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EXHIBIT 10.21
CORPORATE INTEGRITY AGREEMENT
BETWEEN THE
OFFICE OF INSPECTOR GENERAL
OF THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND
LIFEPOINT HOSPITALS, INC.
I. PREAMBLE
LifePoint Hospitals, Inc. ("LifePoint") 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 by its subsidiaries, and their officers, directors,
employees, physicians, contractors and agents with the statutes, regulations and
written directives of Medicare, Medicaid and all other Federal health care
programs (as defined in 42 U.S.C. ss. 1320a-7b(f))("Federal health care program
requirements").
Upon its formation and prior to the execution of this CIA, LifePoint
voluntarily established a compliance program (the "Compliance Program") which is
designed to ensure that its participation in the Federal health care programs is
in conformity with Federal health care program requirements. The Compliance
Program includes specifically LifePoint's Code of Conduct, as well as policies
and procedures designed to implement the Code of Conduct. Therefore, during the
term of this CIA, LifePoint hereby agrees to maintain a compliance program in
accordance with the requirements of this CIA. The Compliance Program may be
modified by LifePoint as appropriate, but at a minimum, shall always comply with
the integrity obligations enumerated in this CIA.
II. TERM OF THE CIA, DEFINITION, AND CONTINGENT RELEASE
A. Term. The period of the compliance obligations assumed by LifePoint
under this CIA shall be five years from the effective date of this CIA (unless
otherwise specified). The effective date of this CIA shall be the date on which
the final signatory of this CIA executes this CIA. Sections VII, VIII, IX, X and
XII shall remain in effect until OIG has completed its review of the final
annual report and any additional materials submitted by LifePoint pursuant to
OIG's request.
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B. Definition of Covered Person. For the purposes of this CIA, a
Covered Person means any: (i) officer, director, or employee of LifePoint; or
(ii) agent or other individual who furnishes health care items or services at a
LifePoint owned or operated location for which LifePoint claims reimbursement
from any Federal health care program or who participates in the preparation or
submission of claims for payment on behalf of LifePoint with respect to items or
services for which LifePoint claims reimbursement from any Federal health care
program (regardless of where such activity takes place). Notwithstanding the
above, part-time or per diem agents or employees who work less than 160 hours
per year are not Covered Persons.
C. HCA Investigation and Contingent Release. LifePoint is entering this
Agreement in connection with the investigation by the United States of HCA - The
Healthcare Company ("HCA"). HCA and the United States may enter into a
settlement agreement or agreements to resolve that investigation. LifePoint's
hospitals were formerly owned by HCA and LifePoint and its subsidiaries may be
subject to permissive exclusion pursuant to 42 U.S.C. ss. 1320a-7(b)(7) for
conduct that occurred while the hospitals were owned by HCA. Once this CIA is
effective and the United States releases claims under the False Claims Act, 31
U.S.C. xx.xx. 3729-3733, against HCA for conduct described in a settlement
agreement between the United States and HCA ("Covered Conduct"), the OIG agrees
to release and refrain from instituting any action seeking exclusion from the
Medicare, Medicaid or other Federal health care programs against LifePoint and
its subsidiaries under 42 U.S.C. ss. 1320a-7a (Civil Monetary Penalties Law), or
42 U.S.C. ss. 1320a-7(b) (permissive exclusion), for the Covered Conduct. The
release described in this paragraph is subject to the same limitations and
conditions with respect to LifePoint as apply to the parallel release granted to
HCA for the Covered Conduct; provided, however, that the terms of such release
shall not impose additional obligations on LifePoint beyond those contained in
this CIA.
III. CORPORATE INTEGRITY OBLIGATIONS
LifePoint hereby agrees to maintain its Compliance Program so that it
includes the following elements for the term of this CIA:
A. Compliance Officers and Committees.
1. Audit and Compliance Committee of the Board of Directors.
LifePoint currently has an Audit and Compliance Committee of the Board of
Directors ("Board Committee") comprised of at least three outside directors of
LifePoint. The Board Committee is responsible for the review of matters related
to the Compliance Program,
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this CIA, and compliance with Federal health care program requirements. The
Board Committee shall meet at least four times each year. When new members of
the Board Committee are appointed or the responsibilities or authorities of the
Board Committee are substantially changed, LifePoint shall notify the OIG, in
writing, within 15 days of such a change.
2. Compliance Officer. LifePoint has, pursuant to its
Compliance Program, created a position known as the Vice President, Audit &
Compliance and appointed an individual to serve in that capacity ("Compliance
Officer"). The Compliance Officer is 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 is charged with the responsibility for the
day-to-day compliance activities in furtherance of the integrity obligations
assumed herein, as well as for any reporting obligations established under this
Agreement. The Compliance Officer, who is a member of senior management, has the
authority and ability to report directly to the Chief Executive Officer and the
Board Committee at any time and shall report to the CEO and/or Board Committee
at least quarterly on compliance issues. Any changes in the identity or position
description of the Compliance Officer, or any actions or changes that would
reasonably be expected to affect the Compliance Officer's ability to perform the
duties necessary to meet the obligations in this CIA, must be reported to OIG,
in writing, within 15 days of such a change.
3. Internal Audit and Compliance Department. LifePoint
currently has an Internal Audit and Compliance Department ("Compliance
Department"). The Compliance Department is managed by the Compliance Officer and
is responsible for the operation of the Compliance Program and for compliance
with this CIA and Federal health care program requirements. In the event the
responsibilities or authorities of the Compliance Department are substantially
changed, LifePoint shall notify the OIG, in writing, within 15 days of such a
change.
4. Local Ethics and Compliance Officers. LifePoint currently
has a Local Ethics and Compliance Officer ("ECO") at each of its hospitals. Each
ECO shall have sufficient management responsibility so as permit the effective
performance of his or her duties. Each ECO is and shall remain responsible for
implementation and oversight of the Ethics and Compliance Program at the
hospital and for the hospital's compliance with this CIA and Federal health care
program requirements. LifePoint shall make proper execution of ECO duties a
component of the performance evaluations of ECOs. In the event any substantial
change in the responsibilities or authorities of the ECOs relating to
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LifePoint's Compliance Program is made, LifePoint shall notify the OIG in
writing within 15 days of such change.
5. Corporate Compliance Committee. LifePoint currently has a
Corporate Compliance Committee ("Compliance Committee"). The Compliance
Committee is chaired by the Compliance Officer and includes the CEO, COO, CFO,
General Counsel, SVP-Human Resources, and presidents of LifePoint's two
divisions. The Compliance Committee is responsible for overseeing the
implementation and operation of the Compliance Program and with LifePoint's
compliance with this CIA and with Federal health care program requirements. The
Compliance Committee shall conduct at least 10 meetings per year and shall keep
a record of its proceedings that shall be available to the OIG upon request.
6. Hospital Compliance Committees. Each Hospital shall have a
Hospital Ethics and Compliance Committee ("Hospital Committee"). The Hospital
Committee shall be chaired by the ECO of the facility and, generally, shall
include the heads of each of the facility's major departments, such as billing,
Health Information Management ("HIM"), quality, risk management, finance, and
human resources. The Hospital Committee shall be responsible for assisting the
ECO in implementing the Compliance Program, and ensuring compliance by the
facility with this CIA and Federal health care program requirements.
B. Written Standards.
1. Code of Conduct. LifePoint currently has a Code of Conduct.
LifePoint has implemented a program to distribute the Code of Conduct to Covered
Persons. LifePoint shall continue to make the promotion of, and adherence to,
the Code of Conduct an element in evaluating the performance of the Compliance
Officer and each ECO. All employees who violate the Code of Conduct are, and
shall continue to be, subject to discipline, up to and including termination.
LifePoint has implemented a program to obtain an acknowledgment from each
Covered Person that he or she has received LifePoint's Code of Conduct and
understands that it represents the mandatory policies of the organization.
Within 90 days of the effective date of this CIA, LifePoint shall have obtained
a certification from each of its facilities and corporate office that, based on
information and belief, this distribution and acknowledgment process is
complete. New Covered Persons shall receive the Code of Conduct and shall
complete the required acknowledgment within 30 days after becoming a Covered
Person. LifePoint currently plans to make non-substantive revisions to its
current Code of Conduct and distribute the revised Code of Conduct to Covered
Persons during the next annual cycle of general
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training. For the distribution of this revised Code of Conduct and any future
revisions, LifePoint shall implement a program to obtain an acknowledgment from
each Covered Person that he or she has received the revised Code of Conduct,
understands that it represents the mandatory policies of the organization, and
agrees to abide by it. Future revisions shall be distributed as expeditiously as
possible after initiating such a change and no later than 60 days after the
effective date of the revised Code of Conduct. Within 90 days of the effective
date of the revised Code of Conduct, LifePoint shall obtain a certification from
each of its facilities and corporate office that, based on information and
belief, this distribution and acknowledgment process is complete. LifePoint
shall obtain the acknowledgments and certifications described in the preceding
two sentences every time that a revised Code of Conduct is distributed.
2. Policies and Procedures. LifePoint represents that it has
developed, distributed to its employees, and placed into effect written policies
and procedures regarding the operation of its Compliance Program and its overall
compliance with Federal health care program requirements. LifePoint shall,
during the term of this CIA, maintain policies and procedures, which shall at a
minimum specifically address: (a) the need for compliance in connection with all
submissions for reimbursement for inpatient and outpatient procedures; (b) the
need for compliance in connection with all submissions for cost based
reimbursement; (c) medical record documentation requirements; (d) a process for
reasonable verification of compliance with these requirements; and (e) methods
for employees to make disclosures or otherwise report on compliance issues to
management and/or supervisors through the Confidential Disclosure mechanisms
outlined in Section III.E. LifePoint shall assess and update the policies and
procedures annually or more frequently, as appropriate. At a minimum, a summary
of the policies and procedures will be provided to OIG in the Implementation
Report, as provided in Section V.A. The policies and procedures will be
available to OIG upon request. Within 90 days of the effective date of the CIA,
LifePoint shall provide to all Covered Persons, to the extent it has not already
done so, the policies and procedures that are relevant to their respective tasks
and responsibilities in connection with LifePoint's participation in the Federal
health care programs. LifePoint will continue to take actions that it considers
reasonable and effective to communicate these policies to Covered Persons.
Appropriate compliance officers or supervisory personnel are available to
explain policies and procedures.
C. Training and Education. LifePoint shall meet the following training
requirements. The training requirements are cumulative, i.e., not exclusive, so
that one person may be required to attend training in several substantive areas
in addition to the general training. All training requirements set forth below
in paragraphs 1 to 5 shall be
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implemented within 90 days of the effective date of this CIA and conducted as
specified below. Subject to paragraphs 1 through 5 below, with respect to the
initial training required during the first 90 days after the effective date of
this CIA, LifePoint need not provide such training to persons who have received
training after January 1, 2000, if the training provided meets all the subject
matter and duration requirements that would apply to the initial training under
the CIA. All training shall be conducted as specified below:
1. General Training. Throughout the term of this CIA,
LifePoint shall provide at least one hour of training initially to each Covered
Person and one hour of refresher training annually thereafter. This general
training shall cover the Compliance Program, the Code of Conduct, and this CIA.
Covered Persons who have received LifePoint's general compliance training in the
past shall be considered to have completed the initial general training
requirement notwithstanding the fact that such training did not cover the CIA.
Covered Persons who have not received initial general training prior to the
effective date of this CIA shall receive such training within 90 days after the
effective date of this CIA. New Covered Persons shall receive the general
training described above within 30 days of becoming a Covered Person or within
90 days after the effective date of this CIA, whichever is later. After
receiving the initial training described above, each Covered Person shall
receive at least one hour of general training annually.
2. Coding Training. Throughout the term of this CIA, LifePoint
shall continue to provide at least 10 hours per year of continuing education for
all Covered Persons with responsibility for coding, including coding directors
and coders.
3. Billing Training. Throughout the term of this CIA,
LifePoint shall continue to provide at least 8 hours of continuing education per
year for individuals responsible for billing, including members of billing
departments and laboratory and business office directors. This training provides
information on essential rules of billing for Federal health care programs.
4. Cost Report Training. Throughout the term of this CIA,
LifePoint shall continue to require at least 20 hours of continuing education
for Covered Persons in the Reimbursement Department (and others who engage in
the preparation of cost reports) annually which includes cost report preparation
and other job-related training.
5. New Persons. Affected new Covered Persons shall receive the
training required by this CIA promptly (but in no event later than 30 days
after: (i) the person becomes a Covered Person; or (ii) the person begins work
on the matter for which they must be trained, whichever is later) so that the
persons are fully qualified by virtue of
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such training to perform whatever responsibilities may be assigned to them. With
respect to initial training of new Covered Persons, training provided to that
Covered Person in the six-month period prior to becoming a Covered Person will
count toward meeting the hourly training requirements of this CIA if the
training provided meets all the subject matter requirements that would apply to
the initial training of a new Covered Person under the CIA. In any situation
where training requirements have not been completed, a fully trained LifePoint
employee shall carefully monitor the work of the untrained person.
6. Certifications and Retention. LifePoint shall continue to
maintain sufficient records to demonstrate that required training has occurred.
These records shall include certifications from Covered Persons that they have
attended the required training. The certifications may be acquired through:
attendance/sign-in sheets for in-person group training sessions; computer
attestations for computer-based training; or similar mechanisms for other forms
of training. The Compliance Officer shall retain training records in a manner
that permits reporting about the training, along with specific course materials
to the OIG upon request. The Compliance Officer may delegate the maintenance of
such materials.
D. Review Procedures.
1. General Description.
a. Retention of Independent Review Organization.
Within 90 days of the effective date of this CIA,
LifePoint shall retain an entity (or entities), such
as an accounting, auditing or consulting firm
(hereinafter "Independent Review Organization" or
"IRO"), to perform review engagements to assist
LifePoint in evaluating its billing and coding
practices and its compliance obligations pursuant to
this CIA. Each Independent Review Organization
retained by LifePoint shall have expertise in the
billing, coding, reporting and other requirements of
the particular sector of the health care industry
pertaining to matters that the IRO is reviewing and
in the general requirements of the Federal health
care program(s) from which LifePoint seeks
reimbursement.
b. Types of Engagements. LifePoint's Internal Audit
and Compliance Department (references to "LifePoint"
in the review procedures described in this CIA and
the incorporated appendices refer to this department)
and the Independent Review
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Organization(s) shall conduct the following
engagements. One engagement shall address LifePoint's
billing and coding to the Federal health care
programs ("Billing Engagement") and shall include a
review of DRG and laboratory claims. The second
engagement shall address LifePoint's compliance with
the obligations assumed under this CIA ("Compliance
Engagement").
c. Frequency of Billing and Compliance Engagements.
The Billing Engagement shall be performed annually
and shall cover each of the calendar years 2001
through 2005. The Compliance Engagement shall be
performed by the IRO for the calendar year 2001.
d. Retention of records. The IRO and LifePoint shall
retain and make available to the OIG upon request all
work papers related to the engagements (including,
but not limited to, all substantive correspondence
exchanged regarding the reports) and all draft and
final reports delivered to LifePoint.
2. Billing Engagement. The Billing Engagement shall be
composed of the following types of reviews: a "DRG Claims
Review," a "Laboratory Claims Review," a "Systems Review," and
an Operations DRG Review." The Claims Reviews and
corresponding Reports are discussed in detail in Appendices A,
B, and C to this CIA, which are incorporated by reference.
a. DRG Claims Review.
i. DRG Claims Review. LifePoint shall
perform a Claims Review to identify any
overpayments through an appraisal of
inpatient discharges paid by Medicare DRG to
LifePoint. The Claims Reviews shall be
performed in accordance with the procedures
set forth in Appendix A to this CIA. The
Claims Reviews shall cover the two six-month
periods during each year covered by the
Billing Engagement. LifePoint will perform
Claims Reviews at a minimum of two hospitals
during each six-month period (for a minimum
of four hospitals each year.) The hospitals,
and the DRGs to be reviewed at each
hospital, will be chosen as set forth in
section III.D.2.c.
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ii. DRG Claims Review Report. LifePoint
shall prepare a report based upon each
Claims Review performed ("Claims Review
Report"). The Claims Review Report shall be
created in accordance with the procedures
set forth in Appendix A to this CIA.
iii. IRO Review. With respect to LifePoint's
Claims Reviews, the IRO will prepare a
report documenting the IRO's findings with
respect to the following procedures:
A. The IRO will obtain LifePoint's
workpapers and perform procedures to
test concurrence with the criteria
included in section III.D.2.c.
B. The IRO will select a random
sample of a minimum of 10% of the
Items reviewed by LifePoint pursuant
to the DRG Claims Review and
reperform LifePoint's workplan
steps.
b. Laboratory Claims Review.
i. Claims Review. LifePoint shall perform a
Claims Review to identify any overpayments
through an appraisal of outpatient
laboratory claims submitted by LifePoint to
the Medicare program and paid by Medicare.
The Claims Reviews shall be performed in
accordance with the procedures set forth in
Appendix A to this CIA. The Claims Reviews
shall cover the two six-month periods during
each year covered by the Billing Engagement.
LifePoint will perform Claims Reviews at a
minimum of two hospitals during each
six-month period (for a minimum of four
hospitals each year.) The hospitals, and the
tests to be reviewed at each hospital, will
be chosen as set forth in section III.D.2.c.
ii. Laboratory Claims Review Report.
LifePoint shall prepare a report based upon
each Laboratory Claims Review performed
("Claims Review Report"). The Claims Review
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Report shall be created in accordance with
the procedures set forth in Appendix A to
this CIA.
iii. IRO Review. With respect to LifePoint's
Laboratory Claims Review, the IRO will
prepare a report documenting the IRO's
findings with respect to the following
procedures:
A. The IRO will obtain LifePoint's
workpapers and perform procedures
to test concurrence with the
criteria set forth in section
III.D.2.c.
B. The IRO will select a random
sample of a minimum of 10% of the
Items reviewed pursuant to the
Laboratory Review and re-perform
LifePoint's workplan steps.
c. Selection of Hospitals for Claims Reviews.
i. DRG Claims Review Hospital Selection.
LifePoint shall select the two hospitals
subject to review during each six-month
period as follows:
A. The hospital that has the highest
percentage of Medicare focused DRGs,
as compared to total Medicare DRGs,
during the relevant six month period
under review, will be chosen.
(However, if a hospital has already
been selected under this process
during any of the immediately
preceding two reviews then the
hospital with the next highest
percentage shall be chosen instead).
B. One hospital will be randomly
selected using RAT-STATS. A
replacement hospitals should be
generated in case the hospital
randomly selected has already been
identified under section
III.d.2.C.i.A.
ii. Laboratory Claims Review Hospital
Selection. LifePoint shall select the two
hospitals subject to review during each
six-month period as follows:
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A. The hospital that has the highest
percentage of Medicare outpatient
laboratory services revenue, as
compared to total Medicare
outpatient services revenue, during
the relevant six month period, will
be chosen. (However, if a hospital
has already been selected under this
process during any of the
immediately preceding two reviews
then the hospital with the next
highest percentage shall be chosen
instead).
B. One hospital will be randomly
selected using RATSTATS. A
replacement hospital should be
generated in case the hospital
randomly selected has already been
identified under section
III.d.2.C.ii.A.
d. Systems Review. LifePoint shall review LifePoint's
billing and coding systems and/or operations (the
"Systems Review"). The Systems Review shall include
the reviews described in Appendix B for at least four
hospitals. The Systems Review shall consist of a
thorough review of the following as more specifically
described in Appendix B:
i. LifePoint's billing systems and/or
operations relating to claims submitted to
all Federal health care programs (including,
but not limited to, the operation of the
billing system, safeguards to ensure proper
claim submission and billing, and procedures
to correct inaccurate billing); and
ii. LifePoint's coding systems and/or
operations relating to claims submitted to
all Federal health care programs (including,
but not limited to, the process by which
claims are coded, safeguards to ensure
proper coding, and procedures to correct
inaccurate coding).
e. Systems Review Report. LifePoint shall prepare a
report based upon each Systems Review performed
("Systems Review Report"). The Systems Review Report
shall include LifePoint's findings and supporting
rationale regarding:
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i. all findings and recommendations
regarding LifePoint's billing systems and/or
operations;
ii. all findings and recommendations
regarding LifePoint's coding systems and/or
operations; and
iii. any recommendations LifePoint may have
to improve any of these systems, operations,
and processes.
f. Operational DRG Review. LifePoint shall review
LifePoint's DRG coding for hospital inpatients (the
"Operational DRG Review"). The Operational DRG Review
shall include the reviews described in Appendix C for
at least eight hospitals. The Operational DRG Review
shall consist of a thorough review of the DRG coding
operations (including a review of at least 50 DRG
claims at each hospital) as more specifically
described in Appendix C. Except for the fact that the
review of claims need not meet the statistical
confidence and precision parameters set forth in
Appendix A, the Operational DRG Review shall be
conducted in a manner consistent with Appendix A,
e.g., paid claims without supporting documentation
shall be considered an error and the total
reimbursement received by LifePoint for such Paid
Claim shall be deemed an Overpayment.
g. Operational DRG Review Report. LifePoint shall
provide to the OIG in its Annual Reports the
Executive Summaries related to the Operational DRG
Reviews. The Executive Summaries shall include a
summary of the Medicare and other Federal health care
program overpayments (including number of
overpayments, dollar amount of overpayments, and
percentage of paid dollars attributable to
overpayments) identified in each Operational DRG
Review. All other documents related to the
Operational DRG Reviews shall be available to the OIG
upon request.
3. Compliance Engagement.
a. Compliance Review. The IRO shall conduct a review
of LifePoint's compliance activities ("Compliance
Review"). The Compliance Review shall consist of a
review of LifePoint's
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compliance with the obligations set forth in each
section of this CIA.
b. Compliance Review Report. The IRO shall prepare a
report based upon the Compliance Review performed
(the "Compliance Review Report"). The Compliance
Review Report shall include the IRO's findings,
supporting rationale, and a summary of such findings
and rationale regarding LifePoint's compliance with
the terms of each section of the CIA, as applicable.
4. Validation Review. In the event the OIG has reason to
believe that: (a) LifePoint's Billing or Compliance Engagement fails to conform
to the requirements of this CIA or (b) the findings or Claims Review results are
inaccurate, the OIG may, at its sole discretion, conduct its own review to
determine whether the Billing and Compliance Engagement comply with the
requirements of the CIA and/or the findings or Claims Review results are
inaccurate. LifePoint agrees to pay for the reasonable cost of any such review
performed by the OIG or any of its designated agents so long as it is initiated
before one year after the final submission (as described in section II) is
received by the OIG.
E. Confidential Disclosure Program. LifePoint, pursuant to its
Compliance Program, has established a confidential disclosure program which
includes its Compliance Hotline, a toll-free telephone line, as a means to
enable individuals to report instances of noncompliance and/or make inquiries on
compliance issues. LifePoint shall continue to maintain a confidential
disclosure program, including a mechanism such as the Compliance Hotline, which
shall be available to all individuals for the purpose of reporting or inquiring
on matters of compliance with the Compliance Program, this CIA, and Federal
health care program requirements.
The Confidential Disclosure Program shall continue to have a non-retribution,
non-retaliation policy, and allow anonymous, confidential communications. Upon
receipt of a disclosure, the Compliance Officer (or designee) shall continue to
gather all information believed to be relevant from the disclosing individual.
The Compliance Officer (or designee) shall continue to make a preliminary, good
faith inquiry into the allegations set forth in every disclosure in order to
obtain 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,
LifePoint shall continue to conduct an internal review of the allegations set
forth in such a disclosure and ensure that proper follow-up is conducted.
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The Compliance Officer (or his or her designee) shall maintain a confidential
disclosure log, which shall include a record and summary of each disclosure
received, the status of the respective internal reviews, and any corrective
action taken in response to the internal reviews. The confidential disclosure
log shall be available to OIG upon request.
F. Ineligible Persons.
1. Definition. For purposes of this CIA, an "Ineligible
Person" shall be any individual or entity who: (a) is currently excluded,
debarred or otherwise ineligible to participate in the Federal health care
programs or in Federal procurement or non-procurement programs; or (b) has been
convicted of a criminal offense related to the provision of health care items or
services, but has not yet been excluded, debarred or otherwise declared
ineligible.
2. Screening Requirements. LifePoint shall not hire or engage
as contractors or grant staff privileges to any Ineligible Person. To prevent
hiring or contracting with any Ineligible Person, LifePoint shall screen all
prospective employees and prospective contractors prior to engaging their
services and screen physicians prior to granting staff privileges by: (a)
requiring applicants to disclose whether they are Ineligible Persons; and (b)
reviewing the General Services Administration's List of Parties Excluded from
Federal Programs (available through the Internet at xxxx://xxxx.xxxxx.xxx) and
the HHS/OIG List of Excluded Individuals/Entities (available through the
Internet at xxxx://xxx.xxx.xxx/xxx) (these lists will hereinafter be referred to
as the "Exclusion Lists").
3. Review and Removal Requirement. Within 90 days of the
effective date of this CIA, LifePoint shall review its list of current employees
and contractors and physicians with staff privileges against the Exclusion
Lists. Thereafter, LifePoint shall review the list semi-annually. In addition,
within 90 days of the effective date of this CIA, LifePoint shall require
employees, new or renewed contractors, and physicians with staff privileges to
disclose immediately any debarment, exclusion or other event that makes the
person an Ineligible Person. If LifePoint has notice that an employee,
contractor or physician with staff privileges has become an Ineligible Person,
LifePoint shall remove such person from responsibility for, or involvement with,
LifePoint's business operations related to the Federal health care programs and
shall remove such person from any position for which the person's salary or the
items or services rendered, ordered, or prescribed by the person are paid in
whole or part, directly or indirectly, by
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Federal health care programs or otherwise with Federal funds at least until such
time as the person is reinstated into participation in the Federal health care
programs.
4. Pending Charges and Proposed Exclusions. If LifePoint has
notice that an employee or contractor is charged with a criminal offense related
to any Federal health care program, or is proposed for exclusion during his or
her employment or contract, LifePoint shall take all appropriate actions to
ensure that the responsibilities of that employee or contractor have not and
shall not adversely affect the quality of care rendered to any beneficiary,
patient or resident, or the accuracy of any claims submitted to any Federal
health care program.
G. Notification of Government Investigation or Legal Proceedings.
Within 30 days of discovery, LifePoint shall notify OIG, in writing, of
any ongoing investigation or legal proceeding conducted or brought by a
governmental entity or its agents involving an allegation that LifePoint 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.
LifePoint shall also provide written notice to OIG within 30 days of the
resolution of the matter, and shall provide OIG with a description of the
findings and/or results of the proceedings, if any.
H. Reporting.
1. Overpayments
a. Definition of Overpayments. For purposes of this
CIA, an "overpayment" shall mean the amount of money
LifePoint has received in excess of the amount due
and payable under any Federal health care program
requirements. LifePoint may not subtract any
underpayments for purposes of determining the amount
of relevant "overpayments."
b. Reporting of Overpayments. If, at any time,
LifePoint identifies or learns of any overpayments,
LifePoint shall notify the payor (e.g., Medicare
fiscal intermediary or carrier) and repay any
identified overpayments within 30 days of
identification and take remedial steps within 60 days
of identification (or such additional time as may be
agreed to by the payor) to correct the problem,
including
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preventing the underlying problem and the
overpayments from recurring. Also, within 30 days of
identification of the overpayment, LifePoint shall
repay the overpayment to the appropriate payor to the
extent such overpayment has been quantified
(submission of corrected bills in conformance with
payor policy within 30 days fulfills this
requirement). If not yet quantified, within 30 days
of identification, LifePoint 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
contractor should be done in accordance with the
contractor policies. For Medicare overpayments the
notice to the contractor must include the information
contained on the Overpayment Refund Form, attached to
this CIA, unless such information is not required by
the contractor.
2. Reportable Events.
a. Definition of Reportable Event. For purposes of
this CIA, a "Reportable Event" means anything that
involves:
(i) a substantial overpayment; or
(ii) a matter that a reasonable person would
consider a potential violation of criminal,
civil, or administrative laws applicable to
any Federal health care program for which
penalties or exclusion may be authorized.
A Reportable Event may be the result of an isolated
event or a series of occurrences.
b. Reporting of Reportable Events. If LifePoint
determines that there is a Reportable Event,
LifePoint shall notify OIG, in writing, within 30
days of making the determination that the Reportable
Event exists. The report to the OIG shall include the
following information:
(i) If the Reportable Event results in an
overpayment, the report to the OIG shall be
made at the same time as the notification to
the payor required in section III.H.1, and
shall
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include all of the information on the
Overpayment Refund Form, provided as
Appendix E to this CIA, as well as:
(A) the payor's name, address, and
contact person to whom the
overpayment was sent; and
(B) the date of the check and
identification number (or electronic
transaction number) on which the
overpayment was repaid/refunded;
(ii) a complete description of the
Reportable Event, including the relevant
facts, persons involved, and legal and
Federal health care program authorities
implicated;
(iii) a description of LifePoint's actions
taken to correct the Reportable Event; and
(iv) any further steps LifePoint plans to
take to address the Reportable Event and
prevent it from recurring.
IV. NEW BUSINESS UNITS OR LOCATIONS
In the event that LifePoint: (1) purchases or establishes a new
hospital, freestanding ambulatory surgery center, home health agency, or another
line of business that provides services that are billed to Federal health care
programs; or (2) sells or divests an existing hospital, freestanding ambulatory
surgery center, or home health agency, LifePoint shall notify OIG of this fact
within 30 days of the date of purchase, establishment, sale, or divestiture.
This notification shall include the location of the operation(s), telephone
number, fax number, Federal health care program provider number(s) (if any), and
the corresponding payor(s) (contractor specific) that has issued each provider
number. All Covered Persons at new locations shall be subject to the
requirements in this CIA that apply to new Covered Persons (e.g., completing
certifications and undergoing training). If LifePoint sells all of the assets
related to a location, then that location shall no longer be considered part of
LifePoint for the purposes of this CIA. If the location is still owned or
operated in whole or in part by LifePoint or any of its subsidiaries,
affiliates, or their successors, then the location shall continue to be
considered part of LifePoint for the purposes of this CIA.
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V. IMPLEMENTATION AND ANNUAL REPORTS
A. Implementation Report. Within 120 days after the effective date of
this CIA, LifePoint shall submit a written report to OIG summarizing the status
of its implementation of the requirements of this CIA. This Implementation
Report shall include:
1. the name, title, address, facility name (if applicable),
and telephone number of all of the individuals who are in
positions, or on committees, described in section III.A
(except that with respect to section III.A.6 only, the
Compliance Officer shall certify that the Hospital Committees
are in place as required and the information otherwise
required by this section shall be available to the OIG upon
request);
2. a copy of all Policies and Procedures required by section
III.B.2 that have not been previously provided to the OIG;
3. a description of the training required by section III.C,
including a description of the targeted audiences and a
schedule of when the training sessions were held;
4. a certification by the Compliance Officer that, except as
set forth in the Implementation Report:
a. the Policies and Procedures required by section
III.B have been developed and implemented, and have
been distributed to all pertinent Covered Persons;
b. all Covered Persons have completed the Code of
Conduct certification required by section III.B.1;
and
c. all Covered Persons required to have received
training have completed the training and executed the
certification required by section III.C;
5. the identity of the Independent Review Organization(s) and
the proposed start and completion date of the first set of
reviews;
6. a summary of personnel actions taken pursuant to section
III.F.
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7. a list of all of LifePoint's locations (including physical
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 provider
identification number(s), and the contractor's name and
address that issued each provider identification number; and;
8. To the extent not already furnished to OIG, or if modified,
a description of LifePoint's corporate structure, including
identification of any parent, sister, and other related
companies, subsidiaries and their respective lines of
business.
9. the certification required by section V.C.
B. Annual Reports. LifePoint shall submit to OIG Annual Reports with
respect to the status of and findings regarding of LifePoint's compliance
activities for each of the calendar years from 2001 through and including 2005.
The first Annual Report shall cover the time period from the effective date of
the CIA through December 31, 2001. (The one-year period covered by each Annual
Report shall be referred to as "the Reporting Period").
Each Annual Report shall include:
1. any change in the identity, title, address, facility name
(if applicable), telephone number, and position description of
all of the individuals who are in positions, or on committees,
described in section III.A (except that with respect to
section III.A.6 only, the Compliance Officer shall certify
that the Hospital Committees are in place as required and the
information otherwise required by this section shall be
available to the OIG upon request);
2. a certification by the Compliance Officer that, except as
set forth in the Annual Report:
a. all Covered Persons have completed the annual Code
of Conduct certification required by section III.B.1;
and
b. all Covered Persons have completed the training
and executed the certification required by section
III.C;
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(the documentation supporting this certification shall be
available to OIG, upon request);
3. 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);
4. a description of the training required by section III.C
conducted during the Reporting Period, including a description
of the targeted audiences, length of sessions, which sessions
were mandatory and for whom, percentage of completion of
requirement by those required to attend, and a schedule of
when the training sessions were held;
5. a complete copy of all reports prepared pursuant to the
Review Procedures referenced in III.D, including a copy of the
methodology used, along with a copy of the IRO's engagement
letter;
6. LifePoint's response and corrective action plan(s) related
to any issues raised by the IRO or LifePoint's Internal Audit
and Compliance Department;
7. a summary of Reportable Events (as defined in III.H)
identified during the Reporting Period and the status of any
corrective and preventative action relating to all such
Reportable Events;
8. a report of the aggregate overpayments that have been
returned to the Federal health care programs. Overpayment
amounts should be broken down into the following categories:
inpatient Medicare, outpatient Medicare, Medicaid (report each
applicable state separately), and other Federal health care
programs;
9. a summary of the disclosures in the confidential disclosure
log required by section III.E that: (a) relate to Federal
health care programs; or (b) allege abuse or neglect of
patients;
10. a description of any personnel actions (other than hiring)
taken by LifePoint as a result of the obligations in section
III.F, and the name, title, and responsibilities of any person
that falls within the ambit of section
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III.F.4, and the actions taken in response to the obligations
set forth in that section;
11. 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;
12. a description of all changes to the most recently provided
list (as updated) of LifePoint's locations (including
locations and mailing addresses) as required by section V.A.7,
the corresponding name under which each location is doing
business, the corresponding phone numbers and fax numbers,
each location's Federal health care program provider
identification number(s), and the contractor name and address
that issued each provider identification number; and
13. the certification required by section V.C.
The first Annual Report shall be received by the OIG no later than May
1, 2002. Subsequent Annual Reports shall be received by OIG no later than May 1
of the calendar year following the year covered by the Annual Report.
C. Certifications. The Implementation Report and Annual Reports shall
include a certification by the Compliance Officer that: (1) except as otherwise
described in the applicable report, LifePoint is in compliance with all of the
requirements of this CIA, to the best of his or her knowledge; and (2) the
Compliance Officer has reviewed the Report and has made reasonable inquiry
regarding its content and believes that the information is accurate and
truthful.
D. Designation of Information: LifePoint 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
exempt from disclosure under the Freedom of Information Act ("FOIA"), 5 U.S.C.
ss. 552. LifePoint shall refrain from identifying any information as exempt from
disclosure if that information does not meet the criteria for exemption from
disclosure under FOIA.
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VI. NOTIFICATIONS AND SUBMISSION OF REPORTS
Unless otherwise stated in writing after the effective date of this
CIA, all notifications and reports required under this CIA shall be submitted to
the following entities:
OIG:
Civil Recoveries Branch - Compliance Unit
Office of Counsel to the Inspector General
Office of Inspector General
U.S. Department of Health and Human Services
Xxxxx Building, Room 5527
000 Xxxxxxxxxxxx Xxxxxx, XX
Xxxxxxxxxx, XX 00000
Phone 000.000.0000
Fax 000.000.0000
LifePoint:
Xxxx X. Xxxx
Vice President, Audit and Compliance
000 Xxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Phone 000.000.0000
Fax 000.000.0000
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.
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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 LifePoint's books, records, and other documents and supporting
materials and/or conduct on-site reviews of any of LifePoint's locations for the
purpose of verifying and evaluating: (a) LifePoint's compliance with the terms
of this CIA; and (b) LifePoint's compliance with the requirements of the Federal
health care programs in which it participates. The documentation described above
shall be made available by LifePoint 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 LifePoint'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. LifePoint agrees to assist OIG or
its duly authorized representative(s) in contacting and arranging interviews
with such individuals upon OIG's request. LifePoint's employees may elect to be
interviewed with or without a representative of LifePoint present.
VIII. DOCUMENT AND RECORD RETENTION
In addition to any other requirements for record retention, LifePoint
shall maintain for inspection all documents and records: (1) related to
reimbursement from the Federal health care programs for at least five years
after the submission of the request for reimbursement (or longer if otherwise
required); and (2) necessary to establish LifePoint's compliance with this CIA
for at least three years following the submission of the Annual Report covering
the relevant year. Imaged copies of documents shall satisfy this requirement.
IX. DISCLOSURES
Consistent with HHS's FOIA procedures, set forth in 45 C.F.R. Part 5,
the OIG shall make a reasonable effort to notify LifePoint prior to any release
by OIG of information submitted by LifePoint pursuant to its obligations under
this CIA and identified upon submission by LifePoint as trade secrets, or
information that is commercial or financial and privileged or confidential,
under the FOIA rules. With respect to such releases, LifePoint shall have the
rights set forth at 45 C.F.R. ss. 5.65(d). LifePoint shall refrain from
identifying any information as exempt from release if that information does not
meet the criteria for exemption from disclosure under FOIA.
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X. BREACH AND DEFAULT PROVISIONS
LifePoint 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, LifePoint and OIG hereby agree that failure to comply
with certain obligations 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 LifePoint
fails to have in place any of the following:
a. all of the personnel and committees required in
section III.A;
b. a written Code of Conduct as described by section
III.B.1;
c. written Policies and Procedures as described by
section III.B.2;
d. a requirement that Covered Persons be trained as
described in section III.C; and
e. a Confidential Disclosure Program as described in
section III.E.
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 LifePoint
fails to retain an IRO, as required in section III.D.
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 LifePoint
fails to meet any of the deadlines for the submission of the Implementation
Report or the Annual Reports to OIG.
4. A Stipulated Penalty of $2,000 (which shall begin to accrue
on the date the failure to comply began) for each day LifePoint employs,
contracts with, or grants staff privileges to an Ineligible Person and that
person: (i) has responsibility for, or involvement with, LifePoint's business
operations related to the Federal health care programs; or (ii) is in a position
for which the person's salary or the items or services rendered, ordered, or
prescribed by the person are paid in whole or part, directly or indirectly, by
Federal health care programs or otherwise with Federal funds (the
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Stipulated Penalty described in this paragraph shall not be demanded for any
time period during which LifePoint can demonstrate that it did not discover the
person's exclusion or other ineligibility after making a reasonable inquiry (as
described in section III.F) as to the status of the person).
5. A Stipulated Penalty of $1,500 for each day LifePoint fails
to grant access to the information or documentation as required in section VII
of this CIA. (This Stipulated Penalty shall begin to accrue on the date
LifePoint fails to grant access.)
6. A Stipulated Penalty of $1,000 (which shall begin to accrue
10 days after the date that OIG provides notice to LifePoint of the failure to
comply) for each day LifePoint fails to comply fully and adequately with any
obligation of this CIA, where the failure to comply does not form the basis for
Stipulated Penalties under the provisions of section X.A.1 through X.A.5. In its
notice to LifePoint, OIG shall state the specific grounds for its determination
that the LifePoint has failed to comply fully and adequately with the CIA
obligation(s) at issue. With respect to the Stipulated Penalty provision
described in this section X.A.6 only, the OIG shall not seek a Stipulated
Penalty if LifePoint demonstrates to the OIG's satisfaction that the alleged
failure to comply could not be cured within the 10-day period, but that: (i)
LifePoint has begun to take action to cure the failure to comply, (ii) LifePoint
is pursuing such action with due diligence, and (iii) LifePoint has provided to
OIG a reasonable timetable for curing the failure to comply.
B. Timely Written Requests for Extensions. LifePoint 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 LifePoint 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 two business days after LifePoint 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.
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C. Payment of Stipulated Penalties.
1. Demand Letter. Upon a finding that LifePoint 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
LifePoint of: (a) LifePoint's failure to comply; and (b) the OIG's exercise of
its contractual right to demand payment of the Stipulated Penalties (this
notification is hereinafter referred to as the "Demand Letter").
2. Response to Demand Letter. Within 10 days of the receipt of
the Demand Letter, LifePoint 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 LifePoint elects to request an ALJ hearing,
the Stipulated Penalties shall continue to accrue until LifePoint 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.
3. Form of Payment. Payment of the Stipulated Penalties shall
be made by certified or cashier's check, payable to: "Secretary of the
Department of Health and Human Services," and submitted to OIG at the address
set forth in section VI.
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
LifePoint 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. Monetary Penalty for Material Breach of this CIA.
1. Definition of Material Breach. A material breach of this
CIA means:
a. a failure by LifePoint to report a Reportable
Event, take corrective action and make the
appropriate refunds, as required in section III.H.2;
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b. a repeated or flagrant violation of the
obligations under this CIA, including, but not
limited to, the obligations addressed in section X.A;
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 retain and use an Independent Review
Organization in accordance with section III.D.
2. Notice of Material Breach and Intent to Impose Material
Breach Penalty. The parties agree that a material breach of this CIA by
LifePoint constitutes grounds for OIG to impose an enhanced stipulated penalty
that is separate and apart from the Stipulated Penalties described in Sections
X.A-B, above. This monetary penalty (hereinafter referred to as the "Material
Breach Penalty") shall be $25,000 per day. Upon a determination by OIG that
LifePoint has materially breached this CIA and that a Monetary Penalty should be
imposed, OIG shall notify LifePoint of: (a) LifePoint's material breach; and (b)
OIG's intent to exercise its contractual right to impose the Material Breach
Penalty (this notification is hereinafter referred to as the "Notice of Material
Breach").
3. Opportunity to Cure. LifePoint shall have 30 days from the
date of receipt of the Notice of Material Breach to demonstrate to OIG's
satisfaction that:
a. LifePoint is in full compliance with this CIA;
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) LifePoint has begun
to take action to cure the material breach; (ii)
LifePoint is pursuing such action with due diligence;
and (iii) LifePoint has provided to OIG a reasonable
timetable for curing the material breach.
4. Penalty Letter. If at the conclusion of the 30-day period,
LifePoint fails to satisfy the requirements of section X.D.3, OIG may impose the
Material Breach Penalty on LifePoint, and the Material Breach Penalty shall
begin to accrue on that day. OIG will notify LifePoint in writing of its
determination to impose the Material Breach Penalty (this letter shall be
referred to hereinafter as the "Material Breach Penalty
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Letter"). Within 15 days of receipt of the Material Breach Penalty Letter,
LifePoint shall either: (a) cure the material breach to OIG's satisfaction and
pay the applicable Material Breach Penalty; or (b) request a hearing before an
HHS administrative law judge ("ALJ") to dispute OIG's determination of material
breach, pursuant to the agreed upon provisions set forth below in Section X.E.
E. Dispute Resolution
1. Review Rights. Upon OIG's delivery to LifePoint of its
Demand Letter or of its Material Breach Penalty Letter, and as an agreed-upon
contractual remedy for the resolution of disputes arising under this CIA,
LifePoint shall be afforded certain review rights comparable to the ones that
are provided in 42 U.S.C. ss. 1320a-7(f) and 42 C.F.R. Part 1005 as if they
applied to the Stipulated Penalties or Material Breach Penalty sought pursuant
to this CIA. Specifically, OIG's determination to demand payment of Stipulated
Penalties or Material Breach Penalty shall be subject to review by an ALJ and,
in the event of an appeal, the Departmental Appeals Board ("DAB"), in a manner
consistent with the provisions in 42 C.F.R. xx.xx. 1005.2-1005.21.
Notwithstanding the language in 42 C.F.R. ss. 1005.2(c), the request for a
hearing involving Stipulated Penalties shall be made within fifteen (15) days of
the date of the Demand Letter or the Material Breach Penalty Letter.
2. Stipulated Penalties Review. Notwithstanding any provision
of Title 42 of the United States Code or Chapter 42 of the Code of Federal
Regulations, the only issues in a proceeding for Stipulated Penalties under this
CIA shall be: (a) whether LifePoint was in full and timely compliance with the
obligations of this CIA for which the OIG demands payment; and (b) the period of
noncompliance. LifePoint shall have the burden of proving its full and timely
compliance and the steps taken to cure the noncompliance, if any. If the ALJ
agrees with OIG with regard to a finding of a breach of this CIA and orders
LifePoint to pay Stipulated Penalties, such Stipulated Penalties shall become
due and payable 20 days after the ALJ issues such a decision unless LifePoint
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. Material Breach Penalty Review. Notwithstanding any
provision of Title 42 of the United States Code or Chapter 42 of the Code of
Federal Regulations, the only issues in a proceeding for a Material Breach
Penalty shall be:
a. whether LifePoint was in material breach of this
CIA;
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b. whether such breach was continuing on the date of
the Material Breach Penalty Letter; and
c. whether the alleged material breach could not have
been cured within the 30 day period, but that:
(i) LifePoint had begun to take action to
cure the material breach within that period;
(ii) LifePoint has pursued and is pursuing
such action with due diligence; and
(iii) LifePoint provided to OIG within that
period a reasonable timetable for curing the
material breach and LifePoint has followed
the timetable.
If the ALJ finds for OIG with regard to a finding of a material breach of this
CIA and orders LifePoint to pay a Material Breach Penalty, such Material Breach
Penalty shall become due and payable 20 days after the ALJ issues such a
decision notwithstanding that LifePoint may request review of the ALJ decision
by the DAB.
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.
XI. UNALLOWABLE COSTS
LifePoint agrees that all costs (as defined in the Federal Acquisition
Regulations ("FAR") ss. 31.205-47 and in Titles XVIII and XIX of the Social
Security Act, 42 U.S.C. xx.xx. 1395-1395ggg (1997) and 1396-1396v (1997)), and
the regulations promulgated thereunder) incurred by or on behalf of LifePoint in
connection with: (1) LifePoint's investigation, defense, and corrective actions
undertaken in response to the Government's audit(s) and civil and criminal
investigation(s) in connection with the matters covered by the Settlement
Agreement with HCA (including attorney's fees); (2) the negotiation of this CIA;
and (3) the obligations under this CIA to: (i) perform Review Procedures as
described in section III.D (except to the extent that such Review Procedures are
performed by LifePoint); and (ii) prepare and submit reports to the OIG-HHS, are
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unallowable costs on Government contracts and under the Medicare Program,
Medicaid Program, TRICARE Program, Veterans Affairs Program (VA) and Federal
Employee Health Benefits Program (FEHBP) (hereafter, "unallowable costs"). These
unallowable costs will be separately estimated and accounted for by LifePoint,
and LifePoint will not charge such unallowable costs directly or indirectly to
any contracts with the United States or any state Medicaid program, or seek
payment for such unallowable costs through any cost report, cost statement,
information statement or payment request submitted by LifePoint or any of its
subsidiaries to the Medicare, Medicaid, TRICARE, VA or FEHBP programs. LifePoint
further agrees that within 60 days of the effective date of this CIA it will
identify to applicable Medicare and TRICARE fiscal intermediaries, carriers
and/or contractors, and Medicaid, VA and FEHBP fiscal agents, any unallowable
costs (as defined in this section) included in payments previously sought from
the United States, or any State Medicaid Program, including, but not limited to,
payments sought in any cost reports, cost statements, information reports, or
payment requests already submitted by LifePoint or any of its subsidiaries, and
will request, and agree, that such cost reports, cost statements, information
reports or payment requests, even if already settled, be adjusted to account for
the effect of the inclusion of the unallowable costs. LifePoint agrees that the
United States will be entitled to recoup from LifePoint any overpayment as a
result of the inclusion of such unallowable costs on previously-submitted cost
reports, information reports, cost statements or requests for payment. Any
payments due after the adjustments have been made shall be paid pursuant to the
direction of the OIG and/or the affected agencies. The OIG and/or the affected
agencies reserve their rights to disagree with any calculations submitted by
LifePoint or any of its subsidiaries on the effect of inclusion of unallowable
costs on LifePoint or any of its subsidiaries' cost reports, cost statements or
information reports. Nothing in this CIA shall constitute a waiver of the rights
of the OIG to examine or reexamine the unallowable costs described in this
Paragraph.
XII. EFFECTIVE AND BINDING AGREEMENT
LifePoint and OIG agree as follows:
A. This CIA shall be binding on the successors, assigns, and
transferees of LifePoint, consistent with the provisions of section IV of this
CIA;
B. This CIA shall become final and binding on the date the final
signature is obtained on the CIA;
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LifePoint Hospitals, Inc. 30
31
C. Any modifications to this CIA shall be made with the prior written
consent of the parties to this CIA;
D. This CIA is being entered into by LifePoint in contemplation of the
settlement between HCA and the United States. Through the settlement agreement
and this CIA, LifePoint hospitals will be entitled to the same release that
shall be provided to HCA facilities through the HCA settlement. In the event
that HCA and United States have not been able to reach a the above-contemplated
settlement on or before December 31, 2001, then this Agreement may be terminated
by LifePoint upon notice to OIG, and thereafter, this Agreement shall be of no
further force and effect; and
E. The undersigned LifePoint 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.
Corporate Integrity Agreement:
LifePoint Hospitals, Inc. 31
32
ON BEHALF OF LIFEPOINT
/s/ Xxxxx X. Xxxxxxxxx, Xx. December 20, 2000
------------------------------------- --------------------------
XXXXX X. XXXXXXXXX, XX. DATE
Chairman and Chief Executive Officer
LifePoint Hospitals, Inc.
/s/ Xxxx Xxxx December 20, 2000
------------------------------------- --------------------------
XXXX XXXX DATE
Vice President, Audit and Compliance
LifePoint Hospitals, Inc.
Corporate Integrity Agreement:
LifePoint Hospitals, Inc. 32
33
ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL
OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
/s/ Xxxxx Xxxxxx December 21, 2000
------------------------------------- --------------------------
XXXXX XXXXXX DATE
Assistant Inspector General for Legal Affairs
Office of Inspector General
U. S. Department of Health and Human Services
Corporate Integrity Agreement:
LifePoint Hospitals, Inc. 33
