CMS Response to PRA Comments (2)

Medicare Part C & Part D Universal Audit Guide
CMS Response to PRA Public Comments

Comment: Several commenters suggested that we list all regulations and manual chapters
applicable to each element.
Response: CMS has adopted this recommendation.
Comment: Several commenters noted the duplication of element numbers used throughout the
Universal Audit Guide and recommended the duplication be corrected by assigning unique
element numbers.
Response: CMS has adopted this recommendation.
Comment: Several commenters recommended formatting changes throughout the Universal
Audit Guide such as inserting page numbers and correcting various typos.
Response: CMS has adopted these recommendations.
Comment: Several commenters requested that we specify which elements are applicable to
specific types of Medicare Part C and Part D plans such as RPPO, SNP, PFFS, Cost plans.
Response: We have identified whether elements are applicable to Part C and/or Part D. We are
concerned that plans may be using the Universal Audit Guide to dictate their internal operating
procedures. To be clear, the Universal Audit Guide may not represent all requirements that plans
are responsible to comply with and therefore should never be used to guide a plan’s internal
operations. Plans should be referring to statute, regulations, and manuals for the requirements
that they are required to comply with and should not be using an audit guide to steer their
internal operations. Plans should not be using the Universal Audit Guide as a basis to determine
plan requirements.
Comment: A couple of commenters indicated the verbiage pertaining to Chapter 1 Element
ER14: Working Aged Survey should be amended based on the 2010 CMS Call Letter.
Response: CMS agrees that the language did not reflect updates established in the 2010 CMS
Call Letter and have updated the guide accordingly.
Comment: One commenter expressed their concern that auditors may use different standards
when reviewing Chapter 10 Element EP01: Electronic Prescribing. They requested that we
provide clarification in this element further describing the element and its requirements.
Response: The purpose of the audit guide is not to detail all program requirements. If a plan
wants more information regarding a specific element listed and wants CMS’ full guidance and
instructions around the requirements for that element, please refer to the regulatory and manual
citations listed for the element in question. Plans should not be using the Universal Audit Guide
as a basis to determine plan requirements.
Comment: Several commenters requested that we publish methods of evaluations and
worksheets to aide plans in preparing for audit.
Response: We consider methods of evaluations and worksheets internal audit tools and will not
be releasing these internal documents. The purpose of publishing the audit guide is to allow
plans’ an opportunity to determine the level of effort required in this information collection
effort. Worksheets and MOEs are used internally to evaluate information after it has been
collected; they are never used to actually collect information and are therefore not pertinent to
establishing a plan’s level of effort during an audit. CMS has provided the tool that is used for
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Medicare Part C & Part D Universal Audit Guide
CMS Response to PRA Public Comments

data collection that will be sent to plans during audits. CMS expects plans to develop and
conduct their own internal monitoring efforts to ensure all CMS requirements are met.
Comment: A couple of commenters requested that we define terms in the Universal Audit Guide
such as sample element, on-site element and ongoing element.
Response: These terms were accidentally included in the Universal Audit Guide and are internal
references used by us to identify at what point an element is evaluated. These terms have been
removed to eliminate any confusion as they are not relevant to materials a sponsor must provide
for audit.
Comment: One commenter suggested that the burden estimates projected by CMS appeared low
and requested they be revised to adjust for various factors including non-dedicated programming
staff, customized data and information collection required during audit.
Response: CMS was able to reduce burden calculations based on several changes which have
occurred. These changes include conducting targeted, data-driven and risk-based audits and
allowing requested audit information to be burned to a CD thereby eliminating the need for a
plan to print, copy or ship large quantities of paper which greatly reduces the hours required to
respond to these requirements. Finally, without specific information we cannot consider
changing our burden estimate.
Comment: A couple of commenters requested a “redlined” version of the Universal Audit Guide
and/or a list of new elements added to the guide.
Response: The Universal Audit Guide is a combination of the following prior audit guides; MA,
MAPD, PDP, PFFS, RPPO, SNP and Cost plans. Therefore, there are no new elements nor is
there an available “redlined” version.
Comment: One commenter suggested a crosswalk of the old audit guide to the Universal Audit
Guide be provided to show the old audit element number and the new audit element number if
changed.
Response: The Universal Audit Guide is a combination of the following prior audit guides; MA,
MAPD, PDP, PFFS, RPPO, SNP and Cost plans. Therefore, there are no new elements. The
regulatory and manual citations listed for each element should be sufficient information for plans
who wish to know what audit guides such element previously appeared in. To the extent that an
element was specific to a certain plan type, we have indicated this in the element.
Comment: One commenter recommended that Chapter 8 Element GV01: Organization
Determinatios and Reconsiderations Not Categorized as Grievances and GV02: Grievance
Decision Notification (Timeliness) include additional descriptions.
Response: For additional information on these and any other elements, please refer to the
regulatory and manual citations listed for that element. Plans should not be using the Universal
Audit Guide as a basis to determine plan requirements.
Comment: One commenter inquired if the Marketing Guide would continue to be a standalone
guide for compliance or will it become integrated into the Universal Audit Guide.

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Medicare Part C & Part D Universal Audit Guide
CMS Response to PRA Public Comments

Response: We evaluate marketing requirements as demonstrated in Chapter 4: Marketing in the
Universal Audit Guide. The Medicare Marketing Guidelines is a separate tool used by sponsors
to understand compliance with CMS requirements.
Comment: One commenter requested that elements be alphabetized for easier referencing.
Response: The Universal Audit Guide is currently organized by subject matter (e.g., Chapter 4:
Marketing includes all the Marketing elements), which CMS believes is the most understandable
format. Listing elements in alphabetical order would mix elements on different subjects and we
believe that this would serve no additional referencing purpose.
Comment: One commenter asked for the anticipated effective date and publication date of the
Universal Audit Guide.
Response: Guides are usually uploaded into HPMS at the beginning of the year, in this case
2010.
Comment: One commenter suggested that Chapter 15 Element CP01: Compliance with Federal
and State Standards should have the statement “by the time a Part D contract with CMS is
signed” removed as this is not currently required by law or CMS guidance.
Response: In accordance with Federal regulations at 42 CFR §423.504(b) and published CMS
guidance, a Part D plan sponsor must establish a compliance plan no later than the pending
contract signature date in order to contract as a Part D plan sponsor. CMS has updated element
CP01 accordingly.
Comment: One commenter requested that we provide Medicare Part C Fraud, Waste and Abuse
guidance relative to compliance plans.
Response: Medicare Part C Fraud, Waste and Abuse guidance can be found in Federal
regulations at 42 CFR §422.503(b)(4)(vi) and the December 5, 2007 Final Rule at Federal
Regulations Vol. 72, No. 233. Pages 68705-68707.
Comment: One commenter suggested that Chapter 15 Element CP08: Comprehensive Fraud and
Abuse Plan be removed stating there were no Federal laws requiring this element.
Response: In accordance with Federal regulations at 42 CFR §422.503(b)(4)(vi) and
§423.504(b)(4)(vi), a plan sponsor is required to have a compliance plan that must include
measures to detect, correct, and prevent fraud, waste and abuse.
Comment: One commenter pointed out the duplicity between Chapter 1 Element numbers
ER05: Enrollment Acknowledgement and ER20: Enrollment Notice Requirement, recommending
that Element ER20 is satisfied by ER05.
Response: CMS has adopted this recommendation.
Comment: One commenter suggested that Chapter 4 Element MR08: No Engagement in
Activities Which Mislead, Confuse, or Misrepresent the Sponsoring Organization lists references
to the Medicare Marketing Guidelines twice, recommending the duplicative reference be
removed.
Response: CMS reviewed this section and did not find any duplication.

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Medicare Part C & Part D Universal Audit Guide
CMS Response to PRA Public Comments

Comment: One commenter requested clarification on Chapter 1 Element DN04: Refund of
Premium specifically for the term “incorrectly collected.”
Response: For additional information, please refer to the regulatory and manual citations listed
for each element. Plans should not be using the Universal Audit Guide as a basis to determine
plan requirements.
Comment: One commenter requested clarification on Chapter 8 Element CD05: Decision to
Accept or Deny a Request to Expedite a Coverage Determination specifically for the term
“complaint.”
Response: For additional information, please refer to the regulatory and manual citations listed
for each element. Plans should not be using the Universal Audit Guide as a basis to determine
plan requirements.
Comment: One commenter asked that we clarify if plans were still accountable for Chapter 8
Elements OP10: Detailed Explanation of Non-Coverage (Timeliness) and OP11: Detailed
Explanation of Non-Coverage (Notice Content) and to provide additional descriptions.
Response: These are current elements that CMS may review upon audit. For additional
information on these and any other elements, please refer to the regulatory and manual citations
listed for each element. Plans should not be using the Universal Audit Guide as a basis to
determine plan requirements.
Comment: One commenter suggested that Chapter 13 Elements OC01 through OC07, OC201 &
OC202 should be moved to Chapter 12 “Claims Processing and Payment” as they deal solely
with claims.
Response: Elements OC01 through OC07, OC201 and OC202 currently fall under Chapter 8:
Organizational / Coverage Determinations, Appeals and Grievances (as opposed to the stated
Chapter 13). CMS believes the commenter was suggesting moving these elements to Chapter
17: Claims Processing and Payment (as opposed to the stated Chapter 12). The listed elements
deal with coverage determinations, as opposed to claims processing, which is why we believe
these elements more closely fit (and should remain) within Chapter 8.

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