Cms-10191 Fa Audit Process And Data Request

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

Attachment_II_FA_AuditProcess_DataRequest

Medicare Parts C and D Program Audit Protocols and Data Requests

OMB: 0938-1000

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

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

Table of Contents
Audit Purpose and General Guidelines ......................................................................................................... 3
Universe Preparation & Submission ............................................................................................................. 6
Audit Elements.............................................................................................................................................. 7
I. Formulary Administration ..................................................................................................................... 7
II. Transition ............................................................................................................................................. 9
III. Website ............................................................................................................................................. 11
Appendix ..................................................................................................................................................... 12
Appendix A—-Part D Formulary and Benefit Administration Record Layouts .................................... 12
Table 1: Rejected Claims Formulary Administration (RCFA) Record Layout .................................. 12
Table 2: Rejected Claims Transition – New Contract Year (RCT-N) Record Layout ....................... 15
Table 3: Rejected Claims Transition – Previous Contract Year (RCT-P) Record Layout.................. 17
Table 4: Prescription Drug Event (PDE) Data Record Layout ........................................................... 20
Table 5: New Member (NM) Record Layout ..................................................................................... 21

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Audit Purpose and General Guidelines
1. Purpose: To evaluate performance in the three 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.

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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. For the website review portion of the audit,
sponsors will also submit a zip file of all sponsor specific coverage determination forms including
general and/or drug specific Prior Authorization (PA) and Exception Request forms.
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 on-going
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

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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.

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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) or
Comma Separated Values (.csv) 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.

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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 as follows: 15 claims for non-protected class drugs and 15
claims for protected class drugs. If 15 claims are not available for one group (e.g., protected class
drugs), auditors may supplement with claims from the other group (e.g., non-protected class drugs).
The sample will consist of 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.

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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.

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II. Transition
1. Select Sample Cases: CMS will select a targeted sample of 15 claims from the rejected transition
claims universes for continuing members as well as for new enrollees as follows: 7 claims each for
non-protected class drugs and 8 claims each for protected class drugs. If the target number of claims
are not available for one group (e.g., protected class drugs), auditors may supplement with claims
from the other group (e.g., non-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

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•
•

Beneficiary transition notice
Prescriber transition notice and/or prescriber notification

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 (15 for continuing members and 15 for
new enrollees). 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.

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III. Website
(Performed prior to the entrance conference, results communicated to sponsor during live portion
of the audit)
1. Select Sample Contracts and Cases: CMS will select one contract per sponsor formulary ID to
review. Contract selection will be made in the following order: PDP or if applicable, MMP contract,
if none then  MAPD contract, if none then  EGWP contract. CMS will select a targeted sample
of 15 formulary drugs from the approved formulary of each selected contract as follows:
•
•

5 drugs to evaluate PA criteria
10 drugs to evaluate formulary information

CMS will compare the CMS approved formulary file to the formulary information (e.g., tier
placement, UM edits, etc.), utilization management (UM) criteria, and coverage determination request
forms posted on the sponsor’s website. NOTE: EGWPs that have a website with a posted
formulary are not exempt from this review.
2. Review Sample Case and Request Form Documentation: Prior to the start of the audit, CMS will
review all sample case file documentation to determine if the Part D sponsor has inaccurate web
material based on the approved formulary and to determine whether sponsor specific Coverage
Determination forms including general and/or drug specific Prior Authorization (PA) and Exception
Request forms, have the potential to steer beneficiaries to mail order or specialty pharmacies.
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. PA Criteria
3.1.1. Are the web posted PA criteria consistent with the CMS approved criteria?
3.2. Formulary Information
3.2.1. Is the web posted formulary consistent with the CMS approved formulary?
3.3. Coverage Determination Request Forms (Prior Authorization (PA) and Exception)
3.3.1. Is the web posted drug specific PA request form devoid of any mechanism(s) to steer
beneficiaries to mail order or specialty pharmacies?
3.3.2. Is the web posted Coverage Determination request form devoid of any mechanism(s) to
steer beneficiaries to mail order or specialty pharmacies?
4. Sample Case and Request Form Results: CMS will test each of the 15 cases (5 for PA criteria and
10 for formulary information) and the request forms. 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.

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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) or Comma Separated Values (.csv) 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 or Comma Separated Values
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 Medicare-Medicaid Plans
(MMPs)).
Column
ID
A

Field Name

Field Type

Beneficiary HICN

CHAR Always
Required

B

Beneficiary First Name

50

C

Beneficiary Last Name

50

Last name of the beneficiary.

D

Date of Birth

10

E

Enrollment Effective
Date

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

Health Insurance Claim Number assigned by the
Social Security Administration to an individual for
the purpose of identifying him/her as a Medicare
beneficiary. The number is typically between seven
and 11 digits long excluding hyphens or dashes
(e.g., 123456789A) and should be submitted as it
appears in MARx.
First name of the beneficiary.

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., 2016/01/01).
Effective date of disenrollment for the beneficiary
(PBP level). Submit in CCYY/MM/DD format
(e.g., 2017/02/01). 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.

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Field
Length
15

10

5
3

Description

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Column
ID
J

Field Name

Field Type

NDC

CHAR Always
Required

Field
Length
11

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

Description
11-Digit National Drug Code
When no NDC is available enter the applicable
Uniform Product Code (UPC) or Health Related
Item Code (HRI). Do not include any spaces,
hyphens or other special characters. For multiingredient compound claims, include the drug
information that matches the NDC of the most
expensive Part D covered drug.
This field contains the date a fill for a rejected claim
was attempted. Submit in CCYY/MM/DD format
(e.g., 2017/01/01).
Date of rejection for the drug claim. Submit in
CCYY/MM/DD format (e.g., 2017/01/01).
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.

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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.

Formulary and Benefit Administration (FA)
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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
15

Beneficiary HICN

CHAR Always
Required

B

Beneficiary First Name

CHAR Always
Required

50

Health Insurance Claim Number assigned by the
Social Security Administration to an individual for
the purpose of identifying him/her as a Medicare
beneficiary. The number is typically between seven
and 11 digits long excluding hyphens or dashes
(e.g., 123456789A) and should be submitted as it
appears in MARx.
First name of the beneficiary.

C

Beneficiary Last Name

50

Last name of the beneficiary.

D

Date of Birth

10

E

Enrollment Effective
Date

CHAR Always
Required
CHAR Always
Required
CHAR Always
Required

F

Effective Disenrollment
Date

CHAR Always
Required

10

G

Cardholder ID

20

H

Contract ID

I

Plan ID

3

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., 2017/01/01).
Effective date of disenrollment for the beneficiary
(PBP level). Submit in CCYY/MM/DD format
(e.g., 2016/02/01). 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.

11

11-Digit National Drug Code

10

5

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

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11

Description

When no NDC is available enter the applicable
Uniform Product Code (UPC) or Health Related
Item Code (HRI). Do not include any spaces,
hyphens or other special characters. For multiingredient compound claims, include the drug
information that matches the NDC of the most
expensive Part D covered drug.
This field contains the date a fill for a rejected claim
was attempted. Submit in CCYY/MM/DD format
(e.g., 2017/01/01).
Date of rejection for the drug claim. Submit in
CCYY/MM/DD format (e.g., 2017/01/01).
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.

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Column
ID
O

Field Name

Field Type

Patient Residence

CHAR Always
Required

P

Pharmacy Service Type

CHAR Always
Required

5

Q

Compound Code

CHAR Always
Required

1

R

Reject Reason Code*

CHAR Always
Required

7

S

Pharmacy Message*

CHAR Always
Required

Field
Length
5

1000

Description
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.
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.

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 MedicareMedicaid 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
15

Beneficiary HICN

CHAR Always
Required

B

Beneficiary First Name

CHAR Always
Required

50

Health Insurance Claim Number assigned by the
Social Security Administration to an individual for
the purpose of identifying him/her as a Medicare
beneficiary. The number is typically between seven
and 11 digits long excluding hyphens or dashes
(e.g., 123456789A) and should be submitted as it
appears in MARx.
First name of the beneficiary.

C

Beneficiary Last Name

50

Last name of the beneficiary.

D

Date of Birth

10

E

Enrollment Effective
Date

CHAR Always
Required
CHAR Always
Required
CHAR Always
Required

F

Effective Disenrollment
Date

CHAR Always
Required

10

G

Cardholder ID

20

H

Contract ID

I

Plan ID

3

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., 2016/11/01).
Effective date of disenrollment for the beneficiary
(PBP level). Submit in CCYY/MM/DD format
(e.g., 2016/12/31). 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.

11

11-Digit National Drug Code

10

5

K

Date of Service

CHAR Always
Required

10

L

Date of Rejection

CHAR Always
Required

10

Description

When no NDC is available enter the applicable
Uniform Product Code (UPC) or Health Related
Item Code (HRI). Do not include any spaces,
hyphens or other special characters. For multiingredient compound claims, include the drug
information that matches the NDC of the most
expensive Part D covered.
This field contains the date a fill for a rejected claim
was attempted. Submit in CCYY/MM/DD format
(e.g., 2016/11/05).
Date of rejection for the drug claim. Submit in
CCYY/MM/DD format (e.g., 2016/11/05).

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

Field Name

Field Type

Field
Length
11

Claim Quantity

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

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 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 18 of 21

v. 10-2016

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 19 of 21

v. 10-2016

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

Beneficiary HICN

CHAR Always
Required

B

Beneficiary First
Name
Beneficiary Last
Name

CHAR Always
Required
CHAR Always
Required

50

Health Insurance Claim Number assigned by the
Social Security Administration to an individual for
the purpose of identifying him/her as a Medicare
beneficiary. The number is typically between seven
and 11 digits long excluding hyphens or dashes
(e.g., 123456789A) and should be submitted as it
appears in MARx.
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

11-Digit National Drug Code

C

Field
Length
15

I

Date of Service

CHAR Always
Required

10

J

Claim Quantity

CHAR Always
Required

11

K

Claim Days Supply

NUM Always
Required

3

L

Compound Code

CHAR Always
Required

1

Page 20 of 21

Description

When no NDC is available enter the applicable
Uniform Product Code (UPC) or Health Related
Item Code (HRI). Do not include any spaces,
hyphens or other special characters. For multiingredient compound claims, include the drug
information that matches the NDC of the most
expensive Part D covered.
This field contains the date on which the
prescription was filled. Submit in CCYY/MM/DD
format (e.g., 2016/10/11).
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. 10-2016

Formulary and Benefit Administration (FA)
AUDIT PROCESS AND DATA REQUEST
Table 5: New Member (NM) Record Layout
• Include all new members (including members enrolled in employer plans and Medicare-Medicaid
Plans (MMPs)).
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

Beneficiary HICN

CHAR Always
Required

B

Beneficiary First Name

CHAR Always
Required

50

Health Insurance Claim Number assigned by the
Social Security Administration to an individual for
the purpose of identifying him/her as a Medicare
beneficiary. The number is typically between seven
and 11 digits long excluding hyphens or dashes
(e.g., 123456789A) and should be submitted as it
appears in MARx.
First name of the beneficiary.

C

Beneficiary Last Name

50

Last name of the beneficiary.

D

Date of Birth

10

E

Enrollment Effective
Date

CHAR Always
Required
CHAR Always
Required
CHAR Always
Required

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.,
2017/01/01).
Effective date of disenrollment for the beneficiary
(PBP level). Submit in CCYY/MM/DD format
(e.g., 2017/02/01). 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.

Page 21 of 21

Field
Length
15

10

5
3

Description

v. 10-2016


File Typeapplication/pdf
File TitlePart D Formulary and Benefit Administration (FA) Program Area
SubjectFormulary Adminstration, Program Audits, 2017 Protocols
AuthorCMS
File Modified2016-12-06
File Created2016-10-24

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