Engagement Letter/Start Notice

DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
Center for Medicare
7500 Security Boulevard, Mail Stop C1-22-06
Baltimore, Maryland 21244-1850

Medicare Part C and D Oversight and Enforcement
Group

EMAIL:
CEO NAME,
ADDRESS OF SPONSOR & CONTACT INFO
Re: 2013 CMS Program Audit – Medicare Advantage and Prescription Drug Plan Contract;
:
HPMS Audit ID:
Dear :
This letter is to notify you that your organization has been selected for a program audit by the
Centers for Medicare & Medicaid Services (CMS) for the above-listed Medicare Advantage and
Prescription Drug Plan contracts. We will review the following areas:
x
x
x
x
x
x

Prescription Drug (Part D) Formulary Administration (FA)
Part D Coverage Determinations, Appeals & Grievances (CDAG)
Part C Organization Determinations, Appeals & Grievances,
(ODAG)
Part C and Part D Compliance Program Effectiveness (CPE)
Special Need Plans – Model of Care (SNP-MOC)
Outbound Enrollment Verification (OEV)

The audit will be conducted over a two week period beginning . The first week
the audit will be conducted virtually via webinar and will cover all program areas except Part C
and Part D Compliance Program Effectiveness. The Part C and Part D Compliance Program
Effectiveness area will be conducted the second week either virtually or onsite. We will conduct
an entrance conference at 10:00 a.m. EST on Monday, , a pre-exit summary
conference at 10:00 am EST on Friday, and final exit conference at 10:00 am
EST on Friday, . All of these conferences will be conducted via conference
call.
Access to Facilities and Records
In order for CMS to conduct these audits effectively, we will require access to your facilities,
records, office staff, and leadership.

CEO Name
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Information to be Provided Prior to the Audit
Universe Data and Associated Documentation:
As part of the audit, CMS is requesting universes for each of the above-mentioned performance
areas. These documents also contain requests for data universes (and associated documentation
as necessary). Attachments I-A, II-A, IV-VI, VII-A, IX-A, and X-A contain the templates for
your organization to submit the requested data.
Attachments I-B, III-A, IX-B contains the sample case file minimum documentation required
once we start the audit and provide you with sample requests. Please pay particular attention to
these documents as this is the evidence CMS will be auditing to determine compliance with
CMS requirements. We expect most if not all of this data and documentation to be available to
the auditors electronically from your information systems during the audit but will confirm these
details with your organization prior to the audit.
CMS is requesting that your organization provide a list (using Attachment VI) of previously selfdisclosed and self-identified issues of non-compliance that may be found in the data universes
requested by CMS. If these issues of non-compliance were corrected prior to receiving the
audit start notice and CMS is able to verify their correction, this may prevent these issues
from negatively impacting your audit score. Any non-compliant issues that have been
corrected and are not disclosed on this list or were corrected after the audit start notice will
be counted against your organization in the event the audit team detects the issue.
Method and Deadline for Submissions:
All of the above-requested data and documentation submissions must be submitted electronically
via Electronic File Transfer (EFT) Application within 10 business days (by 5p.m. EST on
). In order to use the EFT Application, CMS needs your organization to provide
us with the contact information for 1 user that will be responsible for the EFT electronic
submittal process. Please submit this information by 12 noon EST . CMS will
then forward an EFT user guide and login instructions to the designated user.
Please note that the HPMS Audit Module will require CEO-level attestation for all data uploaded
into the system. Please validate all data (and documentation) submissions before they are
provided to CMS. The sponsor validation process must include ensuring that the data is
readable, complete, (e.g., contain data from all contracts and plan benefit packages within
contracts), and contain all data (or documentation) responsive to the request.
Specific Requirements For Webinar Capability
CMS will use its webinar capability to conduct this audit. In advance of the start date, CMS will
conduct a test with your organization to ensure our webinar capability is fully functional with
your information technology. If technological issues arise, CMS will work with your

CEO Name
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organization to handle them accordingly. If your organization has secure webinar capability and
you prefer to use it, please discuss that with the CMS audit lead. CMS expects that your
organization will have the appropriate staff available during the webinar to answer any questions
raised.
Please note that webinar audits may run concurrently for each audit area. Organizations
that prefer to use their webinar system should have the appropriate staff available to
facilitate the webinars during the time of the audit.
On-Site Audit
As previously stated, the compliance audit may be onsite the second week of the audit. If it is
onsite, we request that your organization provide a conference room for CMS staff that can
accommodate approximately 5 people, has a conference phone, and has a projector to display
information on the wall. The other audit areas will be conducted virtually during the first week
of the audit. Your audit lead will have more details for you regarding the compliance audit.
Access to Key Personnel and Systems Requirements During Audit
CMS expects your organization to have key personnel available to the CMS auditors from any of
your operational areas or delegated entities that perform functions related to the areas of audit
identified above (e.g., pharmacy benefit manager). You also need to ensure that the reviewers
have the ability to access any electronic information systems and electronic records (regardless
of whether these systems or records are housed remotely or with delegated entities) related to the
above-listed performance areas, including, but not limited to, those systems and records related
to formulary administration, pharmacy claims and adjudication, coverage determinations,
appeals and grievances, and any systems and records related to the operations.
Key personnel in each of the areas selected for audit should be at a minimum prepared to explain
your internal policies and procedures, how your systems operate and be familiar with CMS
requirements and how these requirements have been operationalized in your organization.
Personnel should also be able to maneuver through the necessary systems (i.e., formulary claims,
coverage determinations and appeals, etc.) while the review is being conducted.
In order to clarify our audit process requirements and respond to any initial questions you may
have about the information requested or the audit process, we will be contacting your
organization immediately to set up a conference call within two (2) days of the date of this
notice.
Please ensure that your CEO logs on to the HPMS Audit module to attest that you received this
notice within two (2) business days of this notice.
In the meantime, if questions arise regarding the audit, this letter, or the data we are requesting,
please contact your CMS audit lead at at or .

CEO Name
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We look forward to your cooperation.
Sincerely,
/s/
Tawanda Holmes
Director, Division of Audit Operations
Medicare Part C and D Oversight and Enforcement Group

cc:
Michelle Turano, CMS/CM/MOEG
Michael Dibella, CMS/CM/MOEG
Jonathan Blanar, CMS/CM/MOEG
Doreen Gagliano, CMS/CM/MOEG
, Audit Lead, CMS/CM/MOEG
, Account Manager, CMS/
, Branch Manager, CMS/
, ,
, ,

The following documentation is available for download in the HPMS Audit module by
navigating to the Submission Materials page. Additional instructional documentation with
regards to the audit process may be found under the Documentation section.
Files are available in both .xlsx and .txt formats.

Attachment I – FA Audit Process and Universe Request
Attachment I-A – FA Universe Template
Attachment I-B – Sample Case Minimum Documentation Required
Attachment II – CDAG Audit Process and Universe Request
Attachment II-A – CDAG Universe Template
Attachment III – CPE Data and Documentation Request
Attachment III-A – CPE Sample Case Minimum Documentation Required
Attachment III-B – CPE Compliance Program Contacts
Attachment IV – CPE Organizational Structure and Governance PowerPoint Presentation
Template
Attachment V – CPE Self-Assessment Questionnaire
Attachment VI –Self Disclosure Report
Attachment VII – ODAG Audit Process and Universe Request
Attachment VII-A – ODAG Universe Template

CEO Name
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Attachment VIII – 2013 Audit Process Document
Attachment IX – SNP MOC Audit Process and Universe Request – (if applicable)
Attachment IX – A – SNP MOC Universe Template (if applicable)
Attachment IX- B – SNP MOC Sample Case Minimum Documentation Required (if applicable)
Attachment X – OEV Protocol Audit Process and Universe Request
Attachment X – A – OEV Universe Template