Cms-10191 Mtm Pilot Audit Process And Data Request

Part D Medication Therapy
Management (MTM)
Program Area PILOT
AUDIT PROCESS AND DATA REQUEST

Expires: TBD

Medication Therapy Management (MTM) PILOT
AUDIT PROCESS AND DATA REQUEST

Table of Contents
Audit Purpose and General Guidelines .................................................................................................. 3
Universe Preparation & Submission ...................................................................................................... 5
Audit Elements ....................................................................................................................................... 6
I. Enrollment/Disenrollment .............................................................................................................. 6
II. Comprehensive and Targeted Medication Review (CTMR) ........................................................ 7
Appendix ................................................................................................................................................ 9
Appendix A – Medication Therapy Management (MTM) Record Layout ........................................ 9
Table 1. Medication Therapy Management Enrollee (MTME) Record Layout ............................. 9

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Audit Purpose and General Guidelines
1. Purpose: To evaluate the implementation of the sponsor’s CMS approved Medicare Part D
Medication Therapy Management (MTM) Program. 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 MTM program area audit is described below. CMS
reserves the right to expand the review period to ensure a sufficient universe size and/or to
capture appropriate information according to the sponsor’s CMS approved MTM program.
2.1. MTM Universe
•

All beneficiaries who were enrolled in the sponsor’s MTM program(s) as required under
42 CFR 423.153(d) (including members enrolled in employer plans and MedicareMedicaid Plans (MMPs)). This includes all enrollees that were disenrolled from the
MTM program during the contract year. Do not include beneficiaries that were offered
MTM services, but do not meet the eligibility criteria under section 423.153(d). The
audit review period for this universe covers January 1st through December 31st of the
contract year immediately prior to the audit year. For example, for audits conducted in
2017, sponsors should populate this universe using the MTM data for the 2016 contract
year.

2.2. Prescription Drug Event (PDE) Universe - CMS will extract final action PDE data from
the contract year immediately prior to the audit year for audited sponsors from the Integrated
Data Repository (IDR). The PDE universe will be used to identify enrollees who were
potentially eligible for auto-enrollment in a MTM program for the contract year of interest,
but were not enrolled at any time during that year. Beneficiaries that were enrolled by the
sponsor in an MTM program for the contract year of interest will be omitted from this
universe.
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 as
provided 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.

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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.
NOTE: During the pilot period, the MTM program area results will not be included in the overall
audit score nor will they be displayed in the final audit report.
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 pilot 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; however, during the pilot
period the results of this pilot program area will not be included in the final report.

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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 Universe: The universe collected for this program area tests whether sponsors are 1)
accurately identifying and appropriately enrolling targeted beneficiaries in MTM programs, 2)
appropriately disenrolling beneficiaries enrolled in MTM programs, and 3) offering and providing
required MTM services to the MTM program enrollees. The universe should be compiled using
the appropriate record layout as described in Appendix A. This record layout includes:
•

Medication Therapy Management Enrollee (MTME) Universe

NOTE:
• The sponsor should include all cases that match the description for this universe for all
contracts in its organization as identified in the audit engagement letter (e.g., all
beneficiaries, for all contracts in your organization, that were auto-enrolled in each
MTM program for the contract year immediately prior to the audit year).
3. Submit Universe to CMS: Sponsors should submit the 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 layout shown in Appendix A (Table 1). The sponsor should
submit its universe in whole and not separately for each contract.

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Audit Elements
I. Enrollment/Disenrollment
1. Select Sample Cases: CMS will select a total of 20 cases from the PDE and MTM universes to
test the appropriateness of the sponsor’s enrollment of eligible beneficiaries into a MTM program
as well as disenrollment from a MTM program. These 20 cases will consist of:
•
•

10 cases – non-enrolled members
10 cases – disenrolled members

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 proper identification and processing
of targeted beneficiaries for enrollment into an MTM program, and/or the appropriate
disenrollment and processing of MTM program members.
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:
• Beneficiary Name
• Cardholder or member ID
• CMS Contract ID
• Effective date of eligibility determination
• Documentation of targeted beneficiary’s MTM program eligibility, including but not limited
to drug and diagnosis information
• Effective date of enrollment into the MTM program
• Operational policies and procedures for implementing the MTM program
• Documentation regarding the cognitive impairment determination of the enrollee
• Effective date of opt-out
• Documentation of beneficiary’s/authorized representative’s request to opt-out from the MTM
program
• Documentation of beneficiary’s/authorized representative’s declination of MTM program
services
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 MTM program requirements not being met.
3.1. Did the sponsor appropriately identify beneficiaries who met the targeting criteria of
their CMS approved MTM program?
3.2. Did the sponsor appropriately disenroll beneficiaries, when applicable?
4. Sample Case Results: CMS will test each of the 20 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.

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II. Comprehensive and Targeted Medication Review (CTMR)
1. Select Sample Cases: CMS will select a targeted sample of 20 cases from the MTM universe.
2. Review Sample Case Documentation: CMS will review all sample case file documentation to
determine if MTM program enrollees were offered and/or provided appropriate, complete and
accurate CMRs, including interventions for beneficiaries and/or prescribers, and written CMR
summaries in CMS’ standardized format. CMS will also review at least 10 cases to determine
whether beneficiaries auto-enrolled in an MTM program received accurate, complete and at least
quarterly TMRs with follow-up interventions when necessary. During the live review portion of
the audit CMS will also verify the accuracy of the dates provided in the universe submission.
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, where applicable:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•

Effective date of eligibility determination
Documentation of targeted beneficiary’s MTM program eligibility
Effective date of enrollment into the MTM program
Documentation regarding the cognitive impairment determination of the enrollee
Documentation regarding identification and outreach to authorized representative for
cognitively impaired beneficiaries
Documentation of comprehensive medication review (CMR) offer
Documentation of beneficiary’s/authorized representative’s declination of individual MTM
services (including CMRs)
Documentation including date that a required CMR was administered to the beneficiary as a
part of the MTM process (e.g., copy of the comprehensive medication review report)
Documentation regarding provider’s inability to administer CMR
Documentation of personnel involved in the comprehensive medication review
Copy of written summary of the comprehensive medication review or alternative
documentation of the CMR
Documentation including date that a targeted medication review was performed (e.g., copy of
the targeted medication review report)
Documentation of personnel involved in the targeted medication review
Documentation of any interventions taken as a result of the targeted review (or
documentation that interventions were not necessary)
Effective date of opt-out
Documentation of beneficiary’s/authorized representative’s request to opt-out from the MTM
program

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 MTM requirements not being met.
3.1. Was a CMR offered at least annually? For newly targeted beneficiaries, was a CMR
offered within 60 days of enrollment?
3.2. For cognitively impaired members, did the sponsor perform appropriate outreach to
the beneficiary’s authorized representative to offer a CMR?

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3.3. Did the sponsor perform an annual comprehensive medication review in accordance
with CMS’ professional service definition?
3.4. Did the sponsor provide the beneficiary or their authorized representative with a
written summary of the comprehensive medication review?
3.4.1. Was the written summary provided in the standardized format?
3.4.2. Was the written summary provided within 14 days of the completed CMR?
3.5. Did the sponsor utilize the appropriate qualified staff when performing the CMR?
3.6. Were the required CMR services offered and provided consistent with the approved
MTM description?
3.7. Did the sponsor provide TMRs at least quarterly or according to the timeframe as
described in the CMS approved MTM description?
3.8. Were the TMRs performed consistent with the approved MTM description?
3.9. Did the sponsor implement beneficiary and/or prescriber interventions resulting from
TMRs when necessary and/or as described in the CMS approved MTM description?
4. Sample Case Results: CMS will test each of the 20 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.

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Appendix
Appendix A – Medication Therapy Management (MTM) Record Layout
The universe for the Medication Therapy Management 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 response, enter this information on the next record at the appropriate start position.
Table 1. Medication Therapy Management Enrollee (MTME) Record Layout
• Include all beneficiaries auto-enrolled in the sponsor’s MTM program as required under 42
CFR § 423.153(d) and the CMS approved MTM Description. If a beneficiary was autoenrolled more than once in an MTM program during the contract year, include information
related to the first effective enrollment in a MTM program during that year. This would
include MTM information from the date of the first contract enrollment that offered an MTM
program through the end of the year or through disenrollment from the MTM program (if
applicable) – whichever comes first.
o When populating this universe, sponsors should use data from the contract year
immediately prior to the audit year. For example, for audits conducted in 2017,
sponsors should populate this universe using the MTM data from contract year 2016.
• Exclude beneficiaries who did not meet the eligibility criteria under section 42 CFR §
423.153(d).
Column
ID
A

Field Name

B

Beneficiary First Name

C

Beneficiary Last Name

D

Date of Birth

E

Enrollment Effective
Date (Contract)

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HICN

Field
Type
CHAR
Always
Required

Field
Length
15

Description

CHAR
Always
Required
CHAR
Always
Required
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.

10

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

10

Effective date of enrollment for the beneficiary into a
contract. If the beneficiary was enrolled in multiple
contracts during the year, enter the contract
enrollment effective date for the first contract ID that
offered an MTM program. Submit in CCYY/MM/DD
format (e.g., 2016/01/01).

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Column
ID
F

Field Name

Field
Type
CHAR
Always
Required
CHAR
Always
Required

Field
Length
20

Description

G

Contract ID

5

MTM Eligibility Date

CHAR
Always
Required

10

I

MTM Enrollment Date

10

J

Did beneficiary Opt-out
of the MTM Program?

CHAR
Always
Required
CHAR
Always
Required

K

MTM Opt-out Date

CHAR
Always
Required

10

L

MTM Opt-out Reason

CHAR
Always
Required

2

The contract number (e.g., H1234) of the
organization. If the beneficiary was enrolled in
multiple contracts during the year, enter the first
contract ID that offered an MTM program.
Date sponsor determined the beneficiary’s eligibility
for the MTM program. If the beneficiary was enrolled
in multiple contracts during the year, enter the MTM
program eligibility determination date for the first
contract ID that offered an MTM program. Submit in
CCYY/MM/DD format (e.g., 2016/02/01).
First effective date of auto-enrollment for the
beneficiary into the MTM program. Submit in
CCYY/MM/DD format (e.g., 2016/02/01).
Yes (Y) or No (N) indicator of whether the
beneficiary opted-out of the first auto-enrollment in
the MTM program. Opt-out includes a request from
the beneficiary or authorized representative to be
disenrolled from the MTM program, beneficiary
changing to a different contract not covered by the
existing MTM program, or death. Opt-out does not
include a request to decline individual MTM services,
such as CMRs.
Date beneficiary or authorized representative optedout of the first MTM program. If the opt-out was due
to death, please include the date the sponsor was
made aware of the beneficiary’s death if the actual
date of death is not available. Submit in
CCYY/MM/DD format (e.g., 2016/03/01). Answer
NA if the beneficiary did not opt-out of the MTM
program.
Reason for opt-out of the first MTM program. Valid
values are:
01 = Death
02 = Beneficiary disenrolled from contract
03 = Beneficiary requested opt-out
04 = Other (e.g., authorized representative requested
opt-out)

H

Cardholder ID

1

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

Enter NA if the beneficiary did not opt-out of the first
MTM program into which they were auto-enrolled.

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Column
ID
M

Field Name
MTM Opt-out Reason
Explanation

Field
Type
CHAR
Always
Required

Field
Length
750

Description
Answer NA if the opt-out type was “01 (Death),” “02
(Disenrolled from contract),” or the beneficiary was
not disenrolled by the organization from the first
MTM program.
If “03 (Beneficiary requested opt-out)” was selected
for the MTM program opt-out reason, explain why
the beneficiary requested to opt-out of the MTM
program. Answer “no reason provided” if the
beneficiary did not provide an explanation for their
request to opt-out of the MTM program. If “04
(Other)” was selected, please further define this
option and explain the reason it led to an opt-out.

N

O

P

Was the beneficiary
residing in a long term
care facility?

Cognitively Impaired

Authorized
Representative

CHAR
Always
Required

CHAR
Always
Required

CHAR
Always
Required

2

2

2

Indicate whether the beneficiary was identified as
being in long term care facility either at the time the
first CMR was offered or administered during the
year. Sponsors should use all available information to
determine LTC status at the time the MTM services
are offered and administered, such as the patient
residence code on drug claims data and the Long
Term Institutionalized (LTI) resident report. Valid
values are:
Y = Yes
N = No
U = Unknown
Answer NA if no CMRs were offered or administered
during the year.
Indicate whether the beneficiary was identified as
being cognitively impaired either at the time the first
CMR was offered or administered? Valid values are:
Y = Yes
N = No
U = Unknown
Answer NA if no CMRs were offered or administered
during the year.
Indicate whether the beneficiary had an authorized
representative (e.g., prescriber, caregiver, health care
proxy or legal guardian) either at the time the first
CMR was offered or administered during the year?
Valid values are:
Y = Yes
N = No
U = Unknown
Answer NA if no CMRs were offered or administered
during the year.

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Column
ID
Q

Field Name
Number of CMRs
offered

R

Number of CMRs
administered

S

Number of written CMR
summaries

T

Date of 1st CMR offer

U

1st CMR offer declined?

V

Who declined 1st CMR
offer?

W

Date 1st CMR
administered

X

1st CMR Delivery
Method

Y

Qualified Provider of 1st
CMR

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Field
Type
CHAR
Always
Required

Field
Length
2

CHAR
Always
Required
CHAR
Always
Required

2

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

10

CHAR
Always
Required
CHAR
Always
Required

10

CHAR
Always
Required

300

2

2

2

2

Description
Total number of distinct CMRs for which offers were
delivered to the beneficiary, regardless of the number
and type of delivery methods attempted for the CMR
offer. Answer “0” (zero) if no CMRs were offered
during the year.
NOTE: In order to count as a CMR offer it must have
been received by the MTM program member (e.g.,
returned mail or incorrect phone numbers do not
count as an offer).
Total number of CMRs administered during the year.
Answer “0” (zero) if no CMRs were administered
during the year.
Total number of written CMR summaries provided
during the year. Answer “0” (zero) if no CMRs were
administered or no written CMR summaries were
provided during the year.
Date the first CMR was offered. Submit in
CCYY/MM/DD format (e.g., 2016/02/16). Answer
NA if no CMRs were offered in during the year.
Yes (Y) or No (N) indicator of whether the first CMR
offered was declined. Answer NA if no CMRs were
offered during the year.
Indicate who declined the first CMR offer. Valid
values include: Beneficiary (B) and authorized
representatives such as the Prescriber (P), Caregiver
(C), or other Authorized Individual (AI) such as a
beneficiary’s health care proxy or legal guardian.
Answer NA if no CMRs were offered during the year
or the first CMR offer was not declined.
Date the first CMR was administered. Submit in
CCYY/MM/DD format (e.g., 2016/03/01). Answer
NA if no CMRs were administered during the year.
Indicate the delivery method for the first CMR
administered. Valid values include: Face-to-face (FF),
Telephone (T), Telehealth Consultation (TH) (e.g.,
video-conference) or Other (O). Answer NA if no
CMRs were administered during the year or the
beneficiary/authorized representative declined CMR
services.
Indicate the type of qualified provider that
administered the first CMR. Valid values include:
Physician; Registered Nurse; Licensed Practical
Nurse; Nurse Practitioner; Physician’s Assistant;
Local Pharmacist; LTC Consultant Pharmacist; Plan
Sponsor Pharmacist; Plan Benefit Manager (PBM)
Pharmacist; MTM Vendor Local Pharmacist; MTM
Vendor In-house Pharmacist; Hospital Pharmacist;
Pharmacist – Other; or Other.
Answer NA if no CMRs were administered during the
year or the beneficiary/authorized representative
declined CMR services.

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Column
ID
Z

Field Name

Field
Type
CHAR
Always
Required

Field
Length
10

AA

Date 1st Written CMR
Summary Provided

CHAR
Always
Required

10

AB

Number of TMRs
performed

3

AC

Date of 1st TMR
performed

AD

Were interventions
necessary for any
TMRs?

CHAR
Always
Required
CHAR
Always
Required
CHAR
Always
Required

AE

Date of 1st TMR
requiring intervention(s)

CHAR
Always
Required

10

AF

TMR Intervention
Recipient(s)

CHAR
Always
Required

20

1st CMR Recipient

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10

2

Description
Indicate who received the first CMR. Valid values
include: Beneficiary (B) and authorized representative
such as the Prescriber (P), Caregiver (C), or other
Authorized Individual (AI) such as a beneficiary’s
health care proxy or legal guardian. If there were
multiple recipients, separate entries by forward
slashes (/). Answer NA if no CMRs were offered
during the year or the beneficiary/authorized
representative declined CMR services.
Date the first written CMR summary was provided in.
Submit in CCYY/MM/DD format (e.g., 2016/03/15).
If the CMR summary is not given to the beneficiary
immediately after the CMR, enter the date the CMR
summary leaves the sender’s establishment by US
mail, fax, or electronic communication. Answer NA if
no written CMR summaries were provided during the
year.
Total number of TMRs performed during the year.
Answer “0” (zero) if no TMRs were performed.
Date of the first TMR performed during the year.
Submit in CCYY/MM/DD (e.g., 2016/02/05). Answer
NA if no TMRs were performed.
Yes (Y) or No (N) indicator of whether follow-up
interventions were deemed necessary based on the
results of any TMRs conducted during the year.
Answer NA if no TMRs were performed.
Date of the first TMR requiring follow-up
intervention(s). This may be different than the date of
the first TMR performed as some TMRs may not
result in the need for an intervention. Submit in
CCYY/MM/DD (e.g., 2016/03/01). Answer NA if no
TMRs were performed during the year or
interventions were not necessary for any TMRs.
Indicate who was targeted to receive the first TMR
follow-up intervention(s). Valid values include:
Beneficiary (B) only, Prescriber (P) only, or both
Beneficiary and Prescriber (BP). Answer NA if no
TMRs were performed during the year or
interventions were not necessary for any TMRs.

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Column
ID
AG

Field Name
TMR Intervention(s)
Delivered?

Field
Type
CHAR
Always
Required

Field
Length
2

Description
Yes (Y), No (N), or Some (S) indicator of whether the
first TMR drug therapy problem (DTP)
recommendation intervention(s) were delivered.
Answer “Y” if every DTP intervention was delivered.
Answer “N” when no attempt was made to deliver an
intervention or an attempt was unsuccessful (e.g.,
returned mail or wrong number). Answer “S” if some,
but not all of the first TMR DTP interventions were
delivered.

AH

TMR Intervention(s)
Delivery Date

CHAR
Always
Required

10

Answer NA if no TMR interventions were delivered,
no TMRs were performed during the year, or
interventions were not necessary for any TMRs.
Date the first TMR DTP recommendation
intervention was delivered to the targeted recipient.
When there are multiple DTP recommendation
interventions for the TMR, submit the date that the
last one was delivered. Submit in CCYY/MM/DD.
Answer NA if no TMR interventions were delivered,
no TMRs were performed during the year, or
interventions were not necessary for any TMRs.

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