Back to Form 10-Q [form10-q.htm]
Exhibit 10.1

  CORPORATE INTEGRITY AGREEMENT
between the
Office of Inspector General
of the
Department of Health and Human Services
and
WellCare Health Plans, Inc.

 
I.           Preamble

 
 WellCare Health Plans, Inc. and its affiliates and subsidiaries (WellCare)
hereby enters into this Corporate Integrity Agreement (CIA) with the Office of
Inspector General (OIG) of the United States Department of Health and Human
Services (HHS) to promote compliance with the statutes, regulations, and written
directives of Medicare, Medicaid, and all other Federal health care programs (as
defined in 42 U.S.C. § 1320a-7b(f)) (Federal health care program requirements).
Contemporaneously with this CIA, WellCare is entering into a Settlement
Agreement with the United States (Settlement Agreement).
 
II.          Term and Scope of the CIA
 
 A.      The period of the compliance obligations assumed by WellCare under this
CIA shall be 5 years from the effective date of this CIA, unless otherwise
specified. The effective date shall be the date on which the final signatory of
this CIA executes this CIA (Effective Date). Each one-year period, beginning
with the one-year period following the Effective Date, shall be referred to as a
“Reporting Period.”
 
 B.      Sections VII, X, and XI shall expire no later than 120 days after OIG’s
receipt of:  (1) WellCare’s final annual report; or (2) any additional materials
submitted by WellCare pursuant to OIG’s request, whichever is later.
 
             C.      The scope of this CIA shall be governed by the following
definitions:
 
1.   “Covered Persons” includes:
 
a. all natural persons who are owners (other than shareholders who: (1) have an
ownership interest of less than 5%; and (2) acquired the ownership interest
through public trading or in connection with 
 
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equity awards made pursuant to an employment contract or Company equity
compensation plans), officers, directors, and employees of WellCare; and

 
b. all contractors, subcontractors, agents, and other persons who perform
Reimbursement Related Functions.
 
Notwithstanding the above, this term does not include (1) part-time or per diem
employees, contractors, subcontractors, agents, and other persons who are not
reasonably expected to work more than 160 hours per year, except that any such
individuals shall become “Covered Persons” at the point when they work more than
160 hours during the calendar year; or (2) employees, contractors,
subcontractors, agents, and other persons of WellCare who perform only physical
plant maintenance, facility security, janitorial and/or cafeteria-related
duties.

 
2.   “Relevant Covered Persons” includes all Covered Persons whose job
responsibilities relate to Reimbursement Related Functions.

 
3.   “Reimbursement Related Functions” includes those functions related to
reimbursement from any Federal health care program, including, but not limited
to: (a) the preparation and submission of reports of costs and expenditures,
claims and/or encounter data, reconciliation data or any other information used
to support or substantiate the receipt of reimbursement from any Federal health
care program; (b) coding, billing, auditing, and accounting, and/or preparation
and submission of material information related to any claim or request for
payment from any Federal health care program; and (c) the preparation and
submission of bids and other data or information in response to requests for
proposals.

 
4.   “Plan” includes WellCare and any subsidiary of WellCare that contracts with
Medicare or any Medicaid program.

 
III.        Corporate Integrity Obligations

 
 WellCare shall establish and maintain a Compliance Program that includes the
following elements:

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 A.      Compliance Responsibilities of Corporate Officers, Corporate Compliance
Committee, Board Regulatory Compliance Committee, and Management.
 
1.   Chief Compliance Officer. Prior to the Effective Date, WellCare appointed a
Chief Compliance Officer, and WellCare shall maintain a Chief Compliance Officer
throughout the term of the CIA. The Chief Compliance Officer shall be
responsible for developing and implementing policies, procedures, and practices
designed to ensure compliance with the requirements set forth in this CIA and
with Federal health care program requirements. The Chief Compliance Officer
shall be a member of senior management of WellCare, shall report directly to the
Chief Executive Officer of WellCare, shall make periodic (at least quarterly)
reports regarding compliance matters directly to the Board of Directors of
WellCare, and shall be authorized to report on such matters to the Board of
Directors at any time. The Chief Compliance Officer shall not be, or be
subordinate to, the General Counsel or the Chief Financial Officer (CFO).  The
Chief Compliance Officer shall be responsible for monitoring the day-to-day
compliance activities engaged in by WellCare as well as for any reporting
obligations created under this CIA. Any noncompliance job responsibilities of
the Chief Compliance Officer shall be limited and must not interfere with the
Chief Compliance Officer's ability to perform the duties outlined in this CIA.

 
             WellCare shall report to OIG, in writing, any change in the
identity of the Chief Compliance Officer, or any actions or changes that would
affect the Chief Compliance Officer's ability to perform the duties necessary to
meet the obligations in this CIA, within five days after the change.
 
2.   Corporate Compliance Committee. Prior to the Effective Date, WellCare
appointed a Compliance Committee comprised of members of senior management
(Corporate Compliance Committee), and WellCare shall maintain the Corporate
Compliance Committee throughout the term of the CIA. The Corporate Compliance
Committee shall, at a minimum, include the Chief Compliance Officer and other
members of senior management necessary to meet the requirements of this CIA
(e.g., senior executives of relevant departments, such as billing, clinical,
human resources, audit, and operations). The Chief Compliance Officer shall
chair the Corporate Compliance Committee and the Committee shall support the
Chief Compliance Officer in fulfilling his/her responsibilities (e.g., shall
assist in the analysis of the organization's risk areas and shall oversee
monitoring of internal and external audits and investigations).  The Corporate
Compliance Committee shall meet at least quarterly.

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            WellCare shall report to OIG, in writing, any changes in the
composition of the Corporate Compliance Committee, or any actions or changes
that would affect the Corporate Compliance Committee's ability to perform the
duties necessary to meet the obligations in this CIA, within 15 days after such
a change.
 
3.   Compliance Liaisons. Within 120 days after the Effective Date, WellCare
shall appoint, and shall maintain during the term of the CIA, individuals to
serve as compliance liaisons at each of WellCare's seven principal locations
(Compliance Liaisons). The Compliance Liaisons shall be responsible for: (a)
assisting the Chief Compliance Officer to implement the policies, procedures,
and practices designed to ensure compliance with the requirements set forth in
this CIA, applicable Plan contracts with Medicare, Medicaid, and Federal health
care program requirements for the applicable Plans; (b) assisting the Chief
Compliance Officer to monitor the day-to-day compliance activities at the
applicable Plans; and (c) serving as a contact person for the Chief Compliance
Officer for compliance activities at the applicable Plans. The Compliance
Liaisons shall make periodic (at least semi-annual) written reports regarding
compliance matters directly to the Chief Compliance Officer, and shall be
authorized to report on such matters directly to the Board Regulatory Compliance
Committee at any time. The Compliance Liaisons shall be independent from
WellCare's Legal Department. WellCare shall report to OIG, in writing, any
changes in the identity or position description of any Compliance Liaisons, or
any actions or changes that would affect any Compliance Liaison's ability to
perform the duties necessary to meet the obligations in this CIA, within 15 days
after any such change.
 
4.   Board Regulatory Compliance Committee. Prior to the Effective Date,
WellCare formed the Regulatory Compliance Committee of the Board of Directors
(Board Regulatory Compliance Committee). The Board Regulatory Compliance
Committee is charged with overseeing WellCare’s regulatory Compliance Program,
its compliance with federal and state laws and regulations, and its compliance
with the WellCare Code of Conduct and Business Ethics (Code of Conduct) and
related policies. The Board Regulatory Compliance Committee shall also be
responsible for oversight of the obligations of this CIA. The Board Regulatory
Compliance Committee's Reporting Policy requires that compliance issues and
concerns be timely reported to the Board Regulatory Compliance Committee. In
addition, WellCare’s Code of Conduct provides that employees may report
violations of the Code of Conduct, or pose questions about reporting violations,
to the Chair of the Board Regulatory Compliance Committee. At least quarterly,
the Chief Compliance Officer reviews with the Board Regulatory Compliance
Committee all aspects of WellCare’s compliance program, focusing on
 
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specific areas of risk and concern.  In addition, the Chief Compliance Officer
and other members of senior management provide interim reports to the Chair of
the Board Regulatory Compliance Committee, and to the Committee, during informal
briefings and specially-convened meetings.  The Board Regulatory Compliance
Committee understands that it may be advisable, in certain circumstances, to
consult with its own independent professionals, and the Chair of Board
Regulatory Compliance Committee will promptly notify OIG upon such consultation
with such professional.  The Board Regulatory Compliance Committee shall, at a
minimum, be responsible for the following:
 
a.           The Board Regulatory Compliance Committee shall meet at least
quarterly to review and oversee WellCare’s Compliance Program, including but not
limited to, the performance of the Chief Compliance Officer and Compliance
Department.

 
b.           Within 120 days of the Effective Date, and annually thereafter, the
Board Regulatory Compliance Committee shall review the effectiveness of
WellCare's Compliance Program (Compliance Program Review) for each Reporting
Period of the CIA. The Board Regulatory Compliance Committee shall document its
findings and conclusions in writing (Compliance Program Review Assessment). The
Compliance Program Review Assessment shall be in addition to any mention of the
Compliance Program Review in minutes of the Board Regulatory Compliance
Committee.  A copy of the Compliance Program Review Assessment shall be provided
to OIG in each Annual Report submitted by WellCare.

 
c.           For each Reporting Period of the CIA, the Board Regulatory
Compliance Committee shall adopt a resolution, signed by each individual member
of the Board Regulatory Compliance Committee, summarizing its review and
oversight of WellCare’s compliance with Federal health care program requirements
and the obligations of this CIA.

 
At minimum, the resolution shall include the following language:

 
           “The Board Regulatory Compliance Committee has made a reasonable
inquiry into the operations and efficacy of WellCare's Compliance Program,
including the performance of the Chief Compliance Officer and the Compliance
Department.  Based on the information it has received and obtained, and the
findings contained in its Compliance Program Review Assessment, the Board
Regulatory Compliance Committee has concluded that, to the best of its
knowledge, WellCare has implemented an effective 
 
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Compliance Program to meet Federal health care program requirements and the
obligations of the CIA.”
 
If the Board Regulatory Compliance Committee is unable to provide such a
conclusion in the resolution, the Board Regulatory Compliance Committee shall
include in the resolution a written explanation of the reasons why it is unable
to do so and the steps it is taking to implement an effective Compliance Program
at WellCare.

 
WellCare shall report to OIG, in writing, any changes in the composition of the
Board Regulatory Compliance Committee, or any actions or changes that would
affect the Board Regulatory Compliance Committee’s ability to perform the duties
necessary to meet the obligations in this CIA, within 15 days after such a
change.

 
5.   Management Accountability and Certifications: In addition to the
responsibilities set forth in this CIA for all Covered Persons, certain WellCare
officials (“Certifying Employees”) are specifically expected to monitor and
oversee activities within their areas of authority and shall annually certify
that the applicable WellCare component is compliant with Federal health care
program requirements and the obligations of this CIA. The Certifying Employees
include, at a minimum, the following: Chief Executive Officer; CFO; Chief
Administrative Officer; Chief Medical Officer; General Counsel; President of
National Health Plans; President of Florida/Hawaii Division; President of South
Division; President of Northeast Division; Senior Vice President of Health
Services; all Vice Presidents in Health Services Department; all Vice Presidents
in Finance Department (Direct reports to CFO); Regional Chief Operating Officers
or Market Directors; and Compliance Liaisons.

 
For each Reporting Period, each Certifying Employee shall sign a certification
that states:

 
“I have been trained on and understand the Federal health care program
compliance requirements and obligations and responsibilities of the Corporate
Integrity Agreement (CIA) as they relate to [department or functional area], an
area under my supervision.  I have had the opportunity to obtain supplemental
guidance on those requirements and responsibilities from the Compliance and
Legal Departments and my management when necessary. My job responsibilities
include ensuring compliance of the [department or functional area] with all
applicable Federal health care program requirements, obligations of the CIA, and
WellCare policies, and I have undertaken to do so. In the event that I have
identified potential issues of non-compliance with these requirements, I have 
 
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referred all such issues to the Compliance and Legal Departments for further
review and follow-up.  Apart from those referred issues, I am not currently
aware of any potential violation of Federal health care program requirements,
the requirements of the CIA, or any WellCare Policy. I understand that this
certification is being provided to and relied upon by the United States.”
 
            B. Written Standards.
 
1.  Code of Conduct.  Prior to the Effective Date, WellCare developed,
implemented, and distributed a written Code of Conduct to all Covered
Persons.  WellCare shall make the promotion of, and adherence to, the Code of
Conduct an element in evaluating the performance of all employees. To the extent
not already accomplished, within 90 days after the Effective Date, WellCare
shall ensure that the Code of Conduct shall, at a minimum, set forth:
 
a.   WellCare's commitment to full compliance with all Federal health care
program requirements;

 
b.   WellCare's requirement that all of its Covered Persons shall be expected to
comply with all Federal health care program requirements and with WellCare's own
Policies and Procedures;

 
c.   the requirement that all of WellCare's Covered Persons shall be expected to
report to the Chief Compliance Officer, or other appropriate individuals
designated by WellCare, suspected violations of any Federal health care program
requirements or of WellCare's own Policies and Procedures; and
 
d.   the right of all individuals to use the Disclosure Program described in
Section III.E, and WellCare's commitment to nonretaliation and to maintain, as
appropriate, confidentiality and anonymity with respect to such disclosures.

 
Within 90 days after the Effective Date, each Covered Person shall certify, in
writing or electronically, that he or she has received, read, understood, and
shall abide by WellCare's Code of Conduct.  New Covered Persons shall receive
the Code of Conduct and shall complete the required certification within 30 days
after becoming a Covered Person or within 90 days after the Effective Date,
whichever is later.  Covered Persons
 
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who had made the required certification within 60 days prior to the Effective
Date are not required to recertify.
 
WellCare shall periodically review the Code of Conduct to determine if revisions
are appropriate and shall make any necessary revisions based on such
review.  Any revised Code of Conduct shall be distributed within 30 days after
any revisions are finalized. Each Covered Person shall certify, in writing or
electronically, that he or she has received, read, understood, and shall abide
by the revised Code of Conduct within 30 days after the distribution of the
revised Code of Conduct.

 
2.   Policies and Procedures. Prior to the Effective Date, WellCare implemented
written Policies and Procedures regarding the operation of WellCare’s compliance
program and its compliance with Federal health care program requirements. To the
extent not already accomplished, within 90 days after the Effective Date,
WellCare shall ensure that the Policies and Procedures address or shall continue
to address:

 
a.   the subjects relating to the Code of Conduct identified in Section III.B.l;

 
b.   appropriate ways to conduct Reimbursement Related Functions in compliance
with all Federal health care program requirements;

 
c.   WellCare’s commitment to fair, accurate, and complete accounting and
reporting of all revenues, expenditures and costs incurred in providing any
service to any Federal health care program beneficiary;

 
d.   measures designed to ensure that WellCare’s accounting and reported
revenues, expenditures, and costs are fair, accurate, and complete;

 
e.   measures designed to ensure complete and accurate reporting of all Federal
health care program information;

 
f.    measures designed to ensure complete and appropriate documentation of
medical records;

 
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g.   measures designed to ensure all claims submitted for Federal health care
program reimbursement are accurate and complete;

h.   measures designed to ensure the accurate and complete preparation,
certification, and submission of bids to Federal health care programs; and

 
i.    measures designed to ensure adherence to Federal health care program
requirements for managed care organizations, including, but not limited to,
requirements related to marketing and advertising, and the enrollment and
disenrollment of beneficiaries.

 
Within 90 days after the Effective Date, the Policies and Procedures shall be
distributed to all Covered Persons.  Appropriate and knowledgeable staff shall
be available to explain the Policies and Procedures.

 
            At least annually (and more frequently, if appropriate), WellCare
shall assess and update, as necessary, the Policies and Procedures. Within 30
days after the effective date of any revisions, any such revised Policies and
Procedures shall be distributed to all Covered Persons.
 
C.  Training and Education.
 
1.   General Training. Within 90 days after the Effective Date, WellCare shall
provide at least two hours of General Training to each Covered Person.  This
training, at a minimum, shall explain WellCare’s:

 
a.   CIA requirements; and

 
b.   Compliance Program, including the Code of Conduct.

 
New Covered Persons shall receive the General Training described above within 30
days after becoming a Covered Person or within 90 days after the Effective Date,
whichever is later. After receiving the initial General Training described
above, each Covered Person shall receive at least one hour of General Training
in each subsequent Reporting Period.

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                2.  Specific Training. Within 90 days after the Effective Date,
WellCare shall require that Relevant Covered Persons receive at least three
hours of Specific Training in addition to the General Training required above.

 
This Specific Training shall include a discussion of:

 
a.   all applicable Federal health care program requirements related to
Reimbursement Related Functions;

 
b.   all WellCare policies, procedures, and other requirements related to
Reimbursement Related Functions;

 
c.   the personal obligation of each individual in Reimbursement Related
Functions to comply with all applicable Federal health care program requirements
and all other applicable legal requirements;

 
d.   the accurate and complete accounting and reporting of all revenues,
expenditures and costs incurred in providing any service to any Federal health
care program beneficiary or submitted to any Federal health care program;

 
e.   the accurate and complete reporting of all Federal health care program
information;

 
f.    the accurate and complete preparation, certification, and submission of
bids to Federal health care programs;

 
g.   policies, procedures, and other requirements applicable to the
documentation of medical records;

 
h.   Federal health care program requirements regarding the accurate coding and
submission of claims;

 
i.     all applicable reimbursement statutes, regulations, and program
requirements and directives;

 
j.    the legal sanctions for violations of the Federal health care program
requirements; and

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k.   examples of proper and improper accounting and reporting of expenditures
and other information to Federal health care programs, and proper and improper
claims submission practices.

 
To the extent that WellCare provided Specific Training to Relevant Covered
Persons during the 180 days immediately prior to the Effective Date that
satisfied the requirement set forth in Section III.C.2 above, WellCare is not
required to repeat initial Specific Training for those individuals for the first
Reporting Period.

 
New Relevant Covered Persons shall receive this training within 30 days after
the beginning of their employment or becoming Relevant Covered Persons, or
within 90 days after the Effective Date, whichever is later. A new Relevant
Covered Person who has not completed the Specific Training shall not perform
Reimbursement Related Functions until such time as he or she completes his or
her Specific Training consistent with categories of work that trigger training
in this Section.

 
After receiving the initial Specific Training described in this Section, each
Relevant Covered Person shall receive at least two hours of Specific Training in
each subsequent Reporting Period.

 
3.   Certification. Each individual who is required to attend training shall
certify, in writing, or in electronic form, if applicable, that he or she has
received the required training.  The certification shall specify the type of
training received and the date received.  The Chief Compliance Officer (or
designee) shall retain the certifications, along with all course
materials.  These shall be made available to OIG, upon request.

 
4.   Qualifications of Trainer. Persons providing the training shall be
knowledgeable about the subject area.

 
5.   Update of Training. WellCare shall review the training annually, and, where
appropriate, update the training to reflect changes in Federal health care
program requirements, any issues discovered during internal audits or the
Reviews, and any other relevant information.

 
6.   Computer-based Training. WellCare may provide the training required under
this CIA through appropriate computer-based training approaches or modules.  If
WellCare chooses to provide computer-based training, it shall make available
 
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appropriately qualified and knowledgeable staff or trainers to answer questions
or provide additional information to the individuals receiving such training.
 
D. Review Procedures.
 
1.   General Description.

 
a.   Engagement of Independent Review Organization. Within 120 days after the
Effective Date, WellCare shall engage an entity (or entities), such as an
accounting, auditing, or consulting firm (hereinafter “Independent Review
Organization” or “IRO”), to perform reviews to assist WellCare in assessing and
evaluating its Reimbursement Related Functions and certain other obligations
pursuant to this CIA and the Settlement Agreement. The applicable requirements
relating to the IRO are outlined in Appendix A to this CIA, which is
incorporated by reference.

 
The IRO shall evaluate and analyze:  (1) WellCare's reporting practices related
to Federal health care programs (Program Report Review); (2) WellCare's bid
submissions to Federal health care programs (Bid Submissions Systems Review);
and (3) if applicable, whether WellCare sought payment for certain unallowable
costs (Unallowable Cost Review) (collectively, the “Reviews”).

 
b.   Frequency of Reviews. The Reviews shall be performed annually and shall
cover each of the Reporting Periods. The IRO(s) shall perform all components of
each annual Review.

 
c.    Frequency of Unallowable Cost Review. If applicable, the IRO shall perform
the Unallowable Cost Review for the first Reporting Period.

 
d.   Retention of Records. The IRO and WellCare shall retain and make available
to OIG, upon request, all work papers, supporting documentation, correspondence,
and draft reports (those exchanged between the IRO and WellCare) related to the
reviews.

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2.   Program Report Review. The Program Report Review shall consist of the
following:

 
a.   Program Report Review. The Program Report Review shall include a review of
three different reports submitted to Medicaid, Medicare, or other Federal health
care program (as described further in Appendix B).  The IRO shall analyze the
contents of each selected report and shall gain an understanding of the process
WellCare uses to generate the report.  The engagement shall be designed to:  (a)
compare WellCare's practices with best practices among similarly situated
entities in the industry; (b) determine the accuracy and completeness of each
report; and (c) produce findings and recommendations aimed at improving
WellCare's reporting processes.  The specific focus of the engagement shall be
to document and recommend improvements to the steps that WellCare takes to
ensure that proper information is being recorded on such reports and that
controls are reasonably designed to ensure the accuracy and completeness of the
information provided.

 
b.   Program Report Review Report. The IRO shall prepare a report based upon the
Program Report Review engagement and appropriate consulting standards (as
described more fully in Appendix B) (Program Report Review Report). The Program
Report Review Report shall include the IRO’s findings and supporting rationale
regarding (i) the weaknesses in WellCare’s report preparation process; (ii) any
recommendations the IRO may have to improve any of the systems, operations, and
processes; and (iii) a summary of conclusions from the Program Report Review.

 
3.   Bid Submissions Systems Review. The Bid Submission Review shall consist of
the following:

 
a.   Bid Submissions Systems Review. The Bid Submissions Review shall include a
review of bid submissions from three different Plans (as described further in
Appendix B). The IRO shall analyze the contents of each selected bid and also
shall gain an understanding of WellCare’s bid submission process, including the
WellCare policy on bid Submissions for Federal 
 
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and State Health Care Programs. The engagement shall be designed to:  (a) assess
the accuracy and completeness of the bids; (b) compare WellCare’s practices with
best practices among similarly situated entities in the industry; and (c)
produce findings and recommendations aimed at improving WellCare’s bid
submission processes.  The specific focus of the engagement shall be to document
and recommend improvements to the steps that WellCare takes to ensure that
proper information is being recorded on such submissions to the Federal health
care program and that controls are reasonably designed to ensure the accuracy
and completeness of the information provided.  In conducting the Bid Submissions
Review, the IRO shall perform work that is necessary and appropriate to present
findings and recommendations on WellCare’s bid submission preparation policies,
procedures, and operational processes. The IRO may conduct interviews and shall
review relevant policies and procedures and operational processes, along with
the pertinent requests for proposals and the bid submissions under review.
 
b.   Bid Submissions Systems Review Report. The IRO shall prepare a report based
upon the Bid Submission engagement and appropriate consulting materials (as
described more fully in Appendix B) (Bid Submissions Systems Review Report). The
Bid Submissions Systems Review Report shall include the IRO's findings and
supporting rationale regarding (i) the weaknesses in WellCare's bid submission
processes; (ii) any recommendations the IRO may have to improve any of the
systems, operations, and processes; and (iii) a summary of the conclusions from
the Bid Submission Systems Review.

 
4.   Unallowable Cost Review.   If applicable, the IRO shall conduct a review of
WellCare’s compliance with the unallowable cost provisions of the Settlement
Agreement.  The IRO shall determine whether WellCare has complied with its
obligations not to charge to, or otherwise seek payment from, federal or state
payors for unallowable costs (as defined in the Settlement Agreement) and its
obligation to identify to applicable federal or state payors any unallowable
costs included in payments previously sought from the United States, or any
state Medicaid program. This unallowable cost analysis shall include, but not be
limited to, payments sought in any cost reports, cost statements, information
reports, or payment requests already submitted by WellCare or any affiliates. To
the extent that such cost reports, cost statements,
 
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information reports, or payment requests, even if already settled, have been
adjusted to account for the effect of the inclusion of the unallowable costs,
the IRO shall determine if such adjustments were proper. In making this
determination, the IRO may need to review cost reports and/or financial
statements from the year in which the Settlement Agreement was executed, as well
as from previous years.
 
a.   Unallowable Cost Review Report. If applicable, the IRO shall prepare a
report based upon the Unallowable Cost Review performed (Unallowable Cost Review
Report).  The Unallowable Cost Review Report shall include the IRO’s findings
and supporting rationale regarding the Unallowable Cost Review and whether
WellCare has complied with its obligation not to charge to, or otherwise seek
payment from, federal or state payors for unallowable costs (as defined in the
Settlement Agreement) and its obligation to identify to applicable federal or
state payors any unallowable costs included in payments previously sought from
such payor.

 
5.   Validation Review. In the event OIG has reason to believe that: (a) any of
the required Reviews fails to conform to the requirements of this CIA; or (b)
the IRO’s findings or the results of the Reviews are inaccurate, OIG may, at its
sole discretion, conduct its own review to determine whether the Review at issue
complied with the requirements of the CIA and/or the findings or the results of
the Review are inaccurate (Validation Review).  WellCare shall pay for the
reasonable cost of any such review performed by OIG or any of its designated
agents.  Any Validation Review of Reports submitted as part of WellCare’s final
Annual Report shall be initiated no later than one year after WellCare’s final
submission (as described in Section II) is received by OIG.

 
   Prior to initiating a Validation Review, OIG shall notify WellCare of its
intent to do so and provide a written explanation of why OIG believes such a
review is necessary.  To resolve any concerns raised by OIG, WellCare may
request a meeting with OIG to:  (a) discuss the results of any Review
submissions or findings; (b) present any additional information to clarify the
results of any Review or to correct the inaccuracy of any Review; and/or (c)
propose alternatives to the proposed Validation Review.  WellCare agrees to
provide any additional information as may be requested by OIG under this Section
III.D.6 in an expedited manner.  OIG will attempt in good faith to resolve any
Review issues with WellCare prior to conducting a Validation Review. However,
the
 
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 final determination as to whether or not to proceed with a Validation Review
shall be made at the sole discretion of OIG.
 
   6.   Independence and Objectivity Certification. The IRO shall include in its
report(s) to WellCare a certification or sworn affidavit that it has evaluated
its professional independence and objectivity, as appropriate to the nature of
the engagement, with regard to the Reviews and that it has concluded that it is,
in fact, independent and objective.

 
E. Disclosure Program.

 
To the extent not already accomplished, within 90 days after the Effective Date,
WellCare shall establish a Disclosure Program that includes a mechanism (e.g., a
toll-free compliance telephone line) to enable individuals to disclose, to the
Chief Compliance Officer or some other person who is not in the disclosing
individual’s chain of command, any identified issues or questions associated
with WellCare's policies, conduct, practices, or procedures with respect to a
Federal health care program believed by the individual to be a potential
violation of criminal, civil, or administrative law.  WellCare shall
appropriately publicize the existence of the disclosure mechanism (e.g., via
periodic e-mails to employees or by posting the information in prominent common
areas).

 
The Disclosure Program shall emphasize a nonretribution, nonretaliation policy,
and shall include a reporting mechanism for anonymous communications for which
appropriate confidentiality shall be maintained. Upon receipt of a disclosure,
the Chief Compliance Officer (or designee) shall gather all relevant information
from the disclosing individual.  The Chief Compliance Officer (or designee)
shall make a preliminary, good faith inquiry into the allegations set forth in
every disclosure to ensure that he or she has obtained all of the information
necessary to determine whether a further review should be conducted.  For any
disclosure that is sufficiently specific so that it reasonably: (1) permits a
determination of the appropriateness of the alleged improper practice; and (2)
provides an opportunity for taking corrective action, WellCare shall conduct an
internal review of the allegations set forth in the disclosure and ensure that
proper follow-up is conducted.
 
The Chief Compliance Officer (or designee) shall maintain a confidential
disclosure log, which shall include a record and summary of each disclosure
received (whether anonymous or not), the status of the respective internal
reviews, and any corrective action taken in response to the internal
reviews.  The confidential disclosure 
 
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log shall be made available to OIG upon request.
 
F.  Ineligible Persons.
 
1.   Definitions. For purposes of this CIA:
 
a.   an “Ineligible Person” shall include an individual or entity who:
 
i.  is currently excluded, debarred, suspended, or otherwise ineligible to
participate in the Federal health care programs or in Federal procurement or
nonprocurement programs; or

 
ii.  has been convicted of a criminal offense that falls within the scope of 42
U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or
otherwise declared ineligible.

 
b.   “Exclusion Lists” include:

 
i.  the HHS/OIG List of Excluded Individuals/Entities (available through the
Internet at http://www.oig.hhs.gov); and

 
ii.  the General Services Administration’s List of Parties Excluded from Federal
Programs (available through the Internet at http: //www. epls. gov).

 
   2.   Screening Requirements. WellCare shall ensure that all prospective and
current Covered Persons are not Ineligible Persons, by implementing the
following screening requirements.

 
a.   WellCare shall screen all prospective and current Covered Persons against
the Exclusion Lists prior to engaging their services and, as part of the hiring
or contracting process, shall require such Covered Persons to disclose whether
they are Ineligible Persons.

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b.   WellCare shall screen all Covered Persons against the Exclusion Lists
within 90 days after the Effective Date and on an annual basis thereafter.
 
c.   WellCare shall implement a policy requiring all Covered Persons to disclose
immediately any debarment, exclusion, suspension, or other event that makes that
person an Ineligible Person.

 
   Nothing in this Section affects the responsibility of (or liability for)
WellCare to refrain from billing Federal health care programs for items or
services furnished, ordered, or prescribed by an Ineligible Person. WellCare
understands that items or services furnished by excluded persons are not payable
by Federal health care programs and that WellCare may be liable for overpayments
and/or criminal, civil, and administrative sanctions for employing or
contracting with an excluded person regardless of whether WellCare meets the
requirements of Section III.F.

 
3.   Removal Requirement. If WellCare has actual notice that a Covered Person
has become an Ineligible Person, WellCare shall remove such Covered Person from
responsibility for, or involvement with, WellCare's business operations related
to the Federal health care programs and shall remove such Covered Person from
any position for which the Covered Person's compensation or the items or
services furnished, ordered, or prescribed by the Covered Person are paid in
whole or part, directly or indirectly, by Federal health care programs or
otherwise with Federal funds at least until such time as the Covered Person is
reinstated into participation in the Federal health care programs.

 
4.   Pending Charges and Proposed Exclusions. If WellCare has actual notice that
a Covered Person is charged with a criminal offense that falls within the scope
of 42 U.S.C. §§ 1320a-7(a), 1320a-7(b)(l)-(3), or is proposed for exclusion
during the Covered Person's employment or contract term or during the term of a
physician’s or other practitioner’s medical staff privileges, WellCare shall
take all appropriate actions to ensure that the responsibilities of that Covered
Person have not and shall not adversely affect the quality of care rendered to
any beneficiary, patient, or resident, or any claims submitted to any Federal
health care program.

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G. Notification of Government Investigation or Legal Proceedings.
 
Within 30 days after discovery, WellCare shall notify OIG, in writing, of any
ongoing investigation or legal proceeding known to WellCare conducted or brought
by a governmental entity or its agents involving an allegation that WellCare has
committed a crime or has engaged in fraudulent activities. This notification
shall include a description of the allegation, the identity of the investigating
or prosecuting agency, and the status of such investigation or legal proceeding.
WellCare shall also provide written notice to OIG within 30 days after the
resolution of the matter, and shall provide OIG with a description of the
findings and/or results of the investigation or proceedings, if any.

 
H. Repayment of Overpayments.
 
1.   Definition of Overpayments.  For purposes of this CIA, an “Overpayment”
shall mean any funds that WellCare receives or retains under a Federal health
care program to which WellCare, after applicable reconciliation, is not
entitled.

 
2.   Repayment of Overpayments.

 
a.   If, at any time, WellCare identifies any Overpayment, WellCare shall repay
the Overpayment to the appropriate payor (e.g., State Medicaid agency) within 30
days after identification of the Overpayment and take remedial steps within 60
days after identification (or such additional time as may be agreed to by the
payor) to correct the problem, including preventing the underlying problem and
the Overpayment from recurring.  If not yet quantified, within 30 days after
identification, WellCare shall notify the payor of its efforts to quantify the
Overpayment amount along with a schedule of when such work is expected to be
completed.  Notification and repayment to the payor shall be done in accordance
with the payor's policies or as otherwise directed by the payor in writing.

 
b.   Notwithstanding the above, notification and repayment of any Overpayment
amount that routinely is reconciled or adjusted pursuant to policies and
procedures established by the payor should be handled in accordance with such
policies and procedures or as otherwise directed by the payor in writing.

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I. Reportable Events.

 
1.   Definition of Reportable Event. For purposes of this CIA, a “Reportable
Event” means anything that involves:

 
a.   a substantial Overpayment;

 
b.   a matter that a reasonable person would consider a probable violation of
criminal, civil, or administrative laws applicable to any Federal health care
program for which penalties or exclusion may be authorized; or

 
c.   the employment of or contracting with a Covered Person who is an Ineligible
Person as defined by Section III.F.l.a; or

 
d.   the filing of a bankruptcy petition by WellCare.
 
A Reportable Event may be the result of an isolated event or a series of
occurrences.

 
2.    Reporting of Reportable Events. If WellCare determines (after a reasonable
opportunity to conduct an appropriate review or investigation of the
allegations) through any means that there is a Reportable Event, WellCare shall
notify OIG, in writing, within 30 days after making the determination that the
Reportable Event exists.

 
3.   Reportable Events under Section III.I.1.a.  For Reportable Events under
Section III.I.l.a, the report to OIG shall be made at the same time as the
repayment to the payor required in Section III.H, and shall include:

 
a.   a copy of the notification and repayment to the payor required in Section
III.H.2;

 
b.   a description of the steps taken by WellCare to identify and quantify the
Overpayment;

 
c.   a complete description of the Reportable Event, including the relevant
facts, persons involved, and legal and Federal health care program authorities
implicated;

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d.   a description of WellCare's actions taken to correct the Reportable Event;
and

 
e.   any further steps WellCare plans to take to address the Reportable Event
and prevent it from recurring.

 
4.   Reportable Events under Section III.I.1.b and III.I.l.c.  For Reportable
Events under Section III.I.l.b and III.I.l.c, the report to OIG shall include:

 
a.   a complete description of the Reportable Event, including the relevant
facts, persons involved, and legal and Federal health care program authorities
implicated;

 
b.   a description of WellCare's actions taken to correct the Reportable Event;

 
c.   any further steps WellCare plans to take to address the Reportable Event
and prevent it from recurring; and

 
d.    if the Reportable Event has resulted in an Overpayment, a description of
the steps taken by WellCare to identify and quantify the Overpayment.

 
5.   Reportable Events under Section III.I.l.d.  For Reportable Events under
Section III.I.l.d, the report to the OIG shall include documentation of the
bankruptcy filing and a description of any Federal health care program
authorities implicated.

 
6.   Reportable Events Involving the Stark Law.  Notwithstanding the reporting
requirements outlined above, any Reportable Event that involves only a probable
violation of section 1877 of the Social Security Act, 42 U.S.C. §1395nn (the
Stark Law) should be submitted by WellCare to the Centers for Medicare &
Medicaid Services (CMS) through the self-referral disclosure protocol (SRDP),
with a copy to the OIG.  The requirements of Section III.H.2 that require
repayment to the payor of any identified Overpayment within 30 days shall not
apply to any Overpayment that may result from a probable violation of only the
Stark Law that is disclosed to CMS pursuant to the SRDP.

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IV.          Changes to Business Units or Locations
 
A.      Change or Closure of Unit or Location. In the event that, after the
Effective Date, WellCare changes locations or closes a business unit or location
doing business with any Federal health care programs, WellCare shall notify OIG
of this fact as soon a possible, but no later than within 30 days after the date
of change or closure of the location.

 
B.      Purchase or Establishment of New Unit or Location. In the event that,
after the Effective Date, WellCare purchases or establishes a new business unit
or location doing business with any Federal health care program, WellCare shall
notify OIG no later than five days after the date that the purchase or
establishment is publicly disclosed.  This notification shall include the
address of the new business unit or location, phone number, fax number, any
Federal health care program provider number and/or supplier number (if
applicable), and the name and address of the Federal health care program
contractor or Medicaid agency with which the new business unit or location does
business, and the tax identification number of each new business unit or
location. Each new business unit or location and all Covered Persons at each new
business unit or location shall be subject to the applicable requirements of
this CIA.

 
C.      Sale of Unit or Location.  In the event that, after the Effective Date,
WellCare proposes to sell any or all of its business units or locations that are
subject to this CIA, WellCare shall notify OIG of the proposed sale no later
than five days after the date the sale is publicly disclosed.  This notification
shall include a description of the business unit or location to be sold, a brief
description of the terms of the sale, and the name and contact information of
the prospective purchaser.  This CIA shall be binding on the purchaser of such
business unit or location, unless otherwise determined and agreed to in writing
by the OIG.
 
V.           Implementation and Annual Reports

 
   A.      Implementation Report. Within 150 days after the Effective Date,
WellCare shall submit a written report to OIG summarizing the status of its
implementation of the requirements of this CIA (Implementation Report). The
Implementation Report shall, at a minimum, include:

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               1.   the name, address, phone number, and position description of
the Chief Compliance Officer required by Section III.A, and a summary of other
noncompliance job responsibilities the Chief Compliance Officer may have;

 
   2.   names and positions of the members of the Corporate Compliance
Committee, Compliance Liaisons, and Board Regulatory Compliance Committee
required by Section III.A;

 
3.   names and positions of the Certifying Employees required by Section III.A;

 
4.   a copy of WellCare's Code of Conduct required by Section III.B.l;

 
5.   the number of individuals required to complete the Code of Conduct
certification required by Section III.B.l, the percentage of individuals who
have completed such certification, and an explanation of any exceptions (the
documentation supporting this information shall be available to OIG, upon
request);

 
   6.   a summary of all Policies and Procedures required by Section III.B.2 (a
copy of such Policies and Procedures shall be made available to OIG upon
request);

 
7.   the following information regarding each type of training required by
Section III.C:

 
a.   a description of such training, including a summary of the topics covered,
the length of sessions, and a schedule of training sessions; and

 
b.   the number of individuals required to be trained, percentage of individuals
actually trained, and an explanation of any exceptions.

 
A copy of all training materials and the documentation supporting this
information shall be available to OIG, upon request.
 
8.   the following information regarding the IRO(s):  (a) identity, address, and
phone number; (b) a copy of the engagement letter; and (c) a summary and
description of any and all current and prior engagements and agreements between
WellCare and the IRO;

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9.   a certification from the IRO(s) regarding its/their professional
independence and objectivity with respect to WellCare;

 
                           10. a description of the Disclosure Program required
by Section III.E;

 
11. a description of the process by which WellCare fulfills the requirements of
Section III.F regarding Ineligible Persons;

 
12. the name, title, and responsibilities of any person who is determined to be
an Ineligible Person under Section III.F; the actions taken in response to the
screening and removal obligations set forth in Section III.F; and the actions
taken to identify, quantify, and repay any overpayments to Federal health care
programs relating to items or services furnished, ordered or prescribed by an
Ineligible Person;

 
13. a list of all of WellCare's locations (including locations and mailing
addresses); the corresponding name under which each location is doing business;
the corresponding phone numbers and fax numbers; each location's Medicare and
state Medicaid program provider number and/or supplier number(s) (if
applicable); and the name and address of each Medicare and state Medicaid
program contractor to which WellCare currently submits claims (if applicable);

 
14. a description of WellCare's corporate structure, including identification of
any parent and sister companies, subsidiaries, and their respective lines of
business; and

 
                           15. the certifications required by Section V.C.

 
B. Annual Reports. WellCare shall submit to OIG annually a report with respect
to the status of, and findings regarding, WellCare’s compliance activities for
each of the five Reporting Periods (Annual Report).

 
Each Annual Report shall include, at a minimum:

 
1.   any change in the identity, position description, or other noncompliance
job responsibilities of the Chief Compliance Officer and any change in the
membership of the Corporate Compliance Committee, Compliance Liaisons, Board
Regulatory Compliance Committee, or Certifying Employees described in Section
III.A;

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2.   a complete copy of the Compliance Program Review Assessment required by
Section III.A.4.b;

 
3.   a summary of any significant changes or amendments to the Code of Conduct
required by Section III.B.l and the reasons for such changes;

 
4.   the number of individuals required to complete the Code of Conduct
certification required by Section III.B.l, the percentage of individuals who
have completed such certification, and an explanation of any exceptions (the
documentation supporting this information shall be available to OIG, upon
request);

 
5.   a summary of any significant changes, additions or amendments to the
Policies and Procedures required by Section III.B.2 and the reasons for such
changes (e.g., change in CMS or State Medicaid Agency policy);

 
6.   the following information regarding each type of training required by
Section III.C:

 
a.   a description of the initial and annual training, including a summary of
the topics covered, the length of sessions, and a schedule of training sessions;
and

 
b.   the number of individuals required to complete the initial and annual
training, the percentage of individuals who actually completed the initial and
annual training, and an explanation of any exceptions.

 
A copy of all training materials and the documentation supporting this
information shall be available to OIG, upon request.

 
7.   a complete copy of all reports prepared pursuant to Section III.D, along
with a copy of the IRO’s engagement letter;

 
8.   WellCare’s response to the reports prepared pursuant to Section III.D,
along with corrective action plan(s) related to any issues raised by the
reports;

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9.   a summary and description of any and all current and prior engagements and
agreements between WellCare and the IRO, if different from what was submitted as
part of the Implementation Report;

 
10. a certification from the IRO regarding its professional independence and
objectivity with respect to WellCare;

 
11. a summary of the disclosures in the confidential disclosure log required by
Section III.E that relate to Federal health care programs;

 
12. any changes to the process by which WellCare fulfills the requirements of
Section III.F regarding Ineligible Persons;

 
13. the name, title, and responsibilities of any person who is determined to be
an Ineligible Person under Section III.F; the actions taken in response to the
screening and removal obligations set forth in Section III.F; and the actions
taken to identify, quantify, and repay any overpayments to Federal health care
programs relating to items or services furnished, ordered or prescribed by an
Ineligible Person;
 
14. a summary describing any ongoing investigation or legal proceeding required
to have been reported pursuant to Section III.G.  The summary shall include a
description of the allegation, the identity of the investigating or prosecuting
agency, and the status of such investigation or legal proceeding;
 
15. a report of the aggregate Overpayments that have been returned to the
Federal health care programs pursuant to Section III.H.  Overpayment amounts
shall be broken down into the following categories:  Medicare Advantage,
Medicare Part D, Medicaid (report each applicable state separately, if
applicable), and other Federal health care programs. Overpayment amounts that
are routinely reconciled or adjusted pursuant to policies and procedures
established by the payor do not need to be included in this aggregate
Overpayment report;

 
16. a summary of Reportable Events (as defined in Section III.I) identified
during the Reporting Period and the status of any corrective and preventative
action relatmg to all such Reportable Events;

 
17. a description of all changes to the most recently provided list of
WellCare’s locations (including addresses) as required by Section V.A.I3; the 
 
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corresponding name under which each location is doing business; the
corresponding phone numbers and fax numbers; each location’s Medicare and state
Medicaid program provider number(s) and/or supplier number(s) (if applicable);
and the name and address of each Medicare and state Medicaid program contractor
to which WellCare currently submits claims (if applicable); and

 
18. the certifications required by Section V.C.
 
The first Annual Report shall be received by OIG no later than 60 days after the
end of the first Reporting Period.  Subsequent Annual Reports shall be received
by OIG no later than the anniversary date of the due date of the first Annual
Report.

 
C.  Certifications. The following certifications shall be included in the
Implementation Report and each Annual Report:

 
                           1.   Certifying Employees: In each Annual Report,
WellCare shall include the certifications of Certifying Employees as required by
Section III.A.

 
                           2.   Board Regulatory Compliance Committee:  In each
Annual Report, WellCare shall include the Board Regulatory Compliance
Committee’s Resolution as required by Section III.A.4.d.
 
                           3.   Chief Compliance Officer: In each Implementation
and Annual Report, WellCare shall include the following individual certification
by the Chief Compliance Officer:

 
a.   he or she has reviewed the report and has made reasonable inquiry regarding
its content and believes that the information in the report is accurate and
truthful; and

 
b.   to the best of his or her knowledge, except as otherwise described in the
applicable report, WellCare is in compliance with Federal health care program
requirements and the obligations of the CIA.

 
   D.  Designation of Information.  WellCare shall clearly identify any portions
of its submissions that it believes are trade secrets, or information that is
commercial or financial and privileged or confidential, and therefore
potentially exempt from disclosure 
 
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under the Freedom of Information Act (FOIA), 5 U.S.C. § 552. WellCare shall
refrain from identifying any information as exempt from disclosure if that
information does not meet the criteria for exemption from disclosure under FOIA.

VI.       Notifications and Submission of Reports

 
            Unless otherwise stated in writing after the Effective Date, all
notifications and reports required under this CIA shall be submitted to the
following entities:
 

 
OIG:
  Administrative and Civil Remedies Branch
Office of Counsel to the Inspector General
Office of Inspector General
U.S. Department of Health and Human Services
Cohen Building, Room 5527
330 Independence Avenue, S.W.
Washington, DC 20201
Telephone: 202.619.2078
Facsimile: 202.205.0604
              WellCare:   Blair Todt
Senior Vice President & Chief Compliance Officer
WellCare Health Plans, Inc.
8735 Henderson Road, Renaissance 2
Tampa, FL 33634
Telephone: 813.206.6833
Fax: 813.262.2985
 

                
Unless otherwise specified, all notifications and reports required by this CIA
may be made by certified mail, overnight mail, hand delivery, or other means,
provided that there is proof that such notification was received. For purposes
of this requirement, internal facsimile confirmation sheets do not constitute
proof of receipt. Upon request by OIG, WellCare may be required to provide OIG
with an electronic copy of each notification or report required by this CIA in
searchable portable document format (pdf), either instead of or in addition to,
a paper copy.

 
VII.     OIG Inspection, Audit, and Review Rights

 
            In addition to any other rights OIG may have by statute, regulation,
or contract, 
 
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OIG or its duly authorized representative(s) may examine or request copies of
WellCare's books, records, and other documents and supporting materials and/or
conduct on-site reviews of any of WellCare’s locations for the purpose of
verifying and evaluating: (a) WellCare’s compliance with the terms of this CIA;
and (b) WellCare’s compliance with the requirements of the Federal health care
programs in which it participates.  The documentation described above shall be
made available by WellCare to OIG or its duly authorized representative(s) at
all reasonable times for inspection, audit, or reproduction.  Furthermore, for
purposes of this provision, OIG or its duly authorized representative(s) may
interview any of WellCare’s employees, contractors, or agents who consent to be
interviewed at the individual’s place of business during normal business hours
or at such other place and time as may be mutually agreed upon between the
individual and OIG. WellCare shall assist OIG or its duly authorized
representative(s) in contacting and arranging interviews with such individuals
upon OIG's request. WellCare's employees may elect to be interviewed with or
without a representative of WellCare present.
 
VIII.    Document and Record Retention

 
            WellCare shall maintain for inspection all documents and records
relating to reimbursement from the Federal health care programs and to
compliance with this CIA for six years (or longer if otherwise required by law)
from the Effective Date.
 
IX.       Disclosures

 
            Consistent with HHS’s FOIA procedures, set forth in 45 C.F.R. Part
5, OIG shall make a reasonable effort to notify WellCare prior to any release by
OIG of information submitted by WellCare pursuant to its obligations under this
CIA and identified upon submission by WellCare as trade secrets, or information
that is commercial or financial and privileged or confidential, under the FOIA
rules. With respect to such releases, WellCare shall have the rights set forth
at 45 C.F.R. § 5.65(d).
 
X.        Breach and Default Provisions

 
            WellCare is expected to fully and timely comply with all of its CIA
obligations.

 
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A.  Stipulated Penalties for Failure to Comply with Certain Obligations. As a
contractual remedy, WellCare and OIG hereby agree that failure to comply with
certain obligations as set forth in this CIA may lead to the imposition of the
following monetary penalties (hereinafter referred to as “Stipulated Penalties”)
in accordance with the following provisions.
 
             1.  A Stipulated Penalty of $2,500 (which shall begin to accrue on
the day after the date the obligation became due) for each day WellCare fails to
establish and implement any of the following obligations as described in Section
III:

 
a.
a Chief Compliance Officer;
 

b.
a Corporate Compliance Committee;
 

c.
Compliance Liaisons;
 

d.
a Board Regulatory Compliance Committee;
 

e.
Compliance Program Review Assessment;
 

f.
Board Regulatory Compliance Committee Resolution;
 

g.
Certifying Employee certification;
 

h.
a written Code of Conduct;
 

i.
written Policies and Procedures;
 

j.
the training of Covered Persons and Relevant Covered Persons;

 
k.
a Disclosure Program;

 
1.
Ineligible Persons screening and removal requirements;

 
m . notification of Government investigations or legal proceedings; and

 
n.   reporting of Reportable Events.

 
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2.   A Stipulated Penalty of $2,500 (which shall begin to accrue on the day
after the date the obligation became due) for each day WellCare fails to engage
an IRO, as required in Section III.D, Appendix A, and Appendix B.

3.   A Stipulated Penalty of $2,500 (which shall begin to accrue on the day
after the date the obligation became due) for each day WellCare fails to submit
the Implementation Report or any Annual Reports to OIG in accordance with the
requirements of Section V by the deadlines for submission.

 
4.   A Stipulated Penalty of $2,500 (which shall begin to accrue on the day
after the date the obligation became due) for each day WellCare fails to submit
any Report in accordance with the requirements of Section III.D and Appendix B.

 
5.   A Stipulated Penalty of $1,500 for each day WellCare fails to grant access
as required in Section VII. (This Stipulated Penalty shall begin to accrue on
the date WellCare fails to grant access.)

 
6.   A Stipulated Penalty of $10,000 for each false certification submitted by
or on behalf of WellCare as part of its Implementation Report, Annual Report,
additional documentation to a report (as requested by the OIG), or otherwise
required by this CIA.

 
7.   A Stipulated Penalty of $1,000 for each day WellCare fails to comply fully
and adequately with any obligation of this CIA. OIG shall provide notice to
WellCare stating the specific grounds for its determination that WellCare has
failed to comply fully and adequately with the CIA obligation(s) at issue and
steps WellCare shall take to comply with the CIA.  (This Stipulated Penalty
shall begin to accrue 10 days after WellCare receives this notice from OIG of
the failure to comply.)  A Stipulated Penalty as described in this Subsection
shall not be demanded for any violation for which OIG has sought a Stipulated
Penalty under Subsections 1-6 of this Section.

 
B. Timely Written Requests for Extensions. WellCare may, in advance of the due
date, submit a timely written request for an extension of time to perform any
act or file any notification or report required by this CIA. Notwithstanding any
other provision in this Section, if OIG grants the timely written request with
respect to an act, notification, or report, Stipulated Penalties for failure to
perform the act or file the notification or report shall not begin to accrue
until one day after WellCare fails to meet the revised deadline set by OIG.
Notwithstanding any other provision in this Section, if OIG denies 
 
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such a timely written request, Stipulated Penalties for failure to perform the
act or file the notification or report shall not begin to accrue until three
business days after WellCare receives OIG’s written denial of such request or
the original due date, whichever is later. A “timely written request” is defined
as a request in writing received by OIG at least five business days prior to the
date by which any act is due to be performed or any notification or report is
due to be filed.

 
C.   Payment of Stipulated Penalties.

 
1.   Demand Letter. Upon a finding that WellCare has failed to comply with any
of the obligations described in Section X.A and after determining that
Stipulated Penalties are appropriate, OIG shall notify WellCare of:  (a)
WellCare’s failure to comply; and (b) OIG's exercise of its contractual right to
demand payment of the Stipulated Penalties (this notification is referred to as
the “Demand Letter”).

 
2.   Response to Demand Letter.  Within 10 days after the receipt of the Demand
Letter, WellCare shall either: (a) cure the breach to OIG’s satisfaction and pay
the applicable Stipulated Penalties or (b) request a hearing before an HHS
administrative law judge (ALJ) to dispute OIG’s determination of noncompliance,
pursuant to the agreed upon provisions set forth below in Section X.E.  In the
event WellCare elects to request an ALJ hearing, the Stipulated Penalties shall
continue to accrue until WellCare cures, to OIG’s satisfaction, the alleged
breach in dispute. Failure to respond to the Demand Letter in one of these two
manners within the allowed time period shall be considered a material breach of
this CIA and shall be grounds for exclusion under Section X.D.

 
3.   Form of Payment. Payment of the Stipulated Penalties shall be made by
electronic funds transfer to an account specified by OIG in the Demand Letter.

 
4.   Independence from Material Breach Determination. Except as set forth in
Section X.D.l.d, these provisions for payment of Stipulated Penalties shall not
affect or otherwise set a standard for OIG’s decision that WellCare has
materially breached this CIA, which decision shall be made at OIG’s discretion
and shall be governed by the provisions in Section X.D, below.

 
                D.  Exclusion for Material Breach of this CIA.

 
1.   Definition of Material Breach. A material breach of this CIA means:

 
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a.   a repeated or flagrant violation of the obligations under this CIA,
including, but not limited to, the obligations addressed in Section X.A;
 
b.   a failure by WellCare to report a Reportable Event, take corrective action,
and make the appropriate refunds, as required in Section III.I;
 
c.   a failure to engage and use an IRO in accordance with Section III.D and
Appendix B;

 
d.   a failure to respond to a Demand Letter concerning the payment of
Stipulated Penalties in accordance with Section X.C; and

 
e.   a failure by the Board Regulatory Compliance Committee to issue a
resolution in accordance with Section III.A.4.d.

 
2.   Notice of Material Breach and Intent to Exclude.  The parties agree that a
material breach of this CIA by WellCare constitutes an independent basis for
WellCare’s exclusion from participation in the Federal health care
programs.  Upon a determination by OIG that WellCare has materially breached
this CIA and that exclusion is the appropriate remedy, OIG shall notify WellCare
of:  (a) WellCare's material breach; and (b) OIG’s intent to exercise its
contractual right to impose exclusion (this notification is hereinafter referred
to as the “Notice of Material Breach and Intent to Exclude”).

 
3.   Opportunity to Cure. WellCare shall have 30 days from the date of receipt
of the Notice of Material Breach and Intent to Exclude to demonstrate to OIG’s
satisfaction that:

 
a.   WellCare is in compliance with the obligations of the CIA cited by OIG as
being the basis for the material breach;
 
b.   the alleged material breach has been cured; or
 
c.   the alleged material breach cannot be cured within the 30 day period, but
that: (i) WellCare has begun to take action to cure the material breach; (ii)
WellCare is pursuing such action with due diligence; and (iii) WellCare has
provided to OIG a reasonable
 
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WellCare Health Plans, Inc.
 
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timetable for curing the material breach.
 
                           4.   Exclusion Letter.  If, at the conclusion of the
30 day period, WellCare fails to satisfy the requirements of Section X.D.3, OIG
may exclude WellCare from participation in the Federal health care
programs.  OIG shall notify WellCare in writing of its determination to exclude
WellCare (this letter shall be referred to hereinafter as the “Exclusion
Letter”).  Subject to the Dispute Resolution provisions in Section X.E, below,
the exclusion shall go into effect 30 days after the date of WellCare’s receipt
of the Exclusion Letter.  The exclusion shall have national effect and shall
also apply to all other Federal procurement and nonprocurement
programs.  Reinstatement to program participation is not automatic.  After the
end of the period of exclusion, WellCare may apply for reinstatement by
submitting a written request for reinstatement in accordance with the provisions
at 42 C.F.R. §§ 1001.3001-.3004.
 
               E. Dispute Resolution

 
1.   Review Rights. Upon OIG’s delivery to WellCare of its Demand Letter or of
its Exclusion Letter, and as an agreed-upon contractual remedy for the
resolution of disputes arising under this CIA, WellCare shall be afforded
certain review rights comparable to the ones that are provided in 42 U.S.C. §
1320a-7(f) and 42 C.F.R. Part 1005 as if they applied to the Stipulated
Penalties or exclusion sought pursuant to this CIA.  Specifically, OIG’s
determination to demand payment of Stipulated Penalties or to seek exclusion
shall be subject to review by an HHS ALJ and, in the event of an appeal, the HHS
Departmental Appeals Board (DAB), in a manner consistent with the provisions in
42 C.F.R. § 1005.2-1005.21.  Notwithstanding the language in 42 C.F.R. §
1005.2(c), the request for a hearing involving Stipulated Penalties shall be
made within 10 days after receipt of the Demand Letter and the request for a
hearing involving exclusion shall be made within 25 days after receipt of the
Exclusion Letter.

 
2.   Stipulated Penalties Review.  Notwithstanding any provision of Title 42 of
the United States Code or Title 42 of the Code of Federal Regulations, the only
issues in a proceeding for Stipulated Penalties under this CIA shall be:  (a)
whether WellCare was in full and timely compliance with the obligations of this
CIA for which OIG demands payment; and (b) the period of
noncompliance.  WellCare shall have the burden of proving its full and timely
compliance and the steps taken to cure the noncompliance, if any.  OIG shall not
have the right to appeal to the DAB an adverse ALJ decision related to
Stipulated Penalties.  If the ALJ agrees with OIG with regard to a finding of a
breach of this CIA and orders WellCare to pay Stipulated Penalties, such
Stipulated Penalties
  
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shall become due and payable 20 days after the ALJ issues such a decision unless
WellCare requests review of the ALJ decision by the DAB.  If the ALJ decision is
properly appealed to the DAB and the DAB upholds the determination of OIG, the
Stipulated Penalties shall become due and payable 20 days after the ALJ
issues its decision.
 
                           3.   Exclusion Review. Notwithstanding any provision
of Title 42 of the United States Code or Title 42 of the Code of Federal
Regulations, the only issues in a proceeding for exclusion based on a material
breach of this CIA shall be:
 
a.   whether WellCare was in material breach of this CIA;

 
b.   whether such breach was continuing on the date of the Exclusion Letter; and

 
c.   whether the alleged material breach could not have been cured within the
30-day period, but that: (i) WellCare had begun to take action to cure the
material breach within that period; (ii) WellCare has pursued and is pursuing
such action with due diligence; and (iii) WellCare provided to OIG within that
period a reasonable timetable for curing the material breach and WellCare has
followed the timetable.

 
For purposes of the exclusion herein, exclusion shall take effect only after an
ALJ decision favorable to OIG, or, if the ALJ rules for WellCare, only after a
DAB decision in favor of OIG.  WellCare’s election of its contractual right to
appeal to the DAB shall not abrogate OIG’s authority to exclude WellCare upon
the issuance of an ALJ’s decision in favor of OIG.  If the ALJ sustains the
determination of OIG and determines that exclusion is authorized, such exclusion
shall take effect 20 days after the ALJ issues such a decision, notwithstanding
that WellCare may request review of the ALJ decision by the DAB. If the DAB
finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall
take effect 20 days after the DAB decision.  WellCare shall waive its right to
any notice of such an exclusion if a decision upholding the exclusion is
rendered by the ALJ or DAB.  If the DAB finds in favor of WellCare, WellCare
shall be reinstated effective on the date of the original exclusion.

 
4.   Finality of Decision. The review by an ALJ or DAB provided for above shall
not be considered to be an appeal right arising under any statutes or
regulations.
 
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Consequently, the parties to this CIA agree that the DAB’s decision (or the
ALJ’s decision if not appealed) shall be considered final for all purposes under
this CIA.

XI.       Effective and Binding Agreement
 
WellCare and OIG agree as follows:

 
            A.      This CIA shall be binding on the successors, assigns, and
transferees of WellCare;
 
B.      This CIA shall become final and binding on the date the final signature
is obtained on the CIA;
 
            C.      This CIA constitutes the complete agreement between the
parties and may not be amended except by written consent of the parties to this
CIA;
 
            D.      OIG may agree to a suspension of WellCare’s obligations
under this CIA based on a certification by WellCare that it is no longer
providing health care items or services that will be billed to any Federal
health care program and that it does not have any ownership or control interest,
as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health
care program. If WellCare is relieved of its CIA obligations, WellCare will be
required to notify OIG in writing at least 30 days in advance if WellCare plans
to resume providing health care items or services that are billed to any Federal
health care program or to obtain an ownership or control interest in any entity
that bills any Federal health care program. At such time, OIG shall evaluate
whether the CIA will be reactivated or modified.
 
            E.      The undersigned WellCare signatories represent and warrant
that they are authorized to execute this CIA. The undersigned OIG signatory
represents that he is signing this CIA in his official capacity and that he is
authorized to execute this CIA.
 
            F.      This CIA may be executed in counterparts, each of which
constitutes an original and all of which constitute one and the same CIA.
Facsimiles of signatures shall constitute acceptable, binding signatures for
purposes of this CIA.

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On Behalf of WellCare

 

         /s/ Blair W. Todt    4/20/11  
Blair Todt  
Senior Vice President & Chief Compliance Officer
  DATE  

 
                                                                                    

 
On behalf of the Office of Inspector General
of the Department of Health and Human Services

 

 

         /s/ Gregory E. Demske    4/26/11  
GREGORY E. DEMSKE
Assistant Inspector General for Legal Affairs
Office of Inspector General
U. S. Department of Health and Human Services
  DATE  

 
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APPENDIX A

 
INDEPENDENT REVIEW ORGANIZATION

 
This Appendix contains the requirements relating to the Independent Review
Organization (IRO) required by Section III.D of the CIA.  WellCare may engage a
different IRO for each Review or engage the same IRO for all the Reviews
provided that the entity has the necessary expertise and capabilities to perform
the Reviews.

 
A.
IRO Engagement.

 
            WellCare shall engage an IRO that possesses the qualifications set
forth in Paragraph B, below, to perform the responsibilities in Paragraph C,
below.  The IRO shall conduct the Reviews in a professionally independent and
objective fashion, as set forth in Paragraph D.  Within 30 days after OIG
receives the information identified in Section V.A.8 and Section V.A.9 of the
CIA, OIG will notify WellCare if the IRO(s) is/are unacceptable. Absent
notification from OIG that the IRO(s) is/are unacceptable, WellCare may continue
to engage the IRO.

 

            If WellCare engages a new IRO during the term of the CIA, this IRO
shall also meet the requirements of this Appendix.  If a new IRO is engaged,
WellCare shall submit the information identified in Section V.A.8 and Section
V.A.9 of the CIA to OIG within 30 days of engagement of the IRO.  Within 30 days
after OIG receives this information, OIG will notify WellCare if the IRO is
unacceptable.  Absent notification from OIG that the IRO is unacceptable,
WellCare may continue to engage the IRO.
 
B.
IRO Qualifications.

 
The IRO shall:

 
                1.    assign individuals to conduct the Program Report Review,
Bid Submissions Systems Review, and Unallowable Cost Review engagements who have
expertise in the reimbursement involving managed care organizations and in the
general requirements of the State and Federal health care program(s) from which
WellCare seeks reimbursement;
           
             2.    assign individuals to design and select the Reviews who are
knowledgeable about appropriate reporting and bid submission processes and about
statistical sampling techniques; and
 
             3.     have sufficient staff and resources to conduct the Reviews
required by the CIA on a timely basis.
     
 
 

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C.        IRO Responsibilities.
 
The IRO shall:

 
            1.      perform each Review in accordance with the specific
requirements of the CIA;
 
            2.      follow all applicable Medicare, Medicaid, and Federal health
care program rules and reimbursement guidelines in making assessments in the
Reviews;
 
            3.     if in doubt of the application of a particular Medicare,
Medicaid, or other Federal health care program policy or regulation, request
clarification from the appropriate authority (e.g., fiscal intermediary or
carrier);
          
            4.      respond to all OIG inquires in a prompt, objective, and
factual manner; and
 
            5.      prepare timely, clear, well-written reports that include all
the information required by Appendix B to the CIA.

 
D.        IRO Independence and Objectivity.
 
The IRO must perform the Review(s) in a professionally independent and objective
fashion, as appropriate to the nature of the engagement, taking into account any
other business relationships or engagements that may exist between the IRO and
WellCare.

 
E.         IRO Removal/Termination.
 
            1.      Provider. If WellCare terminates its IRO during the course
of the engagement, WellCare must submit a notice explaining its reasons to OIG
no later than 30 days after termination.  WellCare must engage a new IRO in
accordance with Paragraph A of this Appendix.

 
            2.     OIG Removal of IRO. In the event OIG has reason to believe
that the IRO does not possess the qualifications described in Paragraph B, is
not independent and/or objective as set forth in Paragraph D, or has failed to
carry out its responsibilities as described in Paragraph C, OIG may, at its sole
discretion, require WellCare to engage a new IRO in accordance with Paragraph A
of this Appendix.
 
Prior to requiring WellCare to engage a new IRO, OIG shall notify WellCare of
its intent to do so and provide a written explanation of why OIG believes such a
step is necessary.  To resolve any concerns raised by OIG, WellCare may request
a meeting with OIG to discuss any aspect of the IRO’s qualifications,
independence or performance of its responsibilities and to present additional
information regarding these matters.  WellCare

Appendix A to Corporate Integrity Agreement
WellCare Health Plans, Inc.
 
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shall provide any additional information as may be requested by OIG under this
Paragraph in an expedited manner.  OIG will attempt in good faith to resolve any
differences regarding the IRO with WellCare prior to requiring WellCare to
terminate the IRO.  However, the final determination as to whether or not to
require WellCare to engage a new IRO shall be made at the sole discretion of
OIG.

Appendix A to Corporate Integrity Agreement
WellCare Health Plans, Inc.
 
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APPENDIX B
REIMBURSEMENT FUNCTIONS REVIEWS

I.      Reviews of Reimbursement Functions

 
                 As specified more fully below, WellCare shall retain an
Independent Review Organization (IRO) to perform the Reviews to assist WellCare
in assessing and evaluating its systems, processes, policies, procedures, and
practices related to WellCare’s Reimbursement Related Functions.  The Reviews
shall consist of: (1) a review of reports provided to Federal health care
programs (Program Report Review); (2) a review of WellCare’s bid submissions to
Federal health care programs (Bid Submissions Systems Review); and (3) if
applicable, a review to determine any unallowable costs (Unallowable Cost
Review).  WellCare may engage a different IRO for each Review or engage the same
IRO for all the Reviews provided that the entity has the necessary expertise and
capabilities to perform the Reviews.

 

A.     Program Report Review
 
           1.   Description of Program Report Review
 
  The Program Report Review shall be a review of reports that WellCare provides
to Medicaid, Medicare, and any Federal health care program.  Within 15 days
after the end of the Reporting Period, WellCare shall provide the OIG with a
complete list of reports that it submitted to Federal health care programs
during the previous Reporting Period.  The listed reports shall include, but are
not limited to: (a) program-mandated reports of cost and/or expenditures whether
or not the reports impact reimbursement from the federal or state program; (b)
bids to the federal or state program in response to requests for proposals; (c)
state Medicaid program special reports, such as the State of New York’s
“Medicaid Managed Care Operating Report”; (d) reports providing data that will
be used for Medicare and Medicaid rate-setting; (e) reports providing encounter
data detailing the services furnished to beneficiaries; and (f) reports
involving pharmacy claims and other data used in the final year-end
reconciliation for Plans under Medicare Part D. The OIG will select three
reports from the list for the Program Report Review.  The three reports will be
from different Plans and may involve different Federal health care programs.

 

           The IRO shall analyze the contents of each selected report and shall
gain an understanding of the process WellCare uses to generate the report.  The
engagement shall be designed to: (a) compare WellCare’s practices with best
practices among similarly situated entities in the industry; (b) determine the
accuracy and completeness of each report; and (c) produce findings and
recommendations aimed at improving WellCare’s reporting processes.  The specific
focus of the engagement shall be to document and recommend improvements to the
steps that WellCare takes to ensure that proper
 
Appendix B to Corporate Integrity Agreement
WellCare Health Plans, Inc.
 
 

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information is being recorded on such reports and that controls are reasonably
designed to ensure the accuracy and completeness of the information
provided.  In conducting the Program Report Review, the IRO may conduct
interviews and shall perform work that is necessary and appropriate including
the review of relevant policies and procedures and operational processes.  The
IRO shall present findings and recommendations on WellCare’s report preparation
policies, procedures, and processes for each selected report.

            If the report selected involves a program in which reimbursement
depends in part upon WellCare's reporting of costs and/or expenditures, the IRO
also shall analyze all costs reported to the Federal health care program as part
of the report, including, but not limited to, expenditures for medical versus
administrative services. The IRO also shall analyze any other data or
information used to support or substantiate WellCare's submission to that
program. The IRO's testing of costs and expenses shall demonstrate whether: (a)
the costs claimed accurately reflect services rendered or expenses incurred; (b)
the costs are supported by documentation; and (c) any money is owed to the
Federal health care program.

 
If the report selected involves a program in which reimbursement or rate-setting
depends in part upon WellCare’s submission of claims and/or encounter data, the
IRO shall review all claims and encounter data provided as part of the report to
ensure the accuracy and completeness of the information provided. The IRO’s
findings and recommendations shall include a determination of whether WellCare
reported claims and/or encounter data accurately and completely and whether the
information provided was supported by documentation.

 
2.  Program Report Review Report

 
            The IRO shall prepare a report based on the Program Report
Review.  For each of the reports reviewed, the Program Report Review Report
shall include the following items:
                         
a.
an analysis of the accuracy and completeness of the report;

b.
an analysis of internal controls that verify that proper information is
provided;

c.
a description of the documentation reviewed and any personnel interviewed;

d.
a detailed description of WellCare's systems, policies, processes, and
procedures related to the specified report, including a description of
WellCare’s control and accountability systems;

e.
a description of the manner in which the control and accountability systems and
written policies related to the specific report are made known or disseminated
within WellCare;

Appendix B to Corporate Integrity Agreement
WellCare Health Plans, Inc.
 
 

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f.
findings and supporting rationale regarding any weaknesses in WellCare's
systems, processes, policies, procedures, and practices;

g.
if applicable, findings of whether WellCare reported all costs and/or
expenditures accurately and completely, and whether money is owed to the Federal
health care program;

h.
if applicable, findings of whether WellCare reported claims and/or encounter
data accurately and completely;

i.
a summary of all conclusions based on the review; and

j.
recommendations to improve any of the systems, policies, processes, procedures,
or practices relating to the reviewed policies and procedures.

 
         B.   Bid Submissions Systems Review

 
1.   Description of Bid Submissions Systems Review

 
The Bid Submissions Systems Review shall be a review of bids and responses to
requests for proposals that WellCare provides to Medicaid, Medicare, and any
Federal health care program.  Within 15 days after the end of the Reporting
Period, WellCare shall provide the OIG with a complete list of bids or responses
to requests for proposals that it submitted to Federal health care programs
during the Reporting Period.  The OIG will select three bids from that list for
the Bid Submissions Systems Review.  The bids will be from different Plans.

 
The IRO shall analyze the contents of each selected bid and also shall gain an
understanding of WellCare's bid submission process.  The engagement shall be
designed to:  (a) assess the accuracy and completeness of the bids; (b) compare
WellCare's practices with best practices among similarly situated entities in
the industry; and (c) produce findings and recommendations aimed at improving
WellCare's bid submission processes.  The specific focus of the engagement shall
be to document and recommend improvements to the steps that WellCare takes to
ensure that proper information is being recorded on such submissions to the
Federal health care program and that controls are reasonably designed to ensure
the accuracy and completeness of the information provided.  The IRO may conduct
interviews, and shall review relevant policies and procedures and operational
processes, along with the pertinent requests for proposals and the bid
submissions under review.  The IRO shall present findings and recommendations on
WellCare’s bid submission preparation policies, procedures, and processes for
each selected report.

Appendix B to Corporate Integrity Agreement
WellCare Health Plans, Inc.
 
 

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2.   Bid Submissions Systems Review Report

 
The IRO shall prepare a report based on the Bid Submissions Systems Review.  For
each of the bids or responses to requests for proposals reviewed, the Bid
Submissions Systems Review Report shall include the following items:

 
a.
an analysis of the accuracy and completeness of the bid or response to requests
for proposals, including, but not limited to, a review of cost information
provided to justify proposed rates;

b.
an analysis of internal controls that verify that proper information is
provided;

c.
a description of the documentation reviewed and any personnel interviewed;

d.
a detailed description of WellCare’s systems, policies, processes, and
procedures related to the specified bid, including a description of WellCare’s
control and accountability systems;

e.
a description of the manner in which the control and accountability systems and
written policies related to the specific bid are made known or disseminated
within WellCare;

f.
findings and supporting rationale regarding any weaknesses in WellCare’s
systems, processes, policies, procedures, and practices;

g.
findings of whether the information that WellCare submitted with the bid is
accurate and complete;

h.
a summary of all conclusions based on the review; and

i.
recommendations to improve any of the systems, policies, processes, procedures,
or practices relating to the reviewed policies and procedures.

 
Appendix B to Corporate Integrity Agreement
WellCare Health Plans, Inc.