Pharmacy
Services staff for immediate remediation). Answer TBD if
results have yet to be determined and shared with others for an
ongoing activity.

Column P in the previous
version is now Column Q.
Modified Activity Results
Shared description language
to instruct sponsors to provide
a summary instead of full
description.

Column Q Field Name: Activity Results Shared?
Description: Provide a summary that describes how the results of
the audit or monitoring activity were communicated or shared with
sponsor’s affected components, compliance department, senior
management, and/or the FTE. Answer TBD if results have yet to be
determined and shared with others for an ongoing activity.

Field Name: Employee First Name
Description: First name of the employee.

Added governing body
member to field description.

Field Name: Employee First Name
Description: First name of the employee or governing body
member.

Field Name: Employee Last Name
Description: Last name of the employee.

Added governing body
member to field description.

Field Name: Employee Last Name
Description: Last name of the employee or governing body member.

Field Name: Employee’s Title
Description: Position or title of the employee.

Added governing body
member to field description.

Field Name: Employee’s Title
Description: Position or title of the employee or governing body
member.

Table 2 - Column B

Attachment I CPE
Audit Process and Data
request
Table 2 - Column C

Attachment I CPE
Audit Process and Data
request
Table 2 - Column D

Page 12 of 112

Current Section in
CMS-10191
Attachment I CPE
Audit Process and Data
request
Table 2 - Column G
Attachment I CPE
Audit Process and Data
request

Original Language

Field Name: Direct Phone Number

Clarification or Change

Revised Language

Removed Direct Phone
Number field from the
universe. Column H in the
previous version is now
Column G.
Column I in the previous
version is now Column H.
Added governing body
member to field description.

Field Name: Date of Hire or Appointment

Column J Field Name: Medicare Compliance Department
Employee?
Description: Yes(Y)/No (N) indicator of whether the
employee works for the Medicare Compliance Department.
Note: Indicate Yes (Y) for any full-time compliance staff, as well
as any staff from an operational area that serve as a primary
compliance liaison between the Compliance Department and its
operational area in any capacity.
Column K Field Name: Compliance Department Job Description

Column J in the previous
version is now Column I.
Removed the “Note” from the
field description

Column I Field Name: Medicare Compliance Department
Employee?
Description: Yes(Y)/No (N) indicator of whether the employee
works for the Medicare Compliance Department.

Column K in the previous
version is now Column J.

Column J Field Name: Compliance Department Job Description

Column L Field Name: Compliance Committee Member?
Description: Yes(Y) or No (N) indicator of whether the employee
is a member of the compliance committee that addresses Medicare
compliance issues.

Column L in the previous
version is now Column K.
Provided examples of the
types of compliance
committees and added
governing body member to
field description.
Column M in the previous
version is now Column L.
Modified language to instruct
sponsors to provide a
summary instead of full
description.

Column K Field Name: Compliance Committee Member?
Description: Yes(Y) or No (N) indicator of whether the employee
or governing body member participates on a compliance committee
that addresses Medicare compliance issues (e.g. corporate
compliance committee, compliance and audit committee of the
board, committee that focuses on the compliance of FDRs.

Column I Field Name: Employee Type
Description: Indicate whether the employee is full-time, parttime, temporary, or a volunteer.

Column H Field Name: Employee Type
Description: Indicate whether the individual is a governing body
member, full-time employee, part-time employee, temporary
employee, or a volunteer.

Table 2 - Column H
Attachment I CPE
Audit Process and Data
request
Table 2 - Column I

Attachment I CPE
Audit Process and Data
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Table 2 - Column J
Attachment I CPE
Audit Process and Data
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Table 2 - Column K

Attachment I CPE
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Table 2 - Column L

Page 13 of 112

Column M Field Name: Compliance Committee Member’s Role
Description: Provide a description of the role and/or expertise
each employee brings as a member of the compliance committee
(e.g., Manager of appeals & grievances responsible for
addressing Part C appeals and grievance issues and concerns that
severely impact enrollees and developing corrective action plans
for the affected internal departments and FDRs.)

Column L Field Name: Compliance Committee Member’s Role
Description: Provide a summary of the role and/or expertise each
employee brings as a member of the compliance committee (e.g.,
Manager of appeals & grievances responsible for addressing Part C
appeals and grievance issues and concerns that severely impact
enrollees and developing corrective action plans for the affected
internal departments and FDRs

Current Section in
CMS-10191
Attachment I CPE
Audit Process and Data
request
Table 3 - Instructions

Attachment I CPE
Audit Process and Data
request
Table 3 - Instructions

Page 14 of 112

Original Language

Clarification or Change

Revised Language

Include: All audit activities (formal review of compliance
with a particular set of standards as base measures) performed
by the sponsor to ensure that its internal business and/or
operational areas are in compliance with Medicare Parts C
and D program requirements and to ensure that corrective
actions are undertaken timely and effectively. All audit
activities initiated, started, re-opened or completed during the
audit review period. This includes audit activities that started
prior to the audit review period, but were completed within the
audit period and activities that were started during the audit
review period but not yet completed. Audit activities that are
performed on a scheduled basis (e.g., daily, monthly,
quarterly, annually), should be included in the universe each
time it was performed. If an audit activity is conducted daily,
only include it once in the universe, but identify all
deficiencies, corrective actions, etc. for all auditing performed
throughout the audit review period.

Modified instructions to
reflect the inclusion of FWA
and compliance auditing
activities in the IA universe.
Removed references to daily
audit activities from the
universe.

Include: Compliance and fraud, waste and abuse (FWA) audit
activities (formal review of compliance with a particular set of
standards as base measures) performed by the sponsor to ensure that
its internal business and/or operational areas are in compliance with
Medicare Parts C and D program requirements and to ensure that
corrective actions are undertaken timely and effectively. Audit
activities performed during the audit review period to identify and
address potential or suspected non-compliance and FWA at the
sponsor level in the delivery of Medicare Part C and/or D benefits.
Audit activities that reviewed reports from internal operational areas
to detect non-compliance and FWA trends and abnormalities. Audit
activities to investigate allegations of non-compliance and fraudulent
,wasteful, abusive or questionable behavior performed by employees
and board members involved in administering or overseeing the
sponsor’s Medicare Part C and/or D operations (e.g. employee
misconduct, internal operations, fraudulent provider or pharmacy
claims, fraudulent FTE invoices, misuse of Medicare beneficiary
information, overpayments, complaints or tips received through
hotlines, referrals, members, MEDIC, law enforcement, etc.) Audit
activities initiated, started, re-opened or completed during the audit
review period. This includes audit activities that started prior to the
audit review period, but were completed within the audit period and
activities that were started during the audit review period but not yet
completed. Audit activities that are performed on a scheduled basis
(e.g., monthly, quarterly, annually, ad-hoc), should be included in the
universe each time it was performed.

Exclude: Audit activities for non-Medicare lines of business
(e.g., commercial, Medicaid) and audit activities performed
for first-tier entities during the audit review period.

Added language clarifying
that daily audit activities to
the excluded from the
universe.

Exclude: Audit activities for non-Medicare lines of business (e.g.,
commercial, Medicaid) and audit activities performed for first-tier
entities during the audit review period.
Audit activities that are performed on a daily basis.

Current Section in
CMS-10191
Attachment I CPE
Audit Process and Data
request

Original Language

Revised Language

Column D Field Name: Audit Frequency

Added a new field beginning at
Column D to indicate whether
the audit activity is compliance
or FWA related. All columns
shifted down one as a result.

Column D Field Name: Compliance or FWA?
Description: Enter whether the activity was a “compliance” or a
“FWA” activity.

Column D Field Name: Audit Frequency
Description: Provide the frequency of the audit activity (i.e.,
daily, weekly, monthly, quarterly, annually, or ad-hoc).

Column D in the previous
version is now Column E.
Removed “daily” from the field
description.

Column E Field Name: Audit Frequency
Description: Provide the frequency of the audit activity (i.e.,
weekly, monthly, quarterly, annually, or ad-hoc).

Column E Field Name: Audit Rationale

Column E in the previous
version is now Column F.

Column F Field Name: Audit Rationale

Column F Field Name: Audit Description

Column F in the previous
version is now Column G.

Column G Field Name: Audit Description

Column G Field Name: Audit Start Date
Description: Date that the specific audit activity was initiated,
started or reopened. For example, if the sponsor started an audit
of the appeals process/function within the sponsor on January 1,
2017, that is the date that would be used for the date the audit
started. For an audit activity conducted on a daily basis, only
include the most recent start date.

Column G in the previous
version is now Column H.
Removed all references to daily
activities.

Column H Field Name: Audit Start Date
Description: Date that the specific audit activity was initiated,
started or reopened. For example, if the sponsor started an audit
of the appeals process/function within the sponsor on January 1,
2017, that is the date that would be used for the date the audit
started.

Table 3 - Column D
Attachment I CPE
Audit Process and Data
request

Clarification or Change

Table 3 - Column E
Attachment I CPE
Audit Process and Data
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Table 3 - Column F
Attachment I CPE
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Table 3 - Column G
Attachment I CPE
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Table 3 - Column H

Page 15 of 112

Current Section in
CMS-10191
Attachment I CPE
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Table 3 - Column I

Attachment I CPE
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Table 3 - Column J
Attachment I CPE
Audit Process and Data
request
Table 3 - Column K
Attachment I CPE
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Table 3 - Column L
Attachment I CPE
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Table 3 - Column M

Page 16 of 112

Original Language

Column H Field Name: Audit Completion Date
Description: Date that the specific audit activity ended. For
example, if the sponsor ended an audit of the appeals
process/function within the sponsor on January 31, 2017, that is
the date that would be used for the date the audit ended.

Clarification or Change

Revised Language

Column H in the previous
version is now Column I.
Removed all references to daily
activities from the description.

Column I Field Name: Audit Completion Date
Description: Date that the specific audit activity ended. For
example, if the sponsor ended an audit of the appeals
process/function within the sponsor on January 31, 2017, that is
the date that would be used for the date the audit ended.

Column I in the previous
version is now Column J.

Column J Field Name: Identified Deficiencies

Column J Field Name: Number of Deficiencies
Description: Provide the number of deficiencies,
findings or issues identified. For an audit activity
conducted on a daily basis, include the total number of
deficiencies identified in all of the daily audit activities
during the audit review period.
Column K Field Name: Description of Deficiencies
Description: Provide a full description of all deficiencies,
findings or issues identified during the audit activity. If the audit
was identified in the pre-audit issue summary submitted to
CMS, please include the issue number.

Column J in the previous
version is now Column K.
Removed all references to daily
activities from the description.

Column K Field Name: Number of Deficiencies
Description: Provide the number of deficiencies, findings or
issues identified.

Column K in the previous
version is now Column L.
Modified language to instruct
sponsors to provide a summary
instead of full description.

Column L Field Name: Description of Deficiencies
Description: Provide a summary of all deficiencies, findings or
issues identified during the audit activity. If the audit was
identified in the pre-audit issue summary submitted to CMS,
please include the issue number.

Column L Field Name: Corrective Action Required

Column L in the previous
version is now Column M.

Column M Field Name: Corrective Action Required

For an audit activity conducted on a daily basis, only include the
completion date for the previously indicated most recent start
date.
Column I Field Name: Identified Deficiencies

Current Section in
CMS-10191
Attachment I CPE
Audit Process and Data
request
Table 3 - Column N

Attachment I CPE
Audit Process and Data
request
Table 3 - Column O

Original Language

Table 4 - Introductory Text

Page 17 of 112

Revised Language

Column M Field Name: Corrective Action Description
Description: Provide a description of the corrective action(s)
implemented by the sponsor in response to the noncompliance
or potential FWA, including any root cause analysis, timeframes
for specific achievements and any ramifications for failing to
implement the corrective action satisfactorily.

Column N in the previous
version is now Column N.
Modified language to instruct
sponsors to provide a summary
instead of full description.

Column N Field Name: Corrective Action Description
Description: Provide a summary of the corrective action(s)
implemented by the sponsor in response to the noncompliance or
potential FWA, including any root cause analysis, timeframes for
specific achievements and any ramifications for failing to
implement the corrective action satisfactorily.

Column N Field Name: Audit Results Shared?
Description: Describe how the results of the audit activity
were communicated or shared with sponsor’s affected
components, compliance department, senior management,
and/or the FTE.

Column N in the previous
protocol is now Column O.
Modified language to instruct
sponsors to provide a summary
instead of full description and
removed language identifying
multiple issues.

Column O Field Name: Audit Results Shared?
Description: Provide a summary that describes how the results of
the audit activity were communicated or shared with sponsor’s
affected components, compliance department, senior management,
and/or the FTE.

Modified instructions to reflect
the inclusion of FWA and
compliance auditing activities
in the IA universe. Removed
references to daily audit
activities from the universe.

Bullet 1: Include: Compliance and fraud, waste and abuse (FWA)
monitoring activities (routine, scheduled and ad-hoc reviews as
part of normal operations) performed by the sponsor to test and
confirm internal business and/or operational areas are in
compliance with Medicare Parts C and/or Part D program
requirements and to ensure that corrective actions are undertaken
timely and effectively. Monitoring activities performed during the
audit review period to identify and address potential or suspected
non-compliance and FWA at the sponsor level in the delivery of
Medicare Part C and/or D benefits.

For an audit activity that identified multiple issues, separate how
the results of each issue were communicated with internal and
external stakeholders by a number as needed (e.g., 1. the
compliance department sent the pharmacy services department a
formal report of the billing errors and member impact identified
during the pharmacy mail order monitoring and is responsible for
the ongoing tracking and trending of the pharmacy’s
performance with the mail order benefit, 2. the members
impacted by the pharmacy errors were communicated to the
Medicare Pharmacy Officer and Pharmacy Services staff for
immediate remediation).
Attachment I CPE
Audit Process and Data
request

Clarification or Change

Bullet 1: Include: all monitoring activities (routine, scheduled
and incident/event-based reviews as part of normal operations)
performed by the sponsor to test and confirm internal business
and/or operational areas are in compliance with Medicare
Parts C and/or Part D program requirements and to ensure that
corrective actions are undertaken timely and effectively. All
monitoring activities initiated, started, re-opened or completed
during the audit review period. This includes monitoring
activities that started prior to the audit review period, but were
completed within the audit review period and activities that
were started during the audit review period but not yet
completed.

Current Section in
CMS-10191

Original Language

Clarification or Change

For monitoring activities that are performed on a scheduled
basis (e.g., daily, monthly, quarterly, annually), it should be
included in the universe each time it was performed. If a
monitoring activity is conducted daily, only include it once in
the universe, but identify all deficiencies, corrective actions, etc.
for all monitoring performed throughout the year.

Attachment I CPE
Audit Process and Data
request

Revised Language

Monitoring activities that reviewed reports from internal
operational areas to detect non-compliance and FWA trends and
abnormalities. Monitoring activities to investigate allegations of
non-compliance and fraudulent, wasteful, abusive or questionable
behavior performed by employees and board members involved in
administering or overseeing the sponsor’s Medicare Part C and/or
D operations (e.g. employee misconduct, internal operations,
fraudulent provider or pharmacy claims, fraudulent FTE invoices,
misuse of Medicare beneficiary information, overpayments,
complaints or tips received through hotlines, referrals, members,
MEDIC, law enforcement, etc.) All monitoring activities initiated,
started, re-opened or completed during the audit review period.
This includes monitoring activities that started prior to the audit
review period, but were completed within the audit review period
and activities that were started during the audit review period but
not yet completed. For monitoring activities that are performed on
a scheduled basis (e.g., weekly monthly, quarterly, annually, adhoc), it should be included in the universe each time it was
performed.
Bullet 2: Exclude: Monitoring activities for non-Medicare lines of
business (e.g., commercial, Medicaid).and monitoring activities
performed for first-tier entities during the audit review period.
Monitoring activities that are performed on a daily basis.

Bullet 2: Exclude: Monitoring activities for nonMedicare lines of business (e.g., commercial,
Medicaid).and monitoring activities performed for firsttier entities during the audit review period.

Added language clarifying that
daily audit activities to the
excluded from the universe.

Column D Field Name: Monitoring Frequency

Added a field to indicate
whether the audit activity is
compliance or FWA related.
Shifted all columns down
beginning with Column D.

Column D Field Name: Compliance or FWA?
Description: Enter whether the activity was a “compliance” or a
“FWA

Column D Field Name: Monitoring Frequency
Description: Provide the frequency of the monitoring activity
(i.e., daily, weekly, monthly, quarterly, annually, or ad-hoc).

Column D in the previous
version is now Column E.
Removed “daily” from the field
description.

Column E Field Name: Monitoring Frequency
Description: Provide the frequency of the monitoring activity
(e.g. weekly, monthly, quarterly, annually, or ad-hoc).

Table 4 - Introductory Text
Attachment I CPE
Audit Process and Data
request
Table 4 - Column D
Attachment I CPE
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Table 4 - Column E

Page 18 of 112

Current Section in
CMS-10191
Attachment I CPE
Audit Process and Data
request
Table 4 - Column F
Attachment I CPE
Audit Process and Data
request
Table 4 - Column G
Attachment I CPE
Audit Process and Data
request
Table 4 - Column H

Attachment I CPE
Audit Process and Data
request
Table 4 - Column I

Original Language

Clarification or Change

Revised Language

Column E Field Name: Monitoring Rationale

Column E in the previous
version is now Column F.

Column F Field Name: Monitoring Rationale

Column F Field Name: Monitoring Description

Column F in the previous
version is now Column G.

Column G Field Name: Monitoring Description

Column G Field Name: Monitoring Start Date
Description: Date that the specific monitoring activity was
initiated, started or reopened. For example, if the sponsor
started monitoring of the appeals process/function within the
sponsor on January 1, 2017, that is the date that would be used
for the date the monitoring started. For a monitoring activity
conducted on a daily basis, only include the most recent start
date.
Column H Field Name: Monitoring Completion Date
Description: Date that the specific monitoring activity ended.
For example, if the sponsor ended monitoring of the appeals
process/function within the sponsor on January 31, 2017, that is
the date that would be used for the date the monitoring ended.

Column G in the previous
version is now Column H.
Removed daily activities from
the field description.

Column H Field Name: Monitoring Start Date
Description: Date that the specific monitoring activity was
initiated, started or reopened. For example, if the sponsor started
monitoring of the appeals process/function within the sponsor on
January 1, 2017, that is the date that would be used for the date the
monitoring started.

Removed daily activities from
the field description.

Column I Field Name: Monitoring Completion Date
Description: Date that the specific monitoring activity ended. For
example, if the sponsor ended monitoring of the appeals
process/function within the sponsor on January 31, 2017, that is
the date that would be used for the date the monitoring ended.

Column I in the previous
version is now Column J.

Column J Field Name: Identified Deficiencies

For a monitoring activity conducted on a daily basis, only
include the completion date for the previously indicated most
recent start date.
Attachment I CPE
Audit Process and Data
request
Table 4 - Column J

Page 19 of 112

Column I Field Name: Identified Deficiencies

Current Section in
CMS-10191
Attachment I CPE
Audit Process and Data
request
Table 4 - Column K

Attachment I CPE
Audit Process and Data
request
Table 4 - Column L
Attachment I CPE
Audit Process and Data
request
Table 4 - Column M
Attachment I CPE
Audit Process and Data
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Table 4 - Column N

Attachment I CPE
Audit Process and Data
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Table 4 - Column ID O

Page 20 of 112

Original Language

Clarification or Change

Revised Language

Column J Field Name: Number of Deficiencies
Description: Provide the number of deficiencies, findings
or issues identified. For a monitoring activity conducted on
a daily basis, include the total number of deficiencies
identified in all of the daily monitoring activities during the
audit review period.

Column J in the previous
protocol is now Column K.
Removed daily activities from
the field description.

Column K Field Name: Number of Deficiencies
Description: Provide a summary of all deficiencies, findings or
issues identified during the monitoring activity. If the monitoring
activity is identified in the pre-audit issue summary submitted to
CMS, please include the issue number.

Column K Field Name: Description of Deficiencies

Column K in the previous
version is now Column L.

Column L Field Name: Description of Deficiencies

Column L Field Name: Corrective Action Required

Column L in the previous
version is now Column M.

Column M Field Name: Corrective Action Required

Column M Field Name: Corrective Action Description
Description: Provide a summary of the corrective action(s)
implemented by the sponsor in response to the noncompliance or
potential FWA, including any root cause analysis, timeframes for
specific achievements and any ramifications for failing to
implement the corrective action satisfactorily.

Column M in the previous
version is now Column N.
Modified description language
to instruct sponsors to provide
a summary instead of full
description.

Column N Field Name: Corrective Action Description
Description: Provide a summary of the corrective action(s)
implemented by the sponsor in response to the noncompliance or
potential FWA, including any root cause, timeframes for specific
achievements and any ramifications for failing to implement the
corrective action satisfactorily.

Column ID N Field Name: Monitoring Results Shared?
Description: Describe how the results of the monitoring
activity were communicated or shared with sponsor’s affected
components, compliance department, senior management,
and/or the FTE. For a monitoring activity that identified multiple
issues, separate how the results of each issue were
communicated with internal and external stakeholders by a
number as needed (e.g., 1. the compliance department sent the
pharmacy services department a formal report of the billing
errors and member impact identified during the pharmacy mail
order monitoring and is responsible for the ongoing tracking and
trending of the pharmacy’s performance with the mail order
benefit, 2. the members impacted by the pharmacy errors were
communicated to the Medicare Pharmacy Officer and Pharmacy
Services staff for immediate remediation).

Column ID N in the previous
version is now Column ID O.
Modified description language
to instruct sponsors to provide
a summary instead of full
description and removed
language identifying multiple
issues.

Column ID O Field Name: Monitoring Results Shared?
Description: Provide a summary that describes how the results of
the monitoring activity were communicated or shared with
sponsor’s affected components, compliance department, senior
management and/or the FTE.

Current Section in
CMS-10191
Attachment I-A
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SAQ
Instructions

Page 21 of 112

Original Language

Clarification or Change

Revised Language

Note: Sponsoring Organizations should not interpret every
question as a mandatory CMS requirement, but rather as a guide in
evaluating the effectiveness of their Compliance Program. While
Element V of the Medicare Part C and D Compliance Program
Guidelines – Well Publicized Disciplinary Standards –is a
required and critical component of a compliance program, it has
been omitted from this version of the SA-Q. This version of the
SA-Q is a tool to be used with the 2017 Compliance Program
Effectiveness Audit Protocol. However, sponsoring organizations
must ensure structures and procedures are in place to successfully
implement all required elements of a compliance program.
This document will help your organization evaluate the
effectiveness of your Medicare Compliance Program.

Modified language to clarify
the instructions for completing
the SAQ.

This version of the SA-Q tool is to be used with the 2017
Compliance Program Effectiveness Audit Protocol. Sponsoring
Organizations should not interpret every question as a mandatory
CMS requirement, but rather as a guide to establish and maintain
the core requirements of a compliance program to prevent, detect
and correct Medicare program non-compliance and fraud, waste
and abuse. This questionnaire is identical to the Medicare Part C
and D Compliance Program Guidelines and can be used as a
monitoring tool to assist sponsors with evaluating their
compliance program for CMS requirements. While Element V of
the Medicare Part C and D Compliance Program Guidelines –
Well Publicized Disciplinary Standards –is a required and critical
component of a compliance program, it has been omitted from this
version of the SA-Q. However, sponsoring organizations must
ensure structures and procedures are in place to successfully
implement all required elements of a compliance program Please
note the use of this tool by itself does not constitute a formal audit
of the compliance program. For example, the formal audit of the
compliance program effectiveness should be meet the definition of
“audit” noted in the Compliance Program Guidelines and
performed by staff not affiliated in any way with the Compliance
department. Directions for completing the self-assessment
questionnaire: Please respond to each question according to the
status of your compliance program during the audit review
period. If the answer is “YES” to any question below, check the
“YES” box and provide a BRIEF description of what documents
support that response in the “Documentation” column. The
documentation description should also provide a cross reference
(when applicable) to where this documentation can be located.
For example, if your response is “YES” to the third question
below

Current Section in
CMS-10191

Original Language

Clarification or Change

Attachment I-A
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SAQ

(“Do your written Ps & Ps and/or Standards of
Conduct articulate the organization’s commitment to
comply with all applicable Federal and State standards
including but not limited to statutes, regulations and
sub regulatory guidance”), please indicate the
section/page of the Standards of Conduct or policies
and procedures where these compliance provisions are
found. If the answer is “NO” to a question, check the
“NO” box and document the rationale for the response
in the “Documentation” column. For the limited
situations when a question does not apply to your
organization, enter “N/A” in the “YES/NO” box and
document the rationale for the response in the
“Documentation” column. If multiple individuals are
responsible for the compliance program (e.g. Corporate
Compliance Officer, Medicare Compliance Officer,
SVP of Audit and Compliance) and have different
responses to the questions, please consolidate
responses and incorporate into one document.
Please specifically note the following when completing
the questionnaire:

Instructions (cont’d)

Attachment I-A
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SAQ
Attachment I-A
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SAQ

Page 22 of 112

Revised Language

Question #7
Does your compliance officer have express authority (oral or
written, preferably written) to make in-person reports to your CEO
and Board of Directors in the compliance officer’s sole discretion?

Changed “board of directors: to
“governing body”.

Question #7
Does your compliance officer have express authority (oral or
written, preferably written) to make in-person reports to your CEO
and governing body in the compliance officer’s sole discretion?

Question #10
Does your Board of Directors periodically receive compliance
reports on Medicare program noncompliance and Medicare fraud,
waste and abuse (“FWA”) which include issues identified,
investigated, and resolved?

Changed “board of directors”
to “governing body”.

Does your governing body periodically receive compliance reports
on Medicare program noncompliance and Medicare fraud, waste
and abuse (“FWA”) which include issues identified, investigated,
and resolved?

Current Section in
CMS-10191

Original Language

Clarification or Change

Revised Language

Attachment I-A
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SAQ

Question #11
If your compliance officer does not report in-person to your Board
of Directors, are his/her reports routed through the compliance
infrastructure?

Changed “board of directors”
to “governing body”.

Question #11
If your compliance officer does not report in person to your
governing body, as his/her reports routed through the compliance
infrastructure?

Attachment I-A
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SAQ

Question #15
Does your compliance officer and
compliance committee provide the Board of Directors with
regularly scheduled updates on the status and activities of the
compliance program, including compliance program outcomes,
the results of internal and external audits and about all government
compliance enforcement activity?
Question #16
Do you establish, implement and provide effective training and
education, addressing compliance and FWA for your employees,
including temporary employees, volunteers and Board of
Directors?

Changed “board of directors”
to “governing body”.

Question #15
Does your compliance officer and compliance committee provide
the governing body with regularly scheduled updates on the status
and activities of the compliance program, including compliance
program outcomes, the results of internal and external audits and
about all government compliance enforcement activity?

Changed “board of directors”
to “governing body”.

Question #16
Do you establish, implement and provide effective training and
education, addressing compliance and FWA for your employees,
including temporary employees, volunteers and governing body?

Question #22
Do you have an effective method(s) to communicate information
from your compliance officer to others, within a reasonable time
frame, including changes in laws, regulations and sub- regulatory
guidance as well as changes to your Standards of Conduct and Ps
& Ps?
Question #23
Do your Standards of Conduct and/or
Ps & Ps require your employees and members of the Board of
Directors to report compliance concerns and potential FWA?

Added “HPMS memos” to the
question.

Question #22
Do you have an effective method(s) to communicate information
from your compliance officer to others, within a reasonable time
frame, including changes in laws, regulations and sub- regulatory
guidance, HPMS memos, as well as changes to your Standards of
Conduct and Ps & Ps?
Question #23
Do your Standards of Conduct and/or
Ps & Ps require your employees and members of the governing
body to report compliance concerns and potential FWA?

Question #24
Do you have a system to receive, record, respond to and track
compliance questions or concerns and reports of potential FWA
from your employees, members of your Board of Directors, FDRs
and their employees and enrollees?

Changed “board of directors”
to “governing body”.

Attachment I-A
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SAQ
Attachment I-A
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SAQ
Attachment I-A
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SAQ
Attachment I-A
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SAQ

Page 23 of 112

Changed “board of directors”
to “governing body”.

Question #24
Do you have a system to receive, record, respond to and track
compliance questions or concerns and reports of potential FWA
from your employees, members of your governing body, FDRs
and their employees and enrollees?

Current Section in
CMS-10191

Original Language

Clarification or Change

Revised Language

Attachment I-A
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SAQ

Question #28
Are your reporting mechanisms user- friendly, easy to access and
navigate and available 24 hours a day for employees, members of
your Board of Directors and FDRs?

Changed “board of directors”
to “governing body”.

Question #28
Are your reporting mechanisms user-friendly, easy to access and
navigate and available 24 hours a day for employees, members of
your governing body and FDRs?

Attachment I-A
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SAQ

Question #35
Does your compliance officer or his/her designees provide updates
on the results of monitoring and auditing activities to your
compliance committee, CEO, senior leadership and Board of
Directors?

Changed “board of directors”
to “governing body”.

Attachment I-A
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SAQ

Question #44
Do you audit the effectiveness of your compliance program at
least annually (once a year)? NOTE: The CMS program audit of a
sponsor’s compliance program effectiveness does NOT satisfy this
audit requirement. Sponsor must conduct its own audit of the
effectiveness of

Modified language to clarify
the requirement for an annual
compliance program
effectiveness requirement.

Attachment I-A
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SAQ

Question #47
Do you review the OIG and GSA exclusion lists for your
employees (including temporary employees), volunteers,
consultants and the members of your board of directors prior to
hiring/contracting/appointment and monthly thereafter?

Changed “board of directors”
to “governing body”.

Question #44
Do you conduct a formal audit to evaluate the effectiveness of
your compliance program at least annually (once a year)?
NOTE: The formal audit should produce an audit report with
results and identified root cause(s) and a corrective action plan
should be a part of the evaluation. The CMS program audit of a
sponsor’s compliance program effectiveness does NOT satisfy this
audit requirement. Sponsor must conduct its own audit of the
effectiveness of its compliance program at least annually.
Question #47
Do you review the OIG and GSA exclusion lists for your
employees (including temporary employees), volunteers,
consultants and the members of your governing body prior to
hiring/contracting/appointment and monthly thereafter?

Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q

This questionnaire will assist CMS with understanding how the
Medicare Compliance Officer is vested in the day-to-day
operations of the Medicare compliance program and the processes
for working with key business operations and reporting to senior
management and oversight bodies on the activities and status of
the Medicare program. We recognize that your time is valuable
and appreciate your availability to provide responses to our
questions regarding the compliance program.

Added clarifying language to
reflect the purpose of the
questionnaire and how to
record responses for multiple
individuals.

Page 24 of 112

This questionnaire will assist CMS with understanding the
sponsoring organization’s mechanisms for overseeing the performance
and effectiveness of the compliance program from the compliance
officer’s perspective. The responses to these questions may be
discussed during the onsite portion of the CPE audit.
We recognize that your time is valuable and appreciate your
availability to provide responses to our questions regarding the
compliance program. If multiple individuals are responsible for
the operations and oversight of the compliance program (e.g.
Corporate Compliance Officer, Medicare Compliance Officer,
SVP of Audit and Compliance) and have different responses to the
questions, please consolidate responses and incorporate into one
document.

Current Section in
CMS-10191
Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q
Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q
Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q
Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q
Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q
Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q

Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q

Page 25 of 112

Original Language

Clarification or Change

Revised Language

Question #1
How long have you been employed at [MA/PD] Sponsor?

Modified the question.

Question #1
How long have you been employed with the sponsor and served as
the Compliance Officer of the Medicare line of business?

Question #3
Please describe your background and how it relates to your role as
Compliance Officer.

Modified the question.

Question #2
Briefly describe your background and how it relates to your role as
an effective Compliance Officer for the sponsor.

Question #4
Who do you report to?

This question was removed
from the document.

None

Question #6
Please describe your responsibility for the regulatory compliance
of the Medicare program.

This question was removed
from the document.

None

Added this question to the
questionnaire.

Question #3
Provide a general view of your responsibilities as the
Compliance Officer.

Question #7
Briefly describe the design and infrastructure of the compliance
program, including whether the program has centralized or
decentralized organizational structures. Centralized organizational
structures rely on the individual to make decisions and provide
direction for the company. Decentralized organizational structures
often have several individuals making decisions and rely on a
team environment at different levels in the business.
Question #8
If centralized, please answer 8a & 8b: Is the compliance staff
dedicated to your C/D lines of business or do they also have
responsibilities relative to the marketplace, Medicaid and/or
commercial products? Is the compliance staff assigned to specific
operational departments? If so, based on what criteria?

This question was removed
from the document

None

This question was removed
from the document.

None

Current Section in
CMS-10191
Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q

Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q
Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q
Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q
Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q
Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q

Page 26 of 112

Original Language

Clarification or Change

Revised Language

Question #9
If decentralized, please answer 9a – 9d: a. How many compliance
staff sit within operations? What area?
b. Does your compliance staff have responsibilities other than
compliance? c. How often does your compliance staff report
issues and provide updates to you? What sorts of information
about the operation of the compliance program do you regularly
receive from your compliance staff?
Question #10
What tools and processes do you have in place that keep you upto-date on tasks and assignments that have been delegated to both
operational and compliance staff?

This question was removed
from the document.

None

Modified the question.

Question #5
What are some of the tools used to keep the compliance
department up-to-date on tasks and assignments that have been
delegated to both operational and FDRs?

Question #11
Do you have sufficient support and resources to successfully
perform your responsibilities as compliance officer over the
Medicare Parts C and/or D program? Please explain.

This question was removed
from the document.

None

Question #12
Do you face any challenges as a compliance officer of the
Medicare Parts C and/or D program? Are there any barriers that
you face in overcoming these challenges?

This question was removed
from the document.

None

Question #13
What resources do you use on a regular basis to keep yourself
current on CMS compliance, audit, and enforcement information?

Modified the document.

Question #6
What resources do you use on a regular basis to keep the
organization current on CMS compliance, audit, and enforcement
information and activities?

Question #14
Tell us about the structure and operation of the compliance
committee.

This question was removed
from the document.

None

Page 27 of 112

Original Language

Clarification or Change

Revised Language

Question #15
Do you have specific criteria for determining what issues are and
which are not reported to the compliance committee?

This question was removed
from the document.

None

Question #16
What are your expectations, as the Compliance Officer, about
what the Compliance Committee should do once issues are
reported to it?

This question was removed
from the document.

None

Question #17
Who reports compliance issue to the governing body?

This question was removed
from the document.

None

Question #18
Are all compliance issues reported to the governing body?

This question was removed
from the document.

None

Question #19
If all compliance issues are not reported to the governing body,
please explain how you determine which issues are and which are
not reported to them.

This question was removed
from the document.

None

Question #20
Who reports compliance issues to the governing body?

This question was removed
from the document.

None

Question #21
In what format are issues reported?

This question was removed
from the document.

None

Current Section in
CMS-10191
Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q

Original Language

Revised Language

This question was removed
from the document.

None

This question was removed
from the document.

None

Question #24
How often do you provide general compliance training and FWA
training to your employees and governing body members?

This question was removed
from the document.

None

Added a new question to the
document.

Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q

None

Added a new question to the
questionnaire.

Question #7
Provide an example of a compliance issue you had to deal with
during the audit review period that involved a Medicare
operational area and/or a first-tier, downstream or related entity
(FDR) and impacted a significant number of your enrollees from
receiving their health or drug benefits time in accordance with
CMS requirements. Describe what happened and how you handled
Question #8
Provide an example of a time when communicating compliance
issues to the compliance committee, senior management or
governing body regarding was challenging. Briefly discuss how
you handled it.

Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q

None

Added a new question to the
document.

Page 28 of 112

Question #22
Is the governing body subsequently made aware of corrective
actions and the results of actions?

Clarification or Change

Question #23
How do you ensure any new employees (including temporary
workers and volunteers) and governing body members
receive general compliance training and fraud, waste and
abuse (FWA) training upon hire or appointment?

Question #9
Describe a recent experience you had with a miscommunication
with an employee(s) when dealing with suspected, detected or
reported incidents of noncompliance or fraud, waste and abuse
(FWA)? How did you or the compliance department solve the
problem

Current Section in
CMS-10191

Original Language

Clarification or Change

Revised Language

Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q

None

Added a new question to the
document.

Question #10
During the audit review period, have you ever had to make
a decision when no or limited internal or CMS policy was
available to provide guidance on how to handle the issue?
Describe what happened and how you handled it.

Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q
Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q

None

Added a new question to the
document.

Question #11
What has been your experience in dealing with poor compliance
performance of Medicare operations within your organization?
Provide an example

None

Added a new question to the
document.

Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q

None

Added a new question to the
document.

Question #12
In your position as Compliance Officer, what types of
decisions do you make at your level without consulting with
senior management ultimately responsible for the Medicare
Advantage and/or Part D contract with CMS? What are
some of indicators that tell you to escalate the decision or
issue to senior management?
Question #13
CMS understands that every compliance issue is not
presented to senior management or the governing body.
Explain the criteria used by the compliance department for
escalating issues to the CEO and senior management that
present high-impact risks to the organization. Include
how/when the parties are advised of operational and
regulatory compliance activities (e.g. critical discussions
with the CMS Account Manager, Notices of NonCompliance, Civil Money Penalties, Marketing/Enrollment
Sanctions, etc.).

Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q

Question #27
Describe your role in implementing any recommendations made
as a result of performance reviews?

This question was removed
from the document.

Page 29 of 112

None

Page 30 of 112

Original Language

Clarification or Change

Revised Language

Question #28
What processes are in place to communicate operational area
concerns to the compliance department?

Changed “processes” to
“mechanisms”.

Question #16
What mechanisms are in place to communicate operational area
concerns/issues to the compliance department?

Question #29
Can you provide us with specific examples when the compliance
department initiated a review of procedures within an operational
area based on a concern identified by the operational area?

This question was removed
from the document.

None

Question #30
How are you able to ensure that operational areas are fully
reporting compliance issues to you and your staff?

This question was removed
from the document.

None

Question #31
Do you have any concerns about your oversight over operations
given the existing process of identifying risks?

This question was removed
from the document.

None

Question #32
Describe the risk assessment process. How are risks associated
with the Medicare line of business compiled and ranked?

This question was removed
from the document.

None

Question #33
How often are risks evaluated and/or updated?

This question was removed
from the document.

None

Question #34
Is this process the same for operational areas and FDRs? If FDRs
are assessed separately, please describe that process.

This question was removed
from the document.

None

Current Section in
CMS-10191

Original Language

Clarification or Change

Revised Language

None

Added a new question to the
document.

Question #17
What have been major obstacles with executing an effective
compliance program which you have had to overcome in your role
as the Compliance Officer? How did you deal with them

Question #36
Who has responsibility for ensuring your employees (including
temporary workers and volunteers) and governing body members
are checked monthly against the OIG/GSA exclusion lists?

This question was removed
from the document.

None

Question #37
Who has responsibility for ensuring your FDRs (and their
employees) were checked monthly against the OIG/GSA
exclusion lists?

This question was removed
from the document.

None

Question #38
How long after you receive reports of potential non-compliance do
you initiate an investigation into the incident?

This question was removed
from the document.

None

Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q

Question #39
How long after you receive reports of potential FWA do you
initiate an investigation into the incident? If FWA cases are
handled through the Special Investigations Unit (SIU), please
explain how the compliance department is updated on forwarded
cases.

This question was removed
from the document.

None

Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q
Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q

Question #40
How do you document the results of your investigations?

This question was removed
from the document.

None

Question #41
What are your organization’s biggest Medicare compliance and/or
performance challenges at present?

This question was removed
from the document.

None

Page 31 of 112

Current Section in
CMS-10191

Original Language

Clarification or Change

Revised Language

Question #42
What is being done to address these challenges?

This question was removed
from the document.

None

Question #43
With respect to the compliance program, what keeps you up at
night?

This question was removed
from the document.

None

Added a new question to the
document.

Question #19
What suggestions or changes would you make to encourage
transparency and strengthen the communication between
your organization and CMS (e.g. Central Office, Regional
Office, and Account Manager) as it relates to compliance
issues?

Attachment I-B
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness CO-Q
Attachment I-C
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness
Organizational Structure
and Governance PPT
Template

Question #45
Were you surprised by this CMS audit and what do you expect to
see regarding the final results of this audit?

This question was removed
from the document.

None

Added a new section to the
template for sponsor’s to
provide an overview of the
organization’s standardized
processes, tools and controls
used to conduct the day-to-day
oversight of compliance and
FWA issues that may impact
Medicare business operations.
This information is critical for
the tracer evaluation portion of
the CPE audit.

Compliance Program Infrastructure and Process Overview

Page 32 of 112

Current Section in
CMS-10191

Original Language

Clarification or Change

Revised Language

Attachment I-D
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness FDR
Oversight Questionnaire
FDR-Q

This questionnaire will assist CMS with understanding how the
individual who is responsible for the oversight of FDRs is vested
in the day-to-day operations of the Medicare compliance program
and the processes for working with key business operations and
reporting to senior management and oversight bodies on the
activities and status of the Medicare program.
We recognize that your time is valuable and appreciate your
availability to provide responses to our questions regarding the
compliance program.

Added clarifying language to
reflect the purpose of the
questionnaire and how to
record responses for multiple
individuals.

Attachment I-D
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness FDR
Oversight Questionnaire
FDR-Q
Attachment I-D
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness FDR
Oversight Questionnaire
FDR-Q
Attachment I-D
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness FDR
Oversight Questionnaire
FDR-Q

Question #1
How long have you been employed at [Insert name of MA/PD
Sponsor]?

Modified the question.

Question #3
How long have you been in your current position? Who do you
report to?

This question was removed
from the document.

None

Question #4
Describe your day-to-day responsibilities as the
[Manager/Director] of [MA/PD]’s Vendor Oversight Program?

This question was removed
from the document.

None

Page 33 of 112

This questionnaire will assist CMS with understanding the
sponsoring organization’s accountabilities and oversight of its
delegated entities to ensure their compliance with Medicare program
requirements. The responses to these questions may be discussed
during the onsite portion of the CPE audit. We recognize that your
time is valuable and appreciate your availability to provide
responses to our questions regarding the compliance program. If
multiple individuals are responsible for the operations and
oversight of first-tier, downstream and related entities (e.g.
Corporate Compliance Officer, Delegated Entity Compliance
Officer, Vendor Management Group, etc.) and have different
responses to the questions, please consolidate responses and
incorporate into one document.
Question #1
How long have you been employed with the sponsor and been in
involved with overseeing FDRs?

Current Section in
CMS-10191
Attachment I-D
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness FDR
Oversight Questionnaire
FDR-Q
Attachment I-D
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness FDR
Oversight Questionnaire
FDR-Q
Attachment I-D
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness FDR
Oversight Questionnaire
FDR-Q
Attachment I-D
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness FDR
Oversight Questionnaire
FDR-Q
Attachment I-D
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness FDR
Oversight Questionnaire
FDR-Q

Page 34 of 112

Original Language

Clarification or Change

Revised Language

None

Added a new question to the
document.

Question #3
Are delegated entities managed by one individual or a group of
individuals/departments?

None

Added a new question to the
document.

Question #4
Provide a general overview of the delegated entity oversight
program.

Question #5
Do you have policies and procedures that document your oversight
of FDRs?

This question was removed
from the document.

None

Question #8
Who or what operational area(s) is responsible for initiating the
contracts for Medicare Parts C/D administrative or health care
functions delegated to FDRs?

Modified the question.

Question #7
Who or which business operations are involved with the precontractual assessment to ensure contractual and regulatory
obligations are met.

Question #9
Who is responsible for ensuring FDRs comply with the terms of
their contract, including complying with Medicare program
requirements?

Modified the question.

Question #8
Once the contract has been initiated with the delegated entity, who
or which business operations are responsible for tracking and
monitoring the FDRs performance and day to day oversight for
compliance issues?

Page 35 of 112

Original Language

Clarification or Change

Revised Language

Question #10
Have you clearly defined administrative or health care services,
including the roles and responsibilities of each FDR?

This question was removed
from the document.

None

Question #11
Please describe the process for distrusting compliance policies and
procedures and the Code of Conduct to FDRs.

This question was removed
from the document.

None

Question #12
Please describe your interactions and routine communications with
the Compliance Officer and Compliance Department.

This question was removed
from the document.

None

Added a new question to the
document.

Question #9
Describe the mechanisms used for oversight activities (e.g.
structure, risk assessment, specialized teams focused on specific
functions, etc.)

Question #13
What types of communications exist between the two of you
regarding Medicare requirements, policy updates, performance
concerns or issues with FDRs, specifically the first-tier entities
such as your PBM, enrollment/membership functions, coverage or
claims adjudication, network management, etc.?

Modified the question.

Question #10
Describe specific examples of the types of communications that
exist between the Compliance Department and FDR Oversight
regarding Medicare requirements, policy updates, performance
concerns or issues with FDRs, specifically the first-tier entities
such as your PBM, enrollment/membership functions, coverage or
claims adjudication, network management, etc.?

Current Section in
CMS-10191

Original Language

Clarification or Change

Revised Language

Attachment I-D
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness FDR
Oversight Questionnaire
FDR-Q

Question #17
How do you ensure FDRs are trained appropriately on CMS’s
rules, regulations and policy for the administrative or health care
service performed on the plan sponsor’s behalf?

Modified the question.

Question #13
How do you share information or train FDRs on your
organization’s culture, compliance and productivity expectations,
CMS regulations, and policy for the Medicare function performed
on the sponsoring organization’s behalf?

Question #18
How do you ensure your FDRs (and the appropriate FDR
employees) are completing annual general compliance training
and fraud, waste and abuse training as required by CMS? Do you
advise FDRs which roles or functions within their organization are
subject to the compliance training requirements?

Modified the question.

Question #14
Describe the training, education and communication program for
FDRs (e.g. roles and responsibilities, compliance and FWA
training, job-specific, exchange of information, compliance
disclosures and failures, etc.).

Question #19
How do you communicate clear roles, responsibilities, and
expectations to your FDRs in terms of performance and
compliance with CMS requirements?

This question was removed
from the document.

None

Question #20
Describe how your organization governs the exchange of
information with FDRs, including performance monitoring,
compliance disclosures and failures, and corrective action
requirements?

This question was removed
from the document.

None

Question #21
What formal processes do you have to support the sharing of
information, including a centralized repository of information for
process flows, assumptions, change requests, etc.?

This question was removed
from the document.

None

Page 36 of 112

Current Section in
CMS-10191

Original Language

Clarification or Change

Revised Language

Question #22
What methods do you have to receive periodic monitoring reports
from FDRs?

Modified the question.

Question #15
Provide examples of the types of periodic monitoring reports your
organization receives from FDRs.

Question #23
Does your strategy for monitoring and auditing your first tier
entities include:
a. Ensuring that they are in compliance with Medicare Parts C and
D requirements?
b. Ensuring that they are monitoring their downstream entities’
compliance?

Modified the question.

Question #16
Describe the strategy for monitoring and auditing your first tier
entities for compliance regulatory requirements, downstream
oversight, and implementation of corrective actions.

Question #24
Does your monitoring and auditing work plan include the number
of first tier entities that will be audited and how the entities will be
identified for auditing?

This question was removed
from the document.

None

Question #25
What procedures do you have to ensure that your FDR’s are not
excluded from participation in Federal health care programs? Does
your system include review of the OIG and GSA exclusion lists
prior to hiring or contracting and monthly thereafter for FDRs and
their employees either by you, your first entities, or the
downstream entities themselves?

This question was removed
from the document.

None

Attachment I-D
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness FDR
Oversight Questionnaire
FDR-Q

Question #26
How do you ensure that needed corrective actions are taken by
first tier entities?

Modified the question.

Question #17
What happens if a FDR fails to satisfactorily implement a
corrective action plan or commits a serious act of noncompliance
with Medicare requirement that affects enrollees from receiving
their health care or drug benefit appropriately or timely?

Page 37 of 112

Page 38 of 112

Original Language

Clarification or Change

Revised Language

Question #27
How do you ensure that noncompliance or FWA committed by
FDR’s is well-documented and includes ramifications should the
FDR fail to satisfactorily implement the corrective action plan?

This question was removed
from the document.

None

Question #28
Do you maintain thorough documentation of all deficiencies
identified and the corrective actions taken?

This question was removed
from the document.

None

Question #29
Do you continue to monitor FDR corrective actions after their
implementation to ensure that they are effective?

This question was removed
from the document.

None

Question #30
Please discuss the performance of some of your FDRs responsible
for critical, high-risk functions and any compliance/FWA
challenges or issues experienced in the past 12 months? (e.g.,
PBM, sales brokers, entities with direct member contact, provider
networks, etc.)

Modified the question.

Question #18
What are a few of the challenges or issues with effectively
overseeing FDRs your organization has experienced within the
audit review period (e.g., PBM, sales brokers, entities with direct
member contact, provider networks, etc.).

Question #31
What are the company’s top 5 opportunities for improvement with
overseeing FDRs performance and compliance with Medicare C/D
program requirements?

Modified the question.

Question #19
List a few of your accomplishments for FDR oversight during the
audit review period? What are your priorities for delegation for the
next two years?

Current Section in
CMS-10191

Original Language

Clarification or Change

Revised Language

Attachment I-D
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness FDR
Oversight Questionnaire
FDR-Q
Attachment I-E
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SIU/FWA
Prevention and Detection
Questionnaire FWA-Q

None

Added this question to the
document.

Question #21
Do you have any comments or questions for CMS?

This questionnaire will assist CMS with understanding how the
individual responsible for the SIU or FWA prevention and
detection staff is vested in the day-to-day operations of the
Medicare compliance program and the processes for working with
key business operations and reporting to senior management and
oversight bodies on the activities and status of the Medicare
program. We recognize that your time is valuable and appreciate
your availability to provide responses to our questions regarding
the compliance program.

Added clarifying language to
reflect the purpose of the
questionnaire and how to
record responses for multiple
individuals.

This questionnaire will assist CMS with understanding the
sponsoring organization’s program to prevent, detect and correct
suspected fraud, waste and abuse for their Medicare line of business.
The responses to these questions may be discussed during the
onsite portion of the CPE audit. We recognize that your time is
valuable and appreciate your availability to provide responses to
our questions regarding the compliance program. If multiple
individuals are responsible for the operations and oversight of
first-tier, downstream and related entities (e.g. Corporate
Compliance Officer, SIU Director, Ethics and Integrity Officer,
Investigators, etc.) and have different responses to the questions,
please consolidate responses and incorporate into one document.

Question #1
How long have you been employed at [Insert Name of MA/PD
Sponsor]?

Modified the question.

Question #1
How long have you been employed with the sponsor and been in
involved with FWA prevention and detection activities?

Question #2
Briefly describe your day-to-day responsibilities.

Removed this question from
the document.

None

Question #3
How are compliance expectations with respect to FWA operations
communicated to employees that work in the SIU or FWA
department?

Removed this question from
the document.

None

Page 39 of 112

Current Section in
CMS-10191
Attachment I-E
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SIU/FWA
Prevention and Detection
Questionnaire FWA-Q
Attachment I-E
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SIU/FWA
Prevention and Detection
Questionnaire FWA-Q
Attachment I-E
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SIU/FWA
Prevention and Detection
Questionnaire FWA-Q
Attachment I-E
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SIU/FWA
Prevention and Detection
Questionnaire FWA-Q
Attachment I-E
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SIU/FWA
Prevention and Detection
Questionnaire FWA-Q

Page 40 of 112

Original Language

Clarification or Change

Revised Language

None

Added this question to the
document.

Question #2
Have you held any positions in the company, prior to being the
person or a part of the team responsible for the SIU and/or FWA
prevention/detection activities?

None

Added this question to the
document.

Question #3
Is FWA managed by one individual or a team/department such as
the compliance department or special investigations unit (SIU)?

Question #4
Briefly describe the structure and operations of the SIU.

Modified the question.

Question #4
Provide a general overview of the unit/department responsible
for conducting surveillance and methods of investigation relating
to potential FWA (e.g. number of personnel, types of detection
and prevention activities, etc.)

Question #5
If this wasn’t already addressed in question #4, is there a separate
SIU or are the responsibilities generally conducted by a SIU
handled by the compliance department?

This question was removed from
the document.

None

Question #6
How large is the SIU?

This question was removed from
the document.

None

Page 41 of 112

Original Language

Clarification or Change

Revised Language

Question #7
How many people are dedicated to FWA identification, detection,
and investigation?

This question was removed from
the document.

None

Question #8
About what percentage of the workload is spent on Medicare?

This question was removed from
the document.

None

Question #9
Describe the communication and coordination between the SIU
and compliance department.

Modified the question.

Question #5
Describe the working relationship between the compliance
department and SIU as it relates to the compliance program.

Question #10
Is there a hotline available to anonymously report noncompliance
and/or FWA issues?

Modified the question.

Question #6
Describe a few of the mechanisms that exist for employees,
providers, members and FDRs to report compliance, ethics and
FWA concerns and how are they advertised internally and
externally. Please indicate if multiple hotline numbers are used to
report various categories of compliance and FWA inquiries.

Question #11
If there is a voicemail capacity on the hotline, how often do you
check for messages?

This question was removed from
the document.

None

Original Language

Clarification or Change

Revised Language

Question #12
Are there separate hotlines numbers for compliance or do you
each share one?

This question was removed from
the document.

None

Question #13
How do you ensure the hotline is anonymous (e.g. Does your
phone show Caller ID?)

This question was removed from
the document.

None

Question #14
If the hotline is handled by the SIU, please answer 13a – 13d: a.
How many referrals have there been within the past twelve
months? b. If there is a voicemail capacity on the hotline, how
often do you check for messages?
c. How is the hotline advertised?
d. Is it available externally and internally?

This question was removed from
the document.

None

Attachment I-E
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SIU/FWA
Prevention and Detection
Questionnaire FWA-Q

Question #15
If the hotline is outsourced, please answer 14a – 14c: a. To whom
is the incoming information referred to: SIU or compliance?
b. If compliance, how does the SIU become informed of potential
FWA issues?
c. How often is the information referred from the outsourced party
to the SIU or to Compliance?

This question was removed from
the document.

None

Attachment I-E
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SIU/FWA
Prevention and Detection
Questionnaire FWA-Q

Question #16
Besides a hotline, how else can employees or FDRs report to you?

This question was removed from
the document.

None

Page 42 of 112

Page 43 of 112

Original Language

Clarification or Change

Revised Language

Question #17
How are reporting mechanisms publicized?

This question was removed from
the document.

None

Added this question to the
document.

Question #7
How many reports did the hotline(s) receive during the audit
review period? If multiple hotline numbers to report various
categories of compliance and FWA inquiries, please separate
responses for each hotline number.

None

Added this question to the
document.

Question #8
From your perspective, does the number of calls received
demonstrate the effectiveness of your reporting mechanisms?

Question #18
Are investigations handled by the SIU?

This question was removed from
the document.

None

Question #19
Have you found it challenging to complete investigations due to
resource or time constraints?

This question was removed from
the document.

None

Page 44 of 112

Original Language

Clarification or Change

Revised Language

Question #20
Do you refer cases to the NBI MEDIC?

This question was removed from
the document.

None

Question #21
When do you make a determination to refer a case to the NBI
MEDIC?

This question was removed from
the document.

None

Question #22
Are potential fraud cases referred to the NBI MEDIC and/or law
enforcement?

This question was removed from
the document.

None

Question #23
How many potential fraud cases have been referred over the past
12 months?

This question was removed from
the document.

None

Question #24
How were these allegations discovered? (e.g., proactive data
mining, monitoring, reported internally or from beneficiaries?)

This question was removed from
the document.

None

Page 45 of 112

Original Language

Clarification or Change

Revised Language

Question #25
What is the status of the fraud cases referred to either the NBI
MEDIC or to law enforcement, but now have been returned back
to the SIU?

This question was removed from
the document.

None

Question #26
Does the SIU receive many requests from the NBI MEDIC or law
enforcement for additional information?

This question was removed from
the document.

None

Question #27
Who handles Part D specific investigations?

This question was removed from
the document.

None

Question #28
Do the SIU or FWA professionals attend any health care task force
meetings, at US Attorney’s offices, for example?

This question was removed from
the document.

None

Question #29
How often do you attend and when was the last meeting you
attended?

This question was removed from
the document.

None

Current Section in
CMS-10191

Original Language

Clarification or Change

Question #30
Do the SIU or FWA professionals attend the quarterly O&E
MEDIC Fraud, Waste and Abuse Training Meetings, or webinars?

This question was removed from
the document.

None

Question #31
Does the SIU conduct any of the internal FWA training to
employees, members of the Board of Directors, or FDRs? a. If yes,
what method of training is used? If no, do you provide any of the
materials if the training is conducted by another component within
the company?

This question was removed from
the document.

None

Question #32
How do you track that employees complete the CMS Medicare
Parts C/D FWA training on annual basis?

This question was removed from
the document.

None

This question was added to the
document.

Question #9
Describe proactive measures to investigate suspicions of FWA
and inappropriate payments made by the sponsoring
organization.

None

This question was added to the
document.

Question #10
How does the organization engage participation from the NBI
MEDIC, law enforcement and other business partners on
suspected FWA cases or investigations?

Page 46 of 112

Revised Language

Page 47 of 112

Original Language

Clarification or Change

Revised Language

None

This question was added to the
document.

Question #11
How many suspected FWA cases were referred to the NBI
MEDIC or law enforcement agency within the audit review
period?

None

This question was added to the
document.

Question #12
Describe the triage process for cases referred to the SIU for fraud
investigation, including timeframes associated with the intake
and validation functions.

Question #33
How is data analysis conducted?

Modified the question

Question #13
Describe how data analytics or data analysis software are used to
monitor potential FWA activity and identify unusual patterns in
the delivery of Medicare Parts C and/or D benefits (e.g. queries
for pharmacy patterns, provider billing, drug utilization, etc.).

Question #34
Is the data analysis conducted by the SIU or another department?

This question was removed from
the document.

None

Question #35
Are you using The Predictive Learning Analytics Tracking
Outcome (PLATO)? • PLATO is a web-based application tool
made available by CMS to the plans in the summer of 2015 to
present fraud and abuse lead information visually to Medicare Part
D plan sponsors in detecting and prevent fraud, waste and abuse.

Modified the question.

Question #15
Does the organization use the web-based application tool, The
Predictive Learning Analytics Tracking Outcome (PLATO),
made available by CMS? Explain whether the use of PLATO has
been effective for your organization?

Page 48 of 112

Original Language

Clarification or Change

Revised Language

Question #36
Has the use of PLATO been effective? If yes or no, please explain.

This question was removed from
the document.

None

Question #37
Are routine queries run to determine FWA for your Medicare C
and/or D plans?

This question was removed from
the document.

None

Question #38
What types of queries are run?

This question was removed from
the document.

None

Question #39
Have these queries have been effective in preventing FWA? ( e.g.
pharmacy patterns, provider billing, drug utilization)

This question was removed from
the document.

None

Question #40
Are you familiar with the HEAT Task Force cities? Does your
organization operate or have Medicare members that reside in any
of these cities?
• “HEAT” is the joint HHS-DOJ Health Care Fraud Prevention
and Enforcement Action Team. Current HEAT cities are: Baton
Rouge - Louisiana, Brooklyn - New York, Chicago - Illinois,
Dallas - Texas, Detroit - Michigan, Houston - Texas, Los Angeles
- California, Miami – Florida, Tampa Bay – Florida.

Modified the question.

Question #16
Provide an overview that describes the organization’s monitoring
activities in the HEAT Medicare Strike Force cities. HEAT is
the joint HHS-DOJ Health Care Fraud Prevention and
Enforcement Action Team. The list of the nine cities can be
found at:
https://www.stopmedicarefraud.gov/aboutfraud/heattaskforce/

Current Section in
CMS-10191

Attachment I-E
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SIU/FWA
Prevention and Detection
Questionnaire FWA-Q
Attachment I-E
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SIU/FWA
Prevention and Detection
Questionnaire FWA-Q
Attachment I-E
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SIU/FWA
Prevention and Detection
Questionnaire FWA-Q
Attachment I-E
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SIU/FWA
Prevention and Detection
Questionnaire FWA-Q
Attachment I-E
Medicare Advantage and
Prescription Drug
Compliance Program
Effectiveness SIU/FWA
Prevention and Detection
Questionnaire FWA-Q

Page 49 of 112

Original Language

Clarification or Change

Revised Language

Question #41
Describe the focus of your organization’s monitoring for FWA
placed on the HEAT cities?

This question was removed from
the document.

None

Question #43
What analyses are performed of the reports?

This question was removed from
the document.

None

Question #44
How often are these reports provided and who analyzes the
reports?

This question was removed from
the document.

None

Question #45
What are the top 3 trends or issues discovered during the review of
the PBM reports?

This question was removed from
the document.

None

Question #46
How does the SIU keep current on potential FWA trends in
Medicare C and/or D program?

This question was removed from
the document.

None

Page 50 of 112

Original Language

Clarification or Change

Revised Language

Question #47
How is that information disseminated to the SIU staff, compliance
department, and senior leadership (e.g., CEO, reported to the
board)?

This question was removed from
the document.

None

Question #48
How are the fraud alerts issued through CMS’ Health Plan
Management System (HPMS) handled?

Modified the question

Question #17
How are the CMS fraud alerts issued through the Health Plan
Management System (HPMS) incorporated into FWA prevention
and detection monitoring and audit activities?

Question #49
When you receive notifications from CMS concerning FWA
studies, are you incorporating the findings into your monitoring
and auditing work plans?

This question was removed from
the document.

None

Question #50
If findings from CMS FWA studies are incorporated into
monitoring and auditing work plans, please answer 48a & 48b:
a. How is this done? b. How soon does the monitoring occur once
you are notified of the study?

This question was removed from
the document.

None

Added this question to the
document.

Question #18
Would you like to share any best practices that may assist others
with succeeding in preventing, identifying, and controlling FWA
practices?

Original Language

Clarification or Change

Revised Language

None

Added this question to the
document.

Question #19
Highlight a few accomplishments of the FWA operations/SIU
during the audit review period.

To evaluate performance in the three areas outlined below related
to Part D Formulary and Benefit Administration (FA).

Changed wording from “below”
to “in this protocol.”

To evaluate performance in the three areas outlined in this
protocol related to Part D Formulary and Benefit Administration
(FA).

Revised language to remove
year specific references.

•

Audit Purpose and General
Guidelines
Purpose
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Audit Purpose and General
Guidelines
Review Period
Transition
Rejected Claims – New
Contract Year

Page 51 of 112

•
•

Sponsors with ≥ 100,000 enrollees: All rejected claims with
dates of service for January 2017.
Sponsors with < 100,000 enrollees: All rejected claims with
dates of service for January and February 2017.

•

Sponsors with ≥ 100,000 enrollees: All rejected claims with
dates of service for January of the audit year.
Sponsors with < 100,000 enrollees: All rejected claims with
dates of service for January and February of the audit year.

Current Section in
CMS-10191
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request

Original Language

•

Clarification or Change

Revised Language

Beneficiaries with effective enrollment dates of November or
December 2016: All rejected claims with dates of service for
November and December 2016.

Revised language to remove
year specific references.

•

Beneficiaries with effective enrollment dates of November
or December of the contract year immediately prior to the
audit year: All rejected claims with dates of service for
November and December of the contract year immediately
prior to the audit year.

Beneficiaries in both of the Rejected Claims Transition
universes (new and previous contract year): All final action
PDEs accepted by CMS with dates of service September –
December 2016.

Changed language to clarify that •
the PDEs should be for what was
submitted in either of the
Rejected Claims Transition
Universes and revised language
to remove year specific
references.

Beneficiaries submitted in either of the Rejected Claims
Transition universes (new and previous contract year): All
final action PDEs accepted by CMS with dates of service
September – December of the contract year immediately
prior to the audit year.

Audit Purpose and General
Guidelines
Review Period
Transition
Rejected Claims – Previous
Contract Year
Attachment II – Formulary •
and Benefit Administration
Audit Process and Data
Request
Audit Purpose and General
Guidelines
Review Period
Transition
Prescription Drug Event
(PDE) Data

Page 52 of 112

Current Section in
CMS-10191
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Audit Purpose and General
Guidelines
Review Period
Transition

Original Language

•

Sponsors with ≥ 100,000 enrollees:
o All CY 2016 beneficiaries with an effective enrollment
date of November 2016 or December 2016 regardless of
whether they continued in the same plan in CY 2017.
o All CY 2017 beneficiaries with an effective enrollment
date of January 2017.
Sponsors with < 100,000 enrollees:
o All CY 2016 beneficiaries with an effective enrollment
date of November 2016 or December 2016 regardless of
whether they continued in the same plan in CY 2017.
o All CY 2017 beneficiaries with an effective enrollment
date of January 2017 or February 2017.

Clarification or Change

Revised language to remove
year specific references.

New Members

Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request

After the 3rd failed attempt or when the sponsor determines after
fewer attempts that they are unable to provide an accurate universe
within the timeframe specified during the audit, the sponsor will
be cited an Invalid Data Submission (IDS) condition relative to
each element that cannot be tested, grouped by the type of case.

Changed wording from “3rd” to
“third.”

The universes collected for the FA program area test whether the
sponsor has deficiencies related to the appropriate point-of-sale
claims adjudication.

Changed wording from “the FA”
to “this.”

Universe Preparation &
Submission
Responding to Universe
Requests
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Universe Preparation &
Submission
Pull Universes

Page 53 of 112

Revised Language

Sponsors with ≥ 100,000 enrollees:
o All beneficiaries with an effective enrollment date of
November or December of the contract year
immediately prior to the audit year regardless of
whether they continued in the same plan during the audit
year.
o All beneficiaries with an effective enrollment date of
January of the audit year.
•
Sponsors with < 100,000 enrollees:
o All beneficiaries with an effective enrollment date of
November or December of the contract year
immediately prior to the audit year regardless of
whether they continued in the same plan in the audit
year.
o All beneficiaries with an effective enrollment date of
January or February of the audit year.
After the third failed attempt or when the sponsor determines
after fewer attempts that they are unable to provide an accurate
universe within the timeframe specified during the audit, the
sponsor will be cited an Invalid Data Submission (IDS) condition
relative to each element that cannot be tested, grouped by the
type of case.
•

The universes collected for this program area test whether the
sponsor has deficiencies related to the appropriate point-of-sale
claims adjudication.

Current Section in
CMS-10191

Clarification or Change

Revised Language

NOTE: For each respective universe, the sponsor should include
all cases that match the description for that universe for all
contracts and PBPs in its organization as identified in the audit
engagement letter (e.g., all rejected claims for all contracts and
PBPs in your organization that were received during the review
period).

Provided clarification to specify
that rejected claims for all
contracts and PBPs in an
organization for dates of service
that fall within the review
period.

The sponsor will need access to the following information during
the live webinar and may be requested to produce screenshots. The
screenshots must be provided to CMS via a Microsoft® Word or
PDF document. The sponsor must provide a legend that directs
CMS to the requested information on the screenshot. At a
minimum, the first shot of each screen type must clearly indicate
where the requested information resides on the screen. The
sponsor may include additional documentation not requested,
including but not limited to a narrative summary of the case, to
provide additional detail or clarity. Requested information will
include:

Made consistent with other
protocols, deleted repetitive text,
and clarified information
regarding reviewing
documentation during audit.

The sponsor will need access to the following documents during
the live audit webinar and may be requested to produce
screenshots of any of the following:

•
•
•

Removed the possessive
character from days. Added
clarification regarding the
comment log which displays the
pharmacy messages and
documentation may pertain to
the history for all rejected and
paid claims. Revised language to
remove year specific references.

•
•

Original Language

Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Universe Preparation &
Submission
Pull Universes
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Audit Elements
Formulary Administration
and Transition
Review Sample Case
Documentation
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request

Days’ supply
Comment log associated with the rejected claim.
[Formulary only] A history of all CY 2017 rejected claims
for the same drug (brand name, dosage form, route of
administration).

Audit Elements
•
Formulary Administration
and Transition
Review Sample Case
Documentation

Page 54 of 112

[Transition only] A history of CY 2016 and/or 2017 rejected
claims for the same drug (brand name, dosage form, route of
administration).

•

Days supply
Comment log associated with the rejected claim that displays
the pharmacy messages.
[Formulary only] A history of all rejected and paid claims
for the same drug (brand name, dosage form, route of
administration) during the audit year.
[Transition only] A history of rejected and paid claims for
the same drug (brand name, dosage form, route of
administration) from the audit year and/or the previous
contract year.

Current Section in
CMS-10191
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request

Original Language

Clarification or Change

Revised Language

Continuing members: The sample will consist of rejected claims
related to cross-year formulary changes between 2016 and 2017
(e.g., formulary deletions).

Revised language to remove
year specific references.

Continuing members: The sample will consist of rejected
claims related to cross-year formulary changes between the audit
year and the previous contract year (e.g., formulary deletions).

Contract selection will be made in the following order: PDP
contract, if none then  MAPD contract, if none then  EGWP
contract.

Inserted MMP contract into the
selection order.

Contract selection will be made in the following order: PDP or if
applicable, MMP contract, if none then  MAPD contract, if
none then  EGWP contract.

Bullet 1: Include all rejected claims adjudicated by the sponsor
for the applicable timeframe.

Specified that rejected claims
should include dates of service
that fall within the applicable
review period timeframe and
universes should also include
members enrolled in employer
plans and MMPs.

Bullet 1: Include all rejected claims with dates of service that
fall within the applicable review period timeframe (including
members enrolled in employer plans and Medicare-Medicaid
Plans (MMPs)).

Bullet 1: Include all rejected claims adjudicated by the sponsor
with dates of service for November and December 2016, for
beneficiaries with effective enrollment dates of November or
December 2016.
Bullet 2: Exclude rejected claims for beneficiaries with effective
enrollment dates other than November or December 2016.

Universes should also include
members enrolled in employer
plans and MMPs. Revised
language to remove year specific
references.

Bullet 1: Include all rejected claims with dates of service for
November and December of the contract year immediately prior
to the audit year, for beneficiaries with effective enrollment dates
of November or December of that contract year (including
members enrolled in employer plans and Medicare-Medicaid
Plans (MMPs)).
Bullet 2: Exclude rejected claims for beneficiaries with effective
enrollment dates other than November or December of the
contract year immediately prior to the audit year.

Audit Elements
Transition
Select Sample Cases
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Website
Select Sample Contracts
and Cases
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Tables 1 and 2 Introductory Text
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Table 3 - Introductory Text

Page 55 of 112

Current Section in
CMS-10191
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request

•
•

Original Language

Clarification or Change

Include all final action PDEs accepted by CMS with dates of
service in September – December of 2016.
Include PDEs only for beneficiaries in the Rejected Claims
Transition Universes (RCT-N and RCT-P).

Changed language to clarify that
the PDEs should be for what was
submitted in either of the
Rejected Claims Transition
Universes, universes should also
include members enrolled in
employer plans and MMPs, and
revised language to remove year
specific references.

Table 4 - Introductory Text

Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request

Table 5 - Introductory Text
o

Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Tables 1, 2, 3, 4, and 5 Column ID B

Page 56 of 112

For sponsors with ≥ 100,000 enrollees include:

All CY 2016 beneficiaries with an effective
enrollment date of November 2016 or December
2016 regardless of whether they continued in the
same plan in CY 2017.

All CY 2017 beneficiaries with an effective
enrollment date of January 2017.
For sponsors with < 100,000 enrollees:

All CY 2016 beneficiaries with an effective
enrollment date of November 2016 or December
2016 regardless of whether they continued in the
same plan in CY 2017.

All CY 2017 beneficiaries with an effective
enrollment date of January 2017 or February 2017.

Field Length: 100

Revised language to remove
year specific references.

Revised Language

•

Include all final action PDEs accepted by CMS with dates
of service in September – December of the contract year
immediately prior to the audit year.
o Include PDEs only for beneficiaries submitted in
either of the Rejected Claims Transition Universes
(RCT-N and RCT-P) (including members enrolled in
employer plans and Medicare-Medicaid Plans
(MMPs)).

Changed field length.

For sponsors with ≥ 100,000 enrollees include:

All beneficiaries with an effective enrollment
date of November or December of the contract
year immediately prior to the audit year
regardless of whether they continued in the same
plan in the audit year.

All beneficiaries with an effective enrollment
date of January of the audit year.
For sponsors with < 100,000 enrollees:

All beneficiaries with an effective enrollment
date of November or December of the contract
year immediately prior to the audit year
regardless of whether they continued in the same
plan in the audit year.

All beneficiaries with an effective enrollment
date of January or February of the audit year.

Field Length: 50

Current Section in
CMS-10191
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Tables 1, 2, 3, 4, and 5 Column ID C
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request

Original Language

Clarification or Change

Revised Language

Field Length: 100

Changed field length.

Field Length: 50

Description: Effective date of enrollment for the beneficiary.
Submit in CCYY/MM/DD format (e.g., 2016/01/01).

Specified enrollment date should
be at the PBP level.

Description: Effective date of enrollment for the beneficiary
(PBP level).

Description: Effective date of disenrollment for the beneficiary.

Specified disenrollment date
should be at the PBP level.

Description: Effective date of disenrollment for the beneficiary
(PBP level).

Provided clarification for how to
populate this field for multi
ingredient compound claims.

Description: 11-Digit National Drug Code
When no NDC is available enter the applicable Uniform Product
Code (UPC) or Health Related Item Code (HRI). Do not include
any spaces, hyphens or other special characters. For multiingredient compound claims, include the drug information that
matches the NDC of the most expensive Part D covered drug.

Field Length: 10
Description: Number of drug dosage units entered in the claim
(e.g., 30 [tablets], 0.42 [milliliters of liquid]).

Changed field length and
provided clarification for how to
populate this field.

Field Length: 11
Description: Number of drug dosage units entered in the claim
(e.g., 30 [tablets], 0.42 [milliliters of liquid]), including decimal
values, when applicable. Units of measurement should not to be
reported.

Tables 1, 2, 3, and 5 Column ID E
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Tables 1, 2, 3, and 5 Column ID F
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Tables 1, 2, and 3 - Column
ID J
Table 4 - Column ID H
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Tables 1, 2, 3 - Column ID
M
Table 4 - Column ID J

Page 57 of 112

Current Section in
CMS-10191

Original Language

Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request

Field Name: Claim Days’ Supply
Description: Days’ supply of the drug entered on the claim (e.g.,
30 [days]).

Removed the possessive
character from the field name
and provided clarification for
how to populate this field.

Field Name: Claim Days Supply
Description: Days supply of the drug entered on the claim (e.g.,
30 [days]). Units of measurement should not to be reported.

Description: Answer “NA” in the Reject Reason Code field for
pharmacy messages included in column S not paired with a reject
reason code.

Clarified language for pharmacy
messages that are not paired
with a reject reason code.

Description: Answer “NA” in the Reject Reason Code field for
pharmacy messages included in column S that are not paired with
a reject reason code.

None

Added a third note about when
pharmacy messaging is not
linked with a corresponding
reject code.

Description: ***In the event that specific pharmacy messages
are not linked with a corresponding reject code, include all
pharmacy messages in this field and repeat for each reject reason
code submitted.

Description: Pharmacy service type as submitted by the
pharmacy. Answer “UNK” if this field is left blank by the
pharmacy.

Specified that pharmacy service
type should be as submitted by
the pharmacy on the claim.

Description: Pharmacy service type as submitted by the
pharmacy on the claim. Answer “UNK” if this field is left blank
by the pharmacy.

Clarification or Change

Revised Language

Tables 1, 2, 3 - Column ID
N
Table 4 - Column ID K
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Tables 1, 2, and 3 - Column
ID R
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Tables 1, 2, and 3 - Column
ID S
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request
Tables 2 and 3 -Column ID
P

Page 58 of 112

Current Section in
CMS-10191
Attachment II – Formulary
and Benefit Administration
Audit Process and Data
Request

Original Language

Clarification or Change

Revised Language

Number of Days Beneficiary Went Without Target Medication Enter N/A if never received.

Provided clarification that
sponsors should use either target
or related medications when
populating this field.

Number of Days Beneficiary Went Without Medication (Target
or Related) - Enter N/A if never received.

The review period will be decided based on your organization’s
total enrollment. CMS reserves the right to expand the review
period to ensure sufficient universe size.

Added a note about call log
universe size being included in
the appendix.

Note: The audit review period for the Call Logs - Part D
universe (Table 16) is specified in the audit universe record
layout and the audit review period varies depending on
organization size.

Clarified that call logs will be
calls from enrollees and/or their
representatives.

Sponsors will provide universes… as well as a call log of all calls
received by the sponsor from enrollees or their representatives
relating to their Part D benefit.

Formulary and Benefit
Administration Impact
Analysis
Number of Days
Beneficiary Went Without
Target Medication (Column
ID AB)
Attachment III CDAG
Audit Process and Data
Request
Audit Purpose and General
Guidelines

•

Review Period

•
•

Attachment III CDAG
Audit Process and Data
Request
Universe Preparation &
Submission
Pull Universes

Page 59 of 112

Plans with <50,000 enrollees: The review period will be
the 3 month period preceding and including the date of
the audit engagement letter.
Plans with >50,000 but <250,000 enrollees: The review
period will be the 2 month period preceding and
including the date of the audit engagement letter.
Plans with >250,000 enrollees: The review period will
be the 1 month period preceding and including the date
of the audit engagement letter.

Sponsors will provide universes … as well as a call log of all calls
received by the sponsor during the audit period relating to their
Part D benefit.

Current Section in
CMS-10191
Attachment III CDAG
Audit Process and Data
Request
Universe Preparation &
Submission

Original Language

Clarification or Change

Revised Language

For each respective universe, the sponsor should include all cases
that match the description for that universe for all contracts and
Plan Benefit Packages (PBPs) in its organization as identified in
the audit engagement letter (e.g., all standard tiering exception
CDs for all contracts and PBPs in your organization).

Added a comment directing
people to the record layouts for
specific instructions on
populating universes.

Instructions for what should be included in each universe are
listed above the tables listed in Appendix A. For each respective
universe, the sponsor should include all cases that match the
description for that universe for all contracts and Plan Benefit
Packages (PBPs) in its organization as identified in the audit
engagement letter (e.g., all standard tiering exception CDs for all
contracts and PBPs in your organization).

3.2.4 Was the reconsideration reviewed by a different physician
with expertise in the field of medicine that is appropriate for the
services at issue?

Changed “reconsideration” to
“redetermination” to be
consistent with Part D
terminology.

3.2.4 Was the redetermination reviewed by a different physician
with expertise in the field of medicine that is appropriate for the
services at issue?

3.2.8. Did the beneficiary receive a therapeutic alternative or other
formulary medication?

Removed compliance standard.

None

Pull Universes
Attachment III CDAG
Audit Process and Data
Request
Appropriateness of Clinical
Decision Making
Apply Compliance
Standard
Clinical Appropriateness/
Denials
Attachment III CDAG
Audit Process and Data
Request
Appropriateness of Clinical
Decision Making
Apply Compliance
Standard
Clinical Appropriateness/
Denials

Page 60 of 112

Current Section in
CMS-10191
Attachment III CDAG
Audit Process and Data
Request
Grievances and
Misclassification of
Requests
Select Sample Cases
Attachment III CDAG
Audit Process and Data
Request
Grievances and
Misclassification of
Requests

Original Language

Clarification or Change

Revised Language

CMS will select a targeted sample of 10 total grievances: 7 from
the standard grievances record layout and 3 from the expedited
grievances record layout (Appendix A, Tables 14 and 15). The
sample will consist of oral and written grievances. CMS will also
select a targeted sample of 10 calls from the sponsor’s Part D call
logs (Table 16).

Clarified sampling when there
are no expedited grievances.

CMS will select a targeted sample of 10 total grievances: 7 from
the standard grievances record layout and 3 from the expedited
grievances record layout (Appendix A, Tables 14 and 15). If the
sponsor does not have enough expedited grievances, the auditors
will sample additional cases from the standard grievance
universe. CMS will also select a targeted sample of 10 calls from
the sponsor’s Part D call logs universe.

Copy of all notices, letters, call logs, or other documentation
showing when the sponsor sent acknowledgement of grievance
receipt to the beneficiary and/or requested additional information
from the beneficiary and/or their representative date/time stamp of
the request. If request was made via phone call, copy of call log
detailing what was communicated to the enrollee.

Deleted the reference to sending
an acknowledgment of grievance
receipt.

Copy of all notices, letters, call logs, or other documentation
showing when the sponsor received the grievance and/or
requested additional information from the beneficiary and/or
their representative date/time stamp of the request. If request was
made via phone call, copy of call log detailing what was
communicated to the enrollee.

3.1 Was the case or call correctly classified, and if not, was it
quickly transferred to the appropriate process?

Clarified that “case” can mean
“grievance”.

3.1 Was the case (e.g. grievance) or call correctly classified, and
if not, was it quickly transferred to the appropriate process?

Please use a comma (,) to separate multiple values within one field
if there is more than one piece of information for a specific field.
Please ensure that all cases in your universes are in one
standardized time zone.

Deleted the requirement that all
universes be submitted in one
standardized time zone, and
added instructions that the time
zone be consistent for each case
(based on when the case was
received).

Please use a comma (,) to separate multiple values within one
field if there is more than one piece of information for a specific
field. Please ensure that all case information (dates and times) are
included in the specific time zone that the case was received.

Review Sample Case
Documentation
For Grievances
Attachment III CDAG
Audit Process and Data
Request
Grievances and
Misclassification of
Requests
Apply Compliance
Standard
Attachment III CDAG
Audit Process and Data
Request
Record Layout Instructions

Page 61 of 112

Current Section in
CMS-10191
Attachment III CDAG
Audit Process and Data
Request
Record Layout Instructions
Attachment III CDAG
Audit Process and Data
Request
Tables 1,2,4 and 5 Column ID G
Attachment III CDAG
Audit Process and Data
Request

Original Language

Clarification or Change

Revised Language

There is a maximum of 4,000 characters per record row.

Added clarification on 4,000
character count and made
consistent with ODAG protocol.

There is a maximum of 4,000 characters per record row and
spaces count toward this 4,000 character limit.

Patient residence code for the beneficiary as submitted on the
coverage determination or as submitted by the pharmacy on the
rejected claim that led to the coverage determination. Answer
“UNK” if the patient residence is unknown.

Changed this field to assess
whether the beneficiary was
residing in a long term care
facility. Changed field name
and description.

None

Made consistent with ODAG
and added AOR fields into
record layouts.

Indicate whether the beneficiary was identified as residing in a
long term care facility when the coverage determination was
received. Valid values are:
Y = Yes
N = No
U = Unknown
Description: Yes (Y)/ No (N) indicator of whether the request
was made by a representative or someone claiming to be a
representative.

None

Made consistent with ODAG
and added AOR fields into
record layouts.

Tables 1,2,4,5,9 and 10 Column ID J
Tables 3,6 and 7 - Column
ID H
Table 8 - Column ID I
Attachment III CDAG
Audit Process and Data
Request
Tables 1,2,4,5,9 and 10 Column ID K
Tables 3,6 and 7 - Column
ID I
Table 8 - Column ID J

Page 62 of 112

Description: Date the Appointment of Representative (AOR)
form or other appropriate documentation received by the sponsor.
Submit in CCYY/MM/DD format (e.g., 2015/01/01). Answer
None if no AOR was received. Answer NA if no AOR form was
required.

Current Section in
CMS-10191
Attachment III CDAG
Audit Process and Data
Request

Original Language

Clarification or Change

None

Made consistent with ODAG
and added AOR fields into
record layouts.

Description: Time the Appointment of Representative (AOR)
form or other appropriate documentation received by the sponsor.
Submit in HH:MM:SS format (e.g., 23:45:59). Answer None if
no AOR was received. Answer NA if no AOR form was
required.

Description: Date check or reimbursement provided to the
enrollee (i.e., mailed to the enrollee). Submit in CCYY/MM/DD
format (e.g., 2017/01/01). Answer NA if the request was not
approved, or if check was not provided.

Added an option to enter NRD if
no reimbursement was due to the
enrollee when a request was
approved.

Description: Date check or reimbursement provided to the
enrollee (i.e., mailed to the enrollee). Submit in CCYY/MM/DD
format (e.g., 2017/01/01). Enter NRD if the request was
approved but no reimbursement was due to the enrollee. Answer
NA if the request was not approved.

Field Length: 16

Changed character field length
from 16 to 20 to be consistent
with other tables.

Field Length: 20

Description: Yes (Y)/No (N) indicator of review by physician if
case was denied for lack of medical necessity. Answer NA if the
request was not denied for lack of medical necessity or not denied
(e.g., approved).

Added “CD” into Field Name.
Changed “case” to “the coverage
determination” to clarify that the
review by a physician on
redetermination is triggered by
the initial coverage
determination being denied for
lack of medical necessity.
Changed field name to
“Grievance/Complaint
Description” to be consistent
with ODAG.

Description: Yes (Y)/No (N) indicator of review by physician if
the coverage determination was denied for lack of medical
necessity. Answer NA if the request was not denied for lack of
medical necessity or not denied (e.g., approved).

Tables 1,2,4,5,9 and 10
Column ID L
Table 8 - Column ID K
Attachment III CDAG
Audit Process and Data
Request
Table 3 - Column ID P
Table 7 - Column ID T
Table 12 - Column ID M
Attachment III CDAG
Audit Process and Data
Request
Table 5 - Column ID V
Table 7 - Column ID O
Table 8 - Column ID S
Attachment III CDAG
Audit Process and Data
Request
Table 6 - Column ID R
Table 7 - Column ID Q
Table 8 - Column ID U
Attachment III CDAG
Audit Process and Data
Request
Table 14 - Column ID J
Table 15 - Column ID K

Page 63 of 112

Revised Language

Field Name: Issue Description

Field Name: Grievance/ Complaint Description

Current Section in
CMS-10191
Attachment III CDAG
Audit Process and Data
Request
Table 14 - Column ID J and
Q
Table 15 - Column ID K
and P
Attachment III CDAG
Audit Process and Data
Request
Table 15: Column ID I
Attachment III CDAG
Audit Process and Data
Request
Table 15 - Column ID J

Page 64 of 112

Original Language

Clarification or Change

Revised Language

Field Length: 1500

Expanded the field lengths to
1800 and made consistent with
ODAG grievance field lengths.

Field Length: 1800

Field Length: 40

Changed to 7 characters to
match the standard grievance
table.

Field Length: 7

Description: Describe the category of the grievance/complaint. If
this grievance was over the plan’s refusal to expedite a request,
indicate Refusal to Expedite in this field. If the grievance was
over another issue, please use the following categories:
Enrollment/Disenrollment; Plan Benefits; Pharmacy Access;
Marketing; Customer Service; Coverage Determinations/
Redetermination Process; Quality of Care; CMS Issues; or; Other.

Removed the categories not
relevant to expedited grievances
but left sponsors an option to put
“other” if the organization
chooses to expedite grievances
for other reasons.

Current Section in
CMS-10191
Attachment III CDAG
Audit Process and Data
Request

Original Language
•
•

Table 16 - Introduction
bullets and description of
pull instructions for call
logs

Attachment III CDAG
Audit Process and Data
Request
Table 16 - Column IDs A,
B, and C
Attachment III CDAG
Audit Process and Data
Request
Table 16 - Column IDs J
and K

Page 65 of 112

•

Include all calls received by your organization (or
another entity) that relate to your Medicare Part D line
of business.
Exclude any calls not relating to your Part D business
(i.e., Medicare advantage, commercial).
Submit all calls based on the date the call was received
by your organization, PBM or other entity.

Clarification or Change

Added more instructions on how
to pull call logs. Made the
record layout a recommendation
(not required for formatting).
Narrowed the universe for calls
to range from 2 to 4 weeks
depending on organization size.
Additionally, limiting calls to
incoming calls from enrollees
and representatives (e.g., calls to
the customer service line(s).
Excluding calls from prescribers.

Column ID A Field Length: 30
Column ID B Field Length: 30
Column ID C Field Length: 8

Changed these fields to be
consistent with the character
lengths in other tables.

Column ID J Field Length: 2000
Column ID K Field Length: 1000

Changed field lengths to
increase the outcome of call field
and make the fields as large as
possible (and consistent as
possible).

Revised Language

NOTE:

Sponsors are not required to submit the information
below in the format provided by the record layout as
long as the information provided is sufficient for
CMS review.

•

Include all incoming calls received by your
organization (or another entity) from Part D enrollees
and/or their representatives that relate to your Medicare
Part D line of business (i.e., calls made to your
customer service line(s)).
•
Exclude any calls not relating to your Part D business
(i.e., Medicare advantage, commercial).
•
Exclude provider/ prescriber calls, or any calls not
from an enrollee/ representative.
•
Submit all calls based on the date the call was received
by your organization, PBM or other entity using the
following criteria:
•
Plans with <50,000 enrollees: Plans should submit calls
for the first 2-weeks of the audit review period as
defined above in the Audit Purpose and General
Guidelines.
•
Plans with >50,000 but <250,000 enrollees: Plans
should submit calls for the first 3-weeks of the audit
review period as defined above in the Audit Purpose
and General Guidelines.
•
Plans with >250,000 enrollees: Plans should submit
calls for the first 4-weeks of the audit review period as
defined above in the Audit Purpose and General
Guidelines.
Column ID A Field Length: 50
Column ID B Field Length: 50
Column ID C Field Length: 10

Field Length: 1800

Current Section in
CMS-10191
Attachment III-A_CDAG
Supplemental Questions
Question 4
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Review Period
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Timeliness Test
Compliance Standards
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Select Sample Cases

Page 66 of 112

Original Language

Clarification or Change

Revised Language

If response to #6 is yes, please attach the portion of your policy
that specifically address this question.

This should have referred back
to question 3

If response to #3 is yes, please attach the portion of your policy
that specifically addresses this question.

None

Added note to clarify the Call
Log universe audit review period
is different than the overall
ODAG audit review period

Note: The audit review period for the Call Logs - Part C universe
(Table 14) is specified in the audit universe record layout and the
audit review period varies depending on organization size.

See SOD, EOD, SREC, EREC and PREC timeframes.

Added Claims and DMR
universes as compliance
standards for the Dismissals
universe (Table 13 – DIS).

See SOD, EOD, Claims, DMR, SREC, EREC and PREC
timeframes.

None

Added page number.

Page 8 of 53

CMS will select a targeted sample of 10 total grievances: 7 from
the standard grievances record layout and 3 from the expedited
grievances record layout (Appendix A, Tables 11 and 12). The
sample will consist of oral and written grievances. CMS will also
select a targeted sample of 10 calls from the sponsor’s Part C Call
Logs (Table 14).

Clarified CMS’ sampling
approach to include clarify
sampling process.

CMS will select a targeted sample of 10 total grievances: 7 from
the standard grievances record layout and 3 from the expedited
grievances record layout (Appendix A, Tables 11 and 12). If the
sponsor does not have enough expedited grievances, the auditors
sample additional cases from the standard grievance universe.
CMS will also select a targeted sample of 10 calls from the
sponsor’s Part C Call Log universe (Table 14).

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Clinical
Appropriateness/Denials
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Clinical
Appropriateness/Denials
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Sample Case Results
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Record Layout Instructions

Page 67 of 112

Original Language

Clarification or Change

Revised Language

3.2.3. Was the request reviewed by a physician or other
appropriate health care professional with sufficient medical and
other expertise including knowledge of Medicare coverage
criteria?

Removed duplicate compliance
standard #3.2.3

None

3.2.10. Did the enrollee get a clinically equivalent or alternate
service?

Clarified that this compliance
standard may not be applicable
for all circumstances.

3.2.10. Did the enrollee get a clinically equivalent or alternate
service, if applicable?

CMS will test each of the 20 cases (10 grievances and 10 calls). If
CMS requirements are not met, conditions (findings) are cited. If
CMS requirements are met, no conditions (findings) are cited.

Clarified CMS’ sampling
approach.

CMS will test each of the 20 cases (10 to 15 grievances and 10
calls). If CMS requirements are not met, conditions (findings) are
cited. If CMS requirements are met, no conditions (findings) are
cited.

Revised time zone standards to
be based on where the request
was received.

Please use a comma (,) to separate multiple values within one
field if there is more than one piece of information for a specific
field. Please ensure that all cases in your universes are populated
based on the time zone where the request was received.

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 1 - Introductory Text
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 1 - Introductory Text

Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 1 – Column ID J
Table 2 – Column ID K
Table 3 – Column ID J
Table 4 – Column ID J
Table 5 – Column ID J
Table 6 – Column ID K
Table 7 – Column ID H
Table 8 – Column ID G
Table 9 – Column ID G
Table 10 – Column ID G

Page 68 of 112

Original Language

Clarification or Change

Revised Language

Note: There is a maximum of 4,000 characters per record row.
Therefore, should additional characters be needed for a variable,
enter this information on the next record at the appropriate start
position.

Clarified that spaces count
toward the character limits.

Note: There is a maximum of 4,000 characters per record row
and spaces count toward this 4,000 character limit. Therefore,
should additional characters be needed for a variable, enter this
information on the next record at the appropriate start position.

Bullet 2: Exclude payment requests, withdrawn requests, all
requests processed as expedited organization determinations,
concurrent review for inpatient hospital and SNF services, postservice reviews, notification of admission, requests for extensions
of previously approved services, duplicate claims and payment
adjustments to claims, claims that are denied for invalid billing
codes, billing errors, denied claims for bundled or separately
payable items, denied claims for beneficiaries who are not
enrolled on the date of service, and claims denied due to
recoupment of payment
Description: Provide the enrollee diagnosis/diagnoses ICD-10
codes related to this request. If the ICD codes are unavailable,
provide a description of the diagnosis, or for drugs provide the 11
digit National Drug Code (NDC).

Revised types of excluded cases.

Bullet 2: Exclude payment requests, dismissals, reopenings,
withdrawn requests and all requests processed as expedited
organization determinations.

Revised field description

Description: Provide the enrollee diagnosis/diagnoses ICD-10
codes related to this request. If the ICD codes are unavailable,
provide a description of the diagnosis, or for drugs provide the 11
digit National Drug Code (NDC) as well as the ICD-10 code
related to the request.

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request

Original Language

Clarification or Change

Revised Language

Field Name: Subsequent expedited request
Description: If a request was made after the organization
determination to expedite the request, indicate who made the
subsequent request to expedite the request: contract provider (CP),
non-contract provider (NCP), beneficiary (B), beneficiary’s
representative (BR) or sponsor (S). Answer NA if no expedited
timeframe was requested.

Revised field name.

Bullet 2: Exclude payment requests, withdrawn requests, all
requests processed as expedited organization determinations,
concurrent review for inpatient hospital and SNF services, postservice reviews, notification of admission, requests for extensions
of previously approved services, duplicate claims and payment
adjustments to claims, claims that are denied for invalid billing
codes, billing errors, denied claims for bundled or separately
payable items, denied claims for beneficiaries who are not
enrolled on the date of service, and claims denied due to
recoupment of payment
Description: Provide the date the request was received by your
organization. Submit in CCYY/MM/DD format (e.g.,
2015/01/01).

Revised types of excluded cases.

Bullet 2: Exclude payment requests, dismissals, reopenings,
withdrawn requests and all requests processed as standard
organization determinations.

Added a note to clarify how
subsequently expedited requests
should be populated.

Description: Provide the date the request was received by your
organization. Submit in CCYY/MM/DD format (e.g.,
2015/01/01).

Revised field description to
remove “contract provider” and
“sponsor” as valid responses.

Field Name: Request for expedited timeframe
Description: If a request was made after the organization
determination to expedite the request, indicate who made the
subsequent request to expedite the request: non-contract provider
(NCP), beneficiary (B), beneficiary’s representative (BR).
Answer NA if no expedited timeframe was requested.

Table 1 – Column ID N
Table 5 – Column ID N
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 2 - Introductory Text
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 2 – Column ID I
Table 6 – Column ID I
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 2 – Column ID J
Table 6 – Column ID J

Page 69 of 112

Note: If the request was received as a standard organization
determination request, but later expedited, enter the date of the
request to expedite the organization determination.

Description: Provide the time the request was received by your
organization. Submit in HH:MM:SS military time format (e.g.,
23:59:59).

Added a note to clarify how
subsequently expedited requests
should be populated.

Description: Provide the time the request was received by your
organization. Submit in HH:MM:SS military time format (e.g.,
23:59:59).
Note: If the request was received as a standard organization
determination request, but later expedited, enter the time of the
request to expedite the organization determination.

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 2 – Column ID N
Table 6 – Column ID O
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 2 – Column ID N
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 2
Column ID

Page 70 of 112

Original Language

Clarification or Change

Field Name: Was the request made under the standard timeframe
but processed by the plan under the expedited timeframe?

This field has been removed in
its entirety. All Column ID IDs
shift up one letter beginning
with Column ID N in Table 2
and Column ID O in Table 6.

None

Column ID O Field Name: Subsequent expedited request
Description: If a request was made after the organization
determination to expedite the request, indicate who made the
subsequent request to expedite the request: contract provider (CP),
non-contract provider (NCP), beneficiary (B), beneficiary’s
representative (BR) or sponsor (S). Answer NA if no expedited
timeframe was requested.

Modified Column ID and added
clarification that “NA” is
appropriate where no subsequent
expedited timeframe was
requested.

Column ID N Field Name: Subsequent expedited request
Description: If a request was made after the organization
determination to expedite the request, indicate who made the
subsequent request to expedite the request: contract provider
(CP), non-contract provider (NCP), beneficiary (B), beneficiary’s
representative (BR) or sponsor (S). Answer NA if no subsequent
expedited timeframe was requested.

Field Name and Column ID:

Changed column IDs

Field Name and Column ID:

Revised Language

Current Section in
CMS-10191

Original Language

Clarification or Change

Date service authorization entered/effectuated in the sponsor's
system (Column ID AA)
Time service authorization entered/effectuated in the sponsor's
system (Column ID AB)
AOR receipt date (Column ID AC)
AOR receipt time (Column ID AD)
First Tier, Downstream, and Related Entity (Column ID AE)
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 4 – Column M
Table 5 – Column ID Q
Table 6 – Column ID R
Table 7 – Column ID K
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 3 - Introductory Text
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 3 - Introductory Text

Page 71 of 112

Revised Language

Date service authorization entered/effectuated in the sponsor's
system (Column ID Z)
Time service authorization entered/effectuated in the sponsor's
system (Column ID AA)
AOR receipt date (Column ID AB)
AOR receipt time (Column ID AC)
First Tier, Downstream, and Related Entity (Column ID AD)

Field Length: 36

Revised field length to account
for spaces.

Field Length: 41

Bullet 2: Exclude all requests processed as direct member
reimbursements, duplicate claims and payment adjustments to
claims, reopenings, claims denied for invalid billing codes, denied
claims for beneficiaries who are not enrolled on the date of service
and claims denied due to recoupment of payment

Revised types of excluded cases.

Bullet 2: Exclude all requests processed as direct member
reimbursements, dismissals, duplicate claims and payment
adjustments to claims, reopenings, claims denied for invalid
billing codes, denied claims for beneficiaries who are not
enrolled on the date of service and claims denied due to
recoupment of payment.

Bullet 3: Submit payment organization determinations (claims)
based on the date the claim was paid or denied, or should have
been paid or denied (the date the request was initiated may fall
outside of the review period).

Clarified the dates for submitting
the universe are based on the
date the claim was paid or the
notification date of the denial.

Bullet 3: Submit payment organization determinations (claims)
based on the date the claim was paid, or should have been paid,
or the notification date of the denial, or the date the denial
notification should have been sent (the date the request was
initiated may fall outside of the review period).

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 3 - Column ID H
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request

Original Language

Clarification or Change

Revised Language

Description: Yes/No indicator flag to indicate whether the claim
is clean (Y) or unclean (N). Answer NA for untimely requests that
are still open.

Added clarification that a
response of “NA” is appropriate
where the clean status has not
yet been determined.

Description: Yes/No indicator flag to indicate whether the claim
is clean (Y) or unclean (N). Answer NA for untimely requests
that are still open or if clean status has not yet been determined.

Field Name: Date the claim was paid or denied
Description: Date the claim was paid or denied. Submit in
CCYY/MM/DD format (e.g., 2015/01/01). Answer NA for
untimely cases that are still open.

Clarified that this field is only
for the date a claim is paid

Field Name: Date the claim was paid
Description: Date the claim was paid. Submit in
CCYY/MM/DD format (e.g., 2015/01/01). Answer DENIED for
claims that were denied. Answer NA for untimely cases that are
still open.

Description: Date written notification provided to enrollee. The
term “provided” means when the letter left the sponsor’s
establishment by US Mail, fax, or electronic communication. Do
not enter the date a letter is generated or printed within the
sponsor’s organization. Submit in CCYY/MM/DD format (e.g.,
2015/01/01). Answer Pending if written notification has not yet
been provided, but is anticipated to be provided in a forthcoming
EOB notice. Answer NA if no written notification provided to the
enrollee.
Bullet 2: Exclude all requests processed as contract and noncontract provider claims.

Clarified that this field is
applicable to both EOB and IDN
notifications.

Description: Date written notification provided to enrollee. The
term “provided” means when the EOB, IDN or letter left the
sponsor’s establishment by US Mail, fax, or electronic
communication. Do not enter the date a letter is generated or
printed within the sponsor’s organization. Submit in
CCYY/MM/DD format (e.g., 2015/01/01). Answer Pending if
written notification has not yet been provided, but is anticipated
to be provided in a forthcoming EOB or IDN notice. Answer NA
if no written notification provided to the enrollee.
Bullet 2: Exclude all requests processed as contract and noncontract provider claims, reopenings and dismissals.

Bullet 3: Submit direct member reimbursement requests based on
the date the reimbursement was issued or denied, or should have
been issued or denied (the date the request was initiated may fall
outside of the review period).

Clarified the dates for submitting
the universe are based on the
date the claim was paid or the
notification date of the denial.

Table 3 - Column ID N
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 3 - Column ID R
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 4 - Introductory Text
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 4 - Introductory Text

Page 72 of 112

Revised types of excluded cases.

Bullet 3: Submit direct member reimbursement requests based
on the date the reimbursement was issued, or should have been
issued, or the notification date of the denial, or the date the denial
notification should have been sent(the date the request was
initiated may fall outside of the review period).

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 4 - Column ID N
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 4 - Column ID R
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 5 - Introductory Text

Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 6 - Introductory Text

Page 73 of 112

Original Language

Clarification or Change

Revised Language

Field Name: Date reimbursement was issued or denied
Description: Date the sponsor issued payment to the member or
provider (for approvals) or the date the sponsor denied the
member’s reimbursement request. Submit in CCYY/MM/DD
format (e.g., 2015/01/01). Sponsors should answer NA for
untimely cases that are still open.

Clarified that this field is only
for the date a reimbursement is
paid

Field Name: Date the reimbursement was paid
Description: Date the sponsor issued payment to the member or
provider. Submit in CCYY/MM/DD format (e.g., 2015/01/01).
Answer DENIED for reimbursement requests that were denied.
Sponsors should answer NA for untimely cases that are still
open.

Description: Date enrollee notified that request was forwarded to
the IRE due to denial or untimely decision. Submit in
CCYY/MM/DD format (e.g., 2015/01/01). Answer NA if
approved or not forwarded to IRE.

Added clarification that a
response of “NA” is appropriate
for organization determination
requests.

Description: Date enrollee notified that request was forwarded
to the IRE due to denial or untimely decision. Submit in
CCYY/MM/DD format (e.g., 2015/01/01). Answer NA if
approved, request was an organization determination or not
forwarded to IRE.

Bullet 2: Exclude all requests processed as expedited
reconsiderations, withdrawn reconsideration requests, concurrent
review for inpatient hospital and SNF services, post-service
reviews, notification of admission, requests for extensions of
previously approved services, duplicate claims and payment
adjustments to claims, claims that are denied for invalid billing
codes, billing errors, denied claims for bundled or separately
payable items, denied claims for beneficiaries who are not
enrolled on the date of service, and claims denied due to
recoupment of payment

Revised types of excluded cases.

Bullet 2: Exclude all requests processed as expedited
reconsiderations, dismissals, reopenings and withdrawn
reconsideration requests.

Bullet 2: Exclude all requests processed as standard
reconsiderations, withdrawn reconsideration requests concurrent
review for inpatient hospital and SNF services, post-service
reviews, notification of admission, requests for extensions of
previously approved services, duplicate claims and payment
adjustments to claims, claims that are denied for invalid billing
codes, billing errors, denied claims for bundled or separately
payable items, denied claims for beneficiaries who are not
enrolled on the date of service, and claims denied due to
recoupment of payment

Revised types of excluded cases.

Bullet 2: Exclude all requests processed as standard
reconsiderations, dismissals, reopenings and withdrawn
reconsideration requests.

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 6 - Column ID N
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 6 - Column IDs

Page 74 of 112

Original Language

Clarification or Change

Revised Language

Description: If an expedited timeframe was requested, indicate
who requested the expedited reconsideration timeframe: contract
provider (CP), non-contract provider (NCP), beneficiary (B),
beneficiary’s representative (BR) or sponsor (S). Answer NA if no
expedited timeframe was requested. Answer BR if a contract
provider submitted the expedited reconsideration request on behalf
of an enrollee.

Removed “NA” as a valid
response.

Description: If an expedited timeframe was requested, indicate
who requested the expedited reconsideration timeframe: contract
provider (CP), non-contract provider (NCP), beneficiary (B),
beneficiary’s representative (BR) or sponsor (S). Answer BR if a
contract provider submitted the expedited reconsideration request
on behalf of an enrollee.

Field Name and Column ID:

Changed column IDs

Field Name and Column ID:

Was a timeframe extension taken? (Column ID P)
If an extension was taken, did the sponsor notify the member of
the reason(s) for the delay and of their right to file an expedited
grievance? (Column ID Q)
Request Disposition (Column ID R)
Date of sponsor decision (Column ID S)
Time of sponsor decision (Column ID T)
Was the request denied for lack of medical necessity? (Column ID
U)
If denied for lack of medical necessity, was the review completed
by a physician or other appropriate health care professional?
(Column ID V)
If the request was denied for lack of medical necessity, was the
reconsideration completed by a physician other than the person
involved in making the initial OD? (Column ID W)
Date oral notification provided to enrollee (Column ID X)
Time oral notification provided to enrollee (Column ID Y)
Date written notification provided to enrollee (Column ID Z)
Time written notification provided to enrollee (Column ID AA)
Date service authorization entered/effectuated in the sponsor's
system (Column ID AB)
Time service authorization entered/effectuated in the sponsor's
system (Column ID AC)
Date forwarded to IRE if denied or untimely (Column ID AD)
If request denied or untimely, date enrollee notified request has
been forwarded to IRE (Column ID AE)
AOR receipt date (Column ID AF)
AOR receipt time (Column ID AG)
First Tier, Downstream, and Related Entity (Column ID AH)

Was a timeframe extension taken? (Column ID O)
If an extension was taken, did the sponsor notify the member of
the reason(s) for the delay and of their right to file an expedited
grievance? (Column ID P)
Request Disposition (Column ID Q)
Date of sponsor decision (Column ID R)
Time of sponsor decision (Column ID S)
Was the request denied for lack of medical necessity? (Column
ID T)
If denied for lack of medical necessity, was the review completed
by a physician or other appropriate health care professional?
(Column ID U)
If the request was denied for lack of medical necessity, was the
reconsideration completed by a physician other than the person
involved in making the initial OD? (Column ID V)
Date oral notification provided to enrollee (Column ID W)
Time oral notification provided to enrollee (Column ID X)
Date written notification provided to enrollee (Column ID Y)
Time written notification provided to enrollee (Column ID Z)
Date service authorization entered/effectuated in the sponsor's
system (Column ID AA)
Time service authorization entered/effectuated in the sponsor's
system (Column ID AB)
Date forwarded to IRE if denied or untimely (Column ID AC)
If request denied or untimely, date enrollee notified request has
been forwarded to IRE (Column ID AD)
AOR receipt date (Column ID AE)
AOR receipt time (Column ID AF)
First Tier, Downstream, and Related Entity (Column ID AG)

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 7 - Introductory Text
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 7 - Introductory Text
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 7 – Column ID L
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 7 – Column ID M
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 8 – Column ID L

Page 75 of 112

Original Language

Clarification or Change

Bullet 2: Exclude all requests processed as direct member
reimbursements and direct member reimbursement reconsideration
requests, duplicate claims and payment adjustments to claims,
reopenings, claims denied for invalid billing codes, denied claims
for beneficiaries who are not enrolled on the date of service and
claims denied due to recoupment of payment.

Revised types of excluded cases.

Bullet 4: If a claim has more than one line item, include all of the
claim’s line items in a single row and enter the multiple line items
as a single claim.

Clarified that this universe
applies to reconsideration
requests.

Field Name: Date the claim was paid or denied
Description: Date the claim was paid or the date the denied claim
was upheld, which may be the IRE auto-forward date. Submit in
CCYY/MM/DD format (e.g., 2015/01/01). Sponsors should
answer NA for untimely cases that are still open.

Revised field name.

Field Name: Was interest paid on the claim?
Description: Yes (Y)/No (N) indicator of whether interest was
paid on the claim.

Revised field name.

Description: Provide the time the sponsor received the IRE
overturn decision. Submit in HH:MM:SS military time format
(e.g., 23:59:59).

Added clarification that a
response of “NA” is appropriate
for standard requests.

Revised field description to
clarify it is applicable to
reconsideration requests.

Revised Language

Bullet 2: Exclude all requests processed as direct member
reimbursements and direct member reimbursement
reconsideration requests, dismissals, reopenings, duplicate
reconsideration requests and payment adjustments to
reconsideration requests, reopenings, reconsideration requests
denied for invalid billing codes, denied reconsideration requests
for beneficiaries who are not enrolled on the date of service and
reconsideration requests denied due to recoupment of payment.
Bullet 4: If a reconsideration request has more than one line
item, include all of the request’s line items in a single row and
enter the multiple line items as a single request.

Field Name: Date the reconsideration request was paid or
denied
Description: Date the reconsideration request was paid or the
date the denied claim was upheld, which may be the IRE autoforward date. Submit in CCYY/MM/DD format (e.g.,
2015/01/01). Sponsors should answer NA for untimely cases
that are still open.
Field Name: Was interest paid on the reconsideration request?
Description: Yes (Y)/No (N) indicator of whether interest was
paid on the reconsideration request.

Description: Provide the time the sponsor received the IRE
overturn decision. Submit in HH:MM:SS military time format
(e.g., 23:59:59). Answer NA the request was not expedited.

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 8 – Column ID N
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 10 – Column ID J
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request

Original Language

Clarification or Change

Revised Language

Description: Time effectuated in the sponsor's system. Submit in
HH:MM:SS military time format (e.g., 23:59:59).

Added clarification that a
response of “NA” is appropriate
for standard requests.

Description: Time effectuated in the sponsor's system. Submit
in HH:MM:SS military time format (e.g., 23:59:59). Answer NA
the request was not expedited.

Description: Indicate whether the pre-service request was
processed under the expedited (E) timeframe or standard (S)
timeframe.

Added clarification that a
response of “NA” is appropriate
for standard requests.

Description: Indicate whether the pre-service request was
processed under the expedited (E) timeframe or standard (S)
timeframe. Answer NA for payment requests.

Bullet 2: Exclude all requests processed as expedited oral and
written grievances, and CTM complaints

Clarified that this universe
applies to reconsideration
requests.

Bullet 2: Exclude all requests processed as expedited oral and
written grievances, dismissals, and CTM complaints.

Description: Indicate whether the grievance was submitted by a
contract provider (CP), non-contract provider (NCP), beneficiary
(B) or beneficiary’s representative (BR).

Removed “CP” and “NCP” as
valid responses.

Description: Indicate whether the grievance was submitted by a
beneficiary (B) or a beneficiary’s representative (BR).

Table 11
Introductory Text
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 11 – Column ID F
Table 12 – Column ID F

Page 76 of 112

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request

Original Language

Clarification or Change

Revised Language

Field Length: 40
Description: Describe how the grievance/complaint was received
from the beneficiary or authorized representative (e.g., written
letter, call to Customer Services, etc.).

Revised field length to account
for spaces.

Field Length: 50

Revised field length to account
for spaces.

Field Length: 54

Field Name: Issue description
Field Length: 300

Revised field name. Revised
field length to account for
spaces.

Field Name: Grievance/complaint description
Field Length: 1800

None

A new field has been added as
Column ID K in this universe.

Field Name: Was this a quality of care grievance?
Field Type: CHAR Always Required
Field Length: 1
Description: Yes (Y)/No (N) indicator of whether the grievance
was a quality of care grievance.

Revised field description to
provide valid responses rather
than free text.

Field Length: 7
Description: Describe how the grievance/complaint was first
received from the beneficiary or authorized representative. Valid
values include: Oral or Written.

Table 11 – Column ID H
Table 12 – Column ID I

Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 11 – Column ID I
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 11 – Column ID J
Table 12 – Column ID K
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 11 – New Field

Page 77 of 112

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 11
Column ID

Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request

Original Language

Field Name and Column ID:

Clarification or Change

Changed column IDs

Was a timeframe extension taken? (Column ID K)
If an extension was taken, did the sponsor notify the member of
the reason(s) for the delay? (Column ID L)
If the extension was taken because the sponsor needed more
information, did the notice include how the delay was in the best
interest of the enrollee? (Column ID M)
Resolution Description (Column ID N)
Date oral notification of resolution provided to enrollee (Column
ID O)
Date written notification of resolution provided to enrollee
(Column ID P)
AOR receipt date (Column ID Q)
First Tier, Downstream, and Related Entity (Column ID R)

Revised Language

Field Name and Column ID:
Was a timeframe extension taken? (Column ID L)
If an extension was taken, did the sponsor notify the member of
the reason(s) for the delay? (Column ID M)
If the extension was taken because the sponsor needed more
information, did the notice include how the delay was in the best
interest of the enrollee? (Column ID N)
Resolution Description (Column ID Q)
Date oral notification of resolution provided to enrollee (Column
ID O)
Date written notification of resolution provided to enrollee
(Column ID P)
AOR receipt date (Column ID R)
First Tier, Downstream, and Related Entity (Column ID S)

Bullet 2: Exclude all requests processed as standard oral and
written grievances, and CTM complaints

Revised types of excluded cases.

Bullet 2: Exclude all requests processed as standard oral and
written grievances, dismissals, and CTM complaints.

Field Name: Was a timeframe extension taken?

This field has been removed in
its entirety.

None

Table 12
Introductory Text
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 12 – Column ID L

Page 78 of 112

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 12 – Column ID M
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 12 – Column ID N
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 12 – Column ID O
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 12
Column ID

Page 79 of 112

Original Language

Clarification or Change

Revised Language

Field Name: If an extension was taken, did the sponsor notify the
member of the reason(s) for the delay?

This field has been removed in
its entirety.

None

Field Name: If the extension was taken because the sponsor
needed more information, did the notice include how the delay
was in the best interest of the enrollee?

This field has been removed in
its entirety.

None

Column ID O Field Name: Resolution Description

This field has been moved from
Column ID O to Column ID P.

Column ID P Field Name: Resolution Description

Field Name and Column ID:

Changed column IDs

Field Name and Column ID:

Date oral notification of resolution provided to enrollee (Column
ID P)
Time oral notification of resolution provided to enrollee (Column
ID Q)
Date written notification of resolution provided to enrollee
(Column ID R)
Time written notification of resolution provided to enrollee
(Column ID S)
AOR receipt date (Column ID T)
AOR receipt time (Column ID U)
First Tier, Downstream, and Related Entity (Column ID V)

Date oral notification of resolution provided to enrollee (Column
ID L)
Time oral notification of resolution provided to enrollee (Column
ID M)
Date written notification of resolution provided to enrollee
(Column ID N)
Time written notification of resolution provided to enrollee
(Column ID O)
AOR receipt date (Column ID Q)
AOR receipt time (Column ID R)
First Tier, Downstream, and Related Entity (Column ID S)

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request

Original Language

Clarification or Change

Revised Language

Field Name: Person who made the request?

Revised field name

Field Name: Who made the request?

Field Length: 42

Revised field length to account
for spaces.

Field Length: 45

Field Name: Time the request was received

This field has been removed in
its entirety.

None

Added new field

Field Name and Column ID: Was a timeframe extension taken?
(Column ID M)
Field Type: CHAR Always Required
Field Length: 1
Field Description: Yes (Y)/No (N) indicator of whether the
sponsor extended the timeframe before dismissing the request.

Table 13 – Column ID G
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 13 – Column ID H
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 13 – Column ID K
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 13 – New Column

Page 80 of 112

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request

Original Language

Clarification or Change

Revised Language

Field Name: Time the request was dismissed

This field has been removed in
its entirety.

None

Field Name: Time written notification provided to
enrollee/provider

This field has been removed in
its entirety.

None

Field Name and Column ID:

Changed column IDs

Field Name and Column ID:

Table 13 – Column ID O
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 13 – Column ID R
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 13
Column ID

Page 81 of 112

Description of the Issue (Column ID L)
Is this an expedited or standard request? (Column ID M)
Reason for Dismissal (Column ID P)
Date written notification provided to enrollee/provider (Column
ID Q)
Appealed to IRE? (Column ID S)
Date forwarded to IRE (Column ID T)
First Tier, Downstream, and Related Entity (Column ID U)

Description of the Issue (Column ID K)
Is this an expedited or standard request? (Column ID L)
Reason for Dismissal (Column ID O)
Date written notification provided to enrollee/provider (Column
ID P)
Appealed to IRE? (Column ID Q)
Date forwarded to IRE (Column ID R)
First Tier, Downstream, and Related Entity (Column ID S)

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 14 - Introductory
Text
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 14 – Column ID D
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 14 – Column ID E
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request
Table 14 – Column ID H

Page 82 of 112

Original Language

Clarification or Change

Revised Language

None

Added note to clarify call log
universe layout expectations.

NOTE: Sponsors are not required to submit the information
below in the format provided by the record layout as long as the
information provided is sufficient for CMS review.

Field Type: CHAR Always Required

Field is now optional.

Field Type: CHAR Optional

Field Type: CHAR Always Required

Field is now optional.

Field Type: CHAR Optional

Field Type: CHAR Always Required

Field is now optional.

Field Type: CHAR Optional

Current Section in
CMS-10191
Attachment IV – Part C
Organization
Determinations, Appeals,
and Grievances (ODAG)
Audit Process and Data
Request

Original Language

Clarification or Change

None

Added new field

The review period for SNPs that have been operational for at least
a year, will be the (13) thirteen month period preceding the date of
the audit engagement letter (for example, for an engagement letter
sent on January 25, 2016, the universe review period would be
December 1, 2015 through January 25, 2017)

Revised example date to reflect
13 month period.

The universes collected for this program area tests the sponsor’s
performance in processing enrollments, care transitions, and plan
performance monitoring and evaluation of the MOC.

Paragraph 1: revised language
to be consistent with Chapter 5
of the Medicare Managed Care
Manual.

Table 14 – Column ID K
Attachment V SNP-MOC
Audit Process and Data
Request
Audit Purpose and General
Guidelines
Review Period
Attachment V SNP-MOC
Audit Process and Data
Request
Universe Preparation &
Submission
Pull Universes and Submit
Background Information

Page 83 of 112

The sponsor will provide a universe consisting of all SNP
beneficiaries who have been continuously enrolled for a period of
at least 13 months as of the engagement letter date.
The sponsor will also submit quality measurement and
performance improvement metrics utilized by your organization to
monitor and evaluate the effectiveness of the MOC. All
applicable fields of the plan performance monitoring and
evaluation record layout should be completed; a separate record
layout should be submitted for each unique MOC.

Paragraph 2: added clarification
regarding continuous
enrollment.
Paragraph 3: added the option
for sponsors to submit one
workbook with a separate tab for
each unique MOC.

Revised Language

Field Name and Column ID: First Tier, Downstream, and
Related Entity
Field Type: CHAR Always Required
Field Length: 70
Field Description: Insert the name of the First Tier,
Downstream, and Related Entity that processed the dismissal
(e.g., Independent Physician Association, Physicians Medical
Group or Third Party Administrator). Answer NA if not
applicable.
The review period for SNPs that have been operational for at
least a year, will be the (13) thirteen month period preceding the
date of the audit engagement letter (for example, for an
engagement letter sent on January 25, 2017, the universe review
period would be December 1, 2015 through January 25, 2017)

The universes collected for this program area tests the sponsor’s
performance in processing enrollments, care coordination, and
plan performance monitoring and evaluation of the MOC.
The sponsor will provide a universe consisting of all SNP
beneficiaries who have been enrolled in any of the sponsoring
organization’s SNPs, with no breaks in enrollment (i.e.
continuously enrolled)for a period of at least 13 months as of the
engagement letter date. Members may have switched from one
SNP plan to another so long as they did not experience a break in
enrollment.
The sponsor will also submit quality measurement and
performance improvement metrics utilized by your organization
to monitor and evaluate the effectiveness of the MOC. All
applicable fields of the plan performance monitoring and
evaluation record layout should be completed; a separate record
layout should be submitted for each unique MOC. Sponsors may
opt to submit one workbook with a separate tab for each unique
MOC.

Current Section in
CMS-10191
Attachment V SNP-MOC
Audit Process and Data
Request
Sample Selection
Select Sample Cases

Original Language

Audit Elements

Revised Language

CMS will select a sample of 30 beneficiaries from the sponsorsubmitted universe as follows:

Removed MMP as MMP will
have its own protocol in 2017.

CMS will select a sample of 30 beneficiaries from the sponsorsubmitted universe as follows:

•
•
•
•

Added commas for emphasis
that a minimum of 5 will be
selected. Added clarification
that the sample proportions will
be based off each existing SNP
type in the universe.

•
•
•

% selected = % of D-SNP beneficiaries
% selected = % of I-SNP beneficiaries
% selected = % of C-SNP beneficiaries
% selected = % of MMP beneficiaries

CMS will sample proportionally with a minimum of 5 for each
existing SNP type to obtain a total sample size of 30.
Attachment V SNP-MOC
Audit Process and Data
Request

Clarification or Change

•
•
•

Documentation showing sponsor’s verification of SNP
eligibility prior to submission of the enrollment to CMS.
Documentation of the completed enrollment request.
Documentation showing sponsor’s verification of SNP
eligibility prior to submission of the enrollment to CMS.

Removed duplicate bullet

% selected = % of D-SNP beneficiaries
% selected = % of I-SNP beneficiaries
% selected = % of C-SNP beneficiaries

CMS will sample proportionally, with a minimum of 5, for each
existing SNP type represented in the universe to obtain a total
sample size of 30.
•
•

Documentation showing sponsor’s verification of SNP
eligibility prior to submission of the enrollment to CMS.
Documentation of the completed enrollment request.

Population to be Served –
Enrollment Verification
For All Beneficiaries
Attachment V SNP-MOC
Audit Process and Data
Request

2.2.2. Did the ICP include specific interventions designed to meet
the needs identified in the HRA?

Revised compliance standard
question to align with CMS
regulations.

Did the sponsor develop a comprehensive ICP designed to
address needs identified in the HRA, consistent with the MOC?

Field Length: 7

Revised field length to 5 to be
consistent with other protocols

Field Length: 5

Revised field length to 3 to be
consistent with other protocols

Field Length: 3

Audit Elements
Care Coordination
Attachment V SNP-MOC
Audit Process and Data
Request
Table 1 - Column ID E
Attachment V SNP-MOC
Audit Process and Data
Request
Table 1 - Column ID F

Page 84 of 112

Current Section in
CMS-10191
Attachment V SNP-MOC
Audit Process and Data
Request
Table 1 - Column ID H
Attachment V SNP-MOC
Audit Process and Data
Request

Original Language

Table 1 - Column ID L
Attachment V SNP-MOC
Audit Process and Data
Request

Revised to include passive
enrollments.

Description: Enrollment mechanism for the beneficiary. Enter
one of the following descriptions: Paper, Electronic, Telephonic,
Passive or Seamless.

Description: Enter Yes if the beneficiary received an initial HRA
within 90 days before or after his/her effective date of enrollment.
Enter No if the beneficiary did not receive an initial HRA within
90 days before or after his/her effective date of enrollment.

Revised language to demonstrate
the intent of the question is to
determine whether or not an
HRA was
administered, completed or
conducted within 90 days of
enrollment.
Added slashes to date example
given in Description

Description: Enter Yes if sponsor completed an initial Enter
Yes if the sponsor completed an initial HRA within 90 days
before or after the member's effective date of enrollment. Enter
No if the member did not have an initial HRA within 90 days
before or after his/her effective date of enrollment.

Revised language to demonstrate
the intent of the question is to
determine whether or not an
HRA was
administered, completed or
conducted within the audit
period.
Revised description to include
the option to enter NA if no
HRA was conducted during the
audit period.

Description: Enter Yes if the sponsor completed an HRA within
the 13-month audit period. Enter No if the beneficiary did not
have an HRA completed within the audit period.

Revised description to reflect
that sponsors should include
capitated payments in these
totals. Added clarification
regarding which claims should
be excluded.

Description: Enter the total dollar amount for all paid claims
with dates of service during the audit review period (e.g.,
$430,265). This field is not to be populated with the number of
claims. Sponsors should exclude data related to the types of
claims cited; duplicate claims and payment adjustments to
claims, claims that are denied for invalid billing codes, billing
errors, denied claims for bundled or not separately payable items,
denied claims for beneficiaries who are not enrolled on the date
of service and claims denied due to recoupment of payment.

Description: Date of the beneficiary’s first HRA after enrolling.
Submit in CCYY/MM/DD format (e.g., 20130101).

Description: Enter Yes if the beneficiary received an HRA within
the 13-month audit period. Enter No if the beneficiary did not
receive an HRA within the audit period.

Table 1 - Column ID M

Attachment V SNP-MOC
Audit Process and Data
Request
Table 1 - Column ID N
Attachment V SNP-MOC
Audit Process and Data
Request
Table 1 - Column ID Q

Page 85 of 112

Revised Language

Description: Enrollment mechanism for the beneficiary. Enter
one of the following descriptions: Paper, Electronic, Telephonic or
Seamless.

Table 1 - Column ID K

Attachment V SNP-MOC
Audit Process and Data
Request

Clarification or Change

Description: Submit in CCYY/MM/DD format (e.g.,
2013/01/01).
If HRA was not conducted during the current audit period, please
enter the date of the most recently conducted HRA.
Description: Enter the total dollar amount for all paid claims with
dates of service during the audit review period (e.g., $430,265). If
the arrangement with a provider group is capitated, sponsors
should enter "N/A". This field is not to be populated with the
number of claims.

Description: Date of the beneficiary’s first HRA after enrolling.
Submit in CCYY/MM/DD format (e.g., 2013/01/01).

Description: Submit in CCYY/MM/DD format (e.g.,
2013/01/01). If no HRA was conducted during current audit
period, please enter NA.

Current Section in
CMS-10191
Attachment V SNP-MOC
Audit Process and Data
Request

Original Language

Clarification or Change

Table 1 - Column ID R

Description: Enter the total dollar amount for all denied claims
with dates of service during the audit review period (e.g.,
$99,782). If the arrangement with a provider group is capitated,
sponsors should enter "N/A". This field is not to be populated with
the number of claims.

Revised description to reflect
that sponsors should include
capitated payments in these
totals. Added clarification
regarding which claims should
be excluded.

Attachment V SNP-MOC
Audit Process and Data
Request

Description: Enter the number of all paid claims with dates of
service during the audit review period (e.g., 10,000). This field is
not to be populated with a dollar amount.

Added language to clarify which
claims should be excluded.

Description: Enter the number of all denied claims with dates of
service during the audit review period (e.g., 2,000). This field is
not to be populated with a dollar amount.

Added language to clarify which
claims should be excluded.

Description: Sponsors should enter the baseline result value (e.g.,
percentage 66.6%, ratio 33:50, etc.).

Revised description to allow the
option to enter NA when no
baseline information was
collected/available.

Description: Sponsor will report data for the 2 most recently
conducted data measurement/ assessments. Enter the start date of
the 1st measurement period. Submit in CCYY/MM/DD format
(e.g., 20140331). Example: if the 1st of the 2 most recent
measurement periods began on January 1, 2014, then enter
2014/01/01. If no measurement was conducted enter N/A

Added slashes to date example
given in description

Table 1 - Column ID S

Attachment V SNP-MOC
Audit Process and Data
Request
Table 1 - Column ID T

Attachment V SNP-MOC
Audit Process and Data
Request
Table 2 - Column ID E
Attachment V SNP-MOC
Audit Process and Data
Request
Table 2 - Column ID I

Page 86 of 112

Revised Language

Description: Enter the total dollar amount for all denied claims
with dates of service during the audit review period (e.g.,
$99,782). This field is not to be populated with the number of
claims. Sponsors should exclude data related to the types of
claims cited; duplicate claims and payment adjustments to
claims, claims that are denied for invalid billing codes, billing
errors, denied claims for bundled or not separately payable items,
denied claims for beneficiaries who are not enrolled on the date
of service and claims denied due to recoupment of payment.
Description: Enter the number of all paid claims with dates of
service during the audit review period (e.g., 10,000). This field is
not to be populated with a dollar amount. Sponsors should
exclude data related to the types of claims cited; duplicate claims
and payment adjustments to claims, claims that are denied for
invalid billing codes, billing errors, denied claims for bundled or
not separately payable items, denied claims for beneficiaries who
are not enrolled on the date of service and claims denied due to
recoupment of payment.
Description: Enter the number of all denied claims with dates of
service during the audit review period (e.g., 2,000). This field is
not to be populated with a dollar amount. Sponsors should
exclude data related to the types of claims cited; duplicate claims
and payment adjustments to claims, claims that are denied for
invalid billing codes, billing errors, denied claims for bundled or
not separately payable items, denied claims for beneficiaries who
are not enrolled on the date of service and claims denied due to
recoupment of payment.
Description: Sponsors should enter the baseline result value
(e.g., percentage 66.6%, ratio 33:50, etc.).
Enter NA if no baseline information was collected/available.

Description: Sponsor will report data for the 1 most recently
conducted data measurement/ assessments.
Enter the start date of the 1st measurement period. Submit in
CCYY/MM/DD format (e.g., 2014/03/31).
Example: if the 1st of the 2 most recent measurement periods
began on January 1, 2014, then enter 2014/01/01.
If no measurement was conducted enter NA.

Current Section in
CMS-10191
Attachment V SNP-MOC
Audit Process and Data
Request
Table 2 - Column ID J
Attachment V SNP-MOC
Audit Process and Data
Request
Table 2 - Column ID L

Attachment V SNP-MOC
Audit Process and Data
Request
Table 2 - Column ID Q

Attachment V SNP-MOC
Audit Process and Data
Request
Table 1 & Table 2

Page 87 of 112

Original Language

Clarification or Change

Revised Language

Description: Enter the end date of the 1st measurement period.
Submit in CCYYMMDD format (e.g., 20140331). Example: if
the 1st of the 2 most recent measurement periods ended on March
31, 2014, then enter 2014/03/31. If no measurement was
conducted enter N/A.

Added slashes to date example
given in

Description: Enter the end date of the 1st measurement period.
Submit in CCYYMMDD format (e.g., 2014/03/31). Example: if
the 1st of the 2 most recent measurement periods ended on
March 31, 2014, then enter 2014/03/31. If no measurement was
conducted enter NA.

Field Name: Goal Met/Not Met
Description: Determination of whether the target value was met
after the 2nd measurement period. (Yes/No)
Enter Yes if the result for measurement period 2 is equal to or
greater than the target percentage goal (e.g., target goal 90%,
measurement period 2 results 95.5%
 goal
Enter No if the result for measurement period 2 is less than the
target percentage goal (e.g., target goal 90%, measurement period
2 results 45.5%
 goal not met, enter No)
Field Name: Goal Met/Not Met
Description: Determination of whether the target value was met
after the 2nd measurement period. (Yes/No)
Enter Yes if the result for measurement period 2 is equal to or
greater than the target percentage goal (e.g., target goal 90%,
measurement period 2 results 95.5%
 goal
Enter No if the result for measurement period 2 is less than the
target percentage goal (e.g., target goal 90%, measurement period
2 results 45.5%
 goal not met, enter No)
N/A

Removed “Not Met” from field
name. Revised description to
reflect that it relates to
measurement period 1,
simplified instructions to allow
for multiple scenarios of the goal
being met.

Field Name: Goal Met
Description: Determination of whether the target value was met
after the 1st measurement period. (Yes/No) Enter Yes if the
goal is met. Enter No if the goal is not met. Enter NA if no
information is available.

Removed “Not Met” from field
name.

Field Name: Goal Met
Description: Determination of whether the target value was met
after the 2nd measurement period. (Yes/No) Enter Yes if the
goal was met. Enter No if the goal was not met. Enter NA if no
information was collected/available.

Revised description to allow for
multiple scenarios of the goal
being met.

Revised all instances where N/A
abbreviation was used to NA

Current Section in
CMS-10191

Attachment VI –
Medication Therapy
Management Program Area
Pilot Audit Process and
Data Request
Audit Purpose and General
Guidelines
Review Period

Original Language

2.1 CY 2015 MTM Universe
•

All beneficiaries who were enrolled in the sponsor’s CY 2015
MTM program(s) as required under 42 CFR 423.153(d)
(including members enrolled in employer plans and
Medicare-Medicaid Plans (MMPs)). This includes all
enrollees that were disenrolled from the MTM program
during the 2015 contract year. Do not include beneficiaries
that were offered MTM services, but do not meet the
eligibility criteria under section 423.153(d). The audit review
period for this universe covers January 1, 2015 through
December 31, 2015.

2.2. CY 2016 MTM Universe
•
All beneficiaries who were enrolled in the sponsor’s CY 2016
MTM program(s) as required under 42 CFR 423.153(d)
(including members enrolled in employer plans and
Medicare-Medicaid Plans (MMPs)). This includes all
enrollees that were disenrolled from the MTM program
during the 2016 contract year. Do not include beneficiaries
that were offered MTM services, but do not meet the
eligibility criteria under section 423.153(d). The audit review
period for this universe covers January 1, 2016 through
December 31, 2016.
CY 2016 Prescription Drug Event (PDE) Universe - CMS will
extract final action CY 2016 PDE data for audited sponsors from
the Integrated Data Repository (IDR). The PDE universe will be
used to identify enrollees who were potentially eligible for autoenrollment in a CY 2016 MTM program, but were not enrolled at
any time during CY 2016. Beneficiaries that were enrolled by the
sponsor in a CY 2016 MTM program will be omitted from this
universe.

Page 88 of 112

Clarification or Change

Removed the CY 2015 MTM
Universe, changed the names of
the remaining two universes, and
revised language to remove year
specific references.

Revised Language

2.1 MTM Universe
•

All beneficiaries who were enrolled in the sponsor’s MTM
program(s) as required under 42 CFR 423.153(d) (including
members enrolled in employer plans and MedicareMedicaid Plans (MMPs)). This includes all enrollees that
were disenrolled from the MTM program during the contract
year. Do not include beneficiaries that were offered MTM
services, but do not meet the eligibility criteria under section
423.153(d).

The audit review period for this universe covers January 1st
through December 31st of the contract year immediately prior to
the audit year. For example, for audits conducted in 2017,
sponsors should populate this universe using the MTM data for
the 2016 contract year.
2.2 Prescription Drug Event (PDE) Universe - CMS will extract
final action PDE data from the contract year immediately prior to
the audit year for audited sponsors from the Integrated Data
Repository (IDR). The PDE universe will be used to identify
enrollees who were potentially eligible for auto-enrollment in a
MTM program for the contract year of interest, but were not
enrolled at any time during that year. Beneficiaries that were
enrolled by the sponsor in an MTM program for the contract year
of interest will be omitted from this universe.

Current Section in
CMS-10191

Attachment VI –
Medication Therapy
Management Program Area
Pilot Audit Process and
Data Request

Original Language

Clarification or Change

Revised Language

CMS will determine if each condition cited is an Observation (0
points), Corrective Action Required (CAR) (1 point), Immediate
Corrective Action Required (ICAR) (2 points) or an Invalid Data
Submission (IDS) (1 point). IDS conditions will be cited when a
sponsor is not able to produce an accurate universe within 3
attempts.

Modified language to be
consistent with other protocols.

CMS will determine if each condition cited is an Observation (0
points), Corrective Action Required (CAR) (1 point) or an
Immediate Corrective Action Required (ICAR) (2 points).
Invalid Data Submission (IDS) conditions will be cited when a
sponsor is not able to produce an accurate universe within 3
attempts. IDS conditions will be worth one point.

Changed wording from “3rd” to
“third”.

After the third failed attempt or when the sponsor determines
after fewer attempts that they are unable to provide an accurate
universe within the timeframe specified during the audit, the
sponsor will be cited an Invalid Data Submission (IDS) condition
relative to each element that cannot be tested, grouped by the
type of case.

Pull Universes: The universes collected for this audit assist CMS
in evaluating whether sponsors are 1) accurately identifying and
appropriately enrolling targeted beneficiaries in MTM programs,
2) appropriately disenrolling beneficiaries enrolled in MTM
programs, and 3) offering and providing required MTM services
to the MTM program enrollees. The universes should be compiled
using the appropriate record layout as described in Appendix A.
These record layouts include:

Made text singular as applicable; Pull Universe: The universe collected for this program area tests
whether sponsors are 1) accurately identifying and appropriately
revised text to make consistent
enrolling targeted beneficiaries in MTM programs, 2)
with other program area
appropriately disenrolling beneficiaries enrolled in MTM
protocols; removed CY 2015
programs, and 3) offering and providing required MTM services
Medication Therapy
to the MTM program enrollees. The universe should be compiled
Management (MTM-2015)
using the appropriate record layout as described in Appendix A.
Universe; renamed the universe
This record layout includes:
for CY 2016 as Medication
Therapy Management Enrollee
•
Medication Therapy Management Enrollee (MTME)
(MTME) Universe; removed the
Universe
note related to the deleted
universe; and revised language
to remove year specific
references.

Audit Purpose and General
Guidelines
Calculation of Score
Attachment VI –
Medication Therapy
Management Program Area
Pilot Audit Process and
Data Request
Universe Preparation and
Submission
Responding to Universe
Requests
Attachment VI –
Medication Therapy
Management Program Area
Pilot Audit Process and
Data Request
Universe Preparation and
Submission
Pull Universes

•
•

Page 89 of 112

CY 2015 Medication Therapy Management (MTM-2015)
Universe
CY 2016 Medication Therapy Management (MTM-2016)
Universe

Current Section in
CMS-10191

Original Language

NOTE:
For these universes, the sponsor should include all cases that
match the description for that universe for all contracts in its
organization as identified in the audit engagement letter (e.g.,
all beneficiaries for all contracts in your organization that were
enrolled in each CY 2016 MTM program).
•
The CY 2015 MTM universe data from will be used in
conjunction with elements I and II of the Pilot MTM protocol
to assist with identifying members that were previously autoenrolled in an MTM program and to establish a look back date
for the annual CMR for continuing MTM program enrollees.
Attachment VI –
Submit Universes to CMS: Sponsors should submit each
Medication Therapy
universe in the Microsoft Excel (.xlsx) or Comma Separated
Management Program Area Values (.csv) file format with a header row (or Text (.txt) file
format without a header row) following the record layouts shown
Pilot Audit Process and
in Appendix A (Tables 1 and 2). The sponsor should submit its
Data Request
universes in whole and not separately for each contract.
Universe Preparation &
Submission

Clarification or Change

NOTE:
•
The sponsor should include all cases that match the
description for this universe for all contracts in its
organization as identified in the audit engagement letter
(e.g., all beneficiaries, for all contracts in your organization,
that were auto-enrolled in each MTM program for the
contract year immediately prior to the audit year).

•

Submit Universes to CMS
Attachment VI –
Medication Therapy
Management Program Area
Pilot Audit Process and
Data Request
Audit Elements
Enrollment/ Disenrollment
Select Sample Cases

Page 90 of 112

CMS will select a total of 20 cases from the CY 2016 PDE and
MTM universes to test the appropriateness of the sponsor’s
enrollment of eligible beneficiaries into a CY 2016 MTM program
as well as disenrollment from a CY 2016 MTM program. These
20 cases will consist of:

Revised Language

Made text and table references
singular as a result of deleting
one universe.

Submit Universe to CMS: Sponsors should submit the universe
in the Microsoft Excel (.xlsx) or Comma Separated Values (.csv)
file format with a header row (or Text (.txt) file format without a
header row) following the record layout shown in Appendix A
(Table 1). The sponsor should submit its universe in whole and
not separately for each contract.

Revised language to remove
year specific references.

CMS will select a total of 20 cases from the PDE and MTM
universes to test the appropriateness of the sponsor’s enrollment
of eligible beneficiaries into a MTM program as well as
disenrollment from a MTM program. These 20 cases will consist
of:

Current Section in
CMS-10191

Original Language

Attachment VI –
Medication Therapy
Management Program Area
Pilot Audit Process and
Data Request

Revised text to make consistent
with other program area
protocols.

The sponsor will need access to the following documents during
the live audit webinar and may be requested to produce
screenshots of any of the following:

•
•

Replaced disenrollment with
opt-out.

•
•

Elements II and III were
combined into a single element.
Element III was deleted.

Element II. Comprehensive and Targeted Medication Review
(CTMR)

Audit Elements
Enrollment/ Disenrollment

Clarification or Change

Revised Language

Review Sample Case
Documentation
Attachment VI –
Medication Therapy
Management Program Area
Pilot Audit Process and
Data Request

Effective date of disenrollment/opt-out
Documentation of beneficiary’s/authorized representative’s
request to disenroll from the MTM program

Effective date of opt-out
Documentation of beneficiary’s/authorized representative’s
request to opt-out from the MTM program

Audit Elements
Enrollment/ Disenrollment
Review Sample Case
Documentation
Attachment VI –
Medication Therapy
Management Program Area
Pilot Audit Process and
Data Request
Audit Elements
Comprehensive and
Targeted Medication
Review (CTMR)

Page 91 of 112

Element II. Comprehensive Medication Review (CMR)

Current Section in
CMS-10191
Attachment VI –
Medication Therapy
Management Program Area
Pilot Audit Process and
Data Request

Original Language

Clarification or Change

Revised Language

CMS will select a targeted sample of 15 cases from the CY 2016
MTM universe.

The number of total cases was
reduced from 30 across 2
elements to 20 for the combined
element. Also, dropped CY
2016 from the universe name.

CMS will select a targeted sample of 20 cases from the MTM
universe.

CMS will review all sample case file documentation to determine
if MTM program enrollees were offered and/or provided
appropriate, complete and accurate CMRs, including interventions
for beneficiaries and/or prescribers and written summaries in
CMS’ standardized format. During the live review portion of the
audit CMS will also verify the accuracy of the dates provided in
the universe submission.
The sponsor will need access to the following documents during
the live audit webinar and may be requested to produce
screenshots of any of the following, where applicable:

Consolidated the case
documentation section from the
previous Elements II and III into
one new Element II. Text was
also revised to make it consistent
with other program area
protocols.

CMS will review all sample case file documentation to determine
if MTM program enrollees were offered and/or provided
appropriate, complete and accurate CMRs, including
interventions for beneficiaries and/or prescribers, and written
CMR summaries in CMS’ standardized format. CMS will also
review at least 10 cases to determine whether beneficiaries autoenrolled in an MTM program received accurate, complete and at
least quarterly TMRs with follow-up interventions when
necessary. During the live review portion of the audit CMS will
also verify the accuracy of the dates provided in the universe
submission.

Audit Elements
Comprehensive and
Targeted Medication
Review (CTMR)
Select Sample Cases
Attachment VI –
Medication Therapy
Management Program Area
Pilot Audit Process and
Data Request
Audit Elements
Comprehensive and
Targeted Medication
Review (CTMR)
Review Sample Case
Documentation

Page 92 of 112

The sponsor will need access to the following documents during
the live audit webinar and may be requested to produce
screenshots of any of the following, where applicable:

Current Section in
CMS-10191

Original Language

Attachment VI –
Medication Therapy
Management Program Area
Pilot Audit Process and
Data Request

•
•

Audit Elements

•

Comprehensive and
Targeted Medication
Review (CTMR)

•

Review Sample Case
Documentation

•
•

Attachment VI –
Medication Therapy
Management Program Area
Pilot Audit Process and
Data Request

•

Audit Elements

•

Comprehensive and
Targeted Medication
Review (CTMR)

•

Review Sample Case
Documentation (cont’d)

•
•
•

•
•

Effective date of eligibility determination
Documentation of targeted beneficiary’s MTM program
eligibility
Effective date of enrollment into the MTM program
Documentation regarding the cognitive impairment
determination of the enrollee
Documentation regarding identification and outreach to
authorized representative for cognitively impaired
beneficiaries
Documentation regarding provider’s inability to administer
CMR
Documentation of CMR offer
Documentation of beneficiary’s/authorized representative’s
declination of individual MTM services (including CMRs)
Documentation that a required CMR was administered to the
beneficiary as a part of the MTM process
Date the comprehensive medication review was administered
Copy of the comprehensive medication review report
Documentation of personnel involved in the comprehensive
medication review
Documentation of notification to beneficiary regarding the
comprehensive medication review
Copy of the written summary of the comprehensive
medication review
Effective date of disenrollment/opt-out
Documentation of beneficiary’s/authorized representative’s
request to disenroll from the MTM program

Clarification or Change

Consolidated the
documentation sampled from
the previous Elements II and III
into one new Element II. Also
made minor modifications to
text for more clarity.

Revised Language

•
•
•
•
•
•

•
•

•
•
•
•
•
•
•
•

Page 93 of 112

Documentation of beneficiary’s/authorized representative’s
declination of individual MTM services (including CMRs)
Documentation including date that a required CMR was
administered to the beneficiary as a part of the MTM
process (e.g., copy of the comprehensive medication review
report)
Documentation regarding provider’s inability to administer
CMR
Documentation of personnel involved in the comprehensive
medication review
Copy of written summary of the comprehensive medication
review or alternative documentation of the CMR
Documentation including date that a targeted medication
review was performed (e.g., copy of the targeted medication
review report)
Documentation of personnel involved in the targeted
medication review
Documentation of any interventions taken as a result of the
targeted review (or documentation that interventions were
not necessary)
Effective date of opt-out
Documentation of beneficiary’s/authorized representative’s
request to opt-out from the MTM program

Current Section in
CMS-10191

Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Audit Elements
Comprehensive and
Targeted Medication
Review (CTMR)
Apply Compliance
Standard

Page 94 of 112

Original Language

Apply Compliance Standard: At a minimum, CMS will evaluate
cases against the following criteria. CMS may review factors not
specifically addressed in these questions if it is determined that
there are other related MTM requirements not being met.
•
Was a CMR offered at least annually? For newly targeted
beneficiaries, was a CMR offered within 60 days of
enrollment?
•
For cognitively impaired members, did the sponsor perform
appropriate outreach to the beneficiary’s authorized
representative to offer a CMR?
•
Did the sponsor perform an annual comprehensive medication
review in accordance with CMS’ professional service
definition?
•
Did the sponsor provide the beneficiary or their authorized
representative with a written summary of the comprehensive
medication review?
i. Was the written summary provided in the
standardized format?
ii. Was the written summary provided within 14 days
of the completed CMR?
•
Did the sponsor utilize the appropriate qualified staff when
performing the CMR?
•
Were the required CMR services offered and provided
consistent with the approved MTM description?

Clarification or Change

Consolidated the compliance
standards from previous
Elements II and III into one
new Element II.

Revised Language

Apply Compliance Standard: At a minimum, CMS will
evaluate cases against the following criteria. CMS may review
factors not specifically addressed in these questions if it is
determined that there are other related MTM requirements not
being met.
•
Was a CMR offered at least annually? For newly targeted
beneficiaries, was a CMR offered within 60 days of
enrollment?
•
For cognitively impaired members, did the sponsor perform
appropriate outreach to the beneficiary’s authorized
representative to offer a CMR?
•
Did the sponsor perform an annual comprehensive
medication review in accordance with CMS’ professional
service definition?
•
Did the sponsor provide the beneficiary or their authorized
representative with a written summary of the
comprehensive medication review?
i. Was the written summary provided in the
standardized format?
ii. Was the written summary provided within 14 days
of the completed CMR?
•
Did the sponsor utilize the appropriate qualified staff when
performing the CMR?
•
Were the required CMR services offered and provided
consistent with the approved MTM description?
•
Did the sponsor provide TMRs at least quarterly or
according to the timeframe as described in the CMS
approved MTM description?
•
Were the TMRs performed consistent with the approved
MTM description?
•
Did the sponsor implement beneficiary and/or prescriber
interventions resulting from TMRs when necessary and/or
as described in the CMS approved MTM description?

Current Section in
CMS-10191

Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request

Original Language

Clarification or Change

Revised Language

CMS will test each of the 15 cases.

Modified the total cases to 20
to account for merging
Elements II and III into one
new Element II.

CMS will test each of the 20 cases.

Select Sample Cases: CMS will select 15 targeted cases from the
CY 2016 MTM universe who received a targeted medication
review (TMR).
Review Sample Case Documentation: CMS will review all
sample case file documentation to determine if beneficiaries autoenrolled in an MTM program received accurate, complete and at
least quarterly TMRs with follow-up interventions when necessary.
During the live review portion of the audit, CMS will also verify
the accuracy of the dates provided in the universe submission.
The sponsor will need access to the following documents during the
live audit webinar and may be requested to produce screenshots of
any of the following, where applicable:

Removed Element III and
combined into a new Element
II (Comprehensive and
Targeted Medication Review
(CTMR)).

None.

Audit Elements
Comprehensive and
Targeted Medication
Review (CTMR)
Sample Case Results
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Audit Elements
Targeted Medication
Review (TMR)

•
•
•
•
•
•
•

Page 95 of 112

Effective date of eligibility determination
Documentation of targeted beneficiary’s MTM program
eligibility
Effective date of enrollment into the MTM program
Date the targeted medication reviews were performed
Documentation that a targeted medication review was
performed
Copy of the targeted medication review report
Documentation of personnel involved in the targeted
medication review

Current Section in
CMS-10191

Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Audit Elements
Targeted Medication
Review (TMR) (cont’d)
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Audit Elements
Targeted Medication
Review (TMR) (cont’d)

Original Language

•
•
•
•

Clarification or Change

Revised Language

Modified language from record
layouts to record layout and
from universes to universe.

The universe for the Medication Therapy Management program
area must be submitted as a Microsoft Excel (.xlsx) or Comma
Separated Values (.csv) file with a header row reflecting the field
names (or Text (.txt) file without a header row).

Documentation of any interventions taken as a result of the
targeted review (or documentation that interventions were not
necessary)
Documentation of beneficiary’s/authorized representative’s
declination of individual MTM services
Effective date of disenrollment/opt-out
Documentation of beneficiary’s/authorized representative’s
request to disenroll from the MTM program

Apply Compliance Standard: At a minimum, CMS will evaluate
cases against the following criteria. CMS may review factors not
specifically addressed in these questions if it is determined that
there are other related MTM requirements not being met.
3.1 Did the sponsor provide TMRs at least quarterly or according
to the timeframe as described in the CMS approved MTM
description?
Were the TMRs performed consistent with the approved MTM
description?
3.2 Did the sponsor implement beneficiary and/or prescriber
interventions resulting from TMRs when necessary and/or as
described in the CMS approved MTM description?

Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Record Layout
Instructions

Page 96 of 112

Sample Case Results: CMS will test each of the 15 cases.
The universes for the Medication Therapy Management program
area must be submitted as a Microsoft Excel (.xlsx) or Comma
Separated Values (.csv) file with a header row reflecting the field
names (or Text (.txt) file without a header row).

Current Section in
CMS-10191
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request

Original Language

Clarification or Change

Revised Language

Table 1. CY 2015 Medication Therapy Management Program
(MTM-2015) Record Layout

Deleted existing table 1 and
renamed remaining table.

Table 1. Medication Therapy Management Enrollee (MTME)
Record Layout

Bullet 1: Include all beneficiaries auto-enrolled in the sponsor’s
CY 2016 MTM program as required under 42 CFR § 423.153(d)
and the CMS approved MTM Description. If a beneficiary was
auto-enrolled more than once in an MTM program during CY 2016,
include information related to the first effective enrollment in a
2016 MTM program. This would include MTM information from
the first contract enrollment date through the end of the year or
through disenrollment from the MTM program (if applicable) –
whichever comes first.

Revised language to remove
year specific references.

Bullet 1: Include all beneficiaries auto-enrolled in the sponsor’s
MTM program as required under 42 CFR § 423.153(d) and the
CMS approved MTM Description. If a beneficiary was autoenrolled more than once in an MTM program during the contract
year, include information related to the first effective enrollment
in a MTM program during that year. This would include MTM
information from the date of the first contract enrollment that
offered an MTM program through the end of the year or through
disenrollment from the MTM program (if applicable) –
whichever comes first.

Table 1

Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Introductory
Text

Page 97 of 112

When populating this universe, sponsors should use
data from the contract year immediately prior to the
audit year. For example, for audits conducted in 2017,
sponsors should populate this universe using the MTM
data from contract year 2016.

Current Section in
CMS-10191

Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request

Original Language

Field Name:
Field Name:
Field Name:
Field Name:
Field Name:
Field Name:

Beneficiary MTM Enrollment Type
MTM Disenrollment Date
Number of CMR offers declined
TMR Intervention Description(s)
TMR Intervention Delivery Method(s)
TMR Intervention Resolution(s)

Clarification or Change

Revised Language

Removed fields from the
remaining record layout.

None

Field Length: 100

Changed field length

Field Length: 50

Field Length: 100

Changed field length

Field Length: 50

Description: Effective date of enrollment for the beneficiary into a
CY 2016 contract. If the beneficiary was enrolled in multiple
contracts in CY 2016, enter the contract enrollment effective date
for the first CY 2016 contract ID that offered an MTM program.

Revised language to remove
year specific references.

Description: Effective date of enrollment for the beneficiary into
a contract. If the beneficiary was enrolled in multiple contracts
during the year, enter the contract enrollment effective date for
the first contract ID that offered an MTM program.

Table 1 –
Column ID J
Column ID M
Column ID T
Column ID AJ
Column ID AM
Column ID AN

Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID B
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID C
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID E

Page 98 of 112

Current Section in
CMS-10191
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID G
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID H
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID I

Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID J

Page 99 of 112

Original Language

Clarification or Change

Revised Language

Description: If the beneficiary was enrolled in multiple contracts
in CY 2016, enter the first CY 2016 contract ID that offered an
MTM program.

Revised language to remove
year specific references.

Description: If the beneficiary was enrolled in multiple
contracts during the year, enter the first contract ID that offered
an MTM program.

Description: Date sponsor determined the beneficiary’s eligibility
for the CY 2016 MTM program. If the beneficiary was enrolled in
multiple contracts in CY 2016, enter the MTM program eligibility
determination date for the first CY 2016 contract ID that offered an
MTM program.

Revised language to remove
year specific references.

Description: Date sponsor determined the beneficiary’s
eligibility for the MTM program. If the beneficiary was enrolled
in multiple contracts during the year, enter the MTM program
eligibility determination date for the first contract ID that offered
an MTM program.

Description: First effective date of auto-enrollment for the
beneficiary into the CY 2016 MTM program. For continuing
members from CY 2015, this would be the date the member was reenrolled in the same contract’s MTM program for all of CY 2016.
For new members (i.e., never enrolled in an MTM program or
enrolled in a different contract’s MTM program in CY 2015 as
compared to CY 2016), this would be the date the beneficiary was
newly auto-enrolled in the CY 2016 MTM program.

Revised language to remove
year specific references and
removed text regarding
specification of continuing and
new members.

Description: First effective date of auto-enrollment for the
beneficiary into the MTM program.

Column ID K Field Name: Did beneficiary Opt-out of the MTM
Program?
Description: Yes (Y) or No (N) indicator of whether the
beneficiary opted-out of the first auto-enrollment in a CY 2016
MTM program.
Opt-out does not include a request to decline individual MTM
services.

Column ID K in the previous
version is now Column J,
provided clarification for
populating field such as giving
an example of individual MTM
services, and revised language
to remove year specific
references.

Column ID J Field Name: Did beneficiary Opt-out of the
MTM Program?
Description: Yes (Y) or No (N) indicator of whether the
beneficiary opted-out of the first auto-enrollment in the MTM
program.
Opt-out does not include a request to decline individual MTM
services, such as CMRs.

Current Section in
CMS-10191
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request

Original Language

Table 1 - Column ID L

Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID M

Page 100 of 112

Revised Language

Column ID L Field Name: MTM Opt-out Date
Description: Date beneficiary or authorized representative optedout of the first CY 2016 MTM program. Submit in CCYY/MM/DD
format (e.g., 2016/03/01).

Column ID L in the previous
version is now Column ID K,
added clarification for
populating field when the optout was due to death and
revised language to remove
year specific references.

Column ID K Field Name: MTM Opt-out Date Description:
Date beneficiary or authorized representative opted-out of the
first MTM program. If the opt-out was due to death, please
include the date the sponsor was made aware of the beneficiary’s
death if the actual date of death is not available. Submit in
CCYY/MM/DD format (e.g., 2016/03/01). Answer NA if the
beneficiary did not opt-out of the MTM program.

Column ID N Field Name: MTM Disenrollment Reason

Column ID N in the previous
version is now Column ID L,
replaced the term “disenrolled
/disenrollment” with “opt-out,”
clarified options 3 and 4, and
revised language to remove
year specific references.

Column ID L Field Name: MTM Opt-out Reason

Table 1 - Column ID K
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request

Clarification or Change

Description: Reason for disenrollment by the organization from
the first CY 2016 MTM program. Valid values are:
01 = Death
02 = Beneficiary disenrolled from contract
03 = Beneficiary/authorized representative requested disenrollment
04 = Other
Enter NA if the beneficiary was not disenrolled by the organization
from the first CY 2016 MTM program.
Column ID O Field Name: MTM Disenrollment Explanation of
Reason
Description: If “03 (Requested Disenrollment)” or “04 (Other)”
was selected for the CY 2016 MTM program disenrollment reason,
explain why the beneficiary was disenrolled by the organization
from the MTM program. Answer “no reason provided” if the
beneficiary or authorized representative did not provide an
explanation for their request to opt-out of the MTM program.
Answer NA if the disenrollment type was “01 (Death),” “02
(Disenrolled from contract),” or the beneficiary was not disenrolled
by the organization from the first CY 2016 MTM program.

Column ID O in the previous
version is now Column ID M,
modified field name, reordered
description paragraphs,
replaced the “disenrollment/
disenrolled/” with “opt-out” as
applicable, and revised
language to remove year
specific references.

Description: Reason for opt-out of the first MTM program.
Valid values are:
01 = Death
02 = Beneficiary disenrolled from contract
03 = Beneficiary requested opt-out
04 = Other (e.g., authorized representative requested opt-out)
Enter NA if the beneficiary did not opt-out of the first MTM
program into which they were auto-enrolled.
Column ID M Field Name: MTM Opt-out Reason Explanation
Description: Answer NA if the opt-out type was “01 (Death),”
“02 (Disenrolled from contract),” or the beneficiary was not
disenrolled by the organization from the first MTM program. If
“03 (Beneficiary requested opt-out)” was selected for the MTM
program opt-out reason, explain why the beneficiary requested to
opt-out of the MTM program. Answer “no reason provided” if
the beneficiary did not provide an explanation for their request to
opt-out of the MTM program. If “04 (Other)” was selected,
please further define this option and explain the reason it led to
an opt-out.

Current Section in
CMS-10191
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request

Original Language

Table 1 - Column ID O
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID P
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID Q

Page 101 of 112

Revised Language

Column ID P Field Name: Was the beneficiary residing in a long
term care facility? (Column ID P)
Description: Indicate whether the beneficiary was identified as
being in long term care facility either at the time the first CY 2016
CMR was offered or administered. Answer NA if no CMRs were
offered or administered in CY 2016.

Column ID P in the previous
version is now Column ID N,
added guidance about
determining beneficiary
residence status, and revised
language to remove year
specific references.

Column ID Field Name N: Was the beneficiary residing in a
long term care facility?
Description: Indicate whether the beneficiary was identified as
being in long term care facility either at the time the first CMR
was offered or administered during the year. Sponsors should use
all available information to determine LTC status at the time the
MTM services are offered and administered, such as the patient
residence code on drug claims data and the Long Term
Institutionalized (LTI) resident report. Answer NA if no CMRs
were offered or administered during the year.

Column ID Q Field Name: Cognitively Impaired
Description: Indicate whether the beneficiary was identified as
being cognitively impaired either at the time the first CY 2016
CMR was offered or administered? Answer NA if no CMRs were
offered or administered in CY 2016.

Column ID Q in the previous
version is now Column ID O,
revised language to remove
year specific references.

Column ID O Field Name: Cognitively Impaired
Description: Indicate whether the beneficiary was identified as
being cognitively impaired either at the time the first CMR was
offered or administered? Answer NA if no CMRs were offered or
administered during the year.

Column ID R Field Name: Authorized Representative
Description: Indicate whether the beneficiary had an authorized
representative (e.g., prescriber, caregiver, health care proxy or legal
guardian) either at the time the first CY 2016 CMR was offered or
administered? Answer NA if no CMRs were offered or
administered in CY 2016.

Column ID R in the previous
version is now Column ID P,
revised language to remove
year specific references.

Column ID P Field Name: Authorized Representative
Description: Indicate whether the beneficiary had an authorized
representative (e.g., prescriber, caregiver, health care proxy or
legal guardian) either at the time the first CMR was offered or
administered during the year? Answer NA if no CMRs were
offered or administered during the year.

Column ID S Field Name: Number of CMRs offered
Description: Total number of distinct CMRs in CY 2016 for
which offers were delivered to the beneficiary, regardless of the
number and type of delivery methods attempted for the CMR offer.
Answer NA if no CMRs were offered in CY 2016.

Column ID S in the previous
version is now Column ID Q,
replaced NA with a zero
option, and revised language to
remove year specific
references.

Column ID Q Field Name: Number of CMRs offered
Description: Total number of distinct CMRs for which offers
were delivered to the beneficiary, regardless of the number and
type of delivery methods attempted for the CMR offer. Answer
“0” (zero) if no CMRs were offered during the year.

Table 1 - Column ID N

Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request

Clarification or Change

Current Section in
CMS-10191
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request

Original Language

Clarification or Change

Revised Language

Column ID U Field Name: Number of CMRs administered
Description: Total number of CMRs administered in CY 2016.
Answer NA if no CMRs were administered in CY 2016.

Column ID R Field Name: Number of CMRs administered
Description: Total number of CMRs administered during the
year. Answer “0” (zero) if no CMRs were administered during
the year.

Table 1 - Column ID R
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request

Column ID U in the previous
version is now Column ID R,
replaced NA with a zero
option, and revised language to
remove year specific
references.

Column ID V Field Name: Number of written CMR summaries
Description: Total number of written CMR summaries provided in
CY 2016. Answer NA if no CMRs were administered in CY 2016
or no written CMR summaries were provided in CY 2016.

Column ID S Field Name: Number of written CMR summaries
Description: Total number of written CMR summaries provided
during the year. Answer “0” (zero) if no CMRs were
administered or no written CMR summaries were provided
during the year.

Table 1 - Column ID S
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request

Column ID V in the previous
version is now Column ID S,
replaced NA with a zero
option, and revised language to
remove year specific
references.

Column ID W Field Name: Date of 1st CMR offer in 2016
Description: Date the first CMR was offered in CY 2016. Answer
NA if no CMRs were offered in CY 2016.

Column ID W in the previous
version is now Column ID T,
revised language to remove
year specific references.

Column ID T Field Name: Date of 1st CMR offer
Description: Date the first CMR was offered. Answer NA if no
CMRs were offered in during the year.

Table 1 - Column ID T
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request

Column ID X Field Name: 1st CMR offer declined?
Description: Yes (Y) or No (N) indicator of whether the first CY
2016 CMR offered was declined. Answer NA if no CMRs were
offered in CY 2016.

Column ID X in the previous
version is now Column ID U
revised language to remove
year specific references.

Column ID U Field Name: 1st CMR offer declined?
Description: Yes (Y) or No (N) indicator of whether the first
CMR offered was declined. Answer NA if no CMRs were
offered during the year.

Column ID Y Field Name: Who declined 1st CMR offer?
Description: Indicate who declined the first CY 2016 CMR offer.
Answer NA if no CMRs were offered in CY 2016 or the first CY
2016 CMR offer was not declined.

Column ID Y in the previous
version is now Column ID V,
revised language to remove
year specific references.

Column ID V Field Name: Who declined 1st CMR offer?
Description: Indicate who declined the first CMR offer.
Answer NA if no CMRs were offered during the year or the first
CMR offer was not declined.

Table 1 - Column ID U
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID V

Page 102 of 112

Current Section in
CMS-10191
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request

Original Language

Column ID Z Field Name: Date 1st CMR administered
Description: Date the first CMR was administered in CY 2016.
Submit in CCYY/MM/DD format (e.g., 2016/03/01). Answer NA if
no CMRs were administered in CY 2016.

Clarification or Change

Revised Language

Column ID Z in the previous
version is now Column ID W,
revised language to remove
year specific references.

Column ID W Field Name: Date 1st CMR administered
Description: Date the first CMR was administered. Submit in
CCYY/MM/DD format (e.g., 2016/03/01). Answer NA if no
CMRs were administered during the year.

Table 1 - Column ID W
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request

Column ID AA Field Name: 1st CMR Delivery Method
Description: Indicate the delivery method for the first CMR
administered in CY 2015. Answer NA if no CMRs were
administered in CY 2016 or the beneficiary/authorized
representative declined CY 2016 CMR services.

Column ID AA in the previous
version is now Column X,
revised language to remove
year specific references.

Column ID X Field Name: 1st CMR Delivery Method
Description: Indicate the delivery method for the first CMR
administered. Answer NA if no CMRs were administered during
the year or the beneficiary/authorized representative declined
CMR services.

Table 1 - Column ID X
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request

Column ID AB Field Name: Qualified Provider of 1st CMR
Description: Indicate the type of qualified provider that
administered the first CY 2016 CMR. Answer NA if no CMRs
were administered or the beneficiary/authorized representative
declined CY 2016 CMR services.

Column ID AB in the previous
version is now Column Y,
revised language to remove
year specific references.

Column ID Y Field Name: Qualified Provider of 1st CMR
Description: Indicate the type of qualified provider that
administered the first CMR. Answer NA if no CMRs were
administered during the year or the beneficiary/authorized
representative declined CMR services.

Column ID AC Field Name: 1st CMR Recipient

Column ID AC in the previous
version is now Column Z,
revised language to remove
year specific references.

Column ID Z Field Name:1st CMR Recipient

Table 1 - Column ID Y
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID Z
Attachment VI –
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Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID AA

Page 103 of 112

Description: Indicate who received the first CY 2016 CMR.
Answer NA if no CY 2016 CMRs were offered or the
beneficiary/authorized representative declined CY 2016 CMR
services.
Column ID AD Field Name: Date 1st Written CMR Summary
Provided
Description: Date the first written CMR summary was provided in
CY 2016. Submit in CCYY/MM/DD format (e.g., 2015/03/15).
Answer NA if no written CMR summaries were provided in CY
2016.

Column ID AD in the previous
version is now Column AA,
revised example date and
revised language to remove
year specific references.

Description: Indicate who received the first CMR.
Answer NA if no CMRs were offered during the year or the
beneficiary/authorized representative declined CMR services.

Column ID AA Field Name: Date 1st Written CMR Summary
Provided
Description: Date the first written CMR summary was provided
in. Submit in CCYY/MM/DD format (e.g., 2016/03/15). Answer
NA if no written CMR summaries were provided during the year.

Current Section in
CMS-10191
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID AB
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID AC
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID AD
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID AE
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID AF

Page 104 of 112

Clarification or Change

Revised Language

Column ID AE Field Name: Number of TMRs performed
Description: Total number of TMRs performed during CY 2016.
Answer NA if no TMRs were performed in CY 2016.

Column ID AE in the previous
version is now Column AB,
replaced NA with a “0” option,
and revised language to remove
year specific references

Column ID AB Field Name: Number of TMRs performed
Description: Total number of TMRs performed during the year.
Answer “0” (zero) if no TMRs were performed.

Column ID AF Field Name: Date of 1st TMR performed
Description: Date of the first TMR performed in CY 2016.
Answer NA if no TMRs were performed in CY 2016.

Column ID AF in the previous
version is now Column AC,
revised language to remove
year specific references.

Column ID AC Field Name: Date of 1st TMR performed
Description: Date of the first TMR performed during the year.
Answer NA if no TMRs were performed.

Column ID AG Field Name: Were interventions necessary for
any TMRs?
Description: Yes (Y) or No (N) indicator of whether follow-up
interventions were deemed necessary based on the results of any
TMRs conducted in CY 2016. Answer NA if no TMRs were
performed in CY 2016.

Column ID AG in the previous
version is now Column AD,
revised language to remove
year specific references.

Column ID AD Field Name: Were interventions necessary for
any TMRs?
Description: Yes (Y) or No (N) indicator of whether follow-up
interventions were deemed necessary based on the results of any
TMRs conducted during the year. Answer NA if no TMRs were
performed.

Column ID AH Field Name: Date of 1st TMR requiring
intervention(s)
Description: Date of the first CY 2016 TMR requiring follow-up
intervention(s). This may be different than the date of the first CY
2016 TMR performed as some TMRs may not result in the need for
an intervention. Answer NA if no TMRs were performed in CY
2016 or interventions were not necessary for any CY 2016 TMRs.
Column ID AI Field Name: TMR Intervention Recipient(s)
Description: Indicate who was targeted to receive the first CY
2016 TMR follow-up intervention(s). Answer NA if no TMRs
were performed in CY 2016 or interventions were not necessary for
any CY 2016 TMRs.

Column ID AH in the previous
version is now Column AE,
revised language to remove
year specific references.

Column ID AE Field Name: Date of 1st TMR requiring
intervention(s)
Description: Date of the first TMR requiring follow-up
intervention(s). This may be different than the date of the first
TMR performed as some TMRs may not result in the need for an
intervention. Answer NA if no TMRs were performed during the
year or interventions were not necessary for any TMRs.
Column ID AF Field Name: TMR Intervention Recipient(s)
Description: Indicate who was targeted to receive the first TMR
follow-up intervention(s). Answer NA if no TMRs were
performed during the year or interventions were not necessary for
any TMRs.

Original Language

Column ID AI in the previous
version is now Column AF,
revised language to remove
year specific references.

Current Section in
CMS-10191

Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID AG

Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Table 1 - Column ID AH

Page 105 of 112

Original Language

Clarification or Change

Revised Language

Column ID AK Field Name: TMR Intervention(s) Delivered?
Field Length: 200
Description: Yes (Y) or No (N) indicator of whether the first CY
2016 TMR intervention(s) were delivered. A “No” response would
be appropriate when no attempt was made to deliver an intervention
or an attempt was unsuccessful (e.g., returned mail or wrong
number). Answer “Y” if every previously described intervention
was delivered. Answer “N” if none of the previously described
interventions were delivered. If some but not all of the first CY
2016 TMR interventions were delivered, specify which
interventions were and were not delivered and separate by a number
as needed. Use a forward slash (/) to separate the intervention from
the delivery status (e.g., 1. Dosage too high/N, 2. Adherence/Y, 3.
Needs additional drug therapy/Y). Answer NA if no TMRs were
performed in CY 2016 or interventions were not necessary for any
CY 2016 TMRs.
Column ID AL Field Name: TMR Intervention(s) Delivery Date
Field Length: 60
Description: Date(s) the first CY 2016 TMR intervention(s) were
delivered to the targeted recipient(s). Submit in CCYY/MM/DD
and separate by a number as needed for multiple dates (e.g., 1.
2016/03/05, 2. 2016/03/05, 3. 2016/03/09). Answer NA if no CY
2016 TMR interventions were delivered, no TMRs were performed
in CY 2016, or interventions were not necessary for any CY 2016
TMRs.

Column ID AK in the previous
version is now Column AG,
reduced field length, added
clarification for populating this
field, and revised language to
remove year specific
references.

Column ID AG Field Name: TMR Intervention(s) Delivered?
Field Length: 2
Description: Yes (Y), No (N), or Some (S) indicator of whether
the first TMR drug therapy problem (DTP) recommendation
intervention(s) were delivered.
Answer “Y” if every DTP intervention was delivered. Answer
“N” when no attempt was made to deliver an intervention or an
attempt was unsuccessful (e.g., returned mail or wrong number).
Answer “S” if some, but not all of the first TMR DTP
interventions were delivered. Answer NA if no TMR
interventions were delivered, no TMRs were performed during
the year, or interventions were not necessary for any TMRs.

Column ID AL in the previous
version is now Column AH,
reduced field length, added
clarification for populating this
field, and revised language to
remove year specific
references.

Column ID AH Field Name: TMR Intervention(s) Delivery
Date
Field Length: 10
Description: Date the first TMR DTP recommendation
intervention was delivered to the targeted recipient. When there
are multiple DTP recommendation interventions for the TMR,
submit the date that the last one was delivered. Submit in
CCYY/MM/DD.
Answer NA if no TMR interventions were delivered, no TMRs
were performed during the year, or interventions were not
necessary for any TMRs.

Current Section in
CMS-10191
Attachment VI –
Medication Therapy
Management Program
Area Pilot Audit Process
and Data Request
Medication Therapy
Management Impact
Analysis Template

Pre-Audit Issue
Summary

Original Language

Clarification or Change

Revised Language

MTM Program disenrollment date (N/A if not applicable)
MTM Program disenrollment reason (N/A if not applicable)
MTM Program disenrollment method
Date 2015 CMR offered
Date 2014 CMR offered – for continuing members
Date 2015 CMR declined
Method 2015 CMR declined
Provider type(s) administering 2015 CMR
TMR intervention description(s) (N/A if not applicable)
TMR intervention(s) delivery method(s) (N/A if not applicable)
TMR interventions declined (NA if not applicable)
Date TMR intervention(s) declined (MM/DD/YY) (NA if not
applicable)
Method TMR declined (Phone/Fax/Mail/Email/Text/Other) (N/A if
not applicable)
N/A

Removed or changed wording
of impact analysis fields

Removed
Removed
MTM Program opt-out method
Date CMR offered
Removed
Date CMR declined
Method CMR declined
Provider type(s) administering CMR
Removed
Removed
Removed
Removed

Added a column asking for the
program area the disclosed
issue impacted.

Program Area Impacted (CPE, FA, CDAG, ODAG, SNP-MOC,
MTM)

Was the issue previously disclosed to CMS (Y/N)

Deleted this column as CMS
will only be collecting
disclosed issues in 2017.

N/A

Date Issue Disclosed (if applicable MM/DD/YYYY)

CMS will only be requesting
disclosed issues so we are
deleting the “if applicable” and
clarifying this field.

Date Issue Previously Disclosed to CMS (MM/DD/YYYY)

Removed

NEW Column B
Pre-Audit Issue
Summary
Column F
Pre-Audit Issue
Summary
Column H

Page 106 of 112

Current Section in
CMS-10191
CMS-10191_Supporting
Statement A
Background

CMS-10191_Supporting
Statement A

Original Language

Clarification or Change

Currently CMS utilizes the following 7 protocols to audit sponsor
performance: Formulary Administration (FA), Coverage
Determinations, Appeals & Grievances (CDAG), Organization
Determination, Appeals and Grievances (ODAG), Special Needs
Model of Care (SNPMOC) (only administered on organizations
who operate SNPs), Compliance Program Effectiveness (CPE),
Medication Therapy Management (MTM) and Provider Network
Accuracy (PNA).
None

Deleted reference to the 7th
protocol (PNA).

Currently CMS utilizes the following 6 protocols to audit
sponsor performance: Formulary Administration (FA), Coverage
Determinations, Appeals & Grievances (CDAG), Organization
Determination, Appeals and Grievances (ODAG), Special Needs
Model of Care (SNPMOC) (only administered on organizations
who operate SNPs), Compliance Program Effectiveness (CPE),
and Medication Therapy Management (MTM).

Added language about the PNA
pilot in response to comments.

Finally, to assist in improving the audit process, CMS sends
sponsors a link to a survey (Appendix D) at the end of each audit to
complete in order to obtain the sponsors’ feedback. The sponsor is
not required to complete the survey.

Deleted reference to Appendix
D since this survey is not
included in PRA and also
added a clarifying sentence to
explain that the survey is not
included in PRA although the
time associated with the survey
is.
Added a new paragraph
relating to a new monitoring
effort using the CDAG and
ODAG protocols for
timeliness.

Additionally, CMS will continue to pilot the Provider Network
Accuracy (PNA) validation in 2017 as described in the HPMS
memo released on March 16, 2016 (CY 2016 Pilot Audit
Protocol Release and Updates: Medication Therapy Management
(MTM) and Provider Network Accuracy (PNA)). There is no
protocol for the PNA pilot, as we are simply validating that
previously identified errors in a sponsor’s online provider
directory have been corrected.
Finally, to assist in improving the audit process, CMS sends
sponsors a link to a survey at the end of each audit to complete in
order to obtain the sponsors’ feedback. The sponsor is not
required to complete the survey, and the actual survey is not
included in this package, although we accounted for the time
associated with taking the survey in our burden estimate.

Background

CMS-10191_Supporting
Statement A
Background

Page 107 of 112

Revised Language

None

We have changed the number of respondents for one portion of
our audits. For a number of years now, as a result of audit
findings, CMS has determined that several sponsors’ Part C
and Part D appeals data are inaccurate for the calculation of
Star Ratings. In these scenarios, CMS lowered the Star Rating
for the relevant appeals measures to one star. Sponsors raised
concerns with this practice, claiming it unduly harmed
sponsors selected for audit in a given year. Based on these
concerns and wanting the best data for the Star Ratings, CMS
will now request all MA and Part D sponsors to submit
universes annually for their coverage/organization
determinations and appeals.

Current Section in
CMS-10191

Original Language

Clarification or Change

CMS-10191_Supporting
Statement A
Background (cont’d)

CMS-10191_Supporting
Statement A

Sponsoring organizations are able to produce approximately 70%
of requested information from their internal systems. CMS is
able to obtain the remaining 30% via our internal systems.

Reduced sponsor produced data
from 70% to 60% and added a
sentence about 10% of data
being manual.

The 2013 protocols were made available to the public for
review/comment during the 30-day Federal Register notice on July
18, 2013 (78 FR 42957). The 2017 protocols, provided in this
package will be published for a 60-day comment period and
subsequent 30-day Federal Register comment period. This package
can be updated with specific dates when publication dates are
known.

Updated with the dates this
package was published for the
60 day comment period. Also
updated this section to account
for the new timeliness
monitoring effort being
conducted by CMS.

Burden Estimates

Changed title for the burden

Use of Information
Technology
CMS-10191_Supporting
Statement A
Federal Register/Outside
Consultation
Federal Register

CMS-10191_Supporting
Statement A
Burden Estimates and
Hourly Wages
Burden Estimates

Page 108 of 112

Revised Language

This will allow a more comprehensive review of the accuracy
of Part C and D appeals data to calculate Star Ratings.
Additionally, since sponsors continue to have deficiencies in
these two program areas the collection of this data will support
increased oversight of sponsors. The burden estimate now
reflects the new number of respondents who will be submitting
this audit data.
Sponsoring organizations are able to produce approximately
60% of requested information from their internal systems.
CMS is able to obtain the remaining 30% via our internal
systems. The remaining 10% of data is manually entered by
the sponsoring organization in response to questionnaires or
other audit requests.
The 2013 protocols were made available to the public for
review/comment during the 30-day Federal Register notice on
July 18, 2013 (78 FR 42957). The 2017 protocols, provided in
this package were published for a 60-day comment period on
June 13, 2016. Following the 60- day comment period, as
indicated in the background section above, CMS added an
industry- wide timeliness monitoring effort to this package. This
monitoring effort will test timeliness of all Part C organization
determinations, Part D coverage determinations and Part C and D
appeals for each of the 201 sponsoring organizations in the MA
and Part D programs to better evaluate sponsors’ performance in
the respective appeals Star Rating measures and increase
monitoring and oversight of sponsor performance overall in these
two program areas. This package will be published for a
subsequent 30-day Federal Register comment period, and can be
updated with specific dates when publication dates are known.
Burden Estimates for Routine Audits

Current Section in
CMS-10191
CMS-10191_Supporting
Statement A
Burden Estimates and
Hourly Wages
Burden Estimates for
Routine Audits

CMS-10191_Supporting
Statement A

Original Language

Program Director
Compliance Officer
Management Analyst
Quality Assurance Spec.
Computers & Information
Systems Manager
(2) Admin Assistants
Claims Analyst
Total Salary/hour:
$639/ 8 positions=
None

$143
$70
$84
$72

Clarification or Change

Originally estimated 8 staff as
the sponsor burden for program
audits. Increased our estimate
to 30 staff based on comments
received.

$134
$38/assistant
$60
$639
$79.86
Created a burden estimate for
the new industry- wide
monitoring initiative.

Burden Estimates and
Hourly Wages

Revised Language

(2) Program Director
Compliance Officer
(6) Management Analyst
(6) Quality Assurance Spec.
(5) Computers & Information
Systems Manager
(6) Admin Assistants
(4) Claims Analyst

$143
$70
$84
$72
$134
$38/assistant
$60

Total Salary/hour:
$2,430
$2,430/ 8 positions=
$81.00
We also created a burden estimate for the industry- wide
monitoring effort using the same table above.
2 Computer & Information Systems Manager
2 Administrative Assistants
$38/assistant
2 Claims Analyst
$60/analyst

Burden Estimates for
Industry- Wide
Monitoring

Total Salary/hour:
$2,430/6 positions=

$134/manager

$464.00
$77.33

Taking the average of the above rates, we estimate an average
hourly rate of $77.33.
CMS-10191_Supporting
Statement A
Burden Estimates and
Hourly Wages
Burden Estimates
Routine Audits

Page 109 of 112

Based on our audit strategy, routine audits are defined as the audits
scheduled throughout the year. For each sponsoring organization
we estimate an average of 80 hours for administrative and systemic
work to assemble the requested information, 40 hours to review the
information for completeness, 30 minutes to submit the information
to CMS, 80 hours for the actual administration of the audit, 20
hours to review and respond to the draft audit report and 30 minutes
to complete the post audit survey. We believe an additional 120
hours is spend on validation and audit close out activities. This is a
total of approximately 341 hours for each sponsoring organization.
The average number of parent organizations that will receive a
routine audit annually is 40.

Due to comments received,
increased the burden estimate
from 341 hours for a program
audit to 701. Also added costs
of hiring an independent
auditing firm into the burden,
assuming approximately 65%
of sponsors will incur these
costs, and assuming the
average cost is approximately
250,000 dollars.

Based on our audit strategy, routine audits are defined as the
audits scheduled throughout the year. For each sponsoring
organization we estimate an average of 200 hours for
administrative and systemic work to assemble the requested
information, 60 hours to review the information for
completeness, 30 minutes to submit the information to CMS, 160
hours for the actual administration of the audit, 40 hours to
respond to audit documentation requests, 40 hours to review and
respond to the draft audit report and 30 minutes to complete the
post audit survey.

Current Section in
CMS-10191

Original Language

Clarification or Change

CMS-10191_Supporting
Statement A

We believe an additional 200 hours is spend on validation and
audit close out activities. This is a total of approximately 701
hours for each sponsoring organization. The average number of
parent organizations that will receive a routine audit annually is
40. However, while this estimate accounts for sponsor time
spent before, during and after the audit, for many sponsors there
is an additional cost of hiring an Independent Auditing Firm for
validation. We are estimating that 65% of sponsors (26
sponsors) will need to hire an Independent Auditing Firm, and
while costs for that will vary, we estimate the average cost is
$250,000. We will add this cost to the total audit estimate.

Burden Estimates and
Hourly Wages
Burden Estimates
Routine Audits (cont’d)

CMS-10191_Supporting
Statement A

None

Added an explanation of the
burden for the new industrywide monitoring effort.

Burden Estimates and
Hourly Wages
Burden Estimates
Yearly Industry- Wide
Timeliness Monitoring
CMS-10191_Supporting
Statement A
Burden Estimates and
Hourly Wages
Burden Estimates
Attachments
CDAG and ODAG
Program Area Audit
Process and Data Request
attachments

Page 110 of 112

Revised Language

We audit approx. 1/6 to ¼ of MA and Part D Plan Sponsors
annually.

Added monitoring effort to the
attachments.

Yearly Industry- Wide Timeliness Monitoring
For the industry- wide monitoring effort, for each sponsoring
organization we estimate an average of 80 hours for
administrative and systemic work to assemble the requested
information, 24 hours to review the information for
completeness, 30 minutes to submit the information to CMS, and
16 hours to conduct validation webinars to ensure accurate
information. This is a total of approximately 120.5 hours for each
sponsoring organization. This monitoring effort will be done on
each of the 201 sponsoring organizations each year.
We audit approx. 1/6 to ¼ of MA and Part D Plan Sponsors
annually. Additionally we will monitor timeliness on all
sponsors annually.

Current Section in
CMS-10191
CMS-10191_Supporting
Statement A

Original Language

Clarification or Change

Revised Language

Only used if a deficiency is cited during the audit. Response time
can vary based on the size of the impact. It is usually 24-48 hours.

For all IA templates included in
the package, we changed the
response timeframe to 10
business days.

Only used if a deficiency is cited during the audit. Response time
can vary based on the size of the impact, but should not exceed
10 business days.

Total Audit hours (40 x 341)= 13,640
Average hourly wage = 79.86 per hour
Total Cost of Collection Effort=
$1,089,290

Due to our increased staffing
and increased hours (above), as
well as the increased burden of
the annual monitoring effort,
we increased the total cost of
collection.

Total audit hours (40 x 701)= 28,040
Average hourly wage = $81.00 per hour
Independent Auditing (26 x 250,000) = $6,500,000
Total Cost of Auditing= $8,771,240
Total monitoring hours (201 x 120.5)= 24,220.5
Average hourly wage=
$77.33
Total Cost of Monitoring= $1,872,971

Burden Estimates and
Hourly Wages
Burden Estimates
Attachments
All IA templates
CMS-10191_Supporting
Statement A
Burden Estimates and
Hourly Wages
Burden Estimates
Burden Summary

CMS-10191_Supporting
Statement A
Burden Estimates and
Hourly Wages
Burden Estimates
Costs to the Federal
Government
Contractor Costs

None.

Added costs to contractors for
the annual monitoring effort.

Total Cost of the Collection Effort (Total Cost of Auditing +
Total Cost of Monitoring) =
$10,644,211
For the timeliness monitoring effort, the duties from the
contractor include receiving, analyzing and ensuring the
completeness of all of the data collected from each of the 201
sponsors. Additionally, contractors will run validation webinars
with the sponsors to ensure that the data in each universe contain
accurate information. Finally, the contractor will conduct
timeliness tests on the universes and report out on the results.
We estimate that the cost to the contractors will be 1.7 million
dollars for this monitoring effort per year.
Therefore we estimate the total contractor costs of this package to
be:
$7,200,000 + $1,700,000 = $8,900,000

Page 111 of 112

Current Section in
CMS-10191
CMS-10191_Supporting
Statement A
Burden Estimates and
Hourly Wages

Original Language

Staff Cost:
$1,620,557
Travel Cost:
$132,000
Contractor Costs: $7,200,000
Total Cost:

Clarification or Change

Added contractor costs for the
monitoring effort.

Revised Language
Staff Cost:
$1,620,557
Travel Cost:
$132,000
Contractor Costs: $8,900,000
Total Cost:

$8,952,557

$10,652,557

Burden Estimates
Costs to the Federal
Government
CMS-10191_Supporting
Statement A
Burden Estimates and
Hourly Wages
Burden Estimates
Changes to the Burden

CMS-10191_Supporting
Statement A
Collections of Information
Employing Statistical
Methods

Page 112 of 112

Under Routine Audits, the total hour burden has been adjusted from
121 hours to 341 hours to more accurately reflect the entirety of the
audit process. Additionally, PACE organizations have been
removed from this collection request and will be submitted under a
different PRA package, as the collection instruments and burden
estimates for this collection and a PACE audit differ greatly.
Additionally, ad hoc audits have been removed from the burden
estimate because ad hoc audits have not exceeded 3 per year in the
last 5 years and routine audits have not exceeded 30 in the last 3
years. Therefore, we believe the total number of 40 routine audits
more accurately reflects the burden associated with this collection.
Consequently, the total burden has been adjusted from 23,595 hours
to 13,640 hours.

Increased the Changes to the
Burden section in order to
account for other changes to
the burden (increased hours).
We also added the changes to
the burden as a result of the
new monitoring effort.

Under Routine Audits, the total hour burden has been adjusted
from 121 hours to 701 hours to more accurately reflect the
entirety of the audit process. Additionally, PACE organizations
have been removed from this collection request and will be
submitted under a different PRA package, as the collection
instruments and burden estimates for this collection and a PACE
audit differ greatly. Additionally, ad hoc audits have been
removed from the burden estimate because ad hoc audits have
not exceeded 3 per year in the last 5 years and routine audits have
not exceeded 30 in the last 3 years. Therefore, we believe the
total number of 40 routine audits more accurately reflects the
burden associated with this collection. Consequently, the total
burden has been adjusted from 23,595 hours to 28,040 hours.
Additionally, we increased the number of respondents who will
submit coverage determinations, organization determinations and
appeals universes, as we will be conducting industry-wide
monitoring of timeliness to be used for Star Rating purposes. The
changes to the burden are reflected and discussed in this
document. We have also prepared a detailed crosswalk of all the
changes to the burden, as well as crosswalks detailing all changes
to documents from the 60-day to the 30-day comment period.
Please see the crosswalks for changes.

CMS has included 3 questionnaires send during the conduct of the
audit, however, no statistical methods are applied to any of our
audit information collected.

Updated to reflect all CPE
questionnaires, as well as
CDAG and ODAG.

CMS has included 6 questionnaires collected during the audit;
however, no statistical methods are applied to any of our audit
information collected.

File Type	application/pdf
File Title	Crosswalk of Changes to CMS-10191
Subject	Crosswalk, CMS-10191, PRA
Author	CMS
File Modified	2016-11-17
File Created	2016-10-27