Response to 30-day Comments

Responses to Comments Received
Federal Register Notice on (CMS10191)
Medicare Parts C and D Program Audit Protocols and Data
Request
CMS received 13 public submissions, which included 138 comments on the December 12,
2016 (CMS-10191) Medicare Parts C and D Program Audit Protocols and Data Requests
proposed information collection. We then combined the 138 comments into 92 unique
comments and provided responses in the document below. Comments are separated first by
protocol area, and then by element or section of the protocol. Additionally, some general
comments received are addressed in the first part of the document.

GENERAL AUDIT QUESTIONS
Self-Disclosed vs. Self-identified:
Comment 1: One commenter had questions regarding what should be included in Pre-Audit
Issue Summary. The commenter noted that in CY2017 CMS has removed self-identified issues
from items that need to be reported. The commenter went on to state: “As a plan, there are
times that we work through inquiries with our CMS Account Manager that require research and
potentially a corrective action plan for resolution. We recommend if issues were worked
through with our regional account manager that they be included in the Pre-Audit Issue
Summary as CMS would have been aware of these prior to the audit engagement notice being
received.”
Response 1: As we stated in response to the 60 day comments, for 2017, we are eliminating
the reporting of self-identified issues and only asking sponsors to include issues that have
been previously disclosed to CMS that may impact the sponsor’s audit universes. Issues that
are detected and disclosed by the sponsor discussed and then worked on with your account
manager are issues that should be included in the Pre-Audit Issue Summary in 2017. Issues
that are detected by CMS, and result in CMS inquiries or research follow-up from sponsors,
are not considered “disclosed” issues for inclusion on the Pre-Audit Issue Summary. For those
disclosed issues that were promptly identified and corrected, CMS may consider that
disclosure as a reason to downgrade the classification of that condition from an ICAR to a
CAR when on audit. This modified approach will also ensure CMS appropriately recognizes
organizations that are transparent with CMS when discovering issues of non-compliance.
CMS Action 1: No changes were made to the Pre-Audit Issue Summary template or protocols
in response to this comment. No changes were made to the burden estimates in response to
this comment.
Comment 2: Commenters noted that Sponsors will be asked to provide a list of all disclosed
issues of non-compliance that are relevant to the program areas being audited and may be
detected during the audit on the PAIS. Issues identified by CMS through on-going monitoring
or other account management/oversight activities during the plan year are not considered
disclosed.

Commenters stated that this proposal will substantially change when disclosure is required
to CMS. The proposal to include only CMS disclosed items on the PAIS provides an
incentive to disclose all noncompliance events to CMS, regardless of size or significance.
Commenters suggested Regional Offices may want different levels of disclosure and often
react differently to self-disclosed items, with some issuing NONCs more liberally than others
for similarly disclosed events.
Commenters went on to state that if this change were to be finalized, plans would be penalized
for not disclosing all items, even if the impact was only one member. CMS has always been
silent on specific criteria that Plans must follow to determine which issues should be disclosed
to CMS. Plans have been allowed latitude to determine its own criteria, in accordance with its
compliance program, plan size, and relationship with its CMS Regional Office Account
Manager. The CMS audit protocols should not be policy vehicle to substantially change the
disclosure criteria established in Section 50.7.3 in Chapter 9/21.
Response 2: Nothing in the audit protocol supersedes or changes a sponsor’s obligations
under Section 50.7.3 in Chapter’s 9 and 21. The instructions in the audit protocol package are
specific to completing the Pre-Audit Issue Summary. The instruction to include “disclosed”
issues on the PAIS document has not changed in 2017. We are only asking you to limit what
you include on the PAIS document by not including “self-identified” issues that have not been
disclosed to CMS. The self-identification and prompt correction of non-compliance can still be
reported to CMS during the audit and may be considered a mitigating factor when citing or
classifying audit conditions. However, CMS is no longer asking that “self-identified” issues be
reported on the PAIS document. Please maintain normal reporting with your CMS Account
Manager.
CMS Action 2: No changes were made to the Pre-Audit Issue Summary template or protocols
in response to this comment. No changes were made to the burden estimates in response to
this comment.
Comment 3: One commenter wished to clarify both the types of issues to be included in the
PAIS and the timeframe of those issues to be included.
Response 3: As we stated in response to the 60 day comments, for 2017, we are eliminating
the reporting of self-identified issues and only asking sponsors to include issues that have
been previously disclosed to CMS that may impact the sponsor’s audit universes. Disclosed
issues should be pulled by program area based on the audit review period for that particular
protocol. For example, if a sponsor is submitting 3 months of universes for CDAG, their CDAG
disclosure list should include all issues that might affect their Part D coverage determinations,
appeals and grievances for that 3 month period. The actual disclosure date may fall outside of
the audit review period, but CMS will not accept disclosures made after the engagement letter
is issued.
CMS Action 3: No changes were made to the Pre-Audit Issue Summary template or protocols
in response to this comment. No changes were made to the burden estimates in response to
this comment.

Impact Analysis:

Comment 4: One commenter requested clarification on who would request and verify the
accuracy of any requested impact analysis.
Response 4: An impact analysis will be requested by your Team lead or Auditor-in-Charge. It
must be submitted as requested by CMS for every issue of non-compliance present during the
audit. The impact analysis must identify all of the beneficiaries subjected to or directly
impacted by the issue of non-compliance.
CMS Action 4: No changes were made to the protocols in response to this comment. No
changes were made to the burden estimates in response to this comment.

SUPPORTING STATEMENT A
Comment 5: One commenter asked if MMP Contracts would be included in the Timeliness
Monitoring Project (TMP).
Response 5: No, MMP contracts will not be included in the timeliness monitoring project.
CMS Action 5: No changes to the supporting statement, protocols or burden estimates
were made in response to this comment.
Comment 6: One commenter asked which audit elements would be tested during the TMP.
Response 6: The TMP will assess sponsor’s timeliness with processing Part C and Part D
organization and coverage determinations, and appeals; as well the sponsor’s compliance
with auto-forwarding cases to the IRE.
CMS Action 6: No changes to the supporting statement, protocols or burden estimates
were made in response to this comment.
Comment 7: One commenter asked if the TMP would begin in December every year.
Response 7: Yes, we believe it will begin in December/January of each year.
CMS Action 7: No changes to the supporting statement, protocols or burden estimates
were made in response to this comment.
Comment 8: One commenter asked if the universe period for the TMP would be the
same timeframe each year.
Response 8: The universe request period for the TMP will likely change each year.
CMS Action 8: No changes to the supporting statement, protocols or burden estimates
were made in response to this comment.
Comment 9: One commenter asked if a timeliness discrepancy is uncovered during the review,
what would the expected turn-around time be post final report issuance in which a sponsor will
be made aware of any data integrity flags for affected plans?
Response 9: Sponsors will receive information on the results of the timeliness tests in advance
of these results impacting any Star Ratings measures.

CMS Action 9: No changes were made to the supporting statement, protocols or
burden estimate in response to this comment.
Comment 10: Some commenters expressed concern with the TMP project and were
concerned particularly that sponsors and their PBMs would be able to handle the request and
be adequately prepared to submit the data. The commenters expressed concerns that rushing
may lead to erroneous data submissions, especially given that many sponsors have already
programmed the 2017 protocols into their system, and CMS is requesting data in the 2016
format. Given the concerns raised above, commenters urged CMS to further delay the start
date for the TMP. These commenters also raised concerns about using audit data or data from
the TMP for purposes of Star ratings.
Response 10: We thank the commenters for sharing their concerns. We have received a lot of
feedback on the TMP and have been extremely sensitive to other workloads or collections that
plans are subject to, during our request for data. We have also created a request schedule that
breaks up the number of sponsors. CMS is requesting data in 3 waves to make it more
manageable. CMS’ schedule takes into account audit and validation activities, as well as the
sponsors’ PBMs, and how many contracts those PBMs service. To the greatest extent
possible, we staggered sponsors across one of three waves of requests and ensured PBMs
contracts were split across the waves so as to lessen their burden and reduce the likelihood of
errors. Additionally, if a sponsor or PBM raises concerns about scheduling or response times,
we will attempt to be as flexible as possible in accommodating those requests.
CMS used the 2016 audit protocols to request these data, because we were requesting 2016
data, which sponsors already had programmed into their system. Since 2017 protocols were
not finalized, we could not request that sponsors submit data in the 2017 format.
As for the commenter's concern about using audit results to inform Star Ratings, let us be clear
that audit results do not inform any Star ratings measure. Instead, if audit data demonstrate
that the data reported by the IRE to CMS (for a given sponsor) may be inaccurate or
incomplete, then this evidence may be used to support concerns that there are issues related
to the data that is used in measures in the Star Ratings, in this instance, cases auto-forwarded
to the IRE. In other words, if the audit demonstrates that all cases that should have been
forwarded to the IRE were not, then the IRE data relied upon to inform the appeals Star
Ratings measures is no longer valid.
CMS Action 10: No changes to the supporting statement, protocols or burden estimates were
made in response to this comment.
Comment 11: One commenter stated they believed that this collection was duplicative of the
data reviewed via the data validation auditors, which is a separate collection. The commenter
was also concerned we may use the data to target sponsors. This commenter also expressed
concern that without knowing a sponsor’s tolling or mailroom policies, CMS would not be able
to accurately assess timeliness as part of the TMP.
Response 11: We appreciate the concerns raised by the commenter. The data collected by
the data validation contractors is collected in an aggregate format and is not case specific data
that are collected as part of audits and the TMP, so it is not duplicative. We cannot assess
timeliness from the aggregate data submitted to the data validation contractor.

We assure the commenter that data collected as part of the TMP is being used to validate the
completeness of the IRE data used to inform the appeals Star Ratings measures.
Finally, CMS is collecting the sponsor’s tolling and mailroom policies to ensure that during
any subsequent validation webinars that we are applying the appropriate timeframes for
timeliness purposes.
CMS Action 11: No changes to the supporting statement, protocols or burden estimates were
made in response to this comment.
Comment 12: Several comments expressed concerns that CMS’ burden estimate for the time
it takes to complete an audit and/or the time expended in the TMP project are greatly
underestimated, from the commenters’ experiences. One commenter recommended CMS
survey Sponsors post-audit to obtain a more accurate estimate of the hours the sponsor spent
on audit activities. This information could be used to update the burden estimate as appropriate.
Response 12: Thank you for your feedback, we did take sponsor feedback from the 60 day
and 30 day comments and adjusted the estimate to 740 hours for a sponsor to undergo an
audit. This was a significant increase from our initial estimate of roughly 120 hours, which we
agree was not adequate.
We recognize the new estimate will not be representative for all organizations as the sponsors
we audit vary greatly in the number of enrollees they serve, size of the organization, staffing,
etc. CMS has to develop an educated estimate on an "average" number of hours it would take
to go through an audit, taking into account all of the various organizations (large and small) that
we audit. We will continue to request sponsor feedback on level of effort in future packages to
ensure our estimate is reflective of current experience.
CMS Action 12: We did update the hours in the supporting statement and burden
estimate to reflect 740 hours, which is a change from the 701 that were reflected in the
burden estimate during the 30 day comment period. In reviewing the comments and our
estimates in response to comments, we uncovered a calculation error from the 30 day
package. We also changed the burden for the post audit survey from 30 minutes in the
burden to 10 minutes. During the design and testing of this survey, it was designed to
only take an average of 10 minutes. No changes were made to the protocols in response
to this comment.
Comment 13: Some commenters believe that the burden estimate for the TMP are not
adequate, and indicated that larger sponsors, whose PBMs are pulling data, may take weeks of
time.
Response 13: Thank you for your feedback. We have reviewed the comments received on our
burden estimate for the TMP and we believe our burden estimate is representative of the
average number of hours it will take a sponsor to undergo the TMP. As mentioned above with
our audit estimate, sponsors of all sizes and staffing levels will undergo the TMP. Our estimate
will not be a perfect fit for all organizations. We will continue to request feedback on our
estimate in future packages to continually refine our estimate.
CMS Action 13: No changes were made to the supporting statement, protocols or burden

estimates in response to this comment.
Comment 14: Some commenters expressed concerns with the timing of the TMP, and
indicated that CMS may be violating its duties under the Paperwork Reduction Act (PRA). The
commenters asserted that OMB’s review of the package is ongoing and any implementation
should wait until after OMB approval has been received.
Response 14: We thank you for your feedback. CMS takes very seriously our obligations
under the Paperwork Reduction Act. CMS did delay implementation of the TMP in response to
industry concerns. While several updates were made to record layouts and definitions in the
2017 protocol packages, including updating the burden estimate for this effort, the same data
proposed in this package was collected under the previously approved CMS-10191, which is
approved through March 2017.
In addition, it should be noted that CMS received overwhelming feedback from industry, raising
serious concerns about CMS' policy of reducing Star Ratings measures based on audit findings
showing that the source data for those measures was inaccurate). Industry shared their
concern that it adversely impacts only those organizations selected for audit in a given year.
We recognize the importance of having complete and accurate data, particularly when
developing Star Ratings measures. CMS believes that the timeliness monitoring project will
greatly improve the data used to inform appeals measures for the Star Ratings.
CMS Action 14: No changes were made to the supporting statement, protocols or
burden estimates in response to this comment.

PART D COVERAGE DETERMINATIONS, APPEALS AND GRIEVANCES (CDAG)
General:
Comment 15: Several commenters noted that CMS is no longer requiring sponsors to provide
universes in a standardized time zone, and instead, CMS is allowing sponsors to submit
universes in multiple time zones; as long as each case is recorded in the time zone the case
was received in. These commenters requested that they continue to be allowed to provide
universes in a standardized time zone because they had already programmed their systems to
pull data in that way.
Response 15: CMS will accept universes in a standardized time zone or multiple time zones
so long as individual cases are in one time zone per case. Sponsors should let the CMS audit
team know how they will be submitting the universe.
CMS Action 15: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Call Logs:
Comment 16: Several commenters requested clarification regarding the review period for Part
D call logs. These commenters noted that the review period appears to be reversed and that it
was different than the review period in Part C ODAG.
Response 16: The review period for Part D Call Logs in the CDAG protocol was an error and

was corrected prior to the 30 day review period closing. The corrected review period is similar
to ODAG and requests universes based on the size of the sponsor enrollment. Larger
organizations will have a smaller time period of calls to provide during audit because their
volume is typically higher.
CMS Action 16: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 17: One commenter requested that ODAG and CDAG Call Log universes provide
consistent guidance regarding which calls are excluded from the request. Specifically, the
commenter requested that ODAG include the same exception or exclusions that CDAG
listed.
Response 17: CDAG and ODAG are both requesting call logs for 2017, and while we have
tried to make the requests as consistent as possible, some differences are necessary given
the variances in the program areas. For CDAG, we believe we can exclude physicians and
prescriber calls from the request.
CMS Action 17: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 18: One commenter requested clarification regarding whether CMS would provide
translators if audio files were needed and the audit file was not in English.
Response 18: While sponsors are expected to provide call log universes in English, we will
work with organizations on providing access to audio files or call transcripts when calls are
not in English. If the sponsor believes this will be an issue they should raise it to the audit
team.
CMS Action 18: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 19: One commenter requested clarification regarding whether to include calls that
covered both a Part C and Part D question in both the Part C and Part D call logs.
Response 19: If a call relates to both a Part C and a Part D issue and is from an enrollee or
representative, then that call should be included in both the Part C and Part D call log
universe.
CMS Action 19: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 20: One commenter stated that some audio files are difficult to access or pull
quickly, and recommended that CMS allow sufficient time for the organization to access
these files when needed.
Response 20: We agree that sponsors should be allowed adequate time to pull audio files.
Audio files will only be requested when the notes regarding the call are not adequate. Sponsors
may discuss the timeframe for providing audio files with the audit team.
CMS Action 20: No changes were made to the protocol in response to this comment. No

changes were made to the burden estimate in response to this comment.
Comment 21: One commenter thanked CMS for providing further clarification on the call logs,
and limiting the call log universe request based on comments received during the 60 day.
Response 21: We appreciate the support from this commenter.
CMS Action 21: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 22: One commenter requested clarification on the requirements for sponsors to
document incoming calls.
Response 22: CMS will be assessing whether sponsors appropriately identified requests for
coverage or oral complaints as either Part D coverage determinations/ appeals/ grievances,
and will expect documentation regarding the appropriate classification of these requests in
accordance with 42 CFR 423.564(b) 42 CFR 423.564(d) 42 CFR 423.568(a) 42 CFR
423.570(b) and 42 CFR 423.584(b).
CMS Action 22: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 23: One commenter requested clarification on whether call logs would be validated
during the pre-audit validation webinar.
Response 23: CMS will not validate the accuracy of the call logs during the pre-audit webinar,
since timeliness will not be run on the call log universe. However, during the call log review,
CMS will validate that sponsors provided accurate information in response to the audit protocol
request.
CMS Action 23: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Timeliness:
Comment 24: One commenter requested CMS release the internal thresholds used to assess
compliance with timeliness requirements in CDAG.
Response 24: At this time we do not share our internal thresholds. While the regulations and
statute contemplate 100% timeliness that is not the standard we hold sponsors too during
audit. For audit purposes we have created thresholds that we believe are reasonable for a
sponsor to meet.
CMS Action 24: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 25: One commenter requested clarification regarding the timeliness tests in CDAG,
specifically if universes were combined when running timeliness tests. This commenter stated
that this was different than 2016 and therefore clarification was needed.
Response 25: The CDAG protocol combines all similar compliance standards when running
timeliness tests. For example, since all untimely cases require auto-forwarding within 24 hours

of the missed timeframe, all cases eligible for auto-forwarding are merged together to get one
overall result. Merging universes allows CMS to completely assess the requirement without
penalizing the sponsor multiple times for the same failure. This was done in 2016 and will
continue to be done in 2017.
CMS Action 25: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Record Layouts:
Comment 26: One commenter stated that several fields in the record layouts were new and
would impact submissions of universes from the PBM.
Response 26: We agree that some new fields were added to the record layouts for 2017.
Most of these fields were identified based on comments received during the 60 day comment
period in order to make the record layout clearer. While we understand that adding new
fields will require altering universes for submission, we feel the fields added in CDAG are
important for auditors to receive, and are in response to industry feedback.
CMS Action 26: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 27: One commenter requested clarification on the oral notification field, specifically
what constituted a good faith attempt at oral notification and whether good faith attempts
should be reported in the oral notification field for the record layout.
Response 27: Sponsors should refer to Chapter 18 of the Medicare Prescription Drug Manual
and the recent HPMS memo, issued February 22, 2017, that discussed updated outreach
guidance for a definition of what constitutes a good faith attempt. Sponsors should include
good faith attempts at oral notification in the record layout. Sponsors should include the last
good faith attempt made within the applicable timeframe (i.e., for standard coverage
determinations sponsors would input the last good faith attempt made within the 72 hour
timeframe).
CMS Action 27: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 28: Two commenters requested clarification on how to populate the field relating to
whether an enrollee resided in long term care facilities. Specifically, the commenters asked for
clarification on whether point of sale information or residence codes could be used to identify
long term care enrollees.
Response 28: Sponsors can and should use whatever information is available to them to
determine if an enrollee is residing in long term care, including but not limited to point of sale
transactions near the date of the coverage request. For example, if a residence code is
attached to a POS transaction and indicates the enrollee resides in a long term care facility,
the sponsor should indicate “yes” in the long term care field of the record layout.
CMS Action 28: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.

Comment 29: One commenter requested clarification on the medical necessity fields in the
redetermination record layouts (Tables 6, 7, and 8) as well as the reimbursement record
layouts (Tables 3, 7 and 12). Specifically the commenter wanted to clarify that for the
redetermination universes the sponsor should fill out whether or not the original coverage
determination was denied for lack of medical necessity and not whether the redetermination
was denied for lack of medical necessity. For the reimbursement record layouts, the sponsor
requested clarification on why there was a medical necessity field in these tables.
Response 29: We appreciate this commenters request for clarification. For the
redetermination fields the sponsor should indicate if the original coverage determination was
denied for lack of medical necessity. It is the original coverage determination denial that
triggers the need for a physician reviewer on appeal, which is what the field is capturing. As
for the reimbursement fields, reimbursements are coverage determinations and require the
same processing as pre-benefit coverage determinations, including making medical necessity
decisions.
CMS Action 29: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 30: One commenter requested clarification on the reason why CMS was asking
whether or not a reimbursement was an exception request, since that seemed to be more
clinical in nature, and not relevant to a reimbursement request.
Response 30: As indicated above, reimbursements are coverage determinations and require
the same processing as pre-benefit coverage determinations, including requesting supporting
statements from physicians for those cases that are exception requests.
CMS Action 30: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 31: Two commenters requested clarification on the new Authorization of
Representative (AOR) fields that were included in the CDAG record layouts. Specifically, one
commenter requested these fields be removed since populating them would be burdensome on
the sponsor as that information was not easily captured. Another commenter requested
clarification on how to populate the field, especially when the AOR was received prior to the
coverage determination being received, and whether a pharmacy would need to submit an
AOR on behalf of the enrollee when making a request.
Response 31: We appreciate the comments on these new fields. We added these fields
based on industry feedback during the 60 day comment period. These fields are important for
CMS to know in order to judge timely processing of cases, since the start time for a request
begins when the AOR is received. As for populating these fields, a sponsor should enter the
information based on the circumstances of the case. If the case is initially received without an
AOR, the AOR receipt date and time should be populated once the sponsor receives the
AOR. If the sponsor already has an AOR on file, the sponsor should populate the AOR receipt
date and time with the date and time the coverage determination or redetermination request
was received. A sponsor should include information based on the way they handle or process
cases, so if a sponsor requires a pharmacy to submit an AOR, they should indicate that in the

universe.
CMS Action 31: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 32: One commenter requested clarification on partial approvals in CDAG.
Specifically the commenter requested that CMS add a disposition type for partial
approvals.
Response 32: Partial approvals are considered partial denials and should be included as
partial denials for purposes of reporting them on audit. Please enter “partial denial” in the
disposition field.
CMS Action 32: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 33: One commenter requested clarification on what a “hospice” exception type was.
Response 33: Sponsors are required to indicate the type of exception request in the CDAG
record layouts. The types of request include non-formulary, formulary UM, tiering, and hospice.
Since hospice enrollees have drug coverage under the hospice benefit, any decision to provide
a drug under Part D and not hospice is considered an exception based on CMS guidance.
CMS Action 33: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 34: One commenter requested clarification on whether a letter being sent to a postal
sorting house would be considered “provided” for purposes of populating the written notification
fields.
Response 34: For purposes of populating this field, sponsors should indicate the date and time
the letter left the sponsor establishment, which can include leaving the organization through a
postal sorting house.
CMS Action 34: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.

PART C AND D COMPLIANCE PROGRAM EFFECTIVENESS (CPE)
Regulations and Sub-Regulatory Policy:
Comment 35: One commenter recommended that CMS exempt sponsors from complying with
the annual audit of their compliance program in the same year the sponsor undergoes a CMS
program audit.
Response 35: Thank you for the recommendation. CMS disagrees with the proposed change.
CMS’s expectation is that sponsors must audit the effectiveness of the compliance program at
least annually.
CMS Action 35: No changes were made to the protocol in response to this comment. No

changes were made to the burden estimate in response to this comment.
Comment 36: One commenter asked CMS to define certain words or terms from Chapters 9
and 21. One commenter requested CMS explain what is considered “reasonable” and “timely”
responses and corrective actions for compliance and FWA issues.
Response 36: These questions are outside the scope of the PRA package. We cannot offer
policy guidance on what these terms should mean. For audit purposes, sponsors should
populate their universes based on how they process or define these terms. For definitions
and policy guidance, commenters should refer to 42 CFR 422 and 423 Subpart K, Chapter 9
of the Prescription Drug Benefit Manual and Chapter 21 of the Medicare Managed Care
Manual.
CMS Action 36: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 37: One commenter inquired about CMS having a broader definition for determining
when a related entity is acting as a first-tier entity.
Response 37: These questions are outside the scope of the PRA package. We cannot offer
policy guidance on what these terms should mean. For audit purposes, sponsors should
populate their universes based on how they process or define these terms. For definitions and
policy guidance, commenters should refer to 42 CFR 422 and 423 Subpart K, Chapter 9 of the
Prescription Drug Benefit Manual and Chapter 21 of the Medicare Managed Care Manual.
CMS Action 37: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimates as a result of this comment.
Universe Preparation & Submission:
Comment 38: One commenter requested clarification regarding the word “miscommunication”
in question #9 of Attachment I-B.
Response 38: For this question sponsors should discuss an experience during the specified
audit period when the lines of communication between the Compliance Department and a
Medicare operations unit or an employee failed to adequately prevent or identify a Medicare
compliance issue, including how the two entities worked together to resolve the issue.
CMS Action 38: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 39: One commenter requested clarification regarding the types of priorities CMS is
seeking to be listed for Question #19 of Attachment I-D.
Response 39: Sponsors should specify its plans to build successful delegation relations and
oversee its delegated entities continued compliance with Medicare requirements for the
specified timeframe.
CMS Action 39: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.

Comment 40: One commenter thanked CMS for clarifying that sponsors should include both
compliance and FWA activities in the data universes.
Response 40: We appreciate your comment.
CMS Action 40: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment

Comment 41: One commenter expressed appreciation to CMS for reducing the length of the
CPE questionnaires which will allow sponsors to streamline their resources.
Response 41: We appreciate your comment.
CMS Action 41: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment
Comment 42: One commenter recommended that less detail be requested for the CPE
universes.
Response 42: We understand your concerns about the level of detail requested for universes.
Conversely, detailed universes are needed for CMS to select appropriate samples that will
provide sponsors the best opportunities to demonstrate the effectiveness of their compliance
program during the tracer evaluation.
CMS Action 42: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment
Comment 43: One commenter asked CMS to consider only requiring tracer cases for annual
CPE audits on a frequency other than annually, for example, every 3 years.
Response 43: Sponsors are not required to use CMS’ audit methodology and protocols (i.e.
sample selection, tracer evaluation, etc.) when conducting their annual compliance program
effectiveness audit.
CMS Action 43: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Tracer Evaluation:
Comment 44: One commenter requested clarification on whether all of the bulleted items for
section 2.1 are required to be addressed in the tracer case summaries.
Response 44: We appreciate the commenter’s question. Sponsors are expected to provide
the requested information for tracer case summaries. If one of the bulleted items do not apply
to a tracer case, provide a brief statement indicating why the item is non-applicable.
CMS Action 44: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Record Layouts
All Tables
Comment 45: Three commenters thanked CMS for reducing burden on sponsors by removing
monitoring and audit activities performed on a daily basis from the FTEAM, IA and IM universes.
Response 45: We appreciate your comment. Daily monitoring and audit activities are no longer
requested and have been excluded from the CPE universes.
CMS Action 45: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.

Table 1: First-Tier Entity Auditing and Monitoring (FTEAM) Record Layout
Comment 46: One commenter inquired whether it is CMS intent for sponsors to include only
those first-tier entities who provide services directly to Medicare enrollees only in the FTEAM
universe. Additionally, the commenter asked for clarification regarding the types of providers
that should be included.
Response 46: The FTEAM universe should comprise of the first-tier entities that were audited
or monitored by the sponsor during the audit period. A first-tier entity is any party that enters
into a direct written arrangement, acceptable to CMS, with an MAO or Part D plan sponsor to
provide administrative services or health care services to a Medicare eligible individual under
the MA program or Part D program. This universe may contain a range of entities, depending
on first-tier contractual arrangements between the sponsor and its vendors, including but not
limited to pharmacy benefit managers, credentialing, hospital groups, independent practice
associations, individual health care providers, etc.
CMS Action 46: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 47: One commenter requested clarification on whether “initiated” in Column J- Table
1 refers to an activity notice date.
Response 47: CMS acknowledges that sponsors use different terms within their organizations
and audit/monitoring activities “start date” may be acknowledged at different stages (e.g. preplanning work, kick-off meetings, engagement notices, audit fieldwork, etc.). Please provide the
date the auditing or monitoring activity is considered to have started at your organization.
CMS Action 47: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimates as a result of this comment.
Comment 48: One commenter asked CMS to clarify if the types of audits and monitoring
activities that were initiated by allegations are to include just a case investigation which may not
include a formal audit or monitor.
Response 48: Due to insufficient information, we were unable to address the commenter’s
question. We encourage the commenter to resubmit their comment to our audit mailbox with
additional information for an appropriate response.
CMS Action 48: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimates as a result of this comment.
Comment 49: One commenter requested that CMS provide a broader definition for
determining when a related entity is actually acting as a first-tier entity.
Response 49: These questions are outside the scope of the PRA package. We cannot offer
policy guidance on what these terms should mean. For audit purposes, sponsors should
populate their universes based on how they process or define these terms. For definitions and
policy guidance, commenters should refer to 42 CFR 422 and 423 Subpart K, Chapter 9 of the
Prescription Drug Benefit Manual and Chapter 21 of the Medicare Managed Care Manual.

CMS Action 49: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimates as a result of this comment.
Comment 50: One commenter requested that CMS clarify whether providers who provide pure
health care and not a health care related service should be included in Table 1 – FTEAM
universe.
Response 50: For audit purposes, sponsors should populate their universes based on how
they process or define these terms. For definitions and policy guidance, commenters should
refer to 42 CFR 422 and 423 Subpart K, Chapter 9 of the Prescription Drug Benefit Manual and
Chapter 21 of the Medicare Managed Care Manual.
CMS Action 50: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimates as a result of this comment.
Comment 51: One commenter requested clarification on how to respond to Column F – Table
1 when the activity could be both a compliance and a FWA activity.
Response 51: Please choose one of the two options available for Column F. During the audit
engagement process, sponsors will have an opportunity to discuss the universe preparation
process and resolve any issues or questions with the CMS Audit Team.
CMS Action 51: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimates as a result of this comment.
Comment 52: One commenter requested clarification on which date to enter into Column J –
Table 1 when the audit or monitoring activity has two dates (started and reopened).
Response 52: Sponsors should enter the most appropriate date that falls within the audit
period.
CMS Action 52: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimates as a result of this comment.
Comment 53: One commenter requested whether sponsors must enter deficiencies after the
activity was completed or include all deficiencies identified to date even if the activity is still in
progress for Columns L, M, N – Table 1.
Response 53: Sponsors should enter the deficiencies that have been identified to date.
CMS Action 53: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimates as a result of this comment.
Comment 54: One commenter asked CMS to clarify whether sponsors should include
corrective actions that have been implemented or those pending implementation.
Response 54: Sponsors are expected to include both taken and pending corrective actions for
the FTEAM, IA and IM record layouts.
CMS Action 54: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimates as a result of this comment.

Comment 55: One commenter asked if CMS would clarify the term “questionable behavior”
performed by FTEs noted in the Inclusion section of the FTEAM universe – Bullet #5 as they
believe the term is too broad to facilitate consistency across MA plans and Part D sponsors.
Response 55: Questionable behavior refers to any action that has the potential to run afoul of
an internal policy, procedure, or standard that will cause an internal investigation to confirm any
ethical or compliance violations.
CMS Action 55: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimates as a result of this comment.
Table 2: Employees and Compliance Team (ECT) Record Layout
Comment 56: One commenter requested clarification on how to respond to Table 2, Columns
E, F, L, and I that do not apply to members of the governing body.
Response 56: If a column does not apply to governing body members, sponsors may enter
“N/A”
CMS Action 56: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.

PART D FORMULARY AND BENEFIT ADMINISTRATION (FA)
Record Layouts:
Comment 57: One commenter noted that although a beneficiary may change Plan Benefit
Packages (PBPs) resulting in a new PBP effective date, the benefit and formulary may remain
consistent. In such cases, an organization may not identify this beneficiary as a new enrollee as
defined per their transition policy. Because the revised record layout instructions for the
“Enrollment Effective Date” and “Effective Disenrollment Date” fields are to populate at the PBP
level. The commenter recommended that CMS take into consideration such factors when
evaluating universe submissions.
Response 57: CMS recognizes that there may be differences among sponsors in determining
new enrollment status for beneficiaries that change plans or contracts under the same
organization from year to year or during a contract year. Organizations should identify such
members as new vs. continuing for purposes of universe submissions based on their internal
policies and procedures. After receipt of a program audit engagement letter, organizations will
have an opportunity to discuss their approach to help ensure complete and accurate universe
submissions.
CMS Action 57: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 58: One commenter asked how sponsors should populate the NDC field with
respect to multi-ingredient compound claims where a pharmacy did not include drug

information, but rather a value that contains spaces, hyphens, or other special characters.
Another commenter asked how to populate the NDC field for a multi-ingredient compound that
does not include a Part D covered drug.
Response 58: For all claims sponsors should include the 11-digit value as submitted by the
pharmacy and when applicable, should remove special characters separating the labeler,
product, and trade package size. In the event a multi-ingredient compound does not include at
least one Part D covered drug, sponsors may populate the NDC field with “00000000000” to
remain consistent with the 11 digit NDC drug code.
CMS Action 58: The NDC field description was modified to include additional guidance on
populating the NDC field. No changes were made to the burden estimate in response to these
comments.
Comment 59: One commenter asked that CMS clarify the distinction between pharmacy
messages that are not linked to a corresponding reject code and pharmacy messages that are
not paired with a reject reason code, and to provide guidance on how to populate these fields
based on that distinction.
Response 59: It has been CMS’ experience that reject claim codes can be cross-walked or
paired to specific pharmacy messages. However, for some organizations the association
between reject codes and messages is not evident or captured in the system. In addition,
situations may exist where a rejected claim returns a pharmacy message this is unrelated to a
reject code or in the absence of a reject code. For purposes of the universe submissions, if both
reject codes and pharmacy messaging exist for a rejected claim, but the exact association
between them cannot be identified, the organization is permitted to enter the individual reject
code in the “Reject Reason Code” field followed by all of the messaging for that claim in the
“Pharmacy Message” field. This should be repeated for all reject reason codes appearing for
that rejected claim. When pharmacy messages for a rejected claim exist without a reject code,
the organization should enter an “NA” in the “Reject Reason Code” field, followed by the
messaging for that claim in the “Pharmacy Message” field. Likewise when a reject code is
generate without a pharmacy message, the organization should enter “NA” in the “Pharmacy
Message” field.
CMS Action 59: We modified the descriptions for the “Reject Reason Code” and “Pharmacy
Message” fields to clarify the different scenarios that may be encountered and how
organizations should populate these fields for each scenario. No changes were made to the
burden estimate in response to this comment.

PART D MEDICATION THERAPY MANAGEMENT (MTM)
Record Layout:
Comment 60: One commenter asked for clarification about the necessity of the “Was the
beneficiary residing in a long term care facility?” field as well as at what point in time the long
term care (LTC) status for the beneficiaries should be captured.

Response 60: CMS evaluates the administration of the MTM benefit for MTM enrollees in the
long term care setting to ensure that they are not being treated differently as per the MTM
requirements. As detailed in the “Was the beneficiary residing in a long term care facility?” field
description, sponsors should use all available information to determine LTC status at the time
the MTM services are offered and administered, such as patient residence code on drug claims
data and the Long Term Institutionalized (LTI) resident report. The LTC status should be
identified either at the time the first CMR was offered or administered during the year.
CMS Action 60: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.

SPECIAL NEEDS PLANS MODEL OF CARE (SNP MOC)
Universe Preparation & Submission:
Comment 61: One commenter requested clarification regarding how the universe should be
completed when an entire SNP population is migrated into a new SNP plan and there are two
separate entries for that member.
Response 61: Please complete the universe template with one entry per member with the new
plan number. Entries in the record layout data fields should be specific to the enrollment into
that specific contract. If the initial HRA and/or annual HRA was not yet completed because of
the consolidation timing, please enter “NA” in these respective fields. Please advise the audit
team of the situation during the universe call.
CMS Action 61: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Record Layouts:
Table 1: Special Needs Plan Enrollees (SNPE) Record Layout:
Comment 62: One commenter recommended that CMS change the description of Column I –
“Date the Sponsor Received the Completed Enrollment Request” to request the application
received date to be consistent with the data Sponsors are required to capture and submit to
CMS.
Response 62: Thank you for the recommendation. CMS cannot use the date the sponsor
received the enrollment application, because it is possible that the application could be
incomplete on the initial receipt date. CMS needs to know the date that the enrollment
application is complete.
CMS Action 62: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.

PART C ORGANIZATION DETERMINATIONS, APPEALS AND GRIEVANCES (ODAG)
Record Layouts:

All Tables
Comment 63: Several commenters noted that CMS is no longer requiring sponsors to provide
universes in a standardized time zone, and instead, CMS is allowing sponsors to submit
universes in multiple time zones so long as each case is recorded in the time zone the case was
received in. These commenters requested that they continue to be allowed to provide universes
in a standardized time zone because they had already programmed their systems to pull data in
that way.
Response 63: CMS will accept universes in a standardized time zone or multiple time zones so
long as individual cases are in one time zone per case. Sponsors should let the CMS audit
team know how they will be submitting the universe.
CMS Action 63: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 64: One commenter asked whether CMS would consider making the CAR/ICAR
timeliness thresholds public.
Response 64: At this time we do not share our internal thresholds. While the regulations and
statute contemplate 100% timeliness that is not the standard we hold sponsors too during audit.
For audit purposes we have created thresholds that we believe are reasonable for a sponsor to
meet.
CMS Response 64: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 65: We received several questions regarding the “Was the request denied for lack of
medical necessity” field throughout the ODAG universes. Specifically, we were asked how to
populate this field.
Response 65: This field should be populated as follows: If the request was denied for lack of
medical necessity, answer “Y”. If the request was denied for any reason other than lack of
medical necessity (e.g., duplicate request, no prior authorization, untimely, etc.), answer “N”. If
the request was approved and not denied, answer “NA”.
CMS Action 65: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 66: We received several questions regarding the “Diagnosis” field throughout the
ODAG universes. Specifically, we were asked how to populate this field.
Response 66: Sponsors may populate the “Diagnosis” field in the ODAG universes by
providing the ICD-10 code(s), a narrative description, or the ICD-10 and NCD codes.

CMS Action 66: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 67: We received several questions regarding how to populate the “AOR Receipt
Date” and “AOR Receipt time” fields throughout the ODAG universes. Specifically, we were
asked whether sponsors should populate the “request receipt date” and “request receipt time”
fields with the Appointment of Representative (AOR) receipt date and time or the actual date
and time the request was received.
Response 67: Sponsors should populate the “AOR Receipt Date” and “AOR Receipt time”
fields with the actual date and time of receipt of the AOR form, or other appropriate
documentation. The “request receipt date” and “request receipt time” fields are intended to
capture the actual receipt of the request and not the AOR form. Our timeliness tests factor in
AOR receipt dates and times to ensure cases are not inappropriately marked as untimely, even
if the AOR was received before the request.
CMS Action 67: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 68: We received several questions and comments regarding how to populate partial
approvals and partial denials in the ODAG universes. Specifically, commenters inquired if partial
approvals are included in the universes, how to classify partial approvals and partial denials and
whether the request should be included in one line or multiple lines (one for approvals and one
for denials).
Response 68: For purposes of populating the audit universes, partial approvals and partial
denials are considered denials and should be treated the same as denials (where all elements
of a given request are denied) in the ODAG universes. Sponsors should enter these denials in
one row within the appropriate universe(s) with a request disposition of “denied.” If there are
multiple notifications related to the request, enter the date and time of the last notification.
CMS Action 68: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 69: We received several questions regarding how to populate the “Issue description
and type of service” field throughout the ODAG universes, specifically, what level of detail is
required.
Response 69: For approvals, sponsors should enter a description of the service or drug that
was requested and why it was requested, if known. For denials, sponsors should provide this
information in addition to an explanation as to why the request was denied (e.g., duplicate
request, lack of medical necessity, no prior authorization, etc.).
CMS Action 69: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 70: We received several questions regarding how to populate the “date of enrollee
notification” and “time of enrollee notification” fields when mail is first delivered to a third-party
sorting facility, which then places the notification in the mail.

Response 70: If a third-party sorting facility is used to sort or meter the mail before delivering it
to the US Postal Service, we would want the date and time the enrollee’s notification was
actually placed into the hands of the US Postal Service either by the sponsor or by the thirdparty sorting facility.
CMS Action 70: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 71: We received several questions regarding what constitutes “reasonable” efforts to
obtain a Waiver of Liability (WOL) or an Appointment of Representative (AOR) form and what
constitutes a “good faith attempt” to orally notify a beneficiary.
Response 71: Commenters should refer to Chapter 13 of the Medicare Managed Care Manual
and the recent HPMS Memo, issued February 22, 2017, which discussed updated outreach
guidance for more information with respect to reasonable outreach and good faith attempts. For
audit purposes, sponsors should populate their universes based on how they interpret these
terms based on the applicable guidance.
CMS Action 71: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 72: We received several questions regarding whether withdrawn requests, SNF
services, concurrent reviews, post-service reviews notifications of admission and requests for
extensions of previously approved services should be included or excluded from the ODAG
universes.
Response 72: Sponsors should exclude withdrawn requests, requests for SNF services,
concurrent reviews, post-service reviews, notifications of admission and requests for extensions
of previously approved services from their universes. If sponsors have already programmed
their systems to pull in this information, they may include this information in their universes.
CMS Action 72: We have updated the exclusion language above the appropriate universes to
clarify that these types of cases should be excluded from the ODAG universes. No changes
were made to the burden estimate in response to this comment.
Table 1: Standard Pre-Service Organization Determinations (SOD) Record Layout:
Comment 73: One commenter wanted to confirm that Column N (Request for Expedited
Timeframe) was intended to capture requests to upgrade a request from standard to expedited
after the initial request was received, but before a decision was rendered on the request by the
sponsor.
Response 73: CMS confirms that Column N (Request for Expedited Timeframe) was intended
to capture requests that were upgraded from standard to expedited after the initial request was
received, but before a decision was rendered.
CMS Action 73: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Table 2: Expedited Pre-Service Organization Determinations (EOD) Record Layout:

Comment 74: We received several questions regarding Column N (Request for Expedited
Timeframe), specifically, how to populate this field.
Response 74: This field is intended to capture requests that were received as expedited
requests, but later processed as standard requests pursuant to Chapter 13, Section 50.3. If the
request was received as an expedited request, but processed as a standard request, this field
should be populated with the person who asked that the request be expedited. Similarly, if the
plan, on its own, decided to process the standard request as expedited, it is unlikely it would
deny its own request to expedite. Therefore, “CP” is not an option in the SOD universe for this
field.
CMS Action 74: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 75: We received several questions regarding Column N (Subsequent Expedited
Request), specifically, how to populate this field.
Response 75: This field is intended to capture requests that were received as standard
requests, but later processed as expedited requests pursuant to Chapter 13, Section 50. If the
request was received as a standard request, but processed as an expedited request, this field
should be populated with the person who asked that the request be expedited.
CMS Action 75: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 76: We received several questions regarding how to populate Column R (Date of
sponsor decision) and Column S (Time of sponsor decision) for pending cases and whether
pending cases should be included in the universes.
Response 76: If a request is still pending, you may enter "NA" in these fields because they are
untimely cases that are still open. Pending requests that are untimely should be included in the
appropriate universes.
CMS Action 76: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Table 3: Requests for Payment Organization Determinations (Claims) Record Layout:
Comment 77: One commenter asked us to define “clean claim” in the context of a pharmacy
point-of-sale claim.
Response 77: The definition of “Clean claim” can be found in 42 CFR § 422.500.
CMS Action 77: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 78: One commenter asked us to confirm that this universe should only include noncontract provider paid claims and contract and non-contract provider denied claims.
Response 78: We confirm that this universe should only include non-contract provider paid
claims and contract and non-contract provider denied claims.

CMS Action 78: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 79: We have received several questions regarding the inclusion of Part B drugs
within this universe and how to populate this universe for Part B point-of-sale transactions.
Response 79: Sponsors should follow the universe population instructions when inputting data
for Part B drug point-of-sale transactions and treat these requests as any other claim.
CMS Action 79: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Table 4: Direct Member Reimbursement (DMR) Record Layout:
Comment 80: One commenter asked whether we should have included “NA” as an option for
Column O (Was Interest Paid to the Beneficiary), as they believed interest did not have to be
paid to beneficiaries for reimbursement requests.
Response 80: There are some circumstances where interest must be paid to beneficiaries for
member-submitted payment requests. If interest was paid to the beneficiary, an entry of “Y”
would be appropriate for this field, and if interest was not paid to the beneficiary, an entry of “N”
would be appropriate for this field. If interest was not required and interest was not paid to the
beneficiary, plans should enter “N” in this field.
CMS Action 80: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 81: One commenter asked whether a response of “NA” would be appropriate for
Columns Q (Date forwarded to IRE if denied or untimely), R (If request denied or untimely, date
enrollee notified request has been forwarded to IRE) and S (AOR receipt date).
Response 81: Columns Q and R, are applicable to member-submitted payment requests that
are reconsiderations. If a member-submitted payment request is received as an organization
determination, then you would populate these fields with "NA." Column S is applicable to all
member-submitted payment requests, whether an organization determination or a
reconsideration, where the beneficiary has a representative acting on his/her behalf.
CMS Action 81: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 82: We received a question regarding how to populate the “Date reimbursement
paid” field when the payment goes to a provider and not a beneficiary.
Response 82: Sponsors should enter the date the payment was made to the member or the
provider.
CMS Action 82: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 83: We received a question regarding how to populate Column G (Person who made
the request) when there is no distinction between the beneficiary (B) and beneficiary’s

representative (BR) in the sponsor’s internal system.
Response 83: The vast majority of sponsors are able to make the distinction in their systems
between requests submitted by beneficiaries vs. requests made by beneficiaries’
representatives. If you cannot do this, either populate these fields manually with B or BR as
appropriate or discuss this limitation with your Auditor-in-Charge after you receive your
engagement letter.
CMS Action 83: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Table 7: Requests for Payment Reconsiderations (PREC) Record Layout:
Comment 84: One commenter asked how to populate the payment reconsiderations universe
(Table 7 – PREC) and direct member reimbursements universe (Table 4 – DMR). In particular,
the commenter asked what to do in instances where the member disputes cost-sharing but
where favorable appeals would result in the plan adjusting the provider claim (and where the
provider is responsible for adjusting the member cost-sharing as they are the ones who collect
these amounts).
Response 84: The payment reconsiderations universe (Table 7 – PREC) is populated with all
payment reconsideration requests submitted by non-contract providers. The direct member
reimbursement universe (Table 4 – DMR) is populated with all member initiated reimbursement
requests, regardless of how repayment works or whether the provider has any involvement in
how the reimbursement is issued to the beneficiary.
CMS Action 84: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Table 11: Part C Oral & Written Standard Grievances (GRV_S) Record Layout:
Comment 85: One commenter asked whether Columns I (Category of Grievance/Complaint)
and K (Was this a Quality of Care Grievance) are duplicative of one another, considering that
Column I also has “Quality of Care” as a valid response.
Response 85: Column I is intended to capture the general nature of the grievance or complaint
and could result in multiple types of answers (e.g., Enrollment, Access, Quality of care) and
Column K is intended to capture whether the grievance or complaint is related to quality of care,
which would be forwarded to the Quality Improvement Organization (QIO).
CMS Action 85: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Table 13: Dismissals (DIS) Record Layout:
Comment 86: We received a question regarding reasons for dismissing a request other than
those specifically stated in the field description, such as duplicate request or no prior
authorization.
Response 86: Column O (Reason for Dismissal) is a free-text field that may be populated with
a description of why the request was dismissed. The valid values listed are merely illustrative

and are not intended to capture every possible reason for dismissing a request.
CMS Action 86: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Table 14: Call Logs Part C (CLC) Record Layout:
Comment 87: One commenter asked why Column K (First Tier, Downstream and Related
Entity) in this universe references dismissals when dismissals are not handled at call centers.
Response 87: This field is intended to capture the name of the first tier, downstream and
related entity (FDR) that processed inbound calls on behalf of the sponsor.
CMS Action 87: We have revised this field in the protocol to say “Insert the name of the First
Tier, Downstream, and Related Entity that processed the call”. No changes were made to the
burden estimate in response to this comment.
Comment 88: One commenter requested clarification regarding whether CMS would provide
translators if audio files were needed and the audit file was not in English.
Response 88: Although the organization is expected to provide the call log universe in English,
CMS would provide translators if audit files were needed for the review.
CMS Action 88: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 89: One commenter requested clarification regarding whether to include calls that
covered both a Part C and Part D question in both the Part C and Part D call logs.
Response 89: If a call relates to both a Part C and a Part D issue the call may be included in
one or both of the call logs.
CMS Action 89: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 90: Two commenters requested that ODAG and CDAG Call Log universes provide
consistent guidance regarding which calls are excluded from the request as well as whether
transferred calls should be included. Specifically, one commenter requested that ODAG include
the same exception or exclusions that CDAG listed.
Response 90: CDAG and ODAG are both requesting call logs for 2017, and while we have
tried to make the requests as consistent as possible, some differences are necessary given the
differences in the program areas. Also, calls that are transferred should be included in this
universe as long as they relate to your Medicare Part C line of business and are from
beneficiaries or their representatives.
CMS Action 90: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 91: We received a question regarding whether or not calls from providers and/or
prescribers should be excluded from this universe.

Response 91: Calls from providers and prescribers should be excluded from this universe.
CMS Action 91: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.
Comment 92: We received a question asking whether CMS would consider revising the call
logs universe to only request grievances as not as much information is tracked for other types of
calls.
Response 92: CMS recognizes there is no requirement for the information you must collect on
all calls. The information we request in the call logs record layout is a recommendation for the
types of information we would like to see in your call logs universe. However, please be sure to
submit your call logs universe, in one of the approved file formats (e.g., .xls, .txt, etc.)
CMS Action 92: No changes were made to the protocol in response to this comment. No
changes were made to the burden estimate in response to this comment.