60 Day Crosswalk

Crosswalk_60D_Comments508.pdf

Medicare Part C and Part D Program Audit and Industry-Wide Part C Timeliness Monitoring Project (TMP) Protocols (CMS-10717)

60 Day Crosswalk

OMB: 0938-1395

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0938-1395 can be found here:

2023-10-17 - Extension without change of a currently approved collection

Document [pdf]

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Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

Revised Language

CPE Protocol
Document Title

Compliance Program Effectiveness (CPE)

Technical
Clarification

Medicare Part C and Part D Compliance Program Effectiveness
(CPE)

CPE Protocol
Program Audit
Protocol
Purpose

Technical
Clarification

CPE Protocol
Compliance
Standard Integrity
Testing

Supplemental Documentation:
• Compliance Officer Questionnaire
• Customized Organizational Structure and Governance PowerPoint
Presentation
• First-Tier, Downstream, and Related Entities (FDR) Operations
Oversight Questionnaire
• Standards of Conduct/Code of Conduct document (in effect at any
time during the audit review period)
• Corporate Compliance/Medicare Compliance/FWA Plan (or similar
document in effect at any time during the audit review period)
• Risk Assessments and Compliance Performance Mechanisms that
show the extent to which Medicare Parts C and/or D operational areas,
FDRs, and FWA risks were identified and compliance goals were
monitored at any time during the audit review period
• Audit and Monitoring Work Plans (for both internal operations and
FDRs) in effect at any time during the audit review period
• Listing of employees who have involvement in the administration or
delivery of Medicare Advantage (Part C) and/or Prescription Drug
(Part D) benefits who were hired during the 26-week period preceding
and including the date of the audit engagement letter, including the
date of hire

Technical
Clarification

To evaluate performance in the areas outlined in this Program Audit
Protocol and Data Request related to Compliance Program
Effectiveness (CPE). The Centers for Medicare and Medicaid
Services (CMS) performs its program audit activities in accordance
with the CPE Program Audit Data Request and applying the
compliance standards outlined in this Program Audit Protocol and
the Program Audit Process Overview document. At a minimum,
CMS will evaluate cases against the criteria listed below. CMS may
review factors not specifically addressed below if it is determined
that there are other related CPE requirements not being met.
Supplemental Documentation:
• Compliance Officer Questionnaire
• Customized Organizational Structure and Governance PowerPoint
Presentation
• First Tier, Downstream, and Related Entities (FDR) Operations
Oversight Questionnaire
• Standards of Conduct/Code of Conduct document (in effect at any
time during the audit review period)
• Risk Assessments and Compliance Performance Mechanisms that
show the extent to which Medicare Parts C and/or D operational
areas, FDRs, and FWA risks were identified and compliance goals
were monitored at any time during the audit review period
• Audit and Monitoring Work Plans (for both internal operations
and FDRs) in effect at any time during the audit review period
Universe Table 1: Compliance Oversight Activities (COA)

Universe Table 1: Compliance Oversight Activities (COA)

Document in
CMS-10717
(version 05/2020)
CPE Protocol
Compliance
Standard 1.1

Original Language

Supplemental Documentation:
• Compliance Officer Questionnaire
• Standards of Conduct/Code of Conduct document (in effect at any
time during the audit review period)
[Method of Evaluation]
• Articulate the organization/Part D plan sponsor's commitment to
comply with all applicable Federal and State standards;
• Describe how potential compliance issues are investigated and
resolved by the organization/Part D plan sponsor; and

Clarification or
Change
Technical
Clarification

Revised Language

Supplemental Documentation:
• Compliance Officer Questionnaire
• Standards of Conduct/Code of Conduct document (in effect at any
time during the audit review period)
• Customized Organizational Structure and Governance PowerPoint
Presentation
Universe Table 1: Compliance Oversight Activities (COA)
[Method of Evaluation]
• Articulate the Sponsoring organization’s commitment to comply
with all applicable Federal and State standards;
• Describe how potential compliance issues are investigated and
resolved by the Sponsoring organization; and
Select targeted samples of 20 audit participants and 2 First Tier
Entities (FTEs) from attendance logs and impacted individuals and
entities from tracers, supporting documentation and/or
supplemental documentation.
Sample selections will be provided to the Sponsoring organization
on the first day of the onsite audit.
Evaluate the 20 samples and 2 FTEs via live presentation by
Sponsoring organization or review of evidence (e.g., accessibility
of compliance policies and procedures and Standards of Conduct
via the intranet, FTE attestation).

Document in
CMS-10717
(version 05/2020)
CPE Protocol
Compliance
Standard 1.2

Original Language

Supplemental Documentation:
• Compliance Officer Questionnaire
• Customized Organizational Structure and Governance PowerPoint
Presentation
• Listing of employees who have involvement in the administration or
delivery of Medicare Advantage (Part C) and/or Prescription Drug
(Part D) benefits who were hired during the 26-week period preceding
and including the date of the audit engagement letter, including the
date of hire.

Clarification or
Change
Technical
Clarification

Revised Language

Supplemental Documentation:
• Compliance Officer Questionnaire
• Customized Organizational Structure and Governance PowerPoint
Presentation
Supporting Documentation:
• Employee and governing body members training records
[Method of Evaluation]
Conduct review of supplemental and supporting documentation via
interviews with compliance officer and individuals responsible for
SIU/FWA and FDR oversight, as applicable. Assess whether
compliance training was provided annually to the compliance
officer and organization employees, the Sponsoring organization's
chief executive and other senior administrators, managers and
governing body members.

Supporting Documentation:
• Evidence of training
[Method of Evaluation]
Conduct review of supplemental and supporting documentation via
interviews with compliance officer and individuals responsible for
SIU/FWA and FDR oversight, as applicable. Assess whether
compliance training was provided to:
• New employees and new appointment to a chief executive, manager,
or governing body member as part of orientation
• All employees at least annually

Use the same 20 samples of audit participants from attendance logs
and impacted individuals from tracers, supporting documentation
and/or supplemental documentation.
Sample selections will be provided to the Sponsoring organization
on the first day of the onsite audit.

Note: Select 20 samples of audit participants from sign in sheets and
impacted individuals and entities from tracers, supporting
documentation and/or supplemental documentation. Employee
attestation of receipt of compliance policies and procedures and
Standards of Conduct is an acceptable evidence of compliance training.

Evaluate the 20 samples via live presentation by Sponsoring
organization or review of evidence (e.g., training attendance log,
training certificate, employee attestation of receipt of compliance
policies and procedures and Standards of Conduct).

Sample selections will be provided to the Sponsoring organization one
day in advance.
CPE Protocol
Compliance
Standard 2.1

Supplemental Documentation:
• Compliance Officer Questionnaire
• Customized Organizational Structure and Governance PowerPoint
Presentation
• Standards of Conduct/Code of Conduct document (in effect at any
time during the audit review period)

Technical
Clarification

Supplemental Documentation:
• Compliance Officer Questionnaire
• Standards of Conduct/Code of Conduct document (in effect at any
time during the audit review period)

Document in
CMS-10717
(version 05/2020)
CPE Protocol
Compliance
Standard 4.1

CPE Protocol
Compliance
Standard 4.2

Original Language

[Method of Evaluation]
Select 6 tracer cases by targeting those that represent compliance risk
to Sponsoring organization’s operations and enrollees with the
likelihood of touching multiple elements of a compliance program,
including intelligence obtained from documentation received with the
universe, such as oversight of:
• Pharmacy benefit management*
• Appeals and grievances, including call routing
• First-tier entity* performing function other than below*
• Quality improvement program, if applicable*
Tracer case selections will be provided to the Sponsoring organization
two weeks prior to the Entrance Conference.
*Always required
[Data Request]
Universe Table 1: Compliance Oversight Activities (COA)
Supporting Documentation:
• Evidence of communication to the affected or involved business areas
regarding compliance issues
• Meeting minutes/agendas, letters/correspondence, etc. to support
statements within the tracer case summaries
[Method of Evaluation]
Ask compliance officer via interview to provide insight on types,
including examples, of oral communication.

Clarification or
Change
Technical
Clarification

Technical
Clarification

Revised Language

[Method of Evaluation]
Select 6 tracer case samples by targeting those that represent
compliance risk to Sponsoring organization’s operations and
enrollees with the likelihood of touching multiple elements of a
compliance program, including intelligence obtained from
documentation received with the universe. When available, choose:
• Pharmacy benefit management
• Appeals and grievances, including oversight of call routing
process
• FTE performing a delegated function
• Quality improvement program, if applicable
Tracer case sample selections will be provided to the Sponsoring
organization two weeks prior to the Entrance Conference.
[Data Request Universe Table 1: COA removed]
Supporting Documentation:
• Evidence of communication to the affected or involved business
areas regarding compliance issues
• Evidence of oversight activities that occurred as a result of the
detected issue(s)
• Description of the enrollee and/or Sponsoring organization impact
as a result of the detected compliance issues
• Meeting minutes/agendas, letters/correspondence, etc. to support
statements within the tracer case summaries
[Method of Evaluation]
Language removed

Document in
CMS-10717
(version 05/2020)
CPE Protocol
Compliance
Standard 4.3

Original Language

[Data Request]
Universe Table 1: Compliance Oversight Activities (COA)

Clarification or
Change
Technical
Clarification

Supplemental Documentation:
• Corporate Compliance/Medicare Compliance/FWA Plan (or similar
document in effect at any time during the audit review period)

Supporting Documentation:
• Evidence of oversight activities that occurred as a result of the
detected issue(s)
• Description of the enrollee and/or Sponsoring organization impact
as a result of the detected compliance issues
• Meeting minutes/agendas, letters/correspondence, etc. to support
statements within the tracer case summaries

[Method of Evaluation]
Evaluate 6 tracer case summaries via live presentation by Sponsoring
organization, including interviews with compliance officer and
individuals responsible for SIU/FWA and FDR oversight, as
applicable. Assess whether Sponsoring organization established and
implemented:
•An effective system for routine monitoring and identification of
compliance risks including internal monitoring and audits of its
internal operations and FTEs to evaluate compliance with CMS
requirements and the overall effectiveness of the compliance program.

[Data Request]
Universe Table 1: Compliance Oversight Activities (COA)
Supporting Documentation:
• Policies and procedures reviewed and revised in response to detecting
and correcting compliance issues
• Training provided in response to identifying and correcting
compliance issues
• Evidence of accountability and oversight by the Sponsoring
organization when issues are detected at the FDR level, including
response and correction procedures, communication, educational
requirements and engagement with the compliance department,
operational areas and oversight entities
• Meeting minutes/agendas, letters/correspondence, etc. to support
statements within the tracer case summaries

[Data Request]
Universe Table 1: COA removed
Supplemental Documentation language removed

Supporting Documentation:
• Meeting minutes/agendas, letters/correspondence, etc. to support
statements within the tracer case summaries

CPE Protocol
Compliance
Standard 4.4

Revised Language

Technical
Clarification

[Method of Evaluation]
Evaluate the 6 tracer case summaries via live presentation by
Sponsoring organization, including interviews with compliance
officer and individuals responsible for SIU/FWA and FDR
oversight, as applicable. Assess whether Sponsoring organization
established and implemented an effective system for routine
monitoring and identification of compliance risks including internal
monitoring and audits of its internal operations and FTEs to
evaluate compliance with CMS requirements and the overall
effectiveness of the compliance program.
[Data Request]
Universe Table 1: COA removed
Supporting Documentation:
• Policies and procedures reviewed and revised in response to
detecting and correcting compliance issues
• Training provided in response to identifying and correcting
compliance issues
• Evidence of oversight activities that occurred as a result of the
detected issue(s)
• Evidence of accountability and oversight by the Sponsoring
organization when issues are detected at the FDR level, including
response and correction procedures, communication, educational
requirements and engagement with the compliance department,
operational areas and oversight entities
• Description of the enrollee and/or Sponsoring organization impact
as a result of the detected compliance issues
• Meeting minutes/agendas, letters/correspondence, etc. to support
statements within the tracer case summaries

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

Revised Language

CPE Protocol
Program Audit Data
Request
Audit Engagement
and Universe
Submission Phase
Universe
Submissions

Sponsoring organizations must submit each universe, comprehensive
of all contracts and Plan Benefit Packages (PBP) identified in the audit
engagement letter, in either Microsoft Excel (.xlsx) file format with a
header row or Text (.txt) file format without a header row.

Technical
Clarification

Sponsoring organizations must submit the universe, comprehensive
of all contracts and Plan Benefit Packages (PBP) identified in the
audit engagement letter, in either Microsoft Excel (.xlsx) file format
with a header row or Text (.txt) file format without a header row.

CPE Protocol
Table 1: COA
Table Instructions

•Include all auditing, monitoring, and investigation activities
(including compliance and fraud, waste and abuse (FWA) activities)
that were initiated, performed, re-opened or closed, related to the
Sponsoring organization’s Medicare Advantage (Part C) and/or
Prescription Drug (Part D) business during the universe request period.
Include the activity if the Activity Start Date (Column ID G) or
Activity Completion Date (Column ID H) falls within the universe
request period.
•Use consistent naming conventions throughout the submitted
universe. For instance, when the name of the Sponsoring
organization’s component (e.g., department, operational area, business
unit) is requested, a consistent response (e.g., Agent Broker vs. Agent/
Broker vs. vs. A/B) must be used.

Technical
Clarification

• Include all auditing, monitoring, and investigation activities
(including compliance and fraud, waste and abuse (FWA)
activities) that were initiated, performed, or closed, related to the
Sponsoring organization’s Medicare Advantage (Part C) and/or
Prescription Drug (Part D) business during the universe request
period. Include the activity if the Activity Start Date (Column ID
G) or Activity Completion Date (Column ID H) falls within the
universe request period, or if the activity is still in progress but the
start and completion dates fall outside the universe period.
• Daily activities should be rolled up into an aggregate time period
of one month and included in the universe each time the aggregate
time period into which they were rolled occurred.
• Use consistent naming conventions throughout the submitted
universe. For instance, when the name of the Sponsoring
organization’s component (e.g., department, operational area,
business unit) is requested, a consistent response (e.g., Agent
Broker vs. Agent/ Broker vs. AB vs. A/B) must be used.
• Ensure that all fields are populated; do not leave any fields blank
(e.g. if there are no deficiencies enter “0” for Number of
Deficiencies in Column ID I, and Column ID J (Description of
Deficiencies) would be “NA ”.

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

Revised Language

CPE Protocol
Component
Table 1: Column ID
A

[Description]
Enter the name of the Sponsoring organization’s department,
operational area, or FTE conducting the oversight activity (e.g., PBM
Claims Department, SIU, etc.).

Technical
Clarification

[Description]
Enter the name of the Sponsoring organization’s department,
operational area, or First Tier Entity that is the focus of the
oversight activity.

CPE Protocol
Activity Type
Table 1: Column ID
B

[Description]
Enter the activity type as:
• auditing
• monitoring
• investigating non-compliance
• investigating FWA
[Description]
Enter whether the activity was:
• compliance
• FWA
• Both

Technical
Clarification

[Description]
Enter the activity type as:
• Auditing
• Monitoring
• Investigations

Technical
Clarification

[Description]
Enter whether the activity was:
• Compliance
• FWA
• Both

[Description]
Enter the frequency of the oversight activity as:
• daily
• weekly
• monthly
• quarterly
• annually
• ad-hoc

Technical
Clarification

[Description]
Enter the frequency of the oversight activity. Valid values include
but are not limited to:
• Daily
• Weekly
• Bi-monthly
• Monthly
• Quarterly
• Semi-annually
• Annually
• Ad-hoc

CPE Protocol
Compliance or
FWA?
Table 1: Column ID
C
CPE Protocol
Activity Frequency
Table 1: Column ID
D

Field Length: 10

CPE Protocol
Activity Description
Table 1: Column ID
F

[Description]
Enter who is the subject of the oversight activity. Then enter a
description of the activity (e.g., operational area, training requirements,
timeliness, accuracy of organization determinations and notifications,
messaging errors, contractual agreements, unannounced or onsite
audits, spot checks, compliance monitoring, targeted or stratified
sampling, audit protocols).

Technical
Clarification

Field Length: 30
[Description]
Provide a description of the activity (e.g., operational area, training
requirements, timeliness, accuracy of organization determinations
and notifications, messaging errors, contractual agreements,
unannounced or onsite audits, spot checks, compliance monitoring,
targeted or stratified sampling, audit protocols).

Document in
CMS-10717
(version 05/2020)

Original Language

CPE Protocol
Activity Start Date
Table 1: Column ID
G

[Description]
Enter the date that the specific activity was initiated or reopened. For
example, if the Sponsoring organization started an audit of the appeals
process/ function within the Sponsoring organization on January 1,
2020, that is the date that would be used for the date the activity
started.
N/A

CPE Protocol
Description of
Deficiencies
Table 1: Column ID
J

CPE Protocol
Supplemental
Documentation
Requests

1. Compliance Officer Questionnaire
2. Customized Organizational Structure and Governance PowerPoint
Presentation
3. First-Tier, Downstream, and Related Entities (FDR) Operations
Oversight Questionnaire
4. Standards of Conduct/Code of Conduct document (in effect at any
time during the audit review period)
5. Corporate Compliance/Medicare Compliance/FWA Plan (or similar
document in effect at any time during the audit review period)
6. Risk Assessments and Compliance Performance Mechanisms that
show the extent to which Medicare Parts C and/or D operational areas,
FDRs, and FWA risks were identified and compliance goals were
monitored at any time during the audit review period. Compliance
performance mechanisms could include (but are not limited to)
monthly compliance dashboards that track the goals and statuses of the
identified risk/issue, self-assessments, surveys, or any other tools or
mechanisms (outside the risk assessment) that are used to identify
potential compliance risks.
7. Audit and Monitoring Work Plans (for both internal operations and
FDRs) in effect at any time during the audit review period
8. Listing of employees who have involvement in the administration or
delivery of Medicare Advantage (Part C) and/or Prescription Drug
(Part D) benefits who were hired during the 26-week period preceding
and including the date of the audit engagement letter, including the
date of hire

Clarification or
Change
Technical
Clarification

Technical
Clarification Added field &
relettered
remaining
Column IDs
within the table.

Technical
Clarification

Revised Language

[Description]
Enter the date that the specific activity was initiated. For example,
if the Sponsoring organization started an audit of the appeals
process/ function within the Sponsoring organization on January 1,
2020, that is the date that would be used for the date the activity
started.
Field Type: CHAR Always Required
Field Length: 1000
Description: Provide a summary of all deficiencies, findings or
issues identified during the oversight activity. If the oversight
activity is identified in the pre-audit issue summary submitted to
CMS, please include the issue number.
Enter TBD if deficiencies have yet to be identified for an ongoing
activity.
1. Compliance Officer Questionnaire
2. Customized Organizational Structure and Governance
PowerPoint Presentation
3. First Tier, Downstream, and Related Entities (FDR) Operations
Oversight Questionnaire
4. Standards of Conduct/Code of Conduct document (in effect at
any time during the audit review period)
5. Risk Assessments and Compliance Performance Mechanisms
that show the extent to which Medicare Parts C and/or D
operational areas, FDRs, and FWA risks were identified and
compliance goals were monitored at any time during the audit
review period. Compliance performance mechanisms could include
(but are not limited to) monthly compliance dashboards that track
the goals and statuses of the identified risk/issue, self-assessments,
surveys, or any other tools or mechanisms (outside the risk
assessment) that are used to identify potential compliance risks.
6. Audit and Monitoring Work Plans (for both internal operations
and FDRs) in effect at any time during the audit review period

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

Revised Language

CPE Protocol
Tracer Case
Summary
Submissions

i. All communications within the Sponsoring organization and with its
FDRs regarding the issue.

Technical
Clarification

i. All relevant communications within the Sponsoring organization
and with its FDRs regarding the issue.

CPE Protocol
Supporting
Documentation
Submissions

During audit field work, CMS will review 6 tracer case summaries in
addition to 20 employee samples of audit participants selected from
sign in sheets, tracers, supplemental documentation and/or supporting
documentation to determine whether the Sponsoring organization is
compliant with its Part C and/or Part D contract requirements.

Technical
Clarification

CPE Compliance
Officer
Questionnaire (COQ)

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.

Technical
Clarification

During audit field work, CMS will review 6 tracer case summaries
in addition to 20 employee samples of audit participants and 2
FTEs selected from attendance logs, tracers, supplemental
documentation and/or supporting documentation to determine
whether the Sponsoring organization is compliant with its Part C
and/or Part D contract requirements.
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.

CPE Compliance
Officer
Questionnaire (COQ)

Technical
Clarification

Please specifically note the following when completing the
questionnaire:
[Removed FDRs language]
[Added language below]
• “First Tier Entity” refers to any party that enters into a written
agreement, acceptable to CMS, with an organization to provide
administrative services or health care services to a Medicare
eligible individual under the Part C and/or Part D program.
• “Downstream Entity” refers to any party that enters into a written
agreement, acceptable to CMS, with persons or entities involved
with the Medicare Part C and/or Part D benefits below the level of
the arrangement between an organization and a first tier entity.
These written agreements continue down to the level of the ultimate
provider of both health and administrative services.
• “Related Entity” refers to any entity that is related to an
organization by common ownership or control, and
o performs some of an organization’s management functions
under contract or delegation,
o furnishes services to Medicare enrollees under an oral or
written agreement, or
o Leases real property or sells materials to the organization at a
cost of more than $2,500 during a contract period.

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

Revised Language

CPE Compliance
Officer
Questionnaire (COQ)

1. How long have you been employed with the sponsoring organization
and served as the Medicare Compliance Officer?

Technical
Clarification

1. How long have you been employed with the Sponsoring
organization and served as the Medicare Compliance Officer?

CPE Compliance
Officer
Questionnaire (COQ)
CPE Compliance
Officer
Questionnaire (COQ)
CPE Compliance
Officer
Questionnaire (COQ)

3. Do you have any other responsibilities in addition to being the
Compliance Officer for this sponsoring organization? If yes, please
describe those positions and responsibilities.

Technical
Clarification

3. Do you have any other responsibilities in addition to being the
Compliance Officer for this Sponsoring organization? If yes, please
describe those positions and responsibilities.

Technical
Clarification

6. How is the compliance department informed and kept up-to-date on
tasks and assignments that have been delegated to internal operations
and FDRs?

Technical
Clarification

4. What resources do you use to keep current on CMS
requirements, and, compliance, audit, and enforcement information
and activities? How is this information shared throughout your
organization and First Tier, Downstream, and Related Entities?
6. How is the compliance department informed and kept up-to-date
on tasks and assignments that have been delegated to internal
operations and First Tier, Downstream, and Related Entities?

CPE Compliance
Officer
Questionnaire (COQ)

7. Briefly explain how you would handle a compliance issue that
involves a Medicare operational area and/or a FDR that impacts
enrollees’ timely access to their health or drug benefits? Provide an
example if you have one.

Technical
Clarification

CPE Compliance
Officer
Questionnaire (COQ)

8. Describe how you handle, or would handle poor compliance
performance of Medicare operations within your sponsoring
organization.

Technical
Clarification

CPE Compliance
Officer
Questionnaire (COQ)
CPE Compliance
Officer
Questionnaire (COQ)
CPE Compliance
Officer
Questionnaire (COQ)

12. How do you measure employee, governing body member, and
FDR awareness and understanding of the compliance program?

Technical
Clarification

12. How do you measure employee, governing body member, and
First Tier, Downstream, and Related Entity awareness and
understanding of the compliance program?

14. What is your process to ensure written policies and procedures and
standards of conduct are available within your sponsoring
organization?

Technical
Clarification

14. What is your process to ensure written policies and procedures
and standards of conduct are available within your Sponsoring
organization?

N/A

Technical
Clarification Added question &
renumbered
remaining
questions

17. Since CMS no longer collects call logs for program audit
purposes, what has your organization done to ensure that incoming
requests are handled properly?

7. Briefly explain how you would handle a compliance issue that
involves a Medicare operational area and/or a First Tier,
Downstream, and Related Entity that impacts enrollees’ timely
access to their health or drug benefits? Provide an example if you
have one.
8. Describe how you handle, or would handle poor compliance
performance of Medicare operations within your Sponsoring
organization.

Document in
CMS-10717
(version 05/2020)
CPE First Tier
Downstream and
Related Entities
Operations
Oversight
Questionnaire
(FDR-Q)

CPE First Tier
Downstream and
Related Entities
Operations
Oversight
Questionnaire
(FDR-Q)
CPE First Tier
Downstream and
Related Entities
Operations
Oversight
Questionnaire
(FDR-Q)
CPE First Tier
Downstream and
Related Entities
Operations
Oversight
Questionnaire
(FDR-Q)
CPE First Tier
Downstream and
Related Entities
Operations
Oversight
Questionnaire
(FDR-Q)

Original Language

Please specifically note the following when completing the
questionnaire:
• “FDRs” refer to the organization’s first tier, downstream, and related
entities contracted to perform an administrative or healthcare service to
enrollees on behalf of the organization.
• “Related Entity” refers to any entity that is related to an organization
by common ownership or control, and
o performs some of the an organization’s management functions
under contract or delegation
2. How long has the individual identified in Question 1 been employed
with the organization and been involved with overseeing FDRs?

Clarification or
Change
Technical
Clarification

Revised Language

Please specifically note the following when completing the
questionnaire:
[Removed FDRs language]
• “Related Entity” refers to any entity that is related to an
organization by common ownership or control, and
o performs some of an organization’s management functions
under contract or delegation

Technical
Clarification

2. How long has the individual identified in Question 1 been
employed with the organization and been involved with overseeing
First Tier, Downstream, and/or Related Entities?

3. Briefly describe your process for determining if a potential FDR is
capable of complying with contractual, and regulatory obligations.
Who or which business operations are responsible for this process.

Technical
Clarification

3. Briefly describe your process for determining if a potential First
Tier, Downstream, and/or Related Entity is capable of complying
with contractual, and regulatory obligations. Who or which
business operations are responsible for this process.

5. Please describe your criteria/process for determining which
delegated entities are identified as FDRs subject to Medicare
compliance requirements.

Technical
Clarification

5. Please describe your criteria/process for determining which
delegated entities are identified as First Tier, Downstream, and/or
Related Entities subject to Medicare compliance requirements.

7. Describe the communications process between the Compliance
Department and FDR Oversight for Medicare requirements, policy
updates, performance concerns, or issues with FDRs. At minimum,
please include the process for communications about, or for, first tier
entities such as your PBM, appeals and grievances,
enrollment/membership functions, coverage or claims adjudication,
network management, etc.

Technical
Clarification

7. Describe the communications process between the Compliance
Department and First Tier, Downstream, and/or Related Entity
Oversight for Medicare requirements, policy updates, performance
concerns, or issues with First Tier, Downstream, and/or Related
Entities. At minimum, please include the process for
communications about, or for, first tier entities such as your PBM,
appeals and grievances, enrollment/membership functions,
coverage or claims adjudication, network management, etc.

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Original Language

Clarification or
Change

Revised Language

CPE First Tier
Downstream and
Related Entities
Operations
Oversight
Questionnaire
(FDR-Q)

8. How do you ensure compliance issues involving a FDR is
communicated to upper management (e.g., compliance committee,
senior managers, Board of Directors, CEO)? Please provide a recent
example/scenario.

Technical
Clarification

8. How do you ensure compliance issues involving a First Tier,
Downstream, and/or Related Entity is communicated to upper
management (e.g., compliance committee, senior managers, Board
of Directors, CEO)? Please provide a recent example/scenario.

9. How do you share information with FDRs on your organization’s
culture, compliance and productivity expectations, CMS regulations,
and policy for the Medicare function performed on the organization’s
behalf?

Technical
Clarification

9. How do you share information with First Tier, Downstream,
and/or Related Entities on your organization’s culture, compliance
and productivity expectations, CMS regulations, and policy for the
Medicare function performed on the organization’s behalf?

10. What types of monitoring reports do you receive from FDRs, and
how often?

Technical
Clarification

10. What types of monitoring reports do you receive from First
Tier, Downstream, and/or Related Entities, and how often?

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

Technical
Clarification

12. What happens or is the consequence if a First Tier,
Downstream, and/or Related Entity fails to satisfactorily implement
a corrective action plan or commits a serious act of noncompliance
with a Medicare requirement that affects enrollees from receiving
their health care or drug benefit appropriately or timely?

Technical
Clarification

To evaluate performance in the areas outlined in this Program Audit
Protocol and Data Request related to Part D Formulary and Benefit
Administration (FA). The Centers for Medicare and Medicaid
Services (CMS) performs its program audit activities in accordance
with the FA Program Audit Data Request and applying the
compliance standards outlined in this Program Audit Protocol and
the Program Audit Process Overview document. At a minimum,
CMS will evaluate cases against the criteria listed below. CMS may
review factors not specifically addressed below if it is determined
that there are other related FA requirements not being met.

Document in
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Original Language

Clarification or
Change

Revised Language

FA Protocol
Method of
Evaluation column
of the protocol

[Font Sizes 8, 9 and 10]

Technical
Clarification

[Font Size 10]

FA Protocol
Compliance
Standard Universe
Integrity Testing

[Data Request]
Universe Table 1: Rejected Claims Formulary Administration (RCFA)
Universe Table 2: Rejected Claims Transition- New Contract Year
(RCT-N)
Universe Table 3: Rejected Claims Transition- Previous Contract Year
(RCT-P)

Technical
Clarification

[Data Request]
Universe Table 1: Rejected Claims Formulary Administration
(RCFA)
Universe Table 2: Rejected Claims Transition (RCT)

FA Protocol
Compliance
Standard 1.1
Compliance
Standard 1.2
FA Protocol
Compliance
Standard 1.5

[Method of Evaluation]
Select 5 cases from each universe, Tables 1 through 3, for a total of 15
cases.
Prior to field work, CMS will schedule a webinar with the Sponsoring
organization to verify accuracy of data within each rejected claims
universe submission for each of the sampled cases.
Sample selections will be provided to the Sponsoring organization
approximately one hour prior to the scheduled webinar.
[Criteria Effective 01/01/2021] Contract with Part D Sponsors

[Data Request]
Universe Table 1: Rejected Claims Formulary Administration (RCFA)
Universe Table 2: Rejected Claims Transition- New Contract Year
(RCT-N)
Universe Table 4: Prescription Drug Event (PDE) Data

[Method of Evaluation]
Select 5 cases from each universe, Tables 1 and 2, for a total of 10
cases.
Prior to field work, CMS will schedule a webinar with the
Sponsoring organization to verify accuracy of data within each
rejected claims universe submission for each of the sampled cases.
Sample selections will be provided to the Sponsoring organization
approximately one hour prior to the scheduled webinar.

Technical
Clarification

[Criteria Effective 01/01/2021]
Part D Contract with CMS

Technical
Clarification

[Data Request]
Universe Table 1: Rejected Claims Formulary Administration
(RCFA)
Universe Table 2: Rejected Claims Transition (RCT)
Universe Table 3: Prescription Drug Event (PDE) Data

Document in
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FA Protocol
Compliance
Standard 2.1

Original Language

[Data Request]
Universe Table 2: Rejected Claims Transition- New Contract Year
(RCT-N)
Universe Table 3: Rejected Claims Transition- Previous Contract Year
(RCT-P)
Table 4: Prescription Drug Event (PDE) Data
Universe Table 5: New Enrollee (NE)
[Method of Evaluation]
Select a targeted sample of up to 15 claims from Universe Tables 2 and
3 for continuing enrollees as follows: 7 claims for non-protected class
drugs and 8 claims for protected class drugs. If the target number of
claims are not available for one group (e.g. protected class drugs),
consider supplementing with claims from the other group (e.g., nonprotected class drugs).
Select a targeted sample of up to 15 claims from Universe Tables 2 and
3 for new enrollees as follows: 7 claims for non-protected class drugs
and 8 claims for protected class drugs. If the target number of claims
are not available for one group (e.g. protected class drugs), consider
supplementing with claims from the other group (e.g., non-protected
class drugs).
• New and continuing members eligible for a transition fill are afforded
the full transition benefit consistent with the submitted enrollment and
disenrollment date.
• For continuing members that have prior history of the drug determine
the type of change that occurred between contract years for that drug.
• Enrollees with a November or December effective enrollment date
are afforded a full new enrollee transition benefit as well as a full
continuing enrollee transition benefit, if applicable

Clarification or
Change
Technical
Clarification

Revised Language

[Data Request]
Universe Table 1: Rejected Claims Formulary Administration
(RCFA)
Universe Table 2: Rejected Claims Transition (RCT)
Universe Table 3: Prescription Drug Event (PDE) Data
Universe Table 4: New Enrollee (NE)
[Method of Evaluation]
Select a targeted sample of up to 15 claims from Universe Table 2
for continuing enrollees.
Select a targeted sample of up to 15 claims from Universe Table 2
for new enrollees.
• New and continuing enrollees eligible for a transition fill are
afforded the full transition benefit consistent with the submitted
enrollment and disenrollment date.
• For continuing enrollees that have prior history of the drug
determine the type of change that occurred between contract years
for that drug.
• Enrollees with a November or December effective enrollment date
are afforded a full continuing enrollee transition benefit, if
applicable.

Document in
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Original Language

Clarification or
Change

Revised Language

FA Protocol
Compliance
Standard 2.2

[Data Request]
Universe Table 2: Rejected Claims Transition- New Contract Year
(RCT-N)
Universe Table 3: Rejected Claims Transition- Previous Contract Year
(RCT-P)
Universe Table 4: Prescription Drug Event (PDE) Data
Universe Table 5: New Enrollee (NE)

Technical
Clarification

FA Protocol
Audit Engagement
and Universe
Submission Phase
Universe Requests

Universe Requests
1. Universe Table 1: Rejected Claims Formulary Administration
(RCFA) Record Layout
2. Universe Table 2: Rejected Claims Transition – New Contract Year
(RCT-N) Record Layout
3. Universe Table 3: Rejected Claims Transition – Previous Contract
Year (RCT-P) Record Layout
4. Universe Table 4: Prescription Drug Event (PDE) Data Record
Layout
5. Universe Table 5: New Enrollee (NE) Record Layout
Table 3: Submit all rejected claims with dates of service for November
and December of the contract year immediately prior to the audit year
for all enrollees with effective enrollment dates of November or
December of the contract year immediately prior to the audit year.
Table 4: Submit all final action PDEs accepted by CMS with dates of
service September – December of the contract year immediately prior
to the audit year for all enrollees in Tables 2 and 3.
Table 5: Sponsoring organizations with –
• < 100,000 enrollees: submit all enrollees with effective enrollment
dates 11/1/previous audit year (i.e., 2018) through 2/1/current audit
year (i.e., 2019).
• ≥ 100,000 enrollees: submit all enrollees with effective enrollment
dates 11/1/previous audit year (i.e., 2018) through 1/1/current audit
year (i.e., 2019).

Technical
Clarification

Universe Requests
1. Universe Table 1: Rejected Claims Formulary Administration
(RCFA) Record Layout
2. Universe Table 2: Rejected Claims Transition (RCT) Record
Layout
3. Universe Table 3: Prescription Drug Event (PDE) Data Record
Layout
4. Universe Table 4: New Enrollee (NE) Record Layout

Technical
Clarification

Table 3: Submit all final action PDEs accepted by CMS with dates
of service September – December of the contract year immediately
prior to the audit year for all enrollees in Table 2 and enrollees with
effective enrollment dates of November and December of the
contract year immediately prior to the audit year.
Table 4: Sponsoring organizations with –
• < 100,000 enrollees: submit all enrollees with effective enrollment
dates 11/1/previous audit year through 2/1/current audit year.
• ≥ 100,000 enrollees: submit all enrollees with effective enrollment
dates 11/1/previous audit year through 1/1/current audit year.

FA Protocol
Universe Record
Layout/ Scope of
Universe Request

Document in
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FA Protocol
Universe Requests

FA Protocol
Contract ID
Tables 1-2: Column
ID H
Table 3: Column ID
F
Table 2IA: Column
ID B
Table 4: Column ID
H
FA Protocol
NDC
Table 1-2: Column
ID J
Table 3: Column ID
H
Table 2IA: Column
ID I
Related Drug NDC
Table 2IA: Column
ID V
FA Protocol
Universe Table 3:
Prescription Drug
Event (PDE) Data
Record Layout

Original Language

Clarification or
Change

1. Universe Table 1: Rejected Claims Formulary Administration
(RCFA) Record Layout
2. Universe Table 2: Rejected Claims Transition – New Contract Year
(RCT-N) Record Layout
3. Universe Table 3: Rejected Claims Transition – Previous Contract
Year (RCT-P) Record Layout

Technical
Clarification

[Table 1, Table 2, Table 3 & Table 2IA Description]
Enter the contract number (e.g., H1234) of the organization.

Technical
Clarification

Please use the guidance below for the following record layouts:
Universe Table 1: Rejected Claims Formulary Administration
(RCFA) Record Layout
Universe Table 2: Rejected Claims Transition – New Contract Year
(RCT-N) Record Layout

[Table 4 Description] Enter the contract number (e.g., H1234, S1234)
of the organization.

[Description]
Enter the 11-Digit National Drug Code using the NDC 11 format.
Remove special characters separating the labeler, product, and trade
package size.
When less than 11 characters or a blank field is submitted by the
pharmacy or delegate, populate the field as submitted.
If the pharmacy submits a value greater than 11 characters, enter
“valueXeeded” in the field.
For multi-ingredient compound claims populate the field with the NDC
of the most expensive drug (or as submitted on the associated PDE).
When compound claims do not include any Part D drug products,
populate the field with “00000000000” consistent with the NDC 11
format.
[Table Name]
Universe Table 4: Prescription Drug Event (PDE) Data Record Layout

Revised Language

[Table 1, Table 2, Table 3 & Table 2IA Description]
Enter the contract number (e.g., H1234) of the Sponsoring
organization.
[Table 4 Description]
Enter the contract number (e.g., H1234, S1234) of the Sponsoring
organization.

Technical
Clarification

[Table Name]
Universe Table 3: Prescription Drug Event (PDE) Data Record
Layout

Document in
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Original Language

Clarification or
Change

Revised Language

FA Protocol
Table 3: PDE
Table Instructions

o Include PDEs only for the period requested for enrollees from the
rejected claims transition universes Tables 2 and 3 (including enrollees
enrolled in employer plans and Medicare-Medicaid Plans (MMPs)).

Technical
Clarification

o Include PDEs only for the period requested for enrollees from the
rejected claims transition universe Table 2 (including enrollees
enrolled in employer plans and Medicare-Medicaid Plans (MMPs)).

FA Protocol
Universe Table 4:
New Enrollee (NE)
Record Layout
FA Protocol
Audit Field Work
Phase
Supporting
Documentation
Submissions
FA Protocol
Table 1IA: IAS
Table Instructions

[Table Name]
Universe Table 5: New Enrollee (NE) Record Layout

Technical
Clarification

[Table Name]
Universe Table 4: New Enrollee (NE) Record Layout

During audit field work, CMS will review 30 samples selected from
Table 1 and up to 30 samples from Tables 2 and 3 to determine
whether the Sponsoring organization is compliant with its Part D
contract requirements.

Technical
Clarification

During audit field work, CMS will review 30 samples selected from
Table 1 and up to 30 samples from Table 2 to determine whether
the Sponsoring organization is compliant with its Part D contract
requirements.

• Include all medications and enrollees impacted by the issue of noncompliance. This should include medications affected by rejected
claims in addition to non-compliant authorization records that may not
have an associated rejected claim.

Technical
Clarification

• Include all medications impacted by the issue, including those that
may not have an associated rejected claim.

FA Protocol
Methodology for
Identifying Impact
of Noncompliance
List of Medications
Affected
Table 1IA: Column
IDs A & B

N/A

Technical
ClarificationAdded Fields &
relettered
remaining
Column IDs in the
table

Field Type: CHAR Always Required

FA Protocol
Table 2IA: ENR-IA
Table Instructions

• Include all enrollees impacted by the issue of non-compliance.
• Include enrollees affected by rejected claims in addition to noncompliant authorization records that may not be associated with a
claim. For enrollees that have an inappropriate authorization record
with no associated rejected claim, Sponsoring organizations should
only complete the following fields: Cardholder ID, Contract ID, Plan
ID, Effective Date of Enrollment, Is enrollee currently enrolled, and
Drug Name and Strength.

Technical
Clarification

Field Length: 4,000
Description: Describe the process undertaken to determine the
medications and enrollees impacted by the issue of noncompliance.
Description: Provide the list of medications at the RXCUI level (by
drug name, strength, and dosage form) affected by the issue in
vertical list format.
• Include the following data for impacted enrollees:
• Rejected claims affected by the issue of noncompliance;
• Inaccurate records (i.e. authorization, enrollment records) that
may not be associated with a rejected claim. In this scenario,
Sponsoring organizations should only complete the following
fields: Enrollee ID, Contract ID, Plan Benefit Package (PBP),
Enrollment Effective Date, Is enrollee currently enrolled, and Drug
Name and Strength (if applicable).

Document in
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Original Language

FA Protocol
Process Date of
Subsequent Paid
Claim
Table 2IA: Column
ID R

[Description]
Enter the date of the paid claim subsequent to the rejected claim having
the same RXCUI. Submit in (CCYY/MM/DD) format (e.g.,
2020/01/01). Enter NA if never received.

Technical
Clarification

[Description]
Enter the date of the paid claim subsequent to the rejected claim for
the medication utilizing the same RXCUI, GPI, GCN, or HICL.
Submit in CCYY/MM/DD format. (e.g., 2020/01/01). Enter NA if
never received.

FA Protocol
Number of Hours
Enrollee Went
Without Medication
(Target or Related)
Table 2IA: Column
ID AA
FA Supplemental
Questionnaire

[Description]
If the value in the field “Number of Days Enrollee Went Without
Medication” is 0 or 1. Enter the difference between the date and time
of the rejected and paid claim. A whole number is acceptable in this
field.

Technical
Clarificationremoved field &
relettered
remaining
Column IDs in the
table
Technical
Clarification

N/A

CDAG Protocol
Program Audit
Protocol
Purpose

Technical
Clarification

CDAG Protocol
Compliance
Standard 2.6

Universe Table 3: Payment Coverage Determination and
Redeterminations
Universe Table 4: Standard and Expedited Redeterminations

Technical
Clarification

To evaluate performance in the areas outlined in this Program
Audit Protocol and Data Request related to Part D Coverage
Determinations, Appeals and Grievances (CDAG). The Centers
for Medicare and Medicaid Services (CMS) performs its program
audit activities in accordance with the CDAG Program Audit
Data Request and applying the compliance standards outlined in
this Program Audit Protocol and the Program Audit Process
Overview document. At a minimum, CMS will evaluate cases
against the criteria listed below. CMS may review factors not
specifically addressed below if it is determined that there are
other related CDAG requirements not being met.
Universe Table 3: Payment Coverage Determination and
Redeterminations (PYMT_D)
Universe Table 4: Standard and Expedited Redeterminations (RD)

If yes, do not include these enrollees in Table 5: New Enrollee
Universe. If no, include these enrollees in Table 5: New Enrollee
Universe.

Clarification or
Change

Revised Language

If yes, do not include these enrollees in Table 4: New Record
Layout. If no, include these enrollees in Table 4: New Enrollee
Record Layout.

Document in
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(version 05/2020)
CDAG Protocol
Compliance
Standard 3.1

CDAG Protocol
Compliance
Standard 3.2

Original Language

[Data Request]
Universe Table 1: Standard and Expedited Coverage Determination
(CD)
Universe Table 2: Standard and Expedited Coverage Determination
Exception Requests (CDER)
Universe Table 3: Payment Coverage Determinations and
Redeterminations (PYMT_D)
Universe Table 4: Standard and Expedited Redeterminations (RD)
Universe Table 6: Part D Standard and Expedited Grievances
[Method of Evaluation]
Select up to 10 dismissed cases from Tables 1-4 and 6.
Universe Table 6: Part D Standard and Expedited Grievances

Clarification or
Change
Technical
Clarification

Revised Language

[Data Request]
Universe Table 1: Standard and Expedited Coverage Determination
(CD)
Universe Table 2: Standard and Expedited Coverage Determination
Exception Requests (CDER)
Universe Table 3: Payment Coverage Determinations and
Redeterminations (PYMT_D)
Universe Table 4: Standard and Expedited Redeterminations (RD)
[Method of Evaluation]
Select up to 10 dismissed cases from Tables 1-4.

Technical
Clarification

Universe Table 6: Part D Standard and Expedited Grievances
(GRV_D)

CDAG Protocol
Compliance
Standards 4.1, 4.2 &
4.3
CDAG Protocol
Table 1: CD
Table Instructions

Also review case file documentation to ensure Sponsoring organization
made an effort to provide the beneficiary's prescriber(s) of frequently
abused drugs with a copy of the notice.

Technical
Clarification

Also review case file documentation to ensure Sponsoring
organization made reasonable efforts to provide the beneficiary's
prescriber(s) of frequently abused drugs with a copy of the notice.

Each coverage determination request must be listed as its own line
item in the submitted universe (i.e., if multiple requests are made at the
same time but processed as separate cases, enter each case in a separate
row, if a coverage determination request contains multiple distinct
disputes (i.e., multiple drugs), enter each drug in a separate row).

Technical
Clarification

CDAG Protocol
Table 2: CDER
Table Instructions

Each exception request must be listed as its own line item in the
submitted universe (i.e., if multiple requests are made at the same time
but processed as separate cases, enter each case in a separate row).
Requests involving multiple UM criteria that were processed as one
case must be entered as a single line item. If an exception request
contains multiple distinct disputes (i.e., multiple drugs), enter each
drug in a separate row.

Technical
Clarification

Each coverage determination request must be listed as its own line
item in the submitted universe.
If a request for multiple drugs is made at the same time, enter each
drug in a separate row.
Requests for a single drug involving multiple UM criteria (e.g. step
therapy and a prior authorization) must be entered as a single line
item.
Each exception request must be listed as its own line item in the
submitted universe.
If a request for multiple drugs is made at the same time, enter each
drug in a separate row. Requests for a single drug involving
multiple exception types (e.g., tiering exception, prior authorization
exception, quantity limit exception, and step therapy exception)
must be entered as a single line item.

Document in
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CDAG Protocol
Table 3: PYMT_D
Table Instructions

CDAG Protocol
Table 4: RD
Table Instructions

Original Language

The date of the Sponsoring organization’s determination (Column ID
S) must fall within the universe request period.

Clarification or
Change
Technical
Clarification

Revised Language

The date of the Sponsoring organization’s determination (Column
ID T) must fall within the universe request period.

Each request must be listed as its own line item in the submitted
universe (i.e., if multiple requests are made at the same time but
processed as separate cases, enter each case in a separate row. If a
request contains multiple distinct disputes (i.e., multiple drugs), enter
each drug in a separate row).

Each payment request must be listed as its own line item in the
submitted universe.
If a request for multiple drugs is made at the same time, enter each
drug in a separate row. Requests for a single drug must be entered
as a single line item.

Exclude all requests processed as coverage determinations and any
requests for coverage that were withdrawn.
Each redetermination request must be listed as its own line item in the
submitted universe (i.e., if multiple requests are made at the same time
but processed as separate cases, enter each case in a separate row. If a
redetermination request contains multiple disputes (i.e., multiple
drugs), enter each drug in a separate row).

Exclude requests for coverage that were withdrawn.
Technical
Clarification

Exclude all requests processed as payment redeterminations,
withdraws, and direct member reimbursement requests.

Each redetermination request must be listed as its own line item in
the submitted universe.
If a request for multiple drugs is made at the same time, enter each
drug in a separate row.
Requests for a single drug involving multiple UM criteria (e.g. step
therapy and prior authorization) must be entered as a single line
item.
Exclude all requests processed as payment redeterminations and
withdrawn cases.

CDAG Protocol
Table 5: EFF_D
Table Instructions

If a case contains multiple distinct disputes (i.e., multiple drugs), enter
each drug in a separate row.

Technical
Clarification

Exclude any cases that were re-opened by the Sponsoring
organization or that were dismissed or upheld by the IRE, ALJ, or
MAC.

Exclude any cases that were re-opened or that were dismissed or
upheld by the IRE, ALJ, or MAC.
CDAG Protocol
Table 6: GRV_D
Table Instructions

Include all grievances the Sponsoring organization responded to during
the universe request period. The date of the Sponsoring organization’s
response (Column ID P or R) must fall within the universe request
period.
Exclude all grievances that were withdrawn during the universe
request period.

If a case contains multiple drugs, enter each drug in a separate row.

Technical
Clarification

Include all grievances the Sponsoring organization responded to
during the universe request period. The date of the Sponsoring
organization’s notification (Column ID P or R) must fall within the
universe request period.
Exclude all grievances that were withdrawn and dismissed during
the universe request period.

Document in
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Original Language

CDAG Protocol
NDC
Tables 1-5: Column
ID G

[Tables 1, 2 & 3 Description]
For multi-ingredient compound claims populate the field with the NDC
of the most expensive drug (or as submitted on the associated PDE).
When compound claims do not include any Part D drug products,
populate the field with “00000000000” consistent with the NDC 11
format.

CDAG Protocol
Authorization or
Claim Number
Tables 1-5: Column
ID I

[Tables 4 & 5 Description]
When less than 11 characters or a blank field is submitted by the
pharmacy or delegate, populate the field as submitted.
For multi-ingredient compound claims populate the field with the NDC
of the most expensive drug (or as submitted on the associated PDE).
When compound claims do not include any Part D drug products,
populate the field with “00000000000” consistent with the NDC 11
format.
[Description]
Enter the associated authorization number for this request. If an
authorization number is not available, provide the internal tracking or
case number.

Clarification or
Change
Technical
Clarification

Table 3: Column ID
K

[Tables 1, 2, 3, 4 & 6 Description] Enter None if no AOR or equivalent
written notice was received.
Enter NA if no AOR or equivalent written notice was required.

[Tables 1, 2 & 3 Description]
For multi-ingredient compound claims populate the field with the
NDC as submitted on the associated PDE.
[Tables 4 & 5 Description]
When less than 11 characters or a blank field is submitted by the
pharmacy or delegate, or NDC is not applicable (e.g., for at-risk
redeterminations), populate the field as submitted.
For multi-ingredient compound claims populate the field with the
NDC as submitted on the associated PDE.

Technical
Clarification

Enter None if there is no authorization or other tracking number
available.
CDAG Protocol
AOR/Equivalent
notice Receipt Date
Tables 1, 2 & 4:
Column ID L

Revised Language

[Description]
Enter the associated authorization or claim number for this request.
If an authorization or claim number is not available, provide the
internal tracking or case number.
Enter None if there is no authorization, claim or other tracking
number available.

Technical
Clarification

[Tables 1, 2, 3 & 4 Description]
Enter None for dismissed cases or if no AOR or equivalent written
notice was received or required.
[Table 6 Description]
Enter None if no AOR or equivalent written notice was received or
required.

Table 6: Column ID
H

Document in
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CDAG Protocol
AOR/Equivalent
notice Receipt Time
Tables 1, 2 & 4:
Column ID M

Original Language

[Tables 1, 2, 4 & 6 Description]
Enter None if no AOR or equivalent written notice was received.
Enter NA if no AOR or equivalent written notice was required.
Enter NA for dismissed cases.

Clarification or
Change
Technical
Clarification

Table 3: Column ID
M

CDAG Protocol
Was the original
request made under
the standard
timeframe and later
requested to be
expedited?
Tables 1, 2 & 4:
Column ID P

[Tables 1 & 2 Description]
Enter None for dismissed cases or if no AOR or equivalent written
notice was received or required.
[Table 4 Description]
Enter None for standard cases, dismissed cases or if no AOR or
equivalent written notice was received or required.

Table 6: Column ID
I

CDAG Protocol
Request
Determination
Tables 1, 2 & 4:
Column ID N

Revised Language

[Description]
Enter:
• Approved
• Denied
• IRE auto-forward
• Re-opened Approved
• Re-opened Denied
• Dismissed

Technical
Clarificationmoved field up in
order within the
record layout for
consistency with
ODAG &
relettered
remaining
Column IDs in the
tables.

[Description]
Enter:
• Y for Yes
• N for No
• NA if the request was made under the expedited timeframe.

Technical
Clarification

Field Length: 2

[Table 6 Description]
Enter None for standard cases or if no AOR or equivalent written
notice was received or required.
[Description]
Enter:
• Approved
• Denied
• IRE auto-forward
• Re-opened Approved
• Re-opened Denied
• Dismissed

[Description]
Enter:
• Y for Yes
• N for No
• None if the request was made under the expedited timeframe.
Field Length: 4

Document in
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CDAG Protocol
Date request was
upgraded to
expedited
Tables 1, 2 & 4:
Column ID Q
Time the request
was upgraded to
expedited
Tables 1, 2 & 4:
Column ID R
CDAG Protocol
Issue Description
Tables 1, 2 & 4:
Column ID S

Original Language

Clarification or
Change

Revised Language

[Description]
Enter NA if the initial request was made under the expedited
timeframe or if the Sponsoring organization chose not to expedite the
request.

Technical
Clarification

[Description]
Enter None if the initial request was made under the expedited
timeframe, if the Sponsoring organization chose not to expedite the
request, or if the request was received and processed under the
standard timeframe.

[Description]
Enter a description of the issue and, if applicable, why the request was
denied.

Technical
Clarification

[Description]
Enter a description of the issue and, if applicable, why the request
was denied.
For dismissed cases, provide the reason for dismissal.

Table 3: Column ID
O
CDAG Protocol
Formulary UM
Type
Table 1: Column ID
T

[Description]
Enter the formulary UM criteria the enrollee satisfied or was
attempting to satisfy. Enter:
• PA for Prior Authorization
• ST for Step Therapy
• QL for Quantity Limit
If the case was a safety edit enter:
• SE for Safety Edit

Technical
Clarification

[Description]
Enter the formulary UM criteria the enrollee satisfied or was
attempting to satisfy. Enter:
• PA for Prior Authorization
• ST for Step Therapy
If multiple formulary UM criteria apply, enter the criteria
applicable based on the approval or denial reason.

Enter NA if the request was not an attempt to satisfy formulary UM
criteria or was not a safety edit.
If multiple formulary UM criteria apply, enter the criteria applicable
based on the approval or denial reason.

Document in
CMS-10717
(version 05/2020)

Original Language

CDAG Protocol
Date of
Determination
Table 1: Column ID
U
Table 2: Column ID
X
Table 3: Column ID
T
Table 4: Column ID
W

[Tables 1, 2 & 3 Description] Enter the date of the determination.
Submit in CCYY/MM/DD format (e.g., 2020/01/01).

CDAG Protocol
Time of
Determination
Table 1: Column ID
V
Table 2: Column ID
Y
Table 4: Column ID
X
CDAG Protocol
Date effectuated in
the system
Table 1: Column ID
W
Table 2: Column ID
Z
Table 3: Column ID
U
Table 4: Column ID
Y

[Tables 1 & 2 Description]
Enter the time of the determination. Submit in HH:MM:SS military
time format (e.g., 23:59:59).

Time effectuated in
the system
Table 1: Column ID
X
Table 2: Column ID
AA
Table 4: Column ID
Z

Clarification or
Change
Technical
Clarification

[Description]
Enter the date of the determination. Submit in CCYY/MM/DD
format (e.g., 2020/01/01). For dismissed cases, enter the date the
sponsoring organization dismissed the request.

Technical
Clarification

[Tables 1 & 2 Description]
Enter the time of the determination. Submit in HH:MM:SS military
time format (e.g., 23:59:59).
Enter None for dismissed cases.

[Table 4 Description]
Enter the date of the Sponsoring organization's determination. Submit
in CCYY/MM/DD format (e.g., 2020/01/01).

[Table 4 Description]
Enter the time of the Sponsoring organization’s determination. Submit
in HH:MM:SS military time format (e.g., 23:59:59.
For standard cases entering NA is an acceptable response.
[Table 1 Description]
Enter NA for requests that were not approved.

Revised Language

Technical
Clarification

[Table 4 Description]
Enter the time of the determination. Submit in HH:MM:SS military
time format (e.g., 23:59:59).
Enter None for standard cases and dismissed cases.
[Table 1 Description]
Enter None for requests that were not approved.

[Table 2 Description]
Enter NA if the exception was not approved.

[Table 2 Description]
Enter None if the exception was not approved.

[Table 3 Description]
Enter NA if the payment request was not approved.

[Table 3 Description]
Enter None if the payment request was not approved.

[Table 4, Column ID Y Description] Enter NA for requests that were
not approved.

[Table 4, Column ID Y Description]
Enter None for requests that were not approved.

[Table 4, Column ID Z Description] Enter NA for requests that were
not approved. For standard cases entering NA is also an acceptable
response.

[Table 4, Column ID Z Description]
Enter None for standard cases and requests that were not approved.

Document in
CMS-10717
(version 05/2020)
CDAG Protocol
Date oral
notification
provided to enrollee
Table 1: Column ID
Y
Table 2: Column ID
AC
Table 4: Column ID
AB
Time oral
notification
provided to enrollee
Table 1: Column ID
Z
Table 2: Column ID
AD
Table 4: Column ID
AC
CDAG Protocol
Date written
notification
provided to enrollee
Table 1: Column ID
AA
Table 2: Column ID
AE
Table 3: Column ID
W
Table 4: Column ID
AD

Original Language

[Table 1 Description]
Enter None if no oral notification was provided.

Clarification or
Change
Technical
Clarification

[Table 2 Description]
Enter None if no oral notification was attempted or provided.

Revised Language

[Table 1 Description]
Enter None for dismissed cases or if no oral notification was
provided.
[Table 2 Description]
Enter None for dismissed cases or if no oral notification was
provided.

[Table 4, Column ID AB Description] Enter None if no oral
notification was attempted or provided.

[Table 4, Column ID AB Description]
Enter None for standard cases, dismissed cases or if no oral
notification was provided.

[Table 4, Column ID AC Description] Enter None if no oral
notification was attempted or provided. For standard cases, entering
NA is an acceptable response.

[Table 4, Column ID AC Description]
Enter None for standard cases, dismissed cases or if no oral
notification was provided.

[Tables 1, 3 & 4 Description]
Enter the date written notification of determination was provided (i.e.
delivered) to enrollee. Do not enter the date a letter is generated or
printed. Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None for if no written notification was provided.

Technical
Clarification

[Tables 1, 2, 3 & 4 Description]
Enter the date written notification of determination was provided to
enrollee. Do not enter the date a letter is generated or printed.
Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no written notification was provided.

[Table 2 Description]
Enter the date written notification was of determination provided (i.e.
delivered) to enrollee. Do not enter the date a letter is generated or
printed. Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no written notification was provided.

Document in
CMS-10717
(version 05/2020)

Original Language

CDAG Protocol
Time written
notification
provided to enrollee
Table 1: Column ID
AB
Table 2: Column ID
AF
Table 4: Column ID
AE

[Tables 1 & 2 Description]
Enter the time written notification of determination was provided (i.e.
delivered) to the enrollee. Do not enter the time a letter is generated or
printed. Submit in HH:MM:SS military time format (e.g., 23:59:59).
Enter None if no written notification was provided.
Enter NA for dismissed cases.

CDAG Protocol
Who made the
request?
Table 1: Column ID
AC
Table 2: Column ID
AG
Table 3: Column ID
X
Table 4: Column ID
AF

N/A

Clarification or
Change
Technical
Clarification

[Table 4 Description]
Enter the time written notification of determination was provided (i.e.
delivered) to the enrollee. Do not enter the time a letter is generated or
printed. Submit in HH:MM:SS military time format (e.g., 23:59:59).
Enter None if no written notification was provided.
Enter NA for standard and dismissed cases.

Revised Language

[Tables 1 & 2 Description]
Enter the time written notification of determination was provided to
the enrollee. Do not enter the time a letter is generated or printed.
Submit in HH:MM:SS military time format (e.g., 23:59:59).
Enter None for dismissed cases or if no written notification was
provided.
[Table 4 Description]
Enter the time written notification of determination was provided to
the enrollee. Do not enter the time a letter is generated or printed.
Submit in HH:MM:SS military time format (e.g., 23:59:59).
Enter None for standard cases, dismissed cases or if no written
notification was provided.

Technical
ClarificationAdded Field

Field Type: CHAR Always Required
Field Length: 2
Field Description: Enter who made the request:
• E for enrollee
• ER for enrollee’s representative
• P for prescribing physician or other prescriber

Document in
CMS-10717
(version 05/2020)
CDAG Protocol
Date forwarded to
IRE
Table 1: Column ID
AD
Table 2: Column ID
AH
Table 3: Column ID
Z
Table 4: Column ID
AG
Time forwarded to
IRE
Table 1: Column ID
AE
Table 2: Column ID
AI
Table 4: Column ID
AH
CDAG Protocol
Formulary UM
Exception Type
Tables 2 and 4:
Column ID U
Table 3: Column ID
Q
CDAG Protocol
Date prescriber
supporting
statement received
Table 2: Column ID
V
Table 3: Column ID
R

Original Language

Clarification or
Change

Revised Language

[Description]
Enter NF if the request was not forwarded to the IRE.

Technical
Clarification

[Description]
Enter None if the request was not forwarded to the IRE.

[Description]
Enter NA if the request was not a formulary UM exception or safety
edit exception.

Technical
Clarification

[Description]
Enter None if the request was not a formulary UM exception or
safety edit exception.

Field Length: 2

[Description]
Enter NA if no prescriber supporting statement was received.

Field Length: 4

Technical
Clarification

[Description]
Enter None if no prescriber supporting statement was received.

Time prescriber
supporting
statement received
Table 2: Column ID
W

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

CDAG Protocol
Expiration date of
the approval
Table 2: Column ID
AB
Table 3: Column ID
V
Table 4: Column ID
AA
Table 5: Column ID
P
CDAG Protocol
Type of Request
Table 3: Column ID
L

[Table 2 Description]
Enter NA if the exception was not approved.

N/A

Technical
ClarificationAdded Field

Field Type: CHAR Always Required
Field Length: 30
Field Description: Enter:
• payment coverage determination
• payment redetermination

CDAG Protocol
Exception Type
Table 3: Column ID
P
Table 4: Column ID
T
CDAG Protocol
Was the coverage
determination
request denied for
lack of medical
necessity?
Table 3: Column ID
S
Table 4: Column ID
V

[Description]
Enter NA if the request was not an exception request.

Technical
Clarification

[Description]
Enter None if the request was not an exception request.

[Table 3 Description]
NA if the request was not denied (i.e., approved, auto-forwarded,
dismissed).

Technical
Clarification

[Table 3 Description]
None if the request was not denied (i.e., approved, auto-forwarded,
dismissed).

CDAG Protocol
Date reimbursement
provided
Table 3: Column ID
Y
Table 5: Column ID
O

Technical
Clarification

Revised Language

[Table 2 Description]
Enter None if the exception was not approved.

[Tables 3 & 4 Description]
Enter NA if the exception was not approved or if the request was not
an exception request.

[Tables 3 & 4 Description]
Enter None if the exception was not approved or if the request was
not an exception request.

[Table 5 Description]
Enter NA if it was not an exception request.

[Table 5 Description]
Enter None if it was not an exception request.

[Table 4 Description]
Enter:
• Y for Yes
• N for No

[Table 4 Description]
Enter:
• Y for Yes
• N for No
• None if the request was auto-forwarded

Field Length: 2
[Table 3 Description]
Enter NA if the request was not approved.
[Table 5 Description]
Enter the date the check or reimbursement was provided (i.e.
delivered) to the enrollee. Submit in CCYY/MM/DD format (e.g.,
2020/01/01).

Technical
Clarification

Field Length: 4
[Table 3 Description]
Enter None if the request was not approved.
[Table 5 Description]
Enter the date the check or reimbursement was provided to the
enrollee. Submit in CCYY/MM/DD format (e.g., 2020/01/01).

Document in
CMS-10717
(version 05/2020)
CDAG Protocol
Drug Name,
Strength, and
Dosage Form
Table 4: Column ID
F
CDAG Protocol
Is this a protected
class drug?
Tables 4-5: Column
ID H

Original Language

Clarification or
Change

Enter NA if not applicable.

Technical
Clarification

Enter None if not applicable.

[Table 4 Description]
Y for Yes
N for No
NA if not applicable

Technical
Clarification

[Table 4 Description]
Y for Yes
N for No
[Table 5 Description]
Y for Yes
N for No
None if not applicable

[Table 5 Description]
Y for Yes
N for No

CDAG Protocol
Time the request
was received
Table 4: Column ID
K

Revised Language

Field Length: 1
[Description]
If a reconsideration request became valid based on the establishment of
good cause, enter the time the Sponsoring organization received the
information establishing good cause.

Technical
Clarification

Field Length: 4
[Description]
If the Sponsoring organization obtained information establishing
good cause after the 60-day filing timeframe, enter the time the
Sponsoring organization received the information establishing good
cause.

For standard cases entering NA is also an acceptable response.
Enter None for standard cases.
CDAG Protocol
Plan Benefit
Package (PBP)
Table 5: Column ID
E

[Field Name] Plan Benefit Package

Technical
Clarification

[Field Name] Plan Benefit Package (PBP)

Document in
CMS-10717
(version 05/2020)
CDAG Protocol
Date the overturn
decision was
effectuated in the
system
Table 5: Column ID
M
Time the overturn
decision was
effectuated in the
system
Table 5: Column ID
N
CDAG Protocol
Time the grievance
was received
Table 6: Column ID
G
CDAG Protocol
Grievance
Description
Table 6: Column ID
M
CDAG Protocol
Date oral
notification
provided to enrollee
Table 6: Column ID
P
CDAG Protocol
Time oral
notification
provided to enrollee
Table 6: Column ID
Q
CDAG Protocol
Date written
notification
provided to enrollee
Table 6: Column ID
R

Original Language

[Description]
Enter the date the benefit was provided, payment was made or the
change to the at risk determination was implemented. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
Enter NE if the overturn decision was not effectuated or if no
effectuation was required.

Clarification or
Change
Technical
Clarification

Enter the time the benefit was provided, payment was made or the
change to the at risk determination was implemented. Submit in
HH:MM:SS military time format (e.g., 23:59:59).
Enter NE if the overturn decision was not effectuated or if no
effectuation was required.

Revised Language

[Description]
Enter the date the benefit was provided, payment was authorized or
the change to the at-risk determination was implemented. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if the overturn decision was not effectuated or if no
effectuation was required.
Enter the time the benefit was provided, payment was authorized or
the change to the at-risk determination was implemented. Submit in
HH:MM:SS military time format (e.g., 23:59:59).
Enter None if the overturn decision was not effectuated or if no
effectuation was required.

[Description]
For standard cases entering NA is an acceptable response.

Technical
Clarification

[Description]
Enter None for standard cases.

[Description]
Enter the description of the complaint.

Technical
Clarification

[Description]
Enter the description of the grievance.

[Field Name]
Date oral response provided to enrollee

Technical
Clarification

[Field Name]
Date oral notification provided to enrollee

[Description]
Enter None if no oral notification was attempted or provided.
[Field Name]
Time oral response provided to enrollee
[Description]
Enter None if no oral notification was attempted or provided. For
standard cases entering NA is an acceptable response.
[Field Name]
Date written response provided to enrollee
[Description]
Enter the date written response was provided (i.e. delivered) to
enrollee.

[Description]
Enter None if no oral notification was provided.
Technical
Clarification

[Field Name]
Time oral notification provided to enrollee

Technical
Clarification

[Description]
Enter None for standard cases or if no oral notification was
provided.
[Field Name]
Date written notification provided to enrollee
[Description]
Enter the date written notification was provided to enrollee.

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change
Technical
Clarification

Revised Language

CDAG Protocol
Time written
notification
provided to enrollee
Table 6: Column ID
S

[Field Name]
Time written response provided to enrollee

CDAG Protocol
Drug Name,
Strength, and
Dosage Form
Table 7: Column ID
F
CDAG Protocol
Date the Initial
Written Notification
of potential at-risk
status was provided
to enrollee
Table 7: Column ID
G
CDAG Protocol
Date Second
Written Notification
of At-Risk
Determination
Provided to Enrollee
Table 7: Column ID
H
CDAG Protocol
Request
Determination
Table 7: Column ID
J
CDAG Protocol
Type of At-Risk
Limitation
Table 7: Column ID
K

[Description]
Enter NA if this is related to an at risk determination and not specific
to a single drug.

Technical
Clarification

[Description]
Enter the date the initial notification was provided (i.e. delivered) to
the enrollee that identified them as potentially at risk.

Technical
Clarification

[Description]
Enter the date the second written notification or alternate second
written notification was provided (i.e. delivered) to enrollee that
identified them as being at risk. Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter None if no written notification was sent.

Technical
Clarification

[Description]
Enter the date the second written notification or alternate second
written notification was provided to enrollee. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no written notification was provided.

[Description]
Enter the final status of the at risk determination:

Technical
Clarification

[Description]
Enter the determination:

Field Length: 50

Technical
Clarification

Field Length: 54

[Description]
Enter the time written response was provided (i.e. delivered) to
enrollee. Submit in HH:MM:SS military time format (e.g., 23:59:59).
Enter NA for standard cases or if no written notification was provided.

[Field Name]
Time written notification provided to enrollee
[Description]
Enter the time written notification was provided to enrollee. Submit
in HH:MM:SS military time format (e.g., 23:59:59).
Enter None for standard cases or if no written notification was
provided.
[Description]
Enter None if not related to a specific drug (e.g. pharmacy lock-in,
prescriber lock-in) or if the at-risk determination is drug related, but
is not specific to a single drug (e.g. beneficiary level edit blocking
all opioid access, beneficiary level edit allowing a defined
cumulative MME dosage).
[Description]
Enter the date the initial notification was provided to the enrollee
that identified them as potentially at-risk

Document in
CMS-10717
(version 05/2020)
CDAG Protocol
Confirmation of
Agreement to Place
Limitation upon
Enrollee
Table 7: Column ID
L
CDAG Protocol
If an enrollee edit
was used, date the
edit was effectuated
in the system
Table 7: Column ID
M
CDAG Protocol
Expiration date of
the at risk
restriction/lock-in
Table 7: Column ID
N
CDAG Protocol
Audit Field Work
Phase
Supporting
Documentation
Submissions
ODAG Protocol
Header

Original Language

[Description]
Enter NA if no confirmation of agreement was received.

Clarification or
Change
Technical
Clarification

Field Length: 3

Revised Language

[Description]
Enter None if no confirmation of agreement was received.
Field Length: 4

[Description]
Enter NA if no limitations were entered into the system.

Technical
Clarification

[Description]
Enter None if no limitations were entered into the system.

[Description]
Enter NA if there was not a restriction/lock-in placed on enrollee.

Technical
Clarification

[Description]
Enter None if there was not a restriction/lock-in placed on enrollee.

• Copies of any case notes as to why the case was withdrawn or
dismissed.
• Any notification regarding the dismissal or withdrawal.

Technical
Clarification

• Copies of any case notes as to why the case was dismissed.
• Any notification regarding the dismissal.

Program Audit Protocol an Data Request
Part C Organization Determinations, Appeals, and Grievances
(ODAG)

Technical
Clarification

Program Audit Protocol and Data Request
Part C Organization Determinations, Appeals, and Grievances
(ODAG)

Document in
CMS-10717
(version 05/2020)

Original Language

ODAG Protocol
Table of Contents

Universe Requests
Universe Table 1: Standard and Expedited Pre-service Organization
Determinations (OD) Record Layout
Universe Table 2: Standard and Expedited Pre-service
Reconsiderations (RECON) Record Layout
Universe Table 3: Payment Organization Determinations and
Reconsiderations (PYMT_C) Record Layout
Universe Table 4: Part C Effectuations of Overturned Decisions by
IRE, ALJ, or MAC (EFF_C) Record Layout
Universe Table 5: Part C Standard and Expedited Grievances
(GRV_C) Record Layout
Universe Table 6: Standard and Expedited Pre-Service Part B Drug
Organization Determinations and Reconsiderations (Part B Drugs)
Record Layout
Universe Table 7: Dual Special Needs Plan – Applicable Integrated
Plan Reconsiderations (AIP)

ODAG Protocol
Program Audit
Protocol
Purpose

Clarification or
Change

Revised Language

Updated Table of
Contents to
remove Table
Standard and
Expedited PreService Part B
Drug
Organization
Determinations
and
Reconsiderations
(Part B Drugs)
Record Layout.
The DSNP
Applicable
Integrated Plan
table was renamed
and is now Table
6: Dual Special
Needs Plan –
Applicable
Integrated Plan
Reductions,
Suspensions, and
Terminations
(AIP) Record
Layout
Technical
Clarification

Universe Requests
Universe Table 1: Standard and Expedited Pre-service Organization
Determinations (OD) Record Layout
Universe Table 2: Standard and Expedited Pre-service
Reconsiderations (RECON) Record Layout
Universe Table 3: Payment Organization Determinations and
Reconsiderations (PYMT_C) Record Layout
Universe Table 4: Part C Effectuations of Overturned Decisions by
IRE, ALJ, or MAC (EFF_C) Record Layout
Universe Table 5: Part C Standard and Expedited Grievances
(GRV_C) Record Layout
Universe Table 6: Dual Special Needs Plan – Applicable Integrated
Plan Reductions, Suspensions, and Terminations (AIP) Record
Layout

To evaluate performance in the areas outlined in this Program Audit
Protocol and Data Request related to Part C Organization
Determinations, Appeals and Grievances (ODAG). The Centers for
Medicare and Medicaid Services (CMS) performs its program audit
activities in accordance with the ODAG Program Audit Data
Request and applying the compliance standards outlined in this
Program Audit Protocol and the Program Audit Process Overview
document. At a minimum, CMS will evaluate cases against the
criteria listed below. CMS may review factors not specifically
addressed below if it is determined that there are other related
ODAG requirements not being met.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Compliance
Standard Universe
Integrity Testing

ODAG Protocol
Compliance
Standard 1.5

ODAG Protocol
Compliance
Standard 1.2
Compliance
Standard 1.4
ODAG Protocol
Compliance
Standard 1.6
Compliance
Standard 1.8
ODAG Protocol
Compliance
Standard 1.20
Compliance
Standard 1.21
Compliance
Standard 1.22

Original Language

[Data Request]
Universe Table 1: Standard and expedited Pre-Service Organization
Determinations (OD)
Universe Table 2: Standard and Expedited Pre-service
Reconsiderations (RECON)
Universe Table 3: Payment Organization Determinations and
Reconsiderations (PYMT_C)
Universe Table 4: Part C Effectuations of Overturned Decisions by
IRE, ALJ, or MAC (EFF_C)
Universe Table 5: Part C Standard and Expedited Grievances
(GRV_C)
Universe Table 6: Standard and Expedited Pre-Service Part B Drug
Organization Determinations and Reconsiderations (Part B Drugs)
Universe Table 7: Dual Special Needs Plan – Applicable Integrated
Plan Reconsiderations (AIP).

Clarification or
Change
Technical
Clarification

Revised Language

[Data Request]
Universe Table 1: Standard and expedited Pre-Service Organization
Determinations (OD)
Universe Table 2: Standard and Expedited Pre-service
Reconsiderations (RECON)
Universe Table 3: Payment Organization Determinations and
Reconsiderations (PYMT_C)
Universe Table 4: Part C Effectuations of Overturned Decisions by
IRE, ALJ, or MAC (EFF_C)
Universe Table 5: Part C Standard and Expedited Grievances
(GRV_C)
Universe Table 6: Dual Special Needs Plan – Applicable Integrated
Plan Reductions, Suspension, and Terminations (AIP)
[Method of Evaluation ]
Select 10 cases from each universe, Tables 1 through 6, for a total
of 60 cases.

[Method of Evaluation]
Select 10 cases from each universe, Tables 1 through 7, for a total of
70 cases.
[Method of Evaluation]
For DSNP-AIPs, the timeliness assessment will ensure written
notification of the upheld reconsideration decision was provided to the
enrollee in addition to being forwarded to the IRE no later than 30
calendar days after receipt of the request.

Technical
Clarification

Universe Table 6: Standard and Expedited Part B Drug Organization
Determinations and Reconsiderations (Part B Drugs)

Technical
Clarification

[Method of Evaluation]
For DSNP-AIPs, the timeliness assessment will ensure written
notification of the upheld reconsideration decision was provided to
the enrollee in addition to being forwarded to the IRE no later than
30 calendar days or 44 days with extension after receipt of the
request.
Universe Table 1: Standard and expedited Pre-Service Organization
Determinations (OD)

Universe Table 6: Standard and Expedited Part B Drug Organization
Determinations and Reconsiderations (Part B Drugs)

Technical
Clarification

Universe Table 2: Standard and Expedited Pre-service
Reconsiderations (RECON)

Universe Table 7: Dual Special Needs Plan – Applicable Integrated
Plan Reconsiderations (AIP).

Technical
Clarification

Universe Table 6: Dual Special Needs Plan – Applicable Integrated
Plan Reductions, Suspensions, and Terminations (AIP).

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Compliance
Standard 2.1

Original Language

[Data Request]
Universe Table 1: Standard and Expedited Pre-service Organization
Determinations (OD) Record Layout
Universe Table 2: Standard and Expedited Pre-service
Reconsiderations (RECON) Record Layout
Universe Table 3: Payment Organization Determinations and
Reconsiderations (PYMT_C) Record Layout
Universe Table 6: Standard and Expedited Pre-Service Part B Drug
Organization Determinations and Reconsiderations (Part B Drugs)
Record Layout
Universe Table 7: Dual Special Needs Plan – Applicable Integrated
Plan Reconsiderations (AIP)

Clarification or
Change
Technical
Clarification

Revised Language

[Data Request]
Universe Table 1: Standard and Expedited Pre-service Organization
Determinations (OD) Record Layout
Universe Table 2: Standard and Expedited Pre-service
Reconsiderations (RECON) Record Layout
Universe Table 3: Payment Organization Determinations and
Reconsiderations (PYMT_C) Record Layout
Universe Table 6: Dual Special Needs Plan – Applicable Integrated
Plan Reductions, Suspensions, and Terminations (AIP)
[Method of Evaluation]
Select 30 denied requests from tables 1-3. The number of cases per
record layout will vary.
Additionally, select 5 denial cases from Table 6.

[Method of Evaluation]
Select 30 denial cases from tables 1-3 and 6.
Additionally, select 5 denial cases from Table 7.
ODAG Protocol
Compliance
Standard 2.2

Technical
Clarification

[Data Request]
Universe Table 1: Standard and Expedited Pre-service Organization
Determinations (OD) Record Layout
Universe Table 2: Standard and Expedited Pre-service
Reconsiderations (RECON) Record Layout
Universe Table 3: Payment Organization Determinations and
Reconsiderations (PYMT_C) Record Layout
Universe Table 6: Dual Special Needs Plan – Applicable Integrated
Plan Reductions, Suspensions, and Terminations (AIP)

ODAG Protocol
Compliance
Standard 2.3

Technical
Clarification

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

Revised Language

ODAG Protocol
Compliance
Standard 2.4

Technical
Clarification

[Data Request]
Universe Table 1: Standard and Expedited Pre-service Organization
Determinations (OD) Record Layout
Universe Table 2: Standard and Expedited Pre-service
Reconsiderations (RECON) Record Layout
Universe Table 6: Dual Special Needs Plan – Applicable Integrated
Plan Reductions, Suspensions, and Terminations (AIP)

ODAG Protocol
Compliance
Standard 2.5

[Data Request]
Universe Table 1: Standard and Expedited Pre-service Organization
Determinations (OD) Record Layout
Universe Table 2: Standard and Expedited Pre-service
Reconsiderations (RECON) Record Layout
Universe Table 6: Standard and Expedited Pre-Service Part B Drug
Organization Determinations and Reconsiderations (Part B Drugs)
Record Layout
Universe Table 7: Dual Special Needs Plan – Applicable Integrated
Plan Reconsiderations (AIP)
[Data Request]
Universe Table 6: Standard and Expedited Pre-Service Part B Drug
Organization Determinations and Reconsiderations (Part B Drugs)
Record Layout

Technical
Clarification

[Data Request]
Universe Table 1: Standard and Expedited Pre-service Organization
Determinations (OD) Record Layout
Universe Table 2: Standard and Expedited Pre-service
Reconsiderations (RECON) Record Layout
Universe Table 6: Dual Special Needs Plan – Applicable Integrated
Plan Reductions, Suspensions, and Terminations (AIP)

Technical
Clarification

[Data Request]
Universe Table 7: Dual Special Needs Plan – Applicable Integrated
Plan Reconsiderations (AIP)

Technical
Clarification

[Data Request]
Universe Table 6: Dual Special Needs Plan – Applicable Integrated
Plan Reductions, Suspensions, and Terminations (AIP)

Compliance
Standard 2.6

Compliance
Standard 2.7

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Compliance
Standard 3.1

Original Language

Clarification or
Change
Technical
Clarification

Revised Language

[Method of Evaluation]
Select up to 15 dismissals from Tables 1-3, 5 - 7.
ODAG Protocol
Program Audit Data
Request
Audit Engagement
and Universe
Submission Phase
Universe
Submissions

Sponsoring organizations must submit universe tables 1 - 6,
comprehensive of all contracts and Plan Benefit Packages (PBP),
identified in the audit engagement letter, in either Microsoft Excel
(.xlsx) file format with a header row or Text (.txt) file format without a
header row. Sponsoring organizations determined to be an Applicable
Integrated Plan (AIP) must submit universe table 7 comprehensive of
all contracts and/or PBPs offered as Dual Eligible Special Needs Plans
only. Descriptions and clarifications of what must be included in each
submission and data field are outlined in the individual universe record
layouts below. Characters are required in all requested fields, unless
otherwise specified, and data must be limited to the request specified in
each record layout. Sponsoring organizations must provide accurate
and timely universe submissions within 15 business days of the audit
engagement letter date. Submissions that do not strictly adhere to the
record layout specifications will be rejected.

Technical
Clarification

Sponsoring organizations must submit universe tables 1 - 5,
comprehensive of all contracts and Plan Benefit Packages (PBP),
identified in the audit engagement letter, in either Microsoft Excel
(.xlsx) file format with a header row or Text (.txt) file format
without a header row. Sponsoring organizations determined to be
an Applicable Integrated Plan (AIP) must submit universe table 6
comprehensive of all contracts and/or PBPs offered as Dual
Eligible Special Needs Plans only. Descriptions and clarifications
of what must be included in each submission and data field are
outlined in the individual universe record layouts below. Characters
are required in all requested fields, unless otherwise specified, and
data must be limited to the request specified in each record layout.
Sponsoring organizations must provide accurate and timely
universe submissions within 15 business days of the audit
engagement letter date. Submissions that do not strictly adhere to
the record layout specifications will be rejected.

Document in
CMS-10717
(version 05/2020)

Original Language

ODAG Protocol
Program Audit Data
Request
Audit Engagement
and Universe
Submission Phase
Universe Requests

1. Universe Table 1: Standard and Expedited Pre-service Organization
Determinations (OD) Record Layout
2. Universe Table 2: Standard and Expedited Pre-service
Reconsiderations (RECON) Record Layout
3. Universe Table 3: Payment Organization Determinations and
Reconsiderations (PYMT_C) Record Layout
4. Universe Table 4: Part C Effectuations of Overturned Decisions by
IRE, ALJ, or MAC (EFF_C) Record Layout
5. Universe Table 5: Part C Standard and Expedited Grievances
(GRV_C) Record Layout
6. Universe Table 6: Standard and Expedited Part B Drug Organization
Determinations and Reconsiderations (Part B Drugs) Record Layout
Universe
7. Universe Table 7: Dual Eligible Special Needs Plan – Applicable
Integrated Plan Reconsiderations (AIP).
[Universe Record Layout]
Table 1
Table 2
Table 3
Table 4
Table 5
Table 6
Table 7

ODAG Protocol
Program Audit Data
Request
Audit Engagement
and Universe
Submission Phase
Universe Requests

Clarification or
Change

Revised Language

Technical
Clarification

1. Universe Table 1: Standard and Expedited Pre-service
Organization Determinations (OD) Record Layout
2. Universe Table 2: Standard and Expedited Pre-service
Reconsiderations (RECON) Record Layout
3. Universe Table 3: Payment Organization Determinations and
Reconsiderations (PYMT_C) Record Layout
4. Universe Table 4: Part C Effectuations of Overturned Decisions
by IRE, ALJ, or MAC (EFF_C) Record Layout
5. Universe Table 5: Part C Standard and Expedited Grievances
(GRV_C) Record Layout
6. Universe Table 6: Dual Eligible Special Needs Plan – Applicable
Integrated Plan Reductions, Suspensions, and Terminations (AIP).

Technical
Clarification

[Universe Record Layout]
Table 1
Table 2
Table 3
Table 4
Table 5
Table 6

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

Revised Language

ODAG Protocol
Table 1: OD
Table Instructions

• Include all pre-service organization determination requests the
Sponsoring organization approved, denied or dismissed during the
universe request period. The date of the Sponsoring organization’s
determination (Column ID O) must fall within the universe request
period. Include all pre-service requests for supplemental services that
meet the criteria defined in Chapter 4, Section 30.1.
• Include all pre-service requests for supplemental services that meet
the criteria defined in Chapter 4, Section 30.1.
• If a pre-service organization determination includes more than one
service, include all of the request’s line items in a single row and enter
the multiple line items as a single organization determination request.
o Enter any request denied in whole or in part as denied.
• Enter all fields for a single request in the same time zone. For
example, if the Sponsoring organization has systems in EST and CST,
all data in a single line item must be in the same time zone.
• Exclude all requests processed as reconsiderations, payments,
reopenings, withdrawals, and Part B drug requests.
o Exclude all concurrent reviews for inpatient hospital services and
inpatient SNF services, and notifications of admissions.
o Exclude all requests for Value Added Items and Services.

Technical
Clarification

• Include all pre-service organization determination requests the
Sponsoring organization approved, denied or dismissed during the
universe request period. The date of the Sponsoring organization’s
determination (Column ID P) must fall within the universe request
period.
• Include all pre-service requests for supplemental services that
meet the criteria defined in 42 CFR § 422.100(c)(2).
• Include all pre-service organization determination requests for
Part B drugs.
• If a pre-service organization determination includes more than one
service, include all of the request’s line items in a single row and
enter the multiple line items as a single organization determination
request.
o Enter any request denied in whole or in part as denied.
• Enter all fields for a single request in the same time zone. For
example, if the Sponsoring organization has systems in EST and
CST, all data in a single line item must be in the same time zone.
• Exclude all requests processed as reconsiderations, payments,
reopenings, and withdrawals.
o Exclude all concurrent reviews for inpatient hospital services and
inpatient SNF services, and notifications of admissions.
o Exclude all requests for Value Added Items and Services.

ODAG Protocol
First Tier,
Downstream, and
Related Entity
Tables 1-5: Column
ID F

[Tables 1-4 Description]

Technical
Clarification

[Tables 1-4 Description]

Enter the name of the First Tier, Downstream, and Related Entity
(which is any party that enters into a written arrangement, acceptable
to CMS, with the Sponsoring organization to provide administrative or
health care services to an enrollee under the Part C or D program) that
processed the request.
Enter NA if the Sponsoring organization processed the request.

Enter the name of the First Tier, Downstream, and Related Entity
(which is any party that enters into a written arrangement,
acceptable to CMS, with the Sponsoring organization to provide
administrative or health care services to an enrollee under the Part
C or D program) that processed the request.
Enter None if the Sponsoring organization processed the request.

[Table 5 Description]
Enter the name of the First Tier, Downstream, and Related Entity
(which is any party that enters into a written arrangement, acceptable
to CMS, with the Sponsoring organization to provide administrative or
health care services to an enrollee under the Part C or D program)
which processed the grievance. Enter NA if the grievance was
processed by the Sponsoring organization.

[Table 5 Description]
Enter the name of the First Tier, Downstream, and Related Entity
(which is any party that enters into a written arrangement,
acceptable to CMS, with the Sponsoring organization to provide
administrative or health care services to an enrollee under the Part
C or D program) that processed the grievance.
Enter None if the Sponsoring organization processed the grievance.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Authorization or
Claim Number
Tables 1-4 and 6:
Column ID G

Original Language

[Table 1 and Table 3 Description]
Enter the associated authorization number for this request. If an
authorization number is not available, provide the internal tracking or
case number.
Enter None if an authorization or other tracking number is unavailable.

Clarification or
Change
Technical
Clarification

Revised Language

[Tables 1-4 & 6 Description [Column ID G]
Enter the associated authorization or claim number for this request.
If an authorization or claim number is not available, enter the
internal tracking or case number.
Enter None if there is no authorization, claim or other tracking
number available.

[Table 2 Description]
Enter the associated authorization number for this request. If an
authorization number is not available, enter the internal tracking or
case number.
Enter None if there is no authorization or other tracking number
available.
[Table 4 Description]
Enter the associated authorization number for this request. If an
authorization number is not available, provide the internal tracking or
case number.
Enter None if there is no authorization or other tracking number
available.
[Table 6 Column ID F]
The associated authorization number assigned by the DSNP-AIP for
this request. If an authorization number is not available, please provide
your internal tracking or case number. Answer NA if there is no
authorization or other tracking number available.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Time the request
was received
Tables 1-2: Column
ID I

Original Language

[Table 1 Description]
Enter the time the request was received. Submit in HH:MM:SS
military time format (e.g., 23:59:59).
If a standard request was upgraded to expedited, enter the date the
request was upgraded.
Enter NA for standard and dismissed requests.

Clarification or
Change
Technical
Clarification

[Table 2 Description]
Enter the time the reconsideration request was received. If a standard
request was upgraded to expedited, enter the date the request was
upgraded.
If the Sponsoring organization obtained information establishing good
cause after the 60-day filing timeframe, enter the time the Sponsoring
organization received the information establishing good cause. Submit
in HH:MM:SS military time format (e.g., 23:59:59).
Enter NA for standard and dismissed requests.
ODAG Protocol
Part B Drug
Request?
Table 1-2: Column
ID J

N/A

Revised Language

[Table 1 Description]
For all expedited requests and standard Part B drug requests, enter
the time the request was received. Submit in HH:MM:SS military
time format (e.g., 23:59:59).
If a standard request was upgraded to expedited, enter the time the
request was upgraded.
Enter None for standard and dismissed requests.
[Table 2 Description]
For all expedited requests, enter the time the reconsideration
request was received. If a standard request was upgraded to
expedited, enter the time the request was upgraded.
If the Sponsoring organization obtained information establishing
good cause after the 60-day filing timeframe, enter the time the
Sponsoring organization received the information establishing good
cause. Submit in HH:MM:SS military time format (e.g., 23:59:59).
Enter None for standard and dismissed requests.

Technical
Clarification Added field and
relettered
remaining
Column IDs in the
table

[Column ID]
J
[Field Name]
Part B Drug Request?
[Field Type]
CHAR Always Required
[Field Length]
1
[Description]
Enter:
• Y for Yes
• N for No
Sponsors must indicate ‘Y’ for any pre-service request that includes
a Part B drug (primary or ancillary) or Part D drug that is part of a
Sponsor’s step therapy requirement for a Part B drug.

Document in
CMS-10717
(version 05/2020)

Original Language

ODAG Protocol
AOR/Equivalent
notice Receipt Date
Tables 1-2: Column
ID K

[Table 1 Column ID J Description]
Enter the date the Appointment of Representative (AOR) form or
equivalent written notice was received by the Sponsoring organization.
Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no AOR or equivalent written notice was received.
Enter NA for dismissed requests and if no AOR or equivalent written
notice was required.

Table 3: Column ID
I

Clarification or
Change
Technical
Clarification

Revised Language

[Table 1 Column ID K Description]
Enter the date the Appointment of Representative (AOR) form or
equivalent written notice was received by the Sponsoring
organization. Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None for dismissed requests or if no AOR or equivalent
written notice was received or required.
[Table 2 Column ID K and Table 3 Column ID I Description]
Enter the date the Appointment of Representative (AOR) form or
equivalent written notice was received by the Sponsoring
organization. Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None for dismissed requests or if no AOR or equivalent
written notice was received or required.

[Table 2 Column ID J Description]
Enter the date the Appointment of Representative (AOR) form or
equivalent written notice was received by the Sponsoring organization.
Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if an AOR or equivalent written notice was not received.
Enter NA if an AOR or equivalent written notice was not required.
[Table 3 Column ID I Description]
Enter the date the Appointment of Representative (AOR) form or
equivalent written notice was received by the Sponsoring organization.
Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no AOR or equivalent written notice was received.
Enter NA if no AOR or equivalent written notice was required.
ODAG Protocol
AOR Equivalent
notice Receipt Date
Table 5: Column ID
I
Table 6: Column ID
M

[Table 5 Column ID I Description]
Enter the date the Appointment of Representative (AOR) form or
equivalent written notice was received by the Sponsoring organization.
Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if an AOR or equivalent written notice was not received.
Enter NA if an AOR or equivalent written notice was not required.
[Table 7 Column ID Y Description]
Enter the date the Appointment of Representative (AOR) form or
equivalent written notice was received by the Sponsoring organization.
Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no AOR or equivalent written notice was received.
Enter NA if no AOR or equivalent written notice was required.

Technical
Clarification

[Table 5 Column ID I Description]
Enter the date the Appointment of Representative (AOR) form or
equivalent written notice was received by the Sponsoring
organization. Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no AOR or equivalent written notice was received or
required.
[Table 6 Column ID M Description]
Enter the date the Appointment of Representative (AOR) form or
equivalent written notice was received by the Sponsoring
organization. Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None for dismissed requests, if no AOR or equivalent written
notice was received or required, or if the decision was not appealed
as indicated by N in column ID J.

Document in
CMS-10717
(version 05/2020)

Original Language

ODAG Protocol
AOR/Equivalent
notice Receipt Time
Tables 1-2: Column
ID L

[Table 1 Column ID K Description]
Enter the time the Appointment of Representative (AOR) form or
equivalent written notice was received by the Sponsoring organization.
Submit in HH:MM:SS format (e.g., 23:59:59).
Enter None if no AOR or equivalent written notice was received.
Enter NA for standard and dismissed cases or if an AOR or equivalent
written notice was not required.

Clarification or
Change
Technical
Clarification

[Table 2 Column ID K Description]
Enter the time the Appointment of Representative (AOR) form or
equivalent written notice was received by the Sponsoring organization.
Submit in HH:MM:SS format (e.g., 23:59:59).
Enter None if an AOR or equivalent written notice was not received.
Enter NA if an AOR or equivalent written notice was not required.
Enter NA for standard and dismissed requests.

Revised Language

[Table 1 Column ID L Description]
For all expedited requests and standard Part B drug requests, enter
the time the Appointment of Representative (AOR) form or
equivalent written notice was received by the Sponsoring
organization. Submit in HH:MM:SS format (e.g., 23:59:59).
Enter None for standard requests, dismissed requests or if no AOR
or equivalent written notice was received or required.
[Table 2 Column ID L Description]
For all expedited requests, enter the time the Appointment of
Representative (AOR) form or equivalent written notice was
received by the Sponsoring organization. Submit in HH:MM:SS
format (e.g., 23:59:59).
Enter None for dismissed requests or if no AOR or equivalent
written notice was received or required.

ODAG Protocol
AOR/Equivalent
notice Receipt Time
Table 5: Column ID
J

[Table 5 Column ID J Description]
Enter the time the Appointment of Representative (AOR) form or
equivalent written notice was received by the Sponsoring organization.
Submit in HH:MM:SS format (e.g., 23:59:59).
Enter None if an AOR or equivalent written notice was not received.
Enter NA if no AOR or equivalent written notice was required.
Enter NA for standard and dismissed cases.

Technical
Clarification

[Table 5: Column ID J Description]
For expedited grievances, enter the time the Appointment of
Representative (AOR) form or equivalent written notice was
received by the Sponsoring organization. Submit in HH:MM:SS
format (e.g., 23:59:59).
Enter None for standard grievances, dismissed grievances, or if an
AOR or equivalent written notice was not received or required.

ODAG Protocol
Request
Determination
Tables 1-2: Column
ID M

[Column ID]
N

Technical
Clarification moved field up in
order within the
record layout &
relettered
remaining
Column IDs in the
tables.

[Column ID]
M

[Table 2 Field Length] 21

[Table 2 Field Length] 9

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Date of
Determination
Tables 1-2: Column
ID P
Table 3: Column ID
N

ODAG Protocol
Time of
Determination
Tables 1-2: Column
ID Q

Original Language

Table 1 and Table 2 [Column ID]
O

Clarification or
Change
Technical
Clarification

[Description]
Enter the date of the determination. Submit in CCYY/MM/DD format
(e.g., 2020/01/01).

Table 1 and Table 2 [Column ID]
P
[Description]
Enter the date of the determination. Submit in CCYY/MM/DD
format (e.g., 2020/01/01). For dismissed requests, enter the date the
Sponsor dismissed the request.

Table 3 Column ID N
[Description]
Enter the date of the determination. Submit in CCYY/MM/DD format
(e.g., 2020/01/01). This is the date the determination was entered in the
system and may be the same as the date claim was paid.

[Column ID]
P

Revised Language

Table 3 Column ID N
[Description]
Enter the date of the determination. Submit in CCYY/MM/DD
format (e.g., 2020/01/01). This is the date the determination was
entered in the system and may be the same as the date claim was
paid.

Technical
Clarification

[Description]
Enter the time of the determination. Submit in HH:MM:SS military
time format (e.g., 23:59:59).
Enter NA for standard and dismissed requests.

For dismissed requests, enter the date the Sponsor dismissed the
request.
[Column ID]
Q
[Table 1 Description]
For all expedited requests and standard Part B drug requests, enter
the time of the determination. Submit in HH:MM:SS military time
format (e.g., 23:59:59).
Enter None for standard and dismissed requests.
[Table 2 Description]
For all expedited requests, enter the time of the determination.
Submit in HH:MM:SS military time format (e.g., 23:59:59).
Enter None for standard and dismissed requests.

ODAG Protocol
Date oral
notification
provided to enrollee
Table 2: Column ID
R

[Column ID]
Q
[Table 2 Description]
Enter the date oral notification was provided to enrollee. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no oral notification was attempted or provided.

Technical
Clarification

[Column ID]
R
[Table 2 Description]
Enter the date oral notification was provided to enrollee. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
Enter None for dismissed requests or if no oral notification was
provided.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Time oral
notification
provided to enrollee
Tables 1-2: Column
ID S

Original Language

[Column ID]
R
[Table 1 Description]
Enter the time oral notification was provided to enrollee. Submit in
HH:MM:SS military time format (e.g., 23:59:59).
Enter None if no oral notification was provided.
[Table 2 Description]
Enter the time oral notification was provided to enrollee. Submit in
HH:MM:SS military time format (e.g., 23:59:59).
Enter None if no oral notification was attempted or provided.

Clarification or
Change
Technical
Clarification

Revised Language

[Column ID]
S
[Table 1 Description]
For all expedited requests and standard Part B drug requests, enter
the time oral notification was provided to enrollee. Submit in
HH:MM:SS military time format (e.g., 23:59:59).
Enter None for standard requests, dismissed requests, or if no oral
notification was provided.
[Table 2 Description]
For expedited requests, including expedited Part B drug requests,
enter the time oral notification was provided to enrollee. Submit in
HH:MM:SS military time format (e.g., 23:59:59).
Enter None for dismissed requests or if no oral notification was
provided.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Date written
notification
provided to enrollee
Tables 1-2: Column
ID T
Table 3: Column ID
P

Original Language

[Table 1 Column ID]
S
[Description]
Enter the date written notification of determination was provided (i.e.
delivered) to enrollee. Written notification is considered provided on
the date (and time, if applicable) the Sponsoring organization or
delegated entity has deposited the notice in the courier drop box (e.g.,
U.S. Postal Service or FedEx bin). Do not enter the date a letter is
generated or printed. Submit in CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if no written notification was provided.
[Table 2 Column ID]
S
[Description]
Enter the date written notification was provided (i.e. delivered) to
enrollee. Do not enter the date a letter is generated or printed. Submit
in CCYY/MM/DD format (e.g., 2020/01/01).
Enter NA dismissed requests.
Enter None if written notification was not provided.
[Table 3 Column ID]
P
[Description]
Enter the date written notification was provided (i.e. delivered) to
enrollee. Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no written notification was provided.

Clarification or
Change
Technical
Clarification

Revised Language

[Table 1 Column ID]
T
[Description]
Enter the date written notification of determination was provided to
enrollee. Do not enter the date a letter is generated or printed.
Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no written notification was provided.
[Table 2 Column ID]
T
[Description]
Enter the date written notification was provided to enrollee. Do not
enter the date a letter is generated or printed. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no written notification was provided.
[Table 3 Column ID]
P
[Description]
Enter the date written notification was provided to enrollee. Submit
in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no written notification was provided.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Time written
notification
provided to enrollee
Tables 1-2: Column
ID U

Original Language

[Column ID]
T
[Table 1 Description]
Enter the time written notification of determination was provided (i.e.
delivered) to enrollee. Written notification is considered provided on
the date (and time, if applicable) the Sponsoring organization or
delegated entity has deposited the notice in the courier drop box (e.g.,
U.S. Postal Service or FedEx bin).
Do not enter the time a letter was generated or printed. Submit in
HH:MM:SS military time format (e.g., 23:59:59).
Enter NA for standard and dismissed cases.
Enter None if no written notification was provided.
[Table 2 Description]
Enter the time written notification was provided (i.e. delivered) to
enrollee. Do not enter the time a letter is generated or printed. Submit
in HH:MM:SS military time format (e.g., 23:59:59).
Enter NA for standard and dismissed requests.
Enter None if written notification was not provided.

Clarification or
Change
Technical
Clarification

Revised Language

[Column ID]
U
[Table 1 Description]
For all expedited requests and standard Part B drug requests, enter
the time written notification of determination was provided) to
enrollee.
Do not enter the time a letter was generated or printed. Submit in
HH:MM:SS military time format (e.g., 23:59:59).
Enter None for standard requests, dismissed requests, or if no
written notification was provided.
[Table 2 Description]
For all expedited requests, enter the time written notification was
provided to enrollee. Do not enter the time a letter is generated or
printed. Submit in HH:MM:SS military time format (e.g.,
23:59:59).
Enter None for standard requests, dismissed requests, or if no
written notification was provided.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Issue Description
and Type of Service
Table 1: Column ID
W
Table 2: Column ID
AA
Table 3: Column ID
T

Original Language

[Table 1 Column ID]
V

Clarification or
Change
Technical
Clarification

Revised Language

[Table 1 Column ID]
W

[Table 2 Column ID]
Y

[Table 2 Column ID]
AA

[Table 3 Column ID]
S

[Table 3 Column ID]
T

[Description]
Provide a description of the service or item requested and why it was
requested (if known). For denials, also provide an explanation of why
the pre-service request was denied.

[Table 1 and 2 Description]
Provide a description of the service or item requested and why it
was requested (if known). For denials, also provide an explanation
of why the pre-service request was denied.
For dismissed requests, provide the reason for dismissal.
For Part B drugs requests, include the J-Code, National Drug Code
(NDC), or both.
[Table 3 Description]
Provide a description of the service or item requested and why it
was requested (if known). For denials, also provide an explanation
of why the payment organization determination or payment
reconsideration request was denied.
For dismissed requests, please provide the reason for dismissal.
For Part B drugs requests, include the J-Code, National Drug Code
(NDC), or both.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Was an expedited
request made but
processed as
standard?
Tables 1-2: Column
ID X

Original Language

[Table 1 Column ID]
W

Clarification or
Change
Technical
Clarification

Revised Language

[Table 1 Column ID]
X

[Table 2 Column ID]
Z

[Table 2 Column ID]
BB

[Table 1 and Table 2]
[Field Length]
2

[Table 1 and Table 2]
[Field Length]
4

[Description]
Enter:
• Y for Yes if an expedited request was received but downgraded to
standard
• NA for all other requests (e.g. the request was received as expedited
and processed as expedited, the request was received as standard)

Table 1
[Description]
Enter:
• Y for Yes if an expedited request was received but downgraded to
standard
• None for all other requests (e.g. the request was received as
expedited and processed as expedited, the request was received as
standard)
Table 2
[Description]
Enter:
• Y for Yes if an expedited request was received but downgraded to
standard
• None for all other cases (e.g. the request was received as
expedited and processed as expedited, the request was received as
standard.)
• For dismissed requests, populate based on how the request was
received.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Was the request
denied for lack of
medical necessity?
Table 1: Column ID
Y
Was the initial
organization
determination
request denied for
lack of medical
necessity?
Table 2: Column ID
CC

ODAG Protocol
Table 2: RECON
Table Instructions

Original Language

[Table 1 Column ID]
X

Clarification or
Change
Technical
Clarification

Revised Language

[Table 1 Column ID]
Y

[Table 2 Column ID]
AA

[Table 2 Column ID]
CC

[Table 1 Field Length]
2

[Table 1 Field Length]
4

[Table 2 Field Length]
2

[Table 2 Field Length]
1

[Table 1 Description]
Enter:
• Y for Yes
• N for No
• NA if the request was approved or dismissed.

[Table 1 Description]
Enter:
• Y for Yes
• N for No
• None if the request was approved or dismissed.

• Include all pre-service reconsideration requests the Sponsoring
organization approved, denied, auto-forwarded to the IRE or dismissed
during the universe request period. The date of the Sponsoring
organization’s determination (Column ID O) must fall within the
universe request period.
• Include all requests for supplemental services that meet the criteria
defined in Chapter 4, Section 30.1 (e.g., dental, vision).
• If a pre-service reconsideration includes more than one service,
include all of the request’s line items in a single row and enter multiple
line items as a single reconsideration request. Enter any request denied
in whole or in part as denied.
• Enter all fields for a single request in the same time zone. For
example, if the Sponsoring organization has systems in EST and CST,
all data in a single line item must be in a single time zone.
• Exclude all requests processed as organization determinations,
payments, reopenings, withdrawals, or Part B drug requests.
• Exclude all requests for concurrent reviews for inpatient hospital and
inpatient SNF services, and notifications of admissions.
• Exclude all requests for Value Added Items and Services.

Technical
Clarification

• Include all pre-service reconsideration requests the Sponsoring
organization approved, denied, auto-forwarded to the IRE or
dismissed during the universe request period. The date of the
Sponsoring organization’s determination (Column ID P) must fall
within the universe request period.
• Include all pre-service reconsideration requests for supplemental
services that meet the criteria defined at 42 CFR § 422.100(c)(2).
• Include all pre-service reconsideration requests for Part B drugs.
• If a pre-service reconsideration includes more than one service,
include all of the request’s line items in a single row and enter
multiple line items as a single reconsideration request. Enter any
request denied in whole or in part as denied.
• Enter all fields for a single request in the same time zone. For
example, if the Sponsoring organization has systems in EST and
CST, all data in a single line item must be in a single time zone.
• Exclude all requests processed as organization determinations,
payment requests, reopenings, and withdrawals.
• Exclude all requests for concurrent reviews for inpatient hospital
and inpatient SNF services, and notifications of admissions.
• Exclude all requests for Value Added Items and Services.

Document in
CMS-10717
(version 05/2020)

Original Language

ODAG Protocol
Date reconsidered
determination
effectuated in the
system
Table 2: Column ID
V

[Column ID]
U

ODAG Protocol
Time reconsidered
determination
effectuated in the
system
Table 2: Column ID
W

[Column ID]
V

ODAG Protocol
Date forwarded to
IRE
Table 2: Column ID
X
Table 3: Column ID
R

[Table 2 Column ID]
W

Clarification or
Change
Technical
Clarification

[Description]
Enter the date the reconsidered determination was effectuated in the
system. Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter NA if the determination was denied or dismissed.

[Table 3 Description]
Enter the date the request was forwarded to the IRE. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
Enter NF if the request was not forwarded to the IRE.
Enter NA if the request was approved, or dismissed.

[Column ID]
V
[Description]
Enter the date the reconsidered determination was effectuated in the
system. Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if the determination was denied or dismissed.

Technical
Clarification

[Column ID]
W

Technical
Clarification

[Description]
For all expedited requests, enter the time the reconsidered
determination was effectuated in the system. Submit in HH:MM:SS
military time format (e.g., 23:59:59).
Enter None for standard cases, dismissed cases, or if the request
was denied.
[Table 2 Column ID]
X

[Description]
Enter the time the reconsidered determination was effectuated in the
system. Submit in HH:MM:SS military time format (e.g., 23:59:59).
Enter NA for standard cases or if the determination was denied.

[Table 2 Description]
Enter the date the request was forwarded to the IRE. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
Enter NF if the request was not forwarded to IRE.
Enter NA if the beneficiary was notified of the approved
reconsideration.

Revised Language

[Table 2 Description]
Enter the date the request was forwarded to the IRE. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if the beneficiary was notified of the approved
reconsideration, or if the request was not forwarded to the IRE.
[Table 3 Description]
Enter the date the reconsideration request was forwarded to the
IRE. Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None for organization determination requests, or if the
reconsideration request was approved, dismissed, or not forwarded
to the IRE.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Time forwarded to
IRE
Table 2: Column ID
Y

Original Language

N/A

Clarification or
Change
Technical
Clarification

Revised Language

[Column ID]
Y
[Field Type]
CHAR Always Required
[Field Length]
10
[Description]
For all expedited requests, enter the time the request was
forwarded to the IRE. Submit in HH:MM:SS military time format
(e.g., 23:59:59).
Enter None if the beneficiary was notified of the approved
reconsideration or if the request was not forwarded to the IRE.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Table 3: PYMT_C
Table Instructions

Original Language

• Include all payment organization determinations and payment
reconsiderations the Sponsoring organization approved, denied or
dismissed from non-contract providers or enrollees during the universe
request period.
• Submit payment organization determinations (claims) based on the
date the claim was paid (Column O) or notification of the denial to the
provider (if provider submitted the claim -Column Q) or member (if
the member submitted the claim – Column P).
• Include all payment requests for Part B drugs if applicable.
• Include all payment requests for supplemental services (e.g., dental,
vision).
• If a payment organization determination or reconsideration includes
more than one service, include all of the request’s line items in a single
row and enter the multiple line items as a single organization
determination or reconsideration request.
o Enter any request denied in whole or in part as denied.
• Enter all fields for a single case in the same time zone. For example,
if the Sponsoring organization has systems in EST and CST, all data in
a single line item must be in a single time zone.
• Exclude all payment requests processed as:
o duplicate claims,
o payment adjustments,
o reopenings,
o withdrawals, and
o retrospective reviews.
• Exclude all requests for Value Added Items and Services.
• Exclude any payment requests that were denied due to:
o invalid billing codes,
o eligibility (i.e., enrollees who were not enrolled on the date of
service, providers not accepting assignment), or
o recoupment of payment, including pending determination of other
primary insurance such as automobile, worker’s compensation, etc.

Clarification or
Change
Technical
Clarification

Revised Language

• Include all payment organization determinations and payment
reconsiderations the Sponsoring organization approved, denied or
dismissed from non-contract providers, enrollees, and non-contract
pharmacies during the universe request period.
• Submit payment organization determinations (claims) based on
the date the claim was paid (Column O) or notification of the denial
to the provider (if provider submitted the claim - Column Q) or
enrollee (if the enrollee submitted the claim – Column P). Submit
payment reconsiderations based on the date the overturned
reconsideration was paid or, for upheld reconsiderations, submit
based on the date the case was forwarded to the IRE. Submit
dismissed requests based on the date of the decision to dismiss
(Column M).
• Include all payment requests for Part B drugs if applicable.
• Include all payment requests for supplemental services that meet
the criteria defined at 42 CFR § 422.100(c)(2).
• If a payment organization determination or reconsideration
includes more than one service, include all of the request’s line
items in a single row and enter the multiple line items as a single
organization determination or reconsideration request.
o Enter any request denied in whole or in part as denied.
• Enter all fields for a single case in the same time zone. For
example, if the Sponsoring organization has systems in EST and
CST, all data in a single line item must be in a single time zone.
• Exclude all payment requests processed as:
o duplicate claims,
o payment adjustments,
o reopenings,
o withdrawals, and
o retrospective reviews.
• Exclude all requests for Value Added Items and Services.
• Exclude any payment requests that were denied due to:
o invalid billing codes,
o eligibility (i.e., enrollees who were not enrolled on the date of
service, providers not accepting assignment), or
o recoupment of payment, including pending determination of other
primary insurance such as automobile, worker’s compensation, etc.

Document in
CMS-10717
(version 05/2020)

Original Language

ODAG Protocol
Waiver of Liability
(WOL) Receipt
Date
Table 3: Column ID
J
ODAG Protocol
Was it a clean
claim?
Table 3: Column ID
K

[Description]
Enter the date the WOL form was received for non-contracted provider
payment appeals. Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter NA for ODs and member submitted requests.

Technical
Clarification

[Description]
Enter:
• Y for clean claim
• N for unclean claim
• NA if the claim was received from the enrollee

Technical
Clarification

ODAG Protocol
Request
Determination
Table 3: Column ID
M
ODAG Protocol
Date
claim/reconsideratio
n was paid
Table 3: Column O

ODAG Protocol
Date written
notification
provided to provider
Table 3: Column ID
Q

Clarification or
Change

Revised Language

[Description]
Enter the date the WOL form was received for non-contracted
provider payment appeals. Submit in CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None for ODs, enrollee submitted requests, or if a WOL was
never received.
[Description]
Enter:
• Y for clean claim
• N for unclean claim
• None for payment reconsiderations

[Field Length] 2
[Field Length]
8

Technical
Clarification

[Field Length] 4
[Field Length]
9

[Field Name]
Date claim was paid

Technical
Clarification

[Field Name]
Date claim/reconsideration was paid

[Description]
Enter the date the claim was paid. Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter None if payment was not provided.
Enter NA if the request was denied or dismissed.
[Description]
Enter the date written notification was provided (i.e. delivered) to
provider. Do not enter the date a letter is generated or printed. Submit
in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no written notification was provided.
Enter NA if enrollee submitted request.

[Description]
Enter the date the claim/reconsideration was paid. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if payment was not provided, if the request was denied,
or if the request was dismissed.
Technical
Clarification

[Description]
Enter the date written notification was provided to provider. Do
not enter the date a letter is generated or printed. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no written notification was provided or if the enrollee
submitted the request.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Who made the
request?
Table 3: Column ID
S

Original Language

N/A

Clarification or
Change
Technical
Clarification

Revised Language

[Column ID]
S
[Field Name]
Who made the request?
[Field Type]
CHAR Always Required
[Field Length]
3
[Description]
Enter who made the request:
• E for enrollee
• ER for enrollee’s representative
• NCP for requests by a non-contract provider
NCP includes non-contract pharmacies.

ODAG Protocol
Was the initial
organization
determination
request denied for
lack of medical
necessity?
Table 3: Column ID
U

[Column ID]
AF

Technical
Clarification

[Field Name]
Was the initial organization determination request denied for lack
of medical necessity?

[Field Name]
Was the request denied for lack of medical necessity?
[Field Length]
2

[Field Length]
4

[Description]
Enter:
• Y for Yes
• N for No
• NA if the request was approved.
ODAG Protocol
Time the overturned
decision was
received
Table 4: Column ID
K

[Description]
Enter the time the overturned decision was received. Submit in
HH:MM:SS military time format (e.g., 23:59:59).
Enter NA for Standard (pre-service) and Payment reconsideration
cases.

[Column ID]
U

Technical
Clarification

[Description]
Enter:
• Y for Yes
• N for No
• None if the request was approved or dismissed.
[Description]
For expedited requests and Part B drug requests, enter the time the
overturned decision was received. Submit in HH:MM:SS military
time format (e.g., 23:59:59).
Enter None for Standard (pre-service) and Payment reconsideration
cases.

Document in
CMS-10717
(version 05/2020)

Original Language

ODAG Protocol
Date overturned
decision or payment
effectuated in the
system
Table 4: Column ID
L
ODAG Protocol
Time overturned
decision or payment
effectuated in the
system
Table 4: Column ID
M

[Description]
Enter the date overturned decision effectuated in the system. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
Enter NE if the overturned decision was not effectuated.

Technical
Clarification

[Description]
Enter the date overturned decision effectuated in the system.
Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if the overturned decision was not effectuated.

[Description]
Enter the time overturned decision effectuated in the system. Submit in
HH:MM:SS military time format (e.g., 23:59:59).
Enter NA for Standard (pre-service) and Payment reconsideration
cases,
Enter NE if the overturned decision was not effectuated.

Technical
Clarification

[Description]
For expedited requests and Part B drug requests, enter the time the
overturned decision was effectuated in the system. Submit in
HH:MM:SS military time format (e.g., 23:59:59).
Enter None for Standard (pre-service) and Payment reconsideration
cases, or if the overturned decision was not effectuated.

• Include all grievances the Sponsoring organization responded to
during the universe request period. The date of the Sponsoring
organization’s response (Column ID R or S) must fall within the
universe request period.
• Exclude all grievances that were withdrawn during the universe
request period.
• Exclude complaints filed only within the Complaints Tracking
Module (CTM) in HPMS. If a complaint was processed both within the
CTM and was also received as a grievance, exclude the CTM
complaint but include the grievance as processed by the Sponsoring
organization.
[Field Length]
20

Technical
Clarification

• Include all grievances the Sponsoring organization responded to
during the universe request period. The date of the Sponsoring
organization’s notification (Column ID Q or S) must fall within the
universe request period.
• Exclude all grievances that were withdrawn and dismissed during
the universe request period.
• Exclude complaints filed only within the Complaints Tracking
Module (CTM) in HPMS. If a complaint was processed both within
the CTM and was also received as a grievance, exclude the CTM
complaint but include the grievance as processed by the Sponsoring
organization.
[Field Length]
11

Table 5
[Field Name]
Plan ID

Technical
Clarification

ODAG Protocol
Table 5: GRV_C
Table Instructions

ODAG Protocol
Enrollee ID
Table 5: Column ID
C
ODAG Protocol
Plan Benefit
Package (PBP)
Tables 5-6: Column
E

[Description]
Enter the plan number (e.g., 001).

Clarification or
Change

Technical
Clarification

Revised Language

Table 5
[Field name]
Plan Benefit Package (PBP)
[Table 5 and Table 6 Description]
Enter the PBP (e.g., 001).

[Table 7 Description]
The PBP (e.g., 001) of the organization.

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

Revised Language

ODAG Protocol
Time the Grievance
was received
Table 5: Column ID
H
ODAG Protocol
Grievance
Description
Table 5: Column ID
N
ODAG Protocol
Date oral
notification
provided to enrollee
Table 5: Column ID
Q

[Description]
Enter the time the grievance was received. Submit in HH:MM:SS
military time format (e.g., 23:59:59).
Enter NA for standard cases.

Technical
Clarification

[Description]
Enter the time the grievance was received. Submit in HH:MM:SS
military time format (e.g., 23:59:59).
Enter None for standard cases.

[Description]
Enter a description of the complaint.

Technical
Clarification

[Description]
Enter a description of the grievance.

[Field Name]
Date oral response provided to enrollee

Technical
Clarification

[Field Name]
Date oral notification provided to enrollee

ODAG Protocol
Time oral
notification
provided to enrollee
Table 5: Column ID
R

[Field Name]
Time oral response provided to enrollee

ODAG Protocol
Date written
notification
provided to enrollee
Table 5: Column ID
S

[Field Name]
Date written response provided to enrollee

[Description]
Enter the date oral notification was provided to the enrollee. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no oral notification was attempted or provided.

[Description]
Enter the date oral notification was provided to the enrollee.
Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if no oral notification was provided.
Technical
Clarification

[Description]
Enter the time oral notification was provided to the enrollee. Submit in
HH:MM:SS military time format (e.g., 23:59:59).
Enter None if no oral notification was attempted or provided.
Enter NA for standard and dismissed cases.

[Description]
Enter the date written response was provided (i.e. delivered) to
enrollee. Do not enter the date a letter is generated or printed. Submit
in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if a written notification was not provided.

[Field Name]
Time oral notification provided to enrollee
[Description]
Enter the time oral notification was provided to the enrollee.
Submit in HH:MM:SS military time format (e.g., 23:59:59).
Enter None for standard grievances or if no oral notification was
provided.

Technical
Clarification

[Field Name]
Date written notification provided to enrollee
[Description]
Enter the date written notification was provided to enrollee. Do not
enter the date a letter is generated or printed. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if a written notification was not provided.

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

ODAG Protocol
Time written
notification
provided to enrollee
Table 5: Column ID
T

[Field Name]
Time written response provided. to enrollee

ODAG Protocol
Universe Table 6:
Standard and
Expedited PreService Part B Drug
Organization
Determinations and
Reconsiderations
(Part B Drugs)
ODAG Protocol
Table 6: AIP

Universe Table 6: Standard and Expedited Pre-Service Part B Drug
Organization Determinations and Reconsiderations (Part B Drugs)

Technical
Clarification Removed Table

N/A

[Table Name]
Universe Table 7: Dual Special Needs Plan – Applicable Integrated
Plan Reconsiderations (AIP).

Technical
Clarification Renamed Table

ODAG Protocol
Table 6: AIP
Table Instructions

• Include all integrated organization determinations the DSNP-AIPs
notified the enrollee would be terminated, suspended, or reduced
during the universe request period. The date of the DSNP-AIP
Integrated Denial Notification (Column ID G) must fall within the
universe request period.
• Populate this Table with requests involving Medicare-coverable
benefits only.
• Exclude all pre-service reconsideration cases.
Table 7
[Field Name]
Member First Name

Technical
Clarification

[Table Name]
Universe Table 6: Dual Special Needs Plan – Applicable Integrated
Plan Reductions, Suspensions, and Terminations (AIP) Record
Layout
• Include all integrated organization determination cases where a
previously approved service is being reduced, suspended, or
terminated by the DSNP-AIP. The date of the DSNP-AIP
Integrated Denial Notification (Column ID G) must fall within the
universe request period.
• Populate this Table with requests involving Medicare-coverable
benefits only.
• Exclude all pre-service cases.
Table 6
[Field Name]
Enrollee First Name

ODAG Protocol
Enrollee First Name
Table 6: Column ID
A

ODAG Protocol
Enrollee Last Name
Table 6: Column ID
B

Technical
Clarification

Revised Language

[Description]
Enter the time written response was provided (i.e. delivered) to
enrollee.. Submit in HH:MM:SS military time format (e.g., 23:59:59).
Enter NA for standard cases.
Enter None if written notification was not provided.

[Description]
First name of the member.
Table 7
[Field Name]
Member Last Name
[Description]
Last name of the member.

Technical
Clarification

[Description]
Enter the first name of the enrollee.
Table 6
[Field Name]
Enrollee Last Name
[Description]
Enter the last name of the enrollee.

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

Revised Language

ODAG Protocol
Contract ID
Table 6: Column ID
D
ODAG Protocol
First Tier,
Downstream, and
Related Entity
Table 6: Column F

Table 7
[Description]
The contract number (e.g., H1234) of the organization.

Technical
Clarification

Table 6
[Description]
Enter the contract number (e.g., H1234).

[Table 7 Column ID]
Z

[Table 6 Column ID]
F

ODAG Protocol

[Table 7 Column ID]
G

Technical
Clarification moved field up in
order within the
record layout for
consistency
relettered
remaining
Column IDs in the
tables.
Technical
Clarification

Date DSNP-AIP
notified enrollee of
its decision to
reduce, terminate, or
suspend services.
Table 6: Column ID
H

ODAG Protocol
Effective date of
reduction,
termination, or
suspension of
services.
Table 6: Column ID
I

[Description]
Insert the name of the First Tier, Downstream, and Related Entity that
processed the plan level appeal (e.g., Independent Physician
Association, Physicians Medical Group or Third Party Administrator).
Answer NA if not applicable.

[Description]
Enter the name of the First Tier, Downstream, and Related Entity
(which is any party that enters into a written arrangement,
acceptable to CMS, with the Sponsoring organization to provide
administrative or health care services to an enrollee under the Part
C or D program) that processed the request.
Enter None if the Sponsoring organization processed the request.
[Table 6 Column ID]
H

[Field Name]
Date DSNP-AIP notified enrollee of its decision to terminate, reduce
or suspend services

[Field Name]
Date DSNP-AIP notified enrollee of its decision to reduce,
terminate, or suspend services.

[Description]
Indicate the date the DSNP-AIP notified the enrollee of the
termination, suspension, or reduction. Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
[Table 7 Column ID]
H

[Description]
Enter the date the DSNP-AIP notified the enrollee of the reduction,
suspension, or termination. Submit in CCYY/MM/DD format (e.g.,
2020/01/01).
[Table 6 Column ID]
I

[Field Name]
Effective date of termination/
reduction/
suspension of services.
[Description]
Indicate the intended date of action (that is, the date on which a
termination, suspension, or reduction becomes effective). Submit in
CCYY/MM/DD format (e.g., 2020/01/01).

Technical
Clarification

[Field Name]
Effective date of reduction, suspension, or termination of services.
[Description]
Indicate the intended date of action (that is, the date on which
reduction, suspension, or termination became effective). Submit in
CCYY/MM/DD format (e.g., 2020/01/01).

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Was the decision
appealed?
Table 6: Column ID
J

Original Language

[Table 7 Column ID]
I

Clarification or
Change
Technical
Clarification

[Description]
Enter (Y) for Yes or (N) for No.
If (N) is entered, populate all remaining fields with NA.

Revised Language

[Table 6 Column ID]
J
[Description]
Enter:
• Y for Yes
• N for No
If ‘N’ is entered, populate all remaining fields with None.

ODAG Protocol
Who made the
request?
Table 6: Column ID
K

ODAG Protocol
Date the appeal was
received
Table 6: Column ID
L

[Table 7 Column ID]
J

Technical
Clarification

[Description]
Indicate whether the plan level appeal was made by a member (M),
contract provider (CP), non-contract provider (NCP), or member’s
representative (MR).
Note- the term “provider” encompasses physicians and facilities.

[Table 7 Column ID]
K

[Table 6 Column ID]
K
[Description]
Enter who made the plan level appeal:
• E for enrollee
• ER for enrollee’s representative
• CP for requests by a contract provider
• NCP for requests by a non-contract provider
“Provider” includes physicians and facilities.
Enter None if the decision was not appealed as indicated by N in
column ID J.

Technical
Clarification

[Table 6 Column ID]
L

[Field Name]
Date the request was received

[Field Name]
Date the appeal was received

[Description]
Provide the date the request was received by your organization. Submit
in CCYY/MM/DD format (e.g., 2020/01/01).

[Description]
Enter the date the request was received. Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter None if the decision was not appealed as indicated by N in
column ID J.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
AOR/Equivalent
Notice Receipt Date
Table 6: Column ID
M

ODAG Protocol
Was the appeal
processed as
Standard or
Expedited?
Table 6: Column ID
N

Original Language

[Table 7 Column ID]
Y
[Description]
Date the Appointment of Representative (AOR) form or other
appropriate documentation received by the DSNP-AIP. Submit in
CCYY/MM/DD format (e.g., 2020/01/01). Answer NA if no AOR
form was required.

[Table 7 Column ID]
L

Clarification or
Change
Technical
Clarification moved field up in
order within the
record layout for
consistency with
all ODAG record
layouts &
relettered
remaining
Column IDs in the
tables.
Technical
Clarification

Revised Language

[Table 6 Column ID]
M
[Description]
Enter the date the Appointment of Representative (AOR) form or
equivalent written notice was received by the Sponsoring
organization. Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None for dismissed requests, if no AOR or equivalent written
notice was received or required, or if the decision was not appealed
as indicated by N in column ID J.

[Table 6 Column ID]
N

[Field Name]
Was the request processed as Standard or Expedited?

[Field Name]
Was the appeal processed as Standard or Expedited?

[Field Length]
1

[Field Length]
4

[Description]
Enter the manner by which the request was processed:
• S for Standard
• E for Expedited

[Description]
Enter the manner by which the appeal was processed:
• S for Standard
• E for Expedited
Enter None if the decision was not appealed as indicated by N in
column ID J.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Was appeal made
under the expedited
timeframe but
processed by the
plan under the
standard timeframe?
Table 6: Column O

ODAG Protocol
Was a timeframe
extension taken?
Table 6: Column ID
P

ODAG Protocol
If an extension was
taken, did the
DSNP-AIP notify
the enrollee of the
reason(s) for the
delay and of their
right to file an
expedited
grievance?
Table 6: Column ID
Q

Original Language

[Table 7 Column ID]
M

Clarification or
Change
Technical
Clarification

Revised Language

[Table 6 Column ID]
O

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

[Field Name]
Was appeal made under the expedited timeframe but processed by
the plan under the standard timeframe?

[Field Length]
2

[Field Length]
4

[Description]
Yes (Y)/No (N) indicator of whether the request was received as
expedited but was downgraded and processed under the standard
timeframe (e.g., based on the DSNP-AIP deciding that the expedited
plan level appeal was unnecessary). Answer NA if the request was
received as a standard request.

[Description]
Yes (Y)/No (N) indicator of whether the request was received as
expedited but was downgraded and processed under the standard
timeframe (e.g., based on the DSNP-AIP deciding that the
expedited plan level appeal was unnecessary). Enter None if the
request was received as a standard request or if the decision was not
appealed as indicated by N in column ID J.

[Table 7 Column ID]
N

Technical
Clarification

[Table 6 Column ID]
P

[Field Length]
2

[Field Length]
4

[Description]
Yes (Y)/No (N)/ Not Applicable (NA) indicator of whether the DSNPAIP extended the timeframe to make the appeal decision.

[Description]
Yes (Y)/No (N) indicator of whether the DSNP-AIP extended the
timeframe to make the appeal decision.
Enter None if the decision was not appealed as indicated by N in
column ID J.
[Table 6 Column ID]
Q

[Table 7 Column ID]
O

Technical
Clarification

[Field Length]
2

[Field Length]
4

[Description]
Yes (Y)/No (N) indicator of whether the DSNP-AIP notified the
member of the delay. Answer NA if no extension was taken.

[Description]
Yes (Y)/No (N) indicator of whether the DSNP-AIP notified the
enrollee of the delay. Enter None if no extension was taken or if the
decision was not appealed as indicated by N in column ID J.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Did the enrollee
request continuation
of benefits?
Table 6: Column ID
R

ODAG Protocol
Were the benefits
under appeal
provided to the
enrollee during the
plan level appeal
process?
Table 6: Column ID
S
ODAG Protocol
Request Disposition
Table 6: Column ID
T

Original Language

[Table 7 Column ID]
P

Clarification or
Change
Technical
Clarification

Revised Language

[Table 6 Column ID]
R

[Field Length]
2

[Field Length]
4

[Description]
Yes (Y)/No (N) indicator of whether the enrollee requested
continuation of benefits.
Answer NA if no request for continuation of benefits was made.

[Description]
Yes (Y)/No (N) indicator of whether the enrollee requested
continuation of benefits.
Enter None if someone other than the enrollee requested
continuation of benefits or if the decision was not appealed as
indicated by N in column ID J.
[Table 6 Column ID]
S

[Table 7 Column ID]
Q

Technical
Clarification

[Field Length]
2

[Field Length]
4

[Description]
Yes (Y)/No (N) indicator of whether the benefits under appeal were
provided to the enrollee during the reconsideration process.
Answer NA if no request for continuation of benefits was made.

[Description]
Yes (Y)/No (N) indicator of whether the benefits under appeal were
provided to the enrollee during the reconsideration process.
Enter None if no request for continuation of benefits was made or if
the decision was not appealed as indicated by N in column ID J.

[Table 7 Column ID]
R

Technical
Clarification

[Table 6 Column ID]
T

[Field Length]
50

[Field Length]
9

[Description]
Status of the request. Valid values are: approved, denied, denied with
IRE auto forward, or IRE auto-forward due to untimely decision.
DSNP-AIPs should note any requests that are untimely and not yet
resolved (still outstanding) as denied.
All untimely and pending cases should be treated as denials for the
purposes of populating the rest of this record layout’s fields.

[Description]
Enter:
• Approved
• Denied
• Dismissed
Enter None if the decision was not appealed as indicated by N in
column ID J.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Date of DSNP-AIP
decision
Table 6: Column ID
U

ODAG Protocol
Date Oral
Notification
Provided to enrollee
Table 6: Column ID
V

ODAG Protocol
Date written
notification
provided to
enrollee/provider
Table 6: Column ID
W

Original Language

[Table 7 Column ID]
S

Clarification or
Change
Technical
Clarification

[Table 6 Column ID]
U

Technical
Clarification

[Description]
Date of the DSNP-AIP decision. Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter None if the decision was not appealed as indicated by N in
column ID J.
[Table 6 Column ID]
V

[Description]
Date of the DSNP-AIP decision. Submit in CCYY/MM/DD format
(e.g., 2020/01/01).

[Table 7 Column ID]
T

Revised Language

[Field Name]
Date Oral Notification Provided to member

[Field Name]
Date Oral Notification Provided to enrollee

[Description]
Date oral notification provided to member. Submit in CCYY/MM/DD
format (e.g., 2020/01/01). Answer NA if no oral notification provided.

[Description]
Date oral notification provided to enrollee. Submit in
CCYY/MM/DD format (e.g., 2020/01/01). Enter None if no oral
notification provided or if the decision was not appealed as
indicated by N in column ID J.
[Table 6 Column ID]
W

[Table 7 Column ID]
U

Technical
Clarification

[Field name]
Date written notification provided to member/provider

[Field name]
Date written notification provided to enrollee/provider

[Description]
Date written notification provided to member, or if applicable the noncontract provider. The term “provided” means when the letter left the
DSNP-AIP’s establishment by US Mail, fax, or electronic
communication. Do not enter the date when a letter is generated or
printed within the DSNP-AIP’s organization. If no proof of mailing is
available, populate based on worst case scenario according to policies
in place. Submit in CCYY/MM/DD format (e.g., 2020/01/01). Answer
NA if no written notification was provided.

[Description]
Date written notification provided to enrollee, or if applicable the
non-contract provider. Do not enter the date when a letter is
generated or printed within the DSNP-AIP’s organization. Submit
in CCYY/MM/DD format (e.g., 2020/01/01). Enter None if no
written notification was provided or if the decision was not
appealed as indicated by N in column ID J.

Document in
CMS-10717
(version 05/2020)
ODAG Protocol
Date reconsidered
determination
effectuated in the
DSNP-AIP system
Table 6: Column ID
X

ODAG Protocol
Date forwarded to
IRE if denied or
untimely
Table 6: Column ID
Y

ODAG Protocol
If request denied,
date services were
terminated, reduced,
suspended
Table 6: Column ID
Z
ODAG Protocol
Audit Field Work
Phase

Original Language

[Table 7 Column ID]
V

Clarification or
Change
Technical
Clarification

Revised Language

[Table 6 Column ID]
X

[Field Name]
Date service authorization entered/effectuated in the DSNP-AIP
system

[Field Name]
Date reconsidered determination effectuated in the DSNP-AIP
system

[Description]
Date authorization/approval entered in the DSNP-AIP 's system.
Submit in CCYY/MM/DD format (e.g., 2020/01/01). Answer NA for
denials and IRE auto-forwards.
Technical
Clarification

[Description]
Date reconsidered determination effectuated in the DSNP-AIP 's
system. Submit in CCYY/MM/DD format (e.g., 2020/01/01). Enter
None for denials and or if the decision was not appealed as
indicated by N in column ID J.
[Table 6 Column ID]
Y

Technical
Clarification

[Description]
Date the AIP forwarded request to the IRE if request for Medicare
service was denied or processed untimely. Submit in
CCYY/MM/DD format (e.g., 2020/01/01). Answer None if
approved or not forwarded to IRE or if the decision was not
appealed as indicated by N in column ID J.
[Table 6 Column ID]
Z

[Table 7 Column ID]
W
[Description]
Date the AIP forwarded request to the IRE if request for Medicare
service was denied or processed untimely. Submit in CCYY/MM/DD
format (e.g., 2020/01/01). Answer NA if approved or not forwarded to
IRE.
[Table 7 Column ID]
X
[Description]
Date of the DSNP-AIP decision. Submit in CCYY/MM/DD format
(e.g., 2020/01/01).

• If applicable, providing timely notification of dismissals to enrollees
or another party, and informing enrollees and other parties about the
right to request IRE review of the dismissal since Sponsoring
organizations will no longer automatically forward such
reconsideration cases to the IRE for review.

Technical
Clarification

[Description]
Enter the date the services were terminated, reduced, suspended.
Submit in CCYY/MM/DD format (e.g., 2020/01/01).
Enter None if the decision was not appealed as indicated by N in
column ID J.
• If applicable, providing timely notification of dismissed requests
to enrollees or another party, and informing enrollees and other
parties about the right to request IRE review of the dismissed
request since Sponsoring organizations will no longer automatically
forward such reconsideration cases to the IRE for review.

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

SNPCC Protocol
Program Audit
Protocol
Purpose

Technical
Clarification

SNPCC Protocol
Compliance
Standard Universe
Integrity Testing

[Method of Evaluation] Select 10 cases from Universe Table 1.

Technical
Clarification

Prior to field work, CMS will schedule a webinar with the Sponsoring
organization to verify accuracy of data within Table 1 for each of the
sampled cases.

Conduct timeliness test at the universe level of enrollees who have
been enrolled for at least 90 days, to determine whether the Sponsoring
organization conducted an initial health risk assessment (IHRA) for
each applicable enrollee within 90 days of enrollment.
Request an impact analysis for any enrollee identified as having an
untimely IHRA to quantify the outreach made by the Sponsoring
organization in an attempt to conduct the IHRA within 90 days of
enrollment.

To evaluate performance in the areas outlined in this Program Audit
Protocol and Data Request related to Special Needs Plans Care
Coordination (SNPCC). The Centers for Medicare and Medicaid
Services (CMS) performs its program audit activities in accordance
with the SNPCC Program Audit Data Request and applying the
compliance standards outlined in this Program Audit Protocol and
the Program Audit Process Overview document. At a minimum,
CMS will evaluate cases against the criteria listed below. CMS may
review factors not specifically addressed below if it is determined
that there are other related SNPCC requirements not being met.
[Method of Evaluation] Select 10 cases from Universe Table 1.
Prior to field work, CMS will schedule a webinar with the
Sponsoring organization to verify accuracy of data within Table 1
for each of the sampled cases. System data such as enrollment
dates, dates of initial HRA, etc. will be verified.

Sample selections will be provided to the Sponsoring organization
approximately one hour prior to the scheduled webinar.

SNPCC Protocol
Compliance
Standard 1.1

Revised Language

Technical
Clarification

Sample selections will be provided to the Sponsoring organization
approximately one hour prior to the scheduled integrity testing
webinar.
Conduct a timeliness test at the universe level of enrollees who
have been continuously enrolled for at least 90 days, to determine
whether the Sponsoring organization conducted a timely initial
health risk assessments (IHRAs) within 90 days (before or after)
the effective date of enrollment. IHRA Timeliness assessments will
be conducted using current enrollments, from Table 1. Assessments
will be limited to individuals enrolled with effective dates within 12
months of the audit engagement letter.
Request an impact analysis for any enrollee identified as having an
untimely IHRA to quantify the outreach made by the Sponsoring
organization in an attempt to conduct the IHRA within 90 days of
enrollment. Impact analysis review period is limited to the 12 the
month period prior to date of the engagement letter, to align with
the timeliness test. *Outreach data points in Table 2IA are subject
to validation, as requested by CMS.

Document in
CMS-10717
(version 05/2020)
SNPCC Protocol
Compliance
Standard 1.2

SNPCC Protocol
Compliance
Standard 1.3
SNPCC Protocol
Compliance
Standard 1.6

Original Language

Conduct timeliness test at the universe level of enrollees who have
been enrolled for at least 13 consecutive months, to determine whether
the Sponsoring organization conducted an annual health risk
assessment
(AHRA) for each applicable enrollee within 365 days of the prior
HRA.
Request an impact analysis for any enrollee identified as having an
untimely AHRA to quantify the outreach made by the Sponsoring
organization in an attempt to conduct the AHRA within 365 days of
the prior HRA completion date.
Sample selections will be provided to the Sponsoring organization
approximately one hour prior to the scheduled webinar.

Clarification or
Change
Technical
Clarification

Technical
Clarification

Review case management notes, ICT documentation, and systems
information such as utilization management, claims data, and
prescription drug events (PDE) for each of the 30 selected samples to
determine whether the Sponsoring organization implemented the ICP.

Technical
Clarification

SNPCC Protocol
Compliance
Standard 1.7

Review documented ICT notes and communications (amongst ICT
members and/or with enrollees/caregivers) pertaining to each of the 30
selected samples to determine how the enrollee or the
caregiver/representative was involved in the ICP development.

Technical
Clarification

SNPCC Protocol
Compliance
Standard 1.8

Review systems for documented case management notes, ICT member
notes and communications (e.g. documented phone calls, letters
to/from providers regarding member care, etc.), and ICT meeting
agendas/minutes pertaining to each of the 30 selected samples to
determine whether the Sponsoring organization coordinated
communication amongst its personnel, providers, and enrollees.

Technical
Clarification

SNPCC Protocol
Compliance
Standard 1.11

Review documentation for each of the 30 selected samples to
determine whether the Sponsoring organization has knowledgeable,
credentialed individuals performing HRA analysis and ICP
development processes in accordance with their MOC.
Scope of Universe Request*
* CMS reserves the right to expand the review period to ensure
sufficient universe size.

Technical
Clarification

SNPCC Protocol
Universe Requests

Technical
Clarification

Revised Language

Conduct timeliness test at the universe level of enrollees who have
either been continuously enrolled for 365 days or more, or new
enrollees who missed the deadline to complete an initial HRA, to
determine whether the Sponsoring organization conducted timely
annual health re-assessment HRAs (AHRAs).
Request an impact analysis for any enrollee identified as having an
untimely AHRA to quantify the outreach made by the Sponsoring
organization in an attempt to conduct the AHRA within 365 days of
the prior HRA completion date, or date of enrollment, if no initial
HRA was conducted.
Sample selections will be provided to the Sponsoring organization
the Thursday prior to the start of audit field work.
Review documentation which may include, but is not limited to
case management notes, ICT documentation, and systems
information such as utilization management, claims data, and
prescription drug events (PDE) for each of the 30 selected samples
to determine whether the Sponsoring organization implemented the
ICP.
Review documentation which may include, but is not limited to
ICT notes and communications (amongst ICT members and/or with
enrollees/caregivers) pertaining to each of the 30 selected samples
to determine how the enrollee or the caregiver/representative was
involved in the ICP development.
Review systems for documentation which may include but is not
limited to case management notes, ICT member notes and
communications (e.g. documented phone calls, letters to/from
providers regarding member care, etc.), and ICT meeting
agendas/minutes pertaining to each of the 30 selected samples to
determine whether the Sponsoring organization coordinated
communication amongst its personnel, providers, and enrollees.
Review documentation for each of the 30 selected samples to
determine whether ICPs were developed and implemented by staff
that met the professional requirements, including credentials,
described in the MOC.
Scope of Universe Request

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

Revised Language

SNPCC Protocol
Table 1: SNPE
Table Instructions

• List all current SNP enrollees as of the date of the audit engagement
letter that have been enrolled with Sponsoring organization for at least
90 days and for 13 continuous months.
• List each enrollee only once.
• Include enrollees with disenrollment effective dates at the end of
month in which you receive your audit engagement letter.
• Exclude enrollments received before the date of the audit engagement
letter that are not effective until the first day of the month following
the audit engagement letter.

Technical
Clarification

• List all current SNP enrollees as of the date of the audit
engagement letter.
• List each enrollee only once.
• Include enrollees with disenrollment effective dates at the end of
month in which the audit engagement letter is received.
• Exclude enrollments received before the date of the audit
engagement letter that are not effective until the first day of the
month following the audit engagement letter.

SNPCC Protocol
Enrollment
Effective Date
Table 1: Column ID
G

[Description]
Enter the effective date of the most current/continuous enrollment for
the enrollee with the Sponsoring organization.
Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
For a PBP change or consolidation event the Sponsoring organization
must use the pre-event effect date for the enrollee. (e.g., If an enrollee
is effective 4/1/2010 and stays in D- SNP through 12/31/2016 but
moves to C-SNP effective 1/1/2017. We would expect to see
04/01/2010 in the universe).
N/A

Technical
Clarification

[Description]
Enter the effective date of the most current/continuous enrollment
for the enrollee with the Sponsoring organization.
Submit in CCYY/MM/DD format
(e.g., 2020/01/01).

Technical
Clarification Added field and
relettered
remaining
Column IDs in the
table

Field Type: CHAR Always Required
Field Length: 10
Description: Enter the date of last plan change within the
continuous SNP enrollment.
Submit in CCYY/MM/DD format (e.g.,2020/01/01)
For a PBP change or consolidation event the Sponsoring
organization must use the post-event effect date for the enrollee.
Enter None if there were no PBP or plan consolidation events.

Technical
Clarification

[Description]
This is the date of the most recently completed HRA prior to the
date entered in Column ID I.

SNPCC Protocol
Most Recent Plan
Change Effective
Date
Table 1: Column ID
H

SNPCC Protocol
Date of previous
HRA
Table 1: Column ID
J

[Description]
This is the date of the most recently completed HRA prior to the date
entered in Column ID H.

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

Revised Language

SNPCC Protocol
Date Initial HRA
(IHRA) was
completed
Table 1: Column ID
K

[Description]
Enter the date of the enrollee’s first HRA completion (prior to or after
enrolling).
HRA completion date is the date the HRA is returned completed to the
Sponsoring organization by either the enrollee or the enrollee’s
representative.
Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter NA if no HRA was completed.
Enter EXC-10 if the IHRA date is greater than 10 years ago.

Technical
Clarification

SNPCC Protocol
Date of most recent
Individualized
Care Plan (ICP)
Table 1: Column ID
M
SNPCC Protocol
Impact Analysis
Requests
Table 2IA Scope of
Impact Analysis
Request
SNPCC Protocol
Table 1IA CC-IA
Table Instructions

[Description]
Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter None if the enrollee did not receive an ICP.

Technical
Clarification

Submit a list of enrollees who did not receive a timely initial and/or
annual HRA during the 26-week period preceding the date of the audit
engagement letter through the date the issue was identified on audit.

Technical
Clarification

Submit a list of enrollees who did not receive a timely initial and/or
annual HRA within the 12 month period prior to the date of the
engagement letter. Populate untimely cases with the appropriate
outreach information for initial and/or annual HRAs as identified
during the timeliness test.

• Include all enrollees missing either a completed HRA, ICP, or ICT as
specified in the request for an impact analysis.

Technical
Clarification

• Include all enrollees impacted by the care coordination issue as
specified in the request for an impact analysis.

SNPCC Protocol
Initial ICP Date
Table 1IA: Column
ID K

[Description]
Enter the date the initial ICP was completed.
Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter None if no initial ICP created.

Technical
Clarification

[Description]
Enter the date the initial ICP was completed.
Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter None if an initial ICP was not completed.

SNPCC Protocol
Date of Most
Recent ICP revision
Table 1IA: Column
ID L

[Description]
Enter the date the most recent ICP was completed.
Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter NA if most recent ICP not completed.

Technical
Clarification

[Description]
Enter the date the ICP was most recently revised.
Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter NA if the enrollee’s ICP has not been completed or revised
since the initial ICP was completed per Column ID K.

[Description]
Enter the date of the enrollee’s first HRA completion (within 90
days before or after the effective date of enrollment).
HRA completion date is the date the HRA is returned completed to
the Sponsoring organization by either the enrollee or the enrollee’s
representative.
Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter None if no HRA was completed within 90 days before or
after the effective date of enrollment.
Enter EXC-10 if the IHRA date is greater than 10 years ago.
[Description]
Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter None if the Sponsoring organization did not develop an ICP.
If care plan is continuous, enter the date of the most recent update.

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

SNPCC Protocol
Basis of most recent
ICP
Table 1IA: Column
ID M

[Description]
Enter ICP basis:
• Initial
• Annual, or
• Change in Status
Enter NA if no ICP conducted.

Technical
Clarification

SNPCC Protocol
Date of previous
ICP revision
Table 1IA: Column
ID N

[Description]
Enter the date the previous ICP was completed.
Submit in CCYY/MM/DD format
(e.g., 2020/01/01)
In the case of an ICP that was created on January 1, but then updated
on March 1 of the same year, March is the most recent, and January is
the
“previous”
Enter NA if no previous ICP was conducted.

Technical
Clarification

SNPCC Protocol
Basis of previous
ICP
Table 1IA: Column
ID O

[Description]
Enter previous ICP basis:
• Initial
• Annual, or
• Change in Status
Enter NA if no previous ICP conducted.

Technical
Clarification

SNPCC Protocol
Did all members of
enrollee’s ICT
receive annual MOC
training?
Table 1IA: Column
ID W
SNPCC Protocol
Table 2IA HRATIA
Table Instructions

[Field Name]
Did all members of enrollee’s ICT receive annual MOC training.

Technical
Clarification

• Include all enrollees without a completed HRA or with an untimely
HRA as specified in the request for impact analysis.
The look back period is 26 weeks, sponsoring organizations
conducting HRA events within the 26 week look back period on a
single enrollee should populate the IA record layout with the most
recent HRA event that occurred during the applicable timeframe.

Technical
Clarification

Revised Language

[Description]
Enter basis for most recent ICP revision in Column ID L:
• Initial
• Annual, or
• Change in Status
Enter NA if the enrollee’s ICP has not been completed or revised
since the initial ICP was completed per Column ID K.
[Description]
Enter the date the enrollee’s ICP was previously revised compared
to Column ID L.
Submit in CCYY/MM/DD format
(e.g., 2020/01/01)
In the case of an ICP that was revised on January 1, but then
revised again on March 1 of the same year, March is the date of the
most recent ICP revision, and January is the date of the previous
ICP revision.
Enter NA if the enrollee’s ICP has not been completed or revised
since the ICP was revised per Column ID L.
[Description]
Enter basis for previous ICP revision:
• Initial
• Annual, or
• Change in Status
Enter NA if the enrollee’s ICP has not been completed or revised
since the ICP was revised per Column ID L.
[Field Name]
Did all members of enrollee’s ICT receive annual MOC training?

• Include all enrollees without a completed HRA or with an
untimely HRA to quantify outreach attempts, as specified in the
request.
• Impact analysis review period is the 12 month period prior to date
of the engagement letter. Sponsoring organizations conducting
HRA events within the 12-month period on a single enrollee should
populate the IA record layout with the most recent HRA event that
occurred during the applicable timeframe.

Document in
CMS-10717
(version 05/2020)

Original Language

Clarification or
Change

Revised Language

SNPCC Protocol
Date the HRA Unable to Contact
(UTC) Letter was
sent to nonresponding enrollee
Table 2IA: Column
ID V
SNPCC
Supplemental
Questionnaire

[Description]
Enter the date the UTC letter was sent.
Submit in CCYY/MM/DD format
(e.g., 2020/01/01) or enter NA, if no letter sent.
This column should reflect only the most recent HRA event that
occurred during the 26 week look back period.

Technical
Clarification

[Description]
Enter the date the UTC letter was sent.
Submit in CCYY/MM/DD format
(e.g., 2020/01/01) or enter NA, if no letter sent.

3. Describe staffing responsibilities for administering HRAs and
developing ICPs.

[Question 3 removed]

SNPCC
Supplemental
Questionnaire

7. Describe the process of verifying licensure for credentialed
personnel.

SNPCC
Supplemental
Questionnaire

9. Describe the process for tracking the distribution of MOC training
materials to ICT providers.

SNPCC
Supplemental
Questionnaire

10. Describe the internal system utilized for ensuring that ICTs are
comprised of appropriate disciplines, as described in the MOC, and
that ICTs coordinate care and communicate with each other and
enrollees regarding the ICP.

SNPCC
Supplemental
Questionnaire

11. If there are ICT meetings where beneficiary ICPs and care
coordination are discussed, what is the period of time expected
between initial ICP development and presentation to the ICT?

SNPCC
Supplemental
Questionnaire

12. Describe outreach policy pertaining to HRA administration and
ICP development.

Technical
Clarificationquestion removed
& renumbered
remaining
questions
Technical
Clarificationquestion removed
& renumbered
remaining
questions
Technical
Clarificationquestion removed
& renumbered
remaining
questions
Technical
Clarificationquestion removed
& renumbered
remaining
questions
Technical
Clarificationquestion removed
& renumbered
remaining
questions
Technical
Clarification

[Question 7 removed]

[Question 9 removed]

[Question 10 removed]

[Question 11 removed]

7. Describe the outreach policy pertaining to HRA administration
and ICP development. Describe the process for beneficiaries that
cannot or do not want to be contacted.

Document in
CMS-10717
(version 05/2020)
SNPCC
Supplemental
Questionnaire
Supporting
Statement A
Footnote, page 1
Supporting
Statement A
Section 2

Original Language

14. What is the period of time expected between HRA (or completion
of outreach efforts if beneficiary is unreachable) and ICP
development? If there are differences in ICP development timing
expected based on risk stratification level, please explain.
1
The ODAG protocol also evaluates the integrated organization
determinations, appeals, and grievances of sponsoring organizations
offering an applicable integrated SNP plan with exclusively aligned
enrollment as defined at 42 CFR § 561.
The information gathered during this audit will be used by the
Medicare Parts C and D
Oversight and Enforcement Group (MOEG) within the Center for
Medicare (CM) and CMS Regional Offices to assess sponsoring
organizations’ compliance with Medicare program requirements.

Clarification or
Change

Revised Language

Technical
Clarificationquestion removed

[Question 14 removed]

Corrected the
partial omission
of regulation
citation
Technical
Clarification

The ODAG protocol also evaluates the integrated organization
determinations, appeals, and grievances of sponsoring
organizations offering an applicable integrated SNP plan with
exclusively aligned enrollment as defined at 42 CFR § 422.561.
The information gathered during this program audit will be used by the Medicare Parts C and D
Oversight and Enforcement Group (MOEG) within the Center for Medicare (CM) and CMS Regional
Offices to assess sponsoring organizations’ compliance with Medicare program requirements.
Specifically, as part of its FA review, MOEG reviews samples of rejected claims to ensure that the
point-of-sale rejections are appropriate; its purpose is to ensure Part D organizations are administering
their formulary and transition benefit in accordance with their CMS-approved formulary and the

If outliers or other data anomalies are detected, Regional Offices will
work in collaboration with (MOEG) and other divisions within CMS
for follow-up and resolution. Additionally, MA and Part D
organizations will receive the audit results and will be required to
implement corrective action to correct any identified deficiencies.

overriding regulations. MOEG’s ODAG and CDAG reviews focus on the timeliness of coverage
decisions and grievances related to requests for services and drugs. ODAG and CDAG universes are
collected and reviewed at the universe level to ensure organizations are meeting the notification and
effectuation timeframe requirements outlined in regulation, and samples are reviewed to ensure proper
procedures are followed in processing these requests, such as providing appeal rights for denied
requests, ensuring the appropriate level of review when initial requests are denied for lack of medical
necessity, etc. As part of its CPE review, MOEG uses audit universes and information collected via
questionnaires to assess the extent to which Part C and Part D organizations have adopted and
implemented an effective compliance program, inclusive of measures that prevent, detect, and correct
non-compliance with CMS' program requirements. And finally, if the audited MA organization offers a
SNP, MOEG’s review evaluates a sample of SNP enrollees to ensure the SNP is coordinating care,
administering health risk assessments, updating individual care plans, and assigning interdisciplinary
care teams in accordance with the CMS-approved model of care.

If outliers or other data anomalies are detected, MOEG requires audited organizations to provide impact
analyses to better understand and report the scope of the noncompliance. These MA and Part D
organizations then receive their audit results, are required to implement corrective actions, and to
demonstrate correction of all conditions cited in the final audit report by undergoing a validation audit.
If the validation audit demonstrates substantial correction of the conditions, MOEG will communicate
its decision to close the audit in a letter to the MA and Part D organization. Any new or isolated issues
of non-compliance that remain will be referred to the CMS Account Manager for follow-up. Regional
Offices will work in collaboration with MOEG and other divisions within CMS for resolution.

Document in
CMS-10717
(version 05/2020)
Supporting
Statement A
Section 6

Supporting
Statement A
Section 8

Original Language

42 CFR part 423 subpart K and 422 subpart K stipulate that CMS must
oversee a sponsoring organization’s continued compliance with CMS
requirements. In general, CMS attempts to audit each sponsoring
organization once every 4 years. However, the frequency with which
an audit occurs for a sponsoring organization can be based on a variety
of factors, including the identification of compliance issues, referral for
program audit, the size of the organization, and amount of time since
last audit. In addition, CMS conducts annual timeliness monitoring of
Part C organization determinations and appeals, and Part D coverage
determinations and appeals. Less frequent collection of the data from
sponsoring organizations would severely limit CMS’ ability to perform
accurate and timely oversight, monitoring, and compliance and
auditing activities around the Parts C and D Medicare benefits and
could result in an increased potential for harm to Medicare
beneficiaries.
The 60-day notice published in the Federal Register on [TBD] (84 FR
INSERT).

Clarification or
Change
Technical
Clarification

Revised Language

42 CFR part 423 subpart K and 422 subpart K stipulate that CMS must oversee a sponsoring
organization’s continued compliance with CMS requirements. In general, CMS attempts to audit
coverage for at least 95 percent of MA and Part D covered enrollees by conducting program audits at the
parent organization level within a given audit cycle. Each audit cycle averages 4 years in duration, and
organizations with the most MA and Part D enrollees tend to be audited at the beginning of each audit
cycle. Organizations with less MA and Part D enrollees, or organizations that have never been subject
to a program audit, tend to be scheduled in the latter half of the cycle. Given the variance in total
enrollment, the number of audits conducted each year can range from 13 to 40 audits, and the frequency
with which an audit occurs can also be influenced by the identification of compliance issues, referral for
program audit, a spike in the size of an organization, and the amount of time since the last audit. In
addition, CMS conducts annual timeliness monitoring of Part C organization determinations and appeals
. Less frequent collection of the data from sponsoring organizations would severely limit CMS’ ability
to perform accurate and timely oversight, monitoring, compliance, and auditing activities around the
Parts C and D Medicare benefits and could result in an increased potential for harm to Medicare
beneficiaries.

Updated to reflect
changes resulting
from public
comment

The 60-day notice published in the Federal Register on December
6, 2019 (84 FR 66912). CMS received 42 public submissions,
which included 662 comments. We then combined the 662
comments into 329 unique comments and provided responses in the
comment and response summary that is included in this collection
request. We adopted many of the commenters’ suggestions and
believe that those corresponding edits simplify and clarify the
collection instruments. First, we removed the rejected claims
transition record layout for the previous contract year from the FA
Data Request, as well as the Part B Drugs record layout from the
ODAG Data Request to further streamline our review and data
collection. Then, we identified additional opportunities to clarify
and standardize field definitions and locations within the FA,
CDAG, and ODAG record layouts. Next, we redefined field
descriptions within the SNPE record layout, as found in the SNPCC
Data Request, to align our data collection and evaluation with the
2020 Part C Reporting Requirements. Finally, we renamed the
CPE Program Audit Protocol and Data Request document for
consistency and clarification of the audit scope, and spelled out
frequently used acronyms to reduce confusion within the CPE
questionnaires. Please refer to the Crosswalk of Changes for a
complete summary of updates made to this collection request since
the December 6, 2019 publication. The 30-day notice published in
the Federal Register on [TBD] (85 FR INSERT).

Document in
CMS-10717
(version 05/2020)
Supporting
Statement A
Section 12 Burden
Estimates (Hours &
Wages) Wage
Estimates
Supporting
Statement A
Section 14 Cost to
Federal Government
Supporting
Statement A
Section 15 Changes
to Burden

Original Language

Clarification or
Change

Revised Language

May 2018 BLS wage estimates

Updated wage
data

May 2019 BLS wage estimates

[Staff Time]
2019 OPM General Schedule wage data: 1,193,934

Updated wage
data

[Staff Time]
2020 OPM General Schedule wage data: 1,217,400

[Contractor Costs]
$7,493,7768
New collection, not applicable to changes to burden at this time.

Updated to reflect
changes resulting
from public
comment

[Contractor Costs]
$8,513,400
As indicated in Section 8 above, we adopted many of the technical
changes that were suggested in public comment in the interest of
simplifying and clarifying the collection instruments. First, we
removed the rejected claims transition record layout for the
previous contract year from the FA Data Request, as well as the
Part B Drugs record layout from the ODAG Data Request to further
streamline our review and data collection. Then, we identified
additional opportunities to clarify and standardize field definitions
and locations within the FA, CDAG, and ODAG record layouts.
Next, we redefined field descriptions within the SNPE record
layout, as found in the SNPCC Data Request, to align our data
collection and evaluation with the 2020 Part C Reporting
Requirements. Finally, we renamed the CPE Program Audit
Protocol and Data Request document for consistency and
clarification of the audit scope, and spelled out frequently used
acronyms to reduce confusion within the CPE questionnaires.
These changes resulted in no change to burden.
As summarized in the 60-day collection request, we estimate the
total hourly burden for routine program audits at 701 hours to
reflect the entirety of the audit process. The total number of routine
program audits is estimated at 25 and the corresponding total
burden is 17,525 hours.
The total hourly burden for the industry wide timeliness monitoring
project remains at 120.5 hours per respondent. As described above,
the number of respondents for this timeliness monitoring project is
154 sponsoring organizations per year. Consequently, the total
burden for the industry wide monitoring effort is 18,557 hours.

File Type	application/pdf
File Title	Crosswalk 60D Comments
Subject	Crosswalk 60D comments
Author	CMS
File Modified	2020-05-22
File Created	2020-05-22