Exhibit 10.2
CORPORATE INTEGRITY AGREEMENT
BETWEEN THE
OFFICE OF INSPECTOR GENERAL
OF THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND
POLYMEDICA CORPORATION
I. PREAMBLE
PolyMedica Corporation, for itself and its subsidiaries that provide items
and services for which payment may be made by Federal health care programs
(collectively, PolyMedica) hereby enter into this Corporate Integrity Agreement
(CIA) with the Office of Inspector General (OIG) of the United States Department
of Health and Human Services (HHS) to promote compliance with the statutes,
regulations, and written directives of Medicare, Medicaid, and all other Federal
health care programs (as defined in 42 U.S.C. ss. 1320a-7b(f)) (Federal health
care program requirements). Contemporaneously with this CIA, PolyMedica is
entering into a Settlement Agreement with the United States, and this CIA is
incorporated by reference into the Settlement Agreement.
Polymedica has operated voluntary Compliance Programs which, as represented
by PolyMedica, include a Compliance Officer, Compliance Committees, a written
Code of Conduct, policies and procedures, a Disclosure Program and screening of
Ineligible Persons, and are aimed at ensuring that the activities of these
suppliers are in compliance with all Federal health care program requirements
and at meeting PolyMedica's goal of promoting high ethical standards in the
conduct of PolyMedica's business practices. PolyMedica agrees to continue the
operation of its Compliance Program and measures in accordance with the terms
set forth below for the term of this CIA. PolyMedica may modify its voluntary
compliance measures as appropriate (subject to the terms of this CIA) but shall
ensure that during the term of this CIA it complies with the obligations of
PolyMedica set forth in this CIA.
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
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II. TERM AND SCOPE OF THE CIA
A. The period of the compliance obligations assumed by PolyMedica under
this CIA shall be 5 years from the effective date of this CIA, unless otherwise
specified. The effective date shall be the date on which the final signatory of
this CIA executes this CIA (Effective Date). Each one-year period, beginning
with the one-year period following the Effective Date, shall be referred to as a
"Reporting Period."
B. Sections VII, VIII, IX, X, and XI shall expire no later than 120 days
after OIG's receipt of: (1) PolyMedica's final annual report; or (2) any
additional materials submitted by PolyMedica pursuant to OIG's request,
whichever is later.
C. The scope of this CIA shall be governed by the following
definitions:
1. "Covered Persons" includes:
a. all officers, directors, and employees of
PolyMedica; and
b. all individuals, including contractors,
subcontractors, agents, and other persons, who provide
patient care items or services or who perform billing
or coding functions on behalf of PolyMedica;
Notwithstanding the above, this term does not include
part-time or per diem employees, contractors,
subcontractors, agents, and other persons who are not
reasonably expected to work more than 160 hours per year,
except that any such individuals shall become "Covered
Persons" at the point when they work more than 160 hours
during the calendar year.
2. "Relevant Covered Persons" includes:
a. all Covered Persons who solicit, obtain, receive,
fill, or otherwise handle orders from physicians or
individuals for durable medical equipment and/or
supplies on behalf of PolyMedica;
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b. all Covered Persons who code or submit to Medicare
claims for durable medical equipment and/or supplies
on behalf of PolyMedica; and
c. all Covered Persons who make or implement company
policy and procedures for PolyMedica with regard to
durable medical equipment, supplies, and/or Medicare
billing.
III. CORPORATE INTEGRITY OBLIGATIONS
To the extent not already accomplished, PolyMedica shall establish and
maintain a Compliance Program that includes the following elements:
A. Compliance Officer and Committee.
1. COMPLIANCE OFFICER. PolyMedica presently has a Compliance Officer with
responsibility for administering PolyMedica's Compliance Program. PolyMedica
shall maintain a Compliance Officer during the term of the CIA. The Compliance
Officer shall be responsible for developing and implementing policies,
procedures, and practices designed to ensure compliance with the requirements
set forth in this CIA and with Federal health care program requirements. The
Compliance Officer shall be a member of senior management of PolyMedica, shall
make periodic (at least quarterly) reports regarding compliance matters directly
to the Board of Directors of PolyMedica Corporation (or the appropriate
committee thereof), and shall be authorized to reportdirectly on such matters to
the Board of Directors(or the appropriate committee thereof) at any time. The
Compliance Officer shall not be or be subordinate to the General Counsel or
Chief Financial Officer. The Compliance Officer shall be responsible for
monitoring the day-to-day compliance activities engaged in by PolyMedica as well
as for any reporting obligations created under this CIA.
PolyMedica shall report to OIG, in writing, any changes in the identity or
position description of the Compliance Officer, or any actions or changes that
would affect the Compliance Officer's ability to perform the duties necessary to
meet the obligations in this CIA, within 15 days after such a change.
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2. COMPLIANCE COMMITTEE. PolyMedica and presently has Compliance
Committees. PolyMedica shall maintain these Compliance Committees during the
term of the CIA. The Compliance Committees shall, at a minimum, include the
Compliance Officer and other members of senior management necessary to meet the
requirements of this CIA (e.g., senior executives of relevant departments, such
as billing, clinical, human resources, audit, and operations). The Compliance
Officer shall chair the Compliance Committees and the Committees shall support
the Compliance Officer in fulfilling his/her responsibilities (e.g., shall
assist in the analysis of the organization's risk areas and shall oversee
monitoring of internal and external audits and investigations).
PolyMedica shall report to OIG, in writing, any changes in the composition
of the Compliance Committees, or any actions or changes that would affect the
Compliance Committees' ability to perform the duties necessary to meet the
obligations in this CIA, within 15 days after such a change.
B. Written Standards.
1. CODE OF CONDUCT. PolyMedica presently has a written Code of Conduct.
PolyMedica shall maintain a written Code of Conduct during the term of the CIA.
To the extent not already accomplished, within 120 days after the Effective
Date, PolyMedica shall distribute its written Code of Conduct to all Covered
Persons. PolyMedica shall make the promotion of, and adherence to, the Code of
Conduct an element in evaluating the performance of all employees. The Code of
Conduct shall, at a minimum, set forth:
a. PolyMedica's commitment to full compliance with all Federal
health care program requirements, including its commitment to
prepare and submit accurate claims consistent with such
requirements;
b. PolyMedica's requirement that all of its Covered Persons shall
be expected to comply with all Federal health care program
requirements and with PolyMedica's own Policies and Procedures as
implemented pursuant to this Section III.B (including the
requirements of this CIA);
c. the requirement that all of PolyMedica's Covered Persons shall
be expected to report to the Compliance Officer or other
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
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appropriate individual designated by PolyMedica suspected
violations of any Federal health care program requirements or of
PolyMedica's own Policies and Procedures;
d. the possible consequences to both PolyMedica and Covered
Persons of failure to comply with Federal health care program
requirements and with PolyMedica's own Policies and Procedures
and the failure to report such noncompliance; and
e. the right of all individuals to use the Disclosure Program
described in Section III.E, and PolyMedica's commitment to
nonretaliation and to maintain, as appropriate, confidentiality
and anonymity with respect to such disclosures.
To the extent not already accomplished, within 120 days after the Effective
Date, each Covered Person shall certify, in writing, that he or she has
received, read, understood, and shall abide by PolyMedica's Code of Conduct. New
Covered Persons shall receive the Code of Conduct and shall complete the
required certification within 30 days after becoming a Covered Person or within
120 days after the Effective Date, whichever is later. To the extent a Covered
Person is on a leave of absence, such Covered Person shall receive the Code of
Conduct and complete the required certification within 30 days after the
conclusion of the leave of absence.
PolyMedica shall periodically review the Code of Conduct to determine if
revisions are appropriate and shall make any necessary revisions based on such
review. Any revised Code of Conduct shall be distributed within 30 days after
any revisions are finalized. Each Covered Person shall certify, in writing, that
he or she has received, read, understood, and shall abide by the revised Code of
Conduct within 30 days after the distribution of the revised Code of Conduct.
2. POLICIES AND PROCEDURES. During the term of the CIA, PolyMedica
shall maintain written Policies and Procedures regarding the operation of
PolyMedica's compliance program and its compliance with Federal health care
program requirements. At a minimum, the Policies and Procedures shall
address:
a. the subjects relating to the Code of Conduct identified in
Section III.B.1; and
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b. the requirements under the Federal health care programs for
filing claims for durable medical equipment and supplies.
To the extent not already accomplished, within 120 days after the Effective
Date, the relevant portions of the Policies and Procedures shall be distributed
to all individuals whose job functions relate to those Policies and Procedures.
Appropriate and knowledgeable staff shall be available to explain the Policies
and Procedures.
At least annually (and more frequently, if appropriate), PolyMedica shall
assess and update as necessary the Policies and Procedures. Within 30 days after
the effective date of any revisions, the relevant portions of any such revised
Policies and Procedures shall be distributed to all individuals whose job
functions relate to those Policies and Procedures.
C. Training and Education.
1. General Training. Within 120 days after the Effective Date,
PolyMedica shall provide at least two hours of General Training to each
Covered Person. This training, at a minimum, shall explain PolyMedica's:
a. CIA requirements; and
b. PolyMedica's Compliance Program (including the Code
of Conduct and the Policies and Procedures as they
pertain to general compliance issues).
New Covered Persons shall receive the General Training described above
within 30 days after becoming a Covered Person or within 120 days after the
Effective Date, whichever is later. After receiving the initial General Training
described above, each Covered Person shall receive at least one hour of General
Training annually. To the extent a Covered Person is on a leave of absence, such
Covered Person shall receive the General Training within 30 days after the
conclusion of the leave of absence.
2. SPECIFIC TRAINING. Within 120 days after the Effective Date, each
Relevant Covered Person shall receive at least two hours of Specific Training in
addition to the General Training required above. This Specific Training shall
include a discussion of:
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1. the Federal health care program requirements regarding physician
orders for durable medical equipment and supplies;
2. policies, procedures, and other requirements applicable to the
documentation of orders for durable medical equipment and
supplies;
3. the personal obligation of each individual involved in the claims
submission process to ensure that such claims are accurate;
4. applicable reimbursement statutes, regulations, and program
requirements and directives
5. the legal sanctions for violations of the Federal health care
program requirements; and
6. examples of proper and improper claims documentation and
submission practices.
Relevant Covered Persons shall receive this training within 30 days after
the beginning of their employment or becoming Relevant Covered Persons, or
within 120 days after the Effective Date, whichever is later. To the extent a
Relevant Covered Person is on a leave of absence, such Relevant Covered Person
shall receive the General Training within 30 days after the conclusion of the
leave of absence. A PolyMedica employee who has completed the Specific Training
shall review a new Relevant Covered Person's work, to the extent that the work
relates to the delivery of patient care items or services and/or the preparation
or submission of claims for reimbursement from any Federal health care program,
until such time as the new Relevant Covered Person completes his or her Specific
TraininG After receiving the initial Specific Training described in this
Section, each Relevant Covered Person shall receive at least one hour of
Specific Training annually.
3. CERTIFICATION. Each individual who is required to attend training shall
certify, in writing, or in electronic form, if applicable, that he or she has
received the required training. The certification shall specify the type of
training received and the date received. The Compliance Officer (or designee)
shall retain the certifications, along with all course materials. These shall be
made available to OIG, upon request.
4. QUALIFICATIONS OF TRAINER. Persons providing the training shall be
knowledgeable about the subject area.
5. UPDATE OF TRAINING. PolyMedica shall annually review the training, and,
where appropriate, update the training to reflect changes in Federal health care
program requirements,
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any issues discovered during internal audits or the IRO Claims Review and
Unallowable Costs Review, and any other relevant information.
6. COMPUTER-BASED TRAINING. PolyMedica may provide the training required
under this CIA through appropriate computer-based training approaches. If
PolyMedica chooses to provide computer-based training, it shall make available
appropriately qualified and knowledgeable staff or trainers to answer questions
or provide additional information to the individuals receiving such training.
D. Review Procedures.
1. General Description.
a. Engagement of Independent Review Organization. Within 150 days
after the Effective Date, PolyMedica shall engage an entity (or
entities), such as an accounting, auditing, or consulting firm
(hereinafter "Independent Review Organization" or "IRO"), to
perform reviews to assist PolyMedica in assessing and evaluating
its billing and coding practices and certain other obligations
pursuant to this Agreement and the Settlement Agreement. The
applicable requirements relating to the IRO are outlined in
Appendix A to this Agreement, which is incorporated by reference.
Each IRO engaged by PolyMedica shall have expertise in the
billing, coding, reporting, and other requirements of Medicare
claims for durable equipment and supplies and in the general
requirements of the Federal health care program(s) from which
PolyMedica seeks reimbursement. Each IRO shall assess, along with
PolyMedica, whether it can perform the IRO review in a
professionally independent and/or objective fashion, as
appropriate to the nature of the engagement, taking into account
any other business relationships or other engagements that may
exist.
The IRO(s) review shall evaluate and analyze PolyMedica's coding,
billing, and claims submission to the Federal health care
programs and the reimbursement received (Claims Review), and
shall analyze whether Polymedica sought payment for certain
unallowable costs (Unallowable Cost Review).
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
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b. FREQUENCY OF CLAIMS REVIEW. The Claims Review shall be
performed annually and shall cover each of the Reporting Periods.
The IRO(s) shall perform all components of each annual Claims
Review. However, after delivery of the Claims Review and Annual
Report for the third Reporting Period, Polymedia, at its option,
may request that the OIG permit the Claims Review be conducted
internally and subject only to verification by the IRO for the
remainder of the term of the CIA. The OIG retains sole discretion
over whether to permit Claims Review to be conducted internally
by Polymedica and subject to validation by the IRO. If the OIG
denies Polymedica's request, Polymedica agrees to engage the IRO
to complete the remaining Claims Reviews in accordance with the
CIA.
c. FREQUENCY OF UNALLOWABLE COST REVIEW. If applicable, the IRO
shall perform the Unallowable Cost Review for the first Reporting
Period.
d. RETENTION OF RECORDS. The IRO and PolyMedica shall retain and
make available to OIG, upon request, all work papers, supporting
documentation, correspondence, and draft reports (those exchanged
between the IRO and PolyMedica) related to the reviews.
2. CLAIMS REVIEW. The Claims Review shall include a Discovery Sample and,
if necessary, a ull Sample. The applicable definitions, procedures, and
reporting requirements are outlined in Appendix B to this Agreement, which is
incorporated by reference.
a. Discovery Sample. The IRO shall randomly select and review a
sample of 50 Paid Claims submitted by or on behalf of PolyMedica
(Discovery Sample).
The Paid Claims shall be reviewed based on the supporting
documentation available at PolyMedica's office or under
PolyMedica's control and applicable billing and coding
regulations and guidance to determine whether the claim was
correctly coded, submitted, and reimbursed.
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
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i. If the Error Rate (as defined in Appendix B) for the
Discovery Sample is less than 5%, no additional
sampling is required, nor is the Systems Review
required. (Note: The guidelines listed above do not
imply that this is an acceptable error rate.
Accordingly, PolyMedica should, as appropriate, further
analyze any errors identified in the Discovery Sample.
PolyMedica recognizes that OIG or other HHS component,
in its discretion and as authorized by statute,
regulation, or other appropriate authority may also
analyze or review Paid Claims included, or errors
identified, in the Discovery Sample or any other
segment of the universe.)
ii. If the Discovery Sample indicates that the Error
Rate is 5% or greater, the IRO shall perform a Full
Sample and a Systems Review, as described below.
b. Full Sample. If necessary, as determined by procedures
set forth in Section III.D.2.a, the IRO shall perform an
additional sample of Paid Claims using commonly accepted
sampling methods and in accordance with Appendix B. The Full
Sample shall be designed to: (i) estimate the actual
Overpayment in the population with a 90% confidence level
and with a maximum relative precision of 25% of the point
estimate; and (ii) conform with the Centers for Medicare and
Medicaid Services' statistical sampling for overpayment
estimation guidelines. The Paid Claims shall be reviewed
based on supporting documentation available at PolyMedica's
office or under PolyMedica's control and applicable billing
and coding regulations and guidance to determine whether the
claim was correctly coded, submitted, and reimbursed. For
purposes of calculating the size of the Full Sample, the
Discovery Sample may serve as the probe sample, if
statistically appropriate. Additionally, PolyMedica may use
the Items sampled as part of the Discovery Sample, and the
corresponding findings for those 50 Items, as part of its
Full Sample, if: (i) statistically appropriate and (ii)
PolyMedica selects the Full Sample Items using the seed
number generated by the Discovery Sample. OIG, in its sole
discretion, may refer
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the findings of the Full Sample (and any related workpapers)
received from PolyMedica to the appropriate Federal health
care program payor, including the Medicare contractor (e.g.,
carrier, fiscal intermediary, or DMERC), for appropriate
follow-up by that payor.
c. SYSTEMS REVIEW. If PolyMedica's Discovery Sample
identifies an Error Rate of 5% or greater, PolyMedica's IRO
shall also conduct a Systems Review. Specifically, for each
claim in the Discovery Sample and Full Sample that resulted
in an Overpayment, the IRO shall perform a "walk through" of
the system(s) and process(es), that generated the claim to
identify any problems or weaknesses that may have resulted
in the identified Overpayments. The IRO shall provide its
observations and recommendations on suggested improvements
to the system(s) and the process(es) that generated the
claim.
d. REPAYMENT OF IDENTIFIED OVERPAYMENTS. In accordance with
Section III.I.1 of this Agreement, PolyMedica shall repay
within 30 days any Overpayment(s) identified in the
Discovery Sample or the Full Sample (if applicable),
regardless of the Error Rate, to the appropriate payor and
in accordance with payor refund policies. PolyMedica shall
make available to OIG any and all documentation and the
associated documentation that reflects the refund of the
Overpayment(s) to the payor.
3. CLAIMS REVIEW REPORT. The IRO shall prepare a report based upon the
Claims Review performed (Claims Review Report). Information to be included in
the Claims Review Report is described in Appendix B.
4. UNALLOWABLE COST REVIEW. If applicable, the IRO shall conduct a review
of Polymedica's compliance with the unallowable cost provisions of the
Settlement Agreement. The IRO shall determine whether Polymedica has complied
with its obligations not to charge to, or otherwise seek payment from, Federal
or State payors for unallowable costs (as defined in the Settlement Agreement)
and its obligation to identify to applicable Federal or State payors any
unallowable costs included in payments previously sought from the United States,
or any State Medicaid program. This unallowable cost analysis shall include, but
not be limited to, payments sought in any cost reports, cost statements,
information reports, or
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payment requests already submitted by Polymedica or any affiliates. To the
extent that such cost reports, cost statements, information reports, or payment
requests, even if already settled, have been adjusted to account for the effect
of the inclusion of the unallowable costs, the IRO shall determine if such
adjustments were proper. In making this determination, the IRO may need to
review cost reports and/or financial statements from the year in which the
Settlement Agreement was executed, as well as from previous years.
5. UNALLOWABLE COST REVIEW REPORT. If applicable, the IRO shall prepare a
report based upon the Unallowable Cost Review performed. The Unallowable Cost
Review Report shall include the IRO's findings and supporting rationale
regarding the Unallowable Costs Review and whether Polymedica has complied with
its obligation not to charge to, or otherwise seek payment from, Federal or
State payors for unallowable costs (as defined in the Settlement Agreement) and
its obligation to identify to applicable Federal or State payors any unallowable
costs included in payments previously sought from such payor.
6. VALIDATION REVIEW. In the event OIG has reason to believe that: (a)
PolyMedica's Claims Review fails to conform to the requirements of this
Agreement; or (b) the IRO's findings or Claims Review results or Unallowable
Cost Review are inaccurate, OIG may, at its sole discretion, conduct its own
review to determine whether the Claims Review or Unallowable Cost Review
complied with the requirements of the Agreement and/or the findings or Claims
Review results or Unallowable Cost Review results are inaccurate (Validation
Review). PolyMedica shall pay for the reasonable cost of any such review
performed by OIG or any of its designated agents. Any Validation Review of
Reports submitted as part of PolyMedica's final Annual Report must be initiated
no later than one year after PolyMedica's final submission (as described in
Section II) is received by OIG.
Prior to initiating a Validation Review, OIG shall notify PolyMedica of its
intent to do so and provide a written explanation of why OIG believes such a
review is necessary. To resolve any concerns raised by OIG, PolyMedica may
request a meeting with OIG to: (a) discuss the results of any Claims Review or
Unallowable Cost Review submissions or findings; (b) present any additional
information to clarify the results of the Claims Review or Unallowable Cost
Review or to correct the inaccuracy of the Claims Review or Unallowable Cost
Review; and/or (c) propose alternatives to the proposed Validation Review.
PolyMedica agrees to provide any additional information as may be requested by
OIG under this Section in an expedited manner. OIG will attempt in good faith to
resolve any
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Claims Review or Unallowable Cost Review issues with PolyMedica prior to
conducting a Validation Review. However, the final determination as to whether
or not to proceed with a Validation Review shall be made at the sole discretion
of OIG.
7. INDEPENDENCE/OBJECTIVITY CERTIFICATION. The IRO shall include in its
report(s) to Polymedica a certification or sworn affidavit that it has evaluated
its professional independence and/or objectivity, as appropriate to the nature
of the engagement, with regard to the Claims Review or Unallowable Cost Review
and that it has concluded that it is, in fact, independent and/or objective.
E. DISCLOSURE PROGRAM.
PolyMedica presently has a Disclosure Program. PolyMedica shall maintain a
Disclosure Program during the term of the CIA. To the extent not already
accomplished, within 120 days after the Effective Date, PolyMedica shall
establish a Disclosure Program that includes a mechanism (e.g., a toll-free
compliance telephone line) to enable individuals to disclose, to the Compliance
Officer or some other person who is not in the disclosing individual's chain of
command, any identified issues or questions associated with PolyMedica's
policies, conduct, practices, or procedures with respect to a Federal health
care program believed by the individual to be a potential violation of criminal,
civil, or administrative law. PolyMedica shall appropriately publicize the
existence of the disclosure mechanism (e.g., via periodic e-mails to employees
or by posting the information in prominent common areas).
The Disclosure Program shall emphasize a nonretribution, nonretaliation
policy, and shall include a reporting mechanism for anonymous communications for
which appropriate confidentiality shall be maintained. Upon receipt of a
disclosure, the Compliance Officer (or designee) shall gather all relevant
information from the disclosing individual. The Compliance Officer (or designee)
shall make a preliminary, good faith inquiry into the allegations set forth in
every disclosure to ensure that he or she has obtained all of the information
necessary to determine whether a further review should be conducted. For any
disclosure that is sufficiently specific so that it reasonably: (1) permits a
determination of the appropriateness of the alleged improper practice; and (2)
provides an opportunity for taking corrective action, PolyMedica shall conduct
an internal review of the allegations set forth in the disclosure and ensure
that proper follow-up is conducted.
The Compliance Officer (or designee) shall maintain a disclosure log, which
shall include a record and summary of each disclosure received (whether
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
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anonymous or not), the status of the respective internal reviews, and any
corrective action taken in response to the internal reviews. The disclosure log
shall be made available to OIG upon request.
F. INELIGIBLE PERSONS.
1. DEFINITIONS. For purposes of this CIA:
a. an "Ineligible Person" shall include an individual or entity
who:
i. is currently excluded, debarred, suspended, or otherwise
ineligible to participate in the Federal health care
programs or in Federal procurement or nonprocurement
programs; or
ii. has been convicted of a criminal offense that falls
within the ambit of 42 U.S.C.ss.1320a-7(a), but has not yet
been excluded, debarred, suspended, or otherwise declared
ineligible.
b. "Exclusion Lists" include:
i. the HHS/OIG List of Excluded Individuals/Entities
(available through the Internet at xxxx://xxx.xxx.xxx); and
ii. the General Services Administration's List of Parties
Excluded from Federal Programs (available through the
Internet at xxxx://xxxx.xxxxx.xxx).
7. "Screened Persons" include prospective and current owners
(other than shareholders who: (1) have an ownership interest
of less than 5%; and (2) acquired the ownership interest
through public trading), officers, directors, employees,
contractors, and agents of PolyMedica.
2. SCREENING REQUIREMENTS. PolyMedica shall ensure that all Screened
Persons are not Ineligible Persons, by implementing the following screening
requirements.
1. PolyMedica shall screen all Screened Persons against the
Exclusion Lists prior to engaging their services and, as
part of the hiring or
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contracting process, shall require such persons to disclose
whether they are an Ineligible Person.
2. PolyMedica shall screen all Screened Persons against the
Exclusion Lists within 90 days after the Effective Date and
on an annual basis thereafter.
3. PolyMedica shall implement a policy requiring all Screened
Persons to disclose immediately any debarment, exclusion,
suspension, or other event that makes that person an
Ineligible Person.
Nothing in this Section affects the responsibility of (or liability for)
PolyMedica to refrain from billing Federal health care programs for items or
services furnished, ordered, or prescribed by an Ineligible Person.
3. REMOVAL REQUIREMENT. If PolyMedica has actual notice that a Screened
Person has become an Ineligible Person, PolyMedica shall remove such person from
responsibility for, or involvement with, PolyMedica's business operations
related to the Federal health care programs and shall remove such person from
any position for which the person's compensation or the items or services
furnished, 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.
4. PENDING CHARGES AND PROPOSED EXCLUSIONS. If PolyMedica has actual notice
that a Screened Person is charged with a criminal offense that falls within the
ambit of 42 U.S.C. xx.xx. 1320a-7(a), 1320a-7(b)(1)-(3), or is proposed for
exclusion during his or her employment or contract term, PolyMedica shall take
all appropriate actions to ensure that the responsibilities of that person 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 after discovery, Polymedica shall notify OIG, in writing, of
any ongoing investigation or legal proceeding known to PolyMedica conducted or
brought by a governmental entity or its agents involving an allegation that
PolyMedica 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. PolyMedica shall also provide written notice to OIG within 30
days after the resolution of the matter, and shall provide OIG with a
description of the findings and/or results of the investigation or proceedings,
if any.
H. REPORTING.
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1. OVERPAYMENTS.
4. DEFINITION OF OVERPAYMENTS. For purposes of this CIA, an
"Overpayment" shall mean the amount of money PolyMedica has received
in excess of the amount due and payable under any Federal health care
program requirements.
5. REPORTING OF OVERPAYMENTS. If, at any time, PolyMedica identifies
or learns of any Overpayment, PolyMedica shall notify the payor (e.g.,
Medicare fiscal intermediary or carrier) within 30 days after
identification of the Overpayment and take remedial steps within 60
days after identification (or such additional time as may be agreed to
by the payor) to correct the problem, including preventing the
underlying problem and the Overpayment from recurring. Also, within 30
days after identification of the Overpayment, PolyMedica shall repay
the Overpayment to the appropriate payor to the extent such
Overpayment has been quantified. If not yet quantified, within 30 days
after identification, PolyMedica shall notify the payor of its efforts
to quantify the Overpayment amount along with a schedule of when such
work is expected to be completed. Notification and repayment to the
payor shall be done in accordance with the payor's policies, and, for
Medicare contractors, shall include the information contained on the
Overpayment Refund Form, provided as Appendix C to this CIA.
Notwithstanding the above, notification and repayment of any
Overpayment amount that routinely is reconciled or adjusted pursuant
to policies and procedures established by the payor should be handled
in accordance with such policies and procedures.
2. REPORTABLE EVENTS.
8. 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 probable
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
16
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.
6. Reporting of Reportable Events. If PolyMedica determines (after a
reasonable opportunity to conduct an appropriate review or
investigation of the allegations) through any means that there is a
Reportable Event, PolyMedica shall notify OIG, in writing, within 30
days after making the determination that the Reportable Event exists.
The report to OIG shall include the following information:
i. If the Reportable Event results in an Overpayment, the report
to OIG shall be made at the same time as the notification to the
payor required in Section III.H.1, and shall include all of the
information on the Overpayment Refund Form, 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) by 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 PolyMedica's actions taken to correct the
Reportable Event; and
iv. any further steps PolyMedica plans to take to address the
Reportable Event and prevent it from recurring.
IV. NEW BUSINESS UNITS OR LOCATIONS
In the event that, after the Effective Date, PolyMedica changes
locations or sells, closes, purchases, or establishes a new business unit or
location related to the furnishing of items or services that may be reimbursed
by Federal health care programs, PolyMedica shall notify OIG of this fact as
soon as possible, but no later
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
17
than within 30 days after the date of change of location, sale, closure,
purchase, or establishment. This notification shall include the address of the
new business unit or location, phone number, fax number, Medicare Provider
number, provider identification number and/or supplier number, and the
corresponding contractor's name and address that has issued each Medicare
number. Each new business unit or location shall be subject to all the
requirements of this CIA.
V. IMPLEMENTATION AND ANNUAL REPORTS
A. Implementation Report. Within 150 days after the Effective Date,
PolyMedica shall submit a written report to OIG summarizing the status of its
implementation of the requirements of this CIA (Implementation Report). The
Implementation Report shall, at a minimum, include:
1. the name, address, phone number, and position description of the
Compliance Officer required by Section III.A, and a summary of other
noncompliance job responsibilities the Compliance Officer may have;
2. the names and positions of the members of the Compliance Committee
required by Section III.A;
3. a copy of all Codes of Conduct required by Section III.B.1;
4. a copy of all Policies and Procedures required by Section III.B.2;
5. the number of individuals required to complete the Code of Conduct
certification required by Section III.B.1, the percentage of individuals who
have completed such certification, and an explanation of any exceptions (the
documentation supporting this information shall be available to OIG, upon
request);
6. the following information regarding each type of training required by
Section III.C:
a. a description of such training, including a summary of the
topics covered, the length of sessions and a schedule of training
sessions;
b. the number of individuals required to be trained, percentage
of individuals actually trained, and an explanation of any
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
18
exceptions.
A copy of all training materials and the documentation supporting this
information shall be available to OIG, upon request.
7. a description of the Disclosure Program required by Section III.E;
8. the following information regarding the IRO(s): (a) identity, address,
and phone number; (b) a copy of the engagement letter; (c) a summary and
description of any and all current and prior engagements and agreements between
PolyMedica and the IRO; and (d) the proposed start and completion dates of the
Claims Review and Unallowable Cost Review;
9. a certification from the IRO regarding its professional independence
and/or objectivity with respect to PolyMedica;
10. a description of the process by which PolyMedica fulfills the
requirements of Section III.F regarding Ineligible Persons;
11. the name, title, and responsibilities of any person who is determined
to be an Ineligible Person under Section III.F; the actions taken in response to
the screening and removal obligations set forth in Section III.F; and the
actions taken to identify, quantify, and repay any overpayments to Federal
health care programs relating to items or services furnished, ordered or
prescribed by an Ineligible Person;
12. a list of all of PolyMedica's locations (including locations and
mailing addresses); the corresponding name under which each location is doing
business; the corresponding phone numbers and fax numbers; each location's
Medicare Provider number(s), provider identification number(s), and/or supplier
number(s); and the name and address of each Medicare contractor to which
PolyMedica currently submits claims;
13. a description of PolyMedica's corporate structure, including
identification of any parent and sister companies, subsidiaries, and their
respective lines of business; and
14. the certifications required by Section V.C.
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
19
B. ANNUAL REPORTS. PolyMedica shall submit to OIG annually a report with
respect to the status of, and findings regarding, PolyMedica's compliance
activities for each of the 5 Reporting Periods (Annual Report). Each Annual
Report shall include, at a minimum:
1. any change in the identity, position description, or other noncompliance
job responsibilities of the Compliance Officer and any change in the membership
of the Compliance Committee described in Section III.A;
2. 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) and copies of any compliance-related Policies and
Procedures;
3. the number of individuals required to complete the Code of Conduct
certification required by Section III.B.1, the percentage of individuals who
have completed such certification, and an explanation of any exceptions (the
documentation supporting this information shall be available to OIG, upon
request);
4. the following information regarding each type of training required by
Section III.C:
a. a description of such training, including a summary of the topics
covered, the length of sessions and a schedule of training sessions;
b. the number of individuals required to be trained, percentage of
individuals actually trained, and an explanation of any exceptions.
A copy of all training materials and the documentation supporting this
information shall be available to OIG, upon request.
5. a complete copy of all reports prepared pursuant to Section III.D, along
with a copy of the IRO's engagement letter (if applicable);
6. PolyMedica's response and corrective action plan(s) related to any
issues raised by the reports prepared pursuant to Section III.D;
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
20
7. summary and description of any and all current and prior engagements and
agreements between PolyMedica and the IRO, if different from what was submitted
as part of the Implementation Report;
8. a certification from the IRO regarding its professional independence
and/or objectivity with respect to PolyMedica;
9. a summary of Reportable Events (as defined in Section III.H) identified
during the Reporting Period and the status of any corrective and preventative
action relating to all such Reportable Events;
10. a report of the aggregate Overpayments that have been returned to the
Federal health care programs. Overpayment amounts shall be broken down into the
following categories: inpatient Medicare, outpatient Medicare, Medicaid (report
each applicable state separately, if applicable), and other Federal health care
programs. Overpayment amounts that are routinely reconciled or adjusted pursuant
to policies and procedures established by the payor do not need to be included
in this aggregate Overpayment report;
11. a summary of the disclosures in the disclosure log required by Section
III.E that: (a) relate to Federal health care programs; or (b) allege abuse or
neglect of patients;
12. any changes to the process by which PolyMedica fulfills the
requirements of Section III.F regarding Ineligible Persons;
13. the name, title, and responsibilities of any person who is determined
to be an Ineligible Person under Section III.F; the actions taken by PolyMedica
in response to the screening and removal obligations set forth in Section III.F;
and the actions taken to identify, quantify, and repay any overpayments to
Federal health care programs relating to items or services relating to items or
services furnished, ordered or prescribed by an Ineligible Person;
14. a summary describing any ongoing investigation or legal proceeding
required to have been reported pursuant to Section III.G. The summary shall
include a description of the allegation, the identity of the investigating or
prosecuting agency, and the status of such investigation or legal proceeding;
15. a description of all changes to the most recently provided list of
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
21
PolyMedica's locations (including addresses) as required by Section V.A.11; the
corresponding name under which each location is doing business; the
corresponding phone numbers and fax numbers; each location's Medicare Provider
number(s), provider identification number(s), and/or supplier number(s); and the
name and address of each Medicare contractor to which PolyMedica currently
submits claims; and
16. the certifications required by Section V.C.
The first Annual Report shall be received by OIG no later than 60 days
after the end of the first Reporting Period. Subsequent Annual Reports shall be
received by OIG no later than the anniversary date of the due date of the first
Annual Report.
C. CERTIFICATIONS. The Implementation Report and Annual Reports shall
include a certification by the Compliance Officer that:
1. to the best of his or her knowledge, except as otherwise described in
the applicable report, PolyMedica is in compliance with all of the requirements
of this CIA;
2. he or she has reviewed the Report and has made reasonable inquiry
regarding its content and believes that the information in the Report is
accurate and truthful; and
3. PolyMedica has complied with its obligations under the Settlement
Agreement: (a) not to resubmit to any Federal health care program payors any
previously denied claims related to the Covered Conduct addressed in the
Settlement Agreement, and not to appeal any such denials of claims; (b) not to
charge to or otherwise seek payment from Federal or State payors for unallowable
costs (as defined in the Settlement Agreement); and (c) to identify and adjust
any past charges or claims for unallowable costs;
D. DESIGNATION OF INFORMATION. PolyMedica shall clearly identify any
portions of its submissions that it believes are trade secrets, or information
that is commercial or financial and privileged or confidential, and therefore
potentially exempt from disclosure under the Freedom of Information Act (FOIA),
5 U.S.C. ss. 552. PolyMedica shall refrain from identifying any information as
exempt from disclosure if that information does not meet the criteria for
exemption from
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
22
disclosure under FOIA.
VI. NOTIFICATIONS AND SUBMISSION OF REPORTS
Unless otherwise stated in writing after the Effective Date, all
notifications and reports required under this CIA shall be submitted to the
following entities:
OIG: Administrative and Civil Remedies Branch
Office of Counsel to the Inspector General
Office of Inspector General
U.S. Department of Health and Human Services
Xxxxx Building, Room 5527
000 Xxxxxxxxxxxx Xxxxxx, X.X.
Xxxxxxxxxx, XX 00000
Telephone: 000.000.0000
Facsimile: 202.205.0604
PolyMedica: Xx. Xxxxx Xxxxx Xxxxxxxx
0000 Xxxxxxx Xxxx Xxxx
Xx. Xxxxx, Xxxxxxx 00000
Telephone: 000.000.0000
Facsimile: 772.337.7180
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.
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 PolyMedica's books, records, and other documents and supporting
materials and/or conduct on-site reviews of any of PolyMedica's locations for
the purpose of verifying and evaluating: (a) PolyMedica's compliance with the
terms of this CIA; and (b) PolyMedica's compliance with the requirements of the
Federal health care programs in which it participates. The documentation
described above shall be made available by PolyMedica to OIG or its duly
authorized representative(s) at all reasonable times for inspection, audit, or
reproduction.
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
23
Nothing in this Section VII shall require a waiver by Polymedica
or Polymedica's attorney-client, attorney work-product, or other applicable
privileges. Notwithstanding that fact, the existence of any such privilege shall
not be used by Polymedica to avoid its obligation to comply with the provisions
of this Section VII.
Furthermore, for purposes of this provision, OIG or its duly authorized
representative(s) may interview any of PolyMedica'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. PolyMedica shall assist OIG or its
duly authorized representative(s) in contacting and arranging interviews with
such individuals upon OIG's request. PolyMedica's employees may elect to be
interviewed with or without a representative of Polymedica present.
VIII. DOCUMENT AND RECORD RETENTION
PolyMedica shall maintain for inspection all documents and records relating
to reimbursement from the Federal health care programs, or to compliance with
this CIA, for 6 years (or longer if otherwise required by law).
IX. DISCLOSURES
Consistent with HHS's FOIA procedures, set forth in 45 C.F.R. Part 5, OIG
shall make a reasonable effort to notify PolyMedica prior to any release by OIG
of information submitted by PolyMedica pursuant to its obligations under this
CIA and identified upon submission by PolyMedica as trade secrets, or
information that is commercial or financial and privileged or confidential,
under the FOIA rules. With respect to such releases, PolyMedica shall have the
rights set forth at 45 C.F.R. ss. 5.65(d).
X. BREACH AND DEFAULT PROVISIONS
PolyMedica 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, PolyMedica and OIG hereby agree that failure to comply
with certain obligations as set forth in this CIA may lead to the imposition of
the following monetary penalties (hereinafter referred to as "Stipulated
Penalties") in accordance with the following provisions.
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
24
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 PolyMedica fails to
establish and implement any of the following obligations as described in
Section III:
a. a Compliance Officer;
b. a Compliance Committee;
c. a written Code of Conduct;
d. written Policies and Procedures;
e. the training of Covered Persons;
f. a Disclosure Program;
g. Ineligible Persons screening and removal requirements;
and
h. Notification of Government investigations or legal
proceedings.
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 PolyMedica fails to
engage an IRO, as required in Section III.D and Appendix A.
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 PolyMedica fails to
submit the Implementation Report or the Annual Reports to OIG in accordance with
the requirements of Section V by the deadlines for submission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day
after the date the obligation became due) for each day PolyMedica fails to
submit the annual Claims Review Report and Unallowable Costs Review Report in
accordance with the requirements of Section III.D and Appendix B.
5. A Stipulated Penalty of $1,500 for each day PolyMedica fails to grant
access to the information or documentation as required in Section VII. (This
Stipulated Penalty shall begin to accrue on the date PolyMedica fails to grant
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
25
access.)
6. A Stipulated Penalty of $5,000 for each false certification submitted by
or on behalf of PolyMedica as part of its Implementation Report, Annual Report,
additional documentation to a report (as requested by the OIG), or otherwise
required by this CIA.
7. A Stipulated Penalty of $1,000 for each day PolyMedica fails to comply
fully and adequately with any obligation of this CIA. OIG shall provide notice
to PolyMedica, stating the specific grounds for its determination that
PolyMedica has failed to comply fully and adequately with the CIA obligation(s)
at issue and steps PolyMedica shall take to comply with the CIA. (This
Stipulated Penalty shall begin to accrue 10 days after PolyMedica receives this
notice from OIG of the failure to comply.) A Stipulated Penalty as described in
this Subsection shall not be demanded for any violation for which OIG has sought
a Stipulated Penalty under Subsections 1-6 of this Section.
B. TIMELY WRITTEN REQUESTS FOR EXTENSIONS. PolyMedica 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 PolyMedica fails to meet the
revised deadline set by OIG. Notwithstanding any other provision in this
Section, if OIG denies such a timely written request, Stipulated Penalties for
failure to perform the act or file the notification or report shall not begin to
accrue until three business days after PolyMedica receives OIG's written denial
of such request or the original due date, whichever is later. A "timely written
request" is defined as a request in writing received by OIG at least five
business days prior to the date by which any act is due to be performed or any
notification or report is due to be filed.
C. PAYMENT OF STIPULATED PENALTIES.
1. DEMAND LETTER. Upon a finding that PolyMedica 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 PolyMedica of: (a)
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
26
PolyMedica's failure to comply; and (b) OIG's exercise of its contractual right
to demand payment of the Stipulated Penalties (this notification is referred to
as the "Demand Letter").
2. RESPONSE TO DEMAND LETTER. Within 10 days after the receipt of the
Demand Letter, PolyMedica 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 PolyMedica elects to request an ALJ hearing,
the Stipulated Penalties shall continue to accrue until PolyMedica cures, to
OIG's satisfaction, the alleged breach in dispute. Failure to respond to the
Demand Letter in one of these two manners within the allowed time period shall
be considered a material breach of this CIA and shall be grounds for exclusion
under Section X.D.
3. FORM OF PAYMENT. Payment of the Stipulated Penalties shall be made by
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 PolyMedica has
materially breached this CIA, which decision shall be made at OIG's discretion
and shall be governed by the provisions in Section X.D, below.
D. EXCLUSION FOR MATERIAL BREACH OF THIS CIA.
1. Definition of Material Breach. A material breach of this CIA
means:
a. a failure by PolyMedica to report a Reportable Event,
take corrective action, and make the appropriate refunds, as
required in Section III.H;
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;
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
27
or
d. a failure to engage and use an IRO in accordance with
Section III.D.
2. NOTICE OF MATERIAL BREACH AND INTENT TO EXCLUDE. The parties agree that
a material breach of this CIA by PolyMedica constitutes an independent basis for
PolyMedica's exclusion from participation in the Federal health care programs.
Upon a determination by OIG that PolyMedica has materially breached this CIA and
that exclusion is the appropriate remedy, OIG shall notify PolyMedica of: (a)
PolyMedica's material breach; and (b) OIG's intent to exercise its contractual
right to impose exclusion (this notification is hereinafter referred to as the
"Notice of Material Breach and Intent to Exclude").
3. OPPORTUNITY TO CURE. PolyMedica shall have 30 days from the date of
receipt of the Notice of Material Breach and Intent to Exclude to demonstrate to
OIG's satisfaction that:
a. PolyMedica is in compliance with the obligations of the
CIA cited by OIG as being the basis for the material breach;
b. the alleged material breach has been cured; or
c. the alleged material breach cannot be cured within the
30-day period, but that: (i) PolyMedica has begun to take
action to cure the material breach; (ii) PolyMedica is
pursuing such action with due diligence; and (iii)
PolyMedica has provided to OIG a reasonable timetable for
curing the material breach.
4. EXCLUSION LETTER. If, at the conclusion of the 30-day period, PolyMedica
fails to satisfy the requirements of Section X.D.3, OIG may exclude PolyMedica
from participation in the Federal health care programs. OIG shall notify
PolyMedica in writing of its determination to exclude PolyMedica (this letter
shall be referred to hereinafter as the "Exclusion Letter"). Subject to the
Dispute Resolution provisions in Section X.E, below, the exclusion shall go into
effect 30 days after the date of PolyMedica's receipt of the Exclusion Letter.
The exclusion shall have national effect and shall also apply to all other
Federal procurement and nonprocurement programs. Reinstatement to program
participation is not automatic. After the end of the period of exclusion,
PolyMedica may apply for
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
28
reinstatement by submitting a written request for reinstatement in accordance
with the provisions at 42 C.F.R. xx.xx. 1001.3001-.3004.
E. DISPUTE RESOLUTION
1. REVIEW RIGHTS. Upon OIG's delivery to PolyMedica of its Demand Letter or
of its Exclusion Letter, and as an agreed-upon contractual remedy for the
resolution of disputes arising under this CIA, PolyMedica 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, OIG's
determination to demand payment of Stipulated Penalties or to seek exclusion
shall be subject to review by an HHS ALJ and, in the event of an appeal, the HHS
Departmental Appeals Board (DAB), in a manner consistent with the provisions in
42 C.F.R. ss. 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 10 days after receipt of the Demand Letter and the request for a
hearing involving exclusion shall be made within 25 days after receipt of the
Exclusion Letter.
2. STIPULATED PENALTIES REVIEW. Notwithstanding any provision of Title 42
of the United States Code or Title 42 of the Code of Federal Regulations, the
only issues in a proceeding for Stipulated Penalties under this CIA shall be:
(a) whether PolyMedica was in full and timely compliance with the obligations of
this CIA for which OIG demands payment; and (b) the period of noncompliance.
PolyMedica shall have the burden of proving its full and timely compliance and
the steps taken to cure the noncompliance, if any. OIG shall not have the right
to appeal to the DAB an adverse ALJ decision related to Stipulated Penalties. If
the ALJ agrees with OIG with regard to a finding of a breach of this CIA and
orders PolyMedica to pay Stipulated Penalties, such Stipulated Penalties shall
become due and payable 20 days after the ALJ issues such a decision unless
PolyMedica requests review of the ALJ decision by the DAB. If the ALJ decision
is properly appealed to the DAB and the DAB upholds the determination of OIG,
the Stipulated Penalties shall become due and payable 20 days after the DAB
issues its decision.
3. EXCLUSION REVIEW. Notwithstanding any provision of Title 42 of the
United States Code or Title 42 of the Code of Federal Regulations, the only
issues in a proceeding for exclusion based on a material breach of this CIA
shall be:
9. whether PolyMedica was in material breach of this CIA;
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
29
10. whether such breach was continuing on the date of the Exclusion
Letter; and
11. whether the alleged material breach could not have been cured
within the 30-day period, but that: (i) PolyMedica had begun to take
action to cure the material breach within that period; (ii) PolyMedica
has pursued and is pursuing such action with due diligence; and (iii)
PolyMedica provided to OIG within that period a reasonable timetable
for curing the material breach and PolyMedica has followed the
timetable.
For purposes of the exclusion herein, exclusion shall take effect only
after an ALJ decision favorable to OIG, or, if the ALJ rules for PolyMedica,
only after a DAB decision in favor of OIG. PolyMedica's election of its
contractual right to appeal to the DAB shall not abrogate OIG's authority to
exclude PolyMedica upon the issuance of an ALJ's decision in favor of OIG. If
the ALJ sustains the determination of OIG and determines that exclusion is
authorized, such exclusion shall take effect 20 days after the ALJ issues such a
decision, notwithstanding that PolyMedica may request review of the ALJ decision
by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to
OIG, the exclusion shall take effect 20 days after the DAB decision. PolyMedica
shall waive its right to any notice of such an exclusion if a decision upholding
the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of
PolyMedica, PolyMedica shall be reinstated effective on the date of the original
exclusion.
4. FINALITY OF DECISION. The review by an ALJ or DAB provided for above
shall not be considered to be an appeal right arising under any statutes or
regulations. Consequently, the parties to this CIA agree that the DAB's decision
(or the ALJ's decision if not appealed) shall be considered final for all
purposes under this CIA.
XI. 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, PolyMedica
and OIG agree as follows:
A. This CIA shall be binding on the successors, assigns, and transferees of
PolyMedica to the extent of the businesses and operations of PolyMedica that
exist at the time of any transfer;
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
30
B. This CIA shall become final and binding on the date the final signature
is obtained on the CIA;
C. Any modifications to this CIA shall be made with the prior written
consent of the parties to this CIA;
D. OIG may agree to a suspension of PolyMedica's obligations under the CIA
in the event of PolyMedica's cessation of participation in Federal health care
programs. If PolyMedica withdraws from participation in Federal health care
programs and is relieved of its CIA obligations by OIG, PolyMedica shall notify
OIG at least 30 days in advance of PolyMedica's intent to reapply as a
participating provider or supplier with any Federal health care program. Upon
receipt of such notification, OIG shall evaluate whether the CIA should be
reactivated or modified.
E. The undersigned PolyMedica 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.
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
31
ON BEHALF OF POLYMEDICA CORPORATION
AND ITS SUBSIDIARIES
/s/ Xxxxxx X. Xxxxxxxx 11/08/04
--------------------------- -------------------
XXXXXX X. XXXXXXXX DATE
Chairman
PolyMedica Corporation
/s/ Xxxxx Xxxxx Xxxxxxxx 11/04/2004
--------------------------- -------------------
XXXXX XXXXX XXXXXXXX DATE
Chief Compliance Officer
PolyMedica Corporation
/s/ Xxxxxxx X. Xxx 11/03/2004
--------------------------- -------------------
XXXXXXX X. XXX DATE
Sr. Vice President and Deputy General Counsel
PolyMedica Corporation
/s/ Xxxx X. Xxxxxxx 11/03/2004
--------------------------- -------------------
XXXX X. XXXXXXX DATE
Xxxxxxxxx Xxxxxxx, P.A.
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
32
ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL
OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
/s/ Xxxxx X. Xxxxxxxx 11/3/04
--------------------------------------------- -------------
XXXXX X. XXXXXXXX DATE
Assistant Inspector General for Legal Affairs
Office of Inspector General
U. S. Department of Health and Human Services
POLYMEDICA CORPORATE INTEGRITY AGREEMENT
33
APPENDIX A
INDEPENDENT REVIEW ORGANIZATION
This Appendix contains the requirements relating to the Independent Review
Organization (IRO) required by Section III.D of the CIA.
A. IRO ENGAGEMENT.
Polymedica shall engage an IRO that possesses the qualifications set forth
in Paragraph B, below, to perform the responsibilities in Paragraph C, below.
The IRO shall conduct the review in a professionally independent and/or
objective fashion, as set forth in Paragraph D. Within 30 days after OIG
receives written notice of the identity of the selected IRO, OIG will notify
Polymedica if the IRO is unacceptable. Absent notification from OIG that the IRO
is unacceptable, Polymedica may continue to engage the IRO.
If Polymedica engages a new IRO during the term of the CIA, this IRO shall
also meet the requirements of this Appendix. If a new IRO is engaged, Polymedica
shall submit the information identified in Section V.A.8 to OIG within 30 days
of engagement of the IRO. Within 30 days after OIG receives written notice of
the identity of the selected IRO, OIG will notify Polymedica if the IRO is
unacceptable. Absent notification from OIG that the IRO is unacceptable,
Polymedica may continue to engage the IRO.
B. IRO QUALIFICATIONS.
The IRO shall:
1. assign individuals to conduct the Claims Review and Unallowable Cost
Review, if applicable engagement who have expertise in the billing, coding,
reporting, and Medicare claims for durable equipment and supplies and in the
general requirements of the Federal health care program(s) from which Polymedica
seeks reimbursement;
2. assign individuals to design and select the Claims Review sample who are
knowledgeable about the appropriate statistical sampling techniques;
3. assign individuals to conduct the coding review portions of the Claims
Review who have a nationally recognized coding certification (e.g., CCA, CCS,
CCS-P, CPC, RRA, etc.) and who have maintained this certification (e.g.,
completed applicable continuing education requirements); and
4. have sufficient staff and resources to conduct the reviews required by
the CIA on a timely basis.
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C. IRO RESPONSIBILITIES.
The IRO shall:
1. perform each Claim Review in accordance with the specific requirements
of the CIA;
2. follow all applicable Medicare, Medicaid or other Federal health care
program rules and reimbursement guidelines in making assessments in the Claims
Review;
3. if in doubt of the application of a particular Medicare, Medicaid or
other Federal health care program policy or regulation, request clarification
from the appropriate authority (e.g., fiscal intermediary or ---- carrier);
4. respond to all OIG inquires in a prompt, objective, and factual manner;
and
5. prepare timely, clear, well-written reports that include all the
information required by Appendix B.
D. IRO INDEPENDENCE/OBJECTIVITY.
The IRO must perform the Claims Review in a professionally independent and/or
objective fashion, as appropriate to the nature of the engagement, taking into
account any other business relationships or engagements that may exist between
the IRO and Polymedica.
E. IRO REMOVAL/TERMINATION.
1. PROVIDER. If Polymedica terminates its IRO during the course of the
engagement, Polymedica must submit a notice explaining its reasons to OIG no
later than 30 days after termination. Polymedica must engage a new IRO in
accordance with Paragraph A of this Appendix.
2. OIG REMOVAL OF IRO. In the event OIG has reason to believe that the IRO
does not possess the qualifications described in Paragraph B, is not independent
and/or objective as set forth in Paragraph D, or has failed to carry out its
responsibilities as described in Paragraph C, OIG may, at its sole discretion,
require Polymedica to engage a new IRO in accordance with Paragraph A of this
Appendix.
Prior to requiring Polymedica to engage a new IRO, OIG shall notify
Polymedica of its intent to do so and provide a written explanation of why OIG
believes such a step is necessary. To resolve any concerns raised by OIG,
Polymedica may request a meeting
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with OIG to discuss any aspect of the IRO's qualifications, independence or
performance of its responsibilities and to present additional information
regarding these matters. Polymedica shall provide any additional information as
may be requested by OIG under this Paragraph in an expedited manner. OIG will
attempt in good faith to resolve any differences regarding the IRO with
Polymedica prior to requiring Polymedica to terminate the IRO. However, the
final determination as to whether or not to require Polymedica to engage a new
IRO shall be made at the sole discretion of XXX.
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XXXXXXXX X
CLAIMS REVIEW
A. CLAIMS REVIEW.
1. DEFINITIONS. For the purposes of the Claims Review, the following
definitions shall be used:
a. OVERPAYMENT: The amount of money Polymedica has received in excess of
the amount due and payable under any Federal health care program
requirements.
b. ITEM: Any discrete unit that can be sampled (e.g., code, line item,
beneficiary, patient encounter, etc.).
c. PAID CLAIM: A code or line item submitted by Polymedica and for which
Polymedica has received reimbursement from the Medicare program
d. POPULATION: For the first Reporting Period, the Population shall be
defined as all Items for which a code or line item has been submitted by or
on behalf of Polymedica and for which Polymedica has received reimbursement
from Medicare, Medicaid or other Federal health care programs (i.e., Paid
Claim) during the 12-month period covered by the first Claims Review.
For the remaining Reporting Periods, the Population shall be defined as all
Items for which Polymedica has received reimbursement from Medicare
Medicaid or other Federal health care programs (i.e., Paid Claim) during
the 12-month period covered by the Claims Review.
To be included in the Population, an Item must have resulted in at least
one Paid Claim.
e. ERROR RATE: The Error Rate shall be the percentage of net Overpayments
identified in the sample. The net Overpayments shall be calculated by
subtracting all underpayments identified in the sample from all gross
Overpayments identified in the sample. (Note: Any potential cost
settlements or other supplemental payments should not be included in the
net Overpayment calculation. Rather, only underpayments identified as
APPENDIX B:
PAGE 1
part of the Discovery Sample shall be included as part of the net
Overpayment calculation.)
The Error Rate is calculated by dividing the net Overpayment
identified in the sample by the total dollar amount associated with
the Items in the sample.
2. OTHER REQUIREMENTS.
a. PAID CLAIMS WITHOUT SUPPORTING DOCUMENTATION. For the purpose of
appraising Items included in the Claims Review, any Paid Claim for
which Polymedica cannot produce documentation sufficient to support
the Paid Claim shall be considered an error and the total
reimbursement received by Polymedica for such Paid Claim shall be
deemed an Overpayment. Replacement sampling for Paid Claims with
missing documentation is not permitted.
2. REPLACEMENT SAMPLING. Considering the Population shall consist only
of Paid Claims and that Items with missing documentation cannot be
replaced, there is no need to utilize alternate or replacement
sampling units.
c. USE OF FIRST SAMPLES DRAWN. For the purposes of all samples
(Discovery Sample(s) and Full Sample(s)) discussed in this Appendix,
the Paid Claims associated with the Items selected in each first
sample (or first sample for each strata, if applicable) shall be used
(i.e., it is not permissible to generate more than one list of random
samples and then select one for use with the Discovery Sample or Full
Sample).
B. CLAIMS REVIEW REPORT. The following information shall be included in the
Claims Review Report for each Discovery Sample and Full Sample (if
applicable).
1. CLAIMS REVIEW METHODOLOGY.
a. SAMPLING UNIT. A description of the Item as that term is utilized
for the Claims Review.
b. CLAIMS REVIEW POPULATION. A description of the Population subject
to the Claims Review.
c. CLAIMS REVIEW OBJECTIVE. A clear statement of the objective
intended to be achieved by the Claims Review.
APPENDIX B:
PAGE 2
3. SAMPLING FRAME. A description of the sampling frame, which is the
totality of Items from which the Discovery Sample and, if any,
Full Sample has been selected and an explanation of the
methodology used to identify the sampling frame. In most
circumstances, the sampling frame will be identical to the
Population.
e. SOURCE OF DATA. A description of the specific documentation relied
upon by the IRO when performing the Claims Review (e.g., medical
records, physician orders, certificates of medical necessity,
requisition forms, local medical review policies (including title and
policy number), CMS program memoranda (including title and issuance
number), Medicare carrier or intermediary manual or bulletins
(including issue and date), other policies, regulations, or
directives).
f. REVIEW PROTOCOL. A narrative description of how the Claims Review
was conducted and what was evaluated.
2. STATISTICAL SAMPLING DOCUMENTATION.
a. The number of Items appraised in the Discovery Sample and, if
applicable, in the Full Sample.
b. A copy of the printout of the random numbers generated by the
"Random Numbers" function of the statistical sampling software
used by the IRO.
c. A copy of the statistical software printout(s) estimating how
many Items are to be included in the Full Sample, if applicable.
d. A description or identification of the statistical sampling
software package used to select the sample and determine the Full
Sample size, if applicable.
3. CLAIMS REVIEW FINDINGS.
a. NARRATIVE RESULTS.
i. A description of Polymedica's billing and coding system(s),
including the identification, by position description, of the
personnel involved in coding and billing.
2. A narrative explanation of the IRO's findings and supporting
rationale (including reasons for errors, patterns noted,
etc.) regarding the Claims Review, including the results of
the Discovery Sample, and the results of the Full Sample (if
any).
APPENDIX B:
PAGE 3
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b. QUANTITATIVE RESULTS.
i. Total number and percentage of instances in which the IRO
determined that the Paid Claims submitted by Polymedica
(Claim Submitted) differed from what should have been the
correct claim (Correct Claim), regardless of the effect on
the payment.
ii. Total number and percentage of instances in which the
Claim Submitted differed from the Correct Claim and in which
such difference resulted in an Overpayment to Polymedica.
iii. Total dollar amount of all Overpayments in the sample.
iv. Total dollar amount of paid Items included in the sample
and the net Overpayment associated with the sample.
v. Error Rate in the sample.
vi. A spreadsheet of the Claims Review results that includes
the following information for each Paid Claim appraised:
Federal health care program billed, beneficiary health
insurance claim number, date of service, procedure code
submitted, procedure code reimbursed, allowed amount
reimbursed by payor, correct procedure code (as determined
by the IRO), correct allowed amount (as determined by the
IRO), dollar difference between allowed amount reimbursed by
payor and the correct allowed amount. (See Attachment 1 to
this Appendix.)
4. SYSTEMS REVIEW. Observations, findings, and recommendations on possible
improvements to the system(s) and process(es) that generated the Overpayment(s).
5. CREDENTIALS. The names and credentials of the individuals who: (1)
designed the statistical sampling procedures and the review methodology utilized
for the Claims Review; and (2) performed the Claims Review.
APPENDIX B:
PAGE 4
APPENDIX C
OVERPAYMENT REFUND
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TO BE COMPLETED BY MEDICARE CONTRACTOR
================================================================================
Date:_______________
Contractor Deposit Control #______________ Date of Deposit: __________________
Contractor Contact Name:______________________ Phone # _________________________
Contractor Address:_____________________________________________________________
Contractor Fax:_________________________________________________________________
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TO BE COMPLETED BY PROVIDER/PHYSICIAN/SUPPLIER
Please complete and forward to Medicare Contractor. This form, or a similar
document containing the following information, should accompany every voluntary
refund so that receipt of check is properly recorded and applied.
PROVIDER/PHYSICIAN/SUPPLIERNAME_________________________________________________
ADDRESS_________________________________________________________________________
PROVIDER/PHYSICIAN/SUPPLIER #_________________ CHECK NUMBER#__________________
CONTACT PERSON:_________________ PHONE #___________________ AMOUNT OF CHECK
$_______________ CHECK DATE________________
REFUND INFORMATION
For each Claim, provide the following:
Patient Name___________________________________ HIC #___________________________
Medicare Claim Number______________________ Claim Amount Refunded $_____________
Reason Code for Claim Adjustment:_____ (Select reason code from list below.
Use one reason per claim)
(PLEASE LIST ALL CLAIM NUMBERS INVOLVED. ATTACH SEPARATE SHEET, IF NECESSARY)
Note: If Specific Patient/HIC/Claim #/Claim Amount data not available for all
claims due to Statistical Sampling, please indicate methodology and
formula used to determine amount and reason for
overpayment: _____________________________________________________________
For Institutional Facilities Only:
Cost Report Year(s) ____________________
(If multiple cost report years are involved, provide a breakdown by amount and
corresponding cost report year.)
For OIG Reporting Requirements:
Do you have a Corporate Integrity Agreement with OIG? Yes No
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REASON CODES:
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BILLING/CLERICAL ERROR MSP/OTHER PAYER INVOLVEMENT MISCELLANEOUS
---------------------- --------------------------- -------------
01 -- Corrected Date of Service 08 -- MSP Group Health Plan Insurance 13 -- Insufficient Documentation
02 -- Duplicate 09 -- MSP No Fault Insurance 14 -- Patient Enrolled in an HMO
03 -- Corrected CPT Code 10 -- MSP Liability Insurance 15 -- Services Not Rendered
04 -- Not Our Patient(s) 11 -- MSP, Workers Comp. (Including 16 -- Medical Necessity
05 -- Modifier Added/Removed Black Lung) 17 -- Other (Please Specify)
06 -- Billed in Error 12 -- Veterans Administration _________________________
07 -- Corrected CPT Code
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Attachment 1
CLAIM REVIEW RESULTS
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Federal Bene Date of Procedure Procedure Allowed Correct Correct Dollar Difference
Health Care HIC Service Code Code Amount Procedure Allowed Amt Between Amt
Program # Submitted Reimbursed Reimbursed Code (IRO Reimbursed Reimbursed and
Billed determined) (IRO Correct Allowed Amt
determined)
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