Cms-10191 Cpe Self-assessment Questionnaire

ATTACHMENT V
MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE
(Rev. 3, 12-2012)
Name of Sponsoring Organization:______________________________________________
MA-PD/PDP Contract Numbers: _______________________________________________
Name/Title of Person Completing Assessment: ____________________________________
Date of Assessment:__________________________________________________________
Note: Sponsoring Organizations should not interpret every question as a mandatory CMS requirement, but rather as a guide in evaluating the
effectiveness of their Compliance Program.
Directions for completing the self-assessment questionnaire:
This document will help your organization evaluate the effectiveness of your Medicare Compliance Program. Please respond to each
question according to the current status of your Compliance Program. If the answer is “YES” to any question below, check the “YES” box
and provide a BRIEF description of what documents support that response in the “Documentation” column. The Documentation description
should also provide a cross reference (when applicable) to where this documentation can be located. For example, if your response is “YES”
to the third question below (“Do your written Ps & Ps and/or Standards of Conduct articulate the organization’s commitment to comply with
all applicable Federal and State standards including but not limited to statutes, regulations and sub regulatory guidance”), please indicate
the section/page of the Standards of Conduct or policies and procedures where these compliance provisions are found.
If the answer is “NO” to a question, check the “NO” box and document the rationale for the response in the “Documentation” column.
Please specifically note the following when completing the questionnaire:
x

“You” refer to your organization, not necessarily a specific person.

x

“Employees” refers to employees, including senior management, who support your Medicare business.

x

“Compliance Officer” refers to the compliance officer who oversees the Medicare business.
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x

“CEO” refers to Chief Operating Officer of the organization or the most senior officer, usually the President.

x

“Compliance Program” refers to your Medicare compliance program.

x

If the Medicare contract holder is a wholly owned subsidiary of a parent company, references to the board of directors, 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. .

x

Unless specific reference is made in the question to the “full board”, the term “board of directors” means either the full board or a
committee of the board delegated to conduct oversight of the day-to-day operation of the Medicare compliance program on behalf of
the full board.

Element I: Written Policies and Procedures and Standards of Conduct
42 CFR §422.503(b)(4)(vi)(A) and 42 CFR §423.504(b)(4)(vi)(A)
Description

Yes

No

Documentation

1.

Do you have written policies and procedures (Ps & Ps) and/or Standards of Conduct that:

A.

Articulate the organization’s
commitment to comply with all
applicable Federal and State standards?

B.

Describe compliance expectations as
embodied in the standards of conduct?

C.

Implement the operation of the
compliance program?

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element I: Written Policies and Procedures and Standards of Conduct
42 CFR §422.503(b)(4)(vi)(A) and 42 CFR §423.504(b)(4)(vi)(A)

D.

Description
Provide guidance to employees and
others on dealing with potential
compliance issues?

E.

Identify how to communicate
compliance issues to appropriate
compliance personnel?

F.

Describe how potential compliance
issues are investigated and resolved by
the organization?

G.

Include a policy of non-intimidation and
no-retaliation for good faith
participation in the compliance program,
including but not limited to reporting
potential issues, investigating issues,
conducting self-evaluations, audits and
remedial actions, and reporting to
appropriate officials?

2.

Are your Ps & Ps detailed and specific
in their description of the operation of
the compliance program?

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element I: Written Policies and Procedures and Standards of Conduct
42 CFR §422.503(b)(4)(vi)(A) and 42 CFR §423.504(b)(4)(vi)(A)

3.

4.

Description
Do you distribute your Standards of
Conduct and Ps & Ps to your employees
within 90 days of hire, when there are
updates and annually thereafter?

Yes

No

Documentation

Responsible Party or Department

Do you update your Ps & Ps to
incorporate changes in applicable laws,
regulations and other program
requirements?

Element II: Compliance Officer, Compliance Committee, Governing Body
42 CFR §422.503(b)(4)(vi)(B) and 42 CFR §423.504(b)(4)(vi)(B)
5.

Description
Does your CEO receive your
compliance officer’s reports on the
status and activities of the compliance
program?

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element II: Compliance Officer, Compliance Committee, Governing Body
42 CFR §422.503(b)(4)(vi)(B) and 42 CFR §423.504(b)(4)(vi)(B)
6.

Description
If your compliance officer does not
report directly, in-person to your CEO,
are his/her reports routed through the
President of the division that houses the
Medicare and/or through the President
of the organization rather than through
operational management?

7.

Does your compliance officer have
express authority (oral or written,
preferably written) to make in-person
reports to your CEO and Board of
Directors in the compliance officer’s
sole discretion?

8.

Is your compliance officer employed by
your organization, parent organization,
or corporate affiliate?

9.

If employed by your parent or corporate
affiliate, does your compliance officer
have detailed involvement in and
familiarity with your Medicare
operational and compliance activities?

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
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Element II: Compliance Officer, Compliance Committee, Governing Body
42 CFR §422.503(b)(4)(vi)(B) and 42 CFR §423.504(b)(4)(vi)(B)
10.

Description
Does your Board of Directors
periodically receive compliance reports
on Medicare program noncompliance
and Medicare fraud, waste and abuse
(“FWA”) which include issues
identified, investigated, and resolved?

11.

If your compliance officer does not
report in-person to your Board of
Directors, are his/her reports routed
through the compliance infrastructure?

12.

Is your compliance officer a full-time
employee?

13.

Does your compliance officer have both
compliance and operational
responsibilities?

14.

Do you have a compliance committee
whose responsibilities include oversight
of the compliance program?

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element II: Compliance Officer, Compliance Committee, Governing Body
42 CFR §422.503(b)(4)(vi)(B) and 42 CFR §423.504(b)(4)(vi)(B)
15.

Description
Does your compliance officer and
compliance committee provide the
Board of Directors with regularly
scheduled updates on the status and
activities of the compliance program,
including compliance program
outcomes, the results of internal and
external audits and about all government
compliance enforcement activity?

Yes

No

Documentation

Responsible Party or Department

Element III: Effective Training and Education
42 CFR §422.503(b)(4)(vi)(C) and 42 CFR §423.504(b)(4)(vi)(C)
16.

Description
Do you establish, implement and
provide effective training and education,
addressing compliance and FWA for
your employees, including temporary
employees, volunteers and Board of
Directors?

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element III: Effective Training and Education
42 CFR §422.503(b)(4)(vi)(C) and 42 CFR §423.504(b)(4)(vi)(C)
17.

Description
Is your training for employees and board
members provided within 90 days of
hire/appointment and annually
thereafter?

18.

Do you maintain attendance, topic,
certificates of completion and/or test
scores for 10 years?

19.

Do you ensure that your employees are
aware of Medicare requirements related
to their job functions?

20.

Does your general compliance education
include the reporting requirements and
available methods for reporting
noncompliance and potential FWA?

21.

Do you provide training on FWA risks
based on the individual’s job function?

Yes

No

Documentation

Element IV: Effective Lines of Communication
42 CFR §422.503(b)(4)(vi)(D) and 42 CFR §423.504(b)(4)(vi)(D)

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SELF-ASSESSMENT QUESTIONNAIRE
22.

Description
Do you have an effective method(s) to
communicate information from your
compliance officer to others, within a
reasonable time frame, including
changes in laws, regulations and subregulatory guidance as well as changes
to your Standards of Conduct and Ps &
Ps?

23.

Do your Standards of Conduct and/or
Ps & Ps require your employees and
members of the Board of Directors to
report compliance concerns and
potential FWA?

24.

Do you have a system to receive,
record, respond to and track compliance
questions or concerns and reports of
potential FWA from your employees,
members of your Board of Directors,
FDRs and their employees and
enrollees?

25.

Does your system allow anonymous
reporting and maintain confidentiality to
the extent possible?

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element IV: Effective Lines of Communication
42 CFR §422.503(b)(4)(vi)(D) and 42 CFR §423.504(b)(4)(vi)(D)
26.

Description
Does your system emphasize your
policy of non-retaliation and that of your
FDRs’?

27.

Is your system well-publicized
throughout your facilities and those of
your FDRs?

28.

Are your reporting mechanisms userfriendly, easy to access and navigate and
available 24 hours a day for employees,
members of your Board of Directors and
FDRs?

29.

Have you adopted, widely publicized
and enforced a no-tolerance policy for
retaliation or retribution against any
employee, FDR, or FDR employee who
reports potential FWA?

30.

Do you educate your enrollees about
the identification and reporting of
FWA?

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element V: Enforcement of Well-Publicized Disciplinary Standards
42 CFR §422.503(b)(4)(vi)(E) and 42 CFR §423.504(b)(4)(vi)(E)

31.

Description
Have you established and implemented
disciplinary policies and procedures that
reflect clear, specific disciplinary
standards?

32.

Do your disciplinary policies:

A.

Describe your expectations for
reporting compliance issues including
noncompliant, unethical or illegal
conduct?

B.

State that employees must participate in
required training?

C.

State the expectations for assisting in the
resolution of reported compliance
issues?

D.

Identify noncompliant, unethical or
illegal behavior through examples of
violative conduct that employees might
encounter in their jobs?

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element V: Enforcement of Well-Publicized Disciplinary Standards
42 CFR §422.503(b)(4)(vi)(E) and 42 CFR §423.504(b)(4)(vi)(E)

E.

Description
Provide for timely, consistent and
effective enforcement of the standards?

F.

Require disciplinary action that is
appropriate to the seriousness of the
violation?

33.

Do you widely publicize disciplinary
standards to your employees and FDRs?

34.

Do you maintain disciplinary records
for ten years that capture the dates of the
violation and the investigation, a
summary of the findings, the
disciplinary action taken and the date it
was taken?

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element VI: Effective System for Routine Monitoring, Auditing, and Identification of Compliance Risks
42 CFR §422.503(b)(4)(vi)(F) and 42 CFR §423.504(b)(4)(vi)(F)
35.

Description
Do you have a system of ongoing
monitoring and auditing to test and
confirm compliance with Medicare
regulations, sub-regulatory guidance,
contractual agreements and all
applicable federal and state laws?

36.

Are adequate resources devoted to your
audit function considering the scope of
your Parts C and D programs,
compliance history, current compliance
risks and resources available?

37.

Do you have a monitoring and auditing
work plan that addresses risks
associated with Medicare Parts C and
D?

38.

Does your compliance officer receive
regular reports from those who are
conducting the auditing or the audit
department on the results of auditing
and monitoring and on the status and
effectiveness of corrective actions
taken?

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element VI: Effective System for Routine Monitoring, Auditing, and Identification of Compliance Risks
42 CFR §422.503(b)(4)(vi)(F) and 42 CFR §423.504(b)(4)(vi)(F)
39.

Description
Does your compliance officer or his/her
designee provide updates on the results
of monitoring and auditing to your
compliance committee, CEO, senior
leadership and Board of Directors?

Yes

No

Documentation

40.

Have you established and implemented
Ps & Ps to conduct a formal baseline
risk assessment of the major compliance
and risk areas in all Medicare
operational areas?

41.

Does your monitoring and auditing
strategy prioritize (a) risks identified
through CMS audits and oversight and
through your own monitoring; and (b)
those risks that have the greatest
impact?

42.

Do you periodically re-evaluate the
accuracy of your baseline risk
assessment?

43.

Do you have an auditing and monitoring work plan that includes:

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element VI: Effective System for Routine Monitoring, Auditing, and Identification of Compliance Risks
42 CFR §422.503(b)(4)(vi)(F) and 42 CFR §423.504(b)(4)(vi)(F)
A.

Description
A process for responding to all
monitoring and auditing results?

B.

A process for conducting follow-up
reviews of areas found to be
noncompliant to determine if corrective
actions have fully address the
underlying problems?

C.

A schedule that lists all auditing and
monitoring activities for the calendar
year?

44.

Do you use appropriate methods to:

A.

Select operational areas for audit?

B.

Select first tier entities for audit?

C.

Determine sample size?

D.

Extrapolate audit findings to the full
universe, using statistically valid
methods that comply with generally
accepted auditing standards?

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element VI: Effective System for Routine Monitoring, Auditing, and Identification of Compliance Risks
42 CFR §422.503(b)(4)(vi)(F) and 42 CFR §423.504(b)(4)(vi)(F)
E.

Description
Apply specialized targeted techniques or
stratified sampling methods driven by
data mining, complaint monitoring and
aberrant behavior?

F.

Assess compliance with internal
processes and procedures?

45.

Do you have staff dedicated to the audit
function?

A.

Are your auditors Knowledgeable about
CMS operational requirements for areas
under review, independent and not
engaged in self-policing?

46.

Does your audit staff have access to
relevant personnel, information, records
and areas of operation under review,
including operational areas at plan and
FDR level?

47.

Do you audit the effectiveness of your
compliance program at least annually?

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element VI: Effective System for Routine Monitoring, Auditing, and Identification of Compliance Risks
42 CFR §422.503(b)(4)(vi)(F) and 42 CFR §423.504(b)(4)(vi)(F)
48.

Description
Is the audit conducted by persons other
than your compliance officer and/or
compliance department staff?

49.

Do you share the results of the audits of
the effectiveness of the compliance
program with your Board of Directors?

50.

Do you review the OIG and GSA
exclusion lists for your employees
(including temporary employees),
volunteers, consultants and the members
of your board of directors prior to
hiring/contracting/appointment and
monthly thereafter?

51.

Do you utilize data analysis for
monitoring for FWA?

52.

Do you either have a Special
Investigations Unit (“SIU”) or ensure
that the responsibilities generally
conducted by an SIU are conducted by
your compliance department?

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element VI: Effective System for Routine Monitoring, Auditing, and Identification of Compliance Risks
42 CFR §422.503(b)(4)(vi)(F) and 42 CFR §423.504(b)(4)(vi)(F)
53.

54.

Description
If you have an SIU, is it accessible
through multiple channels, e.g. phone,
mail, Internet message?

Yes

No

Documentation

Responsible Party or Department

Do your SIU and compliance
departments communicate and
coordinate closely?

Element VII: Procedures and Systems for Promptly Responding to Compliance Issues
42 CFR §422.503(b)(4)(vi)(G) and 42 CFR §423.504(b)(4)(vi)(G)
55.

56.

Description
Do you make a reasonable inquiry into
all compliance incidents/issues and
potential FWA?

Yes

No

Documentation

Do you require and ensure that your
inquiries are well-documented?

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE

Element VII: Procedures and Systems for Promptly Responding to Compliance Issues
42 CFR §422.503(b)(4)(vi)(G) and 42 CFR §423.504(b)(4)(vi)(G)
57.

58.
A.

Description
Do you require and ensure that inquiries
are initiated as quickly as possible and
not later than two weeks after the date
the potential noncompliance or FWA is
identified?

Yes

No

Documentation

Do you undertake appropriate corrective actions that:
Are designed to correct and prevent
future noncompliance, including
conducting a root cause analysis?

B.

Are tailored to address the particular
FWA, problem or deficiency identified?

C.

Include time frames for specific
achievements?

59.

Do you continue to monitor corrective
actions after their implementation to
ensure that they are effective?

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Element VII: Procedures and Systems for Promptly Responding to Compliance Issues
42 CFR §422.503(b)(4)(vi)(G) and 42 CFR §423.504(b)(4)(vi)(G)
A.

Description
Yes
Do you ensure that noncompliance or
FWA committed by your employees is
documented and includes ramifications
should the employee fail to satisfactorily
implement the corrective action?

60.

Do you maintain thorough
documentation of all compliance
deficiencies identified and the corrective
actions taken?

61.

Do you have procedures to refer
potential FWA issues to the NBI
MEDIC and serious issues of program
noncompliance to CMS?

62.

Do you conclude your investigations of
FWA within a reasonable time after the
activity is discovered?

63.

Do you review past paid claims from
entities identified in fraud alerts and
remove them from their event data
submissions e.g. PDEs?

No

Documentation

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SELF-ASSESSMENT QUESTIONNAIRE

FDR Oversight
Sponsor Accountability for and Oversight of FDRs
42 CFR §422.503(b)(4)(vi) and 42 CFR §423.504(b)(4)(vi)

64.

65.

Description
Do you have a process for determining
which delegated entities are properly
identified as FDRs subject to Medicare
compliance requirements?

Yes

No

Documentation

Responsible Party or Department

Do you have a system to monitor FDRs’
compliance with Medicare program
requirements?

FDR Oversight
Element I: Written Policies and Procedures and Standards of Conduct
42 CFR §422.503(b)(4)(vi)(A) and 42 CFR §423.504(b)(4)(vi)(A)
Description

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
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66.

Do you ensure that either your
Standards of Conduct and Ps & Ps or
comparable Standards of Conduct and
Ps & Ps are distributed to FDR’s
employees within 90 days of hire /
contracting and annually thereafter?

FDR Oversight
Element III: Effective Training and Education
42 CFR §422.503(b)(4)(vi)(C) and 42 CFR §423.504(b)(4)(vi)(C)
67.

Description
Do you ensure that general compliance
information is communicated to your
FDRs?

68.

Do you ensure that your non-deemed
FDRs’ employees receive FWA training
within 90 days of hiring/contracting and
annually thereafter?

69.

Do you provide training directly to your
FDRs, provide them with FWA training
materials or use CMS Learning Network
module for FWA training for your
FDRs?

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
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FDR Oversight
Element III: Effective Training and Education
42 CFR §422.503(b)(4)(vi)(C) and 42 CFR §423.504(b)(4)(vi)(C)
70.

Description
Do you require your FDRs to maintain
records of the FWA training of their
employees for ten years, as required?

Yes

No

Documentation

Responsible Party or Department

FDR Oversight
Element VI: Monitoring and Auditing of FDRs
42 CFR §422.503(b)(4)(vi)(F) and 42 CFR §423.504(b)(4)(vi)(F)
71.

Description
Do you have a strategy to monitor and
audit your first tier entities?

Yes

No

Documentation

72.

Does your strategy for monitoring and auditing your first tier entities include:

A.

Ensuring that they are in compliance
with Medicare Parts C and D
requirements?

B.

Ensuring that they are monitoring their
downstream entities?

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
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FDR Oversight
Element VI: Monitoring and Auditing of FDRs
42 CFR §422.503(b)(4)(vi)(F) and 42 CFR §423.504(b)(4)(vi)(F)
73.

Description
Do you monitor and audit your related
entities?

74.

Does your monitoring and auditing
work plan include the number of first
tier entities that will be audited and
how the entities will be identified for
auditing?

75.

If you do not monitor and audit all of
your first tier entities, do you perform
a risk assessment to identify the high
risk first tier entities and then select a
reasonable number to audit from the
highest risk groups?

76.

Do you have procedures to ensure that
your FDRs are not excluded from
participation in Federal health care
programs? (42 CFR § 1001.1901)

Yes

No

Documentation

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
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FDR Oversight
Element VI: Monitoring and Auditing of FDRs
42 CFR §422.503(b)(4)(vi)(F) and 42 CFR §423.504(b)(4)(vi)(F)
77.

Description
Does your system include review of
the OIG and GSA exclusion lists prior
to hiring or contracting and monthly
thereafter for FDRs and their
employees either by you, your first
entities, or the downstream entities
themselves?

Yes

No

Documentation

Responsible Party or Department

FDR Oversight
Element VII: FDRs: Procedures and System for Prompt Response to Compliance Issues
42 CFR §422.503(b)(4)(vi)(G) and 42 CFR §423.504(b)(4)(vi)(G)
78.

79.

Description
Do you ensure that needed corrective
actions are taken by first tier entities?

Yes

No

Documentation

Do you continue to monitor FDR
corrective actions after their
implementation to ensure that they are
effective?

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MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
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FDR Oversight
Element VI: Monitoring and Auditing of FDRs
42 CFR §422.503(b)(4)(vi)(F) and 42 CFR §423.504(b)(4)(vi)(F)
A.

80.

Description
Do you ensure that noncompliance or
FWA committed by FDRs is welldocumented and includes ramifications
should the FDR fail to satisfactorily
implement the corrective action?

Yes

No

Documentation

Do you maintain thorough
documentation of all deficiencies
identified and the corrective actions
taken?

Compliance Program Effectiveness Self-Assessment Questionnaire Submitted By:
[Name]
[Title]
[Company]
[Address]
[Phone Number]
[Email Address]

________________________
(Signature)

__________________________
(Date)
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