Summary of Comments and Response

Medicare Parts C and D Data Validation Revisions Crosswalk_20121029.pdf

Medicare Part C and Part D Data Validation (42 C.F.R. 422.516g and 423.514g)

Summary of Comments and Response

OMB: 0938-1115

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Revisions Crosswalk (Medicare Parts C and D Data Validation Documentation)
 
 
Comment
ID #

Date
Received

DV Document

Comment

Burden
Impact

CMS Response

CMS thanks you for your comment.
Please note that PDPs and RPPOs are
MSC-4
established at the state level, and
therefore report at that level (by state).
We would like clarification on what "at the contract
However, MA-PDs are required to
level" means specifically. "Applicable Measurereport by their entire service area, as
Specific Criteria: MSC-4: Organization accurately
their contracts are not established at
calculates the number of network LTC pharmacies in the state level.
the service area, including the following criteria:
MSC-4a: Includes the number of contracted LTC
pharmacies at the state level by state for PDPs and
RPPOs, and at the contract level for MA-PDs. by
service area for MA-PDs. [Data Element A]"
CMS thanks you for your comment.
ORGANIZATION DETERMINATIONS /
This clarification exists in the updated
RECONSIDERATIONS:
version of the Part C Technical
Specifications, expected to be
MSC-4
released by October 2012.
In the ODR report (Organization Determinations),
Section 2.5, MSC-4 it states “Excludes withdrawals”
– removing the word “dismissals”. Are dismissals
included? This does not match the 2012 Part C
Technical Specifications (Version January 2012). In
the technical specifications, page 27 under Reporting
Exclusions it says to NOT report Dismissals or
withdrawals.
LTC:

1

9/17/2012

DV Standards,
FDCF

2

9/17/2012

DV Standards,
FDCF

N/A

N/A

Page 1 of 99 
 

Comment
ID #

3

4

5

Date
Received

9/17/2012

9/17/2012

9/17/2012

DV Document

N/A

N/A

N/A

Burden
Impact

Comment

CMS Response

The Data Validation documentation is very thorough
and is a very useful tool. We encourage you to
incorporate the data validation documentation with
the current reporting requirements documentation to
provide consistent and comprehensive
documentation for all reporting requirements. It has
been identified that the data validation documents
have more detail and provide better guidance on
what data should be included/excluded from
reporting than the actual reporting requirements
documentation available in the technical specs. This
has caused inconsistencies when reporting data and
then when it is being reviewed by the independent
auditors as they are utilizing the data validation
documentation.
The Data Validation documentation needs to be
finalized and provided to the plans before the 2013
calendar year begins so that this documentation is
available as we build are reporting specifications. It
is very challenging going into a reporting year when
the documentation is finalized several months in the
reporting year. This creates inconsistencies in
reporting and required possible resubmissions and
rework to be performed.
We agree and applaud the proposal to remove the
noted data elements from validation. We encourage
you to continue to review the elements still requiring
validation to ensure it is a value add to have that data
validated compared to the costs to administer and
validation the information.

CMS thanks you for your comment
and will consider this feedback as we
continue to improve the processes and
procedures associated with the
Medicare Part C and Part D Data
Validation program.
N/A

CMS thanks you for your comment
and will consider this feedback as we
continue to improve the processes and
procedures associated with the
Medicare Part C and Part D Data
Validation program.

CMS thanks you for your comment
and will consider this feedback as we
continue to improve the processes and
procedures associated with the
Medicare Part C and Part D Data
Validation program.

N/A

N/A

Page 2 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
CVS Caremark suggests that the DVR program be
validated at the PBM level. This would be
significantly more cost effective.

6

9/20/2012

N/A

We also recommend that CMS shift the audit dates
to May through June in order to reduce the burden
on the Data Providers for each report measure, as the
audits currently coincide with the 1st quarter
reporting cycle. Facilitating the Data Validation
Review audits along with quarterly reporting
activities impacts efficiencies, creates a burden on
resources; technical and otherwise.
We propose consistency between the various
documentations (Technical
Specifications/Standards/FDCF) which will allow
for less misunderstandings of true requirements.
Examples include:
COVERAGE DETERMINATIONS &
EXCEPTIONS:

7

9/20/2012

Technical
Specifications,
DV Standards,
FDCF

Within the Technical Specification there is no
mention within Element A or Notes to include innetwork and out-of-network transactions. However,
in the Standards/FDCF this requirement is spelled
out. Another example is within the same reporting
measurement on Elements C-N which excludes
members who have UM requirements waived based
on an exception decision made in a previous plan
year or reporting period. But the Technical
Specification utilize the terminology "report on the
transaction during the reporting period".

Burden
Impact

CMS Response
CMS does not contract with PBMs
and therefore does not have the
authority to require them to
participate in the DV cycle. However,
CMS will consider this for future
years.

N/A

CMS thanks you for your comment.
With regards to the inquiries noted in
the comment:
1. The language "in-network and outof-network transactions" is outdated
and has been removed from the
measure-specific criteria.
2. The clarification around waiving
UM requirements based on an
exception decision made in a previous
plan year or reporting period exists in
the updated version of the Part D
Technical Specifications, expected to
be released by October 2012.

N/A

Page 3 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
We propose consistency between the various
documentations (Technical
Specifications/Standards/FDCF) which will allow
for less misunderstandings of true requirements.
Examples include:

8

9

9/20/2012

9/20/2012

Technical
Specifications,
DV Standards,
FDCF

Technical
Specifications,
DV Standards,
FDCF

REDETERMINATIONS:
The 2012 Report Requirements and the Report
Technical Specifications Element A and Notes do
not include any verbiage that states to include all
redetermination requests regardless of who filed the
request (e.g., member, appointed representative, or
prescribing physician. However, this is being listed
as required within the DVR Standards, page 47
under item 5.f.
We propose consistency between the various
documentations (Technical
Specifications/Standards/FDCF) which will allow
for less misunderstandings of true requirements.
Examples include:

Burden
Impact

CMS Response
The language "Includes all
redeterminations regardless of who
filed the request (e.g., member,
appointed representative, or
prescribing physician)" is outdated
and has been removed from the
measure-specific criteria.

N/A

The statement in Appendix B and the
FDCF ("For contracts with both non800 series and 800-series plans, data
for the 800-series plan(s) may be
excluded.") has been re-phrased to
state:

LTC:
"Employer-Direct PDPs, EmployerDirect PFFS, and any other contracts
The Standards make no mention of exclusion of
Employer-Direct PDP, Employer-Direct PFFS on the that have only 800 series plans are
excluded from this reporting. For
Standards or FDCF. This is mentioned within the
contracts with both non-800 series
Technical Specifications.
and 800-series plans, data for the 800series plan(s) may be excluded."

N/A

Page 4 of 99 
 

Comment
ID #

10

Date
Received

9/20/2012

DV Document

Technical
Specifications,
DV Standards,
FDCF

Comment

CMS Response

CVS Caremark received confirmation from CMS on
August 23, 2012, to exclude all 800 plan data from
the 2011 and 2012 LTCU reports. We recommend
that all documentation - Technical Specifications,
Data Validation Standards and FDCF reflect this
new guidance.

The statement in Appendix B and the
FDCF ("For contracts with both non800 series and 800-series plans, data
for the 800-series plan(s) may be
excluded.") has been re-phrased to
state:

COVERAGE DETERMINATIONS AND
EXCEPTIONS:
11

9/20/2012

FDCF

MSC-3

Burden
Impact

"Employer-Direct PDPs, EmployerDirect PFFS, and any other contracts
that have only 800 series plans are
excluded from this reporting. For
contracts with both non-800 series
and 800-series plans, data for the 800series plan(s) may be excluded."
The dates in the FDCF have been
updated to correctly reflect the
reporting due dates of: 05/31, 8/31,
11/30 and 02/28.

N/A

N/A

We recommend that the dates reflect the appropriate
quarterly reporting due dates, which are 05/31, 8/31,
11/30 and 02/28.

Page 5 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
COVERAGE DETERMINATIONS AND
EXCEPTIONS:
MSC-7

12

9/20/2012

DV Standards,
FDCF

Based upon the Technical Specification documents
this measurement should be based upon "decision
date". However, the Standards and FDCF mention
"date of receipt". We recommend that the Standards
and FDCF be updated with the current reporting
requirements and technical specifications.
Consistency between the various documentations
(Technical Specifications/Standards/FDCF) will
allow for fewer misunderstandings of true
requirements.

CMS Response

Burden
Impact

The Data Validation standards have
been updated to correspond with the
Part D Technical Specifications to
correctly state "date of decision."

N/A

Page 6 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
LTC:
MSC-4 (FDCF only)
MSC-7
MSC-8
MSC-9

13

9/20/2012

DV Standards,
FDCF

We propose that for Elements Da-Dh), subsections
4d, 7d, 8e and 9f (Elements Da-Dh) – “including
those without a physical location/address in the
service area”, this language be removed. This
language was not present within the last edition of
the Reporting Technical Specifications. It was only
stated as “Any Long-Term Care pharmacy holding a
license for the state(s) in the sponsor’s service area
should be included”. We recommend that the
Standards and FDCF be updated with the current
reporting requirements and technical specifications.
Consistency between the various documentations
(Technical Specifications/Standards/FDCF) will
allow for fewer misunderstandings of true
requirements.

Burden
Impact

CMS Response
This is additional clarification that
does not result in contradictory
information between the Technical
Specifications and the Data Validation
Standards.

N/A

Page 7 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
LTC:
MSC-10
MSC-11

14

9/20/2012

DV Standards,
FDCF

15

9/20/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
Measure-specific criteria 10 and 11
have been updated to correctly reflect
that MA-PDs report at the contract
level while PDPs and RPPOs report at
the state level.

We are suggesting clarification between the
Standards and FDCF and the Technical Specification
on Elements Ea-Ed, subsection 10a. Conflicting
information between the Standards/FDCF that
PDP’s, RPPO’s and MA-PD’s be report at the
contract level. However, in the Technical
Specification it states service area and contract level?
We recommend that the Standards and FDCF be
updated with the current reporting requirements and
technical specifications. Consistency between the
various documentations (Technical
Specifications/Standards/FDCF) will allow for
fewer misunderstandings of true requirements.
PLAN OVERSIGHT OF AGENTS:
The following statement exists in both
the Part C and Part D Technical
Specifications and aligns with MSCMSC-4
4:
We suggest that the 4a substandard be removed from
"The “number of agents” includes
the Standards and FDCF since this requirement is
only agents who were licensed to sell
not in the latest Technical Specification.
on behalf of the Parent Organization,
We recommend that the Standards and FDCF be
updated with the current reporting requirements and either by being a direct employee or
by contractual arrangement,
technical specifications. Consistency between the
regardless of whether the agent is
various documentations (Technical
Specifications/Standards/FDCF) will allow for fewer actively selling during the reporting
period."
misunderstandings of true requirements.

N/A

N/A

Page 8 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
PLAN OVERSIGHT OF AGENTS:
MSC-9

16

9/20/2012

DV Standards,
FDCF

We suggest that the 9e substandard be removed from
the Standards and FDCF since this requirement is
not in the latest Technical Specification.
We recommend that the Standards and FDCF be
updated with the current reporting requirements and
technical specifications. Consistency between the
various documentations (Technical
Specifications/Standards/FDCF) will allow for fewer
misunderstandings of true requirements.
PLAN OVERSIGHT OF AGENTS:
MSC-9

17

9/20/2012

DV Standards,
FDCF

We suggest that the 9f substandard be removed from
the Standards and FDCF since this requirement is
not in the latest Technical Specification.
We recommend that the Standards and FDCF be
updated with the current reporting requirements and
technical specifications. Consistency between the
various documentations (Technical
Specifications/Standards/FDCF) will allow for fewer
misunderstandings of true requirements.

Burden
Impact

CMS Response
Measure-specific criteria 4c and 9e
have been removed from the Data
Validation Standards to remove
ambiguity. Data related to terminated
agents should not be excluded from
the counts submitted to CMS for the
Plan Oversight of Agents measure.

N/A

CMS thanks you for your comment.
The following clarification exists in
the updated version of the Part C
Technical Specifications, expected to
be released by October 2012:
"If a member switches enrollment
from one benefit package to another,
within the same contract, and uses the
services of a licensed agent, this does
not count as an agent-assisted
enrollment for reporting of element
12.6."

N/A

Page 9 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
MTM:
MSC-5d

18

9/20/2012

DV Standards

It is recommended that the exact wording that CMS
uses in the 2012 Technical Specifications be used:
"A targeted beneficiary should only be reported once
per contract year per contract file". Consistency
between the various documentations (Technical
Specifications/Standards/FDCF) will allow for fewer
misunderstandings of true requirements.

MTM:
MSC-5b

19

9/20/2012

DV Standards,
FDCF

Please revise the verbiage of this requirement to
clarify that this requirement includes only the
Vaccine Administration Fee and does not include
any other administration fees. Consistency between
the various documentations (Technical
Specifications/Standards/FDCF) will allow for less
misunderstandings of true requirements.

Burden
Impact

CMS Response
CMS thanks you for your comment.
MSC-5d has been updated as follows
to reflect the updated language in the
Part D Technical Specifications:
"Includes and reports each targeted
member, reported once per contract
year per contract file, based on the
member's most current HICN."
Also, please note that the measurespecific criteria have been
standardized to use the term
"member."
The measure-specific criteria have
been updated to clarify that the
"vaccine administration fee" is the
only administrative fee included in the
calculation. We will update the
Technical Specifications at a later
date to coincide.

N/A

N/A

Page 10 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
MTM:

Burden
Impact

CMS Response
MSC-9a has been updated to read as
follows:

MSC-9

20

9/20/2012

DV Standards,
FDCF

Since the Beneficiary Eligible File has the ability to
provide up to 3 dates in reference to when a CMR
occurred (Element N), we suggest that this same
terminology be included within the Standards and
FDCF.
Consistency between the various documentations
(Technical Specifications/Standards/FDCF) will
allow for less misunderstandings of true
requirements.
COVERAGE DETERMINATIONS AND
EXCEPTIONS:

21

9/20/2012

DV Standards

"Properly identifies and includes the
date(s) (up to three) the member
received a CMR, if applicable. The
date occurs within the reporting
period, is completed for every
member with a “Y” entered for Field
Name “Received annual
comprehensive medication review,”
and if more than one comprehensive
medication review occurred, includes
the date of the first CMR."
MSC-7a has been updated to correctly
state "date of decision."

MSC-7a

N/A

N/A

Please revise the verbiage of the requirement to
clarify that this data element is based upon the date
of decision, not on the date of receipt.
GRIEVANCES - PART C:

22

9/21/2012

DV Standards,
FDCF

23

9/21/2012

DV Standards,
FDCF

The Part C Technical Specifications
and measure-specific criteria will be
Part C Grievance measure needs to have a note about updated to exclude withdrawn Part C
grievances for the 2013 reporting
excluding withdrawn grievances similar to that of
year.
Part D Grievance measure
This will be updated in the Part D
REDETERMINATIONS:
Technical Specifications and MSC for
Part D Redeterminations needs to clarify whether to the 2013 reporting year.
include or exclude Part B verse Part D coverage
appeal decisions

N/A

N/A

Page 11 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
LTC:
MSC 6 & 7

24

9/21/2012

DV Standards,
FDCF

Needs a note about Location code restriction for
Element D, similar to that described in Element C

LTC:

25

9/21/2012

DV Standards,
FDCF

Needs a note whether as to Element A has to match
with the record counts of Element D

LTC:

26

9/21/2012

DV Standards,
FDCF

Needs a note whether as to Element B has to match
with the record counts of Element E

ORGANIZATION DETERMINATIONS &
RECONSIDERATIONS:
27

9/21/2012

DV Standards,
FDCF

Needs a note about excluding IRE decisions for all
elements i.e., to include only 1st level Plan decisions
for all elements

Burden
Impact

CMS Response
The Part D Technical Specifications
has been updated to state that "Claims
with patient residence code 03 may be
used to identify enrollees. The LTI
report may be another tool for this
reporting." Also, the note in
Allowable Values re: location code
04 and 07 has been removed. In
addition, MSC-6d has been updated to
align with the changes to the Part D
Technical Specifications.
The Part D Technical Specifications
have been updated to specify that
Data Element E is a subset of Data
Element B. In addition, MSC-10f and
11g have been updated to align with
this change to the Part D Technical
Specifications.

N/A

N/A

The Part D Technical Specifications
have been updated to specify that
Data Element E is a subset of Data
Element B. In addition, MSC-10f and
11g have been updated to align with
this change to the Part D Technical
Specifications.

N/A

This Part C Technical Specifications
and MSC for the 2013 reporting year
will be updated to specify that IRE
decisions should not be included in
the data reported to CMS for this
measure.

N/A

Page 12 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment

Burden
Impact

CMS Response

ORGANIZATION DETERMINATIONS &
RECONSIDERATIONS:

28

9/21/2012

DV Standards,
FDCF

29

9/21/2012

OAI

30

9/21/2012

Supporting
Statement

Service authorizations include all
service-related determinations (as
opposed to claims-related decisions)
Needs a note clarifying whether pre-service means to including pre-authorizations,
include pre-authorizations, concurrent authorizations concurrent authorizations, and postand post-authorizations
authorizations. The 2013 Technical
Specifications will be updated to
include this information.
Under 3.3 - Table 4 - "Are all required data elements This statement has been re-phrased in
captured by your data system(s)" – Is the emphasis
the OAI as follows: "Are all required
on informing if all elements are captured? Or is the
data elements captured by your
emphasis on whether they were captured internally
internal data systems?" Also, an
by the plan's data systems or externally by any others addition column has been added: "If
such as a PBM or downstream delegate?
the answer to Column C. is no, please
indicate which delegated entities' data
systems contain data elements."
Provides preferred method of cost estimation - table Table 2 assumes that the level of
effort is identical for each additional
2 or table 3 with few examples. Examples may
contract, regardless of the underlying
include scenarios such as organizations having
technical platform. Table 3 uses this
multiple contracts but their underlying data systems
same assumption but is calculated
are processes are on different platforms mainly due
using the average number of contracts
to mergers/acquisitions. Do we consider the base
per sponsoring organization.
cost plus additional cost per contract as per table 2,
or consider table 3 all together, or table 2 or 3 for
each merger organization which are on different
platforms.

N/A

N/A

N/A

Page 13 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
COVERAGE DETERMINATIONS AND
EXCEPTIONS:

Burden
Impact

CMS Response
MSC-7a has been updated to correctly
state "date of decision."

MSC-7

31

32

9/21/2012

9/24/2012

DV Standards,
FDCF

N/A

Regarding Appendix 1: Data Validation Standards,
please maintain consistency with the Part C and Part
D Technical Specifications. Example: Coverage
Determinations and Exceptions – Measure Specific
Criteria 7 which states to count by date of receipt
regardless of when the final decision was made is not
consistent with the January 2012 Part D Technical
Specifications page 40-41 which states to count
based on the date the decision was made.
Types of Information collected – Unfortunately,
many of the Part C and D reports requested require
that our FIESNP plan pull and report on data that
only partially tells the story of an integrated
Medicare and Medicaid plan. Many of the reports
ask plans to submit Medicare information only. The
actual process of pulling data to report on these
requests is often inefficient and requires systems to
be reconfigured to pull the data. As a FIDESNP, we
look at our performance as an integrated plan not a
Medicare Advantage only plan. The added burden
of validating this information at years’ end requires
plans to clearly document and recreate a process that
does not tell the full story of the FIESNP. The type
of information collected could be helpful if we were
allowed to report both Medicare and Medicaid data.

N/A

CMS thanks you for your comment.
This information is beyond the scope
of the current information collection
request. Please submit your comment
in response to the Part C Reporting
Requirements PRA (OMB Control #
0938-1054, ICF Reference # 2011050938-008).

N/A

Page 14 of 99 
 

Comment
ID #

33

34

Date
Received

9/24/2012

9/24/2012

DV Document

N/A

N/A

Burden
Impact

Comment

CMS Response

Commonwealth Care Alliance (#H2225) feels
strongly that the necessity and utility of collecting
the defined Parts C and D reporting information does
not adequately reflect the Plan’s performance of its
functions. The process of data collection requires
our data analytic team to pull reports – utilizing
approximately 30 hours of 1 FTE staff person in
order for Commonwealth Care Alliance to meet the
regulatory requirements. These reports are not used
internally to gage performance standards for
Commonwealth Care Alliance since in most reports
we only report on Medicare.
Commonwealth Care Alliance (#H2225) has created
additional functional workgroups to support these
reports and we estimate that 30-40 hours of work for
1 FTE per submission is required to validate the
process and the integrity of data. If these reports
were useful to the organization regarding
performance and functions, the additional time spent
on validating reports would not be bothersome.
Unfortunately, the Plan does not use these reports in
any operational way other than to meet regulatory
requirements.

CMS thanks you for your comment.
Please submit your comment in
response to the Part C Reporting
Requirements PRA (OMB Control #
0938-1054, ICF Reference # 2011050938-008).

CMS thanks you for your comment.
Please submit your comment in
response to the Part C Reporting
Requirements PRA (OMB Control #
0938-1054, ICF Reference # 2011050938-008).

N/A

N/A

Page 15 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
COVERAGE DETERMINATIONS AND
EXCEPTIONS:
MSC-12a
Coverage Determination Standards, needs to be
updated to reflect the Chapter 18 requirements.
Please change “after receipt of the request” to after
receipt of prescriber supporting statement.

35

9/24/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
MSC-12a has been updated to reflect
the requirements stated in Chapter 18
to include only exception decisions
for which the member (and the
prescribing physician or other
prescriber involved, as appropriate) is
notified of the decision according to
the following timelines:

expeditiously
as the enrollee’s
-For standard exceptions:
as health
Chapter 18, section 30.1 - Prior Authorization or
condition requires, but no later than
Other Utilization Management Requirements – page 72 hours after receipt of the
31: the plan must notify the enrollee (and the
physician’s or other prescriber’s
prescribing physician or other prescriber involved, as supporting statement.
appropriate) of its decision no later than 24 hours
after receiving the physician’s or other prescriber.
expeditiously
the enrollee’s
-For expeditedasexceptions:
as health
condition requires, but no later than
24 hours after receipt of the
physician’s or other prescriber’s
supporting statement.

N/A

Page 16 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
COVERAGE DETERMINATIONS AND
EXCEPTIONS:
MSC-12b
Coverage Determination Standards, needs to be
updated to reflect the Chapter 18 requirements.
Please change “after receipt of the request” to after
receipt of prescriber supporting statement (verbal or
written statement).

36

37

9/24/2012

9/24/2012

DV Standards,
FDCF

Technical
Specifications,
DV Standards

Burden
Impact

CMS Response
MSC-12b has been updated to reflect
the requirements stated in Chapter 18
to exclude favorable exception
decision in which the sponsor did not
authorize or provide the benefit or
payment under dispute according to
the following timelines:
expeditiously
as the enrollee’s
-For standard exceptions:
as health
condition requires, but no later than
72 hours after receipt of the
physician’s or other prescriber’s
supporting statement.

Chapter 18, section 30.1 - Prior Authorization or
Other Utilization Management Requirements – page
31: the plan must notify the enrollee (and the
prescribing physician or other prescriber involved, as
appropriate) of its decision no later than 24 hours
expeditiously
the enrollee’s
-For
expeditedasexceptions:
as health
after receiving the physician’s or other prescriber.
condition requires, but no later than
24 hours after receipt of the
physician’s or other prescriber’s
supporting statement.
We request that there be one source of truth for the
data to be reported and validated. There are a
number of edits in the data validation standards that
are not addressed in the Part D Technical
Specifications or the Part D Reporting Requirements
and Technical Specifications. To truly validate the
data reported, the audit tool should reflect the
instructions for reporting the data.

CMS thanks you for your comment.
Please note that the Part C and Part D
Technical specifications have been
updated to align with the measurespecific criteria.

N/A

N/A

Page 17 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
GRIEVANCES
ORGANIZATIONS DETERMINATIONS &
RECONSIDERATIONS
COVERAGE DETERMINATIONS &
EXCEPTIONS

Burden
Impact

CMS Response
Thank you for comment. As noted in
the instructions the source data should
represent a random sub-sample of the
data underlying the census/sample
records. Our intent by this statement
is that the source should be related
directly to the cases for the specific
measures.

REDETERMINATIONS

38

39

9/24/2012

DESI

9/24/2012

Technical
Specifications,
DV Standards

Please clarify what is expected as Source Data,
described in Appendix 3, for Grievances,
Organization Determinations/Reconsiderations,
Coverage Determinations/Exceptions and
Redeterminations. The customer service call logs are
very extensive and include thousands of calls in a
year. A sample of all calls may not demonstrate the
data underlying the census/samples records for these
measures. Call logs and member letters related
directly to the cases in these specific measures would
be more appropriate. We
would not be able to identify from all customer
service call logs, the calls that lead directly to a
grievance, for example.
Yes, an appeals grievance is a
GRIEVANCES:
grievance regarding the appeals
process.
Please define what is expected to report and
validation for measure 2.4 Grievances for the
appeals category. The Technical Specifications do
not define what is to be included in this category. Is
this to mean a grievance regarding the appeals
process? We want to ensure we are not double
counting and reporting the same issue more than
once.

N/A

N/A

Page 18 of 99 
 

Comment
ID #

40

Date
Received

9/24/2012

DV Document

N/A

CMS Response

We also suggest that the data validation audit period
be adjusted to run from June –August. This would
allow for staff preparing the annual bid and PBPs to
be available for the data validation audit. We have
conflicting deadlines for the staff that work on the
bids and are some of the same staff who prepare
reports. Moving this audit to after the bid submission
deadline would ensure that both projects are
completed with full attention and dedication of our
staff.
ORGANIZATIONS DETERMINATIONS &
RECONSIDERATIONS:

CMS thanks you for your comment
and will consider this feedback as we
continue to improve the processes and
procedures associated with the
Medicare Part C and Part D Data
Validation program.

MSC-4b
MSC-9a

41

9/24/2012

Technical
Specifications,
DV Standards

Burden
Impact

Comment

For Appendix 1, measure 2.5 Organization
Determinations/Reconsiderations, measure-specific
criteria item 4.b. says “prior authorization requests if
applicable, regardless of when the request was
received.” The Part C Technical Specifications
document describes this as completed organization
determinations and reconsiderations (i.e., plans have
notified enrollee of its decision...). We suggest that
the language in Appendix 1 be reworded to read
“prior authorization decisions, regardless of when
the request was received.” This language is also in
item 9.a.

MSC-4b has been updated to remove
the language: "...prior authorization
requests if applicable, regardless of
when the request was received" as this
is covered by MSC-4a. In addition,
MSC-9a currently reads: "Includes all
completed reconsiderations (Part C
only) with a date of member
notification of the final decision that
occurs during the reporting period,
regardless of when the request for
reconsideration was received."

N/A

N/A

Page 19 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
ORGANIZATIONS DETERMINATIONS &
RECONSIDERATIONS

Burden
Impact

CMS Response
Appendix 4 of the Part C Technical
Specifications contains the following
Q&A (#18):

MSC-4h

42

9/24/2012

DV Standards

For Appendix 1, measure 2.5 Organization
Determinations/Reconsiderations, measure specific
criteria item 4.h. says “include supplemental benefits
provided as part of a plan’s Medicare benefit
package.” Please clarify what is considered
supplemental benefits for this report, would we
include Medicare mandatory supplemental benefits
only or would we also include optional supplemental
benefits? If necessary, we would like to remove
optional supplemental benefits.

Q: "Should supplemental benefit data
be excluded from the Part C
Reporting?"
A: "If the plan’s question refers to
value-added items or services (such as
extra vision or eye care or a health
club membership), such coverage
decisions are not appealable under
the Subpart M reconsideration process
because they are not part of the plan’s
benefit package; thus, value-added
supplemental data is not reportable
under this effort. . However, if a plan
includes a supplemental benefit (e.g.,
a non-Medicare covered item/service)
as part of its Medicare benefit
package, then a dispute concerning
this issue is addressed under the
plan’s reconsideration process and the
organization determination and
reconsideration concerning the
supplemental benefit are reportable
under this effort."

N/A

Page 20 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
PLAN OVERSIGHT OF AGENTS - PART C:
MSC-4c
MSC-9e
MSC-9f

43

9/24/2012

Technical
Specifications,
DV Standards

We suggest that the Part C Technical Specifications
be updated to reflect the changes in the Data
Validation Manual and Appendices. For example,
the exclusion in measure 2.7 Plan Oversight of
Agents, item 4.c and 9.e and f are not addressed in
the Technical Specifications. This will cause a
difference in the data provided and reviewed for the
data validation audit.

Burden
Impact

CMS Response
Measure-specific criteria 4c and 9e
have been removed from the Data
Validation Standards to remove
ambiguity. Data related to terminated
agents should not be excluded from
the counts submitted to CMS for the
Plan Oversight of Agents measure.
In addition, the following clarification
exists in the updated version of the
Part C Technical Specifications,
expected to be released by October
2012:

N/A

"If a member switches enrollment
from one benefit package to another,
within the same contract, and uses the
services of a licensed agent, this does
not count as an agent-assisted
enrollment for reporting of element
12.6."

Page 21 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
MTM:
MSC-4f

44

9/24/2012

Technical
Specifications,
DV Standards

We request that the Part D Technical Specifications
be updated to reflect the exclusion in measure 3.2
MTM, item 4.f to exclude member who received
MTM services outside of the CMS required criteria.
We take this to mean that if we offer MTM services
to members who do not meet the CMS specified
criteria, but we feel would benefit from the services,
that we do not report these members. However, the
Technical Specifications do not make this exclusion
and the reported data will not match what is
reviewed for the data validation audit.

Burden
Impact

CMS Response
The updated version of the Part D
Technical Specifications for MTM
states: "Members who receive MTM
services outside of the CMS-required
MTM criteria defined by the plan
should be excluded from this
reporting."

N/A

Page 22 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment

Burden
Impact

CMS Response

Measure-specific criteria 4c and 9e
have been removed from the Data
Validation Standards to remove
MSC-4c
ambiguity. Data related to terminated
agents should not be excluded from
The proposed data validation standards, specifically
for data Element 12.1, indicate that the report should the counts submitted to CMS for the
Plan Oversight of Agents measure.
exclude agents who were terminated during the
applicable reporting period. Is it the intent of this
element to exclude both voluntary and involuntarily
termed agents during the reporting period? The
reporting period is the entire calendar year by
member effective date. Historically, the report
included the entire possible selling period for these
effective dates and this includes the AEP period of
the prior calendar year. The vast majority of our
applications are sold during AEP. Many agents sell
only during AEP and are then termed in our system.
Therefore, any agent who produces during AEP and
then terms would be excluded from data elements
12.1 through 12.6 . This may result in zero count
across all contracts if termed agents are excluded
from the report.
PLAN OVERSIGHT OF AGENTS - PART C:

45

9/24/2012

DV Standards

N/A

Page 23 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
SNP:

Burden
Impact

CMS Response
CMS's answers to the questions
submitted are as follows:

MSC-4a

46

9/24/2012

DV Standards

The proposed data validation standards, specifically
for the data Element 13.1, indicates that the report
should include all members who were eligible for an
initial assessment during the current reporting
period. Is it CMS’ intent for MAOs to report the
count of new and existing enrollees who have not
completed an initial assessment in 13.1? Also, does
CMS intend Plans to report members only once
under their most recent plan should they have
multiple plan changes during the reporting period?

1. Is it CMS’ intent for MAOs to
report the count of new and existing
enrollees who have not completed an
initial assessment in 13.1?
Yes

N/A

2. Does CMS intend Plans to report
members only once under their most
recent plan should they have multiple
plan changes during the reporting
period?
Yes

Page 24 of 99 
 

Comment
ID #

Date
Received

DV Document

CMS Response

For Data Element 13.3, the proposed data validation
standards indicate that the report should include all
initial assessments that “were completed (within 90
days of enrollment)”. The proposed changes for 13.3
does not account for existing enrollees who had
completed an initial assessment in the reporting
period. Can CMS provide further guidance how
MAOs should apply the 90 day rule to existing
members who have not completed an initial
assessment? The enrollment date does not appear to
be applicable as these members are offered an
assessment at the beginning of each plan year.

CMS will be providing further
guidance in the updated version of the
2012 Technical Specifications,
expected to be released in October
2012. Please note that while this is a
2011 measure being validated during
the 2013 data validation cycle, the
2012 updated Part C Technical
Specifications will not contradict the
data validation standards applicable to
the 2013 data validation cycle. The
updated Part C Technical
Specifications will provide additional
clarification that applies to both the
CY 2011 and CY 2012 reporting
periods.

SNP:
MSC-6a

47

9/24/2012

DV Standards

Burden
Impact

Comment

N/A

Additionally, for these two SNP Care Management
report changes, would CMS consider requesting
MAOs to apply these changes beginning with the
CY 2012 data submission rather than applying the
changes retrospectively with previously submitted
data?

Page 25 of 99 
 

Comment
ID #

48

Date
Received

9/24/2012

Burden
Impact

DV Document

Comment

CMS Response
CMS thanks you for your comment
and will consider this feedback as we
continue to improve the processes and
procedures associated with the
Medicare Part C and Part D Data
Validation program.

N/A

The schedule that CMS has laid out for the data
validation audit does not anticipate an organization
which serves members across the country, thus
requiring staffing and systems in multiple locations
across the country. Completing the rigorous
evaluation process that CMS has detailed may
require more time than the three months allotted due
to the breadth of systems that are reviewed (claims,
UM, broker distribution, grievances, appeals,
network, exceptions. etc.). We recommend that
emphasis should be placed on the meticulous
completion of each audit step rather than placing
focus on the time taken to complete these steps. In
other words, if an organization must start earlier than
April 1st to complete the annual data validation audit
in full this should be allowed as long as the
independent auditor is in agreement that the timing is
designed to meet the audit results submission
deadline of June 30th.

N/A

Page 26 of 99 
 

Comment
ID #

49

50

Date
Received

9/24/2012

9/24/2012

DV Document

N/A

Technical
Specifications,
DV Standards

Burden
Impact

Comment

CMS Response

We recommend that CMS take additional action to
ensure the accuracy and comparability of the Part C
and Part D Reported Data. The technical
specifications are frequently updated on an ad hoc
basis. CMS has also set up Part C and Part D
reporting e-mail boxes for Plans to submit questions.
However, the answers given via e-mail often do not
make it in to the next version of the technical
specifications. Sometimes two entities might receive
conflicting answers to similar questions. As a result,
Plans and even Auditors may have a different
interpretation of the requirements than what CMS
intended. We recommend that CMS publish an
ongoing list of questions / answers on the CMS web
site so that both Plans and data validation auditors
have line of sight to this additional guidance.
Additionally we recommend that CMS set up one or
more meetings with Plans and auditors to provide
definitive answers to any outstanding questions on
the requirements and on the audit itself. The
questions and answers could then be added to the
running Q/A log noted above.
We understand that CMS would want auditors to use
the same standards for evaluating Plans’ compliance
with Part C and Part D reporting requirements.
However, Plans develop their systems outputs and
their business and validation processes based on the
published reporting requirements. It is inefficient to
undergo validation of requirements that are
ambiguous or perhaps erroneous. We recommend
that CMS publish a dual document that serves as
both the reporting requirements and as the data
validation standards.

CMS thanks you for your comment
and will consider this feedback as we
continue to improve the processes and
procedures associated with the
Medicare Part C and Part D Data
Validation program.

N/A

CMS thanks you for your comment
and will consider this feedback as we
continue to improve the processes and
procedures associated with the
Medicare Part C and Part D Data
Validation program.

N/A

Page 27 of 99 
 

Comment
ID #

Date
Received

DV Document

Burden
Impact

Comment

CMS Response

We are concerned that this proposal to change the
deadline for these reports is highly inconsistent with
the goal of the data validation audit of ensuring that
Plans are reporting “data that are reliable, valid,
complete, comparable, and timely.”

CMS thanks you for your comment
and will consider this feedback as we
continue to improve the processes and
procedures associated with the
Medicare Part C and Part D Data
Validation program.

Changing the CMS due dates of these reports to 2/28
will require that Plans complete the data extraction,
consolidation and validation processes in midJanuary. This timeline is in direct conflict with
relevant business process timeframes. As a result,
these reports will have to be run before Plans have
completed all prior year claims processing, before all
prior year data is transferred to relevant data
warehouses, and before all SNP members’ health
risk assessments are completed and collected.
Below are the data completeness / accuracy concerns
specific to each of the reports:
SNP Care Management

51
 

9/24/2012

N/A

The initial health risk assessment for SNP members
is required to be completed within 90 days of
enrollment. Therefore, members with an 11/1
effective will have up to the end of January to
complete the HRA and members with a 12/1
effective will have up the end of February to
complete the HRA. When SNP members cannot be
reached by phone (a frequent occurrence with dual
eligible plan members), our vendor sends the HRA
out via mail. That document then needs to be
returned by mail, the information processed by the
vendor, and the results sent to the Plan. A full HRA
dataset would not be available until late March.

N/A

Page 28 of 99 

Serious Reportable Adverse Events
This report is based on paid claims. The proposed

Comment
ID #

52

53

Date
Received

9/24/2012

9/24/2012

DV Document

PRDVM

N/A

Burden
Impact

Comment

CMS Response

The HPMS Findings Data Collection Form when
exported to Excel is difficult to review and analyze.
The multiple merged cells make it difficult to filter
or compare the data to accurately ensure the data
findings were entered correctly. To be able to
quickly and accurately compare data findings we are
recommending CMS provide a flat report export
which will export the data with all data for specific
Standard/Sub-Standard Id’s and Measure Specific
Criteria Id combinations to fall within one row. The
descriptions, although lengthy, would also fall into
one cell within the specified row. By expanding the
one cell one would be able to see the full description.
Where some descriptions are further broken out by
Data Element by merging cells, we recommend these
fall under their own row with repeated Standard/SubStandard Id’s and Measure Specific Criteria IDs.
This will allow filtering as well as creating simple vlookups to compare data. This also gives us the
capability to upload into an Access database for
further analysis to perform additional data checks for
accuracy and also to look at year over year changes
once the findings are final.
We recommend that CMS remove the 3/31
resubmission deadline to allow Plans every
opportunity to provide CMS with correct, audited
data. In the Medicare Part C and D Reporting
Requirements Data Validation Procedure Manual
Version 2.0: December 2011, p. 1 it states:

Thank you for your comment. The
HPMS team will research this
comment and consider this
recommendation for future versions of
the HPMS Findings Data Collection
Form.

N/A

CMS thanks you for your comment
and will consider this feedback as we
continue to improve the processes and
procedures associated with the
Medicare Part C and Part D Data
Validation program. Unfortunately, at
this time the deadline cannot be
"The purpose of the independent data validation is to adjusted.
ensure that Part C and Part D organizations
(sponsoring organizations) are reporting health and

N/A

Page 29 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment

CMS Response

Burden
Impact

drug plan data that are reliable, valid, complete,
comparable, and timely. The validated data
improves reporting and provides CMS with
assurance that data are credible and consistently
collected and reported by Part C and Part D
sponsoring organizations. CMS uses these reported
data to respond to inquiries from Congress,
oversight agencies, and the public about an
organization’s performance."
Accuracy of reported data is critical to CMS, but the
Agency has limited the opportunity for Plans to
submit corrected data by imposing a 3/31
resubmission deadline. In many cases, this deadline
is 30 days from the original submission deadline.
Given the complexity of Part C and D reporting
where data is extracted from a number of enormous
systems (such as claims, care coordination,
enrollment, etc.), there is the potential for process /
system issue to have a downstream impact on
reporting data. Controls are in place to identify and
resolve these issues quickly, but there may be
instances where the data cannot be rerun and
resubmitted before the start of the audit on April 1st.
Similar to HEDIS auditing, Plans should have the
opportunity correct relatively minor issues and
resubmit the corrected data to CMS during the
course of the audit. Systemic issues in which there
are many factors that result in accurate data would
still be identified since they could not be fixed over
the course of an audit. In these cases, the Auditor
would alert CMS to an organization’s inaccurate data
and CMS would not include that data in its public
datasets.
Page 30 of 99 
 

Comment
ID #

54

Date
Received

9/24/2012

Burden
Impact

DV Document

Comment

CMS Response

Technical
Specifications,
DV Standards

On page one, the Data Validation Standards indicate
that the measure-specific criteria for each measure
“are based on the applicable Part C/Part D Reporting
Requirements Technical Specifications.” However,
we have identified several instances, which are
described below, where the Standards appear to be
inconsistent with the Technical Specifications. We
recommend that CMS review the Standards and the
Part C and Part D Technical Specifications for
consistency and revise the documents as needed.

CMS thanks you for your comment
and will consider this feedback as we
continue to improve the processes and
procedures associated with the
Medicare Part C and Part D Data
Validation program.

N/A

Page 31 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
PLAN OVERSIGHT OF AGENTS - PART C:
MSC-9e
MSC-9f

55

9/24/2012

Technical
Specifications,
DV Standards

CMS is proposing to revise this section of the Data
Validation Standards by adding two exclusions to
Data Element 9, “Organization accurately calculates
the number of “agent assisted enrollments” during
the applicable reporting period.” Specifically, CMS
is proposing to add item e., “Excludes enrollments
that became effective during the reporting period that
were assisted by agents terminated prior to the
reporting period” and item f., “Excludes agent
assisted enrollments that involve only a member’s
change from one benefit package to another within
the same contract.” However, these exclusions are
not included in the corresponding Data Element in
the Part C Reporting Requirements Technical
Specifications Document. (See Data Element 12.6,
page 33). AHIP recommends that CMS resolve this
inconsistency between the Standards and the Part C
Reporting Requirements Technical Specifications.
We note that we have identified a similar issue with
the corresponding Part D Data Validation Standards
and the related Part D Reporting Requirements
Technical Specifications, which is discussed below.

Burden
Impact

CMS Response
Measure-specific criteria 4c and 9e
have been removed from the Data
Validation Standards to remove
ambiguity. Data related to terminated
agents should not be excluded from
the counts submitted to CMS for the
Plan Oversight of Agents measure.
In addition, the following clarification
exists in the updated version of the
Part C Technical Specifications,
expected to be released by October
2012:

N/A
"If a member switches enrollment
from one benefit package to another,
within the same contract, and uses the
services of a licensed agent, this does
not count as an agent-assisted
enrollment for reporting of element
12.6."

Page 32 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
COVREAGE DETERMINATIONS &
EXCEPTIONS:

Burden
Impact

CMS Response
MSC-7a has been updated to correctly
state "date of decision."

MSC-7a

56

9/24/2012

Technical
Specifications,
DV Standards

Item a. under Element 7 of this measure indicates
that the number of reported coverage determinations
and exceptions must include “all coverage
determinations/exceptions with a date of receipt that
occurs during the reporting period, regardless of
when the final decision was made.” (Emphasis
added.) This instruction appears to be inconsistent
with the corresponding section of the Part D
Reporting Requirements Technical Specifications,
which states that requests “for coverage
determinations and exceptions should be reported
based on the decision date” (emphasis added) and
notes that this is a change from the prior year’s
specifications. (See Data Element E., page 52.)
AHIP recommends that CMS resolve the
inconsistency between the Standards and the Part D
technical specifications.

N/A

Page 33 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
PLAN OVERSIGHT OF AGENTS (PART D):
MSC-9e
MSC-9f

57

9/24/2012

Technical
Specifications,
DV Standards

As noted above, CMS is proposing to revise this
section of the Data Validation Standards in the same
manner as the comparable Part C data element, by
adding the two exclusions, item e. and item f. to Data
Element 9, “Organization accurately calculates the
number of “agent assisted enrollments” during the
applicable reporting period.” The proposed
exclusions are not reflected in the corresponding
Data Element in the Part D Reporting Requirements
Technical Specifications Document (See Data
Element F, page 73). AHIP recommends that CMS
resolve this inconsistency between the Standards and
the Part D Reporting Requirements Technical
Specifications.

Burden
Impact

CMS Response
Measure-specific criteria 4c and 9e
have been removed from the Data
Validation Standards to remove
ambiguity. Data related to terminated
agents should not be excluded from
the counts submitted to CMS for the
Plan Oversight of Agents measure.
In addition, the following clarification
exists in the updated version of the
Part C Technical Specifications,
expected to be released by October
2012:

N/A

"If a member switches enrollment
from one benefit package to another,
within the same contract, and uses the
services of a licensed agent, this does
not count as an agent-assisted
enrollment for reporting of element
12.6."

Page 34 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
PLAN OVERSIGHT OF AGENTS (PARTS C &
D):
MSC-4c
The drafted DV standards have introduced a new
criteria for DV for element 12.1 as follows: 4c.
Excludes Agents who were terminated during the
applicable reporting period. This new DV criteria
does not parallel the Technical Specifications.

Burden
Impact

CMS Response
Measure-specific criteria 4c and 9e
have been removed from the Data
Validation Standards to remove
ambiguity. Data related to terminated
agents should not be excluded from
the counts submitted to CMS for the
Plan Oversight of Agents measure.

Is the new 12.1 criteria, perhaps, a typo, in that the
intent was to say, 4c.For other organization types,
please report this reporting section under the
appropriate section in the Part D reporting
requirements. For example, MA-PDs should report
in Part D for this reporting section, listed as a
“section” in Part D. Our suspicion that the word
“during” is a typo is confirmed by inspection of DV
standard 12.5, Organization accurately calculates the
number of agents whose selling privileges were
revoked by the organization based on conduct or
discipline, including the following criteria:
a. Includes all agents with revocations initiated
during the applicable reporting period, regardless of
when the conduct causing the revocation occurred.
b. The number calculated for Data Element 12.5 is a
subset of the total number of agents calculated for
Data Element 12.1.
[Data Element 12.5]
58

 

9/21/2012

DV Standards,
FDCF

An impossible situation is created by the requirement
not report terminated agents in 12.1 and then to
report on a null situation in 12.5.
If not a typo and actually an intended change, this
new DV criteria changes the approach to 12.6 (Is
CMS asking that enrollments due to terminatedduring-the-year agents be removed from 12.6?):

N/A

Page 35 of 99 

Comment
ID #

Date
Received

DV Document

Comment
Based on the proposed changes in 508Supporting
Statement_DataValidation_20120625.pdf as well as
proposed commentary in the Federal Register Vol 77
No 130, please confirm/correct the items below,
assuming the proposed changes become final, for the
next Data Validation cycle:
PROCEDURE FREQUENCY:
1. Will not undergo data validation review for CYs
2011 - 2013.
2. Will CMS collect this measure through HPMS for
CYs 2012 - 2013?

59

9/21/2012

Supporting
Statement

PROVIDER NETWORK ADEQUACY:
1. Will not undergo data validation review for CYs
2012 - 2013.
2. Will CMS collect this measure through HPMS for
CYs 2012 - 2013?
EMPLOYER GROUP PLAN SPONSORS:
1. Will not undergo data validation review for CYs
2012 - 2013.
2. Will CMS collect this measure through HPMS for
CYs 2012 - 2013?
R/HI/LTC PHARMACY ACCESS:
1. Will not undergo data validation review for CYs
2012 - 2013.
2. Elements A&B have already been submitted to
CMS for CY 2012. Will elements C&D still be
collected for CY 2012?
3. Will CMS collect this measure through HPMS for
CY 2013?

Burden
Impact

CMS Response
Please CMS's responses to each
inquiry, as follows:
PROCEDURE FREQUENCY:
1. Will not undergo data validation
review for CYs 2011 - 2013. CONFIRMED
2. Will CMS collect this measure
through HPMS for CYs 2012 - 2013?
- 2012: Yes, 2013: No
PROVIDER NETWORK
ADEQUACY:
1. Will not undergo data validation
review for CYs 2012 - 2013. CONFIRMED
2. Will CMS collect this measure
through HPMS for CYs 2012 - 2013?
- 2012: Yes, 2013: No

N/A

EMPLOYER GROUP PLAN
SPONSORS:
1. Will not undergo data validation
review for CYs 2012 - 2013. CONFIRMED
2. Will CMS collect this measure
through HPMS for CYs 2012 - 2013?
- 2012: Yes, 2013: Yes
R/HI/LTC PHARMACY ACCESS:
1. Will not undergo data validation
review for CYs 2012 - 2013. CONFIRMED

Page 36 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment

SRAEs:

Burden
Impact

CMS Response
2. Elements A&B have already been
submitted to CMS for CY 2012. Will
elements C&D still be collected for
CY 2012? - Yes
3. Will CMS collect this measure
through HPMS for CY 2013? - Yes
This correction has been made to the
measure-specific criteria.

MSC-5a

60

9/21/2012

DV Standards,
FDCF

Typo Issue: The Standard reads - “MSC-5a:
Accurately maps SRAEs to the codes provided by
CMS in Appendix 5 of the Part C Reporting
Requirements Technical Specifications Document,
Table 2.”

N/A

Burchfield’s suggested clarification - “MSC-5a:
Accurately maps SRAEs to the codes provided by
CMS in Appendix 2 of the Part C Reporting
Requirements Technical Specifications Document,
Table 2.”

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Comment
ID #

Date
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Comment
SRAEs:

Burden
Impact

CMS Response
This correction has been made to the
measure-specific criteria.

MSC-6a

61

9/21/2012

DV Standards,
FDCF

Typo Issue: The Standard reads “MSC-6a:
Accurately maps HACs to the codes provided by
CMS in Appendix 2 of the Part C Reporting
Requirements Technical Specifications Document,
Table 3.”
Burchfield’s suggested clarification “MSC-6a:
Accurately maps HACs to the codes provided by
CMS in Appendix 2 of the Part C Reporting
Requirements Technical Specifications Document,
Table 3 and Table 4”
SRAEs:

N/A

This correction has been made to the
measure-specific criteria.

MSC-7a

62

9/21/2012

DV Standards,
FDCF

Typo Issue The Standard reads “MSC-7a:
Accurately maps HACs to the codes provided by
CMS in Appendix 52 of the Part C Reporting
Requirements Technical Specifications Document,
Table 4.”

N/A

Burchfield’s suggested clarification “MSC-7a:
Accurately maps HACs to the codes provided by
CMS in Appendix 52 of the Part C Reporting
Requirements Technical Specifications Document,
Table 4.”

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ID #

Date
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Comment
MTM:
MSC-12c

63

9/21/2012

DV Standards,
FDCF

Typo Issue: The Standard reads “MSC-12c: Properly
identifies and includes the number of changes to
drug therapy made as a result of MTM program
interventions within the reporting period for each
applicable member (includes, but is not limited to,
dosage changes, therapeutic or generic substitutions,
and discontinuation or addition of therapy). [Note to
reviewer: If the change occurred in the calendar year
after the current reporting period, but was the result
of an intervention made within the current reporting
period, the change may be reported for the current
reporting period.] [Data Elements O – Q]”

Burden
Impact

CMS Response
The updated version of the Part D
Technical Specifications, expected to
be published by October 2012
includes updated data element
designations, which align correctly
with the measure-specific criteria in
the Data Validation Standards.

N/A

Burchfield’s suggested clarification “MSC-10c:
Properly identifies and includes the number of
changes to drug therapy made as a result of MTM
program interventions within the reporting period for
each applicable member (includes, but is not limited
to, dosage changes, therapeutic or generic
substitutions, and discontinuation or addition of
therapy). [Note to reviewer: If the change occurred
in the calendar year after the current reporting
period, but was the result of an intervention made
within the current reporting period, the change may
be reported for the current reporting period.] [Data
Elements Q – S]”

Page 39 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
MTM:
MSC-9a & 9b

64

9/21/2012

DV Standards,
FDCF

Typo Issue and Burchfield’s suggested clarification:
MSC 9a and MSC 9b should be for marked as
applicable for data elements N, O, P. Currently just
element N is marked as applicable, yet the
description states "Organization accurately identifies
data on CMR dates", clearly implying the MSCs
should apply to all CMR date-related elements.
GRIEVANCES (PART C):

Burden
Impact

CMS Response
The updated version of the Part D
Technical Specifications, expected to
be published by October 2012
includes updated data element
designations, which align correctly
with the measure-specific criteria in
the Data Validation Standards.

N/A

This correction has been made to the
measure-specific criteria in the FDCF.

MSC-6

65

9/21/2012

FDCF

Typo Issue: The Standards read “Properly sorts the
total number of grievances by grievance category
Fraud; Enrollment/Disenrollment; Benefit Package;
Access; Marketing; Customer Service; Privacy
Issues; Quality of Care; and Appeals. [Data
Elements 5.1-5.5.10]”

N/A

Burchfield’s suggested clarification: “Properly sorts
the total number of grievances by grievance category
Fraud; Enrollment/Disenrollment; Benefit Package;
Access; Marketing; Customer Service; Privacy
Issues; Quality of Care; and Appeals. [Data
Elements 5.1-5.10]”

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Comment
ID #

Date
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DV Document

Comment
COVERAGE DETERMINATIONS &
EXCEPTIONS:

Burden
Impact

CMS Response
The following statement exists in the
June 2012 version of the Part D
Technical Specifications:

MSC-8d

66

9/21/2012

DV Standards,
FDCF

Guidance Issue: Measure Specific Criteria 8d (pg.
40) states, “Includes PA requests that were approved
soon after the adjudication timeframes expired (i.e.,
within 24 hours) and were not auto-forwarded to the
IRE.” So, for element C, requests approved soon
after the timeframe expired (and not sent to the IRE)
should be included (as Chapter 18 allows this grace
period). Are these requests considered timely, and as
such be reported in element D as well? In addition, if
they’re approved, should they be reported in element
E as well?
Burchfield’s suggested clarification:
i. If CMS considers such PA decisions as non-timely
for this reporting, it would be helpful to explicitly
state as such in MSCs 9 and 10. For example, insert
the following into MSCs 9 & 10 “Excludes PA
requests that were approved soon after the
adjudication timeframes expired (i.e., within 24
hours) and were not auto-forwarded to the IRE.”
ii. Alternatively, if CMS considers such PA
decisions as timely for this reporting, it would be
helpful to explicitly state as such in MSCs 9 and 10.
For example, insert the following into MSCs 9 & 10
“Includes PA requests that were approved soon after
the adjudication timeframes expired (i.e., within 24
hours) and were not auto-forwarded to the IRE.”

"Cases that were approved (fully
favorable to the enrollee) soon after
the adjudication timeframe expire
(i.e., within 24 hours) and were not
auto-forwarded to the IRE should be
included in elements C, F, I and L, but
should be excluded from elements D,
G, J, and M."
1. The answer to the first question
("Are these requests considered
timely, and as such be reported in
element D as well?") is no.

N/A

2. The answer to the second question
("In addition, if they’re approved,
should they be reported in element E
as well?") is yes, the updated version
of the Part D Technical Specifications
specifies that decisions "made by the
plan" are to be included for Elements
E, H, K, and N, which includes those
cases that were approved (fully
favorable to the enrollee) soon after
the adjudication timeframe expire
(i.e., within 24 hours) and were not
auto-forwarded to the IRE.

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ID #

Date
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DV Document

Comment
COVERAGE DETERMINATIONS &
EXCEPTIONS:

Burden
Impact

CMS Response
MSC-7a has been updated to correctly
state "date of decision."

MSC-7a

67

9/21/2012

DV Standards,
FDCF

Guidance Issue: Measure Specific Criteria 7a (pg.
39) states, "Includes all coverage
determinations/exceptions with a date of receipt that
occurs during the reporting period, regardless of
when the final decision was made." However,
Measure Specific Criteria 8a (pg. 40) states
"Includes all PA decisions made (both favorable and
unfavorable) with a date of decision that occurs
during the reporting period." Similarly, later
Measure Specific Criteria (i.e. for elements D - N)
all use language with some variation on the
requirement of reporting based on the date o
decision.
Burchfield's suggested clarification: To better align
with the Technical Specifications, we recommend
removing MSC 7a (i.e., it seems likely the intent is
to have plans report based on date of decision, not
date of receipt).
REDETERMINATIONS:
MSC-5c & 5i

68

9/21/2012

DV Standards,
FDCF

Guidance Issue: The Redeterminations specifically
states two MSCs related to IRE activity:
i. “Includes redetermination requests that were
forwarded to the IRE because the organization failed
to make a timely decision.” MSC 5c
ii. “Excludes IRE decisions, as they are considered
to be the second level of appeal”. MSC 5i

N/A

The Coverage Determinations and
Exceptions measure-specific criteria
have been updated to include the
following language for Elements E,
H, K, and N: "Excludes decisions
made by the IRE." In addition, the
Part D Technical Specifications have
been updated to specify that only
those decisions "made by the plan"
are to be included in the counts for
Elements E, H, K, and N.

N/A

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Comment
ID #

Date
Received

DV Document

Comment

CMS Response

Burden
Impact

The phrase "enhanced alternative
drugs" has been removed from MSC5d and updated to state: "Excludes

N/A

Clearly, plans should count redetermination requests
received by the plan, yet forwarded to the IRE if the
plan did not meet the timely decision requirement.
However, plans should exclude the actual decision
made by the IRE from reporting.
Coverage Determinations/Exceptions does have IRE
language for elements C, D, F, G, I, J, L, and M.
Elements C, F, I, and L all have MSCs stating
“Includes [exception type] requests that were
forwarded to the Independent Review Entity (IRE)
because the organization failed to make a timely
decision. “ Additionally, elements D, G, J, and M all
have MSCs stating “Excludes [exception type]
requests that were forwarded to the IRE because the
organization failed to make a timely decision.”
However:
a. There is no Coverage Determinations/Exceptions
element with language similar to Redeterminations
MSC 5i.
b. Additionally, elements E, H, K, and N have no
IRE language at all. Each of these introduces
reporting ambiguity.

69

9/21/2012

DV Standards,
FDCF

Burchfield’s suggested clarification: A simple fix to
remove both ambiguities:
i. For elements C – N: introduce an MSC for each
element similar to Redeterminations MSC 5i:
“Excludes IRE decisions, as they are considered to
be the second level of determination.”
COVERAGE DETERMINATIONS &
EXCEPTIONS:

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Comment
ID #

Date
Received

DV Document

Comment
MSC-5d
Guidance Issue: MSC 5d reads "Excludes pharmacy
transactions for excluded drugs and enhanced
alternative drugs." However, this language is not
repeated for any elements C - N, leading to
ambiguity around whether plans should include
excluded products in the counts for UM decisions.

Burden
Impact

CMS Response
pharmacy transactions for excluded
drug categories."
In addition, MSC-7g has been
updated to read: "Excludes coverage
determinations/ exceptions regarding
excluded drug categories."

Burchfield's suggested clarification:
i. If the intent is to never have plans report excluded
and EA drugs in any element C - N of the report, we
recommend explicitly adding in as an MSC for each
element.
ii. Alternatively, if the intent is to allow plans to
report such products in any elements C - N, leave the
language as-is.
COVERAGE DETERMINATIONS &
EXCEPTIONS:

70

9/21/2012

DV Standards,
FDCF

Please note that the Part D Technical
Specifications state: "A coverage
determination is timely only when the
sponsor makes a decision and
MSC-9b
appropriately notifies the enrollee of
the decision within the applicable
Guidance Issue: MSC 9b reads "Excludes favorable
adjudication timeframe. For
determinations in which the sponsor did not
approvals, sponsors must also
authorize or provide the benefit or payment under
dispute according to the following timelines..." There authorize or provide the benefit (or
payment) under dispute within the
is similar language in MSCs for elements G, J, and
applicable adjudication timeframe.
M. This is the first time appearance of the words
Sponsors should refer to Chapter 18,
payment dispute in the Measure Standards, and we
Sections 40, 50, and 130 of the
want to be sure we understand the intention.
Prescription Drug Benefit Manual."
Certainly, an enrollee’s dispute about payment is a
For this reporting, coverage
coverage determination (per Chapter 18). Now, the
determinations should encompass any
specific mention of excluding non-timely payment
payments that fall into one of the
dispute decisions from Element D seems to imply
specified reporting categories. Any
that timely payment dispute decisions should be

N/A

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Comment
ID #

Date
Received

DV Document

Comment
included in Element D, and both timely and nontimely payment dispute decisions should be included
in Element C. A similar explanation applies to all
other elements F –N.

CMS Response

Burden
Impact

payments that do not fall into one of
the specified reporting categories
should not be reported in this
reporting section.

However, consider the following clarification about
payment disputes previously received from CMS,
which states payment disputes should not be
included in any elements except Element A:
(email to CMS on 2/15/2012)
"Hi Part D Plan Reporting,
Suppose a member fills a prescription at an out-ofnetwork pharmacy (for example, they were on
vacation and not near any network pharmacies). The
pharmacy charges them a higher copay than they’re
used to, and they file a request to be reimbursed by
the plan. Per Chapter 18, these are coverage
determinations. However, suppose the drug was a
generic drug, available on the plan’s formulary, and
is a drug the member regularly receives. In other
words, this coverage determination request isn’t
really a UM-related exception (i.e. it’s not a nonformulary, or tiering exception, etc.).
Certainly, the member’s fill will constitute a
“pharmacy transaction”, so it will be reported in
element A of this report (total pharmacy
transactions). However, should this particular
determination scenario (direct member
reimbursement, but unrelated to PA or UM
exceptions) also be reported in any element C – J of
this report, and if so, which element?"
(response from CMS on 2/24/2012)
"No, this particular scenario would not be reported in
Page 45 of 99 
 

Comment
ID #

Date
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DV Document

Comment

Burden
Impact

CMS Response

any other element besides element A."
Burchfield’s suggested clarification:
i. If the intent is for plans to include payment
disputes in all elements C – N as applicable, we
recommend adding a similar clarification to element
C – N’s MSCs, so there is no ambiguity. This way it
will be clear to plans that payment disputes should
be included, as applicable, in elements C – N.
ii. Alternatively, if the previous email clarification is
still the recommended course of action (i.e., payment
related disputes should not appear in any elements C
– N), we recommend removing the references to the
words payment disputes in elements C – N.
MTM:
Standards 2e & 3a
Typo Issue: Sections 2.e and 3.a have scoring up to
“Data Element J” and continue to contain “Section
II”.
71

9/21/2012

FDCF

Burchfield’s suggested clarification:
i. Data elements should go up to “Data Element S”,
based on the new DV Measure Standards.
ii. Additionally, “Section II” is no longer identified
as such in the DV Measure Standards: recommend
removal from FDCF
iii. Finally, “Data Element A” is no longer present in
the new DV Measure Standards: recommend
removing from the FDCF or recommend “renumbering” the DV Measure Standards

The updated version of the Part D
Technical Specifications, expected to
be published by October 2012 will
include updated data element
designations, which align correctly
with the measure-specific criteria in
the FDCF. In addition, "Section II"
and the "Data Element A" cell have
been removed from Column E in the
FDCF.

N/A

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ID #

Date
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DV Document

Comment
MTM:
MSC-9a & 9b

72

9/21/2012

FDCF
Typo Issue and Burchfield’s suggested clarification:
MSC 9a and MSC 9b should be present for data
elements N, O, P
MTM:
MSC-10a, 10b, & 10c

73

9/21/2012

FDCF
Typo Issue and Burchfield’s suggested clarification:
MSC 10a, MSC10b, and MSC10c should be present
for data elements Q, R, S
COVERAGE DETERMINATIONS &
EXCEPTIONS:
Standards 2e & 3a

74

75

76

9/21/2012

9/21/2012

9/26/2012

FDCF

FDCF

DV Standards,
FDCF

Typo Issue and Burchfield’s suggested clarification:
Sections 2.e and 3.a scoring goes up to “Data
Element J”. However, it seems the data elements
should go up to “Data Element N”, based on the new
DV Measure Standards.
REDETERMINATIONS:

Burden
Impact

CMS Response
The updated version of the Part D
Technical Specifications, expected to
be published by October 2012 will
include updated data element
designations, which align correctly
with the measure-specific criteria in
the FDCF.
The updated version of the Part D
Technical Specifications, expected to
be published by October 2012 will
include updated data element
designations, which align correctly
with the measure-specific criteria in
the FDCF.
The scoring (column E) in the FDCF
for Standard 2e has been corrected in
the updated version of the FDCF. In
addition, the scoring for Standard 3a
has been corrected to include
Elements K - N.

The scoring (column E) in the FDCF
for Standards 2a and 2e has been
Typo Issue: The Findings Data Collection Form does corrected in the updated version of the
FDCF.
not have Data Element “D”.
Burchfield’s suggested clarification: Add Element D.
Data Validation Standard 1c,
DV Standard 1c
changed:
Currently, the Standard reads: “Source documents
“Source documents are error-free
are error-free (e.g., programming code and

N/A

N/A

N/A

N/A

N/A

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ID #

Date
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DV Document

Comment
spreadsheet formulas have no messages or warnings
indicating errors)”
Comment: This standard for 2013 (unchanged since
2011) remains unclear and not useful to validation of
the programming code. There are many times, where
programming code will not throw an error, warning
or other message, but it remains in-fact wrong in
pulling the correct data from many stand points, for
example:
1. The code’s select statements pulls from the wrong
or incomplete fields

CMS Response

Burden
Impact

(e.g., programming code and
spreadsheet formulas have no
messages or warnings indicating
errors).”
TO:
“Source documents are error-free
(e.g., programming code and
spreadsheet formulas have no
messages or warnings indicating
errors, use correct fields, have
appropriate data selection etc.)”

2. The codes select statement uses WHERE or
ORDERBY clauses which produce inaccurate results
(e.g. when the code for pulling enrollment records to
calculate Member Months in MTMP chooses
enrollment records based the last record modified
according to record time stamp as the most current
record for an enrollee, compared to pulling the
selecting the most current “open” enrollment period.)
3. The code pulls records with nulls in fields and so
on, so this Standard will not address basic coding
errors.
ACG recommends that CMS modify this Standard to
read: “Source documents are error-free (e.g.,
programming code and spreadsheet formulas have
no messages or warnings indicating errors, use
correct fields, have appropriate data selection etc.)”

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ID #

Date
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DV Document

Comment
Section 3.3 Requirement for Extraction and Review
of Source Data – Exhibit 5:
ACG recommends the following changes to the
examples of source data to review
i. Part C and Part D Grievances: ACG recommends
that reviewers also review case notes from
Grievances to assure proper categorization; case
notes can be included in the data sample pulled from
systems.

77

9/26/2012

DESI

ii. MTMP: ACG notes that Claims files will NOT
confirm medication reviews or prescriber
interventions (prescriber letters or other
communications will,) it can only confirm changes
to drug therapy.
iii. Coverage Determinations: Similar to Part C and
Part D Grievances, ACG recommends the inclusion
of Coverage Determination Case Notes in the
recommended source data review (this can be
included in data sample pulls by most plans and
PBMs). These case notes are typically the only way
to determine if by example i) the Plan/PBM includes
PA exceptions in the exceptions reports and ii)
formulary exceptions were properly reported in the
right reporting category.

Burden
Impact

CMS Response
Case notes have been added as a
source data example for Grievances
and Coverage Determinations.
Regarding the references to
medication reviews and prescriber
interventions, CMS agrees and
therefore has revised the source data
examples to:
1 - Remove references of confirming
medication reviews and prescriber
interventions with claims files.
2 - Include evidence of
communication (i.e. prescriber letters)
which can be used to confirm
medication reviews and prescriber
interventions.

N/A

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ID #

Date
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DV Document

Comment

Burden
Impact

CMS Response

Section 3.4 Evaluating the Data:

Changed:

For 2013 CMS adds the following to the
instructions: “including the number of errors found
when examining the source data”

“including the number of errors found
when examining the source data.”
TO:

78

9/26/2012

DESI

ACG recommends that CMS change this statement
to read “including the number and percentage of
errors or variance from HPMS filed data found when
examining the source data.” This more clearly ties
the results of the sampling to CMS’ standard of pass
or fail to 10% variance in the sample to the reported
data.
GRIEVANCES (PART D):
MSC-5g
Medicare Part D Technical Specifications for 2012,
page 44, VII-E: In section E. Notes, the 4th bullet
clarifies that withdrawn grievances should be
excluded from reporting.

N/A
“including the number and percentage
of errors or variance from HPMS filed
data found when examining the
source data.”

The Part C Technical Specifications
and measure-specific criteria will be
updated to exclude withdrawn Part C
grievances for the 2013 reporting
year.

Questions and Request for Clarification:
79

9/26/2012

DV Standards,
FDCF

For the identification of grievance withdrawals, why
would it apply to Part D and not Part C? The
difference between Part C and Part D grievance
regulations is minimal and there should be no reason
for one and not the other.

N/A

Also, why is there a special change for grievance
withdrawal when such a provision does not exist in
the regulations? ACG strong believes that the
exclusion of grievance withdrawals has the potential
of causing confusion in the market.
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ID #

Date
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DV Document

Comment
SNP:
MSC-6a
6. "Organization accurately calculates the number of
initial assessments performed on new members,
including the following criteria:
a. Includes all initial assessments that were
completed (within 90 days of enrollment) confirmed

Burden
Impact

CMS Response
The language "Includes all initial
assessments that were completed
(within 90 days of enrollment)" refers
only to the time period (90 days) after
the member enrolls with the plan.

actually
occurred
during
a previous
reporting
during the
reporting
period
(even if the
event
period).”
80

9/26/2012

DV Standards,
FDCF

ACG requests CMS to clarify if the “within 90 days
of enrollment” can include both 90 days prior to
enrollment as well as 90 days after enrollment?

N/A

Rationale: During AEP, Plans can receive Notice of
Enrollment letters in October for members that will
be effective January 1, 201x. The Notice period
during AEP can be 90 days. Some Plans have
assessment programs where contact is initiated with
the enrollees as soon as the Notice of Enrollment is
received. This contact would occur prior to the
effective date of enrollment. The purpose of the
contact is to promote seamless transitional care and
it would seem appropriate to count these
assessments.

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Comment
ID #

Date
Received

DV Document

Comment
SRAE, DV Standard 1a: Remove the words "and
output" to reflect clarified guidance to standards in
Procedure Manual.

81

8/10/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
DV Standard 1a, changed:
"Source documents and output are
properly secured so that source
documents can be retrieved at any
time to validate the information
submitted to CMS via HPMS."

N/A
TO:

SRAE: Move MSC from 4b to 4a, where it is more
applicable.

"Source documents are properly
secured so that source documents can
be retrieved at any time to validate the
information submitted to CMS via
HPMS."
MSC-4a, changed:
"Includes all surgeries with dates of
service that occur during the reporting
period."

82

8/10/2012

DV Standards,
FDCF

TO:

N/A

"Includes all surgeries with dates of
service that occur during the reporting
period. If a date of service is not
available, date of discharge is
acceptable."

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Comment
ID #

Date
Received

DV Document

Comment
SRAE: Move MSC from 4b to 4a, where it is more
applicable.

83

8/10/2012

Burden
Impact

CMS Response
MSC-4b, changed:
"Includes only surgeries that occur in
an acute inpatient hospital setting. If a
date of service is not available, date of
discharge is acceptable"

DV Standards,
FDCF

N/A

TO:
"Includes only surgeries that occur in
an acute inpatient hospital setting."
MSC-5b, changed:

84

85

8/10/2012

8/10/2012

DV Standards,
FDCF

DV Standards,
FDCF

SRAE, MSC-5b: Update to maintain consistency
with the guidance in the 2011 tech specs: “if a report
by date of service is not practical or possible then a
"Includes all specified SRAEs that are
report by discharge date is acceptable."
confirmed during the reporting period
(even if the event actually occurred
during a previous reporting period).
N/A
TO:

SRAE: MSC-5e was originally incorporated in
response to the statement in the 2010 tech specs: “If
an SRAE event is alleged to have occurred in a
previous reporting period but you do not receive a
credible report until a later reporting period, you
report the event in the later reporting period. In other
words report them via HPMS as you become aware
of confirmed SRAE events.” This statement has
since been removed from the tech specs; remove it
from the MSC.

"Includes all specified SRAEs that are
confirmed during the reporting period.
If date of service is not available, date
of discharge is acceptable.
MSC-5e, deleted:
"Includes any supplemental
information provided by the hospital
regarding SRAEs that are confirmed
during the reporting period (even if
the event actually occurred during a
previous reporting period)."

N/A

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Comment
ID #

Date
Received

DV Document

Comment
SRAE: Update to maintain consistency with the
guidance in the 2011 tech specs: “if a report by date
of service is not practical or possible then a report by
discharge date is acceptable."

86

87

8/10/2012

8/10/2012

DV Standards,
FDCF

DV Standards,
FDCF

Burden
Impact

CMS Response
MSC-6b, changed:
"Includes all specified HACs that are
confirmed during the reporting period
(even if the event actually occurred
during a previous reporting period).
The diagnosis code and procedure
code may be on the same claim or on
different claims, and may or may not
be on the same date of service."

N/A
TO:

SRAE: MSC-6f was originally incorporated in
response to the statement in the 2010 tech specs: “If
an SRAE event is alleged to have occurred in a
previous reporting period but you do not receive a
credible report until a later reporting period, you
report the event in the later reporting period. In other
words report them via HPMS as you become aware
of confirmed SRAE events.” This statement has
since been removed from the tech specs; remove it
from the MSC.

"Includes all specified HACs that are
confirmed during the reporting period.
If date of service is not available, date
of discharge is acceptable. The
diagnosis code and procedure code
may be on the same claim or on
different claims, and may or may not
be on the same date of service."
MSC-6f, deleted:
"Includes any supplemental
information provided by the hospital
regarding HACs that are confirmed
during the reporting period (even if
the event actually occurred during a
previous reporting period)."

N/A

Page 54 of 99 
 

Comment
ID #

88

Date
Received

8/10/2012

DV Document

DV Standards,
FDCF

Comment

SRAE, MSC-7b: Update to maintain consistency
MSC-7b, changed:
with the guidance in the 2011 tech specs: “if a report
by date of service is not practical or possible then a
"Includes all specified HACs that are
report by discharge date is acceptable."
confirmed during the reporting period
(even if the event actually occurred
during a previous reporting period).
The diagnosis code and procedure
code may be on the same claim or on
different claims, and may or may not
be on the same date of service."
N/A
TO:

SRAE: Move "or date of discharge, if date of service
is unavailable" from MSC-7e to 7b, where it is more
applicable.

89

8/10/2012

DV Standards,
FDCF

Burden
Impact

CMS Response

"Includes all specified HACs that are
confirmed during the reporting period.
If date of service is not available, date
of discharge is acceptable. The
diagnosis code and procedure code
may be on the same claim or on
different claims, and may or may not
be on the same date of service."
MSC-7e, changed:
"For Data Element 3.18, includes SSI
diagnosis codes with a date of service
(or date of discharge, if date of service
is unavailable) that extends 30 days
from the date of service."

N/A

TO:
"For Data Element 3.18, includes SSI
diagnosis codes with a date of service
that extends 30 days from the date of
service."
Page 55 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
SRAE: Move "or date of discharge, if date of service
is unavailable" from MSC-7f to 7b, where it is more
applicable.

90

8/10/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
MSC-7e, changed:
"For Data Element 3.19, includes SSI
diagnosis codes with a date of service
(or date of discharge, if date of service
is unavailable) that extends 30 days
from the date of service."

N/A

TO:

SRAE: Move "or date of discharge, if date of service
is unavailable" from MSC-7g to 7b, where it is more
applicable.

91

8/10/2012

DV Standards,
FDCF

"For Data Element 3.19, includes SSI
diagnosis codes with a date of service
that extends 30 days from the date of
service."
MSC-7e, changed:
"For Data Element 3.20, includes SSI
diagnosis codes with a date of service
(or date of discharge, if date of service
is unavailable) that extends 30 days
from the date of service."

N/A

TO:
"For Data Element 3.20, includes SSI
diagnosis codes with a date of service
that extends 30 days from the date of
service."

Page 56 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment

Burden
Impact

CMS Response

Grievances (Part C): Add guidance to reflect updated Added the following two statements
policy clarification on aggregating quarterly data
to the header information for Part C
before applying 90% threshold.
Grievances:

92

8/10/2012

"Note to reviewer: Aggregate all
quarterly data submitted within the
reporting year before applying the
90% threshold."

DV Standards,
FDCF

Grievances (Part C), DV Standard 1a: Remove the
words "and output" to reflect clarified guidance to
standards in Procedure Manual.

93

8/10/2012

DV Standards,
FDCF

N/A

"Note to reviewer: Apply the 90%
threshold to the total count of
grievances calculated. Do not apply
the 90% threshold to individual
grievance categories."
DV Standard 1a, changed:
"Source documents and output are
properly secured so that source
documents can be retrieved at any
time to validate the information
submitted to CMS via HPMS."
N/A
TO:
"Source documents are properly
secured so that source documents can
be retrieved at any time to validate the
information submitted to CMS via
HPMS."

Page 57 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Grievances (Part C), MSC-4: Add the word
“improperly” to make it consistent in the Part D
Grievance MSC.

94

95

8/10/2012

8/10/2012

DV Standards,
FDCF

DV Standards,
FDCF

8/10/2012

DV Standards,
FDCF

MSC-4, changed:
"Requests for organization
determinations or appeals are not
categorized as grievances."
N/A

TO:

Grievances (Part C), MSC-5: add language to reflect
the statement in the updated version of the Part C
Technical Specifications: “Report grievances if the
member is ineligible on the date of the call to the
plan but was eligible previously.”

Grievances (Part C), MSC-5: Remove "under the
applicable grievance category" because the purpose
of this MSC is to ensure multiple issues are recorded
as separate grievances. The correct categorization of
each of those issues should be verified by MSC-6.
96

Burden
Impact

CMS Response

"Requests for organization
determinations or appeals are not
improperly categorized as
grievances."
Added MSC-5b:
"Includes all grievances reported by
or on behalf of members who were
previously eligible, regardless of
whether the member was eligible on
the date that the grievance was
reported to the organization."
MSC-5c, changed:

N/A

"If a grievance contains multiple
issues filed under a single
complainant, each issue is calculated
as a separate grievance under the
applicable grievance category."

N/A

TO:
"If a grievance contains multiple
issues filed under a single
complainant, each issue is calculated
as a separate grievance."
Page 58 of 99 
 

Comment
ID #

97

Date
Received

8/10/2012

DV Document

DV Standards,
FDCF

Comment
Organization Determinations / Reconsiderations:
Add guidance to reflect updated policy clarification
on aggregating quarterly data before applying 90%
threshold.

Organization Determinations / Reconsiderations, DV
Standard 1a: Remove the words "and output" to
reflect clarified guidance to standards in Procedure
Manual.

98

8/10/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
Added the following statement to the
header information for Organization
Determinations / Reconsiderations:

N/A

"Note to reviewer: Aggregate all
quarterly data submitted within the
reporting year before applying the
90% threshold."
DV Standard 1a, changed:
"Source documents and output are
properly secured so that source
documents can be retrieved at any
time to validate the information
submitted to CMS via HPMS."

N/A
TO:
"Source documents are properly
secured so that source documents can
be retrieved at any time to validate the
information submitted to CMS via
HPMS."

Page 59 of 99 
 

Comment
ID #

99

Date
Received

8/10/2012

DV Document

DV Standards,
FDCF

Comment
Organization Determinations / Reconsiderations,
MSC-4b: Prior authorization requests are
organization determinations and therefore covered
by MSC-4a. Remove "and prior authorization
requests if applicable, regardless of when the request
was received." This will keep MSC-4b focused
solely on adjudicated claims.

Burden
Impact

CMS Response
MSC-4b, changed:
"Includes adjudicated claims with a
date of adjudication that occurs during
the reporting period and prior
authorization requests if applicable,
regardless of when the request was
received. "

N/A

TO:

Organization Determinations / Reconsiderations:
consolidate MSC-7b and MSC-7c into one MSC.

100

8/10/2012

"Includes all adverse payment (claim)
organization determinations that result
in zero payment being made to noncontract providers."

DV Standards,
FDCF

N/A
TO:

Organization Determinations / Reconsiderations:
consolidate MSC-7b and MSC-7c into one MSC.
101

8/10/2012

DV Standards,
FDCF

"Includes adjudicated claims with a
date of adjudication that occurs during
the reporting period."
MSC-7b, changed:

"Includes all adverse payment (claim)
organization determinations that result
in zero payment being made to
contract and non-contract providers."
MSC-7c, deleted:
"Includes all adverse payment (claim)
organization determinations that result
in zero payment being made to
contract providers/suppliers."

N/A

Page 60 of 99 
 

Comment
ID #

102

103

Date
Received

8/10/2012

8/10/2012

DV Document

DV Standards,
FDCF

DV Standards,
FDCF

Comment
Organization Determinations / Reconsiderations,
MSC-10c: remove this MSC as CMS is no longer
differentiating between contract and non-contract
providers.

Organization Determinations / Reconsiderations,
MSC-11c: remove this MSC as CMS is no longer
differentiating between contract and non-contract
providers.

Organization Determinations / Reconsiderations:
consolidate MSC-12b and MSC-12c into one MSC.

104

8/10/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
MSC-10c, deleted:
"Properly defines contract and noncontract providers/suppliers based on
whether the provider/supplier is under
contract for the plan in which the
member is enrolled on the date of
service."
MSC-11c, deleted:
"Properly defines contract and noncontract providers/suppliers based on
whether the provider/supplier is under
contract for the plan in which the
member is enrolled on the date of
service."
MSC-12b, changed:

N/A

N/A

"Includes all adverse payment (claim)
reconsideration determinations that
result in zero payment being made to
non-contract providers."
N/A
TO:
"Includes all adverse payment (claim)
reconsideration determinations that
result in zero payment being made to
contract and non-contract providers."

Page 61 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Organization Determinations / Reconsiderations:
consolidate MSC-12b and MSC-12c into one MSC.

105

106

8/10/2012

8/10/2012

DV Standards,
FDCF

DV Standards,
FDCF

Organization Determinations / Reconsiderations,
MSC-12d: remove this MSC as CMS is no longer
differentiating between contract and non- contract
providers.

Plan Oversight of Agents (Part C), DV Standard 1a:
Remove the words "and output" to reflect clarified
guidance to standards in Procedure Manual.

107

8/10/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
MSC-12c, deleted:
"Includes all adverse payment (claim)
reconsideration determinations that
result in zero payment being made to
contract providers/suppliers."
MSC-12d, deleted:
"Properly defines contract and noncontract providers/suppliers based on
whether the provider/supplier is under
contract for the plan in which the
member is enrolled on the date of
service."
DV Standard 1a, changed:

N/A

N/A

"Source documents and output are
properly secured so that source
documents can be retrieved at any
time to validate the information
submitted to CMS via HPMS."
N/A
TO:
"Source documents are properly
secured so that source documents can
be retrieved at any time to validate the
information submitted to CMS via
HPMS."

Page 62 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Plan Oversight of Agents (Part C), MSC-5a: update
in response to #183 in the Part C Industry Questions
spreadsheet.

108

109

8/10/2012

8/10/2012

DV Standards,
FDCF

DV Standards,
FDCF

8/10/2012

DV Standards,
FDCF

MSC-5a, changed:
"Includes all agents with
investigations that were completed
during the applicable reporting period,
regardless of when the complaint was
received."
TO:

Plan Oversight of Agents (Part C), MSC-5: update in
response to #183 in the Part C Industry Questions
spreadsheet.

Plan Oversight of Agents (Part C), MSC-9c: 800
series plans do not have to report this measure, the
additional guidance re: excluding 800-series agentassisted enrollments is not necessary and may
confuse readers. Update accordingly.
110

Burden
Impact

CMS Response

N/A

"Includes all agents with
investigations that were completed
during the applicable reporting period,
regardless of when the complaint was
received and whether the member
remained enrolled, disenrolled, or
declined enrollment during the
enrollment process."
Added MSC-5d:
"Excludes investigations in which the
member or agent could be not
contacted."
MSC-9c, changed:
"Includes agent assisted enrollments
from both the individual and group
enrollment process (excluding 800series agent assisted enrollments)."

N/A

N/A

TO:
"Includes agent assisted enrollments
from both the individual and group
enrollment process."
Page 63 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
SNP, DV Standard 1a: Remove the words "and
output" to reflect clarified guidance to standards in
Procedure Manual.

111

8/10/2012

DV Standards,
FDCF

8/10/2012

DV Standards,
FDCF

DV Standard 1a, changed:
"Source documents and output are
properly secured so that source
documents can be retrieved at any
time to validate the information
submitted to CMS via HPMS."
N/A
TO:

SNP, MSC-5: Assessments in the Part C Technical
Specifications are referred to as “health risk
assessments.” Update MSC-5 to mirror this
language.

112

Burden
Impact

CMS Response

"Source documents are properly
secured so that source documents can
be retrieved at any time to validate the
information submitted to CMS via
HPMS."
MSC-5, changed:
"Organization accurately calculates
the number of members eligible for a
reassessment during the reporting
period"
N/A
TO:
"Organization accurately calculates
the number of members eligible for an
annual health risk reassessment
during the reporting period"

Page 64 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
MTM, DV Standard 1a: Remove the words "and
output" to reflect clarified guidance to standards in
Procedure Manual.

113

114

115

8/10/2012

8/10/2012

8/10/2012

DV Standards,
FDCF

DV Standards,
FDCF

DV Standards,
FDCF

Burden
Impact

CMS Response
DV Standard 1a, changed:
"Source documents and output are
properly secured so that source
documents can be retrieved at any
time to validate the information
submitted to CMS via HPMS."

N/A
TO:

MTM,MSC-7a: Per question ID # 116 in the Part D
Industry Questions spreadsheet, update this MSC to
align with the new verbiage added to the Notes
section in the Part D Technical Specifications:
"Sponsors should not count and report a 12/31
disenrollment date as a true opt-out due to
disenrollment."

"Source documents are properly
secured so that source documents can
be retrieved at any time to validate the
information submitted to CMS via
HPMS."
MSC-7a, changed:
"Properly identifies and includes
members’ date of MTM program optout that occurs within the reporting
period."
N/A
TO:

MTM, MSC-8c: Remove this as MSC-4 includes
verification that the sponsor is defining CMR
correctly. This could lead to a no finding in both
places for the same mistake.

"Properly identifies and includes
members’ date of MTM program optout that occurs within the reporting
period, but prior to 12/31."
MSC-8c, deleted:
"Includes all spoken conversations,
voicemails, messages left on
answering machines, or welcome
letters that include a clear offer for a
CMR."

N/A

Page 65 of 99 
 

Comment
ID #

116

117

Date
Received

8/10/2012

8/10/2012

DV Document

DV Standards,
FDCF

DV Standards,
FDCF

Comment
MTM, MSC-8d: Remove this as MSC-4 includes
verification that the sponsor is defining CMR
correctly. This could lead to a no finding in both
places for the same mistake.

MTM, MSC-9b: Remove this as MSC-4 includes
verification that the sponsor is defining CMR
correctly. This could lead to a no finding in both
places for the same mistake.

MTM, MSC-10b: change “should be” to “is” to
remove any potential confusion or room for
interpretation.

118

8/10/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
MSC-8d, deleted:
"Excludes MTM members who the
organization cannot confirm received
the offer (e.g., returned mail or
incorrect phone numbers)."
MSC-9b, deleted:
"Excludes members who were not
delivered a CMR per CMS definitions
(including a person-to-person,
interactive CMR conducted in realtime with a written summary
delivered to the member)."
MSC-10b, changed:
"Properly identifies and includes the
number of prescriber interventions
within the reporting period for each
applicable member, regardless of the
success or result of the intervention,
and counts these interventions based
on the number of unique interventions
made to prescribers (e.g., the number
is not equal to the total number of
prescribers that received intervention
recommendations from the
organization). Organization does not
count each individual problem
identified per prescriber intervention
(e.g., if the organization sent a
prescriber a fax identifying 3 drug
therapy problems for a member, this
should be reported as 1 intervention)."

N/A

N/A

N/A

TO:
Page 66 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment

Burden
Impact

CMS Response

"Properly identifies and includes the
number of prescriber interventions
within the reporting period for each
applicable member, regardless of the
success or result of the intervention,
and counts these interventions based
on the number of unique interventions
made to prescribers (e.g., the number
is not equal to the total number of
prescribers that received intervention
recommendations from the
organization). Organization does not
count each individual problem
identified per prescriber intervention
(e.g., if the organization sent a
prescriber a fax identifying 3 drug
therapy problems for a member, this
is reported as 1 intervention)."
Grievances (Part D): Add guidance to reflect updated Added the following two statements
to the header information for Part D
policy clarification on aggregating quarterly data
before applying 90% threshold.
Grievances:

119

8/10/2012

DV Standards,
FDCF

"Note to reviewer: Aggregate all
quarterly data submitted within the
reporting year before applying the
90% threshold."

N/A

"Note to reviewer: Apply the 90%
threshold to the total count of
grievances calculated. Do not apply
the 90% threshold to individual
grievance categories."

Page 67 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Grievances (Part D), DV Standard 1a: Remove the
words "and output" to reflect clarified guidance to
standards in Procedure Manual.

120

121

8/10/2012

8/10/2012

DV Standards,
FDCF

DV Standards,
FDCF

Burden
Impact

CMS Response
DV Standard 1a, changed:
"Source documents and output are
properly secured so that source
documents can be retrieved at any
time to validate the information
submitted to CMS via HPMS."

N/A
TO:

Coverage Determinations and Exceptions: Add
guidance to reflect updated policy clarification on
aggregating quarterly data before applying 90%
threshold.

"Source documents are properly
secured so that source documents can
be retrieved at any time to validate the
information submitted to CMS via
HPMS."
Added the following statement to the
header information for Coverage
Determinations and Exceptions:
"Note to reviewer: Aggregate all
quarterly data submitted within the
reporting year before applying the
90% threshold."

N/A

Page 68 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Coverage Determinations and Exceptions, DV
Standard 1a: Remove the words "and output" to
reflect clarified guidance to standards in Procedure
Manual.

122

8/10/2012

DV Standards,
FDCF

124

8/10/2012

8/10/2012

"Source documents and output are
properly secured so that source
documents can be retrieved at any
time to validate the information
submitted to CMS via HPMS."
N/A

DV Standards,
FDCF

DV Standards,
FDCF

DV Standard 1a, changed:

TO:

Coverage Determinations and Exceptions, MSC-3b:
Update to reflect clarified guidance to standards in
Procedure Manual re: "other outputs."

123

Burden
Impact

CMS Response

"Source documents are properly
secured so that source documents can
be retrieved at any time to validate the
information submitted to CMS via
HPMS."
MSC-3b, changed:
"All source, intermediate, and final
stage data sets relied upon to enter
data into HPMS are archived."
N/A

TO:

Coverage Determinations and Exceptions, MSC-6:
Update per the new language in the Part D Technical
Specifications: "Multiple transactions for the same
claim should be counted individually." This is in
response to Question #64 in the Part D Industry
Questions spreadsheet.

"All source, intermediate, and final
stage data sets and other outputs relied
upon to enter data into HPMS are
archived."
Added MSC-6d:
"If a prescription drug claim contains
multiple rejections, each rejection is
calculated as a separate pharmacy
transaction."

N/A

Page 69 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Coverage Determinations and Exceptions, MSC-7a:
Update to reflect language in the Part D Technical
Specifications re: "date of decision."

125

8/10/2012

DV Standards,
FDCF

8/10/2012

DV Standards,
FDCF

Coverage Determinations and Exceptions, MSC-9d:
change “should be” to “is” to remove any potential
confusion or room for interpretation.

127

8/10/2012

DV Standards,
FDCF

MSC-7a, changed:
"Includes all coverage
determinations/exceptions with a date
of receipt that occurs during the
reporting period, regardless of when
the final decision was made."
N/A

TO:

Coverage Determinations and Exceptions, MSC-8a:
Remove as this is repetitive of MSC-7a.
126

Burden
Impact

CMS Response

"Includes all coverage
determinations/exceptions with a date
of decision that occurs during the
reporting period, regardless of when
the request for coverage determination
or exception was received."
MSC-8a, deleted:
"Includes all PA decisions made (both
favorable and unfavorable) with a
date of decision that occurs during the
reporting period."
MSC-9d, changed:

N/A

"Number calculated for timely PA
decisions (Data Element D) should be
a subset of the number of PA
decisions made (Data Element C)."
N/A
TO:
"Number calculated for timely PA
decisions (Data Element D) is a subset
of the number of PA decisions made
(Data Element C)."
Page 70 of 99 

 

Comment
ID #

128

129

130

Date
Received

8/10/2012

8/10/2012

8/10/2012

DV Document

DV Standards,
FDCF

DV Standards,
FDCF

DV Standards,
FDCF

Comment
Coverage Determinations and Exceptions, MSC-10:
Add language to exclude IRE decisions from the
count for Data Element E in response to Question
#70 in the Part D Industry Questions spreadsheet and
to align with the updated language in the Part D
Technical Specifications that only decisions "made
by the plan" are to be included.
Coverage Determinations and Exceptions, MSC-10d:
change “should be” to “is” to remove any potential
confusion or room for interpretation.

Burden
Impact

CMS Response
Added MSC-10c:
"Excludes decisions made by the
IRE."

N/A

MSC-10d, changed:
"Number calculated for approved PA
decisions (Data Element E) should be
a subset of the number of PA
decisions made (Data Element C)."
N/A
TO:

"Number calculated for approved PA
decisions (Data Element E) is a
subset of the number of PA decisions
made (Data Element C)."
Coverage Determinations and Exceptions, MSC-11a: MSC-11a, deleted:
Remove as this is repetitive of MSC-7a.
"Includes all decisions made on UM
Exceptions (both favorable and
unfavorable) with a date of decision
that occurs during the reporting
period."

N/A

Page 71 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Coverage Determinations and Exceptions, MSC-12:
add guidance based on Chapter 18, Sections 40, 50
and 130 of the Prescription Drug Benefit Manual re:
notification to the prescribing physician or other
prescriber of the decision.

Burden
Impact

CMS Response
MSC-12a, changed:
"Includes only exception decisions for
which the member is notified of the
decision according to the following
timelines:
expeditiously
as the enrollee’s
-For standard exceptions:
as health
condition requires, but no later than
72 hours after receipt of the request.
expeditiously
the enrollee’s
-For expeditedasexceptions:
as health
condition requires, but no later than
24 hours after receipt of the request."
TO:

131

8/10/2012

DV Standards,
FDCF

"Includes only exception decisions for
which the member (and the
prescribing physician or other
prescriber involved, as appropriate) is
notified of the decision according to
the following timelines:

N/A

expeditiously
as the enrollee’s
-For standard exceptions:
as health
condition requires, but no later than
72 hours after receipt of the
physician’s or other prescriber’s
supporting statement.
expeditiously
the enrollee’s
-For expeditedasexceptions:
as health
condition requires, but no later than
24 hours after receipt of the
physician’s or other prescriber’s
supporting statement."
Page 72 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Coverage Determinations and Exceptions, MSC-12:
add guidance based on Chapter 18, Sections 40, 50
and 130 of the Prescription Drug Benefit Manual re:
notification to the prescribing physician or other
prescriber of the decision.

Burden
Impact

CMS Response
MSC-12b, changed:
"Excludes favorable determinations in
which the sponsor did not authorize or
provide the benefit or payment under
dispute according to the following
timelines:
expeditiously
as the enrollee’s
-For standard exceptions:
as health
condition requires, but no later than
72 hours after receipt of the request.
expeditiously
the enrollee’s
-For expeditedasexceptions:
as health
condition requires, but no later than
24 hours after receipt of the request."

132

8/10/2012

DV Standards,
FDCF

TO:
N/A
"Excludes favorable exception
decisions determinations in which the
sponsor did not authorize or provide
the benefit or payment under dispute
according to the following timelines:
expeditiously
as the enrollee’s
-For standard exceptions:
as health
condition requires, but no later than
72 hours after receipt of the
physician’s or other prescriber’s
supporting statement."
expeditiously
the enrollee’s
-For expeditedasexceptions:
as health
condition requires, but no later than
24 hours after receipt of the
physician’s or other prescriber’s
supporting statement."
Page 73 of 99 

 

Comment
ID #

133

Date
Received

8/10/2012

DV Document

DV Standards,
FDCF

Comment

Burden
Impact

CMS Response

Coverage Determinations and Exceptions, MSC-12d: MSC-12d, changed:
change “should be” to “is” to remove any potential
confusion or room for interpretation.
"Number calculated for timely
exception decisions (Data Element G)
should be a subset of the number of
exception decisions made (Data
Element F)."

N/A

TO:

134

8/10/2012

DV Standards,
FDCF

Coverage Determinations and Exceptions, MSC-13:
Add language to exclude IRE decisions from the
count for Data Element H in response to Question
#70 in the Part D Industry Questions spreadsheet and
to align with the updated language in the Part D
Technical Specifications that only decisions "made
by the plan" are to be included.

"Number calculated for timely
exception decisions (Data Element G)
is a subset of the number of exception
decisions made (Data Element F)."
Added MSC-13c:
"Excludes decisions made by the
IRE."

N/A

Page 74 of 99 
 

Comment
ID #

135

136

Date
Received

8/10/2012

8/10/2012

DV Document

DV Standards,
FDCF

DV Standards,
FDCF

Comment

Burden
Impact

CMS Response

Coverage Determinations and Exceptions, MSC-13d: MSC-13d, changed:
change “should be” to “is” to remove any potential
confusion or room for interpretation.
"Number calculated for favorable UM
exception decisions (Data Element H)
should be a subset of the number of
UM exception decisions made (Data
Element F)."
N/A
TO:
"Number calculated for favorable UM
exception decisions (Data Element H)
is a subset of the number of UM
exception decisions made (Data
Element F)."
Coverage Determinations and Exceptions, MSC-14a: MSC-14a, changed:
Update to reflect language in the Part D Technical
Specifications re: "date of decision."
"Includes all decisions (both favorable
and unfavorable) on whether to permit
a member to obtain a non-preferred
drug at the more favorable costsharing terms applicable to drugs in
the preferred tier, with a date of
decision that occurs during the
reporting period."

N/A

TO:
"Includes all decisions (both favorable
and unfavorable) on whether to permit
a member to obtain a non-preferred
drug at the more favorable costsharing terms applicable to drugs in
the preferred tier."
Page 75 of 99 
 

Comment
ID #

137

138

Date
Received

8/10/2012

8/10/2012

DV Document

DV Standards,
FDCF

Comment
Coverage Determinations and Exceptions, MSC-16:
Add language to exclude IRE decisions from the
count for Data Element K in response to Question
#70 in the Part D Industry Questions spreadsheet and
to align with the updated language in the Part D
Technical Specifications that only decisions "made
by the plan" are to be included.
Coverage Determinations and Exceptions, MSC-11a:
Update to reflect language in the Part D Technical
Specifications re: "date of decision."

DV Standards,
FDCF

Burden
Impact

CMS Response
Added MSC-16c:
"Excludes decisions made by the
IRE."

N/A

MSC-17a, changed:
"Includes all decisions (both favorable
and unfavorable) on whether to permit
a member to obtain a Part D drug that
is not included on the formulary, with
a date of decision that occurs during
the reporting period."

N/A

TO:

139

8/10/2012

DV Standards,
FDCF

Coverage Determinations and Exceptions, MSC-19:
Add language to exclude IRE decisions from the
count for Data Element N in response to Question
#70 in the Part D Industry Questions spreadsheet and
to align with the updated language in the Part D
Technical Specifications that only decisions "made
by the plan" are to be included.

"Includes all decisions (both favorable
and unfavorable) on whether to permit
a member to obtain a Part D drug that
is not included on the formulary."
Added MSC-19c:
"Excludes decisions made by the
IRE."

N/A

Page 76 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Redeterminations: Add guidance to reflect updated
policy clarification on aggregating quarterly data
before applying 90% threshold.

140

8/10/2012

DV Standards,
FDCF

Redeterminations, DV Standard 1a: Remove the
words "and output" to reflect clarified guidance to
standards in Procedure Manual.

141

8/10/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
Added the following statement to the
header information for
Redeterminations:

N/A

"Note to reviewer: Aggregate all
quarterly data submitted within the
reporting year before applying the
90% threshold."
DV Standard 1a, changed:
"Source documents and output are
properly secured so that source
documents can be retrieved at any
time to validate the information
submitted to CMS via HPMS."

N/A
TO:
"Source documents are properly
secured so that source documents can
be retrieved at any time to validate the
information submitted to CMS via
HPMS."

Page 77 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Redeterminations, MSC-4: return the original
reference to Subpart M (instead of B). Subpart B is
the section about eligibility and enrollment.

142

8/10/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
MSC-4, changed:
"Organization properly defines the
term “Redetermination” in accordance
with Title 2, Part 423, Subpart B
§423.560, §423.580, §423.582,
§423.584, and §423.590 and the
Prescription Drug Benefit Manual
Chapter 18, Section 70, and 130. This
includes applying all relevant
guidance properly when performing
its calculations and categorizations."

N/A
TO:
"Organization properly defines the
term “Redetermination” in accordance
with Title 2, Part 423, Subpart M
§423.560, §423.580, §423.582,
§423.584, and §423.590 and the
Prescription Drug Benefit Manual
Chapter 18, Section 70, and 130. This
includes applying all relevant
guidance properly when performing
its calculations and categorizations."

Page 78 of 99 
 

Comment
ID #

143

Date
Received

8/10/2012

DV Document

DV Standards,
FDCF

Comment

Burden
Impact

CMS Response

Redeterminations, MSC-5b: delete “made” and
MSC-5b, changed:
“time” to align with the language in Part D Technical
Specifications.
"Includes all redeterminations
decisions for Part D drugs made with
a date of final decision that occurs
during the reporting time period,
regardless of when the request for
redetermination was received or when
the member was notified of the
decision."

N/A

TO:

144

145

8/10/2012

8/10/2012

DV Standards,
FDCF

DV Standards,
FDCF

Redeterminations, MSC-7: Add language to exclude
IRE decisions from the count for Data Elements C
and D in response to Question #56 in the Part D
Industry Questions spreadsheet and to align with the
updated language in the Part D Technical
Specifications that only decisions "made by the plan"
are to be included.
Long-Term Care Utilization: Add guidance in
response to #98 in the Part D Industry Questions
spreadsheet and to align with the note in the updated
Part D Technical Specifications, which states:
"Contracts with both 800-series plans and individual
plans report only data for individual plans."

"Includes all redeterminations
decisions for Part D drugs with a date
of final decision that occurs during the
reporting period, regardless of when
the request for redetermination was
received or when the member was
notified of the decision."
Added MSC-7c:
"Excludes decisions made by the
IRE."

N/A

Added the following statement to the
header information for Long-Term
Care Utilization:
"Note to reviewer: For contracts with
both non-800 series and 800-series
plans, data for the 800-series plan(s)
may be excluded."

N/A

Page 79 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Long-Term Care Utilization, DV Standard 1a:
Remove the words "and output" to reflect clarified
guidance to standards in Procedure Manual.

146

8/10/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
DV Standard 1a, changed:
"Source documents and output are
properly secured so that source
documents can be retrieved at any
time to validate the information
submitted to CMS via HPMS."

N/A
TO:
"Source documents are properly
secured so that source documents can
be retrieved at any time to validate the
information submitted to CMS via
HPMS."

Page 80 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Long-Term Care Utilization, MSC-6d: update in
response to question #101 in the Part D Industry
Questions spreadsheet and to align with the revision
made in Allowable Values for Element C: "Claims
with patient residence code 03 may be used to
identify enrollees. The LTI report may be another
tool for this reporting." The note re: location codes
04 and 07 has been removed.

147

8/10/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
MSC-6d, changed:
"Includes only members who resided
in a long-term care facility on the date
of service for that Part D drug at the
time the Part D claim for that member
was processed. Note to reviewer:
Claims with location code 03 or the
LTI report may be used to identify
applicable members. Claims with
location code 04 or 07 should not be
included."

N/A

TO:

148

149

8/10/2012

8/10/2012

DV Standards,
FDCF

DV Standards,
FDCF

Long-Term Care Utilization, MSC-7: add language
in response to question #108 in the Part D Industry
Questions spreadsheet, as Element D should only
include the information for pharmacies in Element
A.
Long-Term Care Utilization, MSC-8: add language
in response to question #108 in the Part D Industry
Questions spreadsheet, as Element D should only
include the information for pharmacies in Element
A.

"Includes only members who resided
in a long-term care facility on the date
of service for that Part D drug at the
time the Part D claim for that member
was processed. Note to reviewer:
Claims with patient residence code 03
or the LTI report may be used to
identify applicable members."
Added MSC-7e:
"Number calculated for Data Element
D is a subset of the total number of
network LTC pharmacies calculated
for Data Element A."
Added MSC-8f:
"Number calculated for Data Element
D is a subset of the total number of
network LTC pharmacies calculated
for Data Element A."

N/A

N/A

Page 81 of 99 
 

Comment
ID #

150

151

152

Date
Received

8/10/2012

8/10/2012

8/10/2012

DV Document

DV Standards,
FDCF

DV Standards,
FDCF

DV Standards,
FDCF

Comment
Long-Term Care Utilization, MSC-9: add language
in response to question #108 in the Part D Industry
Questions spreadsheet, as Element D should only
include the information for pharmacies in Element
A.
Long-Term Care Utilization, MSC-10: add language
in response to question #108 in the Part D Industry
Questions spreadsheet, as Element E should only
include the information for pharmacies in Element
B.
Long-Term Care Utilization, MSC-11: add language
in response to question #108 in the Part D Industry
Questions spreadsheet, as Element E should only
include the information for pharmacies in Element
B.
Plan Oversight of Agents (Part D), DV Standard 1a:
Remove the words "and output" to reflect clarified
guidance to standards in Procedure Manual.

153

8/10/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
Added MSC-9g:
"Number calculated for Data Element
D is a subset of the total number of
network LTC pharmacies calculated
for Data Element A."
Added MSC-10f:
"Number calculated for Data Element
E is a subset of the total number of
network retail pharmacies calculated
for Data Element B."
Added MSC-11g:
"Number calculated for Data Element
E is a subset of the total number of
network retail pharmacies calculated
for Data Element B."
DV Standard 1a, changed:

N/A

N/A

N/A

"Source documents and output are
properly secured so that source
documents can be retrieved at any
time to validate the information
submitted to CMS via HPMS."
N/A
TO:
"Source documents are properly
secured so that source documents can
be retrieved at any time to validate the
information submitted to CMS via
HPMS."

Page 82 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Plan Oversight of Agents (Part D), MSC-5a: update
in response to #183 in the Part C Industry Questions
spreadsheet.

154

155

156

8/10/2012

8/10/2012

8/10/2012

DV Standards,
FDCF

DV Standards,
FDCF

DV Standards
(Acronym
Appendix)

Burden
Impact

CMS Response
MSC-5a, changed:
"Includes all agents with
investigations that were completed
during the applicable reporting period,
regardless of when the complaint was
received."
TO:

Plan Oversight of Agents (Part C), MSC-5: update in
response to #183 in the Part C Industry Questions
spreadsheet.

Add acronyms for: Comprehensive Medication
Review, Current Procedural Terminology, Deep
Vein Thrombosis, International Classification of
Diseases, 9th Revision, Present on Admission, and
Targeted Medication Review.

N/A

"Includes all agents with
investigations that were completed
during the applicable reporting period,
regardless of when the complaint was
received and whether the member
remained enrolled, disenrolled, or
declined enrollment during the
enrollment process."
Added MSC-5d:
"Excludes investigations in which the
member or agent could be not
contacted."
DV Standards Appendix, added:
"CMR - Comprehensive Medication
Review
CPT - Current Procedural
Terminology
DVT - Deep Vein Thrombosis
ICD 9 - International Classification of
Diseases, 9th Revision
POA - Present on Admission
TMR - Targeted Medication Review"

N/A

N/A

Page 83 of 99 
 

Comment
ID #
157

158

Date
Received

DV Document

8/10/2012

DV Standards
(Acronym
Appendix)

9/24/2012

DV Standards,
FDCF

Comment
Remove the acronym for Primary Care Physician.

9/24/2012

DV Standards,
FDCF

DV Standards Appendix, deleted:
N/A

Coverage Determinations and Exceptions, MSC-8:
Add measure-specific criteria to including similar
“definition verification” language for consistency
with MSC-14a and 17a.

Coverage Determinations and Exceptions, MSC-9:
eliminate reference to “sponsor.”

159

Burden
Impact

CMS Response

"PCP - Primary Care Physician"
Added MSC-8a:
"Includes all decisions made (both
favorable and unfavorable) on
whether a member has, or has not,
satisfied a PA requirement."
MSC-9, changed:

N/A

"Organization accurately calculates
the number of PA decisions for which
the Part D sponsor provided a timely
notification of the decision, including
the following criteria:"
N/A
TO:
Organization accurately calculates the
number of PA decisions for which it
provided a timely notification of the
decision, including the following
criteria:"

Page 84 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Coverage Determinations and Exceptions, MSC-9b:
eliminate reference to “sponsor.”

160

9/24/2012

9/24/2012

DV Standards,
FDCF

DV Standards,
FDCF

MSC-9b, changed:
"Excludes favorable determinations in
which the sponsor did not authorize or
provide the benefit or payment under
dispute according to the following
timelines:"
N/A
TO:

Coverage Determinations and Exceptions, MSC-11:
Add measure-specific criteria to including similar
“definition verification” language for consistency
with MSC-14a and 17a.
161

Burden
Impact

CMS Response

"Excludes favorable determinations in
which the organization did not
authorize or provide the benefit or
payment under dispute according to
the following timelines:"
Added MSC-11a:
"Includes all decisions made (both
favorable and unfavorable) where a
member/prescribing physician is
seeking an exception to a PA or other
UM requirement (e.g., a physician
indicates that the member would
suffer adverse effects if he or she
were required to satisfy the PA
requirement)."

N/A

Page 85 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Coverage Determinations and Exceptions, MSC-12:
eliminate reference to “sponsor.”

162

9/24/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
MSC-9, changed:
"Organization accurately calculates
the number of UM exception
decisions for which the Part D
sponsor provided a timely notification
of the decision, including the
following criteria:"

N/A

TO:

163

9/24/2012

DV Standards,
FDCF

Organization accurately calculates the
number of UM exception decisions
for which it provided a timely
notification of the decision, including
the following criteria:"
Coverage Determinations and Exceptions, MSC-12b: MSC-9b, changed:
eliminate reference to “sponsor.”
"Excludes favorable exception
decisions in which the sponsor did not
authorize or provide the benefit or
payment under dispute according to
the following timelines:"
N/A
TO:
"Excludes favorable exception
decisions in which the organization
did not authorize or provide the
benefit or payment under dispute
according to the following timelines:"

Page 86 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Coverage Determinations and Exceptions, MSC-15:
eliminate reference to “sponsor.”

164

165

9/24/2012

9/24/2012

DV Standards,
FDCF

DV Standards,
FDCF

Burden
Impact

CMS Response
MSC-15, changed:
"Organization accurately calculates
the number of tier exception decisions
for which the Part D sponsor provided
a timely notification of the decision,
including the following criteria:"

N/A
TO:
Organization accurately calculates the
number of tier exception decisions for
which it provided a timely notification
of the decision, including the
following criteria:"
Coverage Determinations and Exceptions, MSC-15b: MSC-15b, changed:
eliminate reference to “sponsor.”
"Excludes favorable exception
decisions in which the sponsor did not
authorize or provide the benefit or
payment under dispute according to
the following timelines:"
N/A
TO:
"Excludes favorable exception
decisions in which the organization
did not authorize or provide the
benefit or payment under dispute
according to the following timelines:"

Page 87 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Coverage Determinations and Exceptions, MSC-16:
remove the redundancy with “favorable” and
“approved” in the same sentence.

166

167

9/24/2012

9/24/2012

DV Standards,
FDCF

DV Standards,
FDCF

Burden
Impact

CMS Response
MSC-16, changed:
"Organization accurately calculates
the number of favorable tier exception
decisions made that were approved,
including the following criteria:"

N/A
TO:
"Organization accurately calculates
the number of tier exception decisions
made that were approved, including
the following criteria:"
Coverage Determinations and Exceptions, MSC-18a: MSC-18a, changed:
correct the typo (the word "is" appears twice,
adjacent to each other).
"Includes only exception decisions for
which the member (and the
prescribing physician or other
prescriber involved, as appropriate) is
notified of the decision according to
the following timelines:"
N/A
TO:
"Includes only exception decisions for
which the member (and the
prescribing physician or other
prescriber involved, as appropriate) is
notified of the decision according to
the following timelines:"

Page 88 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Coverage Determinations and Exceptions, MSC-18:
eliminate reference to “sponsor.”

168

9/24/2012

DV Standards,
FDCF

Burden
Impact

CMS Response
MSC-18, changed:
"Organization accurately calculates
the number of formulary exception
decisions for which the Part D
sponsor provided a timely notification
of the decision, including the
following criteria:"

N/A

TO:

169

9/24/2012

DV Standards,
FDCF

Organization accurately calculates the
number of formulary exception
decisions for which it provided a
timely notification of the decision,
including the following criteria:"
Coverage Determinations and Exceptions, MSC-18b: MSC-18b, changed:
eliminate reference to “sponsor.”
"Excludes favorable exception
decisions in which the sponsor did not
authorize or provide the benefit or
payment under dispute according to
the following timelines:"
N/A
TO:
"Excludes favorable exception
decisions in which the organization
did not authorize or provide the
benefit or payment under dispute
according to the following timelines:"

Page 89 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Coverage Determinations and Exceptions, MSC-19:
remove the redundancy with “favorable” and
“approved” in the same sentence.

170

9/24/2012

DV Standards,
FDCF

CMS Response

Burden
Impact

MSC-19, changed:
"Organization accurately calculates
the number of favorable formulary
exception decisions made that were
approved, including the following
criteria:"

N/A

TO:

171

172

173

174

175

10/5/2012

10/5/2012

10/5/2012

10/5/2012

10/5/2012

FDCF

MSC-5 should be mapped to Data Element 13.2;
currently no data element is designated.

FDCF

MSC-16c should be mapped to Data Element K;
currently no data element is designated.

FDCF

MSC-18c should be mapped to Data Element K;
currently no data element is designated.

FDCF

MSC-5c should be mapped to Data Element A;
currently no data element is designated.

FDCF

MSC-5f should be mapped to Data Element A;
currently no data element is designated.

"Organization accurately calculates
the number of formulary exception
decisions made that were approved,
including the following criteria:"
MSC-5 in the FDCF, added:
N/A
"Data Element 13.2"
MSC-16c in the FDCF, added:
N/A
"Data Element K"
MSC-18c in the FDCF, added:
N/A
"Data Element M"
MSC-5c in the FDCF, added:
N/A
"Data Element A"
MSC-5f in the FDCF, added:
N/A
"Data Element A"

Page 90 of 99 
 

Comment
ID #

176

Date
Received

8/30/2012

DV Document

OAI

Comment

CMS Response

Burden
Impact

OAI will be mandatory for sponsoring organizations
to complete.

Changed statement: "While not
mandatory, it is strongly
recommended that organizations
complete the OAI to add efficiencies
to the review process." to "CMS
requires that organizations complete
the OAI to add efficiencies to the
review process." Deleted statement:
"If an organization does not elect to
complete the OAI, the reviewer will
use the same tool to collect this
information during the site visit
review, extending the length of the
review."
Changed any instances of "should" to
"must" relating to completion of the
OAI.

N/A

Page 91 of 99 
 

Comment
ID #

177

Date
Received

9/18/2012

DV Document

OAI

Comment

CMS Response

Burden
Impact

Sponsoring Organizations must begin completion of
the OAI prior to the start of the data validation
review period but cannot send the OAI and related
materials to the Data Validation Contractor prior to
the start of the April 1 review period.

Changed statement: "In the early stage
of the data validation review process,
and prior to the site visit, the reviewer
should request that the organization
begin completion of the OAI." to
"Prior to the start of the data
validation review period, the
organization must begin completion
of the OAI."
Changed statement: "Organizations
electing to complete the OAI should
complete each section in advance of
the site visit, or according to the set
timeline of the reviewer" to
"Organizations must complete each
section of the OAI in advance of the
data validation review period, or
according to the set timeline of the
reviewer. The organization should
complete the OAI and provide
documentation to the reviewer as
early as possible at the start of the
data validation review period so that
the DVC can begin recalculations on
April 1."
Inserted table titled Timeline of OAI
Activities in the Instructions section.

N/A

Page 92 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Appendix B: MTM overview: specify that MTM
data is uploaded through Gentran and not the HPMS
submission tool.

178

10/11/2012

Appendix B

Burden
Impact

CMS Response
MTM overview, changed:
“Data file created for submission to
CMS and copy of HPMS screen shots
of data entered”

N/A

TO:

MTM, MSC-5: specify that MTM data is uploaded
through Gentran and not the HPMS submission tool.

179

10/11/2012

Appendix B,
FDCF

“Data file created for submission to
CMS"
MSC-5, changed:
“Organization accurately identifies
data on MTM program participation
and uploads it into the HPMS
submission tool, including the
following criteria:”

N/A

TO:
“Organization accurately identifies
data on MTM program participation
and uploads it into Gentran, including
the following criteria:”

Page 93 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
MTM, MSC-6: specify that MTM data is uploaded
through Gentran and not the HPMS submission tool.

180

10/11/2012

Burden
Impact

CMS Response
MSC-6, changed:
“Organization accurately identifies
MTM eligible long-term care facility
residents and uploads it into the
HPMS submission tool, including the
following criteria:”

Appendix B,
FDCF

N/A

TO:

MTM, MSC-7: specify that MTM data is uploaded
through Gentran and not the HPMS submission tool.

181

10/11/2012

Appendix B,
FDCF

“Organization accurately identifies
MTM eligible long-term care facility
residents and uploads it into Gentran,
including the following criteria:”
MSC-7, changed:
“Organization accurately identifies
data on members who opted-out of
enrollment in the MTM program and
uploads it into the HPMS submission
tool, including the following criteria:”
N/A
TO:
“Organization accurately identifies
data on members who opted-out of
enrollment in the MTM program and
uploads it into Gentran, including the
following criteria:”

Page 94 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
MTM, MSC-8: specify that MTM data is uploaded
through Gentran and not the HPMS submission tool.

182

10/11/2012

10/11/2012

Appendix B,
FDCF

Appendix B,
FDCF

MSC-8, changed:
“Organization accurately identifies
data on CMR offers and uploads it
into the HPMS submission tool,
including the following criteria:”
N/A
TO:

MTM, MSC-9: specify that MTM data is uploaded
through Gentran and not the HPMS submission tool.

183

Burden
Impact

CMS Response

“Organization accurately identifies
data on CMR offers and uploads it
into Gentran, including the following
criteria:”
MSC-9, changed:
"Organization accurately identifies
data on CMR dates uploads it into the
HPMS submission tool, including the
following criteria:"
N/A
TO:
"Organization accurately identifies
data on CMR dates uploads it into
Gentran, including the following
criteria:"

Page 95 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
MTM, MSC-10: specify that MTM data is uploaded
through Gentran and not the HPMS submission tool.

184

10/11/2012

Burden
Impact

CMS Response
MSC-10, changed:
"Organization accurately identifies
data on MTM program interventions
and uploads it into the HPMS
submission tool, including the
following criteria:"

Appendix B,
FDCF

N/A

TO:

Standard 1a, change "HPMS" to "CMS systems: as
data is uploaded through different systems for
different measures (e.g., MTM data is uploaded
through Gentran and not HPMS).

185

10/11/2012

Appendix B,
FDCF

"Organization accurately identifies
data on MTM program interventions
and uploads it into Gentran, including
the following criteria:"
Standard 1a, changed (throughout all
measures):
"Source documents are properly
secured so that source documents can
be retrieved at any time to validate the
information submitted to CMS via
HPMS."

N/A

TO:
"Source documents are properly
secured so that source documents can
be retrieved at any time to validate the
information submitted to CMS via
CMS systems."

Page 96 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
Standard 3a, change "HPMS" to "CMS systems: as
data is uploaded through different systems for
different measures (e.g., MTM data is uploaded
through Gentran and not HPMS).

186

10/11/2012

Appendix B,
FDCF

Burden
Impact

CMS Response
Standard 3a, changed (throughout all
measures):
"Data elements are accurately entered
/ uploaded into the HPMS tool and
entries match corresponding source
documents."

N/A

TO:

Standard 3b, change "HPMS" to "CMS systems: as
data is uploaded through different systems for
different measures (e.g., MTM data is uploaded
through Gentran and not HPMS).

187

10/11/2012

Appendix B,
FDCF

"Data elements are accurately entered
/ uploaded into CMS systems and
entries match corresponding source
documents."
Standard 3b, changed (throughout all
measures):
"All source, intermediate, and final
stage data sets and other outputs relied
upon to enter data into HPMS are
archived."

N/A

TO:
"All source, intermediate, and final
stage data sets and other outputs relied
upon to enter data into CMS systems
are archived."

Page 97 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment

Burden
Impact

CMS Response

Exhibit 7 Sampling Units and Minimum Sample Size MTM has been removed from Exhibit
7.
for "Final Stage List"

188

9/26/2012

DESI

For reporting year 2012, Data Elements A-J have
been removed from the measure. Therefore we are
left with the Beneficiaries Eligible file that clients
upload into HPMS. In reviewing the 6/25/12 draft
version of "Appendix 3: Data Extraction and
Sampling Instructions", MTMP is still listed as a
measure under 'Exhibit 7 Sampling Units and
Minimum Sample Size for “Final Stage List”'. The
sampling unit suggested is Member ID, and the
sampling size is 205.
Since the Beneficiaries Eligible file is already at the
member level, we are unsure as to how we can
effectively sample it for a final stage census review
and against what we would compare the file. We are
pretty clear on how we could perform the primary
source review, but not the final stage census review.
Would you be able to provide direction as what you
would consider a 'best practice' when it comes to
MTMP final stage census review for the coming
year?

N/A

Page 98 of 99 
 

Comment
ID #

Date
Received

DV Document

Comment
CMS has replaced the terms “section” and
“measure” that previously appeared in the Part C and
Part D Reporting Requirement Technical
Specifications with the term “reporting section.”

189

10/25/2012

All DV
Documents

Burden
Impact

CMS Response
The following statement has been
added to all DV documents:
The terms “section” and “measure”
that previously appeared in the Part C
and Part D Reporting Requirement
Technical Specifications have been
replaced with the term “reporting
section.” To ensure alignment with
this new terminology, all references in
the data validation documents to the
term “measure” have been replaced
with the term “reporting section.” In
addition, the term “measure-specific
criteria” has also been revised and
replaced with “reporting section
criteria.”

N/A

 

Page 99 of 99 
 


File Typeapplication/pdf
File TitleRevisions Crosswalk
SubjectMedicare Parts C and D Data Validation Documentation
AuthorCMS
File Modified2012-10-29
File Created2012-10-27

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