CMS-10191 FA Audit Process and Data Request

OMB Control Number 0938-1000 (Expires: TBD)

Part D Formulary and Benefit
Administration (FA)
Program Area
AUDIT PROCESS AND DATA REQUEST

PRA Disclosure Statement 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 0938-1000 (Expires: TBD). 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 C426-05, Baltimore, Maryland 21244-1850. 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 1-800-MEDICARE.

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST

Table of Contents
Audit Purpose and General Guidelines ......................................................................................................... 3
Universe Preparation & Submission ............................................................................................................. 5
Audit Elements.............................................................................................................................................. 6
I. Formulary Administration ................................................................................................................... 6
II. Transition ............................................................................................................................................. 7
Appendix ....................................................................................................................................................... 9
Appendix A—-Part D Formulary and Benefit Administration Record Layouts....................................... 9
Table 1: Rejected Claims Formulary Administration (RCFA) Record Layout..................................... 9
Table 2: Rejected Claims Transition – New Contract Year (RCT-N) Record Layout........................ 12
Table 3: Rejected Claims Transition – Previous Contract Year (RCT-P) Record Layout .................. 15
Table 4: Prescription Drug Event (PDE) Data Record Layout ........................................................... 18
Table 5: New Member (NM) Record Layout...................................................................................... 20

Page 2 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST

Audit Purpose and General Guidelines
1. Purpose: To evaluate performance in the two areas outlined in this protocol related to Part D
Formulary and Benefit Administration (FA). The Centers for Medicare & Medicaid Services (CMS)
will perform its audit activities using these instructions (unless otherwise noted).
2. Review Period: The review period for the Formulary and Benefit Administration Program Area
Audit will be based on your organization’s total enrollment. CMS reserves the right to expand the
review period to ensure a sufficient universe size.
2.1. Formulary Administration
2.1.1. Rejected Claims
• Sponsors with ≥ 20,000 enrollees: all rejected claims with dates of service for the 1
month period preceding and including, the date of the audit engagement letter (i.e.,
prior Month, Day, Year through audit engagement Month, Day, Year).
• Sponsors with < 20,000 enrollees: all rejected claims with dates of service for the 2
month period preceding and including, the date of the audit engagement letter (i.e.,
prior Month, Day, Year through audit engagement letter Month, Day, Year).
2.2. Transition
2.2.1.Rejected Claims - New Contract Year
• Sponsors with ≥ 100,000 enrollees: All rejected claims with dates of service for January
of the audit year.
• Sponsors with < 100,000 enrollees: All rejected claims with dates of service for January
and February of the audit year.
2.2.2. Rejected Claims - Previous Contract Year
• Beneficiaries with effective enrollment dates of November or December of the contract
year immediately prior to the audit year: All rejected claims with dates of service for
November and December of the contract year immediately prior to the audit year.
2.2.3. Prescription Drug Event (PDE) Data
• Beneficiaries submitted in either of the Rejected Claims Transition universes (new and
previous contract year): All final action PDEs accepted by CMS with dates of service
September – December of the contract year immediately prior to the audit year. This
will be used with the rejected claims data to test transition.
2.2.4. New Members (including members enrolled in employer plans and Medicare-Medicaid
Plans (MMPs)). This will be used with the rejected claims data to test transition for new
enrollees.
• Sponsors with ≥ 100,000 enrollees:
o All beneficiaries with an effective enrollment date of November or December
of the contract year immediately prior to the audit year regardless of whether
they continued in the same plan during the audit year.
o All beneficiaries with an effective enrollment date of January of the audit year.
• Sponsors with < 100,000 enrollees:
o All beneficiaries with an effective enrollment date of November or December
of the contract year immediately prior to the audit year regardless of whether
they continued in the same plan in the audit year.

Page 3 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST
o

All beneficiaries with an effective enrollment date of January or February of
the audit year.

3. Responding to Documentation Requests: The sponsor is expected to present its supporting
documentation during the audit and take screen shots or otherwise upload the supporting
documentation, as requested, to the secure site using the designated naming convention and
within the timeframe specified by the CMS Audit Team.
4. Sponsor Disclosed Issues: Sponsors will be asked to provide a list of all disclosed issues of noncompliance that are relevant to the program areas being audited and may be detected during the
audit. A disclosed issue is one that has been reported to CMS prior to the receipt of the audit start
notice (which is also known as the “engagement letter”). Issues identified by CMS through ongoing monitoring or other account management/oversight activities during the plan year are not
considered disclosed.
Sponsors must provide a description of each disclosed issue as well as the status of correction and
remediation using the Pre-Audit Issue Summary template. This template is due within 5 business
days after the receipt of the audit start notice. The sponsor’s Account Manager will review the
summary to validate that “disclosed” issues were known to CMS prior to receipt of the audit start
notice.
When CMS determines that a disclosed issue was promptly identified, corrected (or is actively
undergoing correction), and the risk to beneficiaries has been mitigated, CMS will not apply the
ICAR condition classification to that condition.
5. Impact Analysis (IA): An impact analysis must be submitted as requested by CMS. The impact
analysis must identify all beneficiaries subjected to or impacted by the issue of non-compliance.
Sponsors will have up to 10 business days to complete the requested impact analysis templates.
CMS may validate the accuracy of the impact analysis submission(s). In the event an impact
analysis cannot be produced, CMS will report that the scope of non-compliance could not be fully
measured and impacted an unknown number of beneficiaries across all contracts audited.
6. Calculation of Score: CMS will determine if each condition cited is an Observation (0 points),
Corrective Action Required (CAR) (1 point) or an Immediate Corrective Action Required (ICAR) (2
points). Invalid Data Submission (IDS) conditions will be cited when a sponsor is not able to produce
an accurate universe within 3 attempts. IDS conditions will be worth one point.
CMS will then add the score for that audit element to the scores for the remainder of the audit
elements in a given protocol and then divide that number (i.e., total score), by the number of audit
elements tested to determine the sponsor’s overall FA audit score. Some elements and program areas
may not apply to certain sponsors and therefore will not be considered when calculating program
area and overall audit scores. Observations will be recorded in the draft and final reports, but will
not be scored and therefore will not be included in the program area and audit scores.
7. Informing Sponsor of Results: CMS will provide daily updates regarding conditions discovered
that day (unless the case has been pended for further review). CMS will provide a preliminary
summary of its findings at the exit conference. The CMS Audit team will do its best to be as
transparent and timely as possible in its communication of audit findings. Sponsors will also
receive a draft audit report which they may formally comment on and then a final report will be
issued after consideration of a sponsor’s comments on the draft.

Page 4 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST

Universe Preparation & Submission
1. Responding to Universe Requests: The sponsor is expected to provide accurate and timely universe
submissions within 15 business days of the engagement letter date. CMS may request a revised universe if
data issues are identified. The resubmission request may occur before and/or after the entrance conference
depending on when the issue was identified. Sponsors will have a maximum of 3 attempts to provide
complete and accurate universes, whether these attempts all occur prior to the entrance conference or they
include submissions prior to and after the entrance conference. However, 3 attempts may not always be
feasible depending on when the data issues are identified and the potential for impact to the audit schedule.
When multiple attempts are made, CMS will only use the last universe submitted.
If the sponsor fails to provide accurate and timely universe submissions twice, CMS will document this as an
observation in the sponsor’s program audit report. After the third failed attempt, or when the sponsor
determines after fewer attempts that they are unable to provide an accurate universe within the timeframe
specified during the audit, the sponsor will be cited an Invalid Data Submission (IDS) condition relative to
each element that cannot be tested, grouped by the type of case.
2. Pull Universes: The universes collected for this program area test whether the sponsor has deficiencies
related to the appropriate point-of-sale claims adjudication. Sponsors will provide universes of all rejected
claims and prescription drug event (PDE) data (paid claims) with dates of service that fall within the related
review periods. The sponsor needs to ensure that only standing paid claims of members from the rejected
claims transition universe are submitted for the PDE universe. This may include members that are treated as
new by the sponsor, but that were enrolled in a different Plan Benefit Package (PBP) for the same sponsor
during the new contract year. The universes should be compiled using the appropriate FA record layout as
described in Appendix A. These record layouts include:
•
•
•
•
•

Rejected Claims Formulary Administration (RCFA)
Rejected Claims Transition – New Contract Year (RCT-N)
Rejected Claims Transition – Previous Contract Year (RCT-P)
Prescription Drug Event (PDE)
New Member (NM)

NOTE: For each respective universe, the sponsor should include all cases that match the description for that
universe for all contracts and PBPs in its organization as identified in the audit engagement letter (e.g., all
rejected claims for all contracts and PBPs in your organization for dates of service that fall within the
applicable review period).
3. Submit Universes to CMS: Sponsors should submit each universe in the Microsoft Excel (.xlsx) file format
with a header row (or Text (.txt) file format without a header row) following the record layouts shown in
Appendix A (Tables 1-5). The sponsor should submit its universes in whole and not separately for each
contract and PBP unless otherwise instructed by CMS.

Page 5 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST

Audit Elements
I. Formulary Administration
1. Select Sample Cases: CMS will select a targeted sample of 30 claims from the Formulary Administration
Rejected Claims Universe. The sample will consist of protected and non-protected class drug claims
rejections relating to formulary administration (e.g., prior authorization, step therapy, non-formulary drugs,
and quantity limitations).
2. Review Sample Case Documentation: CMS will review all sample case file documentation to determine if
the Part D sponsor has deficiencies related to the appropriate point-of-sale claim adjudication. The sponsor
will need access to the following documents during the live audit webinar and may be requested to produce
screenshots of any of the following:
2.1. Beneficiary Information
• Beneficiary Name
• Cardholder or member ID
• CMS Contract ID
• CMS Plan Benefit Package (PBP) number
• Effective date of enrollment
2.2. Rejected and/or Paid Claim Information
• National Drug Code (NDC)
• Drug name, strength, dosage form, route of administration
• Quantity
• Days supply
• Date of service
• Date and time of rejection
• Rejection code and messaging to pharmacy
• Dispense As Written (DAW) code
• Pharmacy National Provider Identifier (NPI)
• Whether prior authorization was used to process the claim. If an authorization was used, a
screenshot that documents the level (e.g., GPI-6) and duration of the authorization.
• Comment log associated with the rejected claim that displays the pharmacy messages
• A history of all rejected and paid claims for the same drug (brand name, dosage form, route of
administration) during the audit year
• Claim payment information including beneficiary pay amount, LIS amount and sponsor’s
responsibility
3. Apply Compliance Standard: At a minimum, CMS will evaluate cases against the following criteria. CMS
may review factors not specifically addressed in these questions if it is determined that there are other
related FA requirements not being met.
3.1. Does the claim adjudication process follow the approved CMS formulary?
4. Sample Case Results: CMS will test each of the 30 cases. If CMS requirements are not met,
conditions (findings) are cited. If CMS requirements are met, no conditions (findings) are cited.
NOTE: Cases and conditions may have a one-to-one or a one-to-many relationship. For example, one case
may have a single condition or multiple conditions of non-compliance.

Page 6 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST

II. Transition
1. Select Sample Cases: CMS will select a targeted sample of 30 claims from the rejected transition claims
universes for continuing members as well as for new enrollees. Claims will be selected for both nonprotected class drugs and protected class drugs.
1.1. Continuing members: The sample will consist of rejected claims related to cross-year
formulary changes between the audit year and the previous contract year (e.g., formulary
deletions).
1.2. 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).
2. Review Sample Case Documentation: CMS will review all sample case file documentation to determine if
the Part D sponsor has deficiencies related to improper claims adjudication logic during the transition period
(e.g., logic that prevented beneficiaries who were currently taking a drug from accessing that drug due to a
change between contract years). The sponsor will need access to the following documents during the live
audit webinar and may be requested to produce screenshots of any of the following:
2.1. Beneficiary Information
• Beneficiary Name
• Cardholder or member ID
• CMS Contract ID
• CMS Plan Benefit Package (PBP) number
• Effective date of enrollment
2.2. Rejected and/or Paid Claim Information
• National Drug Code (NDC)
• Drug name, strength, dosage form, route of administration
• Quantity
• Days supply
• Date of service
• Date and time of rejection
• Rejection code and messaging to pharmacy
• Dispense As Written (DAW) code
• Pharmacy National Provider Identifier (NPI)
• Whether prior authorization was used to process the claim. If an authorization was used, a
screenshot that documents the level (e.g., GPI-6) and duration of the authorization.
• Comment log associated with the rejected claim that displays the pharmacy messages
• A history of rejected and paid claims for the same drug (brand name, dosage form, route of
administration) from the audit year and/or the previous contract year
• Claim payment information including beneficiary pay amount, LIS amount and sponsor’s
responsibility
2.3. Transition Notice
• Beneficiary transition notice
• Prescriber transition notice and/or prescriber notification

Page 7 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST
3. Apply Compliance Standard: At a minimum, CMS will evaluate cases against the following criteria. CMS
may review factors not specifically addressed in these questions if it is determined that there are other
related FA requirements not being met.
3.1. Did the sponsor meet the transition fill requirement?
3.2. Did the sponsor meet the transition notice requirement?
4. Sample Case Results: CMS will test each of the 30 cases. If CMS requirements are not met, conditions
(findings) are cited. If CMS requirements are met, no conditions (findings) are cited. NOTE: Cases and
conditions may have a one-to-one or a one-to-many relationship. For example, one case may have a single
condition or multiple conditions of non-compliance.

Page 8 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST

Appendix
Appendix A—-Part D Formulary and Benefit Administration Record Layouts
The universes for the Formulary and Benefit Administration program area must be submitted as a
Microsoft Excel (.xlsx) file with a header row reflecting the field names (or Text (.txt) file without a
header row). Do not include the Column ID variable which is shown in the record layout as a
reference for a field’s column location in an Excel file. Do not include additional information outside
of what is dictated in the record layout. Submissions that do not strictly adhere to the record layout
will be rejected.
NOTE: There is a maximum of 4000 characters per record row. Therefore, should additional
characters be needed for a variable (e.g., for the pharmacy messaging), enter this information on the
next record at the appropriate start position.
Table 1: Rejected Claims Formulary Administration (RCFA) Record Layout
• Include all rejected claims with dates of service that fall within the applicable review
period timeframe (including members enrolled in employer plans and MedicareMedicaid Plans (MMPs)).
Column
ID
A

Field Name

Field Type

Field
Length
11

Description

Medicare Beneficiary
Identifier (MBI)

CHAR Always
Required

B

Beneficiary First Name

50

First name of the beneficiary.

50

Last name of the beneficiary.

10

Enrollment Effective
Date

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

C

Beneficiary Last Name

D

Date of Birth

F

Effective Disenrollment
Date

CHAR Always
Required

10

G

Cardholder ID

20

H

Contract ID

I

Plan ID

CHAR Always
Required
CHAR Always
Required
CHAR Always
Required

Date of birth of the beneficiary. Submit in
CCYY/MM/DD format (e.g., 1940/01/01).
Effective date of enrollment for the beneficiary
(PBP level). Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Effective date of disenrollment for the beneficiary
(PBP level). Submit in CCYY/MM/DD format
(e.g., 2020/02/01). Answer NA if the beneficiary
was not disenrolled.
Cardholder identifier used to identify the
beneficiary. This is assigned by the plan.
The contract number (e.g., H1234) of the
organization.
The plan number (e.g., 001) of the organization.

E

Page 9 of 20

10

5
3

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.

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST
Column
ID
J

Field Name

Field Type

NDC

CHAR Always
Required

Field
Length
11

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

K

Date of Service

CHAR Always
Required

10

L

Date of Rejection

10

M

Claim Quantity

CHAR Always
Required
CHAR Always
Required

N

Claim Days Supply

NUM Always
Required

3

O

Patient Residence

CHAR Always
Required

5

P

Pharmacy Service Type

CHAR Always
Required

5

Q

Compound Code

CHAR Always
Required

1

R

Reject Reason Code*

CHAR Always
Required

7

11

This field contains the date a fill for a rejected claim
was attempted. Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Date of rejection for the drug claim. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
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.
Days supply of the drug entered on the claim (e.g.,
30 [days]). Units of measurement should not to be
reported.
Patient residence code for the beneficiary as
submitted by the pharmacy on the claim. Answer
“UNK” if this field is left blank by the pharmacy.
Pharmacy service type as submitted by the
pharmacy on the claim. Answer “UNK” if this field
is left blank by the pharmacy.
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
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 should be included. Answer “NA” in
the Reject Reason Code field for pharmacy
messages included in column S that are not paired
with a reject reason code.
*If necessary repeat this field as many times as
needed to capture each individual reject reason
code, followed by the corresponding pharmacy
messaging related to the rejected claim.

Page 10 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST
Column
ID
S

Field Name

Field Type

Pharmacy Message*

CHAR Always
Required

Field
Length
1000

Description
Pharmacy message associated with the rejected
claim. All pharmacy messages associated with a
claim should be included.
*If applicable, this field will be paired with a
rejection reason code and should be repeated for
each rejection reason code submitted. For example,
if there are 3 reject reason codes the record would
include 3 pairs of reject codes and pharmacy
messages (reject code 1 pharmacy message 1
reject code 2 pharmacy message 2 reject code
3 pharmacy message 3 reject code).
Pharmacy messages not paired with a reject code
should be preceded with an “NA” in the Reject
Reason code field.
**If there are multiple messages attached to a single
reject code, sponsors should include all applicable
messaging in the same message field.
***In the event that specific pharmacy messages
are not linked with a corresponding reject code,
include all pharmacy messages in this field and
repeat for each reject reason code submitted.

Page 11 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST
Table 2: Rejected Claims Transition – New Contract Year (RCT-N) Record Layout
• Include all rejected claims with dates of service that fall within the applicable review period
timeframe (including members enrolled in employer plans and Medicare-Medicaid Plans
(MMPs)).
Column
ID
A

Field Name

Field Type

Field
Length
11

Description

Medicare Beneficiary
Identifier (MBI)

CHAR Always
Required

B

Beneficiary First Name

CHAR Always
Required

50

First name of the beneficiary.

C

Beneficiary Last Name

50

Last name of the beneficiary.

10

Enrollment Effective
Date

CHAR Always
Required
CHAR Always
Required
CHAR Always
Required

D

Date of Birth

F

Effective Disenrollment
Date

CHAR Always
Required

10

G

Cardholder ID

20

H

Contract ID

I

Plan ID

J

NDC

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

Date of birth of the beneficiary. Submit in
CCYY/MM/DD format (e.g., 1940/01/01).
Effective date of enrollment for the beneficiary
(PBP level). Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Effective date of disenrollment for the beneficiary
(PBP level). Submit in CCYY/MM/DD format
(e.g., 2020/02/01). Answer NA if the beneficiary
was not disenrolled.
Cardholder identifier used to identify the
beneficiary. This is assigned by the plan.
The contract number (e.g., H1234) of the
organization.
The plan number (e.g., 001) of the organization.

E

10

5
3
11

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

Page 12 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST
Column
ID
K

Field Name

Field Type

Date of Service

CHAR Always
Required

L

Date of Rejection

10

M

Claim Quantity

CHAR Always
Required
CHAR Always
Required

N

Claim Days Supply

NUM Always
Required

3

O

Patient Residence

CHAR Always
Required

5

P

Pharmacy Service Type

CHAR Always
Required

5

Q

Compound Code

CHAR Always
Required

1

R

Reject Reason Code*

CHAR Always
Required

7

Field
Length
10

11

Description
This field contains the date a fill for a rejected claim
was attempted. Submit in CCYY/MM/DD format
(e.g., 2020/01/01).
Date of rejection for the drug claim. Submit in
CCYY/MM/DD format (e.g., 2020/01/01).
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.
Days supply of the drug entered on the claim (e.g.,
30 [days]). Units of measurement should not to be
reported.
Patient residence code for the beneficiary as
submitted by the pharmacy on the claim. Answer
“UNK” if this field is left blank by the pharmacy.
Pharmacy service type as submitted by the
pharmacy on the claim. Answer “UNK” if this field
is left blank by the pharmacy.
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
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 should be included. Answer “NA” in
the Reject Reason Code field for pharmacy
messages included in column S not paired with a
reject reason code.
*If necessary repeat this field as many times as
needed to capture each individual reject reason
code, followed by the corresponding pharmacy
messaging related to the rejected claim.

Page 13 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST
Column
ID
S

Field Name

Field Type

Pharmacy Message*

CHAR Always
Required

Field
Length
1000

Description
Pharmacy message associated with the rejected
claim. All pharmacy messages associated with a
claim should be included.
*If applicable, this field will be paired with a
rejection reason code and should be repeated for
each rejection reason code submitted. For example,
if there are 3 reject reason codes the record would
include 3 pairs of reject codes and pharmacy
messages (reject code 1 pharmacy message 1
reject code 2 pharmacy message 2 reject code
3 pharmacy message 3 reject code). Pharmacy
messages not paired with a reject code should be
preceded with an “NA” in the Reject Reason code
field.
** If there are multiple messages attached to a
single reject code, sponsors should include all
applicable messaging in the same message field.
***In the event that specific pharmacy messaging is
not linked with a corresponding reject code, include
all pharmacy messages in this field and repeat for
each reject reason code submitted.

Page 14 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST
Table 3: Rejected Claims Transition – Previous Contract Year (RCT-P) Record Layout
• Include all rejected claims with dates of service for November and December of the contract year
immediately prior to the audit year, for beneficiaries with effective enrollment dates of
November or December of that contract year (including members enrolled in employer plans and
Medicare- Medicaid Plans (MMPs)).
• Exclude rejected claims for beneficiaries with effective enrollment dates other than November
or December of the contract year immediately prior to the audit year.
Column
ID
A

Field Name

Field Type

Field
Length
11

Description

Medicare Beneficiary
Identifier (MBI)

CHAR Always
Required

B

Beneficiary First Name

CHAR Always
Required

50

First name of the beneficiary.

C

Beneficiary Last Name

50

Last name of the beneficiary.

10

Enrollment Effective
Date

CHAR Always
Required
CHAR Always
Required
CHAR Always
Required

D

Date of Birth

F

Effective Disenrollment
Date

CHAR Always
Required

10

G

Cardholder ID

20

H

Contract ID

I

Plan ID

J

NDC

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

Date of birth of the beneficiary. Submit in
CCYY/MM/DD format (e.g., 1940/01/01).
Effective date of enrollment for the beneficiary
(PBP level). Submit in CCYY/MM/DD format
(e.g., 2019/11/01).
Effective date of disenrollment for the beneficiary
(PBP level). Submit in CCYY/MM/DD format
(e.g., 2019/12/31). Answer NA if the beneficiary
was not disenrolled.
Cardholder identifier used to identify the
beneficiary. This is assigned by the plan.
The contract number (e.g., H1234) of the
organization.
The plan number (e.g., 001) of the organization.

E

10

5
3
11

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

Page 15 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST
Column
ID
K

Field Name

Field Type

Date of Service

CHAR Always
Required

L

Date of Rejection

10

M

Claim Quantity

CHAR Always
Required
CHAR Always
Required

N

Claim Days Supply

NUM Always
Required

3

O

Patient Residence

CHAR Always
Required

5

P

Pharmacy Service Type

CHAR Always
Required

5

Q

Compound Code

CHAR Always
Required

1

R

Reject Reason Code*

CHAR Always
Required

7

Field
Length
10

11

Description
This field contains the date a fill for a rejected claim
was attempted. Submit in CCYY/MM/DD format
(e.g., 2019/11/05).
Date of rejection for the drug claim. Submit in
CCYY/MM/DD format (e.g., 2019/11/05).
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.
Days supply of the drug entered on the claim (e.g.,
30 [days]). Units of measurement should not to be
reported.
Patient residence code for the beneficiary as
submitted by the pharmacy on the claim. Answer
“UNK” if this field is left blank by the pharmacy.
Pharmacy service type as submitted by the
pharmacy on the claim. Answer “UNK” if this field
is left blank by the pharmacy.
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
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 should be included. Answer “NA” in
the Reject Reason Code field for pharmacy
messages included in column S that are not paired
with a reject reason code.
*If necessary repeat this field as many times as
needed to capture each individual reject reason
code, followed by the corresponding pharmacy
messaging related to the rejected claim.

Page 16 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST
Column
ID
S

Field Name

Field Type

Pharmacy Message*

CHAR Always
Required

Field
Length
1000

Description
Pharmacy message associated with the rejected
claim. All pharmacy messages associated with a
claim should be included.
*If applicable, this field will be paired with a
rejection reason code and should be repeated for
each rejection reason code submitted. For
example, if there are 3 reject reason codes the
record would include 3 pairs of reject codes and
pharmacy messages (reject code 1 pharmacy
message 1 reject code 2 pharmacy message
2 reject code 3 pharmacy message 3 reject
code). Pharmacy messages not paired with a
reject code should be preceded with an “NA” in
the Reject Reason code field.
** If there are multiple messages attached to a
single reject code, sponsors should include all
applicable messaging in the same message
field.
***In the event that specific pharmacy messaging
is not linked with a corresponding reject code,
include all pharmacy messages in this field and
repeat for each reject reason code submitted.

Page 17 of 20

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST
Table 4: Prescription Drug Event (PDE) Data Record Layout
• Include all final action PDEs accepted by CMS with dates of service in September – December of
the contract year immediately prior to the audit year.
o Include PDEs only for beneficiaries submitted in either of the Rejected Claims Transition
Universes (RCT-N and RCT-P) (including members enrolled in employer plans and
Medicare-Medicaid Plans (MMPs)).
Column
ID
A

Field Name

Field Type

Field
Length
11

Description

Medicare Beneficiary
Identifier (MBI)

CHAR Always
Required

B

Beneficiary First
Name
Beneficiary Last
Name

CHAR Always
Required
CHAR Always
Required

50

First name of the beneficiary.

50

Last name of the beneficiary.

D

Date of Birth

CHAR Always
Required

10

Date of birth of the beneficiary. Submit in
CCYY/MM/DD format (e.g., 1940/01/01).

E

Cardholder ID

CHAR Always
Required

20

Cardholder identifier used to identify the
beneficiary. This is assigned by the plan.

F

Contract ID

CHAR Always
Required

5

The contract number (e.g., H1234) of the
organization.

G

Plan ID

CHAR Always
Required

3

The plan number (e.g., 001) of the organization.

H

NDC

CHAR Always
Required

11

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

C

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.

When less than 11 characters or a blank field is
submitted by the pharmacy or delegate, populate the
field as submitted.
If the pharmacy submits a value greater than 11
characters, enter “valueXeeded” in the field.
For multi-ingredient compound claims populate the
field with the NDC of the most expensive drug (or as
submitted on the associated PDE). When compound
claims do not include any Part D drug products,
populate the field with “00000000000” consistent
with the NDC 11 format.
I

Page 18 of 20

Date of Service

CHAR Always
Required

10

This field contains the date on which the
prescription was filled. Submit in CCYY/MM/DD
format (e.g., 2019/01/01)

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST
Column
ID
J

Field Name

Field Type

Claim Quantity

CHAR Always
Required

K

Claim Days Supply

NUM Always
Required

3

L

Compound Code

CHAR Always
Required

1

Page 19 of 20

Field
Length
11

Description
Number of drug dosage units entered in the claim
(e.g., 30 [tablets], 0.42 [milliliters of liquid]),
including decimal values, when applicable. Units of
measurement should not to be reported.
Days supply of the drug entered in the claim (e.g.,
30 [days]). Units of measurement should not to be
reported.
0 = Not specified
1 = Not a compound
2 = Compound

v. 12-2019

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST
Table 5: New Member (NM) Record Layout
• Include eligible members (including members enrolled in employer plans and Medicare-Medicaid Plans
(MMPs)) for which the Sponsoring organization does not utilize prior claims history. In some cases, the
Sponsoring organization may have the full claims history for the member from the most recent PBP, and
thus, the Sponsoring organization may be able to determine new versus ongoing therapy. In this example,
the member should not be included in the New Member Universe since they are determined to be a
continuing member.
o For sponsors with ≥ 100,000 enrollees include:
 All beneficiaries with an effective enrollment date of November or December of
the contract year immediately prior to the audit year regardless of whether they
continued in the same plan in the audit year.
 All beneficiaries with an effective enrollment date of January of the audit year.
o For sponsors with < 100,000 enrollees:
 All beneficiaries with an effective enrollment date of November or December of
the contract year immediately prior to the audit year regardless of whether they
continued in the same plan in the audit year.
 All beneficiaries with an effective enrollment date of January or February of the
audit year.
Column
ID
A

Field Name

Field Type

Field
Length
11

Description

Medicare Beneficiary
Identifier (MBI)

CHAR Always
Required

B

Beneficiary First Name

CHAR Always
Required

50

First name of the beneficiary.

C

Beneficiary Last Name

50

Last name of the beneficiary.

10

Enrollment Effective
Date

CHAR Always
Required
CHAR Always
Required
CHAR Always
Required

D

Date of Birth

F

Effective Disenrollment
Date

CHAR Always
Required

10

G

Cardholder ID

20

H

Contract ID

I

Plan ID

CHAR Always
Required
CHAR Always
Required
CHAR Always
Required

Date of birth of the beneficiary. Submit in
CCYY/MM/DD format (e.g., 1940/01/01).
Effective date of enrollment for the beneficiary.
Submit in CCYY/MM/DD format (e.g.,
2020/01/01).
Effective date of disenrollment for the beneficiary
(PBP level). Submit in CCYY/MM/DD format
(e.g., 2020/02/01). Answer NA if the beneficiary
was not disenrolled.
Cardholder identifier used to identify the
beneficiary. This is assigned by the plan.
The contract number (e.g., H1234, S1234) of the
organization.
The plan number (e.g., 001, 002) of the
organization.

E

Page 20 of 20

10

5
3

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.

v. 12-2019