Response to Comments

60-Day Comment Response Document.pdf

Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g)) (CMS-10305)

Response to Comments

OMB: 0938-1115

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2018 DV 60-Day Comment Response Document
Overview of Comments
CMS received various comments from Data Validation organizations, Pre-assessment consultants and
other associations. We received 36 comments regarding the following data validation sections: Coverage
Determinations and Redeterminations, Grievances, Improving Drug Utilization Review Controls,
Medication Therapy Management and Organization Determinations and Reconsiderations. There were
several major comments regarding the new section-Improving Drug Utilization Review Controls and
Coverage Determinations and Redeterminations.

Detailed Summary of Comments
Section

CD/RD

Comment

Reporting Section Criteria 5: Is there a typo in k., l., m., and n. in
which the reference to Element 4.B.5 should state Element 4. B.
11?
Reporting Section Criteria 5:
Should this read: Note that Data Elements 1.A.- 1. S. relate to
Coverage Determinations data…?
It currently says Organization Determinations data.
Reporting Section Criteria 14: Fully favorable determinations where
the enrollee was notified
untimely but within 24 hours of the expiration of the adjudication
timeframe and thus not autoforwarded
to the IRE.
Reporting Section Criteria 20 (c.): What
is meant by ‘Includes withdrawals and dismissals input by the IRE’?

CD/RD

Appendix B: Pg #28, 15b: Includes untimely coverage
determinations decisions auto-forwarded to the IRE."

CD/RD

Appendix B: Pg # 26: Section 16, Part C: Includes withdrawals and
dismissals input by the IRE.

CD/RD

Appendix B: Pg # 26: Section 20, Part C:Includes withdrawals and
dismissals input by the IRE.

CD/RD

Appendix B: Pg # 24, 25 and 29: Section 5: Number of
redeterminations by outcome (Data Element 3.E + Data Element
3.F + Data Element 3.G) is equal to total number of
redeterminations (Data Element 3.A). Interpretation: 3.A = 3.E +
3.F + 3.G

CD/RD

Appendix B: Pg # 24, 25 and 29: Section 20: Each number
calculated for requests for redeterminations that were withdrawn
(Data Element 3.H) and requests for redeterminations that were
dismissed (Data Element 3.I) is a subset of the number of
redeterminations decisions made (Data Element 3.A).
Interpretation: 3.A = 3.E + 3.F + 3.G + 3.H + 3.I

CD/RD

Appendix B: Reporting Section Criteria 5: CMS clarifies that the
Total Number of CDs should include withdrawals and dismissals.
However, the same section does
not require inclusion of withdrawals and dismissals in Total Number
of RDs, whereas Reporting Section Criteria 17 requires inclusion of
dismissals and withdrawals. This has led to confusion on whether
dismissals and withdrawals should be included in the Total Number
of RDs.

CD/RD

Appendix B: Data Validation Standards: Pg #23: If the
organization received a CMS outlier/data integrity notice validate
whether or not an internal procedure change was warranted or
resubmission through HPMS.

CD/RD

Revise the Standards to indicate that the total number of coverage
determinations reported (see 5.f.iii) should include withdrawals and
dismissals (i.e.,
Data Elements 2.H and 2.I, respectively). However, we note that
for reporting the
total number of redeterminations (see RSC 5.g), CMS is not
proposing inclusion of
withdrawals and dismissals. In addition, we note that in RSC 17
(“Organization
accurately calculates the total number of redeterminations (Part D
only) …”), CMS is
proposing to require inclusion of dismissals and withdrawals.

Grievances

Appendix B: Data Validation
Standards: Pg #19: If the organization received a CMS outlier/data
integrity notice validate whether or not an internal procedure
change was warranted or resubmission through HPMS.

Grievances

UCare does not support the 100% accuracy threshold for Standard
3a in the Part C and Part D Grievances reporting sections.

DUR

DV Standards: Sections 6aii: The rejected opioid claim due to the
soft formulary-level cumulative opioid MED POS
edit is not associated with an early refill rejection transaction

DUR

DV Standards: Sections 6bii: The rejected opioid claim due to the
hard formulary-level cumulative opioid MED POS
edit is not associated with an early refill rejection transaction

DUR

DV Standards: Sections 4ai: Organization provides documentation
that its soft and/or hard formulary-level cumulative opioid MED
POS edit was properly tested and validated prior to its
implementation date.

DUR

Is RTS a requirement for DUR reports? Should we be excluding
claims from the summary that contain refill too soon errors? If RTS
is a requirement, how are we supposed to know the reasonable
overlapping fill date time for RTS
edits?

DUR

Should strength and dosage form be
included fields on the report?

DUR

Appendix B: Data Validation
Standards: Pg # 32: If the organization received a CMS outlier/data
integrity notice based on their soft/hard/provider/pharmacy
formulary-level cumulative opioid morphine equivalent dose (MED)
threshold, validate whether or not an internal procedure change
was warranted or resubmission through HPMS.

DUR

Reporting Section Criteria Sections 4-9): United does not believe
that the data elements outlined in the Reporting Section Criteria for
sections 4-9 align with the latest (2017) Part D Reporting
Requirement or Technical Specifications. Only data elements A-P
exist per the latest Part D Reporting requirements, rather than data
elements A-S as referenced in the Data Validation Standards
document.

DUR

Edit and Validation section C on page 40: the Data elements listed
do not match the recent HPMS layout data elements. We believe
this is due to the CY2017 Medicare Part D Reporting Requirements
not also being updated with the latest added data element that can
only be found in the HPMS Layout.

DUR

On page 132 there is a statement that refill too soon (RTS) claims
should not be included in the report. This requirement is not
mentioned anywhere in the CMS reporting requirements, technical
specification or HPMS layout documents for this report. Should this
question truly be
in this section?

DUR

RSC-5.cv: The number of unique beneficiaries with at least one
claim rejected that also had a claim successfully processed (paid)
for an opioid drug subject to the hard opioid MED edit such as, but
not limited to, through favorable coverage determination (data
element S) is a value less than or equal to the number of unique
beneficiaries with at least one hard edit claim rejection that also
had a coverage determination request (data element R). (Should
be Data Element P not R). Note: Data element S is from the CDE
report for 'The total number of fully favorable Utilization
Management exceptions made in the reporting period.' It is Data
element Q on the opioid report that is for
'Num_Uniq_Bene_Rejected_Paid_POS'

DUR

RSC-8.c: c: Includes all coverage determinations (fully favorable,
partially favorable, and adverse). Data Element says R but we
know from above that it is for P.
Data elements referenced in this section don't always line up with
the data elements from the current layout that is in HPMS.
Example 1: 2.e RSC-5a mentions data element 'D' and or 'L' but it
looks like this should be 'B' and or 'J' instead. Example 2: There is
reference up to data element 'S' in this section for Improving Drug
Utilization Review Controls (Part D) 2017, but the HPMS layout
only goes to data element 'Q'.

DUR

The measure entitled "Improving Drug Utilization Review Controls"
is a new reporting requirement and, currently, slated for audit
during CY2017MDV season. It is Priority Health's concern that
interpretation issues will arise from the new reporting measure that
require CMS responses within a short timeframe.

MTM

Appendix B: Data Validation Standards: Pg #16: If the organization
received a CMS outlier/data integrity notice validate whether or not
an internal procedure change was warranted or resubmission
through HPMS.

MTM

Reporting Section Criteria: The 2018 Data Validation Standards
state, “...excludes members who disenroll and then re-enroll in the
same contract, if the gap of MTM enrollment is equal to 60 days or
less.” However, the 2017 Part D Technical Specifications removed
the 60 day gap requirement verbiage and now states,
“…Regardless of the duration of the gap in MTM program
enrollment, report the initial date of MTM program enrollment, no
date of MTM program opt out, and all other applicable elements for
activity across all MTM program enrollment periods within the
reporting period.”

OD/RD

Reporting Section Criteria 22: It appears that the following
elements were excluded from the data validation standards:
6.28 Was the case processed under the expedited timeframe (N/Y)
6.29 Case Type (Service or Claim)
6.30 Status of treating provider (Contract, Non-contract)
6.33 Additional Information (Optional)

General

Appendix B DV standards: Pg 12 #9b and pg 13 #12d: How CMS
is defining members who are "unable to be reached"?

General

Appendix B: Data Validation Standards: The Data Validation
Standards often remove the uncertainty when reviewed in
accordance with the Reporting Requirements and Technical
Specifications.

General

Appendix E: Organizational Assessment Instruction: 4.3 Supplemental Questions Regarding Reporting Processes: "Did
your organization receive an outlier/data integrity notification for
any of the reporting sections that are currently undergoing data
validation review (as identified in Table 5) for the contract(s)
included in this OAI? If so, the organization is required to retrieve
such notices via the Download Files page of the Monitoring Parts C
and D Reporting Website received for the reporting section and
any corrective actions taken to address the issue."

General

Procedure Manual Appendix B: CMS Outlier/Data Integrity Notices:
CMS states "If the organization received a CMS outlier/data
integrity notice validate whether or not an internal procedure
change was warranted or resubmission through HPMS." However,
we are unsure why this would be considered a finding if the plan
had completed the correction. We also seek clarification on
whether there would only be a finding if a correction is required and
plan does not make the change.

General

UCare requests that CMS provide additional details about the new
“data integrity check” to help sponsors ensure that they have the
sufficient documentation and/or explanations for data validation.

General

Please align the instructions in the Data Validation Procedure
Manual, section 3.2.2.1 Process for Sponsoring Organization, with
the instructions in the March 15, 2017 HPMS memo, Instructions
for Requesting Consultant Access or Electronic Signature Access
to the Health Plan Management System. The instructions are not
identical and having two different sets of instructions is confusing.

Commenter's Recommendation

CMS Response

Revised Documents Revised Burden
Estimates

We are seeking clarification.

Correction has been made.

Yes

We are seeking clarification regarding
the footnote on page 23.

Correction has been made.

Yes

Please validate these are counted as
untimely and therefore excluded from
the total timely count.

Yes, these are counted as
untimely and therefore excluded
from the total timely count.

Please expand/provide additional
information.

Statement has been removed.

Yes

We respectfully request CMS clarify
that it intended to remove the words
"(as adverse)” in the following
sentence—as compared to the 2016
DVA note.

Yes, we intended to remove the
word "as adverse". CMS intends
for plans to include ALL untimely
coverage determinations
decisions auto-forwarded to the
IRE.
ESI respectfully requests CMS provide The term input has been used in
an example/scenario along with its
previous Data Validation PRA
definition/description of the term “Input” packages. This term is not a
as noted in the following sections, as it newly-introduced term in this
is newly-introduced term in this
collection.
collection.
ESI respectfully requests CMS provide The term input has been used in
an example/scenario along with its
previous Data Validation PRA
definition/description of the term “Input” packages. This term is not a
as noted in the following sections, as it newly-introduced term in this
is newly-introduced term in this
collection.
collection.

We again respectfully request CMS
reaffirm its intent to include withdrawn
and dismissed Redeterminations as a
subset of data Element A in this
document. ESI is concerned
that—absent additional clarification from
CMS—the interpretation of Item #1
conflicts with the interpretation of item
#2.

While CMS does not currently
prescribe the manner in which
Part D plans should process
invalid or withdrawn
redetermination requests, as a
best practice, we do expect plans
to develop policies and
procedures for processing and
responding to redetermination
requests that are either
withdrawn by the requestor or
dismissed by the plan. CMS
expects that coverage requests
that are withdrawn or dismissed
represent a very small
percentage of total Part D
coverage requests a plan
receives. However, these
elements were added to provide
plans with a means to report
requests that are received and
processed but are not
adjudicated as either favorable or
adverse by the plan.

We request CMS' clarification on
whether the Total Number of RDs
should include withdrawals and
dismissals for the reporting year.

Itasca Medical Care is requesting that
CMS provide some direction as to the
expected timing of the release of the
OAI to the DV contractors, with
consideration to the timing of the
release of the outlier/data integrity
reporting outcome. We suggest that
CMS provide direction that the OAI
should not be released to the DV
contractors until after the outlier/data
integrity reports have been released
and the plans have had necessary time
to react to the results. We recommend
that this timing be two weeks (fourteen
calendar days) after the outlier/data
integrity report is available,
guaranteeing that the plan has
adequate time to respond to results of
the report. For example, if the
outlier/data integrity report is available
on March 28, the OAI package would
be released to the DV contractor on
April 11. With this direction, if the
outlier/data integrity reports become
obtainable earlier or later than in the
past, this timing would be flexible
enough that it wouldn't need future
amendment.

CMS evaluates the integrity of
data submission following the last
Monday of February (2/26)
reporting deadline. Plans have
ample time to respond to outlier
and data integrity flags and
resubmit data by 3/31 if
necessary. This is a routine part
of the reporting requirements
process.

For clarity, we recommend that CMS
specify whether the total number of
redeterminations under RSC 5.g should
include withdrawals and dismissals.

The Organizational Assessment
Instrument (OAI) (Appendix E)
focuses on how the SO collects,
stores, and reports data.
Completing the OAI is mandatory
and CMS highly recommends
that SOs complete this document
in advance of the DV, as the DV
review relies significantly on the
information captured in this tool.
The completed OAI may reduce
required DVC resources, and
make the DV review more
efficient and effective. SOs
should provide the completed
OAI to their selected DVC
electronically. CMS estimates
that the OAI should take a
minimum of two weeks to
complete and should be
submitted to the DVC no later
than early April. SOs may not
send their completed OAI or
source code, SOPs, etc. to their
DVCs prior to the start of the DV
cycle on April 1.

UCare does not believe that only a
100% score demonstrates compliance
and requests that Standard 3a for
Grievances use the 90% accuracy
threshold that is used by all other
reporting sections.

CMS does not believe that only a
100 percent score demonstrates
compliance, and has established
a threshold whereby a minimum
of 90% of records are accurate
(e.g., sample or census records,
source documents, policies and
procedures, data entry records)
in order to record a “Yes” finding
for any standard. Applying this
threshold to standards that
require the review of policies and
procedures should be done when
it is possible to readily quantify
the adherence to or
implementation of said policies
and procedures (see Exhibit 16).
Exhibit 15 provides examples of
how to calculate this minimum
threshold specifically for
Standard 3.a, for which the DV
involves samples or the complete
census of records and/or data
values. Note that the 90%
accuracy threshold does not
apply to the individual grievance
categories in the Part C and Part
D Grievances reporting sections;
100% correct records are

These statements do not appear to be
in the related CMS Technical
Specifications for this reporting section.
Given the difference, we want to make
sure that plans should abide by the
statements in the DV Standards and
exclude soft and hard edit rejections
due to early refills from DV reporting.
Please advise.

Early refill exclusion is not stated
in the Technical Specification
document, however Page 14 of
the Reporting Requirements
document states our expectation
of sponsors to apply
specifications to “minimize false
positives such as reasonable
overlapping dispensing dates for
prescription refills or new
prescription orders for continuing
fills. The 2018 TS has been
updated with clarification on this
issue.

We are seeking guidance from CMS as
to what types of documentation you
would recommend we secure from
clients in order for us to comply with this
review standard.
Any examples or direction you could
provide in this regard would be greatly
appreciated.

We have conflicting information as RTS
isn't a requirement
on the Part D Plan report
Requirement/Technical Specifications,
however it is mentioned in the Medicare
Part C and Part D Reporting
Requirements - Data Validation
document.

CMS would expect
documentation stating the dates
and sample prescriptions that
were run through the cumulative
edit and either did or did not
trigger the edit as expected. If a
dummy case was developed
possibly screen-shots of the
response and the dummy case
prescription profile.
Early refill exclusion is not stated
in the Technical Specification
document, however Page 14 of
the Reporting Requirements
document states our expectation
of sponsors to apply
specifications to “minimize false
positives such as reasonable
overlapping dispensing dates for
prescription refills or new
prescription orders for continuing
fills. The 2018 TS has been
updated with clarification on this
issue.

We also see conflicting information
regarding Drug(strength and dosage
form) between the two documents.
Strength and dosage form isn't a
requirement on the Part D Plan report
Requirement/Technical Specifications,
however it is mentioned in the Medicare
Part C and Part
D Reporting Requirements - Data
Validation document.

No conflict found. Note #9 of the
Technical Specifications
document states that “Rejected
claims are counted at the unique
contract, beneficiary, prescriber,
pharmacy, drug (strength and
dosage form), quantity, and date
of service (DOS)". This field
should at least be populated with
a National Drug Code (NDC)
which is a unique product
identifier that codifies a drug’s
characteristics e.g. dosage
form/strength.

United recommends that CMS correct
the Data Validation Standards
document to remove any references to
the following data elements from
sections 4-9 and align with the data
element numbering reflected in the
2017 Part D Reporting Requirements
and Technical Specifications:
E. If yes to element A, the minimum
number of days meeting or exceeding
the MED threshold criterion used.
N. If yes to element J, the minimum
number of days meeting or exceeding
the MED threshold criterion used.
S. Of the total reported in element O,
the number of claims resolved and paid
at the POS (either through a favorable
decision through the coverage
determination or appeals process, or
other mechanism).

CMS has since corrected
Appendix B to align with the
Reporting Requirements data
elements.

Yes

We are noticing the data elements are
not lining up to the definitions. It would
be helpful if all the documents that
pertain the reporting requirements and
data elements are revised to match
when there is a change in the HPMS
layout.

CMS has since corrected
Appendix B to align with the
Reporting Requirements data
elements.

Yes

N/A

Yes, early refill exclusion is not
stated in the Technical
Specification document, however
Page 14 of the Reporting
Requirements document states
our expectation of sponsors to
apply specifications to “minimize
false positives such as
reasonable overlapping
dispensing dates for prescription
refills or new prescription orders
for continuing fills. The 2018 TS
has been updated with
clarification on this issue.

N/A

CMS has since corrected
Appendix B to align with the
Reporting Requirements data
elements: RSC-5.dv The number
of unique beneficiaries with at
least one claim rejected that also
had a
claim successfully processed
(paid) for an opioid drug subject
to the hard opioid MED edit such
as, but not limited to, through
favorable coverage determination
(data element P) is a value less
than or equal to the number of
unique beneficiaries with at least
one hard edit claim rejection that
also had a coverage
determination request (data
element O).

N/A

See above

Yes

Please confirm the documents and data CMS has since corrected
elements used in the making of the data Appendix B to align with the
Reporting Requirements data
validation questions.
elements.

Priority Health requests that CMS
postpones the audit for this new
measure until the CY2018 MDV season.
This change will allow for the settlement
of any interpretation issues prior to the
audit occurring against the measure
reported data.
Itasca Medical Care is requesting that
CMS provide some direction as to the
expected timing of the release of the
OAI to the DV contractors, with
consideration to the timing of the
release of the outlier/data integrity
reporting outcome. We suggest that
CMS provide direction that the OAI
should not be released to the DV
contractors until after the outlier/data
integrity reports have been released
and the plans have had necessary time
to react to the results. We recommend
that this timing be two weeks (fourteen
calendar days) after the outlier/data
integrity report is available,
guaranteeing that the plan has
adequate time to respond to results of
the report. For example, if the
outlier/data integrity report is available
on March 28, the OAI package would
be released to the DV contractor on
April 11. With this direction, if the
outlier/data integrity reports become
obtainable earlier or later than in the
past, this timing would be flexible
enough that it wouldn't need future
amendment.

CMS respectfully disagrees. If
you have specific questions
please feel free to ask.

United seeks clarification on which
requirement should be applied. We
recommend that CMS update the 2018
Data Validation Standards to mirror the
reporting requirement outlined in the
2017 Part D Technical Specifications to
reflect “regardless of duration” instead
of the “60 days or less”.

CMS agrees with United's
recommendation. RSC 8 d. in
Appendix B will be "Excludes
members who disenroll from and
re-enroll in the same contract
regardless of the duration of the
gap of MTM program
enrollment.". The FDCF will also
be updated appropriately.

Yes

United recommends that CMS update We appreciate the commenter's
section 22 to align with the 2017 Part C suggestions, and we will take it
Technical Specifications. Section 22
under advisement.
would be updated with the following:
Organization accurately reports the
following information for each reopened
case.
a. Contract Number
b. Plan ID
c. Case ID
d. Case level (Organization
Determination or Reconsideration)
e. Date of original disposition
f. Original disposition (Fully Favorable;
Partially Favorable or Adverse)
g. Was the case processed under the
expedited timeframe? (Y/N)
h. Case type (Service or Claim)
i. Status of treating provider (Contract,
Non-contract)
j. Date case was reopened
k. Reason(s) for reopening (Clerical
Error, Other Error, New and Material
Evidence, Fraud or Similar Fault, or
Other)
l. Additional Information (Optional)
m. Date of reopening disposition
(revised decision)
n. Reopening disposition (Fully

Requiring 3 phone attempts and a
Document what happened and
follow-up letter works when we have an yes, report at 13.5 or 13.8,
accurate phone number for a member, whichever is appropriate
but we have a large number of
members who have not provided a good
phone number. While we attempt to
locate a good phone number for all
members, if the phone number is
incorrect the first time we call, we are
unlikely to make two more phone calls
to that same non-working number.
Additionally, for some members, we do
not have any phone number to make
even one attempt. With the current
specifications and standards, these
members would not fall into any of the
measured areas (having an
assessment, refusing, or unable to
reach) and would affect our scores
negatively. We respectfully ask CMS to
let us know a way to categorize these
types of members.

Itasca Medical Care would like to
CMS will consider this request in
recommend that CMS consider
the future.
releasing the Data Validation Standards
at the same time as the draft or final
versions of the Reporting
Requirements and the Technical
Specifications. We believe that if CMS
provided the complete set of
expectations at one time this would
enable better understanding of the
requirements as well as possibly
preventing misinterpretations of the
information.

United recommends that this should not CMS will consider this request in
be a finding if the data correction
the future.
(resubmission) occurs prior to the CMS
prescribed deadline. Further, if the data
correction does not occur, then the
Sponsoring Organization would receive
a finding.

Provide additional details.

Yes

Please align the instructions.

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