CMS-10191 SIU/FWA Prevention and Detection Questionnaire

OMB Control Number 0938-1000 (Expires: TBD)

ATTACHMENT I-D
MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM
EFFECTIVENESS (CPE)
SIU/FWA QUESTIONNAIRE (FWA-Q)
This questionnaire is designed to assist CMS in understanding the unique qualities of your
organization’s CPE program operations. Please enter your responses to the questions below and
upload the completed form to HPMS within 15 business days of receiving your audit
engagement letter.
Name of Sponsoring Organization:
Enter your response here
Contract Numbers:
Enter your response here
Name and Title of Person Completing Questionnaire:
Enter your response here
Date Completed:
Select date
This questionnaire will assist CMS with understanding the sponsoring organization’s program to
prevent, detect, and correct suspected fraud, waste, and abuse for their Medicare line of business.
We recognize that your time is valuable and appreciate your availability to provide responses to
our questions regarding the compliance program. The responses to these questions may be
discussed during the onsite portion of the CPE audit.
If multiple individuals are responsible for the operations and oversight of first-tier, downstream
and related entities (e.g., Corporate Compliance Officer, SIU Director, Ethics and Integrity
Officer, Investigators) and have different responses to the questions, please consolidate responses
and incorporate into one document.

PRA Disclosure Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it
displays a valid OMB control number. The valid OMB control number for this information collection is 0938-1000 (Expires: TBD).
The time required to complete this information collection is estimated to average 701 hours per response, including the time to
review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If
you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS,
7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850. Please do
not send applications, claims, payments, medical records or any documents containing sensitive information to the PRA Reports
Clearance Office. Please note that any correspondence not pertaining to the information collection burden approved under the
associated OMB control number listed on this form will not be reviewed, forwarded, or retained. If you have questions or concerns
regarding where to submit your documents, please contact 1-800-MEDICARE.

Program Audit Data Request
Compliance Program Effectiveness (CPE)
SIU/FWA Questionnaire (FWA-Q)
Please specifically note the following when completing the questionnaire:
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“You” refers to your organization, not necessarily a specific person.
“Employees” refer to employees, including senior management, who support yourMedicare
business.
“Compliance Officer” refers to the compliance officer who oversees the Medicarebusiness.
“CEO” refers to the Chief Executive Officer of the organization or the most seniorofficer,
usually the President or Senior Vice President of the Medicare line ofbusiness.
“Compliance Program” refers to your Medicare compliance program.
If the Medicare contract holder is a wholly owned subsidiary of a parent company, references
to the governing body, CEO, and highest level of the organization’s management are to the
board, CEO, and management of the company (parent or subsidiary/contract holder) that the
organization has chosen to oversee its Medicare compliance program.
“FDRs” refer to the organization’s first-tier, downstream and related entities contracted to
perform an administrative or healthcare service to enrollees on behalf of the sponsoring
organization.
“First Tier Entity” refers to any party that enters into a written agreement, acceptable to
CMS, with a sponsoring organization to provide administrative services or health care
services to a Medicare eligible individual under the Parts C and/or Dprogram.
“Downstream Entity” refers to any party that enters into a written agreement, acceptable to
CMS, with persons or entities involved with the Medicare Parts C and/or D benefit, below
the level of the arrangement between a sponsoring organization and a first tier entity. These
written agreements continue down to the level of the ultimate provider of both health and
administrative services.
“Related Entity” refers to any entity that is related to a sponsoring organization by
common ownership or control, and
o performs some of the a sponsoring organization’s management functions undercontract
or delegation,
o furnishes services to Medicare enrollees under an oral or written agreement, or
o leases real property or sells materials to the sponsoring organization at a cost ofmore than
$2,500 during a contract period.
If the Medicare contract holder is a wholly owned subsidiary of a parent company, references
to the governing body, CEO, and highest level of the organization’s management are to the
governing body, CEO and management of the company (parent or subsidiary/contract holder)
that the organization has chosen to oversee its Medicare compliance program.

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Program Audit Data Request
Compliance Program Effectiveness (CPE)
SIU/FWA Questionnaire (FWA-Q)
1. How long have you been employed with a sponsoring organization and been in involved

with FWA prevention and detectionactivities?
Enter your response here
2. Is FWA managed by one individual or a team/department, such as the compliance

department or special investigations unit(SIU)?
Enter your response here
3. Provide a general overview of the unit/department responsible for conducting

surveillance and methods of investigation relating to potential FWA (e.g., number of
personnel, types ofdetection and prevention activities).
Enter your response here
4. Describe the working relationship between the compliance department and SIU as it

relates to the complianceprogram.
Enter your response here
5. Describe a few of the mechanisms that exist for employees, providers, enrollees, and FDRs

to report compliance, ethics, and FWA concerns and how are they advertised internally and
externally. Please indicate if multiple hotline numbers are used to report various categories
of compliance and FWA inquiries.
Enter your response here
6. How many reports did the hotline(s) receive during the audit review period? If there are

multiple hotline numbers to report various categories of compliance and FWA inquiries,
please separate responses for each hotline number.
Enter your response here
7. From your perspective, does the number of calls received demonstrate the effectiveness of

your reportingmechanisms?
Enter your response here
8. How often do you check the hotline and what assurance do you have that the hotline is

confidential?
Enter your response here
9. Describe proactive measures to investigate suspicions of FWA and inappropriate

paymentsmade by the sponsoring organization.
Enter your response here

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Program Audit Data Request
Compliance Program Effectiveness (CPE)
SIU/FWA Questionnaire (FWA-Q)
10. How does the organization engage participation from the Investigations MEDIC (I-

MEDIC), law enforcement, and other business partners on suspected FWA cases or
investigations?
Enter your response here
11. How many suspected FWA cases were referred to the I-MEDIC and/or law enforcement

agency within the audit review period?
Enter your response here
12. Describe the triage process for cases referred to the SIU for fraud investigation,

including timeframes associated with the intake and validationfunctions.
Enter your response here
13. Describe how data analytics or data analysis software are used to monitor potential FWA

activity and identify unusual patterns in the delivery of Medicare Parts C and/or D benefits
(e.g., queries for pharmacy patterns, provider billing, drug utilization).
Enter your response here
14. What types of reports from the PBM assist with identifying potential and suspected unusual

trends, utilization patterns, provider billing practices that pose the greatest risk to the
Medicare program?
Enter your response here
15. Does the organization use the Fraud, Waste and Abuse (FWA) Tracking Tool module that is

available to users in the Health Management Plan System (HPMS)? This tool replaced the
Medicare Advantage and Part D PLATOTM FWA tracking tool. If yes, also explain whether the
use of the Fraud, Waste and Abuse (FWA) Tracking Tool module has been effective for your
organization.
Enter your response here
16. Provide an overview that describes the organization’s monitoring activities in the HEAT

Medicare Strike Force cities. HEAT is the joint HHS-DOJ Health Care Fraud Prevention
and Enforcement Action Team. The list of the cities can be found at:
https://oig.hhs.gov/fraud/strike-force/
Enter your response here
17. How are the CMS fraud alerts issued through HPMS incorporated into FWA

prevention and detection, monitoring, and audit activities?
Enter your response here

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Program Audit Data Request
Compliance Program Effectiveness (CPE)
SIU/FWA Questionnaire (FWA-Q)
18. Highlight a few accomplishments of the FWA operations/SIU during the audit review

period.
Enter your response here
19. Do you have any questions or comments for CMS?

Enter your response here

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