CORPORATE INTEGRITY AGREEMENT
BETWEEN THE
OFFICE OF INSPECTOR GENERAL
OF THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
HEALTH QUEST SYSTEMS, INC.,
HEALTH QUEST MEDICAL PRACTICE, P.C.,
HEALTH QUEST URGENT MEDICAL CARE PRACTICE, P.C., AND
HEALTH QUEST HOME HEALTH CARE, INC.
I.

PREAMBLE

Health Quest Systems, Inc., Health Quest Medical Practice, P.C., Health Quest
Urgent Medical Care Practice, P.C., and Health Quest Home Health Care, Inc. (each
entity hereinafter referred to as a “Covered Entity,” and the entities hereinafter referred to
collectively as “Health Quest”) hereby enter 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, Health Quest Systems, Inc., Health Quest Medical
Practice, P.C., and Health Quest Urgent Medical Care Practice, P.C. are entering into a
Settlement Agreement with the United States.
Health Quest represents that prior to the execution of the CIA, Health Quest voluntarily
established a Compliance Program. The Compliance Program includes a Compliance
Officer, a Compliance Committee, a compliance training and education program,
compliance policies and procedures, a confidential disclosure reporting hotline, and
auditing and monitoring activities. Health Quest shall continue to operate its Compliance
Program throughout the term of this CIA and shall do so in accordance with the terms set
forth below. Health Quest may modify its Compliance Program, as appropriate, but at a
minimum, Health Quest shall ensure that during the term of this CIA, it shall comply
with the obligations set forth herein.

1
Health Quest – Corporate Integrity Agreement

 II.

TERM AND SCOPE OF THE CIA

A.
The period of the compliance obligations assumed by Health Quest 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. Each oneyear 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) Health Quest’s final Annual Report or (2) any additional materials
submitted by Health Quest pursuant to OIG’s request, whichever is later.
C.

For purposes of this CIA, the term “Covered Persons” includes:
(1) all owners who are natural persons, officers, directors, and employees of
Health Quest; and
(2) all contractors, subcontractors, agents, and other persons who furnish
patient care items or services or who perform billing or coding functions on
behalf of Health Quest excluding vendors whose sole connection with
Health Quest is selling or otherwise providing medical supplies or
equipment to Health Quest.
Notwithstanding the above, this term does not include part-time or per diem
employees, contractors, subcontractors, agents, and other persons are not
reasonably expected to work more than 160 hours during a Reporting
Period, except that any such individuals shall become “Covered Persons” at
the point when they work more than 160 hours during a Reporting Period.

III.

CORPORATE INTEGRITY OBLIGATIONS

Health Quest shall establish and maintain a Compliance Program that includes the
following elements:
A.
Compliance Officer and Committee, Board of Directors, and Management
Compliance Obligations

2
Health Quest – Corporate Integrity Agreement

 1.
Compliance Officer. Within 90 days after the Effective Date, Health
Quest shall appoint a Compliance Officer and shall maintain a Compliance Officer for
the term of the CIA. The Compliance Officer shall be an employee and a member of
senior management of Health Quest, shall report directly to the Chief Executive Officer
of Health Quest, and shall not be or be subordinate to the General Counsel or Chief
Financial Officer or have any responsibilities that involve acting in any capacity as legal
counsel or supervising legal counsel functions for Health Quest. The Compliance Officer
shall be responsible for, without limitation:
a.

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;

b.

making periodic (at least quarterly) reports regarding
compliance matters directly to the Board of Directors of
Health Quest and shall be authorized to report on such
matters to the Board of Directors at any time. Written
documentation of the Compliance Officer’s reports to the
Board of Directors shall be made available to OIG upon
request; and

c.

monitoring the day-to-day compliance activities engaged in
by Health Quest as well as 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.
Health Quest shall report to OIG, in writing, any changes 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. Within 90 days after the Effective Date,
Health Quest shall appoint a Compliance Committee. The Compliance Committee shall,

3
Health Quest – Corporate Integrity Agreement

 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 Health Quest’s risk areas and shall oversee monitoring of internal and
external audits and investigations). The Compliance Committee shall meet at least
quarterly. The minutes of the Compliance Committee meetings shall be made available
to OIG upon request.
Health Quest 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 of Directors Compliance Obligations. The Board of
Directors (or a committee of the Board) of Health Quest (Board) shall be responsible for
the review and oversight of matters related to compliance with Federal health care
program requirements and the obligations of this CIA. The Board must include
independent (i.e., non-executive) members.
The Board shall, at a minimum, be responsible for the following:
a.

meeting at least quarterly to review and oversee Health
Quest’s compliance program, including but not limited to the
performance of the Compliance Officer and Compliance
Committee;

b.

submitting to OIG a description of the documents and other
materials it reviewed, as well as any additional steps taken,
such as the engagement of an independent advisor or other
third party resources, in its oversight of the compliance
program and in support of making the resolution below
during each Reporting Period; and

c.

for each Reporting Period of the CIA, adopting a resolution,
signed by each member of the Board summarizing its review

4
Health Quest – Corporate Integrity Agreement

 and oversight of Health Quest’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 of Directors has made a reasonable inquiry into the operations
of Health Quest’s Compliance Program, including the performance of the
Compliance Officer and the Compliance Committee. Based on its inquiry
and review, the Board has concluded that, to the best of its knowledge,
Health Quest has implemented an effective Compliance Program to meet
Federal health care program requirements and the 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 at Health Quest.
Health Quest shall report to OIG, in writing, any changes in the composition of the
Board, or any actions or changes that would affect the Board’s ability to perform the
duties necessary to meet the obligations in this CIA, within 15 days after such a change.
4.
Management Certifications. In addition to the responsibilities set
forth in this CIA for all Covered Persons, certain Health Quest employees (Certifying
Employees) are expected to monitor and oversee activities within their areas of authority
and shall annually certify that the applicable Health Quest department is in compliance
with applicable Federal health care program requirements and the obligations of this CIA.
These Certifying Employees shall include, at a minimum, the following: President/Chief
Executive Officer, Chief Operations Officer, Chief Medical Operations Officer, Chief
Financial Officer, Chief Administrative Officer, Chief Compliance Officer, Chief
Information Officer, and Chief Human Resources Officer. For each Reporting Period,
each Certifying Employee shall sign a certification that states:
“I have been trained on and understand the compliance requirements and
responsibilities as they relate to [insert name of department], an area under
my supervision. My job responsibilities include ensuring compliance with
regard to the [insert name of department] with all applicable Federal health

5
Health Quest – Corporate Integrity Agreement

 care program requirements, obligations of the Corporate Integrity
Agreement, and Health Quest policies, and I have taken steps to promote
such compliance. To the best of my knowledge, the [insert name of
department] of Health Quest is in compliance with all applicable Federal
health care program requirements and the obligations of the Corporate
Integrity Agreement. I understand that this certification is being provided
to and relied upon by the United States.”
If any Certifying Employee is unable to provide such a certification, the Certifying
Employee shall provide a written explanation of the reasons why he or she is unable to
provide the certification outlined above.
Within 120 days after the Effective Date, Health Quest shall develop and
implement a written process for Certifying Employees to follow for the purpose of
completing the certification required by this section (e.g., reports that must be reviewed,
assessments that must be completed, sub-certifications that must be obtained, etc. prior to
the Certifying Employee making the required certification).
B.

Written Standards

Within 120 days after the Effective Date, Health Quest shall develop and
implement written policies and procedures regarding the operation of its compliance
program, including the compliance program requirements outlined in this CIA and Health
Quest’s compliance with Federal health care program requirements (Policies and
Procedures). The Policies and Procedures shall also address 42 U.S.C. § 1320a-7b(b)
(Anti-Kickback Statute) and 42 U.S.C. § 1395nn (Stark Law), and the regulations and
other guidance documents related to these statutes, and business and financial
arrangements or contracts that generate unlawful Federal health care program business in
violation of the Anti-Kickback Statute or the Stark Law.
The Policies and Procedures shall be made available to all Covered Persons.
Throughout the term of this CIA, Health Quest shall enforce its Policies and Procedures

6
Health Quest – Corporate Integrity Agreement

 and shall make compliance with its Policies and Procedures an element of evaluating the
performance of all employees.
At least annually (and more frequently, if appropriate), Health Quest shall assess
and update, as necessary, the Policies and Procedures. Any new or revised Policies and
Procedures shall be made available to all Covered Persons.
All Policies and Procedures shall be made available to OIG upon request.
C.

Training and Education

1.
Covered Persons Training. Within 120 days after the Effective
Date, Health Quest shall develop a written plan (Training Plan) that outlines the steps
Health Quest will take to ensure that all Covered Persons receive at least annual training
regarding Health Quest’s CIA requirements and Compliance Program and the applicable
Federal health care program requirements, including the requirements of the AntiKickback Statute and the Stark Law. The Training Plan shall include information
regarding the following: training topics, identification of Covered Persons required to
attend each training session, length of the training session(s), schedule for training, and
format of the training. Health Quest shall furnish training to its Covered Persons
pursuant to the Training Plan during each Reporting Period.
2.
Board Member Training. Within 90 days after the Effective Date,
each member of the Board of Directors shall receive at least two hours of training. This
training shall address the corporate governance responsibilities of board members, and
the responsibilities of Board members with respect to review and oversight of the
Compliance Program. Specifically, the training shall address the unique responsibilities
of health care Board members, including the risks, oversight areas, and strategic
approaches to conducting oversight of a health care entity. This training may be
conducted by an outside compliance expert hired by the Board and should include a
discussion of the OIG’s guidance on Board member responsibilities.
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.

7
Health Quest – Corporate Integrity Agreement

 3.
Training Records. Health Quest shall make available to OIG, upon
request, training materials and records verifying that Covered Persons and Board
members have timely received the training required under this section.
D.

Review Procedures
1.

General Description
a.

Engagement of Independent Review Organization. Within
120 days after the Effective Date, Health Quest shall engage
an entity (or entities), such as an accounting, auditing, or
consulting firm (hereinafter “Independent Review
Organization” or “IRO”), to perform the reviews 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.

b.

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

c.

Access to Records and Personnel. Health Quest shall ensure
that the IRO has access to all records and personnel necessary
to complete the reviews listed in this Section III.D and that all
records furnished to the IRO are accurate and complete.

2.
Claims Review. The IRO shall review claims submitted by Health
Quest Covered Entities and reimbursed by the Medicare and Medicaid programs, to
determine whether the items and services furnished were medically necessary and
appropriately documented and whether the claims were correctly coded, submitted, and
reimbursed (Claims Review) and shall prepare a Claims Review Report, as outlined in
Appendix B to this CIA, which is incorporated by reference.
3.
Independence and Objectivity Certification. The IRO shall include
in its report(s) to Health Quest a certification that the IRO has (a) evaluated its

8
Health Quest – Corporate Integrity Agreement

 professional independence and objectivity with respect to the reviews required 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. The IRO’s
certification shall include a summary of all current and prior engagements between
Health Quest and the IRO.
E.

Risk Assessment and Internal Review Process

Within 120 days after the Effective Date, Health Quest shall develop and
implement a centralized annual risk assessment and internal review process to identify
and address risks associated with Health Quest’s participation in the Federal health care
programs, including but not limited to the risks associated with the submission of claims
for items and services furnished to Medicare and Medicaid program beneficiaries. The
risk assessment and internal review process shall require compliance, legal, and
department leaders, at least annually, to: (1) identify and prioritize risks, (2) develop
internal audit work plans related to the identified risk areas, (3) implement the internal
audit work plans, (4) develop corrective action plans in response to the results of any
internal audits performed, and (5) track the implementation of the corrective action plans
in order to assess the effectiveness of such plans. Health Quest shall maintain the risk
assessment and internal review process for the term of the CIA.
F.

Disclosure Program

Within 90 days after the Effective Date, Health Quest shall establish 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 Health Quest’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. Health Quest shall appropriately publicize the existence of
the disclosure mechanism (e.g., via periodic e-mails to employees or by posting the
information in prominent common areas).
The Disclosure Program shall emphasize a nonretribution, nonretaliation policy
and shall include a reporting mechanism for anonymous communications for which
appropriate confidentiality shall be maintained. The Disclosure Program also shall
include a requirement that all of Health Quest’s Covered Persons shall be expected to

9
Health Quest – Corporate Integrity Agreement

 report suspected violations of any Federal health care program requirements to the
Compliance Officer or other appropriate individual designated by Health Quest. 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, Health
Quest 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 and shall
record each disclosure in the disclosure log within two business days of receipt of the
disclosure. The disclosure log shall include a 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.
G.

Ineligible Persons
1.

Definitions. For purposes of this CIA:
a.

b.

an “Ineligible Person” shall include an individual or entity
who:
i.

is currently excluded from participation in any Federal
health care program; 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.

“Exclusion List” means the HHS/OIG List of Excluded
Individuals/Entities (LEIE) (available through the Internet at
http://www.oig.hhs.gov).

10
Health Quest – Corporate Integrity Agreement

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

Health Quest shall screen all prospective Covered Persons
against the Exclusion List 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.

b.

Health Quest shall screen all current Covered Persons against
the Exclusion List within 90 days after the Effective Date and
on a monthly basis thereafter.

c.

Health Quest shall implement a policy requiring all Covered
Persons to disclose immediately if they become an Ineligible
Person.

Nothing in this Section III.G affects Health Quest’s responsibility to refrain from
(and liability for) billing Federal health care programs for items or services furnished,
ordered, or prescribed by an excluded person. Health Quest understands that items or
services furnished, ordered, or prescribed by excluded persons are not payable by Federal
health care programs and that Health Quest may be liable for overpayments and/or
criminal, civil, and administrative sanctions for employing or contracting with an
excluded person regardless of whether Health Quest meets the requirements of Section
III.G.
3.
Removal Requirement. If Health Quest has actual notice that a
Covered Person has become an Ineligible Person, Health Quest shall remove such
Covered Person from responsibility for, or involvement with, Health Quest’s business
operations related to the Federal health care program(s) from which such Covered Person
has been excluded 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 any
Federal health care program(s) from which the Covered Person has been excluded at least
until such time as the Covered Person is reinstated into participation in such Federal
health care program(s).

11
Health Quest – Corporate Integrity Agreement

 4.
Pending Charges and Proposed Exclusions. If Health Quest 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)(1)-(3), or is proposed for exclusion during
the Covered Person’s employment or contract term, Health Quest 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 or the accuracy
of any claims submitted to any Federal health care program.
H.

Notification of Government Investigation or Legal Proceeding

Within 30 days after discovery, Health Quest shall notify OIG, in writing, of any
ongoing investigation or legal proceeding known to Health Quest conducted or brought
by a governmental entity or its agents involving an allegation that Health Quest 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. Health Quest also shall provide
written notice to OIG within 30 days after the resolution of the matter and a description
of the findings and/or results of the investigation or proceeding, if any.
I.

Overpayments

1.
Definition of Overpayment. An “Overpayment” means any funds
that Health Quest receives or retains under any Federal health care program to which
Health Quest, after applicable reconciliation, is not entitled under such Federal health
care program.
2.
Overpayment Policies and Procedures. Within 90 days after the
Effective Date, Health Quest shall develop and implement written policies and
procedures regarding the identification, quantification, and repayment of Overpayments
received from any Federal health care program.
J.

Reportable Events

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

a substantial Overpayment;

12
Health Quest – Corporate Integrity Agreement

 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.G.1.a; or

d.

the filing of a bankruptcy petition by Health Quest.

A Reportable Event may be the result of an isolated event or a series of occurrences.
2.
Reporting of Reportable Events. If Health Quest determines (after a
reasonable opportunity to conduct an appropriate review or investigation of the
allegations) through any means that there is a Reportable Event, Health Quest shall notify
OIG, in writing, within 30 days after making the determination that the Reportable Event
exists.
3.
Reportable Events under Section III.J.1.a. and III.J.1.b. For
Reportable Events under Section III.J.1.a and b, the report to OIG shall include:
a.

a complete description of all details relevant to the Reportable
Event, including, at a minimum, the types of claims,
transactions or other conduct giving rise to the Reportable
Event; the period during which the conduct occurred; and the
names of individuals and entities believed to be implicated,
including an explanation of their roles in the Reportable
Event;

b.

a statement of the Federal criminal, civil, or administrative
laws that are probably violated by the Reportable Event, if
any;

c.

the Federal health care programs affected by the Reportable
Event;

13
Health Quest – Corporate Integrity Agreement

 d.

a description of the steps taken by Health Quest to identify
and quantify any Overpayments; and

e.

a description of Health Quest’s actions taken to correct the
Reportable Event and prevent it from recurring.

If the Reportable Event involves an Overpayment, within 60 days of identification
of the Overpayment, Health Quest shall repay the Overpayment, in accordance with the
requirements of 42 U.S.C. § 1320a-7k(d) and 42 C.F.R. § 401.301-305 (and any
applicable CMS guidance) and provide OIG with a copy of the notification and
repayment.
4.
Reportable Events under Section III.J.1.c. For Reportable Events
under Section III.J.1.c, the report to OIG shall include:
a.

the identity of the Ineligible Person and the job duties
performed by that individual;

b.

the dates of the Ineligible Person’s employment or contractual
relationship;

c.

a description of the Exclusion List screening that Health
Quest completed before and/or during the Ineligible Person’s
employment or contract and any flaw or breakdown in the
screening process that led to the hiring or contracting with the
Ineligible Person;

d.

a description of how the Ineligible Person was identified; and

e.

a description of any corrective action implemented to prevent
future employment or contracting with an Ineligible Person.

5.
Reportable Events under Section III.J.1.d. For Reportable Events
under Section III.J.1.d, the report to OIG shall include documentation of the bankruptcy
filing and a description of any Federal health care program requirements implicated.
6.
Reportable Events Involving the Stark Law. Notwithstanding the
reporting requirements outlined above, any Reportable Event that involves solely a

14
Health Quest – Corporate Integrity Agreement

 probable violation of the Stark Law should be submitted by Health Quest to the Centers
for Medicare & Medicaid Services (CMS) through the self-referral disclosure protocol
(SRDP), with a copy to the OIG. If Health Quest identifies a probable violation of the
Stark Law and repays the applicable Overpayment directly to the CMS contractor, then
Health Quest is not required by this Section III.J to submit the Reportable Event to CMS
through the SRDP.
IV.

SUCCESSOR LIABILITY

In the event that, after the Effective Date, Health Quest proposes to (a) sell any or
all of its business, business units, or locations (whether through a sale of assets, sale of
stock, or other type of transaction) relating to the furnishing of items or services that may
be reimbursed by a Federal health care program, or (b) purchase or establish a new
business, business unit, or location relating to the furnishing of items or services that may
be reimbursed by a Federal health care program, the CIA shall be binding on the
purchaser of any business, business unit, or location and any new business, business unit,
or location (and all Covered Persons at each new business, business unit, or location)
shall be subject to the applicable requirements of this CIA, unless otherwise determined
and agreed to in writing by OIG. Health Quest shall give notice of such sale or purchase
to OIG within 30 days following the closing of the transaction.
If, in advance of a proposed sale or a proposed purchase, Health Quest wishes to
obtain a determination by OIG that the proposed purchaser or the proposed acquisition
will not be subject to the requirements of the CIA, Health Quest must notify OIG in
writing of the proposed sale or purchase at least 30 days in advance. This notification
shall include a description of the business, business unit, or location to be sold or
purchased, a brief description of the terms of the transaction and, in the case of a
proposed sale, the name and contact information of the prospective purchaser.
V.

IMPLEMENTATION AND ANNUAL REPORTS
A.

Implementation Report

Within 150 days after the Effective Date, Health Quest 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:

15
Health Quest – Corporate Integrity Agreement

 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.
the names of the Board members who are responsible for satisfying
the Board of Directors compliance obligations described in Section III.A.3;
4.
the names and positions of the Certifying Employees required by
Section III.A.4, as well as the written process for Certifying Employees to follow;
5.

a list of the Policies and Procedures required by Section III.B;

6.
the Training Plan required by Section III.C.1 and a description of the
Board of Directors training required by Section III.C.2 (including a summary of the
topics covered, the length of the training, and when the training was provided);
7.
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; and (d) a
certification from the IRO regarding its professional independence and objectivity with
respect to Health Quest;
8.
a description of the risk assessment and internal review process
required by Section III.E;
9.

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

10.
a description of the Ineligible Persons screening and removal process
required by Section III.G;
11.
a copy of Health Quest’s policies and procedures regarding the
identification, quantification and repayment of Overpayments required by Section III.I;

16
Health Quest – Corporate Integrity Agreement

 12.
a description of Health Quest’s corporate structure, including
identification of any parent and sister companies, subsidiaries, and their respective lines
of business;
13.
a list of all of Health Quest’s locations (including locations and
mailing addresses), the corresponding name under which each location is doing business,
and the location’s Medicare and state Medicaid program provider number and/or supplier
number(s); and
14.
B.

the certifications required by Section V.C.

Annual Reports

Health Quest shall submit to OIG a report on its compliance with the CIA
requirements for each of the five Reporting Periods (Annual Report). Each Annual
Report shall include, at a minimum, the following information:
1.
any change in the identity, position description, or other
noncompliance job responsibilities of the Compliance Officer; a current list of the
Compliance Committee members, a current list of the Board members who are
responsible for satisfying the Board of Directors compliance obligations, and a current
list of the Certifying Employees, along with the identification of any changes made
during the Reporting Period to the Compliance Committee, Board of Directors, and
Certifying Employees, and the written process for Certifying Employees together with
the reasons for any change to the written process for Certifying Employees;
2.
the dates of each report made by the Compliance Officer to the
Board (written documentation of such reports shall be made available to OIG upon
request);
3.
the Board resolution required by Section III.A.3 and a description of
the documents and other materials reviewed by the Board, as well as any additional steps
taken, in its oversight of the compliance program and in support of making the resolution;
4.
a list of any new or revised Policies and Procedures developed
during the Reporting Period;

17
Health Quest – Corporate Integrity Agreement

 5.
a description of any changes to Health Quest’s Training Plan
developed pursuant to Section III.C, and a summary of any Board of Directors training
provided during the Reporting Period;
6.
a complete copy of all reports prepared pursuant to Section III.D and
Health Quest’s response to the reports, along with corrective action plan(s) related to any
issues raised by the reports;
7.
a certification from the IRO regarding its professional independence
and objectivity with respect to Health Quest;
8.
a description of any changes to the risk assessment and internal
review process required by Section III.E, including the reasons for such changes;
9.
a summary of the following components of the risk assessment and
internal review process during the Reporting Period: (a) work plans developed, (b)
internal audits performed, (c) corrective action plans developed in response to internal
audits, and (d) steps taken to track the implementation of the corrective action plans.
Copies of any work plans, internal audit reports, and corrective action plans shall be
made available to OIG upon request;
10.
a summary of the disclosures in the disclosure log required by
Section III.F that relate to Federal health care programs, including at least the following
information: (a) a description of the disclosure, (b) the date the disclosure was received,
(c) the resolution of the disclosure, and (d) the date the disclosure was resolved (if
applicable). The complete disclosure log shall be made available to OIG upon request;
11.
a description of any changes to the Ineligible Persons screening and
removal process required by Section III.G, including the reasons for such changes;
12.
a summary describing any ongoing investigation or legal proceeding
required to have been reported pursuant to Section III.H. 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;
13.
a description of any changes to the Overpayment policies and
procedures required by Section III.I, including the reasons for such changes;

18
Health Quest – Corporate Integrity Agreement

 14.
a summary of Reportable Events (as defined in Section III.J)
identified during the Reporting Period;
15.
a summary of any audits conducted during the applicable Reporting
Period by any Medicare or state Medicaid program contractor or any government entity
or contractor, involving a review of Federal health care program claims, and Health
Quest’s response/corrective action plan (including information regarding any Federal
health care program refunds) relating to the audit findings;
16.
a description of all changes to the most recently provided list of
Health Quest’s locations as required by Section V.A.13;
17.
a description of any changes to Health Quest’s corporate structure,
including any parent and sister companies, subsidiaries, and their respective lines of
business; and
18.

the certifications required by Section V.C.

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

Certifications

1.
Certifying Employees. In each Annual Report, Health Quest shall
include the certifications of Certifying Employees required by Section III.A.4;
2.
Compliance Officer and Chief Executive Officer. The
Implementation Report and each Annual Report shall include a certification by the
Compliance Officer and Chief Executive Officer that:
a.

to the best of his or her knowledge, except as otherwise
described in the report, Health Quest has implemented and is
in compliance with all of the requirements of this CIA;

b.

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

19
Health Quest – Corporate Integrity Agreement

 c.

he or she understands that the certification is being provided
to and relied upon by the United States

3.
Chief Financial Officer. The first Annual Report shall include a
certification by the Chief Financial Officer that, to the best of his or her knowledge,
Health Quest 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 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; and (d) he or she
understands that the certification is being provided to and relied upon by the United
States.
D.

Designation of Information

Health Quest 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. Health Quest 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

20
Health Quest – Corporate Integrity Agreement

 Telephone: 202.619.2078
Facsimile: 202.205.0604
Health Quest:
Claudine Fasse
Chief Compliance Officer
Health Quest
1351 Route 55, Suite 200
Lagrangeville, NY 12540
Telephone: 845.475.9570
Facsmile: 845.475.9740
Unless otherwise specified, all notifications and reports required by this CIA may
be made by electronic mail, overnight mail, hand delivery, or other means, provided that
there is proof that such notification was received. Upon request by OIG, Health Quest
may be required to provide OIG with an electronic copy of each notification or report
required by this CIA 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 conduct interviews, examine and/or
request copies of or copy Health Quest’s books, records, and other documents and
supporting materials, and conduct on-site reviews of any of Health Quest’s locations, for
the purpose of verifying and evaluating: (a) Health Quest’s compliance with the terms of
this CIA and (b) Health Quest’s compliance with the requirements of the Federal health
care programs. The documentation described above shall be made available by Health
Quest to OIG or its duly authorized representative(s) at all reasonable times for
inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG
or its duly authorized representative(s) may interview any of Health Quest’s owners,
employees, contractors, and directors 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. Health Quest shall assist OIG or
its duly authorized representative(s) in contacting and arranging interviews with such
individuals upon OIG’s request. Health Quest’s owners, employees, contractors, and

21
Health Quest – Corporate Integrity Agreement

 directors may elect to be interviewed with or without a representative of Health Quest
present.
VIII. DOCUMENT AND RECORD RETENTION
Health Quest shall maintain for inspection all documents and records relating to
reimbursement from the Federal health care programs and to compliance with this CIA
for six years (or longer if otherwise required by law) from the Effective Date.
IX.

DISCLOSURES

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

BREACH AND DEFAULT PROVISIONS

Health Quest 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, Health Quest 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 Health Quest fails to establish,
implement, or comply with any of the following obligations as described in Section III:
a.

a Compliance Officer;

b.

a Compliance Committee;

22
Health Quest – Corporate Integrity Agreement

 c.

the Board of Directors compliance obligations;

d.

the management certification obligations and the
development and implementation of a written process for
Certifying Employees, as required by Section III.A.4;

e.

written Policies and Procedures;

f.

the development of a written training plan and the training
and education of Covered Persons and Board Members;

g.

a risk assessment and internal review process;

h.

a Disclosure Program;

i.

Ineligible Persons screening and removal requirements;

j.

notification of Government investigations or legal
proceedings;

k.

policies and procedures regarding the repayment of
Overpayments; and

l.

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 Health Quest fails to engage
and use an IRO, as required by Section III.D, Appendix A, or Appendix B.
3.
A Stipulated Penalty of $2,500 (which shall begin to accrue on the
day after the date the obligation became due) for each day Health Quest fails to submit a
complete Implementation Report, Annual Report, or any certification 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 Health Quest fails to submit
any Claims Review Report in accordance with the requirements of Section III.D and

23
Health Quest – Corporate Integrity Agreement

 Appendix B or fails to repay any Overpayment identified by the IRO, as required by
Appendix B.
5.
A Stipulated Penalty of $1,500 for each day Health Quest fails to
grant access as required in Section VII (This Stipulated Penalty shall begin to accrue on
the date Health Quest fails to grant access.).
6.
A Stipulated Penalty of $50,000 for each false certification
submitted by or on behalf of Health Quest as part of its Implementation Report, any
Annual Report, additional documentation to a report (as requested by OIG), or otherwise
required by this CIA.
7.
A Stipulated Penalty of $2,500 for each day Health Quest fails to
grant the IRO access to all records and personnel necessary to complete the reviews listed
in Section III.D, and for each day Health Quest fails to furnish accurate and complete
records to the IRO, as required by Section III.D and Appendix A.
8.
A Stipulated Penalty of $1,000 for each day Health Quest fails to
comply fully and adequately with any obligation of this CIA. OIG shall provide notice to
Health Quest stating the specific grounds for its determination that Health Quest has
failed to comply fully and adequately with the CIA obligation(s) at issue and steps Health
Quest shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue
10 days after the date Health Quest 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 1-7 of
this Section.
B.

Timely Written Requests for Extensions

Health Quest 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 Health Quest 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

24
Health Quest – Corporate Integrity Agreement

 shall not begin to accrue until three days after Health Quest 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 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 Health Quest 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 Health Quest of: (a) Health Quest’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.”)
2.
Response to Demand Letter. Within 10 days after the receipt of the
Demand Letter, Health Quest 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
Health Quest elects to request an ALJ hearing, the Stipulated Penalties shall continue to
accrue until Health Quest 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.1.c, these provisions for payment of Stipulated Penalties shall not
affect or otherwise set a standard for OIG’s decision that Health Quest 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:

25
Health Quest – Corporate Integrity Agreement

 a.

repeated violations or a flagrant violation of any of the
obligations under this CIA, including, but not limited to, the
obligations addressed in Section X.A;

b.

a failure by Health Quest to report a Reportable Event, take
corrective action, or make the appropriate refunds, as required
in Section III.J;

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, or Appendix B.

2.
Notice of Material Breach and Intent to Exclude. The parties agree
that a material breach of this CIA by Health Quest constitutes an independent basis for
Health Quest’s exclusion from participation in the Federal health care programs. The
length of the exclusion shall be in the OIG’s discretion, but not more than five years per
material breach. Upon a determination by OIG that Health Quest has materially breached
this CIA and that exclusion is the appropriate remedy, OIG shall notify Health Quest of:
(a) Health Quest’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. Health Quest shall have 30 days from the date
of receipt of the Notice of Material Breach and Intent to Exclude to demonstrate that:
a.

the alleged material breach has been cured; or

b.

the alleged material breach cannot be cured within the 30 day
period, but that: (i) Health Quest has begun to take action to
cure the material breach; (ii) Health Quest is pursuing such
action with due diligence; and (iii) Health Quest has provided
to OIG a reasonable timetable for curing the material breach.

26
Health Quest – Corporate Integrity Agreement

 4.
Exclusion Letter. If, at the conclusion of the 30 day period, Health
Quest fails to satisfy the requirements of Section X.D.3, OIG may exclude Health Quest
from participation in the Federal health care programs. OIG shall notify Health Quest in
writing of its determination to exclude Health Quest. (This letter shall be 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 Health Quest’s receipt
of the Exclusion Letter. The exclusion shall have national effect. Reinstatement to
program participation is not automatic. At the end of the period of exclusion, Health
Quest 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 Health Quest 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, Health Quest 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. The
procedures relating to the filing of a request for a hearing can be found at
http://www.hhs.gov/dab/divisions/civil/procedures/divisionprocedures.html
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
Health Quest was in full and timely compliance with the obligations of this CIA for
which OIG demands payment; and (b) the period of noncompliance. Health Quest shall
have the burden of proving its full and timely compliance and the steps taken to cure the
noncompliance, if any. OIG shall not have the right to appeal to the DAB an adverse
ALJ decision related to Stipulated Penalties. If the ALJ agrees with OIG with regard to a
finding of a breach of this CIA and orders Health Quest to pay Stipulated Penalties, such

27
Health Quest – Corporate Integrity Agreement

 Stipulated Penalties shall become due and payable 20 days after the ALJ issues such a
decision unless Health Quest 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.
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 whether Health
Quest was in material breach of this CIA and, if so, whether:
a.

Health Quest cured such breach within 30 days of its receipt
of the Notice of Material Breach; or

b.

the alleged material breach could not have been cured within
the 30 day period, but that, during the 30 day period
following Health Quest’s receipt of the Notice of Material
Breach: (i) Health Quest had begun to take action to cure the
material breach; (ii) Health Quest pursued such action with
due diligence; and (iii) Health Quest provided to OIG a
reasonable timetable for curing the material breach.

For purposes of the exclusion herein, exclusion shall take effect only after an ALJ
decision favorable to OIG, or, if the ALJ rules for Health Quest, only after a DAB
decision in favor of OIG. Health Quest’s election of its contractual right to appeal to the
DAB shall not abrogate OIG’s authority to exclude Health Quest 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 Health Quest 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. Health
Quest 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 Health Quest,
Health Quest 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

28
Health Quest – Corporate Integrity Agreement

 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.
XI.

EFFECTIVE AND BINDING AGREEMENT
Health Quest and OIG agree as follows:

A.
This CIA shall become final and binding on the date the final signature is
obtained on the CIA.
B.
This CIA constitutes the complete agreement between the parties and may
not be amended except by written consent of the parties to this CIA.
C.
OIG may agree to a suspension of Health Quest’s obligations under this
CIA based on a certification by Health Quest that it is no longer providing health care
items or services that will be billed to any Federal health care program and 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 Health Quest is relieved of its CIA
obligations, Health Quest shall be required to notify OIG in writing at least 30 days in
advance if Health Quest 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.
D.
All requirements and remedies set forth in this CIA are in addition to and
do not affect (1) Health Quest’s responsibility to follow all applicable Federal health care
program requirements or (2) the government’s right to impose appropriate remedies for
failure to follow applicable Federal health care program requirements.
E.
The undersigned Health Quest signatories represent and warrant that they
are authorized to execute this CIA. The undersigned OIG signatories represent that they
are signing this CIA in their official capacities and that they are 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. Electronically-transmitted

29
Health Quest – Corporate Integrity Agreement

 copies of signatures shall constitute acceptable, binding signatures for purposes of this
CIA.

30
Health Quest – Corporate Integrity Agreement

 ON BEHALF OF HEALTH QUEST
/Claudine Fasse/
June 27, 2018

CLAUDINE FASSE
Chief Compliance Officer
/Heidi A. Sorensen/

DATE

HEIDI A. SORENSEN
Foley & Lardner LLP
Counsel to Health Quest

DATE

Health Quest - Corporate Integrity Agreement

31

 ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL
OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES

/Lisa M. Re/
LISAM.RE
Assistant Inspector General for Legal Affairs
Office of Inspector General
U.S. Department of Health and Human Services
/Keshia B. Thompson/

KESHIA B':'THOMPSON

Senior Counsel V
Office of Counsel to the Inspector General
Office of Inspector General
U.S. Department of Health and Human Services

Health Quest - Corporate Integrity Agreement

32

DATE

 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.
Health Quest 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 E. Within 30 days after OIG receives the information identified in
Section V.A.7 of the CIA or any additional information submitted by Health Quest in
response to a request by OIG, whichever is later, OIG will notify Health Quest if the IRO
is unacceptable. Absent notification from OIG that the IRO is unacceptable, Health
Quest may continue to engage the IRO.
2.
If Health Quest engages a new IRO during the term of the CIA, that IRO
must also meet the requirements of this Appendix. If a new IRO is engaged, Health
Quest shall submit the information identified in Section V.A.7 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 Health Quest at the request of OIG,
whichever is later, OIG will notify Health Quest if the IRO is unacceptable. Absent
notification from OIG that the IRO is unacceptable, Health Quest may continue to engage
the IRO.
B.

IRO Qualifications
The IRO shall:

1.
assign individuals to conduct the Claims Review who have expertise in the
Medicare and state Medicaid program requirements applicable to the claims being
reviewed;
2.
assign individuals to design and select the Claims Review sample who are
knowledgeable about the appropriate statistical sampling techniques;
3.
assign individuals to conduct the coding review portions of the Claims
Review who have a nationally recognized coding certification and who have maintained
this certification (e.g., completed applicable continuing education requirements);

1
Health Quest - Corporate Integrity Agreement - Appendix A

 4.
assign licensed nurses or physicians with relevant education, training and
specialized expertise (or other licensed health care professionals acting within their scope
of practice and specialized expertise) to make the medical necessity determinations
required by the Claims Review; and
5.
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 Claims Review in accordance with the specific requirements
of the CIA;
2.
follow all applicable Medicare and state Medicaid program rules and
reimbursement guidelines in making assessments in the Claims Review;
3.
request clarification from the appropriate authority (e.g., Medicare
contractor), if in doubt of the application of a particular Medicare or state Medicaid
program policy or regulation;
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.

Health Quest Responsibilities

Health Quest shall ensure that the IRO has access to all records and personnel
necessary to complete the reviews listed in Section III.D of this CIA and that all records
furnished to the IRO are accurate and complete.
E.

IRO Independence and Objectivity

The IRO must perform the Claims Review in a professionally independent and
objective fashion, as defined in the most recent Government Auditing Standards issued
by the U.S. Government Accountability Office.

2
Health Quest - Corporate Integrity Agreement - Appendix A

 F.

IRO Removal/Termination

1.
Health Quest and IRO. If Health Quest terminates its IRO or if the IRO
withdraws from the engagement during the term of the CIA, Health Quest must submit a
notice explaining (a) its reasons for termination of the IRO or (b) the IRO’s reasons for
its withdrawal to OIG, no later than 30 days after termination or withdrawal. Health
Quest must engage a new IRO in accordance with Paragraph A of this Appendix and
within 60 days of termination or withdrawal of the IRO.
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 E, or has failed to carry out its responsibilities as described in
Paragraph C, OIG shall notify Health Quest in writing regarding OIG’s basis for
determining that the IRO has not met the requirements of this Appendix. Health Quest
shall have 30 days from the date of OIG’s written notice to provide information regarding
the IRO’s qualifications, independence or performance of its responsibilities in order to
resolve the concerns identified by OIG. If, following OIG’s review of any information
provided by Health Quest regarding the IRO, OIG determines that the IRO has not met
the requirements of this Appendix, OIG shall notify Health Quest in writing that Health
Quest shall be required to engage a new IRO in accordance with Paragraph A of this
Appendix. Health Quest must engage a new IRO within 60 days of its receipt of OIG’s
written notice. The final determination as to whether or not to require Health Quest to
engage a new IRO shall be made at the sole discretion of OIG.

3
Health Quest - Corporate Integrity Agreement - Appendix A

 APPENDIX B
CLAIMS REVIEW
A.
Claims Review. The IRO shall perform the Claims Review annually to cover each
of the five Reporting Periods. The IRO shall perform all components of each Claims
Review. The Claims Review shall be conducted at one Covered Entity for each
Reporting Period and shall consist of the following:
1.
Selection of Health Quest Covered Entity to be Reviewed. At least 60 days
prior to the end of each Reporting Period, Health Quest shall provide OIG with the
following information for each Health Quest Covered Entity for the prior year: (1) the
total dollar amount of the Health Quest Covered Entity’s revenue; and (2) the total dollar
amount of the Health Quest Covered Entity’s Paid Claims. Within 30 days after OIG
receives this information, OIG will notify Health Quest of the Health Quest Covered
Entity to be reviewed.
2.
Definitions. For the purposes of the Claims Review, the following
definitions shall be used:
a.

Overpayment: The amount of money Health Quest has received in
excess of the amount due and payable under Medicare or any state
Medicaid program requirements, as determined by the IRO in
connection with the Claims Review performed under this Appendix
B.

b.

Paid Claim: A claim submitted by Health Quest and for which
Health Quest has received reimbursement from the Medicare
program or a state Medicaid program.

c.

Population: The Population shall be defined as all Paid Claims
during the 12-month period covered by the Claims Review at the
Health Quest Covered Entity selected in accordance with Paragraph
A.1 above.

3.
Claims Review Sample. The IRO shall randomly select and review a
sample of 100 Paid Claims (Claims Review Sample) from the Population at the Health
Quest Covered Entity selected for review. The Paid Claims shall be reviewed based on
the supporting documentation available at Health Quest’s office or under Health Quest’s
control and applicable Medicare and state Medicaid program requirements to determine
whether the items and services furnished were medically necessary and appropriately
documented, and whether the claim was correctly coded, submitted, and reimbursed. For
each Paid Claim in the Claims Review Sample that results in an Overpayment, the IRO
shall review the system(s) and process(es) that generated the Paid Claim and identify any
1
Health Quest - Corporate Integrity Agreement - Appendix B

 problems or weaknesses that may have resulted in the identified Overpayments. The IRO
shall provide its observations and recommendations on suggested improvements to the
system(s) and the process(es) that generated the Paid Claim.
4.

Other Requirements.
a.

Supplemental Materials. The IRO shall request all documentation
and materials required for its review of the Paid Claims in the
Claims Review Sample, and the Health Quest Covered Entity shall
furnish such documentation and materials to the IRO prior to the
IRO initiating its review of the Claims Review Sample. If the IRO
accepts any supplemental documentation or materials from the
Health Quest Covered Entity after the IRO has completed its initial
review of the Claims Review Sample (Supplemental Materials), the
IRO shall identify in the Claims Review Report the Supplemental
Materials, the date the Supplemental Materials were accepted, and
the relative weight the IRO gave to the Supplemental Materials in its
review. In addition, the IRO shall include a narrative in the Claims
Review Report describing the process by which the Supplemental
Materials were accepted and the IRO’s reasons for accepting the
Supplemental Materials.

b.

Paid Claims without Supporting Documentation. Any Paid Claim
for which Health Quest cannot produce documentation shall be
considered an error and the total reimbursement received by Health
Quest 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 the Claims Review
Sample discussed in this Appendix, the first set of Paid Claims
selected 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
Claims Review Sample).

5.
Repayment of Identified Overpayments. Health Quest shall repay within 60
days the Overpayment(s) identified by the IRO in the Claims Review Sample, in
accordance with the requirements of 42 U.S.C. § 1320a-7k(d) and 42 C.F.R. § 401.301305 (and any applicable CMS guidance) (the “CMS overpayment rule”). If Health Quest
determines that the CMS overpayment rule requires that an extrapolated Overpayment be
repaid, Health Quest shall repay that amount at the mean point estimate as calculated by
the IRO. Health Quest shall make available to OIG all documentation that reflects the
refund of the Overpayment(s) to the payor. OIG, in its sole discretion, may refer the
2
Health Quest - Corporate Integrity Agreement - Appendix B

 findings of the Claims Review Sample (and any related work papers) received from
Health Quest to the appropriate Medicare or state Medicaid program contractor for
appropriate follow up by the payor.
B.
Claims Review Report. The IRO shall prepare a Claims Review Report as
described in this Appendix for each Claims Review performed. The following
information shall be included in the Claims Review Report.
1.

2.

3.

Claims Review Methodology.
a.

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

b.

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

c.

Source of Data. A description of (1) the process used to identify
Paid Claims in the Population and (2) the specific documentation
relied upon by the IRO when performing the Claims 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
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 Claims Review
was conducted and what was evaluated.

e.

Supplemental Materials. A description of any Supplemental
Materials as required by Paragraph A.4.a., above.

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 IRO.

b.

A description or identification of the statistical sampling software
package used by the IRO.

Claims Review Findings.
a.

Narrative Results.
3

Health Quest - Corporate Integrity Agreement - Appendix B

 b.

i.

A description of Health Quest’s billing and coding system(s),
including the identification, by position description, of the
personnel involved in coding and billing.

ii.

A description of controls in place at Health Quest to ensure
that all items and services billed to Medicare or a state
Medicaid program are medically necessary and appropriately
documented.

iii.

A narrative explanation of the IRO’s findings and supporting
rationale (including reasons for errors, patterns noted, etc.)
regarding the Claims Review, including the results of the
Claims Review Sample.

Quantitative Results.
i.

Total number and percentage of instances in which the IRO
determined that the coding of the Paid Claims submitted by
Health Quest differed from what should have been the correct
coding and in which such difference resulted in an
Overpayment to Health Quest.

ii.

Total number and percentage of instances in which the IRO
determined that a Paid Claim was not appropriately
documented and in which such documentation errors resulted
in an Overpayment to Health Quest.

iii.

Total number and percentage of instances in which the IRO
determined that a Paid Claim was for items or services that
were not medically necessary and resulted in an Overpayment
to Health Quest.

iv.

Total dollar amount of all Overpayments in the Claims
Review Sample.

v.

Total dollar amount of Paid Claims included in the Claims
Review Sample.

vi.

Error Rate in the Claims Review Sample. The Error Rate
shall be calculated by dividing the Overpayment in the
Claims Review Sample by the total dollar amount associated
with the Paid Claims in the Claims Review Sample.

4
Health Quest - Corporate Integrity Agreement - Appendix B

 c.

vii.

An estimate of the actual Overpayment in the Population at
the mean point estimate.

viii.

A spreadsheet of the Claims Review results that includes the
following information for each Paid Claim: Federal health
care program billed, beneficiary health insurance claim
number, date of service, code submitted (e.g., DRG, CPT
code, etc.), code reimbursed, allowed amount reimbursed by
payor, correct code (as determined by the IRO), correct
allowed amount (as determined by the IRO), dollar difference
between allowed amount reimbursed by payor and the correct
allowed amount.

Recommendations. The IRO’s report shall include any
recommendations for improvements to Health Quest’s billing and
coding system or to Health Quest’s controls for ensuring that all
items and services billed to Medicare or a state Medicaid program
are medically necessary and appropriately documented, based on the
findings of the Claims Review.

4.
Credentials. The names and credentials of the individuals who: (1)
designed the statistical sampling procedures and the review methodology utilized for the
Claims Review and (2) performed the Claims Review.

5
Health Quest - Corporate Integrity Agreement - Appendix B