CORPORATE INTEGRITY AGREEMENT
BETWEEN THE
OFFICE OF INSPECTOR GENERAL
OF THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND
MIM CORPORATION
I. PREAMBLE
MIM Corporation ("MIM") 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 ensure compliance with
the requirements of Medicare, Medicaid and all other Federal health care
programs (as defined in 42 U.S.C. ss. 1320a-7b(f)) (hereinafter collectively
referred to as the "Federal health care programs"), by MIM, its subsidiaries,
and their employees and agents, including independent contractors, who provide a
health care item or service paid for directly or indirectly by a Federal health
care program (hereinafter, "Covered Persons"). Pharmacy networks for whom MIM
provides pharmacy benefit management services are not Covered Persons. MIM's
compliance with the terms and conditions in this CIA shall constitute an element
of MIM's present responsibility with regard to participation in the Federal
health care programs. Contemporaneously with this CIA, MIM is entering into a
Settlement
1
Agreement with the United States, and this CIA is incorporated by reference into
the Settlement Agreement.
On November 5, 1999, MIM provided to the OIG a copy of MIM's
compliance manual entitled MIM Corporation, LEGAL AND ETHICAL POLICIES,
COMPLIANCE MANUAL, October 1999 ("the MIM Compliance Manual"). The MIM Corporate
Integrity Program described herein is intended to supplement MIM's compliance
efforts and policies described in the MIM Compliance Manual. MIM's Compliance
Manual makes clear that if there should be an inconsistency between the
Compliance Manual and this CIA, the CIA shall control. If MIM becomes aware of
any remaining inconsistencies, MIM shall amend the MIM Compliance Manual to
conform to the CIA.
II. TERM OF THE CIA
The period of the compliance obligations assumed by MIM under this
CIA shall be five (5) years from the effective date of this CIA (unless
otherwise specified). The effective date of this CIA will be the date on which
the final signatory of this CIA executes this CIA (the "effective date").
III. CORPORATE INTEGRITY OBLIGATIONS
MIM shall establish a compliance program that includes the following
elements.
A. COMPLIANCE OFFICER. The MIM Compliance Manual identifies MIM's
Compliance Officer (see, MIM Compliance Manual, section 1). For at least the
duration of this CIA, MIM shall continue to employ an individual to serve as
Compliance Officer,
2
who shall be responsible for developing and implementing policies, procedures,
and practices designed to ensure compliance with the requirements set forth in
this CIA and with the requirements of the Federal health care programs. For at
least the duration of this CIA, the Compliance Officer shall continue to be a
member of senior management of MIM, shall make regular (at least quarterly)
reports regarding compliance matters directly to the CEO and/or to the Board of
Directors of MIM and shall be authorized to report to the Board of Directors at
any time at his or her sole discretion. The Compliance Officer shall be
responsible for monitoring the day-to-day activities engaged in by MIM to
further its compliance objectives, as well as any reporting obligations created
under this CIA. In the event a new Compliance Officer is appointed during the
term of this CIA, MIM shall notify the OIG, in writing, within fifteen (15) days
of that person assuming the position.
B. WRITTEN STANDARDS. The MIM Compliance Manual establishes Policies
and Procedures including a Code of Conduct (see, MIM Compliance Manual, section
1). The MIM Compliance Manual also contains Statements of Corporate Policy that
establish Policies and Procedures in several areas, including the following: (1)
Compliance with Legal and Ethical Policies; (2) Reporting and Investigating
Suspected Violations of Legal and Ethical Policies; (3) Remedies and Sanctions
for Violations of Legal and Ethical Policies; (4) Compliance with Laws
Regulating Pharmacy Benefit Managers; (5) Conflicts of Interest; (6) Sanctioned
Individuals; (7) Contact with the Press and Government Agencies (see, MIM
Compliance Manual, sections 2, 3, 4, 5, 10, 15 and 20, respectively). The
Policies and Procedures specifically address the need to avoid conflicts of
interest and the payment or receipt of unlawful remuneration when soliciting or
referring business related to Federal health care programs. In addition, the
Policies and Procedures include disciplinary guidelines and methods for
employees to make disclosures or otherwise report on compliance issues to MIM
management through the Confidential Disclosure Program required by section
III.E, below.
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For at least the duration of this CIA, MIM shall maintain the
written Policies and Procedures regarding the operation of MIM's compliance
program and its compliance with all Federal and State health care statutes,
regulations and guidelines, including the requirements of the Federal health
care programs. The Policies and Procedures shall, at a minimum, set forth:
a. MIM's commitment to full compliance with all statutes,
regulations, and guidelines applicable to Federal health care
programs, including its commitment to prepare and submit accurate
xxxxxxxx consistent with Federal health care program regulations and
procedures or instructions otherwise communicated to MIM by the
Health Care Financing Administration ("HCFA") (or other appropriate
regulatory agencies) and the State of Tennessee and/or their
respective agents;
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b. MIM's requirement that all Covered Persons, when employed by or
doing business with MIM, shall be expected to comply with all
statutes, regulations, and guidelines applicable to Federal health
care programs and with MIM's own Policies and Procedures (including
the requirements of this CIA);
c. the requirement that all Covered Persons, when employed by or
doing business with MIM, shall be expected to report suspected
violations of any statute, regulation, or guideline applicable to
Federal health care programs or of MIM's own Policies and Procedures;
d. the possible consequences to both MIM and to any subsidiary or
Covered Person when employed by or doing business with MIM of failure
to comply with all statutes, regulations, and guidelines applicable
to Federal health care programs and with MIM's own Policies and
Procedures or of failure to report such non-compliance; and
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e. the right of all Covered Persons to use the confidential
disclosure program, as well as MIM's commitment to confidentiality
and non-retaliation with respect to disclosures.
Within one hundred and twenty (120) days of the effective date of
the CIA, each Covered Person shall certify, in writing, that he or she has
received, read, understands, and will abide by the Policies and Procedures set
forth in MIM's Compliance Manual. New Covered Persons shall receive the
Compliance Manual and shall complete the required certification within thirty
(30) days after the commencement of their employment or independent contract or
within one hundred and twenty (120) days of the effective date of the CIA,
whichever is later. In addition, MIM shall make the promotion of, and adherence
to, the Policies and Procedures an element in evaluating the performance of
managers, supervisors, and all other Covered Persons. MIM shall make compliance
staff and/or supervisors available to explain any and all Policies and
Procedures to any inquiring Covered Persons.
MIM will annually review the Policies and Procedures and will make
any necessary revisions. These revisions shall be distributed within thirty (30)
days of the effective date of any such change. Covered Persons shall certify on
an annual basis that they have received, read, understand and will abide by the
Policies and Procedures set forth in the Compliance Manual. A summary of the
Policies and Procedures will be provided to OIG in the Implementation Report.
The Policies and Procedures will be available to OIG upon request.
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C. TRAINING AND EDUCATION.1
1. General Training. Within one hundred and twenty (120) days of the
effective date of this CIA, MIM shall provide at least one (1) hour of "General
Training," as described below, to each Covered Person. This General Training
shall explain:
a. MIM's Corporate Integrity Agreement requirements;
b. MIM's Compliance Program (including the Policies and
Procedures as they pertain to general compliance issues);
c. fraud and abuse risk areas that pertain to pharmacy
benefit managers, particularly those that contract with
managed care organizations.
General Training materials shall be made available to the OIG, upon request.
New Covered Persons shall receive the General Training described
above within thirty (30) days of the beginning of their employment or within one
hundred and twenty (120) days after the effective date of this CIA, whichever is
later. Each Covered Person shall receive retraining in General Training on an
annual basis.
1/ The training and education requirements of this CIA do not apply to agents
and independent contractors in the case of short-term workers who are not
reasonably expected to work more than one month, except to the extent that such
individual actually works in excess of one month during a 12-month period.
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2. Specific Training. Within one hundred and twenty (120) days of the
effective date of this CIA, each Covered Person who is involved directly or
indirectly in one or more of the following activities shall receive training as
described in Attachment A hereto (Training Breakdown), in addition to the
general training required above to address the fraud and abuse risk areas that
he or she should consider when carrying out one or more of the following
activities:
a. processing claims and pharmacy auditing;
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b. negotiating with pharmaceutical manufacturers,
distributors or retailers;
c. handling physician and consumer problems with the
formulary and/or the drug benefit in question;
d. managing compliance with the applicable drug formulary
(including, but not limited to, processing medically
necessary exception requests);
e. providing disease management services; or
f. collecting utilization data for a managed care
organization or other applicable payor(s);
g. sales and marketing;
h. supervision of claims processing personnel; or
i. supervision of non-claims processing personnel.
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At a minimum, this Specific Training shall include a discussion of the
following:
a. the applicable reimbursement rules and principles of the
Federal health care program(s) in question;
b. the legal sanctions for improper xxxxxxxx to Federal
health care programs;
c. the prohibition against improper claims processing for
Federal health care programs, including but not limited to
the failure to process claims or inexcusable delay in
processing claims;
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d. the prohibitions against paying or receiving remuneration
to induce referrals as they relate to Federal health care
programs;
e. the issues of medical necessity and overutilization in the
fee-for-service context and underutilization in the
managed care context;
f. special issues related to pharmacy benefit management
companies in Federal health care programs and their
relationships with managed care organizations,
pharmaceutical manufacturers, pharmacists, physicians and
beneficiaries; and
g. the legal sanctions for making false statements in
connection with Federal health care programs.
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Specific Training materials shall be made available to OIG, upon request.
Persons providing the Specific Training must be knowledgeable about the subject
areas. New Covered Persons shall receive the Specific Training described above
within thirty (30) days of the beginning of their employment or within one
hundred and twenty (120) days after the effective date of this CIA, whichever is
later. Each year, every Covered Person subject to these Specific Training
requirements shall receive annual retraining in the subject areas described
above for a period of time that is at least half of the Specific Training
requirement for applicable new Covered Persons, but in no event will the
Specific Training retraining be less than one hour.
3. Certification. Each Covered Person shall certify, in writing, that
he or she has attended the required training. The certification shall specify
the type of training received and the date received. The Compliance Officer
shall retain the certifications, along with specific course materials. These
shall be made available to OIG upon request.
D. REVIEW PROCEDURES. MIM shall retain one or more entity(ies), such
as accounting, auditing, law (as appropriate), or consulting firm(s)
(hereinafter "Independent Review Organization(s)"), to perform review procedures
to assist MIM in assessing the adequacy of its drug benefit management and
compliance practices pursuant to this CIA. This shall be an annual requirement
and shall cover a twelve (12) month period. The Independent Review Organization
must have expertise in the claims processing, formulary management, reporting
and other requirements of the Federal health care programs from which MIM seeks
reimbursement either directly or indirectly. The Independent Review Organization
must be retained to conduct the audit of the first year within one hundred and
twenty (120) days of the effective date of this CIA.
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The Independent Review Organization will conduct two separate
engagements. One will be an analysis of MIM's claims processing, formulary
management, reporting and other requirements of the Federal health care programs
to assist MIM and OIG in determining compliance with all applicable statutes,
regulations, and directives/guidance ("drug-benefit management engagement"). The
second engagement will determine whether MIM is in compliance with this CIA
("compliance engagement").
1. Drug-Benefit Management Engagement. The drug-benefit management
engagement shall consist of a review of a statistically valid sample of claims
that can be projected to the population of claims for Federal health care
programs processed by MIM for the relevant period. The sample size shall be
determined through the use of a probe sample. At a minimum, the full sample must
be within a ninety (90) percent confidence level and a precision of twenty-five
(25) percent. The probe sample must contain at least thirty (30) sample units
and cannot be used as part of the full sample. Both the probe sample and the
sample must be selected through random numbers. MIM shall use OIG's Office of
Audit Services Statistical Sampling Software, also known as "RAT-STATS," which
is available through the Internet at "xxx.xxx.xxx/xxxxxxx/xxx/xxxxxxx.xxxx".
Each annual drug-benefit management engagement analysis shall include
the following components in its methodology:
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a. Drug-Benefit Management Engagement Objective: A statement
stating clearly the objective intended to be achieved by
the drug-benefit management engagement and the procedure
or combination of procedures that will be applied to
achieve the objective.
b. Drug-Benefit Management Engagement Population: Identify
the population, which is the group about which information
is needed. Explain the methodology used to develop the
population and provide the basis for this determination.
c. Sources of Data: Provide a full description of the source
of the information upon which the drug benefit management
engagement conclusions will be based, including the legal
or other standards applied, documents relied upon, payment
data, and/or any contractual obligations.
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d. Sampling Unit: Define the sampling unit, which is any of
the designated elements that comprise the population of
interest.
e. Sampling Frame: Identify the sampling frame, which is the
totality of the sampling units from which the sample will
be selected.
The drug-benefit management engagement shall provide:
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a. findings regarding the accuracy and integrity of MIM's
drug-benefit management system (including, but not limited
to, its strengths and weaknesses, internal controls, and
effectiveness);
b. findings regarding whether MIM is properly processing
claims reimbursed by Federal health care programs (i.e.,
properly reimbursing providers for goods and services
provided to Federal health care program beneficiaries).
c. findings regarding MIM's procedures to correct inaccurate
or untimely claims processing;
d. findings regarding any problems revealed by the audit
regarding MIM's contractual dealings with manufacturers,
distributors and retailers; and
e. findings regarding the steps MIM is taking to bring its
operations into compliance or to correct problems
identified by the audit.
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2. Compliance Engagement. An Independent Review Organization shall
also conduct a compliance engagement that shall provide findings regarding
whether MIM's program, policies, procedures, and operations comply with the
terms of this CIA. This engagement shall include section by section findings
regarding the requirements of this CIA.
A complete copy of the Independent Review Organization(s)'s
drug-benefit management engagement and compliance engagement shall be included
in each of MIM's Annual Reports to OIG.
3. Disclosure of Overpayments and Reportable Events. If, as a result
of these engagements, MIM or the Independent Review Organization(s) identifies
any claims processing, formulary management or other policies, procedures and/or
practices that result in an overpayment from or Reportable Event (defined in
section III.H) related to any Federal health care program or its agents, MIM
shall follow the Reporting procedures set forth below at section III.H.
4. Verification/Validation. In the event that the OIG determines that
it is necessary to conduct an independent review to determine whether or the
extent to which MIM is complying with its obligations under this CIA, upon
receipt of notice and explanation from the OIG of the need for such independent
review, MIM agrees to pay for the reasonable cost of any such review by the OIG
or any of its designated agents.
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E. CONFIDENTIAL DISCLOSURE PROGRAM. Within one-hundred twenty (120)
days after the effective date of this CIA, MIM shall implement (to the extent it
has not already done so) the Confidential Disclosure Program described at
Chapters 3 and 4 of its Compliance Manual, which program must include measures
(E.G., a toll-free compliance telephone line) to enable Covered Persons or other
individuals to disclose to the Compliance Officer or some other person who is
not in the reporting individual's chain of command, any identified issues or
questions associated with MIM's policies, practices or procedures with respect
to the Federal health care program, believed by the individual to be
inappropriate. As provided in MIM's Compliance Manual, all Covered Persons
working for MIM are required to report suspected legal or compliance violations.
In addition to describing the hotline in the MIM Compliance Manual, MIM shall
publicize the existence of the hotline (E.G., in e-mails to employees and by
posting the hotline number in prominent common areas).
The Confidential Disclosure Program shall emphasize a
NON-RETRIBUTION, NON-RETALIATION policy, and shall include a reporting mechanism
for ANONYMOUS, CONFIDENTIAL communication. Upon receipt of a complaint, the
Compliance Officer (or designee) shall gather the information in such a way as
to elicit all relevant information from the individual reporting the alleged
misconduct. 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, MIM shall conduct an internal review
of the allegations set forth in such a disclosure and ensure that proper
follow-up is conducted.
The Compliance Officer shall maintain a confidential disclosure log,
which shall include a record and summary of each allegation received, the status
of the respective investigations, and any corrective action taken in response to
the investigation.
F. INELIGIBLE PERSONS.
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1. Definition. For purposes of this CIA, an "Ineligible Person" shall
be any individual or entity who: (i) is currently excluded, suspended, debarred
or otherwise ineligible to participate in the Federal health care programs; or
(ii) has been convicted of a criminal offense related to the provision of health
care items or services and has not been reinstated in the Federal health care
programs after a period of exclusion, suspension, debarment, or ineligibility.
2. Screening Requirements. MIM shall not hire or engage as
contractors any Ineligible Person. To prevent hiring or contracting with any
Ineligible Person, MIM shall screen all prospective Covered Persons prior to
engaging their services by (i) requiring applicants to disclose whether they are
Ineligible Persons, and (ii) reviewing the General Services Administration's
List of Parties Excluded from Federal Programs (available through the Internet
at xxxx://xxx.xxxxx.xxx/xxxx) and the HHS/OIG Cumulative Sanction Report
(available through the Internet at xxxx://xxx.xxxx.xxx/xxxxxxx/xxx) (these lists
and reports will hereinafter be referred to as the "Exclusion Lists").
3. Review and Removal Requirement. Within ninety (90) days of the
effective date of this CIA, MIM will review its list of current Covered Persons
against the Exclusion Lists. Thereafter, MIM will review the list semi-annually.
If MIM has notice that a Covered Person has become an Ineligible Person, MIM
will remove such person from responsibility for, or involvement with, MIM'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 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.
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4. Pending Charges and Proposed Exclusions. If MIM has notice that a
Covered Person is charged with a criminal offense related to any Federal health
care program, or is suspended or proposed for exclusion during his or her
employment or contract with MIM, within 10 days of receiving such notice MIM
will remove such individual from responsibility for, or involvement with, MIM's
business operations related to the Federal health care programs until such
criminal action, suspension, or proposed exclusion is resolved.
G. NOTIFICATION OF PROCEEDINGS. Within thirty (30) days of discovery,
MIM shall notify OIG, in writing, of any ongoing investigation or legal
proceeding of which it is aware conducted or brought by a governmental entity or
its agents involving an allegation that MIM has committed a crime or has engaged
in fraudulent activities or any other knowing misconduct. 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.
MIM shall also provide written notice to OIG within thirty (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.
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1. Reporting of Overpayments. If, at any time, MIM identifies or
learns of any billing, coding or other policies, procedures and/or practices
that result in an overpayment, MIM shall notify the payor (E.G., TennCare
managed care organization or Medicaid agency or Medicare fiscal intermediary or
carrier, as applicable) using any prescribed form of such payor, within 30 days
of discovering that an overpayment has been made, and take remedial steps within
a time frame agreed to with the payor to correct the problem, including
preventing the underlying problem and the overpayments from recurring. Where the
payor has no prescribed form, the notice to the payor shall include:
a. a statement that the refund is being made pursuant to this
CIA;
b. a description of the complete circumstances surrounding
the overpayment;
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c. the methodology by which the overpayment was determined;
d. the amount of the overpayment;
e. any claim-specific information used to determine the
overpayment (E.G., beneficiary health insurance number,
claim number, --- service date, and payment date);
f. the provider identification number under which the
repayment is being made.
22
Where it is not feasible for MIM to include all such information in the notice
within the time frame specified, MIM shall specify in the notice the time frame
in which it can reasonably furnish this information to the payor.
2. Reporting of Reportable Events. If MIM determines that a
Reportable Event has occurred, MIM shall notify the OIG within 30 days of such
determination. If the Reportable Event results in an overpayment, MIM shall
notify the OIG at the same time as the notice to the payor and shall include all
of the information required by section III.H.1 plus: (i) the payor's name,
address, and contact person where the overpayment was sent; and (ii) the date of
the check and identification number (or electronic transaction number) on which
the overpayment was repaid. Regardless of whether the Reportable Event resulted
in an overpayment, MIM shall report to the OIG the following:
a. a complete description of the Reportable Event, including
the relevant facts, persons involved, and legal and
program authorities;
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b. MIM's actions to correct the Reportable Event; and
c. any further steps MIM plans to take to address such
Reportable Event and prevent it from recurring.
3. Definition of "Overpayment." For purposes of this CIA, an
"overpayment" shall mean the amount of money MIM has received in excess of the
amount due and payable pursuant to Federal health care programs' statutes,
regulations or program directives applicable to MIM, including carrier,
intermediary, Medicaid agency and TennCare managed care organization
instructions.
4. 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 are authorized.
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IV. NEW LOCATIONS
In the event that MIM purchases or establishes new business units
after the effective date of this CIA, MIM shall notify OIG of this fact within
thirty (30) days of the date of purchase or establishment. This notification
shall include the location of the new operation(s), phone 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 such locations shall be subject to the requirements in this CIA that
apply to new Covered Persons (E.G., completing certifications and undergoing
training).
V. IMPLEMENTATION AND ANNUAL REPORTS
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A. IMPLEMENTATION REPORT. Within one hundred and fifty (150) days
after the effective date of this CIA, MIM 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. any changes to the identity and position of the Compliance Officer
required by section III.A, from the description currently set forth
at Section 1 of the MIM Compliance Manual;
2. any further revisions made to MIM's Policies and Procedures set
forth in the MIM Compliance Manual in order to bring them into
compliance with this CIA;
3. a description of the training programs required by section III.C,
including a description of the targeted audiences and a schedule of
when the training sessions were held;
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4. a certification by the Compliance Officer that:
a. the Policies and Procedures required by section
III.B have been developed, are being
implemented, and have been distributed to all
pertinent Covered Persons;
b. all Covered Persons have completed the
Compliance Manual certification required by
section III.B; and
c. all Covered Persons have completed the training
and executed the certification required by
section III.C.
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5. a description of the confidential disclosure program required by
section III.E;
6. the identity of the Independent Review Organization(s) and the
proposed start and completion date of the first audit;
7. a summary of personnel actions taken pursuant to section III.F;
and
8. a summary of any reporting undertaken pursuant to sections
III.D.3. and/or III.H since the effective date of this CIA.
B. ANNUAL REPORTS. MIM shall submit to OIG an Annual Report with
respect to the status and findings of MIM's compliance activities.
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The Annual Reports shall include:
1. any change in the identity or position description of the
Compliance Officer described in section III.A;
2. a certification by the Compliance Officer that:
a. all Covered Persons have completed the annual
Compliance Manual certification required by
section III.B; and
b. all Covered Persons have completed the training
and executed the certification required by
section III.C.
3. notification of any changes or amendments to the Policies and
Procedures required by section III.B and the reasons for such
changes;
4. a complete copy of the report prepared pursuant to the Independent
Review Organization(s)'s drug-benefit management and compliance
engagement, including a copy of the methodology used;
5. MIM's response/corrective action plan to any issues raised by the
Independent Review Organization;
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6. a summary of the Reportable Events and misconduct reported
throughout the course of the previous twelve (12) months pursuant to
III.D.3 and III.H.
7. a report of the aggregate overpayments that have been returned to
the Federal health care programs that were discovered as a direct or
indirect result of implementing this CIA. Overpayment amounts should
be broken down into the following categories: Medicare, Medicaid
(report each applicable state separately), and other Federal health
care programs;
8. a copy of the confidential disclosure log required by section
III.E;
9. a description of any personnel action (other than hiring) taken by
MIM as a result of the obligations in section III.F;
10. a summary describing any ongoing investigation or legal
proceeding known to MIM conducted or brought by a governmental entity
involving an allegation that MIM has committed a crime or has engaged
in fraudulent activities, which should 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, legal proceeding or requests
for information;
11. a corrective action plan to address the probable violations of
law identified in section III.H; and
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12. a listing of all of MIM's locations (including locations and
mailing addresses), the corresponding name under which each location
is doing business, the corresponding phone numbers and fax numbers,
each location's Federal health care program provider identification
number(s) and the payor (specific contractor or State agency) that
issued each provider identification number.
The first Annual Report shall be received by the OIG no later than
one year and ninety (90) days after the effective date of this CIA. Subsequent
Annual Reports shall be submitted no later than sixty (60) days after the
anniversary date of the effective date of this CIA.
C. CERTIFICATIONS. The Implementation Report and Annual Reports shall
include a certification by the Compliance Officer under penalty of perjury,
that: (1) MIM 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,
upon such inquiry, the information is accurate and truthful.
VI. NOTIFICATIONS AND SUBMISSION OF REPORTS
Unless otherwise stated in writing subsequent to the effective date
of this CIA, all notifications and reports required under this CIA shall be
submitted to the entities listed below:
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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
MIM:
Xxxxx X. Xxxxxx, Esq.
Vice President & General Counsel
MIM Corporation
000 Xxxxxxxxxx Xxxx
Xxxxxxxx, XX 00000
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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 MIM's
books, records, and other documents and supporting materials for the purpose of
verifying and evaluating: (a) MIM's compliance with the terms of this CIA; and
(b) MIM's compliance with the requirements of the Federal health care programs
in which it participates. The documentation described above shall be made
available by MIM 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 MIM's Covered Persons 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.
MIM agrees to assist OIG in contacting and arranging interviews with such
Covered Persons upon OIG's request. MIM's employees may elect to be interviewed
with or without a representative of MIM present.
VIII. DOCUMENT AND RECORD RETENTION
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MIM shall maintain for inspection all documents and records relating
to reimbursement from the Federal health care programs or to compliance with
this CIA, one year longer than the term of this CIA (or longer if otherwise
required by law).
IX. DISCLOSURES
Subject to HHS's Freedom of Information Act ("FOIA") procedures, set
forth in 45 C.F.R. Part 5, the OIG shall make a reasonable effort to notify MIM
prior to any release by OIG of information submitted by MIM pursuant to its
obligations under this CIA and identified upon submission by MIM as trade
secrets, commercial or financial information and privileged and confidential
under the FOIA rules. MIM shall refrain from identifying any information as
trade secrets, commercial or financial information and privileged and
confidential that does not meet the criteria for exemption from disclosure under
FOIA.
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X. BREACH AND DEFAULT PROVISIONS
MIM is expected to fully and timely comply with all of the
obligations herein throughout the term of this CIA or other time frames herein
agreed to.
A. STIPULATED PENALTIES FOR FAILURE TO COMPLY WITH CERTAIN
OBLIGATIONS. As a contractual remedy, MIM 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, beginning
one-hundred twenty (120) days after the effective date of this CIA and
concluding at the end of the term of this CIA, MIM fails to have in place any of
the following:
a. a Compliance Officer;
b. written Policies and Procedures;
c. a training program; and
d. a Confidential Disclosure Program.
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2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the
day after the date the obligation became due) for each day MIM fails to meet any
of the deadlines to submit the Implementation Report or the Annual Reports to
the OIG.
3. A Stipulated Penalty of $2,000 (which shall begin to accrue on the
date the failure to comply began) for each day MIM:
a. hires or enters into a contract with an Ineligible Person after
that person has been listed by a federal agency as excluded, debarred, suspended
or otherwise ineligible for participation in the Medicare, Medicaid or any other
Federal health care program (as defined in 42 U.S.C. ss. 1320a-7b(f)) (this
Stipulated Penalty shall not be demanded for any time period during which MIM
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.2) as to the status of the person);
b. employs or contracts with an Ineligible Person and that person:
(i) has responsibility for, or involvement with, MIM'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 (this Stipulated Penalty shall not
be demanded for any time period during which MIM 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.3) as to the status of the person); or
c. employs or contracts with a person who: (i) has been charged with
a criminal offense related to any Federal health care program, or (ii) is
suspended or proposed for exclusion, and that person has responsibility for, or
involvement with, MIM's business operations related to the Federal health care
programs (this Stipulated Penalty shall not be demanded for any time period
before 10 days after MIM received notice of the relevant matter or after the
resolution of the matter as described in section III.F.4).
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4. A Stipulated Penalty of $1,500 (which shall begin to accrue on the
date MIM fails to grant access) for each day MIM fails to grant access to the
information or documentation as required in section VII of this CIA.
5. A Stipulated Penalty of $1,000 (which shall begin to accrue ten
(10) days after the date that OIG provides notice to MIM of the failure to
comply) for each day MIM fails to comply fully with any obligation of this CIA.
With respect to the Stipulated Penalty provision described in this section X.A.5
only, the OIG shall not seek a Stipulated Penalty if MIM demonstrates to the
OIG's satisfaction that the alleged failure to comply could not be cured within
the 10-day period, but that: (i) MIM has begun to take action to cure the
failure to comply, (ii) MIM is pursuing such action with due diligence, and
(iii) MIM has provided to the OIG a reasonable timetable for curing the failure
to comply.
B. PAYMENT OF STIPULATED PENALTIES.
1. Demand Letter. Upon a finding that MIM has failed to comply with
any of the obligations described in section X.A and determining that Stipulated
Penalties are appropriate, OIG shall notify MIM by personal service or certified
mail of (a) the specific grounds for its determination that MIM has failed to
comply fully with the CIA; 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").
Within ten (10) days of MIM's receipt of the Demand Letter, MIM shall
either (a) cure the breach to the OIG's satisfaction and pay the applicable
stipulated penalties; or (b) request a hearing before an HHS administrative law
judge ("ALJ") to dispute the OIG's determination of noncompliance, pursuant to
the agreed upon provisions set forth below in section X.D. In the event MIM
elects to request an ALJ hearing, the Stipulated Penalties shall continue to
accrue until MIM cures, to the 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.C.
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2. Timely Written Requests for Extensions. MIM may 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 MIM fails to meet the revised deadline as agreed to by the OIG-approved
extension. 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 (2)
business days after MIM receives OIG's written denial of such request. A "timely
written request" is defined as a request in writing received by OIG at least
five (5) 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.
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
otherwise noted, these provisions for payment of Stipulated Penalties shall not
affect or otherwise set a standard for the OIG's determination that MIM has
materially breached this CIA, which decision shall be made at the OIG's
discretion and governed by the provisions in section X.C, below.
C. EXCLUSION FOR MATERIAL BREACH OF THIS CIA
1. Notice of Material Breach and Intent to Exclude. The parties agree
that a material breach of this CIA by MIM constitutes an independent basis for
MIM's exclusion from participation in the Federal health care programs (as
defined in 42 U.S.C. ss. 1320a-7b(f)). Upon a determination by OIG that MIM has
materially breached this CIA and that exclusion should be imposed, the OIG shall
notify MIM by certified mail of (a) MIM's material breach; and (b) OIG's intent
to exercise its contractual right to impose exclusion (this notification is
hereinafter referred to as the "Notice of Material Breach and Intent to
Exclude").
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2. Opportunity to cure. MIM shall have thirty-five (35) days from the
date of the Notice of Material Breach and Intent to Exclude Letter to
demonstrate to the OIG's satisfaction that:
a. MIM 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 35-day period, but that: (i) MIM has
begun to take action to cure the material
breach, (ii) MIM is pursuing such action with
due diligence, and (iii) MIM has provided to
OIG a reasonable timetable for curing the
material breach.
3. Exclusion Letter. If at the conclusion of the thirty five (35) day
period, MIM fails to satisfy the requirements of section X.C.2, OIG may exclude
MIM from participation in the Federal health care programs. OIG will notify MIM
in writing of its determination to exclude MIM (this letter shall be referred to
hereinafter as the "Exclusion Letter"). The Exclusion Letter shall state the
specific grounds for the OIG's determination to exclude MIM. Subject to the
Dispute Resolution provisions in section X.D, below, the exclusion shall go into
effect thirty (30) days after the date of the Exclusion Letter. The exclusion
shall have national effect and will also apply to all other federal procurement
and non-procurement programs. If MIM is excluded under the provisions of this
CIA, MIM may seek reinstatement pursuant to the provisions at 42 C.F.R. xx.xx.
1001.3001-.3004.
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4. Material Breach. A material breach of this CIA means:
a. a failure by MIM to report a Reportable Event
known to MIM, take corrective action and pay
the appropriate refunds, as provided in section
III.D;
b. repeated or flagrant violations of the
obligations under this CIA, including, but not
limited to, the obligations addressed in
section X.A of this CIA;
c. a failure to respond to a Demand Letter
concerning the payment of Stipulated Penalties
in accordance with section X.B above; or
d. a failure to retain and use an Independent
Review Organization for review purposes in
accordance with section III.D.
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D. DISPUTE RESOLUTION
1. Review Rights. Upon the OIG's delivery to MIM of its Demand Letter
or of its Exclusion Letter, and as an agreed-upon contractual remedy for the
resolution of disputes arising under the obligation of this CIA, MIM 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 exclusion sought pursuant to this CIA. Specifically, the
OIG's determination to demand payment of Stipulated Penalties or to seek
exclusion 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 and the request for a hearing involving exclusion shall be made within
thirty (30) days of the date of the Exclusion 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 MIM was in full and timely compliance with the
obligations of this CIA for which the OIG demands payment; (b) the period of
noncompliance; and (c) with respect to a Stipulated Penalty authorized under
section X.A.5 only, whether the failure to comply could not be cured within the
10-day period, but that by the end of that period (i) MIM had begun to take
action to cure the failure to comply, (ii) MIM was and is pursuing such action
with due diligence, and (iii) MIM had provided to the OIG a reasonable timetable
for curing the material breach. MIM shall have the burden of proving its full
and timely compliance and the steps taken to cure the noncompliance, if any. If
the ALJ finds for the OIG with regard to a finding of a breach of this CIA and
orders MIM to pay Stipulated Penalties, such Stipulated Penalties shall become
due and payable twenty (20) days after the ALJ issues such a decision
notwithstanding that MIM may request review of the ALJ decision by the DAB. If
MIM requests review of the ALJ decision by the DAB, then MIM shall deposit the
Stipulated Penalties amount into an interest-bearing escrow account pending the
DAB's decision. If the DAB affirms the ALJ decision, the proceeds of the escrow
account shall be immediately due and payable to the OIG. If the DAB overturns
the ALJ decision, the escrow account shall be dissolved and the proceeds
returned to MIM.
3. Exclusion 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 exclusion based on a material breach of this CIA
shall be (a) whether MIM was in material breach of this CIA; (b) whether such
breach was continuing on the date of the Exclusion Letter; and (c) the alleged
material breach could not have been cured within the 35 day period, but that (i)
MIM had begun to take action to cure the material breach within the 35 day
period, (ii) MIM has pursued and is pursuing such action with due diligence, and
(iii) MIM provided to OIG within the 15 day period a reasonable timetable for
curing the material breach. For purposes of the exclusion herein, exclusion
shall take effect only after an ALJ decision that is favorable to the OIG. MIM's
election of its contractual right to appeal to the DAB shall not abrogate the
OIG's authority to exclude MIM upon the issuance of the ALJ's decision. If the
ALJ sustains the determination of the OIG and determines that exclusion is
authorized, such exclusion shall take effect twenty (20) days after the ALJ
issues such a decision, notwithstanding that MIM 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 and MIM agrees to waive any right it may have to
appeal the decision administratively, judicially or otherwise seek review by any
court or other adjudicative forum.
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XI. PRIVILEGE
Nothing in this CIA, or any communication or report made pursuant to
this CIA, shall constitute or be construed as any waiver by MIM of MIM's
attorney-client, work product or other applicable privileges. Notwithstanding
that fact, the existence of any such privilege does not affect MIM's obligation
to comply with the provisions of this CIA.
XII. EFFECTIVE AND BINDING AGREEMENT
Consistent with the provisions in the Settlement Agreement pursuant
to which this CIA is entered, and into which this CIA is incorporated, MIM and
OIG agree as follows:
A. This CIA shall be binding on the successors, assigns and
transferees of MIM;
B. This CIA shall become final and binding on the date the final
signature is obtained on the CIA, which the parties may sign in separate counter
parts;
C. Any modifications to this CIA shall be made with the prior written
consent of the parties to this CIA; and
D. The undersigned MIM 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.
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ON BEHALF OF MIM CORPORATION
/S/ XXXX XXXXXXX 3/15/00
------------------------------------------------------ -------
Xxxx Xxxxxxx DATE
Compliance Officer
MIM Corporation
/S/ XXXXX X. XXXXXX 3/17/00
--------------------------------------------------- -------
Xxxxx X. Xxxxxx DATE
Vice President and General Counsel
MIM Corporation
/S/ XXXXXX XXXXX 3/21/00
---------------------------------------------------- -------
Xxxxxx X. Xxxxx DATE
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL
OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
/S/ XXXXX XXXXXX 6/15/00
------------------------ -------
XXXXX XXXXXX DATE
Assistant Inspector General for Legal Affairs
Office of Inspector General
U. S. Department of Health and Human Services
43
