Program Audits

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

CDAGProtocol

Program Audits

OMB: 0938-1395

Document [pdf]

Download: pdf | pdf

Part D Coverage
Determinations, Appeals, and
Grievances (CDAG)
PROGRAM AUDIT PROTOCOL AND DATA
REQUEST

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)

Table of Contents

Program Audit Protocol ............................................................................................................................. 3
Purpose ........................................................................................................................................................ 3
Audit Elements Tested ................................................................................................................................ 3
Program Audit Data Request................................................................................................................... 15
Audit Engagement and Universe Submission Phase .............................................................................. 15
Universe Submissions ....................................................................................................................... 15
Universe Requests ............................................................................................................................. 15
Universe Table 1: Standard and Expedited Coverage Determination (CD) Record Layout ............... 16
Universe Table 2: Standard and Expedited Coverage Determination Exception Requests (CDER)
Record Layout ..................................................................................................................................... 23
Universe Table 3: Payment Coverage Determinations and Redeterminations (PYMT_D) Record
Layout ................................................................................................................................................. 32
Universe Table 4: Standard and Expedited Redeterminations (RD) Record Layout .......................... 39
Universe Table 5: Part D Effectuations of Overturned Decisions by IRE, ALJ or MAC (EFF_D)
Record Layout ..................................................................................................................................... 49
Universe Table 6: Part D Standard and Expedited Grievances (GRV_D) Record Layout ................. 53
Universe Table 7: Comprehensive Addiction and Recovery Act (CARA) At-Risk Determination
(AR) Record Layout ........................................................................................................................... 56
Audit Field Work Phase ........................................................................................................................... 59
Supporting Documentation Submissions ........................................................................................ 59
Root Cause Analysis Submissions ................................................................................................... 61
Impact Analysis Submissions ........................................................................................................... 61

Page 2 of 3

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)

Program Audit Protocol
Purpose
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.
Audit Elements Tested
1. Timeliness
2. Processing of Coverage Requests
3. Classification of Requests
4. Administration of Drug Management Program

Page 3 of 4

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Audit
Element
Not
Applicable

Compliance
Standard
Universe
Integrity
Testing

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
Determination
and
Redeterminations
(PYMT_D)

Method of Evaluation
Select 10 cases from each universe, Tables 1
through 7 for a total of 70 cases.
Prior to field work, CMS will schedule a
webinar with the Sponsoring organization to
verify accuracy of data within the universe
submissions, and to confirm effectuation of
approved requests for each of the sampled
cases. For Universe Table 2, verify during the
webinar that the sampled cases are exception
requests. Review all cases selected for
universe integrity testing. The integrity of the
universe will be questioned if data points
specific to the sample case(s) are incomplete,
do not match, or cannot be verified by viewing
the Sponsoring organization’s systems and/or
other supporting documentation.

Criteria Effective
01/01/2021
42 CFR § 423.505(e)
42 CFR § 423.505(f)

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

Universe Table 4:
Standard and
Expedited
Redeterminations
(RD)
Universe Table 5:
Part D
Effectuations of
Overturned
Decisions by the
IRE, ALJ, or
MAC (EFF_D)
Universe Table 6:
Part D Standard
and Expedited
Grievances
(GRV_D)
Universe Table 7:
Comprehensive
Addiction and
Recovery Act
(CARA) At-Risk
Determination
(AR)

Page 4 of 5

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Audit
Element
Timeliness

Timeliness

Page 5 of 6

Compliance
Standard
1.1

1.2

1.3

1.4

1.5

Data Request

Method of Evaluation

Universe Table 1:
Standard and
Expedited
Coverage
Determination
(CD)
Universe Table 1:
Standard and
Expedited
Coverage
Determination
(CD)
Universe Table 2:
Standard and
Expedited
Coverage
Determination
Exception
Requests (CDER)

Conduct timeliness test at the universe level on
standard coverage determinations to determine
whether the Sponsoring organization provided
notification of its determination no later than
72 hours after receipt of the request.

Universe Table 2:
Standard and
Expedited
Coverage
Determination
Exception
Requests (CDER)

Universe Table 3:
Payment
Coverage
Determinations
and
Redeterminations
(PYMT_D)

Conduct timeliness test at the universe level on
expedited coverage determinations to
determine whether the Sponsoring
organization provided notification of its
determination no later than 24 hours after
receipt of the request.
Conduct timeliness test at the universe level on
standard coverage determination exception
requests to determine whether the Sponsoring
organization provided notification of its
determination no later than 72 hours after the
Sponsoring organization received the
physician's or other prescriber’s supporting
statement. If a supporting statement was not
received by the end of 14 calendar days from
receipt of the exceptions request, determine
whether the Sponsoring organization provided
notification of its determination no later than
72 hours from the end of 14 calendar days
from receipt of the exceptions request.
Conduct timeliness test at the universe level on
expedited coverage determination exception
requests to determine whether the Sponsoring
organization provided notification of its
determination no later than 24 hours after the
Sponsoring organization received the
physician's or other prescriber’s supporting
statement. If a supporting statement was not
received by the end of 14 calendar days from
receipt of the exceptions request, determine
whether the Sponsoring organization provided
notification of its determination no later than
24 hours from the end of 14 calendar days
from receipt of the exceptions request.
Conduct timeliness test at the universe level on
payment coverage determinations to determine
whether the Sponsoring organization provided
notification of its determination and made
payment (when applicable) no later than 14
calendar days after receipt of the request.

Criteria Effective
01/01/2021
42 CFR § 423.568(b)
42 CFR § 423.568(d)
42 CFR § 423.568(f)
42 CFR § 423.572(a)
42 CFR § 423.572(b)

42 CFR § 423.568(b)
42 CFR § 423.568(d)
42 CFR § 423.568(f)

42 CFR § 423.572(a)
42 CFR § 423.572(b)

42 CFR § 423.568(c)

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Audit
Element
Timeliness

Compliance
Standard
1.6

Timeliness

1.7

Timeliness

1.8

Timeliness

1.9

Timeliness

1.10

Timeliness

1.11

Timeliness

1.12

Page 6 of 7

Data Request

Method of Evaluation

Universe Table 7:
Comprehensive
Addiction and
Recovery Act
(CARA) At-Risk
Determination
(AR)

Conduct timeliness test at the universe level on
at-risk determinations to determine whether
the Sponsoring organization provided the
second notice or the alternate second notice not
less than 30 days and not more than the earlier
of the date the Sponsoring organization made
the relevant determination or 60 days after the
date of the Sponsoring organization’s initial
notice.
Conduct timeliness test at the universe level on
payment coverage redeterminations to
determine whether the Sponsoring
organization issued its redetermination no later
than 14 calendar days after the Sponsoring
organization received the redetermination
request and made payment (when applicable)
no later than 30 calendar days after receipt of
the request.
Conduct timeliness test at the universe level on
standard redeterminations to determine
whether the Sponsoring organization provided
notification no later than 7 calendar days after
receipt of the request.
Conduct timeliness test at the universe level on
expedited redeterminations to determine
whether the Sponsoring organization provided
notification no later than 72 hours after receipt
of the request.
Conduct timeliness test at the universe level on
pre-benefit standard decisions overturned by
the IRE, ALJ or MAC to determine whether
the Sponsoring organization authorized or
provided the benefit under dispute no later
than 72 hours after receipt of the notice
reversing the determination.
Conduct timeliness test at the universe level on
standard at-risk determination decisions
overturned by the IRE, ALJ or MAC to
determine whether the Sponsoring
organization implemented the change to the atrisk determination no later than 72 hours after
receipt of the notice reversing the
determination.
Conduct timeliness test at the universe level on
post-service (payment) decisions overturned
by the IRE, ALJ or MAC to determine whether
the Sponsoring organization authorized the
payment no later than 72 hours after receipt of
the notice reversing the determination and
whether the Sponsoring organization made
payment no later than 30 calendar days after
receipt of the notice reversing the
determination.

Universe Table 3:
Payment
Coverage
Determinations
and
Redeterminations
(PYMT_D)
Universe Table 4:
Standard and
Expedited
Redeterminations
(RD)
Universe Table 4:
Standard and
Expedited
Redeterminations
(RD)
Universe Table 5:
Part D
Effectuations of
Overturned
Decisions by IRE,
ALJ or MAC
(EFF_D)
Universe Table 5:
Part D
Effectuations of
Overturned
Decisions by IRE,
ALJ or MAC
(EFF_D)
Universe Table 5:
Part D
Effectuations of
Overturned
Decisions by IRE,
ALJ or MAC
(EFF_D)

Criteria Effective
01/01/2021
42 CFR § 423.153(f)

42 CFR § 423.590(b)
42 CFR § 423.636(a)

42 CFR § 423.590(a)

42 CFR § 423.590(d)

42 CFR § 423.636(b)

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Data Request

Method of Evaluation

Universe Table 5:
Part D
Effectuations of
Overturned
Decisions by IRE,
ALJ or MAC
(EFF_D)
Universe Table 5:
Part D
Effectuations of
Overturned
Decisions by IRE,
ALJ or MAC
(EFF_D)

Conduct timeliness test at the universe level on
pre-benefit expedited decisions overturned by
the IRE, ALJ or MAC to determine whether
the Sponsoring organization authorized or
provided the benefit under dispute no later
than 24 hours after receipt of the notice
reversing the determination.
Conduct timeliness test at the universe level on
expedited at-risk determination decisions
overturned by the IRE, ALJ or MAC to
determine whether the Sponsoring
organization implemented the change to the atrisk determination no later than 24 hours after
receipt of the notice reversing the
determination.
Conduct timeliness test at the universe level on
standard grievances to determine whether the
Sponsoring organization notified the enrollee
of its decision no later than 30 calendar days
after receipt of the grievance, or, if an
extension was taken, no later than 44 calendar
days after receipt of the grievance.
Conduct timeliness test at the universe level on
expedited grievances to determine whether the
Sponsoring organization responded to the
enrollee’s grievance no later than 24 hours
after receipt of the grievance.

Audit
Element
Timeliness

Compliance
Standard
1.13

Timeliness

1.14

Timeliness

1.15

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

Timeliness

1.16

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

Page 7 of 8

Criteria Effective
01/01/2021
42 CFR § 423.638(b)

42 CFR § 423.638(b)

42 CFR § 423.564(e)

42 CFR § 423.564(f)

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Audit
Element
Timeliness

Compliance
Standard
1.17

Data Request

Method of Evaluation

Universe Table 1:
Standard and
Expedited
Coverage
Determination
(CD)

Conduct review at the universe level.
If notification was untimely and autoforwarding to the Independent Review Entity
(IRE) is required, determine if the Sponsoring
organization auto-forwarded the case to the
IRE. Determine the total number of cases in
Tables 1-4, the number of cases in Tables 1-4
that required auto-forwarding to the IRE, and
the total number of cases in Tables 1-4 that
were not auto-forwarded to the IRE as
required.

Universe Table 2:
Standard and
Expedited
Coverage
Determination
Exception
Requests (CDER)
Universe Table 3:
Payment
Coverage
Determinations
and
Redeterminations
(PYMT_D)

Criteria Effective
01/01/2021
42 CFR § 423.568(h)
42 CFR § 423.572(d)
42 CFR § 423.568(h)
42 CFR § 423.578(c)
42 CFR § 423.572(d)
42 CFR § 423.578(c)
42 CFR § 423.568(h)
42 CFR § 423.590(c)
42 CFR § 423.590(e)

Universe Table 4:
Standard and
Expedited
Redeterminations
(RD)

Page 8 of 9

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Audit
Element
Processing of
Coverage
Requests

Compliance
Standard
2.1

Method of Evaluation
Select 10 approval cases. Ensure sample set
represents various types of CDs (e.g. prior
authorization, step therapy authorization,
tiering exception, formulary exception
(including both non-formulary drugs and
formulary drugs with a UM requirement,
reimbursement request etc.).
For each approval case, review case file
documentation for proper notification of the
approval decision. If the enrollee identified a
representative, review case file to determine if
notification was sent to the enrollee’s
representative.
If a prescriber requested the coverage, review
case file to determine if notification of the
decision was also sent to the prescriber.

Criteria Effective
01/01/2021
42 CFR § 423.568(d)
42 CFR § 423.568(e)
42 CFR § 423.572(c)
42 CFR § 423.590(h)
42 CFR § 423.560
42 CFR §423.568(b)
42 CFR §423.572(a)
42 CFR §423.590(d)

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

Universe Table 4:
Standard and
Expedited
Redeterminations
(RD)

Page 9 of 10

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Audit
Element
Processing of
Coverage
Requests

Compliance
Standard
2.2

Data Request
Universe Table 1:
Standard and
Expedited
Coverage
Determination
(CD)

Method of Evaluation
For each sampled approval case, review case
file documentation for proper effectuation
duration.

Criteria Effective
01/01/2021
42 CFR § 423.578(c)

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)

Page 10 of 11

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Audit
Element
Processing of
Coverage
Requests

Compliance
Standard
2.3

Data Request

Method of Evaluation

Universe Table 1:
Standard and
Expedited
Coverage
Determination
(CD)

Select 30 denial cases. Target cases that are
protected class drug denials. Ensure sample set
represents various types of CDs (e.g. prior
authorization, step therapy authorization,
tiering exception, formulary exception,
including both non-formulary drugs and
formulary drugs with a UM requirement,
reimbursement request etc.).

Universe Table 2:
Standard and
Expedited
Coverage
Determination
Exception
Requests (CDER)
Universe Table 3:
Payment
Coverage
Determinations
and
Redeterminations
(PYMT_D)

Processing of
Coverage
Requests

2.4

Universe Table 4:
Standard and
Expedited
Redeterminations
(RD)
Universe Table 1:
Standard and
Expedited
Coverage
Determination
(CD)
Universe Table 2:
Standard and
Expedited
Coverage
Determination
Exception
Requests (CDER)

For each denial case, review case file
documentation for proper notification and
appropriate consideration of clinical
information.
If the enrollee identified a representative,
review case file to determine if notification
was sent to the enrollee’s representative.

Criteria Effective
01/01/2021
42 CFR § 423.568(f)
42 CFR § 423.568(g)
42 CFR § 423.572(c)
42 CFR § 423.590(g)
42 CFR § 423.560
42 CFR § 423.578(c)
42 CFR § 423.568(b)
42 CFR § 423.572(a)
42 CFR § 423.590(d)

If a prescriber requested the coverage, review
case file to determine if notification of the
decision was also sent to the prescriber.
Sample selections will be provided to the
Sponsoring organization approximately one
hour prior to the scheduled webinar.

For each denial case sampled, review case file
documentation for evidence that the
Sponsoring organization’s Medical Director
(physician) or other appropriate health care
professional with sufficient medical and other
expertise reviewed the request for clinical
accuracy.

42 CFR § 423.562(a)
42 CFR § 423.566(d)

Universe Table 3:
Payment
Coverage
Determinations
and
Redeterminations
(PYMT_D)

Page 11 of 12

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Audit
Element
Processing of
Coverage
Requests

Compliance
Standard
2.5

Data Request

Method of Evaluation

Universe Table 1:
Standard and
Expedited
Coverage
Determination
(CD)

For each case sampled, review case file
documentation for proper downgrade from an
expedited determination request to a standard
determination and for proper notification to the
enrollee and prescribing physician or other
prescriber that explains that the Sponsoring
organization must process the request using the
72 hour timeframe for standard determinations,
informs the enrollee of the right to file an
expedited grievance if he or she disagrees with
the decision by the Sponsoring organization
not to expedite, informs the enrollee of the
right to resubmit a request for an expedited
determination with the prescribing physician's
or other prescriber’s support, and provides
instructions about the Sponsoring
organization’s grievance process and its
timeframes.

Universe Table 2:
Standard and
Expedited
Coverage
Determination
Exception
Requests (CDER)

Processing of
Coverage
Requests

2.6

Universe Table 3:
Payment
Coverage
Determination
and
Redeterminations
(PYMT_D)
Universe Table 4:
Standard and
Expedited
Redeterminations
(RD)

Page 12 of 13

If the enrollee identified a representative,
review case file to determine if notification
was sent to the enrollee’s representative.
For the sampled redetermination cases
sampled review case file documentation for
proper for evidence that the person(s) who
were involved in making the coverage
determination or at-risk determination under a
drug management program did not conduct the
redetermination, and if the denial of coverage
was based on a lack of medical necessity, that
the redetermination was made by a physician
with expertise in the field of medicine that was
appropriate for the services at issue.

Criteria Effective
01/01/2021
42 CFR § 423.570(c)
42 CFR § 423.570(d)
42 CFR § 423.560

42 CFR § 423.562(a)
42 CFR § 423.590(f)

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Audit
Element
Classification
of Requests

Compliance
Standard
3.1

Data Request

Method of Evaluation

Universe Table 1:
Standard and
Expedited
Coverage
Determination
(CD)

Select up to 10 dismissed cases from Tables 14.

Universe Table 2:
Standard and
Expedited
Coverage
Determination
Exception
Requests (CDER)

Review case file documentation to determine if
the request was appropriately dismissed or
whether it should have been treated as a
coverage request or grievance.

Criteria Effective
01/01/2021
42 CFR § 423.566
42 CFR § 423.580
42 CFR § 423.582
42 CFR § 423.584

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

42 CFR § 423.590

Select 20 grievance sample cases from Table
6. Sample both verbal and written grievances.

42 CFR § 423.564(a)

42 CFR § 423.564

Universe Table 3:
Payment
Coverage
Determinations
and
Redeterminations
(PYMT_D)

Classification
of Requests

3.2

Universe Table 4:
Standard and
Expedited
Redeterminations
(RD)
Universe Table 6:
Part D Standard
and Expedited
Grievances
(GRV_D)

Target samples that appear to relate to quality
of care; involve multiple issues and do not
appear in the coverage determination and
redetermination universes; and appear to be
misclassified requests.
Review sample case file documentation to
determine if proper notification (i.e., written or
verbal) was provided. If the Sponsoring
organization extended the deadline, review
case file for documentation stating how the
delay is in the interest of the enrollee. Also
review case file for written notification to the
enrollee of the reason(s) for the delay.

42 CFR § 423.564(b)
42 CFR § 423.564(e)
42 CFR § 423.564(g)
42 CFR § 423.560

If the enrollee identified a representative,
review case file to determine if notification
was sent to the enrollee’s representative.
Sample selections will be provided to the
Sponsoring organization approximately one
hour prior to the scheduled webinar.

Page 13 of 14

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Audit
Element
Administration
of Drug
Management
Program

Compliance
Standard
4.1

Data Request
Universe Table 7:
Comprehensive
Addiction and
Recovery Act
(CARA) At-Risk
Determination
(AR)

Method of Evaluation
Select up to 15 drug management program
administration cases.

Criteria Effective
01/01/2021
42 CFR § 423.153(f)

For each case sampled, review case file
documentation for proper initial written notice
to the enrollee for at-risk determinations. Also
review case file documentation to ensure
Sponsoring organization made reasonable
efforts to provide the enrollee's prescriber(s)
of frequently abused drugs with a copy of the
notice.
If the enrollee identified a representative,
review case file to determine if notification
was sent to the enrollee’s representative.

Administration
of Drug
Management
Program

4.2

4.3

Universe Table 7:
Comprehensive
Addiction and
Recovery Act
(CARA) At-Risk
Determination
(AR)

Sample selections will be provided to the
Sponsoring organization approximately one
hour prior to the scheduled webinar.
For each case sampled, wherein the
Sponsoring organization determined the
enrollee is an at-risk beneficiary, review case
file documentation to determine whether the
enrollee submitted preferences for prescribers
or pharmacies and review for proper second
written notice to the enrollee. Also review
case file documentation to ensure Sponsoring
organization made reasonable efforts to
provide the enrollee's prescriber(s) of
frequently abused drugs with a copy of the
notice.
If the enrollee identified a representative,
review case file to determine if notification
was sent to the enrollee’s representative.
For each case sampled, wherein the
Sponsoring organization determined the
enrollee is not an at-risk beneficiary,
review case file documentation for proper
alternate second written notice to the
enrollee. Also review case file
documentation to ensure Sponsoring
organization made reasonable efforts to
provide the enrollee's prescriber(s) of
frequently abused drugs with a copy of the
notice.

42 CFR § 423.153(f)

If the enrollee identified a representative,
review case file to determine if notification
was sent to the enrollee’s representative.

Page 14 of 15

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)

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. 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. Sponsoring organizations may however enter the
time within universes instead of ‘None’ if the time is not required per the field description.
Universe Requests
1. Universe Table 1: Standard and Expedited Coverage Determination (CD) Record
Layout
2. Universe Table 2: Standard and Expedited Coverage Determination Exception
Requests (CDER) Record Layout
3. Universe Table 3: Payment Coverage Determinations and Redeterminations
(PYMT_D) Record Layout
4. Universe Table 4: Standard and Expedited Redeterminations (RD) Record Layout
5. Universe Table 5: Part D Effectuations of Overturned Decisions by IRE, ALJ or
MAC (EFF_D) Record Layout
6. Universe Table 6: Part D Standard and Expedited Grievances (GRV_D) Record
Layout
7. Universe Table 7: Comprehensive Addition and Recovery Act (CARA) At-Risk
Determination (AR) Record Layout
Universe
Record Layout
Table 1
Table 2
Table 3
Table 4
Table 5
Table 6
Table 7

Scope of Universe Request*

Sponsoring organizations with PDP/MAPD enrollment of –
• <50,000 enrollees: submit the 12-week period preceding, and including,
the date of the audit engagement letter.
• ≥50,000 but <250,000 enrollees: submit the 8-week period preceding, and
including, the date of the audit engagement letter.
• ≥250,000 but <500,000 enrollees: submit the 4-week period preceding, and
including, the date of the audit engagement letter.
• ≥500,000 enrollees: submit the 2-week period preceding, and including,
the date of the audit engagement letter.
* CMS reserves the right to expand the review period to ensure sufficient universe size.

Page 15 of 16

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Please use the guidance below for the following record layout:
Universe Table 1: Standard and Expedited Coverage Determination (CD) Record Layout
• Include all coverage determinations the Sponsoring organization approved, denied, reopened approved, re-opened denied, auto-forwarded to the IRE or dismissed for Part D
coverage during the universe request period. The date of the Sponsoring organization’s
determination (Column ID U) must fall within the universe request period.
• For cases with a Request Determination of re-opened approved or re-opened denied, the date
and time the request was received must be the date and time the case was re-opened (i.e., the
determination was made to re-open the case). The original coverage determination or
redetermination is considered a separate case for purposes of audit and must be included in
the universe if the original determination date falls within the audit review period.
• Each coverage determination request must be listed as its own line item in the submitted
universe.
o If a request for multiple drugs is made at the same time, enter each drug in a
separate row.
o 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.
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 payment coverage determinations, direct member
reimbursement requests, withdraws and exception requests.
Column
ID
A

Field Name

Enrollee Last Name

Enrollee ID

Page 16 of 17

Enrollee First Name

Field
Type
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Field
Length
50

Description

Enter the last name of the
enrollee.

Enter the Medicare Beneficiary
Identifier (MBI) of the enrollee.
An MBI is the non-intelligent
unique identifier that replaced the
HICN on Medicare cards as a
result of The Medicare Access and
CHIP Reauthorization Act
(MACRA) of 2015. The MBI
contains uppercase alphabetic and
numeric characters throughout the
11-digit identifier and is unique to
each Medicare enrollee. This
number must be submitted
excluding hyphens or dashes.

Enter the first name of the
enrollee.

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
D

Field Name

Plan Benefit Package
(PBP)

Drug Name, Strength,
and Dosage Form

NDC

Contract ID

Field
Type
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Field
Length
5

Description

Enter the PBP (e.g., 001).

150

Enter the drug name, strength, and
dosage form requested.

Enter the 11-Digit National Drug
Code using the NDC 11 format.
Remove special characters
separating the labeler, product,
and trade package size.

Enter the contract number (e.g.,
H1234).

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.

Is this a protected class
drug?

CHAR
1
Always
Required

Authorization or Claim
Number

CHAR
40
Always
Required

For multi-ingredient compound
claims populate the field with the
NDC as would be submitted on a
paid claim’s PDE.
Enter whether it is a protected
class drug:
• Y for Yes
• N for No
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.

Page 17 of 18

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
J

Field Name

Time the request was
received

CHAR
8
Always
Required

AOR/Equivalent notice
Receipt Date

CHAR
10
Always
Required

Date the request was
received

AOR/Equivalent notice
Receipt Time

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
8
Always
Required

Request Determination

CHAR
Always
Required

Was the request
processed as Standard
or Expedited?

1
CHAR
Always
Required

Page 18 of 19

Description
Enter the date the request was
received. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter the time the request was
received. Submit in HH:MM:SS
military time format (e.g.,
23:59:59).
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.
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 or required.
Enter:
• Approved
• Denied
• IRE auto-forward
• Re-opened Approved
• Re-opened Denied
• Dismissed
Enter the manner by which the
request was processed:
• S for Standard
• E for Expedited

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
P

Field Name

Date request was
upgraded to expedited

Was the original request
made under the standard
timeframe and later
requested to be
expedited?

Time the request was
upgraded to expedited

Field
Field
Type
Length
CHAR
4
Always
Required

Description

CHAR
10
Always
Required

Enter:
• Y for Yes
• N for No
• None if the request was
made under the expedited
timeframe.
Enter the date the request was
received to upgrade the initial
standard request to expedited from
the enrollee, their authorized
representative, their prescriber, or
the Sponsoring organization
determined the request should be
expedited. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).

CHAR
8
Always
Required

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.
Enter the time the request was
received to upgrade the initial
standard request to expedited from
the enrollee, their authorized
representative, or their prescriber,
or the Sponsoring organization
determined the request should be
expedited. Submit in HH:MM:SS
military time format (e.g.,
23:59:59).
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.

Page 19 of 20

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
S

Field Name
Issue Description

Formulary UM Type

Field
Field
Type
Length
CHAR
2,000
Always
Required

CHAR
4
Always
Required

Description
Enter a description of the issue
and, if applicable, why the request
was denied.
For dismissed cases, provide the
reason for dismissal.
Enter the formulary UM criteria
the enrollee satisfied or was
attempting to satisfy. Enter:
• PA for Prior Authorization
• ST for Step Therapy
• SE for Safety Edit
If multiple formulary UM criteria
apply, enter the criteria applicable
based on the approval or denial
reason.

Date of Determination

CHAR
10
Always
Required

Time of Determination

CHAR
8
Always
Required

Enter None if the enrollee did not
satisfy or was not attempting to
satisfy Prior Authorization and/or
Step Therapy criteria.
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.
Enter the time of the
determination. Submit in
HH:MM:SS military time format
(e.g., 23:59:59).
Enter None for dismissed cases.

Date effectuated in the
system

CHAR
10
Always
Required

Enter the date the approved
decision was effectuated in the
system. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None for requests that
were not approved.

Page 20 of 21

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
X

Field Name
Time effectuated in the
system

Date oral notification
provided to enrollee

Time oral notification
provided to enrollee

Date written
notification provided
to enrollee

Time written
notification provided
to enrollee

Field
Field
Type
Length
CHAR
8
Always
Required

CHAR
10
Always
Required

CHAR
8
Always
Required

CHAR
10
Always
Required

CHAR
8
Always
Required

Description
Enter the time the approved
decision was effectuated in the
system. Submit in HH:MM:SS
military time format (e.g.,
23:59:59).
Enter None for requests that were
not approved.
Enter the date oral notification
was provided to enrollee. Submit
in CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None for dismissed cases or
if no oral notification was
provided.
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 cases or
if no oral notification was
provided.
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.
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.

Page 21 of 22

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
AC

Field Name
Who made the request?

Field
Field
Type
Length
CHAR
2
Always
Required

Date auto-forwarded to
IRE

CHAR
10
Always
Required

Time auto-forwarded to
IRE

CHAR
8
Always
Required

Description
Enter who made the request:
• E for enrollee
• ER for enrollee’s
representative or
purported
representative
• P for prescribing physician or
other prescriber
Enter the date the request was
auto-forwarded to the IRE.
Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter None if the request was not
forwarded to the IRE.
Enter the time the request was
auto-forwarded to the IRE.
Submit in HH:MM:SS military
time format (e.g., 23:59:59).
Enter None if the request was not
forwarded to the IRE.

Page 22 of 23

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Please use the guidance below for the following record layout:
Universe Table 2: Standard and Expedited Coverage Determination Exception Requests
(CDER) Record Layout
• Include all coverage determination exception requests the Sponsoring organization
approved, denied, re-opened approved, re-opened denied, auto- forwarded to the IRE or
dismissed for Part D coverage during the universe request period. The date of the
Sponsoring organization’s determination (Column ID X) must fall within the universe
request period.
• For cases with a Request Determination of re-opened approved or re-opened denied, the date
and time the request was received must be the date and time the case was re-opened (i.e., the
determination was made to re-open the case). The original coverage determination or
redetermination is considered a separate case for purposes of audit and must be included in
the universe if the original determination date falls within the audit review period.
• Each exception request must be listed as its own line item in the submitted universe.
o If a request for multiple drugs is made at the same time, enter each drug in
a separate row.
o 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.
o Requests for a single drug involving multiple UM criteria and exception
types must be entered as a single line item in Universe Table 2 only.
o If a request has multiple exception types and includes a tiering exception, enter
the case as a tiering exception.
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 a single
time zone.
• Exclude all requests processed as payment coverage determinations, direct member
reimbursement requests, withdraws, and non-exception request coverage determinations.
Column
ID
A

Field Name

Enrollee Last Name

Page 23 of 24

Enrollee First Name

Field
Type
CHAR
Always
Required
CHAR
Always
Required

Field
Length
50

Description

Enter the last name of the enrollee.

Enter the first name of the
enrollee.

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
C

Field Name

Contract ID

Plan Benefit Package
(PBP)

Drug Name, Strength,
and Dosage Form

NDC

Enrollee ID

Field
Field
Type
Length
CHAR
11
Always
Required

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Description
Enter the Medicare Beneficiary
Identifier (MBI) of the enrollee.
An MBI is the non-intelligent
unique identifier that replaced the
HICN on Medicare cards as a
result of The Medicare Access and
CHIP Reauthorization Act
(MACRA) of 2015. The MBI
contains uppercase alphabetic and
numeric characters throughout the
11-digit identifier and is unique to
each Medicare enrollee. This
number must be submitted
excluding hyphens or dashes.
Enter the contract number (e.g.,
H1234).

Enter the PBP (e.g., 001).

150

Enter the drug name, strength, and
dosage form requested.

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 as would be submitted on a
paid claim’s PDE.

Page 24 of 25

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
H

Field Name

Authorization or Claim
Number

Is this a protected class
drug?

Field
Field
Type
Length
CHAR
1
Always
Required
CHAR
40
Always
Required

Date the request was
received

CHAR
10
Always
Required

Time the request was
received

CHAR
8
Always
Required

AOR/Equivalent notice
Receipt Date

CHAR
10
Always
Required

AOR/Equivalent notice
Receipt Time

CHAR
8
Always
Required

Description
Enter whether it was a protected
class drug:
• Y for Yes
• N for No
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.
Enter the date the request was
received. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter the time the request was
received. Submit in HH:MM:SS
military time format (e.g.,
23:59:59).
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.
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 or required.

Page 25 of 26

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
N

Field Name
Request Determination

Field
Field
Type
Length
CHAR
18
Always
Required

Was the request
processed as Standard or
Expedited?

CHAR
1
Always
Required

Was the original request
made under the standard
timeframe and later
requested to be
expedited?

CHAR
4
Always
Required

Date request was
upgraded to expedited

CHAR
10
Always
Required

Description
Enter:
• Approved
• Denied
• IRE auto-forward
• Re-opened Approved
• Re-opened Denied
• Dismissed
Enter the manner by which the
request was processed:
• S for Standard
• E for Expedited
Enter:
• Y for Yes
• N for No
• None if the original
request was made under
the expedited timeframe.
Enter the date the request was
received to upgrade the initial
standard request to expedited from
the enrollee, their authorized
representative, their prescriber, or
the Sponsoring organization
determined the request should be
expedited. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
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.

Page 26 of 27

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
R

Field Name
Time request was
upgraded to expedited

Issue Description

Exception Type

Field
Field
Type
Length
CHAR
8
Always
Required

CHAR
2,000
Always
Required

CHAR
25
Always
Required

Description
Enter the time the request was
received to upgrade the initial
standard request to expedited from
the enrollee, their authorized
representative, or their prescriber,
or the Sponsoring organization
determined the request should be
expedited. Submit in HH:MM:SS
military time format (e.g.,
23:59:59).
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.
Provide a description of the issue
and, if applicable, why the request
was denied.
For dismissed cases, provide the
reason for dismissal.
Enter the type of exception
request:
• Tiering exception
• Non-formulary exception
• Formulary UM exception
• Hospice
• Safety edit exception
If multiple exception types apply,
enter the exception type applicable
based on the approval or denial
reason.

Page 27 of 28

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
U

Field Name
UM Exception Type

Field
Field
Type
Length
CHAR
4
Always
Required

Description
If the case was a UM exception,
indicate what criteria the
enrollee was attempting to
waive. Enter:
• PA for Prior Authorization
• ST for Step Therapy
• QL for Quantity Limit
If the case was a safety edit
exception enter:
• SE for Safety Edit
Enter None if the request was not
a UM exception or safety edit
exception.

Date prescriber
supporting statement
received

Time prescriber
supporting statement
received

CHAR
10
Always
Required

CHAR
8
Always
Required

If multiple UM exception criteria
apply, enter the criteria
applicable based on the approval
or denial reason.
Enter the date the prescriber's
supporting statement was
received. If the prescriber
statement was received with the
initial request, enter the date the
exception request was received.
Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter None if no prescriber
supporting statement was
received.
Enter the time the prescriber's
supporting statement was
received. If the prescriber
statement was received with the
initial request, enter the time the
exception request was received.
Submit in HH:MM:SS military
time format (e.g., 23:59:59).
Enter None if no prescriber
supporting statement was
received.

Page 28 of 29

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
X

Field Name

Time of Determination

CHAR
8
Always
Required

Date effectuated in the
system

CHAR
10
Always
Required

Date of Determination

Time effectuated in the
system

Expiration date of the
approval

Date oral notification
provided to enrollee

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
8
Always
Required

CHAR
10
Always
Required

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.
Enter the time of the
determination. Submit in
HH:MM:SS military time format
(e.g., 23:59:59).
Enter None for dismissed cases.
Enter the date the approved
decision was effectuated in the
system. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if the exception was
not approved.
Enter the time the approved
decision was effectuated in the
system. Submit in HH:MM:SS
military time format (e.g.,
23:59:59).
Enter None if the exception was
not approved.
Enter the expiration date of the
exception approval. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if the exception was
not approved.
Enter the date oral notification
was provided to enrollee. Submit
in CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None for dismissed cases or
if no oral notification was
provided.

Page 29 of 30

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
AD

Field Name
Time oral notification
provided to enrollee

Date written notification
provided to enrollee

Time written notification
provided to enrollee

Field
Field
Type
Length
CHAR
8
Always
Required

CHAR
10
Always
Required

CHAR
8
Always
Required

Who made the request?

CHAR
2
Always
Required

Date auto-forwarded to
IRE

CHAR
10
Always
Required

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 for dismissed cases or
if no oral notification was
provided.
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.
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.
Enter who made the request:
• E for enrollee
• ER for enrollee’s
representative or
purported
representative
• P for prescribing physician or
other prescriber
Enter the date the request was
auto-forwarded to the IRE.
Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter None if the request was not
forwarded to the IRE.

Page 30 of 31

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
AI

Field Name
Time auto-forwarded to
IRE

Field
Field
Type
Length
CHAR
8
Always
Required

Description
Enter the time the request was
auto-forwarded to the IRE.
Submit in HH:MM:SS military
time format (e.g., 23:59:59).
Enter None if the request was not
forwarded to the IRE.

Page 31 of 32

OMB Approval 0938-1395 (Expires 05/31/2024)

Column
ID
A

Field Name

Enrollee Last Name

Page 32 of 33

Enrollee First Name

Field
Type
CHAR
Always
Required
CHAR
Always
Required

Field
Length
50

Description

Enter the last name of the
enrollee.

Enter the first name of the
enrollee.

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
C

Field Name

Contract ID

Plan Benefit Package
(PBP)

Drug Name, Strength,
and Dosage Form

NDC

Enrollee ID

Field
Field
Type
Length
CHAR
11
Always
Required

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Description
Enter the Medicare Beneficiary
Identifier (MBI) of the enrollee.
An MBI is the non-intelligent
unique identifier that replaced
the HICN on Medicare cards as
a result of The Medicare Access
and CHIP Reauthorization Act
(MACRA) of 2015. The MBI
contains uppercase alphabetic
and numeric characters
throughout the 11-digit identifier
and is unique to each Medicare
enrollee. This number must be
submitted excluding hyphens or
dashes.
Enter the contract number (e.g.,
H1234).

Enter the PBP (e.g., 001).

150

Enter the drug name, strength,
and dosage form requested.

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 as would be
submitted on a paid claim’s
PDE.

Page 33 of 34

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
H

Field Name

Authorization or Claim
Number

Is this a protected class
drug?

Field
Field
Type
Length
CHAR
1
Always
Required
CHAR
40
Always
Required

Date the request was
received

CHAR
10
Always
Required

AOR/Equivalent notice
Receipt Date

CHAR
10
Always
Required

Description
Enter whether it was a protected
class drug:
• Y for Yes
• N for No
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.
Enter the date the request was
received. If the Sponsoring
organization obtained
information establishing good
cause after the 60-day filing
timeframe, enter the date the
Sponsoring organization
received the information
establishing good cause. Submit
in CCYY/MM/DD format (e.g.,
2020/01/01).
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.

Page 34 of 35

Type of Request

CHAR
30
Always
Required

Enter:
• payment coverage
determination
• payment redetermination

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
M

Field Name

Was the request
processed as an exception
request?
Issue Description

Request Determination

Exception Type

Field
Field
Type
Length
CHAR
18
Always
Required

CHAR
1
Always
Required
CHAR
2,000
Always
Required

CHAR
25
Always
Required

Description
Enter:
• Approved
• Denied
• IRE auto-forward
• Re-opened Approved
• Re-opened Denied
• Dismissed
Enter:
• Y for Yes
• N for No
Enter a description of the issue
and, if applicable, why the
request was denied.
For dismissed cases, provide the
reason for dismissal.
Enter the type of exception
request:
• Tiering exception
• Non-formulary exception
• Formulary UM exception
• Hospice
• Safety edit exception
If multiple exception types apply,
enter the exception type
applicable based on the approval
or denial reason.
Enter None if the request was
not an exception request.

Page 35 of 36

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
Q

Field Name
UM Exception Type

Field
Field
Type
Length
CHAR
4
Always
Required

Description
If the case was a UM exception,
indicate what criteria the
enrollee was attempting to
waive. Enter:
• PA for Prior
Authorization
• ST for Step Therapy
• QL for Quantity Limit
If the case was a safety edit
exception enter:
• SE for Safety Edit
Enter None if the request was
not a UM exception or safety
edit exception.

Page 36 of 37

Date prescriber
supporting statement
received

Was the coverage
determination request
denied for lack of
medical necessity?

CHAR
10
Always
Required

CHAR
4
Always
Required

If multiple UM exception
criteria apply, enter the criteria
applicable based on the
approval or denial reason.
Enter the date the prescriber's
supporting statement was
received. If the prescriber
statement was received with the
initial request, enter the date the
exception request was received.
Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter None if no prescriber
supporting statement was
received.
Enter:
• Y for Yes
• N for No
• None if the request was
not denied (i.e.,
approved, autoforwarded, dismissed).

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
T

Field Name

Date effectuated in the
system

Page 37 of 38

Date of Determination

Expiration date of the
approval

Date written notification
provided to enrollee

Who made the request?

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
10
Always
Required

CHAR
2
Always
Required

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.
Enter the date the approved
decision was effectuated in the
system. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if the payment
request was not approved.
Enter the expiration date of the
exception approval. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if the exception was
not approved or if the request
was not an exception request.
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.
Enter who made the request:
• E for enrollee
• ER for enrollee’s
representative or
purported
representative
• P for prescribing physician or
other prescriber

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
Y

Field Name
Date reimbursement
provided

Field
Field
Type
Length
CHAR
10
Always
Required

Description
Enter the date the check or
reimbursement was provided to
the enrollee. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter NRD if the request was
approved but no reimbursement
was due to the enrollee.
Enter NP if the payment has not
been issued at the time of the
universe submission.

Date auto-forwarded to
IRE

CHAR
10
Always
Required

Enter None if the request was
not approved.
Enter the date the request was
auto-forwarded to the IRE.
Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter None if the request was
not forwarded to the IRE.

Page 38 of 39

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Please use the guidance below for the following record layout:
Universe Table 4: Standard and Expedited Redeterminations (RD) Record Layout
• Include all redeterminations the Sponsoring organization approved, denied, re-opened
approved, re-opened denied, auto-forwarded to the IRE or dismissed for Part D coverage
during the universe request period. The date of the Sponsoring organization’s determination
(Column ID X) must fall within the universe request period.
• For cases with a Request Determination of re-opened approved or re-opened denied, the date
and time the request was received must be the date and time the case was re-opened (i.e., the
determination was made to re-open the case). The original coverage determination or
redetermination is considered a separate case for purposes of audit and must be included in
the universe if the original determination date falls within the audit review period.
• Each redetermination request must be listed as its own line item in the submitted universe.
o If a request for multiple drugs is made at the same time, enter each drug in a
separate row.
o 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.
o Requests for a single drug involving multiple UM criteria and exception types
must be entered as a single line item.
o If a request has multiple exception types and includes a tiering exception, enter
the case as a tiering exception.
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 a single time zone.
• Exclude all requests processed as payment redeterminations and withdrawn cases.
Column ID Field Name
A

Enrollee First Name

Enrollee Last Name

Page 39 of 40

Field Type Field
Length
CHAR
50
Always
Required
CHAR
50
Always
Required

Description
Enter the first name of the enrollee.
Enter the last name of the enrollee.

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
C

Field Name

Contract ID

Plan Benefit Package
(PBP)

Drug Name, Strength,
and Dosage Form

Page 40 of 41

Enrollee ID

Field
Field
Type
Length
CHAR
11
Always
Required

CHAR
5
Always
Required
CHAR
3
Always
Required
CHAR
150
Always
Required

Description
Enter the Medicare Beneficiary
Identifier (MBI) of the enrollee.
An MBI is the non-intelligent
unique identifier that replaced the
HICN on Medicare cards as a
result of The Medicare Access
and CHIP Reauthorization Act
(MACRA) of 2015. The MBI
contains uppercase alphabetic
and numeric characters
throughout the 11-digit identifier
and is unique to each Medicare
enrollee. This number must be
submitted excluding hyphens or
dashes.
Enter the contract number (e.g.,
H1234).
Enter the PBP (e.g., 001).
Enter the drug name, strength,
and dosage form requested.
Enter None if not applicable.

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
G

Field Name
NDC

Field
Field
Type
Length
CHAR
11
Always
Required

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, or NDC is
not applicable (e.g., for at-risk
redeterminations), populate the
field as submitted.
If the pharmacy submits a value
greater than 11 characters, enter
“valueXeeded” in the field.

Is this a protected class
drug?

CHAR
4
Always
Required

Authorization or Claim
Number

CHAR
40
Always
Required

For multi-ingredient compound
claims populate the field with the
NDC as would be submitted on a
paid claim’s PDE.
Enter whether it is a protected
class drug:
• Y for Yes
• N for No
• None if not applicable
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.

Page 41 of 42

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
J

Field Name

Time the request was
received

Date the request was
received

AOR/Equivalent notice
Receipt Date

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
8
Always
Required

CHAR
10
Always
Required

Description
Enter the date the request was
received. If the Sponsoring
organization obtained
information establishing good
cause after the 60-day filing
timeframe, enter the date the
Sponsoring organization received
the information establishing good
cause. Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter the time the request was
received. 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 cases.
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.

Page 42 of 43

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
M

Field Name
AOR/Equivalent notice
Receipt Time

Field
Field
Type
Length
CHAR
8
Always
Required

Is this an appeal of an
at-risk determination?

CHAR
1
Always
Required

Request Determination

CHAR
18
Always
Required

Was the request
processed as Standard or
Expedited?

CHAR
1
Always
Required

Was the original request
made under the standard
timeframe and later
requested to be
expedited?

CHAR
4
Always
Required

Page 43 of 44

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 for standard cases
or if no AOR or equivalent
written notice was received or
required.
Enter whether it was an appeal of
an at-risk determination (e.g.
request for a change in pharmacy
and/or prescriber limitations,
request for a change in the
enrollee's at-risk determination
status):
• Y for Yes
• N for No
Enter:
• Approved
• Denied
• IRE auto-forward
• Re-opened Approved
• Re-opened Denied
• Dismissed
Enter the manner by which the
request was processed:
• S for Standard
• E for Expedited
Enter:
• Y for Yes
• N for No
• None if the request was
made under the expedited
timeframe

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
R

Field Name
Date request was
upgraded to expedited

Time request was
upgraded to expedited

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
8
Always
Required

Description
Enter the date the request was
received to upgrade the initial
standard request to expedited
from the enrollee, their
authorized representative, their
prescriber, or the Sponsoring
organization determined the
request should be expedited.
Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
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.
Enter the time the request was
received to upgrade the initial
standard request to expedited
from the enrollee, their
authorized representative, or their
prescriber, or the Sponsoring
organization determined the
request should be expedited.
Submit in HH:MM:SS military
time format (e.g., 23:59:59).
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.

Page 44 of 45

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
T

Field Name
Issue Description

Exception Type

Field
Field
Type
Length
CHAR
2,000
Always
Required

CHAR
25
Always
Required

Description
Enter a description of the
redetermination issue and, if
applicable, why the request was
denied.
For dismissed cases, provide the
reason for dismissal.
Enter the type of exception
request:
• Tiering exception
• Non-formulary exception
• Formulary UM exception
• Hospice
• Safety edit exception
If multiple exception types apply,
enter the exception type
applicable based on the approval
or denial reason.

UM Exception Type

CHAR
4
Always
Required

Enter None if the request was not
an exception request.
If the case was a UM exception,
indicate what criteria the
enrollee was attempting to
waive. Enter:
• PA for Prior
Authorization
• ST for Step Therapy
• QL for Quantity Limit
If the case was a safety edit
exception enter:
• SE for Safety Edit
Enter None if the request was not
a UM exception or safety edit
exception.
If multiple UM exception criteria
apply, enter the criteria
applicable based on the approval
or denial reason.

Page 45 of 46

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
CHAR
4
Enter:
Was the coverage
Always
determination request
• Y for Yes
Required
denied for lack of
• N for No
medical necessity?
• None if the request was
auto-forwarded
CHAR
10
Date of
Enter the date of the
Always
Determination
determination. Submit in
Required
CCYY/MM/DD format (e.g.,
2020/01/01). For dismissed
cases, enter the date the
Sponsoring organization
dismissed the request.
CHAR
8
Time of
Enter the time of the
Always
Determination
determination. Submit in
Required
HH:MM:SS military time format
(e.g., 23:59:59).

Date effectuated in
the system

Time effectuated in
the system

10
CHAR
Always
Required

Enter None for standard cases and
dismissed cases.
Enter the date the approved
decision was effectuated in the
system. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).

8
CHAR
Always
Required

Enter None for requests that
were not approved.
Enter the time the approved
decision was effectuated in the
system. Submit in HH:MM:SS
military time format (e.g.,
23:59:59).
Enter None for standard cases
and requests that were not
approved.

Page 46 of 47

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
AB

Field Name
Expiration date of the
approval

Date oral notification
provided to enrollee

Time oral notification
provided to enrollee

Date written
notification provided
to enrollee

Time written
notification provided
to enrollee

Field
Field
Type
Length
CHAR
10
Always
Required

CHAR
10
Always
Required

CHAR
8
Always
Required

CHAR
10
Always
Required

8
CHAR
Always
Required

Description
Enter the expiration date of the
exception approval. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if the exception was
not approved or if it is not an
exception request.
Enter the date oral notification
was provided to enrollee. Submit
in CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None for standard cases,
dismissed cases or if no oral
notification was provided.
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 cases,
dismissed cases or if no oral
notification was provided.
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.
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.

Page 47 of 48

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
AG

Field Name

Date auto-forwarded to
IRE

Who made the request?

Time auto-forwarded to
IRE

Field
Field
Type
Length
CHAR
2
Always
Required

CHAR
10
Always
Required

CHAR
8
Always
Required

Description
Enter who made the request:
• E for enrollee
• ER for enrollee’s
representative or
purported
representative
• P for prescribing physician or
other prescriber
Enter the date the
redetermination request was
auto-forwarded to the IRE.
Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter None if the request was not
forwarded to the IRE.
Enter the time the
redetermination request was
auto-forwarded to the IRE.
Submit in HH:MM:SS military
time format (e.g., 23:59:59).
Enter None if the request was not
forwarded to the IRE.

Page 48 of 49

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Please use the guidance below for the following record layout:
Universe Table 5: Part D Effectuations of Overturned Decisions by IRE, ALJ or MAC
(EFF_D) Record Layout
• Include all coverage determinations, redeterminations, or at-risk determinations fully or
partially overturned by the IRE, ALJ, or MAC requiring an effectuation as pre-benefit, postservice (payment), or an at-risk determination received from the IRE, ALJ, or MAC during
the universe request period. The date of the Sponsoring organization’s receipt of the overturn
decision (Column ID J) must fall within the universe request period.
• If a case contains multiple drugs, enter each drug in a separate row.
• Exclude any cases that were re-opened by the Sponsoring organization or that were
dismissed or upheld by the IRE, ALJ, or MAC.
Column
ID
A

Field Name

Enrollee Last
Name

Enrollee ID

Contract ID

Plan Benefit
Package (PBP)

Page 49 of 50

Enrollee First
Name

Field
Type
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Field
Length
50

Description

Enter the last name of the enrollee.

Enter the Medicare Beneficiary
Identifier (MBI) of the enrollee.
An MBI is the non-intelligent
unique identifier that replaced
the HICN on Medicare cards as a
result of The Medicare Access
and CHIP Reauthorization Act
(MACRA) of 2015. The MBI
contains uppercase alphabetic
and numeric characters
throughout the 11-digit identifier
and is unique to each Medicare
enrollee. This number must be
submitted excluding hyphens or
dashes.
Enter the contract number (e.g.,
H1234).

CHAR
5
Always
Required
CHAR
3
Always
Required

Enter the first name of the
enrollee.

Enter the PBP (e.g., 001).

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
F

Field Name

Field
Field
Type
Length
150
Drug Name, Strength, and CHAR
Dosage Form
Always
Required

NDC

11
CHAR
Always
Required

Description
Enter the drug name, strength, and
dosage form requested.
Enter None if not applicable.
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, or NDC is
not applicable (e.g., for at-risk
redeterminations), populate the
field as submitted.
If the pharmacy submits a value
greater than 11 characters, enter
“valueXeeded” in the field.

Is this a protected class
drug?

4
CHAR
Always
Required

Authorization or Claim
Number

40
CHAR
Always
Required

For multi-ingredient
compound claims populate the
field with the NDC as would
be submitted on a paid claim’s
PDE.
Enter whether it is a protected
class drug:
• Y for Yes
• N for No
• None if not applicable
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.

Page 50 of 51

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
J

Field Name

Time the overturn
decision was received

8
CHAR
Always
Required

Type of Request reversed
by review entity

43
CHAR
Always
Required

Date the overturn
decision was effectuated
in the system

10
CHAR
Always
Required

Date the overturn
decision was received

Time the overturn
decision was effectuated
in the system

Field
Field
Type
Length
10
CHAR
Always
Required

8
CHAR
Always
Required

Description
Enter the date the overturn
decision was received. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter the time the overturn
decision was received. Submit in
HH:MM:SS military time
format (e.g., 23:59:59).
Enter the type of request:
• Standard request
for benefits
• Standard request
for payment
• Standard request for atrisk determination
• Expedited request
for benefits
• Expedited request for
at- risk determination
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.

Page 51 of 52

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
O

Field Name
Date reimbursement
provided

Field
Field
Type
Length
10
CHAR
Always
Required

Description
Enter the date the check or
reimbursement was provided to
the enrollee. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter NRD if the request was
approved but no
reimbursement was due to
the enrollee.
Enter NP if the payment has
not been issued at the time of
the universe submission.

Expiration date of the
approval

10
CHAR
Always
Required

Enter None if it was not a
post-service (payment)
request.
Enter the expiration date of
the exception approval.
Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter None if it was not
an exception request.

Page 52 of 53

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Please use the guidance below for the following record layout:
Universe Table 6: Part D Standard and Expedited Grievances (GRV_D) Record Layout
• 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.
• Grievances with multiple issues must be entered as a single line item, unless the Sponsoring
organization issued separate notifications.
• 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.
Column
ID
A

Field Name

Enrollee Last
Name

Enrollee ID

Contract ID

Plan Benefit
Package (PBP)

Date the grievance
was received

Page 53 of 54

Enrollee First
Name

Field
Type
CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

Field
Length
50

Description

Enter the last name of the enrollee.

Enter the Medicare Beneficiary Identifier
(MBI) of the enrollee. An MBI is the
non-intelligent unique identifier that
replaced the HICN on Medicare cards as
a result of The Medicare Access and
CHIP Reauthorization Act (MACRA) of
2015. The MBI contains uppercase
alphabetic and numeric characters
throughout the 11-digit identifier and is
unique to each Medicare enrollee. This
number must be submitted excluding
hyphens or dashes.
Enter the contract number (e.g., H1234).

CHAR
5
Always
Required
CHAR
3
Always
Required
CHAR
10
Always
Required

Enter the first name of the enrollee.

Enter the PBP (e.g., 001).
Enter the date the grievance was
received. Submit in CCYY/MM/DD
format (e.g., 2020/01/01).

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
CHAR
8
Time the
Enter the time the grievance was
Always
grievance was
received. Submit in HH:MM:SS military
Required
received
time format (e.g., 23:59:59).
AOR/Equivalent
notice Receipt
Date

AOR/Equivalent
notice Receipt
Time

CHAR
10
Always
Required

CHAR
8
Always
Required

Enter None if no AOR or equivalent
written notice was received or required.
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 cases or if no
AOR or equivalent written notice was
received or required.
Enter:
• Oral
• Written
Enter:
• S for Standard
• E for Expedited

How was the
grievance
received?

CHAR
7
Always
Required

Was the grievance
processed as
Standard or
Expedited?
Category of the
issue

CHAR
1
Always
Required

Grievance
Description

CHAR
1,800
Always
Required

Was this
processed as a
quality of care
grievance?

CHAR
1
Always
Required

Page 54 of 55

Enter None for standard cases.
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).

CHAR
50
Always
Required

Enter the category of the grievance as
assigned by the Sponsoring organization.
Enter based on the Sponsoring
organization’s internal labeling system.
Enter the description of the grievance.
Enter:
• Y for Yes
• N for No

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
O

Field Name

Date oral
notification
provided to
enrollee

Page 55 of 56

Was a timeframe
extension taken?

Time oral
notification
provided to
enrollee

Date
written
notification
provided to
enrollee

Field
Type
CHAR
Always
Required
CHAR
Always
Required

Field
Length
1
10

CHAR
8
Always
Required

CHAR
10
Always
Required

Time
written
notification
provided to
enrollee

CHAR
8
Always
Required

Who made
the
request?

CHAR
2
Always
Required

Description
Enter:
• Y for Yes
• N for No
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
provided.
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 cases or if no
oral notification was provided.
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.
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.
Enter who made the request:
• E for enrollee
• ER for enrollee’s
representative or
purported
representative

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Please use the guidance below for the following record layout:
Universe Table 7: Comprehensive Addiction and Recovery Act (CARA) At-Risk
Determination (AR) Record Layout
• Include all at-risk determinations made by the Sponsoring organization pursuant to
42 CFR §423.153(f) during the universe request period (i.e. Sponsoring
organization determinations that an enrollee is at-risk for prescription drug abuse
and Sponsoring organization determinations that an enrollee is not at-risk for
prescription drug abuse under 42 CFR § 423.153(f)). The date of the Sponsoring
organization’s determination (Column ID I), must fall within the universe request
period.
• Each at-risk determination must be listed as its own line item in the submitted
universe.
• Enter all fields for a single at-risk determination 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 appeals of at-risk determinations.
Column
ID
A
B
C

Page 56 of 57

Field Name

Field Type Field
Length
Enrollee First Name CHAR
50
Always
Required
Enrollee Last Name CHAR
50
Always
Required
Enrollee ID
CHAR
11
Always
Required

Contract ID

CHAR
5
Always
Required

Description
Enter the first name of the enrollee.
Enter the last name of the enrollee.
Enter the Medicare Beneficiary Identifier
(MBI) of the enrollee. An MBI is the nonintelligent unique identifier that replaced
the HICN on Medicare cards as a result of
The Medicare Access and CHIP
Reauthorization Act (MACRA) of 2015.
The MBI contains uppercase alphabetic and
numeric characters throughout the 11- digit
identifier and is unique to each Medicare
enrollee. This number must be submitted
excluding hyphens or dashes.
Enter the contract number (e.g., H1234).

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID
E

Field Name

Drug Name,
Strength, and
Dosage Form

Plan Benefit
Package
(PBP)

Field
Field
Type
Length
CHAR
3
Always
Required
CHAR
150
Always
Required

Description
Enter the PBP (e.g., 001).

Enter the drug name, strength, and
dosage form applicable to the
specific limitation the Sponsoring
organization intends to place on
the beneficiary's access to
coverage for frequently abused
drugs under the program.
Enter Multiple if the intended limitation
applies to more than one drug (e.g.
beneficiary level edit blocking all opioid
access, beneficiary level edit allowing a
defined cumulative MME dosage).

Page 57 of 58

Date the Initial
Written
Notification of
potential at-risk
status was
provided to
enrollee

CHAR
10
Always
Required

Date Second
Written
Notification of
At-Risk
Determination
Provided to
Enrollee

CHAR
10
Always
Required

Enter None if the intended
limitation is not related to a
specific drug (e.g. pharmacy lockin, prescriber lock-in).
Enter the date the initial notification
was provided to the enrollee that
identified them as potentially at-risk.
Submit in CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if no written notification
was provided.
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.

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID

Field Name

Field
Type

Date the AtRisk
Determination
was made
Request
Determination

CHAR
10
Always
Required

Type of At-Risk
Limitation

CHAR
54
Always
Required

Field
Length

CHAR
11
Always
Required

Description
Enter the date the at-risk or not at-risk
determination was made. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter the determination:
• At-Risk
• Not At-Risk
Enter the type of at-risk limitation
imposed upon the enrollee:
• Point of Sale Edit
• Pharmacy Lock-In
• Provider Lock-In
If there are multiple limitations, enter
all limitations that apply (e.g., POS edit,
pharmacy lock-in and prescriber lockin).

Page 58 of 59

Confirmation of
Agreement to
Place Limitation
upon Enrollee

If an enrollee
edit was used,
date the edit was
effectuated in
the system

CHAR
4
Always
Required

CHAR
10
Always
Required

Enter None if an at-risk determination
was not imposed on the enrollee.
Identify if agreement to place limitation
was confirmed by either the pharmacy,
provider or both.
Enter:
• YPR for Yes from Provider
• YPH for Yes from Pharmacy
• YBO for Yes from Both
Enter None if no confirmation of
agreement was received.
Enter the date the enrollee
edit/limitation was effectuated in the
system. Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter None if no limitations were
entered into the system.

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
Column
ID

Field Name

Field
Type

Expiration date of
the at-risk
restriction/lock-in

CHAR
10
Always
Required

Field
Length

Description
Enter the expiration date of the at-risk
restriction/lock-in. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter None if there was not a
restriction/lock-in placed on enrollee.

Audit Field Work Phase
Supporting Documentation Submissions
Each case will be evaluated to determine whether the Sponsoring organization is compliant with
its Part D contract requirements. To facilitate this review, the Sponsoring organization must have
access to, and the ability to save and upload screenshots of, supporting documentation and data
relevant for a particular case, including, but not limited to:
• The initial coverage request.
o If request was received via fax/mail/email, copy of original request including date/time
stamp of receipt.
o If request was received via phone, copy of CSR notes and/or documentation of call
including date/time stamp of call and call details.
• Copy of appointment of representative (AOR) or equivalent written notice, if patient’s
representative placed request and/or received response.
• Copy of all notices, letters, call logs, or other documentation showing when the Sponsoring
organization requested additional information from the prescriber. If the request was made
via phone call, copy of call log detailing what was communicated to the prescriber.
• Copy of all supplemental information submitted by the prescriber.
o If information was received via fax/mail/email, copy of documentation provided
including date/time stamp and call details.
o If information was received via phone, copy of CSR notes and/or documentation of call
including date/time stamp.
• Documentation of the decision (approved or denied), including:
o Documentation showing denial, partial denial, or approval notification to the enrollee
and/or their representative and prescriber, if applicable.
o Name and title of final reviewer and rationale for the decision. Additional documentation
will include, but is not limited to: Sponsoring organization formulary/EOC, Sponsoring
organization clinical criteria, Federal Regulations, CMS Guidance, compendia, peer

Page 59 of 60

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)

•

•
•

•

•
•
•
•

•
•

reviewed literature (where allowed), or any other documentation used when considering
the request.
o Copy of the written decision letter and documentation of date/time letter was mailed.
o If oral notification was given, copy of CSR notes and/or documentation of call including
date/time stamp.
For approvals: documentation of effectuation of request, including:
o Approval in coverage determinations/redeterminations system(s) and evidence of
effectuation in Sponsoring organization claims system clearly showing date and time
override was entered.
o Documentation of paid or rejected claims following the approved coverage determination
or redetermination.
o For approved exception requests, proof that the approval is effective for the remainder of
the plan year.
If case was untimely:
o Documentation showing when the Sponsoring organization auto-forwarded the request to
the IRE.
For reopenings:
o Copy of any case notes as to why the decision was reopened,
o Copy of any notice sent to the enrollee regarding the reason for the reopening,
o Copy of all documentation relating to the decision of the reopening and any subsequent
notification regarding the decision.
If applicable, all documentation to support the Sponsoring organization’s decision to process
an expedited request under the standard timeframe, including any pertinent medical
documentation, and any associated notices provided to the enrollee and the requesting
provider/physician.
If applicable, notice to the enrollee that their request is not being expedited and the right to
file a grievance.
All previous case history/ documentation of initial coverage determinations and/or
redeterminations related to the overturn.
Copy of overturn notice from IRE/ALJ/MAC including date/time stamp of receipt by
Sponsoring organization.
Documentation of effectuation including approval in coverage determinations/
redeterminations system(s) and evidence of effectuation in Sponsoring organization claims
system clearly showing date/time the override was entered. For approved exception requests,
proof that the approval is effective for the remainder of the plan year.
Claims history for drug subsequent to the effectuation showing either paid or rejected claims.
Copies of any case notes as to why the case was dismissed.
Any notification regarding the dismissal.
Initial complaint:
o If complaint was received via fax/mail/email, copy of original complaint.
o If request was received via phone, copy of CSR notes and/or documentation of call
including the call details.
Copy of appointment of representative (AOR) or equivalent written notice, if patient’s
representative filed grievance or received notification.
Copy of all supplemental information submitted by enrollee and/or their representative.
o If information was received via fax/mail/email, copy of documentation provided.

Page 60 of 61

OMB Approval 0938-1395 (Expires 05/31/2024)

Program Audit Protocol and Data Request
Part D Coverage Determinations, Appeals, and Grievances (CDAG)
•

•
•

o If information was received via phone, copy of CSR notes and/or documentation of call.
Documentation showing the steps the Sponsoring organization took to resolve the issue,
including appropriate correspondence with other departments within the organization,
referral to Sponsoring organization’s fraud, waste, and abuse department, outreach to
network pharmacies, and description of the final response.
Documentation showing response to the enrollee and/or their representative.
o Copy of the written decision letter sent and documentation of date letter was mailed.
o If oral notification was given, copy of CSR notes and/or documentation of call.
Documentation that supports a Sponsoring organizations record layout population (e.g.
mailroom policies).

Sponsoring organizations are expected to submit supporting documentation within two business
days of the request.
Root Cause Analysis Submissions
Sponsoring organizations may be required to provide a root cause analysis using the Root Cause
Template provided by CMS. Sponsoring organizations have two business days from the date of
request to respond.
Impact Analysis Submissions
When noncompliance with contract requirements is identified on audit, Sponsoring
organizations must submit each requested impact analysis, 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 using one of
the universe record layouts above, as specified by CMS. The Sponsoring organization must
include all requests impacted by the issue of noncompliance during the impact analysis request
period. Sponsoring organizations must provide accurate and timely impact analysis submissions
within 10 business days of the request Submissions that do not strictly adhere to the record
layout specifications will be rejected.
Verification of Information Collected: CMS may conduct integrity tests to validate the
accuracy of all universes, impact analyses, and other related documentation submitted in
furtherance of the audit. If data integrity issues are noted, Sponsoring organizations may be
required to resubmit their data.

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it
displays a valid OMB control number. The valid OMB control number for this information collection is 0938-1395 (Expires
05/31/2024). This is a mandatory information collection. The time required to complete this information collection is estimated
to average 701 hours per response, including the time to review instructions, search existing data resources, gather the data
needed, and complete and review the information collection. If you have comments concerning the accuracy of the time
estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance
Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850. ****CMS Disclosure**** Please do not send applications,
claims, payments, medical records or any documents containing sensitive information to the PRA Reports Clearance Office.
Please note that any correspondence not pertaining to the information collection burden approved under the associated OMB
control number listed on this form will not be reviewed, forwarded, or retained. If you have questions or concerns regarding
where to submit your documents, please contact [email protected].

Page 61 of 61

OMB Approval 0938-1395 (Expires 05/31/2024)

File Type	application/pdf
File Title	Part D Coverage Determinations Appeals and Grievances Program Audit Protocol and Data Request
Subject	CDAG PROTOCOL AND DATA REQUEST
Author	CMS
File Modified	2023-09-28
File Created	2023-04-07