Medicare Parts C and D Universal Audit Guide

Sample Request Letter
MINIMUM DOCUMENTATION REQUIRED FOR SAMPLE CASE FILES

The minimum documentation requirements for each sample case listed in Enclosure II are shown
below. Each file should contain a checklist confirming that each piece of required
documentation is contained in the file. The documentation should be presented in a logical order
(for example, chronological in ascending order) and easy to find. If a piece of required
documentation is missing, an explanation should be provided on the checklist. If any required
piece of documentation is not present in the file, absent an explanation, it will be presumed
nonexistent and an error will be noted.
If screen print outs are provided as documentation, a key to interpreting the screen print outs
must also be provided.
Any additional documentation/explanations not specifically requested below that would assist
the auditor should also be provided.
Please identify each case file by Sample # (e.g., (Worksheet)-PLATFORM NAME: Sample
# 1, (Worksheet)-(Platform Name Abbreviation): Sample # 2), not by member name or
HIC #. The Sample # for each case file is shown on the list of sample cases selected for each
worksheet. Identify Platform Names as follows: (Platform Names / Platform Name
Abbreviation).
Part I – Part C Samples
ENROLLMENT AND DISENROLLMENT
Enrollment
(Worksheet) - Applications and Enrollment
1) Completed election form or, if applicable, a reproduction of an employer’s record of the
election received via an alternative format (see Medicare Managed Care Manual, Chapter 2,
Section 40.1.1 for more guidance)
2) Documentation of all efforts to obtain additional documentation if election form was
incomplete
3) Documentation of authorized representative, if applicable
4) Acknowledgement notice
5) Notice to confirm enrollment
6) Screen print showing enrollment date shown in MAO’s internal system and key to
interpreting the screen print
7) Documentation showing Medicare Entitlement and Medicaid Entitlement for SNP Members
8) Any other correspondence/information pertinent to the enrollment

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(Worksheet) - MAO Denials
1) Completed election form or, if applicable, a reproduction of an employer’s record of the
election received via an alternative format (see Medicare Managed Care Manual, Chapter 2,
Section 40.1.1 for more guidance)
2) Documentation of all efforts to obtain additional documentation if election form was
incomplete
3) Documentation that the MAO took appropriate action to correct problem or deny enrollment
4) Notice for MAO denial of enrollment
5) Any other correspondence/information pertinent to the enrollment
(Worksheet) - Appropriate and Timely Action
1) Completed election form or, if applicable, a reproduction of an employer’s record of the
election received via an alternative format (see Medicare Managed Care Manual, Chapter 2,
Section 40.1.1 for more guidance)
2) Transaction reply listing(s)
3) Notice sent in response to the transaction (e.g., notice to confirm enrollment)
4) Documentation reflecting that the MAO updated its internal system
5) Documentation reflecting that the MAO took appropriate action to correct problem or deny
enrollment, e.g., documentation reflecting that the MAO resubmitted the transaction to
MARx or CMS RO or CMS Contractor, if applicable
6) Transaction reply listing showing enrollment accepted, if applicable
7) Any other correspondence/information pertinent to the enrollment
(Worksheet) – Enrollment of Institutional Individuals in a SNP
1) Transaction reply listing showing the effective enrollment date
2) Completed election form or, if applicable, a reproduction of an employer’s record of the
election received via an alternative format (see Medicare Managed Care Manual, Chapter 2,
Section 40.1.1 for more guidance)
3) If not designated as an ESRD SNP, an approved waiver form allowing the SNP to serve
members with ESRD
4) State-approved assessment tool or documentation showing that the State does not require use
of a State-approved assessment tool
(Worksheet) – Enrollment of Chronic Care Individuals in a SNP
1) Transaction reply report showing the effective enrollment date (print screen from
organization’s internal system is not sufficient)
2) Completed election form or, if applicable, a reproduction of the election received via an
alternative format (see Medicare Managed Care Manual, Chapter 2, Section 40.1.1 for more
guidance)
3) Documentation showing Medicare Entitlement
4) Documentation of the organization’s confirmation of the chronic condition
5) Documentation showing MAO enrolled the beneficiary at an appropriate time and the
effective date of the enrollment in the SNP
(Worksheet) – Enrollment of Dual Eligible Individuals in a SNP
1) Transaction reply report showing the effective enrollment date (print screen from
organization’s internal system is not sufficient)
Page 2 of 14

2) Completed election form or, if applicable, a reproduction of the enrollment request received
via an alternative format (see Medicare Managed Care Manual, Chapter 2, Section 40.1.1 for
more guidance)
3) Documentation showing Medicare Entitlement
4) Documentation showing Medicaid Entitlement
(Worksheet) -- Group Enrollment Requirements
1) Completed election form or, if applicable, a reproduction of an employer’s record of the
election received via an alternative format (see Medicare Managed Care Manual, Chapter 2,
Section 40.1.1 for more guidance)
2) Transaction reply listing(s)
3) Documentation reflecting the date that the Group Enrollment notification and materials were
sent to the member (e.g., MAO system screen prints showing template Ids and corresponding
material, or copy of cover letter which describes material sent with it)
4) Copy of all material sent to enrollees in employer/union sponsored plans that were enrolled
using the group enrollment mechanism
5) Documentation reflecting that the employer/union sponsor provided all the information
required for the MAO to submit a complete enrollment transaction to CMS.
Disenrollment
(Worksheet) - Voluntary Disenrollment through the MAO
1) Disenrollment request by member or, if applicable, a reproduction of an employer’s record of
the election received via an alternative format (see Medicare Managed Care Manual, Chapter
2, Section 50.1.5 for more guidance)
2) Documentation of authorized representative, if applicable
3) Documentation establishing an SEP, if applicable
4) Disenrollment acknowledgement notice
5) Documentation that any excess premium was refunded, including date of refund (e.g., copy
of cancelled check, screen print from system showing day check was mailed, or other screen
print documenting premium refund and key to interpreting the screen print), or if there was
no refund documentation that none was necessary (e.g., screen print showing payments
received or member in zero premium product and key to interpreting the screen print)
6) Screen print showing the disenrollment date shown in MAO’s internal system and key to
interpreting screen print
7) Any other correspondence/information pertinent to the disenrollment of member
(Worksheet) - Voluntary Disenrollment through sources other than the MAO
1) Copy of transaction reply listing showing the disenrollment
2) Notice to confirm disenrollment
3) Documentation that any excess premium was refunded, including date of refund (e.g., copy
of cancelled check, screen print from system showing day check was mailed, or other screen
print documenting premium refund), or if there was no refund documentation that none was
necessary (e.g., screen print showing payments received or member in zero premium
product). For all of these screen prints, a key to interpreting them should be provided.
4) Documentation showing the disenrollment reason code that was submitted by the MAO
5) Any other correspondence/information pertinent to the disenrollment of member
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(Worksheet) - Involuntary Disenrollment (Move Out of Service Area)
1) Documentation substantiating the date the MAO was notified of the move (or possible move
if from a source of than the member or member’s authorized representative)
2) Address verification form, or equivalent documentation, sent to member, if applicable
3) All correspondence related to the move (or possible move)
4) Disenrollment letter
5) Screen print showing the disenrollment date shown in the MAO’s internal systems and key to
interpreting the screen print
6) Copy of transaction reply listing showing disenrollment accepted
7) Documentation that any excess premium was refunded, including date of refund (e.g., copy
of cancelled check, screen print from system showing day check was mailed or other screen
prints documenting premium refund), or if there was no refund documentation that none was
necessary (e.g., screen print showing payments received or member in zero premium
product) and key to interpreting the screen prints
8) Any other correspondence/information pertinent to the disenrollment of member
(Worksheet) - Involuntary Disenrollment due to Change in Special Needs Status
1) Documentation showing the date on which the member no longer met the MAO-specific
SNP eligibility criteria.
2) Copy of transaction reply listing showing the disenrollment
3) Documentation showing the period that the MAO established to continue deemed eligibility
for an individual reasonably expected to regain eligibility within 6 months.
4) Screen print showing enrollment date shown in MAO’s internal system and key to
interpreting the screen print
5) Documentation showing that the member was grandfathered into the SNP, if applicable

PROVIDER RELATIONS
(Worksheet) – Provider Credentialing
Complete credentialing files including:
1) Completed Application
2) Documentation of verification of license
3) Documentation of verification of board certification, if applicable
4) Documentation of how the board verifies information for education and training, if
applicable
5) Documentation of verification of education
6) Documentation of verification of clinical privileges, if applicable
7) Documentation of verification of malpractice insurance
8) Documentation of DEA or CDS certificate, if applicable
9) Documentation that MAO checked the National Practitioner Data Bank
10) Documentation that quality of care information was considered in recredentialing process
11) Documentation that MAO reviews the most recently issued Sanction Report
12) Documentation that MAO reviews the most recently issued Medicare opt out list
13) Committee decision date and other material used as part of the credentialing process
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CLAIMS, ORGANIZATION DETERMINATIONS, APPEALS, AND GRIEVANCES
Organization Determinations
Please have an ICD-9-CM and CPT code book, or equivalent, available for the auditor’s use.
(Worksheet) – Non-Contracted Provider Paid Claims
The file should contain all information needed to provide a complete auditable history of the
claim for all line items, including all pertinent computer screen printouts.
1) Original claim (or a copy), including documentation of date received and service provided
2) Documentation of any requests for additional information (e.g., phone calls/letters to
provider or member)
3) Documentation of date paid (e.g., screen prints showing day check was mailed or other
screen prints that document the date paid, copy of cancelled check);
4) Provider remittance advice
5) Documentation of calculation and payment of interest (based on check date) if clean claim
was not paid within 30 days
6) Any other correspondence sent to member regarding this claim
7) A key for interpreting the claims processing/payment screens and any other system screens
included in the file
(Worksheet) – Denied Claims
The file should contain all information needed to provide a complete auditable history of the
claim for all line items, including all pertinent computer screen printouts.
1) Original claim (or a copy), including documentation of date received and service provided
2) Documentation of any requests for additional information (e.g., phone calls/ letters to
provider or member)
3) Member denial notice
4) Denial notice sent to provider
5) Explanation of reason for denial, and documentation supporting the determination, such as
clinical information (if necessary to show compliance), or assumptions made by system edits
6) If claim was denied because it did not meet the definition of emergency or urgent care,
provide claims history identifying all claims associated with the episode of care, including
whether they were paid or denied
7) Medical review notes related to the disposition of the claim
8) A key for interpreting the claims processing/payment screens and any other system screens
included in the file
(Worksheet) – Standard Pre-Service Denials
1) Documentation of date service requested, or discontinuation disputed
2) Service requested
3) Provider the member requested to see, if applicable
4) Source of the request
5) Notice of extension and documentation supporting the extension, if applicable
6) Documentation supporting the determination made by the MAO
7) Member denial notice or notice of discharge/discontinuation
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(Worksheet) – Requests for Expedited Pre-Service Organization Determinations
1) Documentation of date and time request received
2) Service requested
3) Provider the member requested to see, if applicable
4) Source of the request
5) Documentation of date, time and content of any verbal notices to the enrollee related to the
request, including, if applicable:
Notice of decision not to expedite
Notice of extension
Notice of approval or denial
6) Written notices to the enrollee related to the request, including:
Notice of decision not to expedite, if applicable
Notice of extension, if applicable
Notice of approval or denial
7) Documentation supporting decision not to expedite, if applicable, and documentation that the
case was transferred to the standard process
8) Documentation supporting extension, if applicable
9) Documentation supporting the determination made by the MAO
Reconsiderations
(Worksheet) – Favorable Claims Reconsiderations
1) Initial claim
2) Organization determination (initial denial notice)
3) Reconsideration request (appeal)
4) Documentation of date paid (e.g., day check was mailed – cancelled check, copy of check)
5) Provider remittance advice
6) Approval notice to member
(Worksheet) – Unfavorable Claims Reconsiderations
1)
2)
3)
4)
5)
6)
7)
8)

Initial claim
Organization determination (initial denial notice)
Reconsideration request (appeal)
Documentation supporting the decision by the MAO
Notice to member of decision to forward to Independent Review Entity (IRE)
Documentation of date case forwarded to IRE
Copy of the decision by the IRE, ALJ, or DAB
Documentation of date paid (e.g., screen prints showing day check was mailed or other
screen prints that document the date paid, copy of cancelled check), if overturned and key
interpreting the screen print
9) Provider remittance advice, if overturned
10) Notice to IRE that claim was paid, if overturned
(Worksheet) – Favorable Standard Pre-Service Reconsiderations
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1)
2)
3)
4)
5)

Organization determination (initial denial notice)
Reconsideration request (appeal)
Extension notice and documentation supporting the extension, if applicable
Notice to member of approval
Documentation of date service authorized or provided

(Worksheet) – Unfavorable Standard Pre-Service Reconsiderations
1)
2)
3)
4)
5)
6)
7)
8)
9)

Organization determination (initial denial notice)
Reconsideration request (appeal)
Documentation supporting the decision made by the MAO
Extension notice and documentation supporting the extension, if applicable
Notice to member of decision to forward to IRE
Documentation of date case forwarded to IRE
Copy of the decision by the IRE, ALJ, or DAB
Documentation of date service authorized or provided, if overturned
Notice to IRE that the overturn decision was effectuated, if overturned

(Worksheet) – Requests for Expedited Reconsiderations
1) Organization determination (initial denial notice)
2) Reconsideration request (appeal)
3) Documentation supporting the decision made by the MAO
4) Documentation of date and time request received, and nature of the request
5) Source of the request
6) Documentation of date service authorized or provided, if MAO overturns its denial
7) Documentation of date, time and content of any verbal notices to the enrollee related to the
request, including, if applicable:
Notice of decision not to expedite
Notice of extension
Notice of approval
Notice to member of decision to forward to IRE
8) Any written notices to the enrollee related to the request, including, if applicable:
Notice of decision not to expedite
Notice of extension
Notice of approval
Notice to member of decision to forward to IRE
9) Documentation supporting decision not to expedite, if applicable
10) Documentation case was transferred to standard review process, if applicable
11) Documentation supporting extension, if applicable
If sent to IRE:
12) Documentation of date case forwarded to IRE
13) Copy of decision made by IRE, ALJ, or DAB
14) Documentation of date and time service authorized or provided, if overturned
15) Notice to IRE that the overturn decision was effectuated, if overturned
Grievances
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(Worksheet) – Grievances
1) Documentation of member grievance, including date received
2) Documentation that the grievance was correctly categorized
3) Documentation of the date the grievance was resolved
4) Any correspondence to the member related to the grievance
5) Documentation of the notification to the member of the resolution of the grievance
6) Any response from the facility or provider against whom the grievance was made
7) Grievances related to quality of care should include documentation that the issue was sent to
the quality management department for evaluation, and any response from the quality
management department

Part II – Part D Samples
MINIMUM DOCUMENTATION REQUIREMENTS FOR SAMPLE CASES
Enrollment and Disenrollment
Worksheet
Name

(Worksheet)

(Worksheet)

(Worksheet)

(Worksheet)

(Worksheet)

Minimum Documentation Required from Part D Sponsor for each Sample Case
Sample size: 30
1. Completed enrollment form or record of the election received via an alternative format
2. Documentation establishing whether the Sponsor provided notices required for this enrollment
in response to transaction replies received on either the weekly "mini" TRR or the monthly TRR.
Note: This documentation is necessary only if the Sponsor’s policy on this changes depending
on the time of year.
3. Documentation establishing the date the Part D sponsor was notified of CMS' acceptance or
rejection of the enrollment (i.e., copy of the monthly or weekly TRR file showing the date it was
available from CMS)
4. Copy of the acknowledgement notice sent to beneficiary (if applicable)
5. Copy of the notice of CMS rejection of enrollment or notice to confirm enrollment sent to
beneficiary
6. Screen print showing enrollment date shown in Part D sponsor’s internal system and key to
interpreting the screen print
7. Documentation showing the date that the sponsor provided an Evidence of Coverage to new
plan members
8. Any other correspondence/information pertinent to the enrollment
Sample size: 10
1. Request to cancel enrollment election or record of the request received via an alternative format
2. Copy of Notice of Part D sponsor cancellation of enrollment sent to beneficiary
Sample size: 10
1. Documentation establishing the date CMS sent the enrollment transaction to the Part D sponsor
(via TRR) or the PDP notification file [PDP sponsors only]
2. Copy of notice to confirm enrollment sent to auto-enrolled member
3. Documentation of the Part D sponsor’s distribution of required plan materials to the autoenrolled member (e.g., mailing log showing materials sent and date of mailing)
Sample size: 10
1. Documentation establishing the date CMS sent the enrollment transaction to the Part D sponsor
(via TRR) or the PDP notification file [PDP sponsors only]
2. Copy of notice to confirm enrollment sent to facilitated-enrolled member
3. Documentation of the Part D sponsor’s distribution of required plan materials to the facilitatedenrolled member (e.g., mailing log showing materials sent and date of mailing)
Sample size: 10
1. Completed enrollment form or record of the election received via an alternative format
2. Statement of the reason the beneficiary was eligible for a SEP.

Page 8 of 14

Worksheet
Name

Minimum Documentation Required from Part D Sponsor for each Sample Case
3.

(Worksheet)

(Worksheet)

(Worksheet)

(Worksheet)

(Worksheet)

Documentation establishing that the beneficiary met the eligibility requirements for a SEP and, if
applicable, CMS’ approval of the SEP for that beneficiary.
Sample size: 10
1. Completed enrollment form or record of the election received via an alternative format
2. Copy of notice to confirm enrollment sent to beneficiary
3. Documentation establishing that the beneficiary confirmed his/her intention to enroll (if
applicable)
4. Documentation establishing that the Sponsor resubmitted the enrollment transaction to CMS
with appropriate flag (if applicable)
5. Copy of notice of Part D sponsor denial of disenrollment sent to beneficiary (if applicable)
6. Copy of the notice of Part D sponsor denial of enrollment sent to the beneficiary (of applicable)
and documentation establishing the date the notice was sent.
Sample size: 30
1. Documentation establishing date that each of the following required materials were sent:
Notice informing beneficiary of the planned enrollment in an employer/union sponsored
plan and the effective date of enrollment
Notice informing beneficiary that the beneficiary may affirmatively opt out of such
enrollment; how to accomplish that; and any consequences to employer/union benefits
opting out would bring
A summary of benefits offered under the employer/union sponsored PDP
An explanation of how to get more information about the PDP
An explanation on how to contact Medicare for information on other Part D options that
might be available to the beneficiaries
Information contained on page 3 of Exhibit 1 of PDP Enrollment Guidance
1. Copies of above documents sent to each enrollee (a sample of materials for each employer
group will be sufficient)
2. Documentation establishing that the employer/union provided all information required to submit
a complete enrollment transaction
Sample size: 15
1. Documentation establishing the date the weekly TRR file was available to Part D Sponsor
2. Documentation establishing that the Enrollment Transaction was properly submitted
3. Documentation establishing the date any required notices were sent
4. Copies of notices sent (if any) to enrollees
5. Documentation (e.g., screen prints) establishing that the Part D sponsor’s internal systems were
updated.
6. Documentation establishing the date the Part D sponsor resubmitted transaction to MARx, if
required.
Sample size: 15
1. Disenrollment request or record of the disenrollment request received via an alternative format
(i.e., copy of the TRR file showing the date it was available from CMS)
2. Copy of the disenrollment acknowledgement notice sent to beneficiary
3. Screen print showing the disenrollment effective date shown in Part D sponsor’s internal system
and key to interpreting screen print
4. Any other correspondence/information pertinent to the disenrollment
Sample size: 10
1. Screen print showing the disenrollment effective date shown in the Part D sponsor’s internal
systems and key to interpreting the screen print
2. Documentation substantiating the date the Part D sponsor was notified of the move (or possible
move if from a source other than the member or member’s authorized representative) (e.g.,
copy of address change notification received from individual/representative, date TRR available,
if notified via CMS)
3. Documentation demonstrating how the Part D sponsor learned of the move
4. Address verification form, or equivalent documentation, sent to beneficiary (if applicable)
5. Documentation substantiating the date the Part D sponsor received confirmation of the move
from the member or his legal representative (if applicable)
6. All correspondence related to the move (or possible move)
7. Copy of disenrollment notice sent to beneficiary
8. Documentation establishing the date the Part D sponsor sent the disenrollment transaction to
CMS
9. Copy of CMS transaction reply report showing disenrollment accepted

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Worksheet
Name

Minimum Documentation Required from Part D Sponsor for each Sample Case
10. Any other correspondence/information pertinent to the disenrollment

Marketing
Worksheet
Name

(Worksheet)

(Worksheet)

(Worksheet)

Minimum Documentation Required from Part D Sponsor for each Sample Case
Sample size: 10
1. Documentation of the date the formulary change became effective.
2. Copy of the Notice of Formulary or Cost-Sharing Change provided to the beneficiary
3. If applicable, evidence that the Sponsor authorized a 60-day supply of the Part D drug under the
same terms as previously allowed at the time a refill was requested
Sample size: 10
1. Mailing log showing which initial post-enrollment information the Sponsor mailed to the
beneficiary at the time of enrollment (for enrollees newly effective during the audit period) or as
required annually (for all other beneficiaries) and the date Sponsor mailed it.
2. For enrollees newly effective during the audit period, mailing log showing the date Sponsor
mailed the initial Evidence of Coverage to the beneficiary (if different from the date Sponsor
mailed other initial post-enrollment information to the beneficiary)
Sample size: 10
1. Documentation of the date the Sponsor learned of the change in eligibility for the Low Income
Subsidy
2. Documentation of the date the Sponsor mailed an LIS Rider to the beneficiary
Copy of LIS Rider to the Evidence of Coverage sent to beneficiary

Transition Process
Worksheet
Name

Minimum Documentation Required from Part D Sponsor for each Sample Case
1.

(Worksheet)

(Worksheet)

2.
3.
4.
5.
1.
2.
3.

Documentation establishing the date the beneficiary received a temporary supply of a nonformulary Part D drug
Documentation establishing that transition fill was provided for a Part D drug
Documentation establishing that transition fill was provided for either a non-formulary drug or a
formulary drug with drug utilization management requirements
Copy of the transition notice sent to the beneficiary
Documentation establishing date the transition notice was sent to the beneficiary
Documentation establishing that transition fill was provided for a Part D drug
Documentation establishing whether multiple refills were requested
Documentation establishing that multiple refills provided when requested

Coordination of Benefits
Worksheet
Name

Minimum Documentation Required from Part D Sponsor for each Sample Case
1.

(Worksheet)

(Worksheet)

2.
1.
2.
1.

(Worksheet)

(Worksheet)

2.

3.
1.
2.
3.

Documentation establishing the date the Part D sponsor received the completed survey from
enrollee
Documentation establishing the date the Part D sponsor reported the information to the CMSCOB contractor
Documentation establishing the date the Part D sponsor received the information from CMS
Documentation establishing the date the Part D sponsor updated the information in the
sponsor's systems
Documentation establishing that the other payer information for enrollee was communicated on
the primary claim to the Pharmacy
Documentation establishing that the Part D sponsor received N transaction from the TrOOP
facilitator containing information on payment made by supplemental payer and beneficiary cost
sharing
Documentation establishing that the information in N transaction was used to adjust TrOOP
Documentation establishing that FIR transaction was received from TrOOP Facilitator
Documentation establishing that the Part D sponsor calculated TrOOP accumulators for each
month the sponsor adjudicated claims for the beneficiary during the coverage year
Documentation establishing that the Part D sponsor correctly responded to FIR transactions

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Worksheet
Name

Minimum Documentation Required from Part D Sponsor for each Sample Case

1.
(Worksheet)

2.

reporting monthly TrOOP accumulators to the TrOOP Facilitator for transmission to the new plan
of record
Documentation establishing that the FIR (Update) transaction reporting monthly TrOOP
accumulator was received
Documentation establishing that the Part D sponsor used the TrOOP accumulator data to
correctly position the beneficiary in the benefit

Grievances, Coverage Determinations and Appeals
Worksheet
Name

(Worksheet)

(Worksheet)

(Worksheet)

(Worksheet)

Minimum Documentation Required from Part D Sponsor for each Sample Case
Sample size: 15
1. Copy of the appropriate Evidence of Coverage(s) (Note: This is not required to be in every file.)
2. Documentation of member grievance, including brief issue description, date grievance
received, format received in (oral or written), and any request for a written response
3. Evidence that the enrollee was informed whether the complaint was subject to grievance or
coverage determination procedures
4. If applicable, copy of the notice of inquiry about an excluded drug
5. Documentation establishing that plan notified enrollee of decision within 30 days (unless
extended), including documentation of the analysis and resolution of the issue
6. If applicable, documentation establishing the date the Part D sponsor determined that an
extension was necessary
7. If applicable, copy of the written notice of extension sent to the enrollee
8. If applicable, documentation that justifies the need for additional information and shows how the
delay is in the interest of the enrollee
9. Documentation of the Part D sponsor’s verbal or oral notification of the grievance resolution to
enrollee, including date. If notification occurred by telephone, a key for interpreting any screen
prints is required.
10. Grievances related to quality of care should include documentation that the issue was sent to
the quality management department for evaluation, and any response from the quality
management department
Sample size: 10
1. Documentation of enrollee’s expedited grievance, including date and time grievance received
and format received in (oral or written)
2. Documentation of verbal or oral notification to enrollee, including date and time. If notification
occurred by telephone, a key for interpreting any screen prints is required.
Sample size: 10
The file should contain all information needed to provide a complete auditable history of the claim
for all line items, including all pertinent computer screen printouts.
1. Documentation of drug benefit request, including documentation of date request received
2. Documentation of any requests for additional information (e.g., phone calls/ letters to provider
or member, additional documentation or medical records received)
3. Any other correspondence sent to member regarding benefit request, including date and time
of oral notification
4. If applicable, copy of the denial notice sent to enrollee
5. If applicable, copy of the denial notice sent to the prescribing physician
6. Explanation of reason for denial, and documentation supporting the determination, such as
clinical information, or assumptions made by system edits
7. Medical review notes related to the disposition of the claim
8. A key for interpreting the claims processing/payment screens and any other system screens
included in the file
9. Documentation of the cost-sharing tier in which the Part D sponsor placed the drug (if sample is
an approved exception request.
If sent to IRE:
1. Documentation of date and time case forwarded to IRE
2. Notification sent to enrollee, including date and time
Sample size: 10
The file should contain all information needed to provide a complete auditable history of the claim
for all line items, including all pertinent computer screen printouts.
1. Original claim (or a copy), including documentation of date and time received and drug

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Worksheet
Name

Minimum Documentation Required from Part D Sponsor for each Sample Case
dispensed
Documentation of any requests for additional information (e.g., phone calls/ letters to provider
or member, additional documentation or medical records received)
3. Any other correspondence sent to member regarding benefit request, including date and time
of oral notification
4. Documentation of date paid (e.g., day check was mailed – cancelled check, copy of check)
5. If applicable, copy of the denial notice sent to enrollee
6. Explanation of reason for denial, and documentation supporting the determination, such as
clinical information, or assumptions made by system edits
7. Medical review notes related to the disposition of the claim
8. A key for interpreting the claims processing/payment screens and any other system screens
included in the file
9. Documentation of the cost-sharing tier in which the Part D sponsor placed the drug (if sample is
an approved exception request)
If sent to IRE:
1. Documentation of date and time case forwarded to IRE
2. Notification sent to enrollee, including date and time
Sample size: 10
1. Documentation of drug benefit request, including documentation of date request received
2. Source of the request
3. Documentation of date, time and content of any verbal notices to the enrollee related to the
request, including, if applicable:
Notice of decision not to expedite
Notice of approval or denial
4. Written notices, including date, to the enrollee related to the request, including:
Notice of decision not to expedite, if applicable
Notice of approval or denial
5. Documentation supporting decision not to expedite, if applicable, and documentation that the
case was transferred to the standard process
6. Documentation supporting the determination made by the Part D sponsor
If sent to IRE:
1. Documentation of date and time case forwarded to IRE
2. Notification sent to enrollee, including date and time
2.

(Worksheet)

(Worksheet)

(Worksheet)

Sample size: 10
1. Part D sponsor’s determination (initial denial notice), including date and name of individual(s)
involved in making the determination
2. Redetermination request (appeal), including date received
3. Documentation of date paid (e.g., day check was mailed – cancelled check, copy of check), if
applicable
4. Written notices, including date, to the enrollee related to the request, including:
Notice of adverse redetermination
Notice regarding requesting reconsideration
5. If applicable, approval notice to member, including date
6. Documentation supporting the decision by the Part D sponsor, including the name of
individual(s) involved in making the redetermination
7. Documentation of date paid (e.g., screen prints showing day check was mailed or other screen
prints that document the date paid, copy of cancelled check), if overturned and key interpreting
the screen print
If sent to IRE:
1. Documentation of date and time case forwarded to IRE
2. Notification sent to enrollee, including date and time
3. Notice to IRE that decision was effectuated, if overturned
If IRE requested file:
1. Documentation of IRE requesting file, including date
2. Documentation of date file forwarded to the IRE
3. Notice to IRE that decision was effectuated, if overturned
Sample size: 10
1. Initial claim, including date and name of individual(s) involved in making the determination
2. Part D sponsor’s determination (initial denial notice), including date and name of person or

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Worksheet
Name

Minimum Documentation Required from Part D Sponsor for each Sample Case
person involved in making the determination
Written notices, including date, to the enrollee related to the request, including:
Notice of adverse redetermination
Notice regarding requesting reconsideration
4. Redetermination request (appeal), including date received
5. Documentation of date paid (e.g., day check was mailed – cancelled check, copy of check), if
applicable
6. If applicable, approval notice to member, including date
7. Documentation supporting the decision by the Part D sponsor, including the name of
individual(s) involved in making the redetermination
8. Notice to member of decision to forward to Independent Review Entity (IRE)
If sent to IRE:
1. Documentation of date and time case forwarded to IRE
2. Documentation of date and time service authorized or provided, if overturned
3. Notice to IRE that claim was paid, if overturned
If IRE requested file:
1. Documentation of IRE requesting file, including date
2. Documentation of date file forwarded to the IRE
3. Notice to IRE that claim was paid, if overturned
Sample size: 10
1. Part D sponsor’s determination (initial denial notice), including date and name of individual(s)
involved in making the determination
2. Redetermination request (appeal), including date and time
3. Documentation supporting the decision made by the Part D sponsor, including the name of
individual(s) involved in making the redetermination
4. Source of the request
5. Documentation of any requests for additional information (e.g., phone calls/ letters to provider
or member, additional documentation or medical records received)
6. Documentation of date and time service authorized or provided, if Part D sponsor overturns its
denial
7. Documentation of date, time and content of any verbal notices to the enrollee related to the
request, including, if applicable:
Notice of decision not to expedite
Notice of approval
Notice to member of decision to forward to IRE
8. Any written notices to the enrollee related to the request, including, if applicable:
Notice of decision not to expedite
Notice of adverse redetermination
Notice regarding requesting reconsideration
Notice of approval
Notice to member of decision to forward to IRE
9. Documentation supporting decision not to expedite, if applicable
10. Documentation case was transferred to standard review process, if applicable
If sent to IRE:
1. Documentation of date case forwarded to IRE
2. Documentation of date and time service authorized or provided, if overturned
3. Notice to IRE that decision was effectuated, if overturned
If IRE requested file:
1. Documentation of IRE requesting file, including date
2. Documentation of date file forwarded to the IRE
3. Notice to IRE that decision was effectuated, if overturned
3.

(Worksheet)

Employer Group Health Plan Premiums
Worksheet
Name
(Worksheet)

Minimum Documentation Required from Part D Sponsor for each Sample Case
1.
2.

Low-income premium subsidy (LIPS) that is provided to beneficiary by CMS
Total Premium charged for enrollee by Part D sponsor (or, for self insured employer, "illustrative

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Worksheet
Name

Minimum Documentation Required from Part D Sponsor for each Sample Case
3.
4.
5.

6.

premium" as defined in PDBM Chapter 12, Section 20.12.1)
Amount of premium that is paid by beneficiary
Documentation establishing that the LIPS amount was passed through to the beneficiary up to
the amount of the premium paid by the beneficiary
Documentation establishing that if the beneficiary’s share of premium is less than the LIPS then
the remaining amount was passed through to the employer up to the amount of employer
contribution, if any
Documentation establishing that if the LIPS amount is greater than the total premium charged by
Part D sponsor (or the illustrative premium for the self-insured employer) the difference was
returned to CMS

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