Exhibit 10.5

CORPORATE INTEGRITY AGREEMENT

BETWEEN THE

OFFICE OF INSPECTOR GENERAL

OF THE

DEPARTMENT OF HEALTH AND HUMAN SERVICES

AND

ODYSSEY HEALTHCARE SERVICES, INC.

I. PREAMBLE

Odyssey Healthcare, Inc. (Odyssey) 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,
Odyssey is entering into a Settlement Agreement with the United States.

Subsequent to the period relating to the Covered Conduct described in the
Settlement Agreement with the United States. Odyssey was acquired by Gentiva
Health Services, Inc. (Parent or Gentiva) and Odyssey, as a wholly owned
subsidiary of Gentiva, and Odyssey’s hospices are now operational and
organizational components of a single hospice division within Gentiva referred
to herein as Odyssey Hospice. Accordingly, although Odyssey is the party to the
Settlement Agreement with the United States and this CIA, and the party
responsible for ensuring implementation of the CIA, the undertakings of this CIA
will, for operational and organizational consistency purposes, relate to the
entirety of Odyssey Hospice even though neither Gentiva nor certain of the
hospice entities and hospices within Odyssey Hospice are alleged by the United
States to have engaged in the Covered Conduct described in the Settlement
Agreement with the United States.

Gentiva established a voluntary compliance program (“Compliance Program”) in
1994 to which Odyssey Hospice is now subject. The Compliance Program currently
includes, among other things, a Compliance Officer, a Code of Business Ethics
and Conduct, written policies and procedures, a disclosure program that allows
for the confidential disclosure and investigation of potential compliance
violations, screening measures for Ineligible Persons (as defined in Section
III.F.l.a below), regular compliance training to all employees, various
compliance auditing programs, and oversight from Gentiva’s Board of Directors.
Gentiva’s Compliance Program was and continues to be

 

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aimed at Gentiva’s goal of promoting the highest standards of professionalism,
ethics and integrity in the conduct of Gentiva’s and the Odyssey Hospice’s
business practices. Gentiva will continue to operate its Compliance Program
throughout the term of this CIA. Gentiva may modify its Compliance Program as
appropriate (subject to the terms of this CIA), but Odyssey Hospice shall ensure
that during the term of this CIA it complies with the obligations of Odyssey
Hospice set forth herein.

II. TERM AND SCOPE OF THE CIA

A. The period of the compliance obligations assumed by Odyssey Hospice under
this CIA shall be five years from the effective date of this CIA. The “Effective
Date” shall be the date on which the final signatory of this CIA executes this
CIA, unless otherwise specified. 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) Odyssey Hospice’s final annual report; or (2) any additional
materials submitted by Odyssey Hospice pursuant to OIG’s request, whichever is
later.

C. The scope of this CIA shall be governed by the following definitions:

1. “Odyssey Hospice” includes Odyssey and all hospices owned or operated by
Odyssey or Parent.

2. “Covered Persons” includes:

 

  a. all owners, officers, directors, and employees of Odyssey and Odyssey
Hospice;

 

  b.

all contractors, subcontractors, agents, Parent employees, and other persons
(including medical directors and associate medical directors) whose job
responsibilities involve, either directly or in a supervisory role, the
provision of patient care items or services or the performance of billing or
coding functions on behalf of Odyssey Hospice, excluding Parent’s financial
services unit employees whose responsibilities with respect to Odyssey Hospice
are limited to the ministerial tasks

 

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  of submitting and tracking claims and vendors whose sole connection with
Odyssey Hospice is selling or otherwise providing medical supplies or equipment
to Odyssey Hospice and who do not bill the Federal health care programs for such
medical supplies or equipment; and

 

  c. all Parent officers or employees whose job responsibilities involve,
directly or indirectly, the provision of legal, compliance, or audit services to
Odyssey Hospice.

Notwithstanding the above, this term does not include 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.

3. Relevant Covered Persons include:

 

  a. “Relevant Hospice Benefit Covered Persons” includes all Covered Persons
whose job responsibilities involve (either directly or in a supervisory role)
determining whether Odyssey Hospice patients meet the requirements for
continuous care services.

 

  b. “Relevant Hospice Marketing Covered Persons” includes all Covered Persons
whose job responsibilities involve (either directly or in a supervisory role)
marketing the hospice benefit, specifically including but not limited to those
marketing to physicians, hospitals, skilled nursing facilities, nursing
facilities, beneficiaries, beneficiary family members, and beneficiary
representatives.

4. “Continuous care services” means hospices services provided on a continuous
basis for as much as 24 hours a day during periods of crisis to maintain the
beneficiary at home, as defined at 42 C.F.R. § 418.204(a).

 

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III. CORPORATE INTEGRITY OBLIGATIONS

Parent has and shall maintain a Compliance Program. Odyssey Hospice shall
participate in and comply with Parent’s Compliance Program, which for Odyssey
Hospice shall, at a minimum, contain the following elements:

A. Compliance Officer and Committee

1. Compliance Officer. Odyssey Hospice has and shall maintain a Compliance
Officer for the term of the CIA. The 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 Compliance Officer shall be a member of
senior management of Parent, shall report directly to the President of Odyssey
Hospice, shall make periodic (at least quarterly) reports regarding compliance
matters directly to the Audit Committee of Parent’s Board of Directors (Board),
and shall be authorized to report on such matters to Parent’s Board Audit
Committee at any time. The Compliance Officer shall not be or be subordinate to
the General Counsel or Chief Financial Officer of Odyssey or Parent. The
Compliance Officer shall be responsible for monitoring the day-to-day compliance
activities engaged in by Odyssey Hospice as well as for any reporting
obligations created under this CIA. Any noncompliance job responsibilities of
the Compliance Officer shall be limited and must not interfere with the
Compliance Officer’s ability to perform the duties outlined in this CIA.

Odyssey Hospice shall report to OIG, in writing, any change in the identity of
the Compliance Officer, or any actions or changes that would affect the
Compliance Officer’s ability to perform the duties necessary to meet the
obligations in this CIA, within five days after such a change.

2. Compliance Committee. Odyssey Hospice has and shall maintain a Compliance
Committee. The Compliance Committee shall, at a minimum, include the 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 Compliance
Officer shall chair the Compliance Committee and the Committee shall support the
Compliance Officer in fulfilling his/her responsibilities (e.g., shall assist in
the analysis of Odyssey Hospice’s risk areas and shall oversee monitoring of
internal and external audits and investigations). The Compliance Committee shall
meet at least quarterly.

 

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

3. Board Audit Committee Compliance Obligations. Parent’s Board has appointed
and shall maintain an Audit Committee of the Board (the Board Audit Committee).
The Board Audit Committee shall be responsible for the review and oversight of
matters related to Odyssey Hospice’s compliance with Federal health care program
requirements and the obligations of this CIA.

The Board Audit Committee shall, at a minimum, be responsible for the following:

 

  a. meeting at least quarterly to review and oversee Parent’s Compliance
Program, including but not limited to the performance of the Compliance Officer
and Compliance Committee;

 

  b. ensuring that Odyssey Hospice adopts and implements policies, procedures,
and practices designed to ensure compliance with the requirements set forth in
this CIA and Federal health care program requirements; and

 

  c. for each Reporting Period of the CIA, adopting a resolution, signed by each
member of the Board Audit Committee summarizing its review and oversight of
Odyssey Hospice’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 Audit Committee has made a reasonable inquiry into the operations of
Parent’s Compliance Program including the performance of the Compliance Officer
and the Compliance Committee. Based on its inquiry and review, the Board Audit
Committee

 

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has concluded that, to the best of its knowledge, Parent has maintained an
effective Compliance Program to meet Federal health care program requirements
and Odyssey Hospice’s obligations of the CIA.”

If the Board is unable to provide such a conclusion in the resolution, the Board
shall include in the resolution a written explanation of the reasons why it is
unable to provide the conclusion and the steps it is taking to implement an
effective Compliance Program.

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

B. Written Standards

1. Code of Business Ethics and Conduct. Parent has and shall maintain for the
term of the CIA a written Code of Business Ethics and Conduct to which Odyssey
Hospice is subject. Odyssey Hospice shall make the promotion of, and adherence
to, the Code of Business Ethics and Conduct an element in evaluating the
performance of all employees. The Code of Business Ethics and Conduct shall, at
a minimum, set forth:

 

  a. Odyssey Hospice’s commitment to full compliance with all Federal health
care program requirements, including its commitment to prepare and submit
accurate claims consistent with such requirements;

 

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

 

  c.

the requirement that all Covered Persons shall be expected to report to the
Compliance Officer, or other appropriate individual designated by Odyssey
Hospice, suspected violations of any Federal health care program requirements or
of Parent’s own Policies and Procedures; and

 

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  d. the right of all individuals to use the Disclosure Program described in
Section III.E, and Odyssey Hospice’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 in electronic form, that he or she has received, read, understood,
and shall abide by Parent’s Code of Business Ethics and Conduct to which Odyssey
Hospice is subject. New Covered Persons shall receive the Code of Business
Ethics and 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.

Odyssey Hospice shall periodically review the Code of Business Ethics and
Conduct to determine if revisions are appropriate and shall recommend to Parent
any necessary revisions based on such review. If Parent rejects these
recommendations, Odyssey Hospice shall report its recommendations and the basis
for Parent’s rejection within 30 days after Parent rejects Odyssey Hospice’s
recommendations. Any revised Code of Business Ethics and Conduct shall be
distributed within 30 days after any revisions are finalized. Each Covered
Person shall certify, in writing, that he or she has received, read, understood,
and shall abide by the revised Code of Business Ethics and Conduct within 30
days after the distribution of the revised Code of Business Ethics and Conduct.

2. Policies and Procedures. Odyssey Hospice represents that its Parent has
implemented written Policies and Procedures regarding the operation of its
compliance program to which Odyssey Hospice is subject, including the compliance
program requirements outlined in this CIA and Odyssey Hospice’s compliance with
Federal health care program requirements. At a minimum, the Policies and
Procedures address and shall continue to address:

 

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

 

  b. the OIG’s Compliance Program Guidance for Hospice:

 

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  c. Federal health care program requirements relating to the coverage of
hospice services and the eligibility requirements for such coverage, including
requirements relating to the initial admission of patients, eligibility of
continued stay patients (i.e., patients who have received more than six
continuous months of hospice care), and eligibility for continuous care
services; and

 

  d. Federal health care program requirements relating to the documentation of
eligibility for hospice services and the services provided, and relating to the
preparation and submission of accurate claims for such services.

The Policies and Procedures are made available online and shall continue to be
made available online to all Covered Persons whose job functions relate to those
Policies and Procedures. Appropriate and knowledgeable staff shall be available
to explain the Policies and Procedures.

At least annually (and more frequently, if appropriate), Parent 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 whose job functions relate to those
Policies and Procedures.

C. Training and Education

1. General Training. Within 90 days after the Effective Date, Odyssey Hospice
shall provide at least two hours of General Training to each Covered Person.
This training, at a minimum, shall explain:

 

  a. Odyssey Hospice’s CIA requirements; and

 

  b. Parent’s Compliance Program to which Odyssey Hospice is subject, including
the Code of Business Ethics and Conduct.

Covered Persons who have received two hours of General Training no earlier than
60 days before the Effective Date shall be deemed to have met this requirement.
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.

 

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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.

2. Specific Training. Within 90 days after the Effective Date, each Relevant
Covered Person shall receive Specific Training in addition to the General
Training required above.

 

  a. Relevant Hospice Benefit Covered Persons shall receive three hours of
Specific Training that covers the following topics:

 

  i. the Federal health care program requirements regarding the hospice benefit,
including eligibility, certification, and recertification, with specific focus
on the requirements for continuous care services;

 

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

 

  iii. the personal obligation of each individual involved in the claims
submission process to ensure that such claims are accurate;

 

  iv. applicable reimbursement statutes, regulations, and program requirements
and directives;

 

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

 

  vi. examples of proper and improper claims submission practices.

After receiving the initial Specific Training described in this section, each
Relevant Hospice Benefit Covered Person shall receive at least two hours of
Specific Training, in addition to the General Training, in each subsequent
Reporting Period.

 

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  b. Relevant Hospice Marketing Covered Persons shall receive two hours of
Specific Training that covers the following topics:

 

  i. the Federal health care program requirements regarding the hospice benefit,
including eligibility, certification, and recertification, with specific focus
on the requirements for continuous care services;

 

  ii. applicable reimbursement statutes, regulations, and program requirements
and directives;

 

  iii. the requirements of Anti-Kickback Statute;

 

  iv. examples of violations of the Anti-Kickback Statute; and

 

  v. the legal sanctions for violations of the Federal health care program
requirements.

After receiving the initial Specific Training described in this section, each
Relevant Hospice Marketing Covered Person shall receive at least one hour of
Specific Training, in addition to the General Training, in each subsequent
Reporting Period.

 

  c. Relevant Covered Persons who have received the pertinent Specific Training
no earlier than 60 days before the Effective Date shall be deemed to have
satisfied this requirement. New Relevant Covered Persons shall receive Specific
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.

3. Board Member Training. Within 90 days after the Effective Date, Parent shall
provide at least two hours of training to each member of the Board of Directors,
in addition to the General Training. This training shall address the
responsibilities of board members and corporate governance.

 

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New members of the Board of Directors shall receive the Board Member Training
described above within 30 days after becoming a member or within 90 days after
the Effective Date, whichever is later.

4. Certification. Each individual who is required to attend training shall
certify, in writing or in electronic form, that he or she has received the
required training. The certification shall specify the type of training received
and the date received. The Compliance Officer (or designee) shall retain the
certifications, along with all course materials.

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

6. Update of Training. Odyssey Hospice 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
Eligibility Review, and any other relevant information.

7. Computer-based Training. Odyssey Hospice may provide the training required
under this CIA through appropriate computer-based training approaches. If
Odyssey Hospice chooses to provide computer-based training, it shall make
available appropriately qualified and knowledgeable staff or trainers to answer
questions or provide additional information to the individuals receiving such
training.

D. Review Procedures

1. Engagement of Independent Review Organization. Within 90 days after the
Effective Date, Odyssey Hospice shall engage an entity (or entities), such as an
accounting, auditing, or consulting firm (hereinafter “Independent Review
Organization” or “IRO”), to perform the Verification Reviews and the Unallowable
Cost Review listed in this Section III.D. The applicable requirements relating
to the IRO are outlined in Appendix A to this CIA, which is incorporated by
reference.

2. Eligibility Review. Odyssey Hospice’s Eligibility Review Team, composed of
individuals listed in Appendix B, shall review the eligibility of Odyssey
Hospice’s Medicare beneficiaries for the hospice services those Medicare
beneficiaries received and shall prepare an Eligibility Review Report, as
outlined in Appendix B to this CIA, which is incorporated by reference.

 

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3. Verification Review. The IRO shall perform a Verification Review of Odyssey
Hospice’s Eligibility Reviews and shall prepare a Verification Review Report, as
outlined in Appendix C to this CIA, which is incorporated by reference.

4. IRO Assumption of Eligibility Review. Following its review of any of Odyssey
Hospice’s Annual Reports, if, in its sole discretion, OIG determines that the
Eligibility Reviews performed by the Eligibility Review Team fail to conform
with the requirements of the CIA, OIG can require that future Eligibility
Reviews be conducted by the IRO.

5. Unallowable Cost Review. For the first Reporting Period, the IRO shall
conduct a review of Odyssey’s compliance with the unallowable cost provisions of
the Settlement Agreement. The IRO shall determine whether Odyssey 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 costs analysis shall include,
but not be limited to, payments sought in any cost reports, cost statements,
information reports, or payment requests already submitted by Odyssey or any
affiliates. To the extent that such cost reports, cost statements, 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.

6. Unallowable Cost Review Report. 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 Odyssey 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.

 

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7. Retention of Records. The IRO and Odyssey Hospice shall retain and make
available to OIG, upon request, all work papers, supporting documentation,
correspondence, and draft reports (those exchanged between the IRO and Odyssey
Hospice, and those exchanged between the Eligibility Review Team and any
individuals who are not on the Eligibility Review Team) related to the reviews.

8. Validation Review. In the event OIG has reason to believe that: (a) Odyssey
Hospice’s Eligibility Review, Verification Review, or Unallowable Cost Review
fails to conform to the requirements of this CIA; or (b) the Eligibility Review
Team’s or IRO’s findings or the Eligibility Review, Verification Review, or
Unallowable Cost Review results are inaccurate, OIG may, at its sole discretion,
conduct its own review to determine whether the Eligibility Review, Verification
Review, or Unallowable Cost Review complied with the requirements of the CIA
and/or the findings or Eligibility Review, Verification Review, or Unallowable
Cost Review results are inaccurate (Validation Review). Odyssey Hospice 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 the
Odyssey Hospice’s final Annual Report shall be initiated no later than one year
after Odyssey Hospice’s final submission (as described in Section II) is
received by OIG.

Prior to initiating a Validation Review, OIG shall notify Odyssey Hospice 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, Odyssey Hospice may
request a meeting with OIG to: (a) discuss the results of any Eligibility
Review, Verification Review, or Unallowable Cost Review submissions or findings;
(b) present any additional information to clarify the results of the Eligibility
Review, Verification Review, or Unallowable Cost Review or to correct the
inaccuracy of the Eligibility Review, Verification Review, or Unallowable Cost
Review; and/or (c) propose alternatives to the proposed Validation Review.
Odyssey Hospice agrees to provide any additional information as may be requested
by OIG under this Section III.D.8 in an expedited manner. OIG will attempt in
good faith to resolve any Eligibility Review, Verification Review, or
Unallowable Cost Review issues with Odyssey Hospice prior to conducting a
Validation Review. However, the final determination as to whether or not to
proceed with a Validation Review shall be made at the sole discretion of OIG.

 

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9. Independence and Objectivity Certification. The IRO shall include in its
report(s) to Odyssey Hospice a certification that the IRO has (a) evaluated its
professional independence and objectivity with respect to the reviews conducted
under this Section III.D and (b) concluded that it is, in fact, independent and
objective, in accordance with the requirements specified in Appendix A to this
CIA.

E. Disclosure Program

Prior to the Effective Date, Odyssey Hospice established and shall maintain for
the term of the CIA a Disclosure Program that includes a mechanism (e.g., a
toll-free compliance telephone line) to enable individuals to disclose, to the
Compliance Officer or some other person who is not in the disclosing
individual’s chain of command, any identified issues or questions associated
with Odyssey Hospice’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. Odyssey Hospice has and
shall continue to 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 Compliance Officer (or designee) shall gather all relevant information from
the disclosing individual. The 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, Odyssey Hospice shall
conduct an internal review of the allegations set forth in the disclosure and
ensure that proper follow-up is conducted.

The Compliance Officer (or designee) shall maintain a 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.

 

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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. Odyssey Hospice shall ensure that all prospective and
current Covered Persons are not Ineligible Persons, by implementing the
following screening requirements.

 

  a. Odyssey Hospice shall screen all prospective 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. Odyssey Hospice shall screen all Covered Persons against the Exclusion
Lists within 90 days after the Effective Date and on an annual basis thereafter.

 

  c. Odyssey Hospice 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 Section III.F affects Odyssey Hospice’s responsibility to refrain
from (and liability for) billing Federal health care programs for items or
services furnished, ordered, or prescribed by excluded persons. Odyssey Hospice
understands that items or services furnished by excluded persons are not payable
by Federal health care programs and that Odyssey Hospice may be liable for
overpayments and/or criminal, civil, and administrative sanctions for employing
or contracting with an excluded person regardless of whether Odyssey Hospice
meets the requirements of Section III.F.

3. Removal Requirement. If Odyssey Hospice has actual notice that a Covered
Person has become an Ineligible Person, Odyssey Hospice shall remove such
Covered Person from responsibility for, or involvement with, Odyssey Hospice’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 Odyssey Hospice 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, Odyssey
Hospice 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, Odyssey Hospice shall notify OIG, in writing, of
any ongoing investigation or legal proceeding known to Odyssey Hospice conducted
or brought by a governmental entity or its agents involving an allegation that
Odyssey Hospice 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. Odyssey Hospice 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 the amount of money Odyssey Hospice has received in excess of the amount
due and payable under any Federal health care program requirements.

2. Repayment of Overpayments

 

  a. If, at any time, Odyssey Hospice identifies or learns of any Overpayment,
Odyssey Hospice shall repay the Overpayment to the appropriate payor (e.g.,
Medicare fiscal intermediary or carrier) 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, Odyssey Hospice
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.

 

  b.

Notwithstanding the above, notification and repayment of any Overpayment amount
that routinely is reconciled or adjusted

 

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  pursuant to policies and procedures established by the payor should be handled
in accordance with such policies and procedures.

 

  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;

 

  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 Odyssey or Parent or any corporate
entity that owns or operates hospices within Odyssey Hospice.

A Reportable Event may be the result of an isolated event or a series of
occurrences.

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

3. Reportable Events under Section III.I. I .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;

 

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  b. a description of the steps taken by Odyssey Hospice 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;

 

  d. a description of Odyssey Hospice’s actions taken to correct the Reportable
Event; and

 

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

4. Reportable Events under Section III.I.1.b and 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 Odyssey Hospice’s actions taken to correct the Reportable
Event;

 

  c. any further steps Odyssey Hospice 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 Odyssey Hospice to identify and quantify the Overpayment.

5. Reportable Events under Section III.I.1.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.

 

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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 Odyssey Hospice 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.

IV. CHANGES TO BUSINESS UNITS OR LOCATIONS

A. Change or Closure of Unit or Location

In the event that, after the Effective Date, Odyssey Hospice changes locations
or closes a business unit or location related to the furnishing of items or
services that may be reimbursed by Federal health care programs, Odyssey Hospice
shall notify OIG of this fact as soon as 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, Odyssey Hospice purchases or
establishes a new business unit or location related to the furnishing of items
or services that may be reimbursed by Federal health care programs. Odyssey
Hospice shall notify OIG at least 30 days prior to such purchase or the
operation of the new business unit or location. This notification shall include
the address of the new business unit or location, phone number, fax number, the
location’s Medicare and state Medicaid program provider number and/or supplier
number(s); and the name and address of each Medicare and state Medicaid program
contractor to which Odyssey Hospice currently submits claims. 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.

 

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C. Sale of Unit or Location

In the event that, after the Effective Date, Odyssey Hospice proposes to sell
any or all of its business units or locations that are subject to this CIA,
Odyssey Hospice shall notify OIG of the proposed sale at least 30 days prior to
the sale of such business unit or location. 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 120 days after the Effective Date, Odyssey Hospice 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:

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

2. the names and positions of the members of the Compliance Committee required
by Section III.A;

3. a copy of Parent’s Code of Business Ethics and Conduct required by Section
III.B.1;

4. the number of individuals required to complete the Code of Business Ethics
and Conduct certification required by Section III.B.1, 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 all Policies and Procedures required by Section III.B (copies of
the Policies and Procedures shall be made available to OIG upon request):

 

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6. 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;

 

  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 made available to OIG upon request.

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

8. the following information regarding the IRO(s): (a) identity, address, and
phone number; (b) a copy of the engagement letter; (c) information to
demonstrate that the IRO has the qualifications outlined in Appendix A to this
CIA; (d) a summary and description of any and all current and prior engagements
and agreements between Odyssey Hospice or Parent and the IRO; and (e) a
certification from the IRO regarding its professional independence and
objectivity with respect to Odyssey Hospice and Parent;

9. a description of the process by which Odyssey Hospice fulfills the
requirements of Section III.F regarding Ineligible Persons;

10. a list of all of Odyssey Hospice’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);
and the name and address of each Medicare and state Medicaid program contractor
to which Odyssey Hospice currently submits claims;

11. a description of Odyssey Hospice’s corporate structure, including
identification of any parent and sister companies, subsidiaries, and their
respective lines of business; and

 

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12. the certifications required by Section V.C.

B. Annual Reports

Odyssey Hospice shall submit to OIG annually a report with respect to the status
of, and findings regarding, Odyssey Hospice’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 Compliance Officer and any change in the membership of
the Compliance Committee described in Section III.A;

2. the Board Audit Committee resolution required by Section III.A.3;

3. a summary of any changes or amendments to Parent’s Code of Business Ethics
and Conduct required by Section III.B.1 and the reason for such changes, along
with a copy of the revised Code of Business Ethics and Conduct;

4. the number of individuals required to complete the Code of Business Ethics
and Conduct certification required by Section III.B.1, the percentage of
individuals who have completed such certification, and an explanation of any
exceptions (the documentation supporting this information shall be made
available to OIG upon request);

5. a summary of any significant changes or amendments to the Policies and
Procedures required by Section III.B and the reasons for such changes (e.g.,
change in contractor 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;

 

  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.

 

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A copy of all training materials and the documentation to support this
information shall be made 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. Odyssey Hospice’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;

9. a summary and description of any and all current and prior engagements and
agreements between Odyssey Hospice or Parent 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 Odyssey Hospice and Parent;

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

12. a report of the aggregate Overpayments that have been returned to the
Federal health care programs. Overpayment amounts shall be broken down into the
following categories: inpatient Medicare, outpatient Medicare, 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;

13. a summary of the disclosures in the disclosure log required by Section III.E
that relate to Federal health care programs (the complete disclosure log shall
be made available to OIG upon request);

 

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14. any changes to the process by which Odyssey Hospice fulfills the
requirements of Section III.F regarding Ineligible Persons;

15. 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;

16. a description of all changes to the most recently provided list of Odyssey
Hospice’s locations (including addresses) as required by Section V.A. 10; 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(s) and/or supplier number(s); and the name and
address of each Medicare and state Medicaid program contractor to which Odyssey
Hospice currently submits claims; and

17. 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 Implementation Report and each Annual Report shall include a certification
by the Compliance Officer that:

1. to the best of his or her knowledge, except as otherwise described in the
report, Odyssey Hospice is in compliance with all of the requirements of this
CIA;

2. 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

3. to the best of his or her knowledge, Odyssey Hospice has complied with its
obligations under the Settlement Agreement: (a) not to resubmit to any Federal
health care program payors any previously denied claims related to the Covered
Conduct

 

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addressed in the Settlement Agreement, and not to appeal any such denials of
claims; (b) not to charge to or otherwise seek payment from federal or state
payors for unallowable costs (as defined in the Settlement Agreement); and
(c) to identify and adjust any past charges or claims for unallowable costs.

D. Designation of Information

Odyssey Hospice 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
under the Freedom of Information Act (FOIA), 5 U.S.C. § 552. Odyssey Hospice
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

 

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Odyssey and Odyssey Hospice:

 

Patrick Cunningham

Vice President Hospice Compliance

Gentiva® Health Services

3350 Riverwood Parkway, Suite 1400

Atlanta, GA 30339

Telephone: 770-951-6489

Facsimile: 913-814-4388

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, Odyssey Hospice 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), 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. OIG or its duly authorized representative(s) may examine or request
copies of Odyssey Hospice’s books, records, and other documents and supporting
materials and/or conduct on-site reviews of any of Odyssey Hospice’s locations
for the purpose of verifying and evaluating: (a) Odyssey Hospice’s compliance
with the terms of this CIA; and (b) Odyssey Hospice’s compliance with the
requirements of the Federal health care programs. The documentation described
above shall be made available by Odyssey Hospice 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 Odyssey Hospice’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. Odyssey Hospice shall
assist OIG or its duly authorized representative(s) in contacting and arranging
interviews with such individuals upon OIG’s request. Odyssey Hospice’s employees
may elect to be interviewed with or without a representative of Odyssey Hospice
present.

 

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VIII. DOCUMENT AND RECORD RETENTION

Odyssey Hospice 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.

I . DISCLOSURES

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

BREACH AND DEFAULT PROVISIONS

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

A. Stipulated Penalties for Failure to Comply with Certain Obligations

As a contractual remedy, Odyssey Hospice 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 Odyssey Hospice fails to
establish and implement any of the following obligations as described in Section
III:

 

  a. a Compliance Officer;

  b. a Compliance Committee;

  c. the Board Audit Committee compliance obligations;

 

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  d. a written Code of Business Ethics and Conduct;

 

  e. written Policies and Procedures;

 

  f. the training of Covered Persons, Relevant Covered Persons, and Board
Members;

 

  g. a Disclosure Program;

 

  h. Ineligible Persons screening and removal requirements;

 

  i. notification of Government investigations or legal proceedings; and

 

  j. reporting of Reportable Events.

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 Odyssey Hospice fails to engage
and use an IRO, as required in Section III.D, Appendix A, Appendix C, and
Appendix B if applicable under Section III.D.4.

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 Odyssey Hospice 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 Odyssey Hospice fails to submit
any Eligibility Review Report, Verification Review Report, or Unallowable Cost
Review Report in accordance with the requirements of Section III.D, Appendix B,
and Appendix C.

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

 

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6. A Stipulated Penalty of $5,000 for each false certification submitted by or
on behalf of Odyssey Hospice 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 Odyssey Hospice fails to comply
fully and adequately with any obligation of this CIA. OIG shall provide notice
to Odyssey Hospice stating the specific grounds for its determination that
Odyssey Hospice has failed to comply fully and adequately with the CIA
obligation(s) at issue and steps Odyssey Hospice shall take to comply with the
CIA. (This Stipulated Penalty shall begin to accrue 10 days after Odyssey
Hospice 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

Odyssey Hospice 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 Odyssey
Hospice fails to meet the revised deadline set by OIG. Notwithstanding any other
provision in this Section, if OIG denies 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 Odyssey Hospice
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 Odyssey Hospice 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 Odyssey Hospice of:
(a) Odyssey Hospice’s failure to comply; and (b) OIG’s exercise of its
contractual right to demand payment of the Stipulated Penalties. (This
notification shall be referred to as the “Demand Letter.”)

 

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2. Response to Demand Letter. Within 10 days after the receipt of the Demand
Letter, Odyssey Hospice 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 Odyssey Hospice elects to request an ALJ hearing, the
Stipulated Penalties shall continue to accrue until Odyssey Hospice 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.c, these provisions for payment of Stipulated Penalties shall not
affect or otherwise set a standard for OIG’s decision that Odyssey Hospice 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:

 

  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 Odyssey Hospice to report a Reportable Event, take corrective
action, and make the appropriate refunds, as required in Section III.I;

 

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

 

  d. a failure to engage and use an IRO in accordance with Section III.D,
Appendix A, Appendix C, and Appendix B if applicable under Section III.D.4.

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

3. Opportunity to Cure. Odyssey Hospice 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. Odyssey Hospice 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) Odyssey Hospice has begun to take action to cure the material breach;
(ii) Odyssey Hospice is pursuing such action with due diligence; and
(iii) Odyssey Hospice has provided to OIG a reasonable timetable for curing the
material breach.

4. Exclusion Letter. If, at the conclusion of the 30 day period, Odyssey Hospice
fails to satisfy the requirements of Section X.D.3, OIG may exclude Odyssey
Hospice from participation in the Federal health care programs. OIG shall notify
Odyssey Hospice in writing of its determination to exclude Odyssey Hospice.
(This letter shall be

 

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referred to 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 Odyssey Hospice’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, Odyssey Hospice 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 Odyssey Hospice 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, Odyssey Hospice 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 Odyssey Hospice was in full and timely compliance with the
obligations of this CIA for which OIG demands payment; and (b) the period of
noncompliance. Odyssey Hospice shall have the burden of proving Odyssey
Hospice’s 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 Odyssey Hospice to
pay Stipulated Penalties, such Stipulated Penalties shall become due and payable
20 days after the ALJ issues such a decision unless Odyssey Hospice 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 DAB issues its
decision.

 

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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 Odyssey Hospice 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) Odyssey Hospice had begun to take action to cure
the material breach within that period; (ii) Odyssey Hospice has pursued and is
pursuing such action with due diligence; and (iii) Odyssey Hospice provided to
OIG within that period a reasonable timetable for curing the material breach and
Odyssey Hospice 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 Odyssey Hospice, only
after a DAB decision in favor of OIG. Odyssey Hospice’s election of its
contractual right to appeal to the DAB shall not abrogate OIG’s authority to
exclude Odyssey Hospice 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 Odyssey Hospice 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.
Odyssey Hospice 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 Odyssey Hospice, Odyssey Hospice 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. 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.

 

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I. EFFECTIVE AND BINDING AGREEMENT

Odyssey, Odyssey Hospice, and OIG agree as follows:

A. This CIA shall be binding on the successors, assigns, and transferees of
Odyssey Hospice.

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 Odyssey Hospice’s obligations under this CIA
based on a certification by Odyssey Hospice 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 Odyssey Hospice is relieved of its CIA obligations, Odyssey Hospice will be
required to notify OIG in writing at least 30 days in advance if Odyssey Hospice
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 Odyssey and Odyssey Hospice 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 THE OFFICE OF INSPECTOR GENERAL

OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

/s/ Gregory E. Demske       2/13/12 GREGORY E. DEMSKE       DATE

Assistant Inspector General for Legal Affairs

Office of Inspector General

U. S. Department of Health and Human Services

     

 

/s/ Laura E. Ellis       2-9-12 LAURA E. ELLIS       DATE

Senior Counsel

Office of Inspector General

U. S. Department of Health and Human Services

     

 

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ON BEHALF OF ODYSSEY HEATHCARE, INC. AND ODYSSEY HOSPICE

 

/s/ John Camperlengo       2/6/12 JOHN CAMPERLENGO       DATE

General Counsel

Odyssey Healthcare, Inc.

     

 

/s/ Gary W. Eiland       2-7-12 GARY W. EILAND (as to form only)       DATE

King & Spalding, LLP

Counsel to Odyssey Healthcare, Inc.

     

 

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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.

A. IRO Engagement

1. Odyssey Hospice 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 review 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 of the CIA or any
additional information submitted by Odyssey Hospice in response to a request by
OIG, whichever is later, OIG will notify Odyssey Hospice if the IRO is
unacceptable. Absent notification from OIG that the IRO is unacceptable, Odyssey
Hospice may continue to engage the IRO.

2. If Odyssey Hospice 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,
Odyssey Hospice shall submit the information identified in Section V.A.8 of the
CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG
receives this information or any additional information submitted by Odyssey
Hospice at the request of OIG, whichever is later, OIG will notify Odyssey
Hospice if the IRO is unacceptable. Absent notification from OIG that the IRO is
unacceptable, Odyssey Hospice may continue to engage the IRO.

B. IRO Qualifications

The IRO shall:

1. assign individuals to conduct the Verification Review, the Eligibility Review
if required by OIG under Section III.D.4 of the CIA, and the Unallowable Cost
Review who have expertise in the clinical, billing, and other standards and
requirements of the hospice industry and Federal health care programs hospice
eligibility requirements;

2. assign individuals to design and select the Verification Review, and the
Eligibility Review, if applicable, sample who are knowledgeable about the
appropriate statistical sampling techniques;

3. assign individuals to conduct the Verification Review, and the Eligibility
Review, if applicable, of patient records who are licensed registered nurses or
physicians (“Eligibility Reviewers”) with demonstrated hospice experience or
expertise; and

 

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4. have sufficient staff and resources to conduct the reviews required by the
CIA on a timely basis.

C. IRO Responsibilities

The IRO shall:

1. perform each Verification Review. Eligibility Review, if applicable, and
Unallowable Cost Review in accordance with the specific requirements of the CIA;

2. follow all applicable Medicare rules and applicable hospice eligibility
guidance in making assessments in the Verification Review, or Eligibility Review
if applicable;

3. if in doubt of the application of a particular Medicare 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 Verification Review, and the Eligibility Review, if
applicable, in a professionally independent and objective fashion, as defined in
the Government Auditing Standards (July 2007 Revision) issued by the United
States Government Accountability Office.

E. IRO Removal/Termination

1. Provider and IRO. If Odyssey Hospice terminates its IRO or if the IRO
withdraws from the engagement during the term of the CIA, Odyssey Hospice must
submit a notice explaining its reasons for termination or the reason for
withdrawal to OIG no later than 30 days after termination or withdrawal. Odyssey
Hospice must engage a new IRO in accordance with Paragraph A of this Appendix
and within 60 days of termination or withdrawal of the prior IRO or at least 60
days prior to the end of the current Reporting Period, whichever is earlier.

 

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2. OIG Removal of IRO. In the event OIG has reason to believe the IRO does not
possess the qualifications described in Paragraph B, is not independent and
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 Odyssey Hospice to engage a new IRO in accordance with Paragraph A of
this Appendix. Odyssey Hospice must engage a new IRO within 60 days of
termination of the prior IRO or at least 60 days prior to the end of the current
Reporting Period, whichever is earlier.

Prior to requiring Odyssey Hospice to engage a new IRO, OIG shall notify Odyssey
Hospice 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,
Odyssey Hospice may present additional information regarding the IRO’s
qualifications, independence or performance of its responsibilities. OIG will
attempt in good faith to resolve any differences regarding the IRO with Odyssey
Hospice prior to requiring Odyssey Hospice to terminate the IRO. However, the
final determination as to whether or not to require Odyssey Hospice to engage a
new IRO shall be made at the sole discretion of OIG.

 

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APPENDIX B

ELIGIBILITY REVIEW

A. Eligibility Review. The Eligibility Review Team shall perform the Eligibility
Review annually to cover each of the five Reporting Periods. Subject to the IRO
Verification Review and Section III.D.4 of the CIA, as applicable, the
Eligibility Review Team shall perform all components of each Eligibility Review.

1. Definitions. For the purposes of the Eligibility Review, the following
definitions shall be used:

 

  a. Eligibility Review Team: A team of internal auditors within Odyssey Hospice
consisting of the Compliance Officer, the internal review team of Odyssey
Hospice, and an outside consultant.

 

  i. The Eligibility Review team members who review the patient records and the
outside consultant shall be licensed registered nurses or physicians with
demonstrated hospice experience, or expertise.

 

  ii. The Eligibility Review Team shall assign individuals to design and select
the Eligibility Review sample who are knowledgeable about the appropriate
statistical sampling techniques.

 

  b. Overpayment: The amount of money Odyssey Hospice has received in excess of
the amount due and payable under any Federal health care program requirements.

 

  c. Patient: A Medicare patient for whom Odyssey Hospice submitted a claim.

 

  d. Paid Claim: A claim submitted by Odyssey Hospice and for which Odyssey
Hospice has received reimbursement from the Medicare program.

 

  e. Population: The Population shall be defined as all Paid Claims during the
12-month period covered by the Eligibility Review.

 

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  f. Error Rate: The Error Rate shall be the percentage of net Overpayments
identified in the sample. The net Overpayments shall be calculated by
subtracting all under payments identified in the sample from all gross
Overpayments identified in the sample.

2. Discovery Sample. The Eligibility Review Team shall randomly select two
hospices from each region within Odyssey Hospice for a total of 10 hospices. The
Eligibility Review Team shall randomly select and review a sample of 50 Paid
Claims from each hospice paid during the 12-month period covered by the
Eligibility Review (Discovery Sample). The Paid Claims shall be reviewed based
on the supporting documentation available at Odyssey Hospice’s office or under
Odyssey Hospice’s control, including the Patient’s medical record, and
eligibility criteria regulations and guidance, to determine whether a
certification was made for the period in which the claim was filed that the
Patient had a terminal diagnosis and whether the evidence in the medical record
supports the terminal diagnosis. If the Paid Claim includes continuous care
services, the Eligibility Review Team shall determine whether evidence in the
record supports a determination that the Patient was eligible for continuous
care services. For any Paid Claim in which the Eligibility Review Team
determines that no certification was made, that the evidence in the record does
not support the terminal diagnosis, or that the evidence in the record does not
support a determination that the Patient was eligible for continuous care
services, the Eligibility Review Team shall review all prior and subsequent
claims for the Patient to determine whether a certification was made that the
Patient had a terminal diagnosis, whether the evidence in the record supports
the terminal diagnosis, and whether the evidence in the record supports
eligibility for continuous care services if Odyssey Hospice submitted any claim
for continuous care services.

If the Error Rate (as defined above) for a Discovery Sample is less than 5%, no
additional sampling is required, nor is a Systems Review required. (Note: The
guidelines listed above do not imply that this is an acceptable error rate.
Accordingly, Odyssey Hospice should, as appropriate, further analyze any errors
identified in the Discovery Samples. Odyssey Hospice recognizes that OIG or
other HHS component, in its discretion and as authorized by statute, regulation,
or other appropriate authority may also analyze or review Paid Claims included,
or errors identified, in a Discovery Sample or any other segment of the
universe.)

3. Full Sample. If a Discovery Sample for a hospice indicates that the Error
Rate is 5% or greater, the Eligibility Review Team shall select an additional
sample of Paid Claims (Full Sample) from that hospice using commonly accepted
sampling methods. The Full Sample shall be designed to: (1) estimate the actual
Overpayment in the population with a 90% confidence level and with a maximum
relative precision of 25% of the point estimate; and (2) conform with the
Centers for Medicare and Medicaid Services’ statistical sampling for overpayment
estimation guidelines. The Eligibility

 

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Review Team shall perform the same review for the Paid Claims selected for the
Full Sample as it performed for the Discovery Sample. For purposes of
calculating the size of the Full Sample, the Discovery Sample may serve as the
probe sample, if statistically appropriate. Additionally, the Eligibility Review
Team may use the Paid Claims sampled as part of the Discovery Sample, and the
corresponding findings for those Paid Claims, as part of its Full Sample, if:
(1) statistically appropriate and (2) the Eligibility Review Team selects the
Full Sample Paid Claims using the seed number generated by the Discovery Sample.
OIG, in its sole discretion, may refer the findings of the Full Sample (and any
related workpapers) received from Odyssey Hospice to the appropriate Federal
health care program payor, including the Medicare contractor (e.g., carrier,
fiscal intermediary, or DMERC), for appropriate follow-up by that payor.

4. Systems Review. If a Discovery Sample identifies an Error Rate of 5% or
greater, the Eligibility Review Team shall also conduct a Systems Review. For
each claim in the Discovery Sample that triggered the Systems Review, the
Eligibility Review Team shall perform a “walk through” of the system(s) and
proccss(es) used to determine eligibility to identify any problems or weaknesses
that may have resulted in the identified Overpayments. The Eligibility Review
Team shall provide its observations and recommendations on suggested
improvements to the system(s) and the process(es) used to determine eligibility.

5. Other Requirements

 

  a. Supplemental Materials. The Eligibility Review Team shall request all
documentation and materials required for its review of the Paid Claims selected
as part of the Discovery Sample or Full Sample (if applicable), and Odyssey
Hospice shall furnish such documentation and materials to the Eligibility Review
Team prior to the Eligibility Review Team initiating its review of the Discovery
Sample or Full Sample (if applicable). If the Eligibility Review Team accepts
any supplemental documentation or materials from Odyssey Hospice after the
Eligibility Review Team has completed its initial review of the Discovery Sample
or Full Sample (if applicable) (Supplemental Materials), the Eligibility Review
Team shall identify in the Claims Review Report the Supplemental Materials, the
date the Supplemental Materials were accepted, and the relative weight the
Eligibility Review Team gave to the Supplemental Materials in its review. In
addition, the Eligibility Review Team shall include a narrative in the
Eligibility Review Report describing the process by which the Supplemental
Materials were accepted and the Eligibility Review Team’s reasons for accepting
the Supplemental Materials.

 

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  b. Paid Claims without Supporting Documentation. Any Paid Claim for which
Odyssey Hospice cannot produce documentation sufficient to support the Paid
Claim shall be considered an error and the total reimbursement received by
Odyssey Hospice for such Paid Claim shall be deemed an Overpayment. Replacement
sampling for Paid Claims with missing documentation is not permitted.

 

  c. Use of First Samples Drawn. For the purposes of all samples (Discovery
Sample(s) and Full Sample(s)) discussed in this Appendix, the Paid Claims
selected in each first sample shall be used (i.e., it is not permissible to
generate more than one list of random samples and then select one for use with
the Discovery Sample or Full Sample).

6. Repayment of Identified Overpayments. Odyssey Hospice shall repay within 30
days any Overpayment(s) identified in the Discovery Sample or the Full Sample
(if applicable), regardless of the Error Rate, to the appropriate payor and in
accordance with payor refund policies. Odyssey Hospice shall make available to
OIG all documentation that reflects the refund of the Overpayment(s) to the
payor.

B. Eligibility Review Report. The Eligibility Review Team shall prepare an
Eligibility Review Report as described in this Appendix for each Eligibility
Review performed. The following information shall be included in the Eligibility
Review Report for each Discovery Sample and Full Sample (if applicable).

 

  1. Eligibility Review Methodology

 

  a. Eligibility Review Population. A description of the Population subject to
the Claims Review.

 

  b. Eligibility Review Objective. A clear statement of the objective intended
to be achieved by the Eligibility Review.

 

  c.

Source of Data. A description of the specific documentation relied upon by the
Eligibility Review Team when performing the Eligibility Review (e.g., medical
records, physician orders, certificates of medical necessity, requisition forms,
local medical review policies (including title and policy number), CMS program
memoranda (including title and

 

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  issuance number), Medicare carrier or intermediary manual or bulletins
(including issue and date), other policies, regulations, or directives).

 

  d. Review Protocol. A narrative description of how the Eligibility Review was
conducted and what was evaluated.

 

  e. Supplemental Materials. A description of any Supplemental Materials as
required by A.5.a., above.

 

  2. Statistical Sampling Documentation

 

  a. A copy of the printout of the random numbers generated by the “Random
Numbers” function of the statistical sampling software used by the Eligibility
Review Team.

 

  b. A copy of the statistical software printout(s) estimating how many Paid
Claims are to be included in the Full Sample, if applicable.

 

  c. A description or identification of the statistical sampling software
package used to select the sample and determine the Full Sample size, if
applicable.

 

  3. Eligibility Review Findings

 

  a. Narrative Results

i. A description of Odyssey Hospice’s eligibility- determination system(s),
including the identification, by position description, of the personnel involved
in eligibility decisions and including any regional or hospice-level systems,
policies, or procedures that differ from Odyssey Hospice’s corporate systems,
policies, and procedures.

ii. A narrative explanation of the Eligibility Review Team’s findings and
supporting rationale (including reasons for errors, patterns noted, etc.)
regarding the Eligibility Review, including the results of the Discovery Sample,
and the results of the Full Sample (if any).

 

  b. Quantitative Results

 

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i. Total number and percentage of instances in which the Eligibility Review Team
determined that the Paid Claims submitted by Odyssey Hospice (Claim Submitted)
differed from what should have been the correct claim (Correct Claim),
regardless of the effect on the payment.

ii. Total number and percentage of instances in which the Claim Submitted
differed from the Correct Claim and in which such difference resulted in an
Overpayment to Odyssey Hospice.

iii. Total dollar amount of all Overpayments in the sample.

iv. Total dollar amount of Paid Claims included in the sample and the net
Overpayment associated with the sample.

v. Error Rate in the sample.

vi. A spreadsheet of the Eligibility Review results that includes the following
information for each Paid Claim: Federal health care program billed, beneficiary
health insurance claim number, date(s) of service, the correct allowed amount
(as determined by the Eligibility Review Team), and the dollar difference
between allowed amount reimbursed by payor and the correct allowed amount.

 

  c. Recommendations. The Eligibility Review Team’s report shall include any
recommendations for improvements to Odyssey Hospice’s eligibility-determination
system based on the findings of the Eligibility Review.

4. Systems Review Findings. The Eligibility Review Team shall prepare a Systems
Review Report based on the Systems Review performed (if applicable) that shall
include the Eligibility Review Team’s observations, findings, and
recommendations regarding suggested improvements to the system(s) and the
process(es) used to determine eligibility.

5. Credentials. The names and credentials of the individuals who: (1) designed
the statistical sampling procedures and the review methodology utilized for the
Eligibility Review and (2) performed the Eligibility Review.

 

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APPENDIX C

VERIFICATION REVIEW

A. Eligibility Review. The IRO shall perform the Verification Review annually to
cover each of the five Reporting Periods. The IRO shall perform all components
of each Verification Review.

1. Definitions. For the purposes of the Verification Review, the definitions in
Section A.1 of Appendix B of the CIA shall be used.

2. Discovery Sample.

 

  a. The IRO shall randomly select 50 Paid Claims from the 500 Paid Claims
selected by the Eligibility Review Team in the Discovery Samples. The IRO shall
review the Paid Claims selected by the Eligibility Review Team. The Paid Claims
shall be reviewed based on the documentation and materials gathered by the
Eligibility Review Team, supplemented as necessary as described in Sections
A.4.b and A.4.c below, to determine whether a certification was made for the
period in which the claim was filed that the Patient had a terminal diagnosis
and whether the evidence in the medical record supports the terminal diagnosis.
If the Paid Claim includes continuous care services, the IRO shall determine
whether evidence in the record supports a determination that the Patient was
eligible for continuous care services.

 

  b. For any Paid Claim in which the Eligibility Review Team determined that no
certification was made, that the evidence in the record does not support the
terminal diagnosis, or that the evidence in the record does not support a
determination that the Patient was eligible for continuous care services, the
IRO shall review all prior and subsequent Patient claims in the Reporting Period
to determine whether a certification was made that the Patient had a terminal
diagnosis, whether the evidence in the record supports the terminal diagnosis,
and whether the evidence in the record supports eligibility for continuous care
services if Odyssey Hospice submitted any claim for continuous care services,
using the documentation and materials gathered by the Eligibility Review Team,
supplemented as necessary as described in Sections A.4.b and A.4.c below.

 

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  c. For any Paid Claim for which the IRO disagrees with the Eligibility Team
determination that a certification was made for the period in which the claim
was filed that the Patient had a terminal diagnosis, that the evidence in the
medical record supports a terminal diagnosis, or, if applicable, that the
evidence in the record supports a determination that the Patient was eligible
for continuous care services, the IRO shall review all prior and subsequent
Patient claims in the Reporting Period to determine whether a certification was
made that the Patient had a terminal diagnosis, whether the evidence in the
record supports the terminal diagnosis, and whether the evidence in the record
supports eligibility for continuous care services if Odyssey Hospice submitted
any claim for continuous care services.

3. Full Sample. If the Eligibility Review Team performs a Full Sample, the IRO
shall randomly select 10 percent of the Paid Claims comprising the Full Sample.
The IRO shall perform the same review for the Paid Claims selected for the Full
Sample as it performed for the Discovery Sample. The IRO may use the Paid Claims
sampled as part of the Discovery Sample, and the corresponding findings for
those Paid Claims, as part of its Full Sample, if: (1) statistically appropriate
and (2) the Eligibility Review Team selected the Full Sample Paid Claims using
the seed number generated by the Discovery Sample.

4. Other Requirements

 

  a. Verification Review Materials. The Eligibility Review Team shall provide
all documents and materials used in its review of the Discovery Sample and, if
applicable, the Full Sample, prior to the IRO initiating its review. For any
prior and subsequent Patient claims reviewed under Section A.2.c above, the IRO
shall request all documentation and materials required for its review of the
claims and Odyssey Hospice shall furnish such documentation and materials to the
IRO prior to the IRO initiating that portion of its review.

 

  b.

Supplemental Record Documentation. If the IRO requests or accepts any
supplemental documentation from Odyssey Hospice or the Eligibility Review Team
(Supplemental Record Documentation), the IRO shall identify in the Verification
Review Report the Supplemental Record Documentation, the date the Supplemental
Record

 

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  Documentation was requested or accepted, and the relative weight the IRO gave
to the Supplemental Record Documentation in its review. In addition, the IRO
shall include a narrative in the Verification Review Report describing the
process by which the Supplemental Record Documentation was requested or accepted
and the IRO’s reasons for requesting or accepting the Supplemental
Documentation.

 

  c. Supplemental Verification Materials. If the IRO relies on any materials
that the Eligibility Review Team did not use in its Eligibility Review
(Supplemental Verification Materials), the IRO shall identify the Supplemental
Verification Materials (e.g., local medical review policies (including title and
policy number), CMS program memoranda (including title and issuance number),
Medicare carrier or intermediary manual or bulletins (including issue and date),
other policies, regulations, or directives) and the IRO’s reasons for using the
Supplemental Verification Materials.

 

  d. Paid Claims without Supporting Documentation. Any Paid Claim for which
Odyssey Hospice cannot produce documentation sufficient to support the Paid
Claim shall be considered an error and the total reimbursement received by
Odyssey Hospice for such Paid Claim shall be deemed an Overpayment.

5. Repayment of Identified Overpayments. Odyssey Hospice shall repay within 30
days any Overpayment(s) identified by the IRO in the Discovery Sample or the
Full Sample (if applicable), regardless of the Error Rate, to the appropriate
payor and in accordance with payor refund policies. Odyssey Hospice shall make
available to OIG all documentation that reflects the refund of the
Overpayment(s) to the payor.

B. Verification Review Report. The IRO shall prepare a Verification Review
Report as described in this Appendix for each Verification Review performed. The
following information shall be included in the Verification Review Report for
each Discovery Sample and Full Sample (if applicable).

1. Verification Review Methodology

 

  a. Verification Review Population. A description of the Population subject to
the Claims Review.

 

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  b. Verification Review Objective. A clear statement of the objective intended
to be achieved by the Verification Review.

 

  c. Source of Data. A description of the Verification Review Materials that the
Eligibility Review Team, and, for claims reviewed under Section A.2.c above,
Odyssey Hospice, provided.

 

  d. Review Protocol. A narrative description of how the Eligibility Review was
conducted and what was evaluated.

 

  e. Supplemental Materials. A description of any Supplemental Record
Documentation and Supplemental Verification Materials as required by Sections
A.4.b and A.4.c, above.

 

  2. Eligibility Review Findings

 

  a. Narrative Results

i. A narrative explanation of the IRO’s findings and supporting rationale
(including reasons for errors, patterns noted, etc.) regarding the Verification
Review, including the results of the Discovery Sample, and the results of the
Full Sample (if any).

ii. A narrative description of the differences, if any, between the Eligibility
Review Team’s and the IRO’s findings and supporting rationale.

iii. The IRO’s observations and recommendations on the Eligibility Review Team’s
performance of the Eligibility Review.

 

  b. Quantitative Results

i. Total number and percentage of instances in which the IRO’s determination
regarding whether the Paid Claims submitted by Odyssey Hospice (Claim Submitted)
differed from what should have been the correct claim (Correct Claim) (IRO
Results) was different than the Eligibility Review Team’s determination
(Eligibility Review Team Results), regardless of the effect on the payment.

 

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ii. Total number and percentage of instances in which the IRO Results differed
from the Eligibility Review Team Results and in which such difference resulted
in an Overpayment to Odyssey Hospice.

iii. The IRO Results’ total dollar amount of all Overpayments in the sample, and
the difference from the Eligibility Review Team Results’ total dollar amount of
all Overpayments in the sample.

iv. Total dollar amount of Paid Claims included in the sample and the net
Overpayment associated with the sample.

v. Error Rate in the sample.

vi. A spreadsheet of the Verification Review results that includes the following
information for each Paid Claim: Federal health care program billed, beneficiary
health insurance claim number, date(s) of service, the allowed amount reimbursed
by the payor, the allowed amount as determined by the Eligibility Review Team,
the correct allowed amount as determined by the IRO, and the dollar difference
between allowed amount reimbursed by payor and the correct allowed amount.

 

  c. Recommendations. The IRO’s report shall include any recommendations for
improvements to Odyssey Hospice’s eligibility-determination system based on the
findings of the Verification Review.

3. Credentials. The names and credentials of the individuals who: (1) designed
the statistical sampling procedures and the review methodology utilized for the
Verification Review and (2) performed the Verification Review.

 

Odyssey Integrity Agreement-Appendix C

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