Program Audits

Part D Formulary and
Benefit Administration
(FA)
PROGRAM AUDIT PROTOCOL AND DATA
REQUEST

Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)

Table of Contents

Program Audit Protocol ............................................................................................................................. 3
Purpose ........................................................................................................................................................ 3
Audit Elements Tested ................................................................................................................................ 3
Program Audit Data Request..................................................................................................................... 8
Audit Engagement and Universe Submission Phase ................................................................................ 8
Universe Submissions ............................................................................................................................. 8
Universe Requests ................................................................................................................................... 8
Universe Table 1: Rejected Claims Formulary Administration (RCFA) Record Layout ....................... 10
Universe Table 2: Rejected Claims Transition (RCT) Record Layout ................................................... 10
Universe Table 3: Prescription Drug Event (PDE) Data Record Layout ............................................... 14
Universe Table 4: New Enrollee (NE) Record Layout .......................................................................... 16
Supplemental Documentation Submission.......................................................................................... 17
Supplemental Documentation Request ............................................................................................... 17
Audit Field Work Phase ........................................................................................................................... 17
Supporting Documentation Submissions ............................................................................................ 17
Root Cause Analysis Submissions........................................................................................................ 18
Impact Analysis Submissions ...............................................................................................................18
Impact Analysis Requests ..................................................................................................................... 18
Table 1IA: Impact Analysis Summary (IAS) Record Layout ................................................................. 20
Table 2IA: Enrollee Impact Analysis (ENR-IA) Record Layout ............................................................ 21

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Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)

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

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Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Audit
Element
Not
Applicable

Compliance
Standard
Universe
Integrity
Testing

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

Method of Evaluation
Select 5 cases from each universe,
Tables 1 and 2, for a total of 10
cases.

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

Prior to field work, CMS will
schedule a webinar with the
Sponsoring organization to verify
accuracy of data within each
rejected claims universe submission
for each of the sampled cases.
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.
Sample selections will be provided
to the Sponsoring organization
approximately one hour prior to the
scheduled webinar.

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Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Audit
Element
Formulary
Administration

Compliance
Standard
1.1

Data Request

Method of Evaluation

Universe Table 1:
Rejected Claims
Formulary Administration
(RCFA)

Select 30 targeted rejected claims
relating to formulary administration
(e.g., prior authorization, step
therapy, non-formulary drugs, and
quantity limitations). Ensure
sample set represents a mix of
claims for non-protected class drugs
and claims for protected class drugs.
Sampling criteria could include but
is not limited to the following:
Rejections for formulary drugs;
Prior authorization rejections where
the prior authorization edit is not
approved; Step therapy rejections
where the step therapy edit is not
approved; Quantity limit rejections
where the quantity limit edit is not
approved or the quantity amount
and/or day’s supply are not within
allowed limits; Rejection messaging
is inconsistent with a drug’s
formulary status and the approved
benefit. This includes nonformulary drugs; Rejections
associated with high cost edits;
Rejections for opioid related safety
edits; Rejections associated with
day supply limitations not consistent
with the plan benefit; Rejections for
Part B versus Part D medications;
Rejections for short cycle fill; and
Rejections for prescriber
identification.

Criteria Effective
01/01/2021
42 CFR § 423.100
42 CFR § 423.104(a)
42 CFR § 423.104(h)
42 CFR § 423.104(c)
42 CFR § 423.154(a)
Part D Contract with
CMS
42 CFR § 423.120(b)
42 CFR § 423.272(b)
CMS Approved
Formulary
CMS Approved Plan
Bid

Sample selections will be provided
to the Sponsoring organization
approximately one hour prior to the
scheduled webinar.
Review the 30 targeted samples
selected above to ensure:
The claim adjudication process
follows the CMS approved
formulary. Unapproved
utilization management edits
are not applied to restrict
formulary and benefit access.
Appropriate effectuation of
authorization records typically
resulting from a coverage
determination.

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Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Audit
Element
Formulary
Administration

Formulary
Administration

Formulary
Administration

Formulary
Administration

Data Request
Compliance
Standard
1.2
Universe Table 1:
Rejected Claims
Formulary Administration
(RCFA)

1.3

1.4

1.5

Universe Table 1:
Rejected Claims
Formulary Administration
(RCFA)

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

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Method of Evaluation
A select number of the 30 samples
above will be reviewed to ensure:
Appropriate administration of prior
authorization or step therapy for
enrollees filling protected class
medications for the first time or
currently taking the drug. Enrollees
determined to be currently taking
the drug should have access to a day
supply consistent with their benefit.
A select number of the 30 samples
above will be reviewed to ensure:
Appropriate administration of
special requirements for long term
care dispensing, such as short cycle
fill requirements.
A select number of the 30 samples
above will be reviewed to ensure:
Appropriate claim rejections based
on prescriber identification
information.
A select number of the 30 samples
above will be reviewed to ensure:
Appropriate administration of
requirements related to the Part D
drug management programs:
• Appropriate administration of
care coordination opioid safety
edits
• Pharmacy and prescriber
coverage limitations
• Appropriate administration of
7 day supply limit for initial
opioid fills

Criteria Effective
01/01/2021
42 CFR § 423.104(a)
42 CFR § 423.104(c)
Part D Contract with
CMS
42 CFR § 423.120(b)

42 CFR § 423.154(a)

42 CFR § 423.120(c)

42 CFR § 423.153
42 CFR § 423.120(b)

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Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Audit
Element
Transition

Compliance
Standard
2.1

Data Request

Method of Evaluation

Universe Table 1:
Rejected Claims
Formulary Administration
(RCFA)

Select a targeted sample of up to 15
claims from Universe Table 2 for
continuing enrollees.
The sample will consist of rejected
claims related to cross-year
formulary changes between the
audit year and the previous contract
year (e.g., formulary deletions).

Universe Table 2:
Rejected Claims
Transition (RCT)
Universe Table 3:
Prescription Drug Event
(PDE) Data
Universe Table 4: New
Enrollee (NE)

Criteria Effective
01/01/2021
42 CFR § 423.120(b)

Select a targeted sample of up to 15
claims from Universe Table 2 for
new enrollees. The sample will
consist of rejected claims related to
formulary administration during
transition (e.g., prior authorization,
step therapy, non-formulary drugs,
and quantity limitations).
Sample selections will be provided
to the Sponsoring organization
approximately one hour prior to the
scheduled webinar.
Review the 30 targeted samples
selected above to determine if the
rejection is appropriate.
Identify and review any protected
class rejections to look for broader
issues that may affect one or more
classes.
Specifically review the samples to
ensure that: New and continuing
enrollees eligible for a transition fill
are afforded the full transition
benefit consistent with the
submitted enrollment and
disenrollment date; For continuing
enrollees that have prior history of
the drug determine the type of
change that occurred between
contract years for that drug;
Enrollees with a November or
December effective enrollment date
are afforded a full continuing
enrollee transition benefit, if
applicable; Enrollees in long term
care are afforded access to
emergency supplies while an
exception or prior authorization
request is being processed; and
Drugs available in their smallest
package size are appropriately
processed during transition.

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Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Audit
Element
Transition

Compliance
Standard
2.2

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

Method of Evaluation
Review the 30 targeted samples
selected above to ensure that:

Criteria Effective
01/01/2021
42 CFR § 423.120(b)

Enrollees and prescribers received
appropriate, timely, and accurate
transition fill notices.

Universe Table 3:
Prescription Drug Event
(PDE) Data
Universe Table 4: New
Enrollee (NE)

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

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Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Universe
Record Layout
Table 1

Scope of Universe Request*

Sponsoring organizations with –
• < 20,000 enrollees: submit all rejected claims with dates of service for the
8-week period preceding and including, the date of the audit engagement
letter (i.e., prior Month, Day, Year through audit engagement letter
Month, Day, Year).
• ≥ 20,000 but < 500,000 enrollees: submit all rejected claims with dates of
service for the 4-week period preceding and including, the date of the
audit engagement letter (i.e., prior Month, Day, Year through audit
engagement Month, Day, Year).
• ≥ 500,000 enrollees: submit all rejected claims with dates of service for
the 2-week period preceding and including, the date of the audit
engagement letter (i.e., prior Month, Day, Year through audit engagement
Month, Day, Year).
Table 2
Sponsoring organizations with –
• < 100,000 enrollees: submit all rejected claims with dates of service for
January and February of the audit year.
• ≥ 100,000 enrollees: submit all rejected claims with dates of service for
January of the audit year.
Table 3
Submit all final action PDEs accepted by CMS with dates of service September –
December of the contract year immediately prior to the audit year for all enrollees
in Table 2 and enrollees with effective enrollment dates of November and
December of the contract year immediately prior to the audit year.
Table 4
Sponsoring organizations with –
• < 100,000 enrollees: submit all enrollees with effective enrollment dates
11/1/previous audit year through 2/1/current audit year.
• ≥ 100,000 enrollees: submit all enrollees with effective enrollment dates
11/1/previous audit year through 1/1/current audit year.
* CMS reserves the right to expand the review period to ensure sufficient universe size.

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Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Please use the guidance below for the following record layouts:
Universe Table 1: Rejected Claims Formulary Administration (RCFA) Record Layout
Universe Table 2: Rejected Claims Transition (RCT) Record Layout
• Include all rejected claims with dates of service that fall within the applicable review period
timeframe (including enrollees enrolled in employer plans and Medicare-Medicaid Plans
(MMPs)).
• Do not filter data under any circumstances.
• Only fields that are submitted blank by the pharmacy may be submitted blank in the universe
submission.
Column
ID
A

Field Name

B

Enrollee First
Name

C

Enrollee Last
Name

D

Date of Birth

E

Enrollment
Effective Date

Page 10 of 27

Enrollee ID

Field
Field
Type
Length
CHAR
11
Always
Required

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

Description

50

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.

50

Enter the last name of the enrollee.

10

Enter the date of birth of the enrollee.
Submit in CCYY/MM/DD format (e.g.,
1940/01/01).
Enter effective date of enrollment for the
enrollee (PBP level). Enter the
enrollment date relevant to the contract
and plan ID of the enrollee at the time of
the claim. Submit in CCYY/MM/DD
format (e.g., 2020/01/01).

10

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Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Column
ID
F

Field Name
Effective
Disenrollment
Date

G

Cardholder ID

H

Contract ID

I

Plan Benefit
Package (PBP)

J

NDC

Field
Field
Type
Length
CHAR
10
Always
Required

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

20
5

Description
Enter effective date of disenrollment for
the enrollee (PBP level). Enter the
disenrollment date relevant to the
contract and plan ID of the enrollee at
the time of the claim. Submit in
CCYY/MM/DD format (e.g.,
2020/02/01).
Enter NA if the enrollee was not
disenrolled.
Enter cardholder identifier used to
identify the enrollee. This is assigned by
the Sponsoring organization.
Enter the contract number (e.g., H1234)
of the Sponsoring organization.

3

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

11

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.

K

Date of Service

L

Date of Rejection

Page 11 of 27

CHAR
10
Always
Required
CHAR
10
Always
Required

For multi-ingredient compound claims
populate the field with the NDC as
would be submitted on a paid claim’s
PDE.
Enter the date of fill for the rejected
claim. Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Enter the date of rejection for the drug
claim. Submit in CCYY/MM/DD format
(e.g., 2020/01/01).

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Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Column
ID
M

Field Name

N

Claim Days
Supply

NUM
3
Always
Required

O

Patient Residence

CHAR
5
Always
Required

P

Pharmacy Service
Type

CHAR
5
Always
Required

Q

Compound Code

CHAR
1
Always
Required

R

Reject Reason
Code

CHAR
7
Always
Required

Claim Quantity

Field
Field
Type
Length
CHAR
11
Always
Required

Description
Enter the number of drug dosage units
entered in the claim (e.g., 30 [tablets],
0.42 [milliliters of liquid]), including
decimal values, when applicable. Units
of measurement should not to be
reported.
Enter the days’ supply of the drug
entered on the claim (e.g., 30 [days]).
Units of measurement should not to be
reported.
Enter the patient residence code for the
enrollee as submitted by the pharmacy
on the claim. While this may typically be
an NCPDP value, other values submitted
on the claim would be accepted.
Enter the Pharmacy service type as
submitted by the pharmacy on the
rejected claim. While this may typically
be an NCPDP value, other values
submitted on the claim would be
accepted.
Enter code indicating whether or not the
drug claim was for a compounded
product. Valid values are:
0 = Not specified
1 = Not a Compound
2 = Compound
Enter the reason code associated with the
rejected claim. This field should always
be followed by the pharmacy message
field. All reject codes associated with a
claim must be included.
Repeat the Reject Reason Code field as
many times as needed to capture each
individual reject reason code, followed
by the corresponding pharmacy
messaging related to the rejected claim.
When a pharmacy message is generated
without a reject reason code, enter NA in
the reject reason code field.

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Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Column
ID
S

Field Name
Pharmacy
Message

Field
Field
Type
Length
CHAR
1,000
Always
Required

Description
All pharmacy messages associated with
the rejected claim must be included. If
there are multiple messages associated
with a single reject code, Sponsoring
organizations must include all applicable
messaging in the same message field
(e.g., reject code 1: list all pharmacy
messages, reject code 2: list all pharmacy
messages, reject code 3: list all pharmacy
messages).
Repeat the Pharmacy Message field as
needed after each reject reason code
submitted.
For pharmacy messages generated in the
absence of a reject reason code, enter NA
in the reject reason code field preceding
the pharmacy message field. Likewise,
when a reject reason code is generated
without a related pharmacy message,
enter NA in the pharmacy message field.
NOTE: In limited circumstances, when
the messaging cannot be separated for
purposes of populating the universe,
Sponsoring organizations may choose to
include all pharmacy messaging in the
first pharmacy message field only. For
subsequent reject codes, please enter NA
in the associated pharmacy message
fields.

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Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Please use the guidance below for the following record layout:
Universe Table 3: Prescription Drug Event (PDE) Data Record Layout
Submit all final action PDEs accepted by CMS with dates of service September – December of
the contract year immediately prior to the audit year, for enrollees in Table 2 and enrollees with
effective enrollment dates of November and December of the contract year immediately prior
to the audit year. Include enrollees in employer plans and Medicare- Medicaid Plans (MMPs).

•

Column
ID
A

Field Name

B

Enrollee First
Name

C

Enrollee Last
Name

D

Date of Birth

E

Cardholder ID

F

Contract ID

G

Plan Benefit
Package (PBP)

Page 14 of 27

Enrollee ID

Field
Field
Type
Length
CHAR
11
Always
Required

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

Description

50

Enter the Medicare Beneficiary Identifier
(MBI) of the enrollee. An MBI is the
non-intelligent unique identifier that
replaces 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 first name of the enrollee.

50

Enter the last name of the enrollee.

10

Enter the date of birth of the enrollee.
Submit in CCYY/MM/DD format (e.g.,
1940/01/01).
Enter cardholder identifier used to
identify the enrollee. This is assigned by
the Sponsoring organization.
Enter the contract number (e.g., H1234)
of the Sponsoring organization.

20
5
3

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

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Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Column
ID
H

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, populate the field as submitted.
If the pharmacy submits a value greater
than 11 characters, enter “valueXeeded”
in the field.

I

Date of Service

CHAR
10
Always
Required

J

Claim Quantity

CHAR
11
Always
Required

K

Claim Days
Supply

NUM
3
Always
Required

L

Compound Code

CHAR
1
Always
Required

Page 15 of 27

For multi-ingredient compound claims
populate the field with the NDC as
would be submitted on a paid claim’s
PDE.
This field contains the date on which the
prescription was filled. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter number of drug dosage units
entered in the claim (e.g., 30 [tablets],
0.42 [milliliters of liquid]), including
decimal values, when applicable. Units
of measurement should not to be
reported.
Enter the days’ supply of the drug
entered in the claim (e.g., 30 [days]).
Units of measurement should not to be
reported.
Enter code indicating whether or not the
drug claim was for a compounded
product. Valid values are:
0 = Not specified
1 = Not a compound
2 = Compound

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

Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Please use the guidance below for the following record layout:
Universe Table 4: New Enrollee (NE) Record Layout
•

Only include eligible enrollees for which the Sponsoring organization does not utilize prior
claims history for purposes of providing transition supplies. In some cases, the Sponsoring
organization may have the full claims history for the enrollee from the most recent PBP, and
thus, the Sponsoring organization may be able to determine new versus ongoing therapy. In
this example, the enrollee should not be included in the New Enrollee Universe since they are
determined to be a continuing enrollee.
Description
Column Field Name
Field
Field
ID
Type
Length
A
Enrollee ID
CHAR
11
Enter the Medicare Beneficiary Identifier
Always
(MBI) of the enrollee. An MBI is the
Required
non-intelligent unique identifier that
replaces 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.
B
CHAR
50
Enter the first name of the enrollee.
Enrollee First
Always
Name
Required
C
CHAR
50
Enter the last name of the enrollee.
Enrollee Last
Always
Name
Required
D
Date of Birth
CHAR
10
Enter the date of birth of the enrollee.
Always
Submit in CCYY/MM/DD format (e.g.,
1940/01/01).
Required
E
CHAR
10
Enrollment
Enter the effective date of enrollment for
Always
Effective Date
the enrollee (PBP level). Submit in
Required
CCYY/MM/DD format (e.g.,
2020/01/01).

F

Page 16 of 27

Effective
Disenrollment
Date

CHAR
10
Always
Required

In this table only, a separate record
should be entered each time an enrollee is
enrolled and considered a new enrollee.
Enter the effective date of disenrollment
for the enrollee (PBP level). Submit in
CCYY/MM/DD format (e.g.,
2020/02/01). Enter NA if the enrollee
was not disenrolled.
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Column
ID

Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Field Name
Field
Field
Description
Type
Length

G

Cardholder ID

H

Contract ID

I

Plan Benefit
Package (PBP)

CHAR
20
Always
Required
CHAR
5
Always
Required
CHAR
3
Always
Required

Enter the cardholder identifier used to
identify the enrollee. This is assigned by
the Sponsoring organization.
Enter the contract number (e.g., H1234,
S1234) of the Sponsoring organization.
Enter the PBP (e.g., 001).

Supplemental Documentation Submission
Sponsoring organizations must submit the requested documentation identified below in either a
Microsoft Word (.docx), Microsoft Excel (.xlsx.), or Adobe Portable Document File (.pdf).
Sponsoring organizations must submit this documentation within 5 business days of the audit
engagement letter date, unless otherwise specified.
Supplemental Documentation Request
1. FA Supplemental Questionnaire

Audit Field Work Phase

Supporting Documentation Submissions
During audit field work, CMS will review 30 samples selected from Table 1 and up to 30
samples from Table 2 to determine whether the Sponsoring organization is compliant with its
Part D contract requirements. 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 to a particular case, including, but not limited to:
• Enrollee Information
o Enrollee Name
o Cardholder or enrollee ID
o CMS Contract ID
o CMS Plan Benefit Package (PBP) number
o Effective date of enrollment
• Rejected and/or Paid Claim Information
o National Drug Code (NDC)
o Drug name, strength, dosage form, route of administration
o Quantity
o Days’ supply
o Date of service
o Date and time of rejection
o Rejection code and messaging to pharmacy
o Dispense As Written (DAW) code
o Pharmacy National Provider Identifier (NPI)
o Whether prior authorization was used to process the claim. If an authorization was used, a

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screenshot that documents the level (e.g., GPI-6) and duration of the authorization.
o Comment log associated with the rejected claim that displays the pharmacy messages
o A history of all rejected and paid claims for the same drug (brand name, dosages form,
route of administration) during the audit year
o Claim payment information including enrollee pay amount, LIS amount, and Sponsoring
organization’s responsibility
•

Transition Notice
o Enrollee transition notice
o Prescriber transition notice and/or prescriber notification

Sponsoring organizations must submit supporting documentation within 2 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 2 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. Descriptions and
clarifications of what must be included in each submission and data field are outlined in the
individual tables below. Characters are required in all requested fields, unless otherwise
specified, and data must be limited to the request specified in each table. 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.
Impact Analysis Requests
1. Table 1IA: Impact Analysis Summary (IAS) Record Layout
2. Table 2IA: Enrollee Impact Analysis (ENR-IA) Record Layout
Impact
Analysis
Record Layout
Table 1IA
Table 2IA

Scope of Impact Analysis Request
Formulary Administration: Submit a list of all medications and/or enrollees
impacted by the noncompliance.
The time period must encompass the date the impact analysis is requested
through the start date of the universe period.

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Table 2IA

Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Transition: Submit a list of all medications and/or enrollees impacted by the
noncompliance.
The time period must encompass the date the impact analysis is requested
through January 1st of the current year.
Please note: When testing transition for enrollees with late enrollment in the
previous year (November or December), the impact analysis should go back to
the date of the enrollee’s new enrollee enrollment date in the previous year.

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Please use the guidance below for the following record layout:
Table 1IA: Impact Analysis Summary (IAS) Record Layout
• Include all medications impacted by the issue, including those that may not have an
associated rejected claim.
Column
ID
A
B

C

D

E

F

G

H

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Field Name
Methodology for
Identifying Impact
of Noncompliance
List of Medications
Affected
Actions Taken to
Resolve
System/Operational
Issues
Date
System/Operational
Remediation
Initiated
Date
System/Operational
Remediation
Completed
Actions Taken to
Resolve Negatively
Impacted Enrollees
Including Outreach
Description and
Status
Date Enrollee
Outreach and
Remediation
Initiated
Date Enrollee
Outreach and
Remediation
Completed

Field
Type
CHAR
Always
Required
CHAR
Always
Required

Field
Length
4, 000
4, 000

CHAR
4,000
Always
Required

Description
Describe the process undertaken to
determine the medications and enrollees
impacted by the issue of noncompliance.
Provide the list of medications at the
RXCUI level (by drug name, strength,
and dosage form) affected by the issue
in vertical list format.
Enter the actions taken to resolve the
system/operational issue.

CHAR
10
Always
Required

Enter the date (CCYY/MM/DD) that the
system/operational remediation of the
issue was initiated.

CHAR
10
Always
Required

Enter the date (CCYY/MM/DD) that the
system/operational remediation of the
issued was completed.

CHAR
4,000
Always
Required

Enter the actions taken to resolve
negatively impacted enrollees.

CHAR
10
Always
Required

Enter the date (CCYY/MM/DD) that
enrollee outreach and remediation was
initiated.

CHAR
10
Always
Required

Enter the date (CCYY/MM/DD) that
enrollee outreach and remediation was
completed.

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Please use the guidance below for the following record layout:
Table 2IA: Enrollee Impact Analysis (ENR-IA) Record Layout
• Include the following data for impacted enrollees:
• Rejected claims affected by the issue of noncompliance;
• Inaccurate records (i.e. authorization, enrollment records) that may not be associated with
a rejected claim. In this scenario, Sponsoring organizations should only complete the
following fields: Enrollee ID, Contract ID, Plan Benefit Package (PBP), Enrollment
Effective Date, and Drug Name and Strength (if applicable).
• Include separate entries for an enrollee each time he/she experienced an inappropriate
rejection at the point of sale as a result of the noncompliance.
Column
ID
A

Field Name

B

Contract ID

C

Plan Benefit
Package (PBP)

D

Enrollment
Effective Date

E

Date of Service

CHAR
10
Always
Required

F

Date of Rejection

CHAR
10
Always
Required

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Enrollee ID

Field
Field
Type
Length
CHAR
11
Always
Required

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

Description
Enter the Medicare Beneficiary Identifier
(MBI) of the enrollee. An MBI is the
non-intelligent unique identifier that
replaces 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)
of the Sponsoring organization.
Enter the PBP (e.g., 001).
Enter the effective date of enrollment for
the enrollee (PBP level). Enter the
enrollment date relevant to the contract
and plan ID of the enrollee at the time of
the claim. Submit in CCYY/MM/DD
format (e.g., 2020/01/01).
Enter the date a fill for a rejected claim
was attempted. Submit in
CCYY/MM/DD format (e.g.,
2020/01/01).
Enter date of rejection for the drug claim.
Submit in CCYY/MM/DD format (e.g.,
2020/01/01).
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Column
ID
G

Field Name

H

NDC

Time of Rejection

Field
Type
CHAR
Always
Required
CHAR
Always
Required

Field
Length
8
11

Description
Enter the time of rejection for the drug
claim. Submit in HH:MM:SS military
time format (e.g., 23:59:59).
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.

I

RxCUI

J

Drug Name and
Strength

K

Drug Quantity

L

Drug Days Supply

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CHAR
10
Always
Required
CHAR
150
Always
Required
CHAR
11
Always
Required

NUM
3
Always
Required

For multi-ingredient compound claims
populate the field with the NDC as
would be submitted on a paid claim’s
PDE.
Enter the RxNorm concept unique
identifier
Enter the drug name and strength.
Enter the number of drug dosage units
entered in the claim (e.g., 30 [tablets],
0.42 [milliliters of liquid]), including
decimal values, when applicable. Units
of measurement should not to be
reported.
Enter the days’ supply of the drug
entered on the claim (e.g., 30 [days]).
Units of measurement should not to be
reported.

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Column
ID
M

Field Name
Reject Reason
Code

Field
Field
Type
Length
CHAR
7
Always
Required

Description
Enter the reason code associated with the
rejected claim. This field should always
be followed by the pharmacy message
field. All reject codes associated with a
claim must be included.
Repeat the Reject Reason Code field as
many times as needed to capture each
individual reject reason code, followed
by the corresponding pharmacy
messaging related to the rejected claim.
When a pharmacy message is generated
without a reject reason code, enter NA in
the reject reason code field.

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ID
N

Program Audit Protocol and Data Request
Part D Formulary and Benefit Administration (FA)
Field Name
Description
Field
Field
Type
Length
CHAR
1,000
Pharmacy
All pharmacy messages associated with
Always
Message
the rejected claim must be included. If
Required
there are multiple messages associated
with a single reject code, Sponsoring
organizations must include all
applicable messaging in the same
message field (e.g., reject code 1: list
all pharmacy messages, reject code 2:
list all pharmacy messages, reject code
3: list all pharmacy messages).
Repeat the Pharmacy Message field as
needed after each reject reason code
submitted.
For pharmacy messages generated in
the absence of a reject reason code,
enter NA in the reject reason code field
preceding the pharmacy message field.
Likewise, when a reject reason code is
generated without a related pharmacy
message, enter NA in the pharmacy
message field.

O

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Pharmacy Service
Type

CHAR
Always
Required

5

NOTE: In limited circumstances, when
the messaging cannot be separated for
purposes of populating the universe,
Sponsoring organizations may choose
to include all pharmacy messaging in
the first pharmacy message field only.
For subsequent reject codes, please
enter NA in the associated pharmacy
message fields.
Enter the pharmacy service type as
submitted by the pharmacy on the
rejected claim. While this may
typically be an NCPDP value, other
values submitted on the claim would be
accepted.

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Column
ID
P

Field Name
Patient Residence

Field
Type
CHAR
Always
Required

Q

Process Date of
Subsequent Paid
Claim

CHAR
10
Always
Required

R

Process Time of
Subsequent Paid
Claim

CHAR
8
Always
Required

S

T

Field
Length
5

Process Date of
Paid Claim for a
Related Drug

CHAR
10
Always
Required

Process Time of
Paid Claim for a
Related Drug

CHAR
8
Always
Required

Description
Enter the patient residence code for
the enrollee as submitted by the
pharmacy on the rejected claim.
While this may typically be an
NCPDP value, other values
submitted on the claim would be
accepted.
Enter the date of the paid claim
subsequent to the rejected claim for
the medication utilizing the same
RXCUI, GPI, GCN, or HICL.
Submit in CCYY/MM/DD format
(e.g., 2020/01/01). Enter NA if never
received.
Enter the time of the paid claim
subsequent to the rejected claim.
Submit in HH:MM:SS military time
format (e.g., 23:59:59).
Enter NA if never received.
Enter the date of the paid claim for a
related drug subsequent to the
rejected claim. Submit in
CCYY/MM/DD (e.g., 2020/01/01).
Enter NA if never received.
Enter the time of the paid claim for a
related drug subsequent to the
rejected claim. Submit in
HH:MM:SS military time format
(e.g., 23:59:59).
Enter NA if never received.

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Column
ID
U

Field Name
Related Drug
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, populate the
field as submitted.
If the pharmacy submits a value
greater than 11 characters, enter
“valueXeeded” in the field.

V

Related Drug
Name and
Strength
Related Drug
Quantity

CHAR
150
Always
Required
CHAR
11
Always
Required

X

Related Drug
Days Supply

NUM
3
Always
Required

Y

Number of Days
Enrollee Went
Without
Medication
(Target or
Related)

CHAR
5
Always
Required

W

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For multi-ingredient compound
claims populate the field with the
NDC as would be submitted on a
paid claim’s PDE.
Enter the drug name and strength for
the related drug.
Enter the number of drug dosage units
entered in the claim (e.g., 30 [tablets],
0.42 [milliliters of liquid]), including
decimal values, when applicable for
related drug. Units of measurement
should not to be reported.
Enter the days’ supply of the drug
entered on the claim for related drug
(e.g., 30 [days]). Units of
measurement should not to be
reported.
Enter the number of days the enrollee
went without medication (target or
related) - Enter NA if never received.
A whole number is acceptable in this
field. NOTE: The Date of Rejection
should be used in this calculation (not
Date of Service).

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Column
ID
Z

Field Name

AA

Patient Paid
Amount ($)

Compound Code

AB

Pharmacy
Service Type

AC

Patient Residence
(e.g., LTC)

AD

AE

AF

Field
Field
Type
Length
CHAR
1
Always
Required

Description

CHAR
10
Always
Required

Enter the amount the enrollee paid for
the subsequent paid claim for the
target or related drug.

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

5
5
1,000

Enter the code indicating whether or
not the drug claim was for a
compounded product. Valid values
are:
0 = Not specified
1 = Not a Compound
2 = Compound

Enter NA if the enrollee never
received the drug.
Enter the pharmacy service type as
submitted by the pharmacy on the
paid claim.
Enter the patient residence code for
the enrollee as submitted by the
pharmacy on the paid claim.
This field is for any other requested
data.

1,000

This field is for any other requested
data.

1,000

This field is for any other requested
data.

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].
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