Exhibit 10.13
CORPORATE INTEGRITY AGREEMENT
BETWEEN THE
Office of Inspector General
of the
Department of Health and Human Services
and
Rotech Medical Corporation
I. Preamble
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Rotech Medical Corporation ("Rotech") 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 by Rotech and each of its subsidiaries that provides items or
services for which payment may be made by any Federal health care program and by
all of Rotech's officers, directors, employees, contractors, and agents, with
the requirements of Medicare, Medicaid and all other Federal health care
programs (as defined in 42 U.S.C. (S) 1320a-7b(f)) (hereinafter collectively
referred to as the "Federal health care programs"). Rotech's compliance with the
terms and conditions in this CIA shall constitute an element of Rotech's present
responsibility with regard to participation in the Federal health care programs.
Rotech is also entering into a Settlement with the United States, as embodied in
the Plan of Reorganization soon to be filed in the Integrated Health Services,
Inc.("IHS") Chapter 11 proceeding (In re IHS), Jointly Administered (the
"Bankruptcy Court")) (hereafter referred to as "Settlement Agreement") and this
CIA is incorporated by reference into the Settlement Agreement.
A. Definitions
1. "Covered Person": any (i) officer, director, or employee of Rotech;
or (ii) agent or other individual who furnishes health care items or
services at a Rotech owned or operated location for which Rotech
claims reimbursement from any Federal health care program or who
participates in the preparation or submission of claims for payment on
behalf of Rotech with respect to items or services for which Rotech
claims reimbursement from any Federal health care program (regardless
of where such activity takes place).
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2. "Contractor": any individual or entity whose work is performed at a
location neither owned nor operated by Rotech, with whom Rotech has
entered into a contract or other arrangement to furnish health care
items or services for which Rotech claims reimbursement from any
Federal health care program.
II. Term of the CIA
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The period of the compliance obligations assumed by Rotech under this CIA
shall be five years (unless otherwise specified) 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.
Sections VII, VIII, IX, X and XI shall remain in effect until the OIG has
completed its review of the final annual report and any additional materials
submitted by Rotech pursuant to OIG's request.
III. Corporate Integrity Obligations
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Rotech warrants and represents that it currently operates and maintains a
compliance program ("Program"). Pursuant to and for the duration of this CIA,
Rotech shall maintain, and as necessary, amend its current Program such that it
adheres to or includes the following obligations or elements.
A. Compliance Officers and Committee
---------------------------------
1. Corporate Compliance Officer. For the duration of this CIA, Rotech
shall continue to maintain an individual to serve as Corporate Compliance
Officer, in adherence with the following requirements. The Corporate Compliance
Officer shall be responsible for ensuring the development and implementation of
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. The Corporate Compliance Officer shall be a member of
senior management of Rotech, shall make regular (at least quarterly) reports
regarding compliance matters directly to the CEO and/or to the Board of
Directors of Rotech and shall be authorized to report to the Board of Directors
at any time. The Corporate Compliance Officer shall be responsible for
monitoring the day-to-day activities engaged in by Rotech to further its
compliance objectives, as well as any reporting obligations created under this
CIA.
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2. Compliance Liaisons.
Within 90 days of the execution of this CIA, Rotech shall also
appoint a Compliance Liaison for each of its six Divisions. The Compliance
Liaison will cooperate with the Corporate Compliance Officer to ensure the
development and implementation of policies, procedures, and practices designed
to ensure compliance with applicable Federal health care program requirements
and with the requirements of this CIA. The Compliance Liaisons shall serve on
the Compliance Committee on a rotating basis. The Compliance Liaisons also shall
be responsible for assisting the Corporate Compliance Officer in meeting the
reporting obligations created by this Agreement and shall report to the
Compliance Officer at least quarterly.
3. Changes in Compliance Officer. In the event a new Corporate
Compliance Officer is appointed during the term of this CIA, Rotech shall notify
the OIG, in writing, within 15 days of such a change. Changes in Compliance
Liaisons will be reported annually.
4. Corporate Compliance Committee. For the duration of this CIA,
Rotech shall continue to maintain its "Corporate Compliance Committee" and, to
the extent necessary, shall amend the Program within 90 days after the effective
date of this CIA to ensure that the Corporate Compliance Committee meets the
following requirements. The Corporate Compliance Committee shall, at a minimum,
include the Compliance Officer, at least one of the six Compliance Liaisons, and
any other member of senior management within the provider's corporate structure
as necessary to meet the requirements of this CIA (e.g., senior executives
----
responsible for major functions, such as billing, clinical, human resources,
audit, and operations). The Compliance Officer shall chair the Corporate
Compliance Committee and the Committee shall support the Compliance Officer in
fulfilling his/her responsibilities.
B. Written Standards.
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1. Code of Conduct. For the duration of this CIA, Rotech shall
continue to maintain its "Code of Conduct" or similar code however denominated
(hereinafter referred to as "Code of Conduct") and, to the extent necessary,
shall amend the Program and/or Code of Conduct within 120 days of the effective
date of this CIA to ensure that the Code of Conduct meets the following
requirements. The Code of Conduct shall be distributed within 120 days of the
effective date of this CIA to all Covered Persons who
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have not already received the Code of Conduct. Rotech shall make adherence to
Company policies and procedures designed to ensure compliance with Federal
health care program requirements an element in evaluating the performance of
managers, supervisors, and all other employees. The Code of Conduct shall, at a
minimum, set forth:
a. Rotech's commitment to full compliance with Federal health
care program requirements, including its commitment to prepare
and submit accurate xxxxxxxx;
b. a requirement that all of its Covered Persons shall be
expected to comply with all applicable Federal health care
program requirements and with Rotech's own policies and
procedures;
c. a requirement that all Covered Persons shall be expected to
report to Rotech suspected violations of any Federal health care
program requirements or of Rotech's own policies and procedures;
d. the possible consequences to both Rotech and Covered Persons
of their failure to comply with the Federal health care program
requirements or with Rotech's own policies and procedures, or of
their failure to report such non-compliance; and
e. the right of all Covered Persons to use the Confidential
Disclosure Program, as well as Rotech's commitment to
confidentiality and non-retaliation with respect to disclosures.
Within 120 days of the effective date of the CIA, each Covered Person shall
certify, in writing, or electronically, that he or she has received, read,
understood, and will abide by Rotech's Code of Conduct. New Covered Persons
shall receive the Code of Conduct within 30 days after becoming a Covered Person
and shall complete the required certification within 30 days after becoming a
Covered Person or within 120 days of the effective date of the CIA, whichever is
later.
Rotech shall annually review the Code of Conduct to determine if revisions
are appropriate and shall make any necessary revisions based on such a review.
Any such revised Code of Conduct shall be distributed within 45 days of
finalizing such changes. Covered persons shall certify that they have received,
read, understand and will abide by the revised Code of Conduct within 30 days of
the distribution of such revisions.
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2. Policies and Procedures. For the duration of this CIA Rotech shall
continue to maintain its current written policies and procedures regarding the
operation of Rotech's compliance program and its compliance with Federal health
care program requirements. Within 120 days of the effective date of this CIA,
Rotech shall review its existing policies and procedures and, amend them if
necessary, to ensure that they at a minimum address the following specific risk
areas identified below associated with the provision and reimbursement of home
oxygen and other durable medical equipment and supplies under Federal health
care programs.
a. Coverage rules and criteria;
b. Medical Necessity requirements;
c. Certificates of Medical Necessity;
d. Physician's Orders;
e. Qualification of Patients for Oxygen Therapy;
f. Billing;
g. Selection of HCPCS Codes;
h. Capped rentals;
h. Collection of Medicare co-pay and deductibles; and
i. Kickbacks and Self-Referrals.
Within 120 days of the effective date of the CIA, the relevant portions of
the Policies and Procedures shall be distributed to all individuals whose job
functions are related to those Policies and Procedures. Appropriate and
knowledgeable staff should be available to explain the Policies and Procedures.
At least annually (and more frequently if appropriate), Rotech shall assess
and update as necessary the Policies and Procedures. Within 45 days of 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 are related to those Policies and Procedures.
C. Training and Education. For the duration of this CIA, Rotech shall
----------------------
continue to maintain its Training and Education program and further develop its
compliance training program to provide necessary training and information to
Covered Persons about applicable Federal health care program requirements and
related Rotech policies and procedures. At a minimum, the compliance training
program shall include the following elements:
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1. General Compliance Training. Within 120 days of the effective date
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of this CIA, Rotech shall provide at least 1 hour of general training to each
Covered Person. This training, at a minimum, shall explain Rotech's:
a. Corporate Integrity Agreement requirements; and
b. Compliance Program (including the Code of Conduct and the
policies and procedures pertaining to general compliance issues)
New Covered Persons shall receive the general training described above within 30
days of becoming a Covered Person or within 120 days after the effective date of
this CIA, whichever is later. After receiving the initial training described
above, each Covered Person shall receive at least one hour of general training
annually.
2. Specialized Training. In addition to the general compliance
--------------------
training described above, all Covered Persons who participate in the delivery of
patient care items or services or participate in the preparation or submission
of claims for reimbursement, (either in paper or electronic format) to any
Federal health care program shall receive at least 3 hours additional training
relating to legal and regulatory issues specifically affecting their
billing-related responsibilities. This training shall cover relevant Federal
health care program requirements, and the specifically identified policies and
procedures risk areas identified in Section III.B.2 above. Additionally, the
training shall address:
a. the submission of correct and accurate bills for services
rendered to all Federal health care program beneficiaries;
b. the personal obligation of each individual to make reasonable
efforts to ensure that information provided in support of a
submission for reimbursement for items or services furnished to
beneficiaries of the Federal health care programs is accurate;
c. applicable Federal health care program requirements;
d. examples of improper billing and documentation practices; and
e. the legal, regulatory, and internal Rotech sanctions for
improper xxxxxxxx.
Persons providing the training must be knowledgeable about the subject area.
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Rotech shall conduct regional specialized training sessions on a quarterly
basis. Those individuals who are Relevant Covered Persons upon the effective
date of this CIA shall receive this training at the first available training
session in their region or within 120 days of the effective date of this CIA,
which ever is later. New Relevant Covered Persons shall receive this training at
the first available training session in their region following the beginning of
their employment or becoming Relevant Covered Persons or within 120 days of the
effective date of this CIA, whichever is later. A Rotech 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 in the preparation or submission of claims for reimbursement
from any Federal health care program, until such time as the new Relevant
Covered Person completes applicable training.
Any training that has been provided by the Rotech Compliance Department
within the 6 months prior to the effective date of this CIA and that satisfies
the requirement with respect to Relevant Covered Persons shall be deemed to have
satisfied the requirements of this provision, so long as such training can be
documented to the OIG.
After receiving the initial training described in this section, every
Relevant Covered Person shall receive at least 2 hours of specialized training
annually.
3. Certification. Each individual who is required to attend training
shall certify, in writing, or electronically, 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 his or her designee)
shall retain the certifications, along with all course materials. These shall be
made available to OIG, upon request.
D. Review Procedures.
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1. General Description.
a. Internal Claims Review Option. For the first Reporting Period (as
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defined in Section III.D.1.d), Rotech may conduct an internal review
of its billing and coding practices with respect to the Federal health
care programs. The review shall comply with all of the requirements
outlined in Section III.D and in Appendix A to this CIA ("Claims
Review"). Rotech will continue to perform the internal Claims Review
in conformance with
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the requirements of Section III.D and Appendix A to this CIA for the
next Reporting Period of this CIA, unless the OIG, in its sole
discretion, determines that Rotech's internal Claims Review has not
been performed satisfactorily. To the extent that OIG permits Rotech
to perform internal Claims Reviews, Rotech shall submit all
information required by the provisions outlined in Section III.D and
in Appendix A to this CIA.
b. Retention of Independent Review Organization. Within 90 days of the
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effective date of this CIA, Rotech shall retain an entity such as an
accounting, auditing or consulting firm (hereinafter "Independent
Review Organization" or "IRO"), to perform review engagements to
assist Rotech in assessing and evaluating its billing and coding
practices and systems pursuant to this CIA and the Settlement
Agreement. Prior to performing any review engagements required under
this CIA, the IRO and Rotech shall design agreed upon procedures as
defined in the AICPA "attest standards" for Agreed Upon Procedures
Engagements (hereafter "agreed upon procedures") outlining the
specific work to be performed by the IRO, and the agreed upon
procedures shall be submitted to the OIG for review. Each IRO retained
by Rotech shall have expertise in the billing, coding, reporting and
other requirements of the particular section of the health care
industry pertaining to this CIA and in the general requirements of the
Federal health care program(s) from which Rotech seeks reimbursement.
Each IRO shall assess, along with Rotech, whether it can perform the
IRO engagement in a professionally independent fashion taking into
account any other business relationships or other engagements that may
exist.
c. IRO Verification or Claims Review
---------------------------------
i. For the first Reporting Period, the IRO shall perform an
agreed upon procedures Verification Review of 7 of the Xxxxxx
Units reviewed by Rotech in its internal Claims Review
("Verification Review"). Such review shall consist of an
assessment of 25 claims for each Xxxxxx Unit.
ii. For any Xxxxxx Units reviewed by Rotech in its internal
Claims Review which are subject to a full sample, the IRO shall
perform a Verification Review of 10% of the sampling units in
each full sample. These sampling units shall be randomly
selected.
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iii. If the IRO's Verification Review, for the previous year, if
applicable, results in (i) no more than a 5% sampling unit
variance from Rotech's internal review; or (ii) neither Rotech's
primary compliance staff nor its internal audit policies and
procedures substantially change, then the IRO shall perform a
Verification Review for the fourth year of the CIA only.
iv. If the IRO's Verification Review, for the previous year, if
applicable, results in (i) more than a 5% sampling unit variance
from Rotech's internal review; or (ii) either Rotech's primary
compliance staff or its internal audit policies and procedures
substantially change; and if Rotech is permitted to perform the
internal Claims Review, the IRO shall, at a minimum, perform a
Verification Review for the next year Reporting Period and for
the fourth year of the CIA.
v. If the OIG does not allow Rotech to perform the Claims Review
internally for any year after the first Reporting Period, the IRO
shall perform a Claims Review for each successive year of the
CIA, unless the OIG in its sole discretion allows Rotech to
recommence internal claims review.
As part of Rotech's Annual Report, the IRO shall submit a report that
verifies that the requirements outlined in Section III.D and in
Appendix A to this CIA have been satisfied and shall report the
results, sampling unit by sampling unit, of any Verification Review or
Claims Review performed.
d. Frequency of Claims Review. The Claims Review shall be performed
--------------------------
annually and shall cover each of the one-year periods of the CIA
beginning with the effective date of this CIA ("Reporting Period").
Rotech and/or the IRO shall conduct the Claims Review in accordance
with Section III.D and Appendix A to this CIA.
e. Frequency of Unallowable Cost Review. To the extent applicable, the
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Unallowable Cost Review shall be performed by the IRO for the first
one-year Reporting Period beginning with the effective date of the
CIA.
f. Retention of Records. Rotech and the IRO(s) shall retain and make
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available to the OIG, upon request, all work papers, supporting
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documentation, correspondence, and draft reports exchanged between the
IRO and Rotech related to the Claims Review.
2. Claims Review. The Claims Review shall include a Discovery Sample
and, if necessary, a Full Sample. The applicable definitions, procedures, and
reporting requirements are outlined in Appendix A to this CIA, which is
incorporated by reference.
a. Discovery Sample. With respect to each facility selected pursuant
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to the facility selection methodology set forth in Appendix A, Rotech
or the IRO shall randomly select and review a sample of 50 Medicare
Paid Claims submitted by or on behalf of Rotech. The Paid Claims shall
be reviewed based on the supporting documentation available at Rotech
or under Rotech's control and applicable billing and coding
regulations and guidance to determine whether the claim submitted was
correctly coded, submitted and reimbursed.
i. Results of Discovery Sample. If the Error Rate (as defined in
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Appendix A) is less than 5%, no additional sampling is required,
nor is the Systems Review required. (Note: The threshold listed
above does not imply that this is an acceptable error rate.
Accordingly, Rotech should, as appropriate, further analyze any
errors identified in the Discovery Sample. Rotech recognizes that
the 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.)
ii. If the Discovery Sample indicates that the Error Rate is 5%
or greater, Rotech or 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
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Sections III.D.l and III.D.2.a, Rotech or the IRO shall perform an
additional sample of Paid Claims using commonly accepted sampling
methods and in accordance with Appendix A. The Full Sample should 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
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Paid Claims shall be reviewed based on supporting documentation
available at Rotech or under Rotech's control and applicable billing
and coding regulations and guidance to determine whether the claim
submitted 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,
Rotech 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. The OIG, in its full discretion, may refer the findings of the
Full Sample (and any related workpapers) received from Rotech 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 the Discovery Sample identifies an Error Rate of
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5% or greater, Rotech or the IRO, as determined by the procedures set
forth in section III.D.1, shall also conduct a Systems Review.
Specifically, for each Item in the Discovery Sample and Full Sample
that resulted in an Overpayment, Rotech or the IRO should 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. Rotech or the IRO shall generate a report
summarizing 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
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III.I.1 of the CIA, Rotech agrees to 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. Rotech agrees to
make available to the OIG any and all documentation that reflects the
refund of the Overpayment(s) to the payor.
3. Unallowable Cost Review. If applicable, the IRO shall conduct a
review of Rotech's compliance with the unallowable cost provisions of the
Settlement Agreement during the first year of this CIA only.
a. The IRO shall determine whether Rotech has complied with its
obligations not to charge to, or otherwise seek payment from, Federal
or
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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 payment requests already submitted by Rotech or any of its
subsidiaries. To the extent 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 will 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.
4. 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 Rotech 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.
5. Claims Review Report. Depending on whether Rotech conducted an internal
Claims Review with an IRO Verification Review or the IRO conducted the Claims
Review, Rotech and/or the IRO shall prepare a report based upon the Claims
Review performed (the "Claims Review Report"). Information to be included in the
Claims Review Report is detailed in Appendix A to this CIA.
6. Validation Review. In the event the OIG has reason to believe that: (a)
Rotech's Claims Review or Unallowable Cost Review fails to conform to the
requirements of this CIA; or (b) Rotech's and/or the IRO's findings or Claims
Review results are inaccurate, the 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 CIA and/or the findings or Claims Review
results are inaccurate ("Validation Review"). Rotech agrees to pay for the
reasonable cost of any such review performed by the OIG or any of its designated
agents so long as it is initiated before one year after Rotech's final
submission (as described in section II) is received by the OIG.
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Prior to initiating a Validation Review, the OIG shall notify Rotech of its
intent to do so and provide a written explanation of why the OIG believes such a
review is necessary. To resolve any concerns raised by the OIG, Rotech may
request a meeting with the OIG to discuss the results of any Claims Review or
Unallowable Cost Review submissions or findings; present any additional or
relevant information to clarify the results of the Claims Review or Unallowable
Cost Review to correct the inaccuracy of the Claims Review; and/or propose
alternatives to the proposed Validation Review. Rotech agrees to provide any
additional information as may be requested by the OIG under this section in an
expedited manner. The OIG will attempt in good faith to resolve any Claims
Review or Unallowable Cost Review with Rotech 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 the OIG.
7. Independence Certification. The IRO shall include in its report(s) to
Rotech a certification or sworn affidavit that it has evaluated its professional
independence with regard to the Claims Review or Unallowable Cost Review and
that it has concluded that it was, in fact, independent.
E. Acquisition Compliance Assessment
---------------------------------
In the event that during the term of this CIA, Rotech acquires, merges
with, purchases the stock or assets of, or otherwise gains an ownership or
control interest of 5% or more in an entity that delivers health care items or
services for which Federal health care program reimbursement is sought
(hereinafter, "Acquisition" or "Acquisition Entity"), Rotech shall complete the
following Acquisition Compliance Assessment ("ACA") procedures prior to
finalizing the Acquisition in order to ensure the appropriateness of Rotech's
consummating the proposed transaction.
Rotech warrants and represents that as part of its Compliance Program it
currently has in place an Acquisition Due Diligence review process, including an
Acquisition Committee. For the duration of this CIA, Rotech shall continue to
maintain as part of its Compliance Program its Acquisition Due Diligence review
process, including the Acquisition Committee, subject to the additional
requirements set forth below. In fulfilling the obligations of the ACA as set
forth below, Rotech may continue to use its current Due Diligence review process
to the extent that it satisfies and/or is consistent with the ACA procedures set
forth below.
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1. Scope of ACA. In the event that the Acquisition Entity consists of
more than a single business and/or operating facility (e.g., a corporate
headquarters, five storefronts or facilities, and one billing center --
hereinafter collectively referred to as "facilities" regardless of composition),
the ACA shall be performed, in the following manner: For any Acquisition Entity
that consists of 2 to 10 total facilities, an ACA of 100% of the facilities
shall be performed. For any Acquisition Entity that consists of 11 to 25
facilities, an ACA of 50% of the facilities shall be performed; but in no event
more than 10. For any Acquisition Entity that consists of 26 to 50 facilities,
an ACA of 25% of the facilities shall be performed, but in no event more than
10. For any Acquisition Entity that consists of more than 50 facilities, an ACA
of 10% of the facilities shall be performed; however, no less than ten and no
more than fifteen total facilities shall be included/1/. For any less than 100%
review of an Acquisition Entity, the facilities shall be randomly selected. All
the ACA steps described below shall be performed at all the facilities required
to be included in the ACA by the aforementioned provisions
2. Responsibility of Acquisition Committee and Compliance Officer. The
Acquisition Committee shall review all potential Rotech Acquisitions. The
Acquisition Committee shall, at a minimum, include the Rotech Corporate
Compliance Officer and members of his or her staff as deemed appropriate. The
Compliance Officer and his or her Compliance Department shall have primary
responsibility for performing any ACA. An Acquisition shall only be consummated
when approved by Rotech's Chief Executive Officer, Chief Operating Officer,
Chief Legal Officer, Chief Financial Officer, and Chief Compliance Officer.
3. Compliance Program Infrastructure Evaluation. Rotech shall
undertake a comprehensive review of the Acquisition Entity's existing compliance
program (to the extent that such program exists) in order to assess whether it
is operating in compliance with Federal health care program requirements. Such
review shall include, at a minimum, an evaluation of the entity's compliance
officer and compliance committee structure and personnel; compliance policies
and procedures, the training and education program; the reporting system; the
disciplinary mechanisms, employee screening process and its overall commitment
to compliance as evidenced by involvement of the board of directors and/or
senior management in the compliance program. The Diligence Questionnaire
attached hereto at Appendix C sets forth the criteria to be used for such an
assessment.
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/1/ To the extent that the required percentage of operational facilities is
not a whole number, Rotech shall round up to the next whole number as the number
of facilities subject to the ACA.
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4. ACA Operational Review. Rotech shall undertake a comprehensive
review of the Acquisition Entity's operations and participation in Federal
health care programs in order to assess whether it is operating in compliance
with Federal health care program requirements. At a minimum, such review shall
focus on eliciting information about the Acquisition Entity's operations that
are associated with the risk areas set forth in the Office of Inspector
General's Compliance Program Guidance for the Durable Medical Equipment,
Prosthetics, Orthotics and Supply Industry (June 1999) (published in 64 Fed.
Reg. 36368) and any updates to this document. At a minimum, such review shall
include the following:
a. interviews of key personnel (including managerial or
supervisory as well as front line employees) available to Rotech
who are involved in the provision of health care items or
services for which the entity seeks reimbursement from any
Federal health care program or who participate in the preparation
or submission of claims for payment on behalf of the entity with
respect to items or services for which the entity seeks
reimbursement from any Federal health care program;
b. review of documents, including policies and procedures and
third party contracts, relevant to the operations of the
Acquisition Entity and its participation in Federal health care
programs; and
c. completion of the Due Diligence Questionnaire (attached as
Appendix C), including a certification as to truthfulness and
accuracy of the responses by the owner.
5. ACA Chart Review. At a minimum, Rotech shall perform a chart review
consisting of at least 50 Medicare oxygen charts and at least 50 DME charts, for
any facility covered by the ACA. For any facility with less than 50 oxygen or 50
DME charts, Rotech shall review all the charts. For multi-facility entities,
pursuant to section III.E.5 above regarding scope of the ACA, the chart reviews
shall be performed at each facility required to be included in the ACA. Such
reviews shall be selected randomly. Nothing in this provision precludes Rotech
from performing as many chart reviews (at as many locations if a multi-facility
entity) as it deems appropriate as part of its acquisition due diligence
process.
Rotech Corporate Integrity Agreement
15
6. ACA Final Report. Within 60 days of closing an Acquisition subject
to an ACA as described above, Rotech shall submit in writing a report to the
OIG, indicating that it performed the steps required under this section of the
CIA and providing an enumeration and description of the procedures performed as
well as a description and timetable for any corrective actions, if needed, being
taken to address compliance issues at the Acquisition Entity, including the
process for assimilating the Acquisition Entity into Rotech's own compliance
program.
7. Validation Review. In the event the OIG has reason to believe that:
(a) Rotech's ACA fails to conform to the requirements of this CIA; or (b) the
ACA Final Report(s) are inaccurate, the OIG may, at its sole discretion, conduct
its own review to determine whether the ACA complies with the requirements of
the CIA and/or the ACA Final Report(s) are inaccurate. Rotech agrees to pay for
the reasonable cost of any such review performed by the OIG or any of its
designated agents so long as it is initiated before one year after Rotech's
final submission (as described in section II) is received by the OIG.
Prior to initiating a Validation Review, the OIG shall notify Rotech
of its intent to do so and provide an explanation for believing why such a
review is necessary. In order to resolve any concerns raised by the OIG, Rotech
may request a meeting with the OIG to discuss the results of any ACA submissions
or any ACA Final Report(s); present any additional or relevant information to
clarify the results of the ACA or to correct the inaccuracy of the ACA Final
Report(s); and/or propose alternatives to the proposed Validation Review. Rotech
agrees to provide any additional information as may be requested by the OIG
under this section in an expedited manner. The OIG will attempt in good faith to
resolve any issues related to the ACA with Rotech 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 the
OIG.
F. Disclosure Program.
------------------
For the duration of this CIA, Rotech shall continue to maintain its
"Compliance Hotline" or similar reporting mechanism however denominated
(hereinafter referred to as "Disclosure Program") and, to the extent necessary,
shall amend the Program and/or Disclosure Program within 90 days of the
effective date of this CIA to ensure that the Disclosure Program meets the
following requirements. The Disclosure Program must include 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
Rotech Corporate Integrity Agreement
16
individual's chain of command, any identified issues or questions associated
with Rotech'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. Rotech 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 non-retribution, non-retaliation
policy, and shall include a reporting mechanism for anonymous, confidential
communications. 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, Rotech 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 (or his or her designee) shall maintain a disclosure
log, which shall include a record and summary of each disclosure received
(whether anonymous or not), the status of the respective internal reviews, and
any corrective action taken in response to the internal reviews. The disclosure
log shall be available to OIG, upon request.
G. Ineligible Persons.
------------------
1. Definition. For purposes of this CIA, an "Ineligible Person" shall
be any individual or entity who: (a) is currently excluded, debarred or
otherwise ineligible to participate in the Federal health care programs or in
Federal procurement or non procurement programs; or (b) has been convicted of a
criminal offense related to the provision of health care items or services, but
has not yet been excluded, debarred or otherwise declared ineligible.
2. Screening Requirements. Rotech shall not hire as employees or
engage as Contractors any Ineligible Person. To prevent hiring or contracting
with any Ineligible Person, Rotech shall screen all prospective employees and
prospective Contractors prior to engaging their services by: (a) requiring
applicants to disclose whether they are
Rotech Corporate Integrity Agreement
17
Ineligible Persons; and (b) reviewing the General Services Administration's List
of Parties Excluded from Federal Programs (available through the Internet at
xxxx://xxxx.xxxxx.xxx) and the HHS/OIG List of Excluded Individuals/Entities
(available through the Internet at xxxx://xxx.xxx.xxx/xxx) (these lists will
hereinafter be referred to as the "Exclusion Lists").
3. Review and Removal Requirement. Within 90 days of the effective
date of this CIA, Rotech shall review its list of current employees and
Contractors against the Exclusion Lists. Thereafter, Rotech shall review its
list of current employees and Contractors against the Exclusion Lists
semi-annually. In addition, Rotech shall require employees and Contractors to
disclose immediately any debarment, exclusion or other event that makes the
employee an Ineligible Person.
If Rotech has notice that an employee or Contractor has become an
Ineligible Person, Rotech shall remove such person from responsibility for, or
involvement with, Rotech'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.
4. Pending Charges and Proposed Exclusions. If Rotech has notice that
an employee or Contractor is charged with a criminal offense related to any
Federal health care program, or is proposed for exclusion during his or her
employment or contract, the Rotech shall take all appropriate actions to ensure
that the responsibilities of that employee or Contractor have not and shall not
adversely affect the quality of care rendered to any beneficiary, patient or
resident, or the accuracy of any claims submitted to any Federal health care
program.
H. Notification of Government Investigation or Legal Proceedings.
-------------------------------------------------------------
Within 30 days of discovery, Rotech shall notify OIG, in writing, of any
ongoing investigation or legal proceeding conducted or brought by a governmental
entity or its agents involving an allegation that Rotech 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. Rotech shall
also provide written notice to OIG within 30 days of the
Rotech Corporate Integrity Agreement
18
resolution of the matter, and shall provide OIG with a description of the
findings and/or results of the proceedings, if any.
I. Reporting.
---------
1. Overpayments
a. Definition of Overpayments. For purposes of this CIA, an
"overpayment" shall mean the amount of money Rotech has received
in excess of the amount due and payable under any Federal health
care program requirements.
b. Reporting of Overpayments. If, at any time, Rotech identifies
or learns of any overpayments, Rotech shall notify the payor
(e.g., Medicare fiscal intermediary or carrier) within 30 days of
----
identification of the overpayment and take remedial steps within
60 days of discovery (or such additional time as may be agreed to
by the payor) to correct the problem, including preventing the
underlying problem and the overpayments from recurring. Also,
within 30 days of identification of the overpayment, Rotech shall
repay the overpayment to the appropriate payor to the extent such
overpayment has been quantified. If not yet quantified, within 30
days of identification, Rotech shall notify the payor of its
efforts to quantify the overpayment amount along with a schedule
of when such work is expected to be completed. Notification and
repayment to the contractor should be done in accordance with the
contractor policies, and for Medicare contractors, must include
the information contained on the Overpayment Refund Form,
provided as Appendix B to this CIA, unless otherwise approved by
the payor. 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. Material Deficiencies.
a. Definition of Material Deficiency. For purposes of this CIA, a
"Material Deficiency" means anything that involves:
Rotech Corporate Integrity Agreement
19
(i) a substantial overpayment;
(ii) a matter that a reasonable person would consider a
potential violation of criminal, civil, or administrative
laws applicable to any Federal health care program for which
penalties or exclusion may be authorized.
A Material Deficiency may be the result of an isolated event or a
series of occurrences.
b. Reporting of Material Deficiencies. If Rotech determines
through any means that there is a Material Deficiency, Rotech
shall notify OIG, in writing, within 30 days of making the
determination that the Material Deficiency exists. The report to
the OIG shall include the following information:
(i) If the Material Deficiency results in an overpayment,
the report to the OIG shall be made at the same time as the
notification to the payor required in section III.H.1, and
shall 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) on which the overpayment
was repaid/refunded, or the offset date;
(ii) a complete description of the Material Deficiency,
including the relevant facts, persons involved, and legal
and Federal health care program authorities implicated;
(iii) a description of Rotech's actions taken to correct the
Material Deficiency; and
(iv) any further steps Rotech plans to take to address the
Material Deficiency and prevent it from recurring.
Rotech Corporate Integrity Agreement
20
IV. New Business Units or Locations
-------------------------------
In the event that, after the effective date of this CIA, Rotech changes
locations or purchases or establishes new business units related to the
furnishing of items or services that may be reimbursed by Federal health care
programs, Rotech shall notify OIG of this fact as soon as possible, but no later
than within 60 days of the date of a purchase and no less than annually with
respect to changes of existing locations or establishments. This notification
shall include the location of the new operation(s), phone number, fax number,
Medicare Rotech number(s) (if any), and the corresponding contractor's name and
address that has issued each Medicare Rotech number. All Covered Persons at such
locations shall be subject to the applicable requirements in this CIA (e.g.,
----
completing certifications and undergoing training).
V. Implementation and Annual Reports
---------------------------------
A. Implementation Report. Within 150 days after the effective date of this
---------------------
CIA, Rotech shall submit a written report to OIG summarizing the status of its
implementation of the requirements of this CIA. This Implementation Report shall
include:
1. the name, address, phone number, position description, and summary
of other non-compliance job responsibilities of the Compliance Officer
and Compliance Liaisons required by section III.A;
2. the names and positions of the members of the Compliance Committee
required by section III.A;
3. a copy of Rotech's Code of Conduct required by section III.B.1, in
the event it was revised pursuant to the CIA;
4. a copy of all compliance-related Policies and Procedures required
by section III.B.2 and a summary of all other Policies and Procedures
required by section III.B.2, in the event they were revised or newly
created pursuant to the CIA;
5. a representative sample of training materials used for the training
required by section III.C, a description of such training, including a
Rotech Corporate Integrity Agreement
21
description of the targeted audiences, length of sessions, which
sessions were mandatory and for whom, percentage of attendance, and a
schedule of when the training sessions were held. A copy of all
training materials used for the training required by section III.C
shall be made available to OIG upon request.;
6. 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 appropriate Covered Persons;
b. all Covered Persons have completed the Code of Conduct
certification required by section III.B.1; and
c. all Covered Persons have completed the applicable training and
executed the certification(s) required by section III.C.;
The documentation supporting this certification shall be available to
OIG, upon request.
7. a description of the Disclosure Program required by section III.F,
in the event it was revised pursuant to the CIA;
8. the identity of the IRO(s), a summary/description of all
engagements between Rotech and the IRO, including, but not limited to,
any outside financial audits, compliance program engagements, or
reimbursement consulting, and the proposed start and completion dates
of the first annual review;
9. a certification from the IRO regarding its professional
independence from Rotech;
10. a summary of personnel actions (other than hiring) taken pursuant
to section III.G.;
11. a list of all of Rotech's locations (including locations and
mailing addresses), the corresponding name under which each location
is doing
Rotech Corporate Integrity Agreement
22
business, the corresponding phone numbers and fax numbers, each
location's Medicare Rotech identification number(s) and the
contractor's name and address that issued each Rotech identification
number;
12. to the extent not already furnished to OIG, or if modified, a
description of Rotech's corporate structure, including identification
of any parent and sister companies, subsidiaries and their respective
lines of business; and
13. the certification required by section V.C.
B. Annual Reports. Rotech shall submit to OIG Annual Reports with respect
--------------
to the status of, and findings regarding, Rotech's compliance activities for
each of the five one-year periods beginning on the effective date of the CIA.
(The one-year period covered by each Annual Report shall be referred to as "the
Reporting Period").
Each Annual Report shall include:
1. any change in the identity, position description, or other
non-compliance job responsibilities of the Compliance Officer and
Compliance Liaisons and any change in the membership of the Compliance
Committee described in section III.A or the Acquisition Committee
described in section III. E.;
2. a certification by the Compliance Officer that:
a. all Covered Persons have completed any Code of Conduct
certifications required by section III.B.1;
b. all Covered Persons have completed the applicable training and
executed the certification(s) required by section III.C;
c. Rotech has complied with its obligations under the Settlement
Agreement: (i) 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; (ii) not to charge to or otherwise
seek payment from Federal or State payors for unallowable costs
(as defined in the Settlement Agreement); and (iii) to identify
and adjust any past charges or claims for unallowable costs;
Roech Corporate Integrity Agreement
23
d. for all Acquisitions, Rotech has complied with its obligations
to perform an Acquisition Compliance Assessment and submit an ACA
Final Report to the OIG in accordance with section III.E.
The documentation supporting this certification shall be available to
OIG, upon request.
3. a summary of any significant changes or amendments to the Policies
and Procedures required by section III.B and the reasons for such
changes (e.g., change in contractor policy) and copies of any
----
compliance-related Policies and Procedures;
4. a representative sample of training materials used for the training
required by section III.C (to the extent it has not already been
provided as part of the Implementation Report), a description of such
training conducted during the Reporting Period, including a
description of the targeted audiences, length of sessions, which
sessions were mandatory and for whom, percentage of attendance, and a
schedule of when the training sessions were held. A copy of all
training materials used for the training; required by section III.C
shall be made available to OIG upon request.;
5. a complete copy of all reports prepared pursuant to the IRO's
billing and compliance engagements, including a copy of the
methodology used, along with a copy of the IRO's engagement letter;
6. Rotech's response and corrective action plan(s) related to any
issues raised by the IRO(s);
7. a revised summary/description of all engagements between Rotech and
the IRO, including, but not limited to, any outside financial audits,
compliance program engagements, or reimbursement consulting, if
different from what was submitted as part of the Implementation
Report;
8. a copy of Rotech's and/or the IRO's Claims Review reports;
9. a summary of Material Deficiencies (as defined in III.I) identified
during the Reporting Period and the status of any corrective and
preventative action relating to all such Material Deficiencies;
Xxxxxx Xxxxxxxxx Xxxxxxxxx Xxxxxxxxx
00
00. a report of the aggregate overpayments that have been returned to
the Federal health care programs. Overpayment amounts should be broken
down into the following categories: inpatient Medicare, outpatient
Medicare, Medicaid (report each applicable state separately) and other
Federal health care programs;
11. a summary of the disclosures in the disclosure log required by
section III.F that: (a) relate to Federal health care programs; or (b)
allege abuse or neglect of patients;
12. a description of any personnel actions (other than hiring) taken
by Rotech as a result of the obligations in section III.G, and the
name; title, and responsibilities of any person that falls within the
ambit of section III.G.4, and the actions taken in response to the
obligations set forth in that section;
13. a summary describing any ongoing investigation or legal proceeding
required to have been reported pursuant to section III.H. The summary
shall include a description of the allegation, the identity of the
investigating or prosecuting agency, and the status of such
investigation or legal proceeding;
14. a description of all changes to the most recently provided list
(as updated) of Rotech's locations (including locations and mailing
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 Federal health care program Rotech
identification number(s), and the contractor name and address that
issued each Rotech identification number; and
15. the certification required by section V.C.
The first Annual Report shall be received by the OIG no later than 90 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 Acquisition Compliance Assessment Reports, the
--------------
Implementation Report, and the Annual Reports shall include a certification by
the Compliance Officer that: (1)except as otherwise described in the applicable
report,
Rotech Corporate Integrity Agreement
25
Rotech is in compliance with all of the requirements of this CIA, to the best of
his or her knowledge; and (2) the Compliance Officer has reviewed the Report and
has made reasonable inquiry regarding its content and believes that the
information is accurate and truthful.
D. Designation of Information: Rotech 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. (S) 552. Rotech shall refrain from identifying any
information as exempt from disclosure if that information does not meet the
criteria for exemption from disclosure under FOIA.
VI. Notifications and Submission of Reports
---------------------------------------
Unless otherwise stated in writing after the effective date of this CIA,
all notifications and reports required under this CIA shall be submitted to the
following entities:
OIG:
Civil Recoveries Branch - Compliance Unit
Office of Counsel to the Inspector General
Office of Inspector General
U.S. Department of Health and Human Services
Xxxxx Building, Room 5527
000 Xxxxxxxxxxxx Xxxxxx, XX
Xxxxxxxxxx, XX 00000
Phone 000.000.0000
Fax 000.000.0000
Rotech:
------
Xxxxx Xxxxxxx
Chief Compliance Officer
Xxxxxxx Xxxxx
Chief Legal Officer
Rotech Medical Corporation
0000 Xxxxxxxxxx Xxxxx
Xxxxx 000
Rotech Corporate Integrity Agreement
26
Xxxxxxx, XX 00000
Phone 000.000.0000
Fax 000.000.0000
Unless otherwise specified, all notifications and reports required by this CIA
may be made by certified mail, overnight mail, hand delivery or other means,
provided that there is proof that such notification was received. For purposes
of this requirement, internal facsimile confirmation sheets do not constitute
proof of receipt.
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 Rotech's books, records, and other documents and supporting materials
and/or conduct on-site reviews of any of Rotech's locations for the purpose of
verifying and evaluating: (a) Rotech's compliance with the terms of this CIA;
and (b) Rotech's compliance with the requirements of the Federal health care
programs in which it participates. The documentation described above shall be
made available by Rotech 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 Rotech'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. Rotech agrees to assist OIG or its duly authorized
representative(s) in contacting and arranging interviews with such individuals
upon OIG's request. Rotech's employees may elect to be interviewed with or
without a representative of Rotech present.
VIII. Document and Record Retention
-----------------------------
Rotech 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, the
OIG shall make a reasonable effort to notify Rotech prior to any release by OIG
of information submitted by Rotech pursuant to its obligations under this CIA
and identified upon
Rotech Corporate Integrity Agreement
27
submission by Rotech as trade secrets, or information that is commercial or
financial and privileged or confidential, under the FOIA rules. With respect to
such releases, Rotech shall have the rights set forth at 45 C.F.R. (S)5.65(d).
Rotech shall refrain from identifying any information as exempt from release if
that information does not meet the criteria for exemption from disclosure under
FOIA.
X. Breach and Default Provisions
-----------------------------
Rotech 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, Rotech 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 Rotech fails to have
in place any of the obligations described in section III:
a. a Compliance Officer and Compliance Liaisons;
b. a Compliance Committee;
c. a written Code of Conduct;
d. written Policies and Procedures;
e. a requirement that Covered Persons be trained; and
f. a Disclosure Program.
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 Rotech fails to
retain an IRO, as required in section III.D.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the
day after the date the obligation became due) for each day Rotech fails to meet
any of the
Rotech Corporate Integrity Agreement
28
deadlines for the submission of the Acquisition Compliance Assessment Reports,
Implementation Report, or the Annual Reports to OIG.
4. A Stipulated Penalty of $2,000 (which shall begin to accrue on the
date the failure to comply began) for each day Rotech employs or contracts with
an Ineligible Person and that person: (i) has responsibility for, or involvement
with, Rotech's business operations related to the Federal health care programs;
or (ii) is in a position for which the person's salary or the items or services
rendered, ordered, or prescribed by the person are paid in whole or part,
directly or indirectly, by Federal health care programs or otherwise with
Federal funds (the Stipulated Penalty described in this paragraph shall not be
demanded for any time period during which Rotech can demonstrate that it did not
discover the person's exclusion or other ineligibility after making a reasonable
inquiry (as described in section III.G) as to the status of the person).
5. A Stipulated Penalty of $1,500 for each day Rotech fails to grant
access to the information or documentation as required in section VII of this
CIA. (This Stipulated Penalty shall begin to accrue on the date Rotech fails to
grant access.)
6. A Stipulated Penalty of $1,000 for each day Rotech fails to comply
fully and adequately with any obligation of this CIA. In its notice to Rotech,
OIG shall state the specific grounds for its determination that Rotech has
failed to comply fully and adequately with the CIA obligation(s) at issue and
steps the Rotech must take to comply with the CIA. (This Stipulated Penalty
shall begin to accrue 10 days after the date that OIG provides notice to Rotech
of the failure to comply.) A Stipulated Penalty as described in this paragraph
shall not be demanded for any violation for which the OIG has sought a
Stipulated Penalty under paragraphs 1-5 of this section.
B. Timely Written Requests for Extensions. Rotech 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 Rotech 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
Rotech 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
Rotech Corporate Integrity Agreement
29
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 Rotech 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 Rotech of: (a) Rotech's
failure to comply; and (b) the OIG's exercise of its contractual right to demand
payment of the Stipulated Penalties (this notification is hereinafter referred
to as the "Demand Letter").
2. Response to Demand Letter. Within 10 days of the receipt of the
Demand Letter, Rotech 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 ("ALT") to dispute OIG's determination of
noncompliance, pursuant to the agreed upon provisions set forth below in section
X.E. In the event Rotech elects to request an ALJ hearing, the Stipulated
Penalties shall continue to accrue until Rotech 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.l.c, these provisions for payment of Stipulated Penalties
shall not affect or otherwise set a standard for OIG's decision that Rotech 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 Rotech to report a material deficiency, take
corrective action and make the appropriate refunds, as required
in section III.H;
Rotech Corporate Integrity Agreement
30
b. a repeated or flagrant violation of the obligations under this
CIA, including, but not limited to, the obligations addressed in
section X.A:
c. a failure to respond to a Demand Letter concerning the payment
of Stipulated Penalties in accordance with section X.C; or
d. a failure to retain and use an Independent Review Organization
in accordance with section III.D; or
e. a failure to perform an Acquisition Compliance Assessment as
required in section III.E.
2. Notice of Material Breach and Intent to Exclude. The parties agree
that a material breach of this CIA by Rotech constitutes an independent basis
for Rotech's exclusion from participation in the Federal health care programs.
Upon a determination by OIG that Rotech has materially breached this CIA and
that exclusion should be imposed, OIG shall notify Rotech of: (a) Rotech'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. Rotech 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. Rotech is in compliance with the obligations of the CIA cited
by the 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) Rotech has begun to take action to cure the
material breach; (ii) Rotech is pursuing such action with due
diligence; and (iii) Rotech has provided to OIG a reasonable
timetable for curing the material breach.
4. Exclusion Letter. If at the conclusion of the 30-day period, Rotech
fails to satisfy the requirements of section X.D.3, OIG may exclude Rotech from
participation
Rotech Corporate Integrity Agreement
31
in the Federal health care programs. OIG will notify Rotech in writing of its
determination to exclude Rotech (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
the Exclusion Letter. The exclusion shall have national effect and shall also
apply to all other Federal procurement and non-procurement programs.
Reinstatement to program participation is not automatic. If at the end of the
period of exclusion, Rotech wishes to apply for reinstatement, Rotech must
submit a written request for reinstatement in accordance with the provisions at
42 C F.R. (S)(S) 1001.3001-.3004.
E. Dispute Resolution
------------------
1. Review Rights. Upon OIG's delivery to Rotech 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, Rotech shall be afforded certain
review rights comparable to the ones that are provided in 42
U.S.C.(S).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. (S)(S) 1005.2-1005.21. Notwithstanding the language
in 42 C F.R. (S) 1005.2(c), the request for a hearing involving Stipulated
Penalties shall be made within 10 days of the receipt of the Demand Letter and
the request for a hearing involving exclusion shall be made within 25 days of
receipt 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 Rotech was in full and timely compliance with the obligations of
this CIA for which the OIG demands payment; and (b) the period of
noncompliance. Rotech shall have the burden of proving its full and timely
compliance and the steps taken to cure the noncompliance, if any. If the ALJ
agrees with OIG with regard to a finding of a breach of this CIA and orders
Rotech to pay Stipulated Penalties, such Stipulated Penalties shall become due
and payable 20 days after the ALJ issues such a decision unless Rotech 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.
Rotech Corporate Integrity Agreement
32
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 Rotech was in material breach of this CIA;
b. whether such breach was continuing on the date of the
Exclusion Letter; and
c. whether the alleged material breach could not have been cured
within the 30 day period, but that:
(i) Rotech had begun to take action to cure the material
breach within that period;
(ii) Rotech has pursued and is pursuing such action with due
diligence; and
(iii) Rotech provided to OIG within that period a reasonable
timetable for curing the material breach and Rotech 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 the Rotech, only after a
DAB decision in favor of OIG. Rotech's election of its contractual right to
appeal to the DAB shall not abrogate the OIG's authority to exclude Rotech upon
the issuance of an ALJ's decision in favor of the OIG. If the ALJ sustains the
determination of the OIG and determines that exclusion is authorized, such
exclusion shall take effect 20 days after the ALJ issues such a decision,
notwithstanding that Rotech 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. Rotech agrees to
waive its/his/her right to any notice of such an exclusion if a decision
upholding the exclusion is rendered by the ALJ or 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.
Rotech Corporate Integrity Agreement
33
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, Rotech and
OIG agree as follows:
A. This CIA shall be binding on the successors, assigns, and transferees of
Rotech;
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 Rotech's obligations under the CIA in
the event of Rotech's cessation of participation in Federal health care
programs. If Rotech withdraws from participation in Federal health care programs
and is relieved from its CIA obligations by the OIG, Rotech agrees to notify OIG
30 days in advance of Rotech's intent to reapply as a participating Rotech or
supplier with the Federal health care programs. Upon receipt of such
notification, OIG will evaluate whether the CIA should be reactivated or
modified.
E. The undersigned Rotech 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.
Rotech Corporate Integrity Agreement
34
On Behalf of Rotech Medical Corporation
/s/ Xxxxxxx X. Xxxxxxx 2/11/02
-------------------------- -------
Xxxxxxx X. Xxxxxxx DATE
President and CEO
Rotech Medical Corporation
/s/ Xxxxx X. Xxxxxxx 1/7/02
-------------------------- -------
Xxxxx X. Xxxxxxx DATE
Xxxxxx & Xxxxxxx
Rotech Corporate Integrity Agreement
35
On Behalf of the Office of Inspector General
Of the Department of Health and Human Services
--------------------------------------------- ----
XXXXX XXXXXX DATE
Assistant Inspector General for Legal Affairs
Office of Inspector General
U. S. Department of Health and Human Services
Rotech Corporate Integrity Agreement
36
APPENDIX A
A. Claims Review.
-------------
1. Facility Selection Methodology: Rotech assigns each of its storefront
locations a unique identifier known as a "Xxxxxx Unit." For each
annual Claims Review, the Xxxxxx Units shall be stratified for
purposes of these Reviews. The basis for such strata determination
shall be the sales recorded by such Xxxxxx Units in the preceding
calendar year. Based on such data any Xxxxxx Units with annual revenue
of $9 million or greater shall be placed into a "special" strata. All
remaining Xxxxxx Units shall be equally divided (to the extent
possible) into "small," "medium" and "large" strata based on sales
revenue (i.e., the largest strata contains the top 3rd Xxxxxx Units
with the highest revenues; the medium strata the next 3rd in revenues;
and the small strata the lowest 3rd in revenues).
a. The Claims Review shall annually be performed for each Xxxxxx
Unit within the special strata, however, if the special strata
contains more than 5 Xxxxxx Units, no more than 5 Xxxxxx Units in
the special strata will be randomly selected for review. After
the 2d annual Claims Review, (i) Rotech may request that the OIG
reevaluate the revenue threshold for determining the special
strata or (ii) the OIG may reevaluate the revenue threshold for
determining the special strata. The OIG will make the final
decision on the revenue threshold for the special strata.
b. For each annual Claims Review, the remainder of the Xxxxxx
Units that do not meet the criteria for inclusion in the special
strata, shall be divided into three equal strata based on the
annual revenues of the Xxxxxx Units. The Xxxxxx Units shall be
assigned to a strata at the end of each CIA reporting period. On
an annual basis, Rotech or the IRO shall perform a Claims Review
on a sample of Xxxxxx Units using the following methodology:
randomly select 20% of the Xxxxxx Units in the large strata, 15%
of Xxxxxx Units in the medium strata, and 10% of the Xxxxxx Units
in the small strata for a Claims Review.
c. Rotech or the IRO shall select the Xxxxxx Units for the Claims
Review by using a random number generator. Every Xxxxxx Unit in
Rotech CIA App. A
each strata shall be included in the facility selection process
for each annual Claims Review.
2. Definitions. For the purposes of the Claims Review, the following
definitions shall be used:
a. Overpayment: The amount of money Rotech 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 Rotech and for which
----------
Rotech has received reimbursement from the Medicare program.
d. Population: All Items for which Rotech has submitted a code or line
----------
item and for which Rotech has received reimbursement from the Medicare
program (i.e., a Paid Claim) during the 12-month period covered by the
----
Claims review, except in the first year of the CIA as explained below.
To be included in the Population, an Item must have resulted in at
least one Paid Claim.
e. Treatment of Reviews in First Year: Notwithstanding the other
----------------------------------
provisions of this Appendix, Rotech or the IRO may choose to conduct
its Claims Review in the first year after the effective date of the
CIA in the follow manner. The Claims Review shall cover Items related
to the time period from the date of Rotech's Bankruptcy confirmation,
to the date of the Claims Review (rather than always relating to the
full preceding 12-month time period as is required in other years).
i. At least 25% of each Claims Review conducted shall cover the
period from the date of Rotech's Bankruptcy confirmation to a
date at least one year after the effective date of the CIA.
ii. At least 25% of each Claims Review conducted shall cover the
period from the date of Rotech's Bankruptcy confirmation to a
date at least 9 months after the effective date of the CIA.
Rotech CIA App. A
iii. The remaining Claims Review (that not described in i. and
ii. above) shall include the period from the date of Rotech's
Bankruptcy confirmation to a date at least 6 months after the
effective date of the CIA.
iv. If Rotech or the IRO chooses to conduct the first year
reviews in accordance with this paragraph, the Xxxxxx Units in
the special strata shall be reviewed first followed by the Xxxxxx
Units in the large strata, the medium strata and finally the
small strata.
f. Error Rate: The Error Rate shall be the percentage of net
----------
overpayments identified in the sample. 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. If Rotech is
permitted to perform the Claims Review internally with the IRO
verification, the following payment errors should be included in
calculating the error rate: (i) all payment errors identified by
Rotech and not verified by the IRO; (ii) all payment errors identified
by Rotech and verified by the IRO; and (iii) all payment errors
identified by the IRO and not identified by Rotech.
3. Other Requirements.
a. Paid Claims without Supporting Documentation. For the purpose of
--------------------------------------------
appraising Items included in the Claims Review, any Paid Claim for
which Rotech cannot produce documentation sufficient to support the
Paid Claim shall be considered an error and the total reimbursement
received by Rotech for such Paid Claim shall be deemed an Overpayment.
Replacement sampling for Paid Claims with missing documentation is not
permitted.
b. 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.
In other words, 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 each
--------------------
Claims Review Report for the Claims Review(s) performed:
1. Claims Review Methodology
Rotech CIA App. A
a. Sampling Unit. A description of the Item as that term is utilized
-------------
for the Claims Review. For purposes of this Claims Review, the term
"Item" may refer to any discrete unit that can be sampled (e.g.,
----
claim, line item, beneficiary, patient encounter, etc.).
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.
d. 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 Rotech or the IRO when performing the Claims Review (e.g.,
----
medical records, physician orders, certificates of medical necessity,
requisition forms, local medical review policies, CMS program
memoranda, Medicare carrier or intermediary manual or bulletins, other
policies, regulations, or directives).
f. Review Protocol: A narrative description of how the Claims Review
---------------
was conducted and what was evaluated.
x. Xxxxxx Unit Data: The annual revenue for each Xxxxxx Unit with the
----------------
strata designations
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
Rotech or the IRO.
Rotech CIA App. A
c. A description or identification of the statistical sampling
software package used to conduct the sampling.
d. A copy of the statistical software printout(s) estimating how many
Items are to be included in the Full Sample.
3. Claims Review Results
a. Narrative Results.
-----------------
i. A description of Rotech's billing and coding system(s),
including the identification, by position description, of the
personnel involved in the coding and billing.
ii. A narrative explanation of Rotech'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)
with the gross Overpayment amount, the net Overpayment amount,
and the corresponding Error Rate(s) related to the net
Overpayment.
b. Quantitative Results.
--------------------
i. Total number and percentage of instances (based on Rotech's
internal Claims Review, if applicable) in which Rotech determined
that the Paid Claims submitted by Rotech ("Claims 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 (based on Rotech's
internal Claims Review, if applicable) in which the Claim
Submitted differed from the Correct Claim and in which such
difference resulted in an Overpayment to Rotech.
iii. Based on Rotech's or the IRO's Claims Review, total dollar
amount of paid Items included in the sample and the net
Overpayment associated with the sample.
iv. Error Rate in the sample(s), as defined in section A.l.e of
this Appendix.
Rotech CIA App. A
v. For each Discovery and Full Sample performed by Rotech: (1)
the number of Items the IRO verified; (2) the number of instances
in which the IRO disagreed with Rotech's payment determinations;
and (3) the dollars associated with the difference between the
IRO's and Rotech's payment determinations.
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 Rotech's internal billing review)
correct procedure code (as determined by the IRO verification),
correct allowed amount (as determined by Rotech's internal
billing review), correct allowed amount (as determined by the IRO
verification), dollar difference between allowed amount
reimbursed by payor and the correct allowed amount (as determined
by Rotech's internal billing review); and dollar difference
between allowed amount reimbursed by payor and the correct
allowed amount (as determined by the IRO verification). (See
Attachment 1 to this Appendix.)
4. Systems Review. Observations and recommendations on possible
improvements to the system(s) and process(es) that generated the
Overpayment(s) in the sample Population.
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 Unallowable Costs Review; (2) performed
the Claims Review and Unallowable Costs Review; and (3) performed the
verification review, if applicable.
Rotech CIA App. A
Attachment 1
Claim Review Results
Correct
Federal Correct Allowed Amt Dollar Difference
Health Care Bene Procedure Procedure Allowed Procedure Reimbursed between Amt
Program HIC Date of Code Code Amount Code(IRO (IRO Reimbursed and
Billed # Service Submitted Reimbursed Reimbursed determined) determined) Correct Allowed Amt
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Rotech CIA Attachment 1 Final.wpd
Rotech Corporate Integrity Agreement
APPENDIX B
OVERPAYMENT REFUND
-------------------------------------------------------------------------------------------------------
TO BE COMPLETED BY MEDICARE CONTRACTOR
--------------------------------------
Date:
-----------
Contractor Deposit Control # Date of Deposit:
---------------------------- ---------------------------
Contractor Contact Name: Phone
--------------------------------------------------------------------------
#
-------------
C o n t r a c t o r
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
a n d r e a s o n f o r
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
-------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------
Reason Codes:
-------------
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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