Response tp Public Comments

60-Day PRA Comments on CY2016 Part D Reporting Requirements - CMS-10185

Reporting
Section

Description of Issue or Question

Commenter's Recommendations

CMS Response

Coverage
Determinations
and
Redeterminations

Elements A -E: Data for elements A-E
contain many multiples of the member
POS experience. A significant number of
events reported under the current
specifications are due to attempts to put a
transmission through the system. These
events differ only by a system-assigned
claim/claim-sequence number or
transmission times that are
minutes/seconds apart.

Recommends CMS defines a unique
transaction, i.e., unique point-of-sale
(POS) event. This would be a unique
combination of member-pharmacydrug-date (but not time). If CMS
intends to capture a unique POS
experience, specifications can be
limited to a transaction type of bill,
excluding reverse and re-bill. CMS
could consult with industry experts at
NCPDP concerning the definition of a
unique transaction in terms of the
member POS experience and define it
in terms of D.0 fields, such as fill date,
prescription number, product ID,
memberID, dispenserID.

CMS will consider such changes in the
future. At this time however, we will not
revise the data collected.

Coverage
Determinations
and
Redeterminations

General comment: Define if and where
(which data element) “direct member
reimbursement” (DMR) and “paper clams”
determinations should be reported:
o DMR requests received without regard to
determination status
o DMR and “paper claims” determinations
for drugs with utilization management edits
o DMR and “paper claims” determinations
without utilization management edits

Recommends CMS defines if and
where DMR determinations should be
reported.

CMS agrees and will provide additional
technical clarifications regarding direct
member reimbursements.

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Reporting
Section

Description of Issue or Question

Commenter's Recommendations

CMS Response

Coverage
Determinations
and
Redeterminations

Resolve the specification contraction that
asks that all Coverage Determinations be
reported, but says to exclude Excluded
Drugs. According to Chapter 18, after the
member has received his Notice of Inquiry
he may request a coverage determination.
The SO will handle such request as a
coverage determination per Chapter 18.

Recommend CMS clarifies that all
Coverage Determinations be reported,
but says to exclude Excluded Drugs.
According to Chapter 18.

CMS agrees this exclusion could be
further clarified in the technical
specifications.

Coverage
Determinations
and
Redeterminations

Element L-S: Specify if Hospice coverage
determinations should or should not be
reported as Exceptions.

Recommend CMS specifies if Hospice
coverage determinations should or
should not be reported as Exceptions.

CMS agrees and will provide additional
technical clarifications about coverage
determinations for beneficiaries enrolled
in hospice.

Coverage
Determinations
and
Redeterminations

General comment: Report rejections, deduplicated, to greatly reduce the volume of
data that needs to be put forward for Data
Validation.

Recommend Sponsors reports
rejections, de-duplicated, as above.

CMS disagrees, as information about
multiple transactions for a single claim is
important for monitoring beneficiary
access to their medications.

Coverage
Determinations
and
Redeterminations

General comment: Discontinue quarterly
reporting. Go to annual reporting. For
purposes of Data Validation, as needed to
reduce file size, large contracts that can
supply their Element A transactions broken
into quarters.

Recommend CMS discontinues
quarterly reporting and go to annual
reporting.

Sponsors already report these data on
an annual basis. At this time, no
changes will be made.

Coverage
Determinations
and
Redeterminations

Element B-E: Combine PA and ST
rejections to reflect industry practice.

Recommend CMS combines PA and
ST rejections to reflect industry
practice.

CMS disagrees with this
recommendation, as these data are
aligned with Part D formulary
requirements. We will continue to collect
separate reporting for prior authorization
(PA) and step therapy rejections.

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Reporting
Section

Description of Issue or Question

Commenter's Recommendations

CMS Response

Coverage
Determinations
and
Redeterminations

Element L-S: Remove the specification to
exclude Excluded Drugs. That way, all
completed coverage determinations can be
reported without a specific additional step
to find and remove those that were
completed Exception Requests related to
Excluded Drugs.

Recommend CMS removes the
specification to exclude Excluded
Drugs.

CMS disagrees with the
recommendation. Data should be limited
to non-excluded drugs in order for CMS
to compare data across all plans,
regardless of benefit designs.

Coverage
Determinations
and
Redeterminations

Element L-S: Discontinue partially
favorable. Most SOs do not recognize the
existence of this type of event. For those
that do, these rare events can be
combined with adverse.

Recommend CMS discontinues
partially favorable.

CMS appreciates this comment, but will
continue to collect partially favorable
data. Discontinuation of this element
would lead to inconsistencies with
categorizing these types of decisions.

Disenrollment

Elements E-G: "Given that good cause
requests are submitted to CMS for
approval, would this data be currently
available to CMS?
Element E:. Of the total reported in D, the
number of disenrolled individuals who
submitted a timely request for
reinstatement for Good Cause.**
F. Of the total reported in E, the number of
favorable Good Cause determinations.**
G. Of the total reported in F, the number of
individuals reinstated.**

Recommend CMS not include these
reporting elements, as the data seem
to be currently available to CMS.

CMS disagrees with the
recommendation. These elements are
not duplicative of other data available to
CMS. There are two paragraphs from the
2016 Call Letter (pages 76-77), where
we explain the transfer of this
responsibility from CMS to plans.
CMS intends to assign the responsibility
to conduct good cause reviews to MAOs,
Part D plan sponsors and cost plans for
CY 2016 and will expect that they
perform the work from start to finish (i.e.,
intake, research, decision, notification,
and effectuation). We will provide
guidance regarding the application of the
good cause criteria and related activities
in our enrollment manuals (Chapter 2
and Chapter 17, Subchapter D, of the
Medicare Managed Care Manual and
Chapter 3 of the Medicare Prescription
Drug Benefit Manual). Our expectation is
that plans will develop their own internal
processes for reviews, based on our

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Reporting
Section

Description of Issue or Question

Commenter's Recommendations

CMS Response
guidance, and carry out the majority of
this workload without involving CMS.
CMS will develop an oversight protocol
for any activities assigned to plans that
are currently carried out by CMS to verify
that plans appropriately apply the
regulatory standards associated with the
good cause process. As part of this
oversight, CMS will retain the authority to
review both favorable and unfavorable
decisions to make certain that results are
fair and sound, and based on regulatory
standards for reinstatement.

Grievances

General comment: Plans that are Fully
Integrated Dual Eligible Special Needs
plan (FIDE SNP) and the Part D technical
specifications (including the data validation
standards provided to data validation
auditors) do not include differences found
in FIDE SNP grievance requirements that
may exist under the Medicaid state
contract approved for the DNSP plan (e.g.
state contract approved by CMS may have
a different timeframe).

Recommend CMS incorporates
language in the Part D Reporting
Requirements Technical Specifications
to include accommodation of FIDE
SNP or MMP plans that may be
subject to different timeframes due to
the nature of dual eligible plan
requirements.

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CMS will transfer this responsibility to
plans starting January 1, 2016, such that
plans will be responsible for the intake
and processing of good cause
reinstatement requests for individuals
disenrolled effective December 31, 2015,
and later.
CMS agrees with this comment.
Medicare/Medicaid Plans (MMPs) should
refer to the Medicare-Medicaid Financial
Alignment Model Reporting
Requirements for additional reporting
guidance. We have revised the
introduction in our Reporting
Requirements document to explicitly
state some MMP measures may have
specific timelines that may be different.

Reporting
Section
Grievances

Description of Issue or Question
General comments:
• Supply a set of definitions, with
examples, for each category
• A text correction is needed to remove D.
Notes 4. This specification language is
inconsistent with Chapter 18.
• A text correction is needed to remove B.
Edits and Validation checks, “excluding
expedited grievances”.

Commenter's Recommendations
Recommendations for CMS:
1. Supply a set of definitions with
examples.
2. Clarify Note 4.
3. Remove incorrect text in B. Edits
and Validation checks, “excluding
expedited grievances”.
4. Discontinue quarterly figures.
Report timeliness only for the total
grievances category.

CMS Response
These comments are out of scope for the
data collection instrument, and are
focused on technical specifications.
CMS provides the following responses:
1. A set of definitions with examples is
not needed for each grievance
category. Technical specifications
already include reference to Chapter
18, Sections 10 and 20 of the
Prescription Drug Benefit Manual;
we will also add that Sponsors can
also refer 20.2.4.2 for examples of
grievances, and definitions
2. We will clarify note 4 of the technical
specifications with the following
information: Sponsors should report
expedited grievances in two
elements: First, in the total number
of expedited grievances. Second, in
the appropriate grievance category.
For example, if an enrollee files an
expedited grievance because the
plan denied their request for an
expedited coverage determination,
that grievance should be reported
both as an “Expedited Grievance”
and also as a “Coverage
Determination and Redetermination
Process” grievance. For this
example, sponsors should report
under element P.
3. The text listed in B. Edits and
Validation checks is correct, but
CMS will consider how to further
clarify. For example, the total
number of grievances (data element
B) should be the sum of the

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Reporting
Section

Description of Issue or Question

Commenter's Recommendations

CMS Response
grievances by category (e.g. data
elements F, H, J, etc). Since
grievances processed as expedited
grievances would also be counted in
a grievance category, Sponsors
should not double-count expedited
grievances when verifying the
number of total grievances has been
reported correctly.

LTC

General comment: Expunge the words
“Service Area” throughout the
specifications, because you have
repeatedly clarified that you want reporting
on the basis of the national network. For
some contracts, a service-area limitation
significantly limits the volumes reported at
elements D and E.

Recommend CMS expunges the
words “Service Area” throughout the
specifications.

LTC

Element D: Specify if element D should be
limited to patient residence code of 03.
Inclusion of patient residence code 04assisted living significantly increases the
volume at element D.

Recommend CMS specifies if element
D should be limited to patient
residence code of 03.

MTM

General comment about 2015 TS: The
second sentence should be stricken from
the specifications because it is
contradicted by the preceding sentence, by
CMS enrollment processes, and by the DV
standards.
8. For Date of MTM program opt-out

Recommend CMS revises the
Technical Specifications (TS)
document.

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4. CMS disagrees, and will continue
collecting on an annual basis,
quarterly snapshots. It is important
for CMS to continue monitoring for
timeliness of grievances by category.
N/A – This reporting section was
suspended effective August 2015. The
data collected are no longer needed, due
to other data available through the
Prescription Drug Event (PDE) data. This
reporting section has been removed from
the draft 2016 Part D Reporting
Requirements for the 30-day comment
period.
N/A – This reporting section was
suspended effective August 2015. The
data collected are no longer needed, due
to other data available through the
Prescription Drug Event (PDE) data. This
reporting section has been removed from
the draft 2016 Part D Reporting
Requirements for the 30-day comment
period.
This comment does not impact the data
collection, but CMS will consider how to
further clarify this issue in the technical
specifications document.

Reporting
Section

Description of Issue or Question

Commenter's Recommendations

CMS Response

(element K) and Reason participant optedout of MTM program (element L), sponsors
should not count and report a member as
having disenrolled from the plan with an
opt-out date of 12/31 simply because it is
the end of the year and the beneficiary will
no longer be enrolled in the plan for the
following year. A 12/31 disenrollment date
should only be counted and reported if the
member truly disenrolled from the plan on
12/31.
MTM

General comment: Reduce the number of
fields by limiting the reporting to
beneficiaries who meet the CMS criteria

Recommend CMS reduces the number
of fields by limiting the reporting to
beneficiaries who meet the CMS
criteria.

CMS disagrees with the
recommendation. The information about
beneficiaries enrolled in the sponsors’
MTM program who met the sponsors’
expanded eligibility criteria is needed to
comprehensively analyze the Part D
MTM programs. For example, to
analyze outcomes of MTM programs, the
analysis must control for who received
MTM services (whether based on CMS’
specifications or other plan-specific
targeting criteria) or not.

MTM

General Comment: The Gentran (and
Connect:Direct) submission/validation
processes took weeks and rejections were
not provided clear messaging to issues
CMS identified based on the files
submitted.

Recommend CMS create an
alternative method to have the
submission and acceptance process
for Gentran (and direct:connect) be
more efficient? None of the other Part
D measures go through a ‘validation’
process and furthermore, a submission
activity report capability is available in
HPMS.

CMS believes this comment is out of
scope for the proposed data collection.
Due to the sensitive nature of the data
being submitted for this measure,
sponsors must use Gentran to submit
beneficiary level data that cannot be
submitted via HPMS. The response files
also must reside on the Gentran server
since this is the mechanism for which the
data are uploaded. We have measures
in place to be sure that responses are
provided timely for future submission
timeframes. CMS will look to improve
communication when this situation
occurs.

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Reporting
Section

Description of Issue or Question

Commenter's Recommendations

CMS Response

MTM

General Comment: The file naming
convention was inaccurate from the
January 2015 memo and was not
corrected until the end of the submission
window period.

Recommend correction of the naming
convention for future submissions.

CMS believes this comment is out of
scope for the proposed data collection.
CMS agrees the naming convention was
incorrect in the January 2015 memo.
Any user calling the HPMS help desk
was provided the correct naming
convention to submit their uploads and
an updated HPMS memo was distributed
to sponsors with the correct naming
convention. CMS will put additional
safeguards in place to prevent this issue
in the future.

MTM

General Comment: We are concerned with
the process for reporting in Gentran (and
direct:connect), under the current guidance
reports are considered timely only if CMS
opens and verifies (validates) the report
was received. Is there an alternative
method to have the submission and
acceptance process for Gentran (and
direct:connect) be more efficient? None of
the other Part D measures go through a
‘validation’ process and furthermore, a
submission activity report capability is
available in HPMS.
General Comment: The CMS-IT helpdesk
resource responses (and response times)
were severely slow and many times during
the last few weeks of reporting,
unresponsive (in that a caller could not get
into a call queue and would be on hold for
hours) and in some cases had to work with
the IT desk for weeks to get resolution.
Could CMS provide a notification process
of known issues to plan sponsors via
HPMS memo or email.

Recommend CMS create an
alternative method to have the
submission and acceptance process
for Gentran (and direct:connect) be
more efficient? None of the other Part
D measures go through a ‘validation’
process and furthermore, a submission
activity report capability is available in
HPMS.

CMS disagrees with the
recommendation. The Gentran
submission is required to protect the
personally identifiable information (PII)
data contained therein. The validation is
to assure that the sponsors are
submitting all associated contracts or
plans and that the format matches the
technical specifications. If we remove all
validations, we run the risk of receiving
invalid data.

Recommend CMS provides a
notification process of known issues to
plan sponsors via HPMS memo or
email.

CMS believes this comment is out of
scope for the proposed data collection.
CMS will look to improve communication
when this situation occurs.

MTM

CMS understands this technical
comment and will be working to improve
response times.

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Reporting
Section

Description of Issue or Question

Commenter's Recommendations

CMS Response

MTM

General Comment: Could CMS utilize
HPMS rather than Gentran (or
direct:connect) to report MTMP?

Recommend CMS utilizes HPMS
rather than Gentran (or direct:connect)
to report MTMP data.

CMS disagrees due to the fact that MTM
submission includes PII and beneficiary
level data cannot be submitted via
HPMS. Therefore, these data are
submitted through Gentran.

General

• Expunge the words “Service Area”
throughout the specifications. This will
greatly simplify programming.
• Round numbers up.

1. Recommend CMS expunges the
words “Service Area” throughout
the specifications.
2. Recommend CMS round numbers
up.

1. This comment does not impact the
data collection instrument. CMS has
clarified the issues around “service
area” in the technical specifications.
2. N/A since the LTC reporting section
has been suspended.

General

Could CMS provide additional guidance for
plans that have fully integrated dual eligible
beneficiaries to accommodate differences
impacting reporting requirements?

Recommend CMS provide additional
guidance for plans that have fully
integrated dual eligible beneficiaries to
accommodate differences impacting
reporting requirements.

General

If guidance is released and there are
issues identified afterwards, or even with
the guidance itself, please send out
corrections to the plans. The CMS
helpdesk identified numerous issues with
2014 reporting, once we were able to get
in contact with them, but additional
guidance was not released to clarify the
issues for all plans.

Recommend CMS send out
corrections to the plans if guidance is
released and there are issues
identified afterwards.

CMS agrees with this comment.
Medicare/Medicaid Plans (MMPs) should
refer to the Medicare-Medicaid Financial
Alignment Model Reporting
Requirements for additional reporting
guidance. We have revised the
introduction in our Reporting
Requirements document to explicitly
state some MMP measures may have
specific timelines that may be different.
CMS believes this comment is out of
scope for the proposed data collection.
CMS however, does agree
communication can be improved if
technical issues occur during a data
submission window. CMS will look to
improve communication when this
situation occurs.

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Reporting
Section

Description of Issue or Question

Commenter's Recommendations

CMS Response

General

Could plans actively seek out clarifications
and guidance regarding the Technical
Specifications? Perhaps responses would
be tracked somewhere (FAQ) on an ongoing basis as sponsors may have similar
questions and it would be helpful to
information share.

Recommend CMS create an ongoing
(FAQ) document as sponsors may
have similar questions and it would be
helpful to share information.

CMS believes this comment is out of
scope for the proposed data collection.
CMS agrees and does consider
questions/suggestions received to make
updates to Reporting Requirement and
the Technical Specifications. CMS will
look to improve communication when
this situation occurs.

General

What does CMS intend to do with this
information?

n/a

Data collected via Medicare Part D
Reporting Requirements are an integral
resource for oversight, monitoring,
compliance and auditing activities
necessary to ensure quality provision of
the Medicare Prescription Drug Benefit
to beneficiaries.

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