university hospitals health system inc 08172006 corporate integrity agreement oig medicare

8/4/2019 University Hospitals Health System Inc 08172006 CORPORATE INTEGRITY AGREEMENT OIG MEDICARE

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CORPORATE INTEGRITY AGREEMENTBETWEEN THEOFFICE F INSPECTORENERAL

OF THEDEPARTMENTF HEALTH ND HUMA N ERVICESANDUNIVERSITY HOSPITALS HEALTH SYSTEM, INC.

University Hospitals Health System, Inc. hereby en ters into this CorporateIntegrity Agreement (CIA ) with the Office of Inspector Genera l (OIG) of the UnitedStates Department of Health and Human Services (HHS) to promote compliance with thestatutes, regulations, and written directives of Medicare, Medicaid, and all other Federalhealth care programs (as defined in 42 U .S.C. fj 1320a-7b(f)) (Federal health careprogram requirements). Contem poraneous ly with this CIA, University Hosp itals HealthSystem, Inc. is entering into a Settlement Agreem ent with the United States.

For purposes o f this CIA, "UHHS" is defined as University Hospitals HealthSystem, Inc., University Hospitals of Cleveland, The Brown Mem orial Hospital (dbaUHH S-Brown M emorial Hospital), The Memorial Hospital of Geneva (dba UHH S-Mem orial Hospital of G eneva), The Comm unity Hospital of Bedford, Inc. (dbaUniversity Hospitals Health System Bedford Medical Center), The Geauga HospitalAssociation, Inc. (dba Un iversity Hospitals Health System Geauga Regiona l Hospital),UHHS-Richmond Heights Hospital, Inc., University Hosp itals Health System HeatherHill Rehab ilitation Hospital, Inc. and University H ospitals Health System-H eather Hill,Inc. Prior to execution of this CIA, UHHS voluntarily established a compliance planthat applies to all UHHS w holly-owned subsidiaries and facilities. UHH S agrees that itshall maintain the compliance plan during the term of the C IA in a manner that meets therequirements of the CIA. UHH S may modifl the compliance plan as appropriate;provided, however, that any such modification of the com pliance plan m eets therequirements of the C IA.


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11. TERM ND SCOPE F THE CIAA. The period of the compliance obligations assumed by UHH S under this CIA

shall be five years from the effective date of this CIA, unless otherwise specified. Theeffective date shall be the date on which the final signatory of this CIA executes this CIA(Effective Date). Each one-yea r period, beginning with the one-year period following theEffective Date, shall be referred to as a "Reporting Period."B. Sections VII, VIII, IX, X, and XI shall expire no later than 120 days afterOIG 's receipt of: (1) UHHS' final annual report; or (2) any additional materialssubmitted by UHHS pursuant to OIG 's request, whichever is later.C. Th e scope of this CIA shall be governed by the following definitions:

1. "Arrangements" shall mean every arrangement or transaction that:a. involves, directly or indirectly, the offer, payment, solicitation, orreceipt of anything of value; and is between UHHS and any actual orpotential source of health care business or referrals to UH HS or anyactual or potential recipient of health care business or referrals fromUHHS. The term "source" shall mean any physician, contractor,vendor, or agen t and the term "health care business or referrals" shallbe read to include referring, recomm ending, arranging for, ordering,leasing, or purchasing of any good, facility, item, or service forwhich paym ent may be made in whole or in part by a Federal healthcare program; orb. is between UHH S and a physician (or a physician's immediatefamily member (as defined at 42 C.F.R. 5 41 1.35 1)) who makes areferral (as defined at 42 U.S.C. 1395nn(h)(5)) to UHHS fordesignated health services (as defined at 42 U.S.C . $1395nn(h)(6)).

2. "Focus Arrangements" means all Arrangements that:a. involve, directly or indirectly, the offer or payment ofanything of value; and are between UH HS and any actualsource of health care business or referrals to UH HS; or


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b. are between UHH S and a physician (or a physician'simmediate family member (as defined at 42 C.F.R. 54 11.351)) who makes a referral (as defined at 42 U.S.C. 51395nn(h)(5)) to UHH S for designated health services (asdefined at 42 U.S.C. 5 1395nn(h)(6)).

3. "Covered Persons" includes:a. all owners, officers, directors, and employees of UHHS(excluding housekeeping, maintenance, and food serviceemployees); andb. all contractors, subcontractors, agents, and other persons whoprovide patient care items or services or who perform billing orcoding functions on behalf of UHHS, excluding vendors whose soleconnection with U HHS is selling or otherwise providing m edicalsupplies or equipment to UHH S; andc. physicians with active medical staff privileges at a UH HSHospital.

Notwithstanding the above, C overed Persons does not include part-time orper diem employees, contractors, subcontractors, agents, and o ther personswho are not reasonably expected to work more than 160 hours per year,except that any such individuals shall becom e "Covered Persons" at thepoint when they w ork more than 160 hours during the calendar year.4. "Arrangements Covered Persons" includes all Covered Persons involvedwith the development, approval, managem ent, or review o f Arrangementson behalf of UH HS.5. "UHHS Hospital" m eans University H ospitals of Cleveland, The BrownMem orial Hospital (dba UHH S-Brown Mem orial Ho spital), The Mem orialHospital of Geneva (dba UH HS-Memorial Hospital of Geneva), TheCom munity Hospital of Bedford, Inc. (dba University H ospitals HealthSystem Bedford Medical C enter), The Geauga Ho spital Association, Inc.(dba University Hospitals Health System Geauga R egional Hospital),UHH S-Richmond Heights H ospital, Inc., University Hospitals Health


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System Heather H ill Rehabilitation Hosp ital, Inc. and University HospitalsHealth System-Heather Hill, Inc.

UHHS shall establish and m aintain a Compliance Program that includes thefollowing elements:A. Compliance Officer and Committee.

1 . Com pliance Officer. Within 90 days after the Effective Date, UHHSshall appoint an individual to serve as the chief compliance officer for UHHS (UHHSComp liance Officer). UHHS shall maintain an UHHS Comp liance Officer for the term ofthe CIA . The UH HS C ompliance Officer shall be responsible for oversight of UHHS 'Compliance Program, including developing and implementing policies, procedures, andpractices designed to ensure comp liance with the requirements set forth in this CIA andwith Federal health care program requirements. The UHHS Compliance Officer shall bea member of senior managem ent of UHHS reporting to the PresidentICEO of UHHS andthe Audit and Compliance Committee of the Board of Directors of UHHS (AuditCommittee). The UH HS Compliance Officer shall make periodic (at least quarterly)reports regarding compliance matters directly to the A udit Com mittee and shall beauthorized to report on such matters to the Audit Com mittee at any time. The UHH SComp liance Officer shall serve as chairperson for the UHHS Compliance ExecutiveOversight Committee (Compliance Oversight Committee). The UHHS C omplianceOfficer shall not be, or be subordinate to, the General Counse l or Chief Financial Officer.The U HHS Comp liance Officer shall be responsible for monitoring the day-to-daycompliance activities engaged in by UHH S as well as for any reporting obligationscreated under this CIA.

In addition, UHHS certifies that it has appointed an individual to serve as thecompliance officer at each UHHS H ospital (Hospital Comp liance Officer). UHHS shallmaintain a Hospital Comp liance Officer for each UHHS Hospital for the term of the CIA.The Hospital Compliance Officers shall be responsible for oversight of the ComplianceProgram at such officer's UHHS Hospital, including implementing and monitoringUHHS' policies, procedures, and practices designed to ensure compliance with therequirements set forth in this CIA and with Federal health care program requirements.The Hospital Com pliance Officers shall report to the PresidentICEO of his or herrespective UHHS Hospital and the UHHS Compliance Officer. The Hospital Compliance


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Officers shall be responsible for monitoring the day-to-day compliance activities engagedin by the UHHS Hospital.UH HS shall report to OIG , in writing, any changes in the identity or positiondescription of the UH HS C ompliance Officer or any Hospital Compliance Officer, or anyactions or changes that would affect the UHH S C ompliance Officer's or any HospitalCom pliance Officer's ability to perform the duties necessary to mee t the obligations inthis CIA, within 15 days after such a change.

2. Compliance Com mittee. UHHS certifies that it has appointed the AuditComm ittee and the Compliance Oversight Comm ittee. UHH S shall maintain the AuditComm ittee and the Compliance Oversight Comm ittee for the term of the CIA. TheCompliance Oversight Comm ittee shall, at a minimum, include the UH HS ComplianceOfficer and other members of senior management necessary to m eet the requirements ofthis CIA &, senior executives of relevant departments, such as billing, clinical, humanresources, audit, and operations). The UHHS Com pliance Officer shall chair theCompliance Oversight Committee. The Compliance Oversight Committee shall supportthe U HHS Compliance Officer in fulfilling hi sh er responsibilities (G, shall assist in theanalysis of the organization's risk areas and shall oversee monitoring o f internal andexternal audits and investigations).

UHHS shall report to OIG, in writing, any changes in the composition of the Auditor Compliance Oversight Comm ittees, or any actions or changes that would affect theAudit or Com pliance Oversight Comm ittees' ability to pe rf o m the duties necessary tomeet the obligations in this CIA, within 15 days after such a change.

B. Written Standards.1. Code of Conduct. UHHS certifies that it has developed, implemented,and distributed, in paper or electronic form, a written Code of Conduct to all employees.UHH S shall maintain a written Code of Conduct for the term of the CIA. UHH S shallrevise the Code of Conduct within 90 days after the Effective Date to the extent necessaryto comply with the terms of the CIA. The Code of Conduct, revised if necessary, shall be

distributed in paper or electronic form to all Covered Persons within 120 days after theEffective Date. UH HS shall make the promotion of, and adherence to, the Code ofConduct an element in evaluating the performance of all employees. The Code o fConduct shall, at a minimum, set forth:


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a. UHHS' commitment to full compliance with all Federal healthcare program requirements, including its comm itment to prepare andsubmit accurate claims consistent with such requirements;b. UHHS' requirement that all of its Covered Persons shall beexpected to comply with all Federa l health care programrequirements and with UHHS ' own Policies and Procedures asimplem ented pursuant to this S ection 1II.B (including therequirements of this CIA);c. the requirement that all of UHHS' Covered Persons shall beexpected to report to the UHH S C ompliance Officer or otherappropriate individual designated by UHHS suspected violations ofany Federal health care program requirements or of UHHS' ownPolicies and Procedures;d. the possible consequences to both UHHS and C overed Persons offailure to comply with Federal health care program requirements andwith UHHS' own Policies and Procedures and the failure to reportsuch noncom pliance; ande. the right of all individuals to use the Disclosure Programdescribed in Section III.F, and UHHS' commitment to nonretaliationand to maintain, as appropriate, confidentiality and anonymity withrespect to such disclosures.

UHHS certifies that the UH HS Code of Conduct shall apply to each UHH SHospital. Within 120 days after the Effective Date, each Covered Person shall certify, inwriting or electronically, that he or she has received, read, understood, and shall abide byUHH S' Code of Conduct. New Covered Persons shall receive the Code of Conduct andshall complete the required certification within 30 days after becom ing a Covered Personor within 120 days after the Effective Date, whichever is later.Add itionally, the follow ing shall constitute the o bligations for UHHS under thisSection 1II.B.1 with respect to physicians who have active medical staff privileges butwith whom UH HS d oes not have a financial relationship ("Excepted Physicians"): (i)UHH S shall distribute the Code of Conduct to Excepted Physicians in accordance withthe time requirem ents for other Covered Persons as set forth in this Section 1II.B.1; ii)


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UH HS shall also use its best efforts to ob tain written certifications fiom E xceptedPhysicians in accordance with the above description; and (iii) UH HS shall keep recordsof the percentage of Excepted Physicians who have com pleted the certificationrequirement.

UH HS shall periodically review the Code of Conduct to determine if revisions areappropriate and shall make any necessary revisions based on such review. Any revisedCod e of Conduct shall be d istributed within 30 days after any revisions are finalized.Each Covered Person shall certify, in writing o r electronically, that he or she hasreceived, read, understood , and shall abide by the revised Code of Conduct within 30days after the distribution of the revised Code of Conduct.2. Policies and Procedures. Within 120 days after the Effective Date,

UHHS shall implement written Policies and Procedures regarding the operation ofUH HS' compliance program and its compliance with Federal health care programrequirements. At a minimum, the Policies and Procedures sha ll address:a. the subjects relating to the Code of Conduct identified in SectionIII.B.1;b. 42 U.S.C. 5 1320a-7b(b) (Anti-Kickback Statute) and 42 U.S.C.5 1395nn (Stark Law), and the regulations and other guidancedocum ents related to these statutes, and business or financialarrangements or contracts that generate unlawful Federal health careprogram business in violation of the Anti-Kickback Statute or theStark Law; andc. the requirements set forth in Section 1II.D (Com pliance with theAnti-Kickback S tatute and S tark Law), including but not limited tothe Focus Arrangements Databases, the internal review and approvalprocess, and the tracking of remuneration to and fiom sources ofhealth care business o r referrals.

UHH S certifies that UHHS' Policies and Procedures shall apply to each UHH SHospital. Within 120 days after the Effective Date, the relevant portions of the Policiesand Procedures shall be distributed in paper or electronic form to all Covered Personswhose job functions relate to those Policies and Procedures. Appropriate andknow ledgeable staff shall be available to explain the Policies and Procedures.


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At least annua lly (and more frequently, if appropriate), UHHS shall assess andupdate as necessary the Policies and Procedures. Within 30 days after the effective dateof any revisions, the relevant portions of any such revised Policies and P rocedures shallbe distributed in paper or electronic form to all Covered Persons whose job hn cti on srelate to those Policies and Procedures.

C. Training and Education.1. General Training. Within 120 days after the Effective Date, UHHSshall provide at least two hours of General Training to each Covered Person. Thistraining, at a minimum , shall explain UH HS':

a. CIA requirements; andb. UHH S' Compliance Program (including the Code of Conduct andthe Policies and Procedures as they pertain to general complianceissues).

If, pursuant to UHHS' Compliance Program, UHHS provided training to CoveredPersons that satisfies the General Training requirements set forth in this section on orafter May 1,2 00 6, then the OIG shall credit such training for purposes of satisfying theapplicable General Training requirements for the first Reporting Period.New Covered Persons shall receive the General Training described above within 30 daysafter becoming a Covered Person or within 120 days after the Effective Date, whicheveris later. After receiving the initial General Training described above, each CoveredPerson sha ll receive at least one hour of General Training annually.

2. Arrangements Training. Within 120 days after the Effective Date, eachArrangem ents Covered Person shall receive at least two hours of Arrangements Training,in addition to the General Training required above. The Arrangem ents Training shallinclude a discussion of:a. Arrangem ents that potentially implicate the Anti-KickbackStatute or the Stark Law, as well as the regulations and otherguidance docum ents related to these statutes;


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b. UHHS' policies, procedures, and other requirements relating toArrangem ents, including but not limited to the Focus ArrangementsDatabases, the internal review and approval process, and the trackingof remuneration to and from sources of health care business orreferrals required by Section 1II.D of the CIA;c. the personal obligation of each Arrangem ents Covered Person toknow the applicable legal requirements and UHHS' policies andprocedures;d. the legal sanctions under the Anti-Kickback S tatute and the StarkLaw; ande. examples of violations of the Anti-Kickback Statute and the StarkLaw.

If, pursuant to UHHS' Com pliance Program, UHHS provided training toArrangem ents Covered Persons that satisfies the Arrangements Training requirements setforth in this section on or after May 1,20 06 , then the OIG shall credit such training forpurposes of satisfying UHHS ' Arrangem ents Training requirements for the firstReporting Period.New Arrangem ents Covered Persons shall receive this training within 30 days

after the beginning of their employment or becom ing Arrangements Covered Persons, orwithin 120 days after the Effective Date, whichever is later. An UH HS employee whohas completed the Arrangements Training shall review a new Arrangements CoveredPerson's work until such time as the new Arrangements Covered Person completes his orher Arrangements Training.After receiving the initial Arrangem ents Training described in this,Section, eachArrangem ents Covered Person shall receive at least two hours of Arrangements Trainingannually.

3 . Certzj'kation. Each individual who is required to attend training shallcertify, in writing, or in electronic form, that he or she has received the required training.The certification shall specify the type of training received and the date received. TheUHHS Com pliance Officer (or designee) shall retain the certifications, along with allcourse materials. These shall be made ava ilable to OIG, upon request.


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4 . Qualijications of Trainer. Persons providing the training shall beknowledgeable about the subject area.5 . Update of Tra ining. UHH S shall annually review the training, and,where appropriate, update the training to reflect changes in Federal health ca re programrequirements, any issues discovered during internal audits or the Focus ArrangementsReview, U nallowable Cost review, and any other relevant information.6 . Computer-based Training. UHH S may provide the training requiredunder this CIA through appropriate computer-based training approaches. If UHHSchooses to provide computer-based training, it shall make available appropriatelyqualified and knowledgeable staff or trainers to answer questions or provide additional

information to the individuals receiving such training.7 . Excepted Physicians. Notwithstanding any other provision of thisSection III.C., UHHS shall: (i) make the G eneral Training available to ExceptedPhysicians; (ii) use its best efforts to encourage the attendance and participation ofExcepted Physicians in the General Training; and (iii) maintain records o f the percentage.of all Excepted Physicians who attend such training.

D. Compliance with the Anti-Kickback S tatute and S tark Law.1. Arrangements Procedures. Within 120 days after the Effective Date,UHH S shall create procedures reasonably designed to ensure that each existing and new .or renewed A rrangemen t does not violate the Anti-Kickback Statute andlor the Stark Lawor the regulations, directives, and guidance related to these statutes (ArrangementsProcedures). These procedures shall include the following:

a. creating and maintaining databases of all existing and new orrenewed Focus Arrangements as described in Appendix A that shallcontain the information specified in Append ix A (collectively the"FOCUS rrangem ents Databases");b. tracking remuneration to and from all parties to each FocusArrangement;c. tracking service and activity logs to ensure that parties to theFocus Arrangemen t are performing the services required under theapplicable Focus A rrangemen t(s) (if applicable);


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d. monitoring the use of leased space, medical supplies, medicaldevices, equipm ent, or other patient care items to ensure that suchuse is consistent with the terms of the app licable FocusArrangement(s) (if applicable);e. establishing and implem enting a written policy and procedu reregarding the review and approval process for all Arrangements,including but not limited to a legal review of Focus Arrangements bycounsel with expertise in the Anti-Kickback Statute and Stark Lawand appropriate docum entation of all internal controls, the purpose o fwhich is to ensure that all new and existing or renewedArrangements do not violate the Anti-Kickback Statute and StarkLaw;f. requiring the UHH S Com pliance Officer to review the FocusArrangements Databases, internal review and approval process, andother Arrangem ents Procedures on at least a quarterly basis and toprovide a report on the results of such review to the Com plianceOversight Com mittee; andg. implementing effective responses when suspected violations ofthe An ti-Kickback Statute and Stark Law are discovered, includingdisclosing Reportable Events and quantifLing and repayingOverpayments pursuant to S ection 111.1(Reporting) whenappropriate.

2. New or Renewed Focus Arrangements. Prior to entering into new FocusArrangements or renewing existing Focus A rrangements, in addition to complying withthe Arrangements Procedures set forth above, UH HS shall comply with the followingrequirements (Focus A rrangements Requirements):a. Ensure that each Focus Arrangement is set forth in writing,signed by UHH S and the other parties to the Focus A rrangementand is tracked in a Focus Arrangements Database; provided,however, that Focus A rrangements constituting non-contractualtransactions sub ject to 42 C.F.R.5 41 1.357(k) are not required to


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be in writing but are required to be tracked in a FocusArrangements Database;b. For each Focus Arrangem ent set forth in writing as provided inSection III.D.2.a above:

i. such written agreement shall include a requirement thatall individuals who meet the definition of CoveredPersons shall comply with UHH S' ComplianceProgram and a certification by the parties to the FocusArrangemen t that the parties shall not violate the Anti-Kickback Statute and the Stark Law with respect to theperformance of the Focus Arrangement; andii. UHH S shall provide each party to the FocusArrangemen t with a paper or electronic copy of itsCode of Conduct and Stark Law and Anti-KickbackStatute Policies and Procedures.

3 . Records R etention and Access. UHH S shall retain and makeavailable to OIG, upon request, the Focus Arrangements Databases, all supportingdocum entation of all Arrangemen ts subject to this Section III.D, and, to the extentavailable, all non-privileged com munications related to the Arrangemen ts and the actualperformance of the duties under the Arrangements.

E. Review Procedures.1. General Description.

a. Engagement of Independent Review Organization. Within 120days after the Effective Date, UHH S shall engage an individual orentity (or entities), such as an accounting, auditing, law, orconsulting firm (hereinafter "Independent Review Organization" or"IRO"), to perform the following reviews: (i) a review to assistUH HS in assessing its compliance with the obligations pursuant toSection 1II.D of this Agreement (Focus A rrangements Review), and(ii) a review to analyze whether UHH S sought payment for certainunallowable costs (Unallowable Cost Review). The IRO(s) engaged


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by UH HS shall have expertise in the subject matter of the i-eview(s)that the IRO(s) islare being engaged to perform and in the generalrequirements of the Federal health care program(s) from whichUHHS seeks reimbursement.Each IRO shall assess, along with U HHS, whether it can perform theIRO rev iew in a professionally independen t and/or objective fashion,as appropriate to the nature of the engagement, taking into accoun tany other business relationships or other engagements that may ex ist.The engagem ent of the IRO for the Focus A rrangements Reviewshall not be deemed to create an attorney-client relationship betweenUHH S and the IRO . The other applicable requirements relating tothe IRO(s) are outlined in Appendix B to this Agreement, which isincorporated by refe rence.b. Frequency of Arrangements Review. The Focus ArrangementsReview shall be performed annually and shall cover each of theReporting Periods. The IRO(s) shall perform all components of eachannual Focus Arrangements Review.c. Frequency o f Unallowable Cost Review. The IRO shall performthe Unallowable Cost Review as set forth below for the firstReporting Period.d. Retention of Records. The IRO and UHHS shall retain and makeavailable to O IG, upon request, all work papers, supportingdocumentation, correspondence, and draft reports (those exchangedbetween the IRO and UH HS) related to the reviews.e. Responsibilities and Liabilities. Nothing in this Section 1II.Eaffects UHH S' responsibilities or liabilities under any criminal, civil,or adm inistrative laws or regulations applicable to any Federal healthcare program including, but not limited to, the Anti-Kickback Statuteandlor the Stark Law.

2. Focus Arrangements Review. The IRO shall perform a review to assesswhether UHH S is complying with the Arrangements Procedures and Focus A rrangementsRequirem ents required by Sections 1II.D.1 and III.D.2 of this CIA. The IRO shall


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randomly select a samp le of 25 Focus Arrangements that were entered into or renewedduring the Rep orting Period (Sample). The Sample shall contain 20 Focus Arrangem entsthat constitute contractual transactions and five Focus Arrangem ents that constitute non-contractual transactions. The IRO shall assess whether UH HS has implemented theArrangements Procedures and, for each selected Focus Arrangement in the S ample, theIRO shall assess whether UH HS has complied with the Arrangements Procedures andFocus A rrangements Requirements specifically with respect to that Focus A rrangement.The IRO's assessment shall include, but is not limited to (a) verifying that the FocusArrangement is listed in the appropriate Focus Arrangements Database; (b) verifying thatthe Focu s Arrangemen t was subject to the internal review and approval process (includingboth a legal and business review) and obtained the necessary approvals and that suchreview and approval is appropriately documented; (c) verifying that the remunerationrelated to the Focus Arrangement is properly tracked; (d) verifying that the service andactivity logs are properly com pleted and reviewed (if applicable); (e) verifying that leasedspace, med ical supplies, medical devices, and equipm ent, and other patient care items areproperly monitored (if applicable); (f) verifying that the UH HS Com pliance Officer isreviewing the Focus Arrangements Databases, internal review and approval process, andother Arrangem ents Procedures on a quarterly basis and reporting the results of suchreview to the Compliance Oversight Comm ittee; (g) verifying that effective responses arebeing im plemented when violations of the Anti-Kickback Statute and S tark Law arediscovered; and (h) verifying that the UHH S has met the requirements of Section III.D.2.

3 . Focus Arrangements Review Report. The IRO shall prepare a reportbased upon the Focus Arrangements Review performed (Focus Arrangements ReviewReport). The Focus Arrangements Review Report shall include the IRO's findings withrespect to (a) whether UH HS has generally implemented the Arrangements Proceduresdescribed in Section 1II.D.1; and (b) specific findings as to whether UH HS has compliedwith the Arrangements Procedures and Focus A rrangements Requirements with respect toeach of the randomly se lected Focus Arrangements reviewed by the IRO. In addition, theFocus A rrangements Review Repo rt shall include any observations, findings, andrecommend ations on possible improvements to UH HS' policies, procedures, and system sin place to ensure that all Arrangements do not violate the A nti-Kickback Statute andStark Law.

4. Unallowable Cost Review. The IRO shall conduct a review of UHHS'compliance with the unallowable cost provisions of the Settlement Agreement. The IROshall determine whether UH HS has com plied with its obligations not to ch arge to, orotherwise seek paym ent from, Federal or State payors for unallow able costs (as defined in


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the S ettlement Agreem ent) and its obligation to iden tifl t o applicab le Federal or Statepayors any unallowable costs included in payments previously sough t from the UnitedStates, or any S tate Medicaid program. This unallowab le cost analysis shall include, butnot be limited to, paym ents sought in any cost reports, cost statements, informationreports, or paym ent requests already submitted by UHH S or any affiliates. To the extentthat such cost reports, cost statements, information reports, or paym ent requests, even ifalready settled, have been adjusted to account for the effect of the inc lusion of theunallowable costs, the IRO shall determine if such adjustments were proper. In makingthis determination, the IRO may need to review cost reports and/or financial statementsfrom the year in w hich the Settlement Agreement was executed, as well as from previousyears.

5. Unallowable Cost Review Report. The IRO shall prepare a report basedupon the Unallowable Cost Review performed. The Unallowable Cost Review Reportshall include the IRO 's findings and supporting rationale regarding the U nallowableCosts Review and whether UH HS has complied with its obligation not to charge to, orotherwise seek paym ent from, Federal or State payors for unallowable costs (as defined inthe Settlement Agreem ent) and its obligation to iden tifl to applicable Federal or Statepayors any unallowable costs included in paym ents previously sought from such payor.

6. Validation Review. In the event OIG has reason to believe that: (a)UHH S' Focus Arrangements Review or Unallowable Cost Review fails to conform to therequirements of this Agreem ent; or (b) the IRO's findings or Focus A rrangements Reviewor Unallowable Cost Review results are inaccurate, OIG may, at its sole discretion,conduct its own review to determine whether the Focus Arrangements Review orUnallowable Cost Review complied with the requirements of the Agreem ent and/or thefindings or Focus A rrangements Review or Unallowable Cost Review results areinaccurate (Validation Rev iew). UH HS shall pay for the reasonable cost of any suchreview performed by OIG or any of its designated agents. Any Validation Review ofReports submitted as part of UHH S' final Annual Report must be initiated no later thanone year after UH HS ' final submission (as described in Section 11) is received by OIG .

Prior to initiating a Validation Review, OIG shall notify UH HS of its intentto do so and provide a written explanation of why OIG believes such a review isnecessa ry. To resolve any concerns raised by O IG, UHHS may request a meeting withOIG to: (a) discuss the results of any Focus Arrangements Review or Unallowable CostReview subm issions or findings; (b) present any additional information to clarify theresults of the Focus Arrangements Review or Unallowable Cost Review or to correct the


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inaccuracy of the Focus A rrangements Review or Unallowable Cost Review; and/or (c)propose alternatives to the proposed Validation Review. UHH S agrees to provide anyadditional information as may be requested by O IG under this Sec tion in an expeditedmanner. OIG will attempt in good faith to resolve any Focus Arrangements Review orUnallowable Cost Review issues with UHH S prior to conducting a Validation Review.How ever, the final determination as to whether or not to proceed with a V alidationReview shall be made at the sole discretion of OIG.

7. IndependenceIObiectivity Certification. The IRO shall include in itsreport(s) to UHH S a ce rtification or sworn affidavit that it has evaluated its professionalindependence andfor objectivity, as appropriate to the nature o f the engagement, withregard to the Focus A rrangements Review or Unallowable Cost Review and that it hasconcluded that it is, in fact, independen t andlor objective.F. Disclosure Program.UH HS certifies that is has e stablished a Disclosure Program that includes amechanism (G, a toll-free compliance telephone line) to enab le individuals to disclose,to the UH HS Compliance Officer or some other person who is not in the disclosingindividual's chain of command, any identified issues or questions associated with UH HS'policies, conduct, practices, or procedures w ith respect to a Federal health care programbelieved by the individual to be a potential violation of crim inal, civil, or adm inistrativelaw. UHH S shall maintain such Disclosure Program for the term of the CIA. UHH S

shall appropriately publicize the existence of the disclosure mechanism (e, ia periodice-mails to employees or by posting the information in prominent common areas).The Disclosure Program shall emphasize a nonretribution, nonretaliation policy,and shall include a reporting mechanism for anonymous comm unications for whichappropriate confidentiality shall be maintained. Upon receipt of a disclosure, the UHH SCom pliance Officer (or designee) shall gather all relevant information from the disclosingindividual. The UH HS Compliance Officer (or designee) shall make a preliminary, goodfaith inquiry into the allegations set forth in every disclosure to ensure that he or she hasobtained all of the information necessary to determine whether a further review should be

conducted.


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For any disclosure that is sufficiently specific so that it reasonably: (1) permits adetermination of the appropriateness of the alleged improper practice; and (2) provides anopportunity for taking corrective action, UHHS shall conduct an internal review of theallegations set forth in the disclosure and ensure that proper follow-up is conducted.

The UH HS Compliance Officer (or designee) shall maintain a disclosure log,which shall include a record and summ ary of each disclosure received (whetheranonym ous or not); the status of the respective internal reviews, and any corrective actiontaken in response to the internal reviews. The disclosure log shall be made ava ilable toOIG upon request.G. Ineligible Persons.

1. Definitions.For purposes of this CIA :a. an "Ineligible Person" shall include an individual or entity who:

i. is currently excluded, debarred, suspended, or otherwiseineligible to participate in the Federal health care programs orin Federal procurement or nonprocurement programs; orii. has been conv icted of a criminal offense that falls withinthe ambit of 42 U.S.C. fj 1320a-7(a), but has not yet beenexcluded, debarred, suspended, or otherwise declaredineligible.

b. "Exclusion Lists" include:i. the HHSIOIG List of Excluded Ind ividualsEntities(available through the Internet at ht tp :// oi ~. hh s. ~o v) ;ndii. the General Services Adm inistration's List of PartiesExcluded from Federal Programs (available through theInternet at http://epls.gov).

c. "Screened Persons" include prospective and current owners,officers, directors, employees, contractors, and agents of UHHS.


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2. Screening Requirements. UHH S shall ensure that all Screened Personsare not Ineligible Persons, by imp lementing the fo llowing screening requirements.a. UHH S shall screen all Screened Persons against the ExclusionLists prior to engaging their services and, as part o f the hiring orcontracting process, shall require all Screened Persons to disclosewhether they are an Ineligible Person.b. UHH S shall screen all Screened Persons against the ExclusionLists within 120 days after the Effective Date and on an annual basisthereafter.c. UH HS shall implement a policy requiring all Screened Persons todisclose immediately any debarment, exclusion, suspension, or otherevent that makes that Screened Person an Ineligible Person.

Nothing in this Section affects the responsibility of (or liability for) UHH Sto refrain from billing Federal health care programs for items or services furnished,ordered, or prescribed by an Ineligible Person.3. Removal Requirement. If UHHS has actual notice that a ScreenedPerson has becom e an Ineligible Person, UHHS shall remove such person fromresponsibility for, or involvement with, UHHS' business operations related to the Federalhealth care programs and shall remove such person from any position for which suchperso n's compensation or the items or services furnished, ordered, or prescribed by suchperson are paid in whole or part, directly or indirectly, by Federal health care programs o rotherwise w ith Federal funds at least until such time as such person is reinstated intoparticipation in the Federal health care program s.4. Pending Charges and Proposed Exclusions. If UHH S has actual noticethat a Screened Person is charged with a criminal offense that falls within the ambit of 42U.S.C. 1320a-7(a) or 1320a-7(b)(l)-(3), or is proposed for exclusion during his or heremploym ent or contract term, or, in the case o f a physician, during the term o f thephysician's medical staff privileges, UHH S shall take all appropriate actions to ensurethat the responsibilities of that person have no t and shall not adversely affect the qualityof care rendered to any beneficiary, patient, or resident, or the accuracy of any claimssubmitted to any Federal health care program .


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H. Notification of Government Investigation or Legal Proceedings.Within 30 days after discovery, UH HS shall notify OIG, in writing, of any ongo ing

investigation or legal proceeding known to U HHS conducted or brought by agovernmental entity or its agents involving an allegation that UHHS has committed acrime or has engaged in fraudulent activities. This notification shall include a descriptionof the allegation, the identity of the investigating or prosecuting agency, and the s tatus ofsuch investigation or legal proceeding. UHHS shall also provide written notice to OIGwithin 30 d ays after the resolution of the matter, and shall provide OIG w ith a descriptionof the findings andlor results of the investigation or proceedings, if any.I. Reporting.

1 Overpayments.a. Definition of Overpayments. For purposes of this CIA, an"Overpayment" shall mean the amount of money UHH S hasreceived in excess of the amount due and payable under any Federalhealth care program requirements.b. Reporting of Overpayments. If, at any time, UHHS identifies orlearns of any Overpayment, UHHS shall notify the payor (G,Medicare fiscal intermediary or carrier) within 30 days afteridentification of the Overpayment and take remedial steps within 60days after identification (or such additional time as may be agreed toby the payor) to correct the problem, including preventing theunderlying problem and the Overpayment from recurring. Also,within 30 days after identification of the Overpaym ent (or suchadditional time as may be agreed to by the payor), UHHS shall repaythe Overpayment to the appropriate payor to the extent suchOverpayment has been quantified. If not yet quantified, within 30days after identification, UHHS shall notify the payor of its efforts toquantify the O verpayment amount along with a schedule of whensuch work is expected to be completed. Notification and repaymentto the payor shall be done in accordance with the payor's policies,and, for Medicare contractors, shall include the informationcontained on the O verpayment Refund Form, provided as AppendixC to this CIA. Notwithstanding the above, notification and


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repayment of any Overpayment amount that routinely is reconciledor adjusted pursuant to policies and procedures established by thepayor should be handled in accordance with such policies andprocedures.

2. Reportable Events.a. Definition of Reportable Event. For purposes of this CIA, a"Reportable Event" means anything that involves:

i. a substantial Overpayment; orii. a matter that a reasonable person would consider aprobable violation of criminal, civil, or administrative lawsapplicable to any Federal health care program for whichpenalties or exclusion may be authorized.

A Reportable Event may be the result of an isolated event or a seriesof occurrences.b. Reporting of Reportable Events. If UHHS determines (after areasonable opportunity to conduct an appropriate review orinvestigation of the allegations) through any means that there is aReportable Event, UHHS shall notify OIG, in writing, within 30days after making the de termination that the Reportable Event exists.The report to OIG shall include the following information:

i. If the Reportable Event results in an Overpayment, thereport to OIG shall be made at the sam e time as thenotifica tion to the payor required in Section 111.1.1, and shallinclude all of the information on the Overpayment RefkndForm, as well as:(A) the payor's name, address, and contact person towhom the Overpayment was sent; and


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(B) the date of the check and identification number (orelectronic transaction number) by which theOverpayment was repaidlrefunded;ii. a complete description of the Reportable Event, includingthe relevant facts, persons involved, and legal and Federalhealth care program authorities implicated;iii. a description of UHHS ' actions taken to correct theReportable Event; andiv. any further steps UHHS plans to take to address theReportable Event and prevent it from recurring.

Notwiths tanding any other prov ision in Section 111.1.2 to thecontrary, in the even t that a submission by UH HS is accepted intothe O IG Provider Self-Disclosure Protocol regarding a R eportableEvent that resulted in an Overpaym ent, OIG may, in its solediscretion and upon the request of UHH S, waive the CIA'Srequirement that UHH S repay the Overpayment within the timeotherwise required in Section 111.1.1 and perm it UH HS to repay theOverpayment within a time period agreed to by O IG.IV. NEWBUSINESS NITSOR LOCATIONS

In the event that, after the Effective Date, UHHS changes locations or sells, closes,purchases, or establishes a new business un it or location related to the furnishing of itemsor services that may be reimbursed by Federal health care program s, UH HS sha ll noti@OIG of this fact as soon as possible, but no later than within 30 days after the date ofchange of location, sale, closure, purchase, or establishment. This notification shallinclude the address of the new business unit or location, phone num ber, fax number,Medicare Provider number, provider identification number and/or supplier number, andthe corresponding contractor's name and address that has issued each Medicare number.Each new business unit or location shall be subject to all the requirements of this CIA.


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V. IMPLEMENTATIONND ANNUALEPORTSA. Implementation Report. Within 150 days after the Effective Date, UHHS shall

submit a written report to OIG summ arizing the status of its implementation of therequirements of this CIA (Implem entation Report). The Implem entation Report shall, at aminimum, include:1. the name, address, phone number, and position description of the UH HSCom pliance Officer and the Hospital Compliance Officers required by Section III.A, anda summ ary of other noncompliance job responsibilities the U HHS Compliance Officer orthe Hospital Compliance Officers may have;2. the names and positions of the members of the Audit and Compliance

Oversight Comm ittees required by Sec tion 1II.A;3. a copy of UHHS' Code of Conduct required by Section 1II.B.1;4. a copy of all Policies and Procedures required by Section III.B.2;5. the number of individuals required to complete the Code of Conductcertification required by Section 1II.B.1, the percentage o f individuals who havecompleted such certification, and an explanation of any exceptions (the documentationsupporting this information shall be available to OIG, upon request);6. the following information regarding each type of training required bySection 1II.C:

a. a description of such training, including a summary of the topicscovered, the length of sessions and a schedule of training sessions;b. the number of individuals required to be trained, percentage ofindividuals actually trained, and an explanation of any excep tions.

A copy of all training materials and the docum entation supporting this information shallbe available to OIG, upon request.7. a description of the Focus Arrangements Databases required by Section1II.D. 1 a;


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8. a description of the internal review and approval process required bySection 1II.D. 1 e;9. a description of the tracking and monitoring procedures and otherArrangem ents Procedures required by Section 1II.D.1;10. a description of the Disclosure Program required by Section 1II.F;11. the following information regarding the IRO(s): (a) identity, address,and phone num ber; (b) a copy of the engagem ent letter; (c) a summary and desc ription ofany and all current and prior engagements and agreements between UH HS and the IRO;and (d) the proposed start and completion dates of the Focus A rrangements-Rev iewor

Unallowable Cost Review;12. a certification fkom the IRO regarding its professional independenceand/or objectivity with respect to UHHS;13. a description of the process by which UH HS fulfills the requirements ofSection 1II.G regarding Ine ligible Persons;14. the name, title, and responsibilities of any person who is determined tobe a n Ineligible Person under Section 1II.G; the ac tions taken in response to the screen ing

and removal ob ligations set forth in Section 1II.G; and the actions taken to identify,quantify, and repay any overpayments to Federal health care programs relating to items orservices furnished, ordered or prescribed by an Ineligible Person;15. a list of all of UHHS' locations (including locations and mailingaddresses); the corresponding nam e under which each location is doing business; thecorresponding phone numbers and fax numbers; each location's Medicare Providernumber(s), provider identification number(s), and/or supplier number(s); and the nam eand address of each Medicare contractor to which UHHS currently subm its claims;16. a description of UH HS' corporate structure, including identification ofany parent and sister companies, subsidiaries, and their respective lines of business; and17. the certifications required by Section V.C.


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B. Annual Reports. UHH S shall submit to OIG annually a report with respect tothe status of, and findings regarding, UH HS' compliance activities for each of the fiveReporting Periods (Annual Report).Each Annual Report shall include, at a minimum:

1. any change in the identity, position description, or other noncom pliancejob responsibilities of the UHH S Com pliance Officer or a Hospital Com pliance Officerand any change in the mem bership of the Audit or C ompliance Oversight Com mitteesdescribed in Section 1II.A;2. a summ ary of any significant changes or amendm ents to the Policies andProcedures required by Section 1II.B and the reasons for such changes(a,hange in

contractor policy) and copies of any com pliance-related Policies and Procedures;3 . the number of individuals required to complete the Code of Conductcertification required by Section 1II.B. 1, the percentage of individuals w ho havecompleted such certification, and an explana tion of any exceptions (the documentationsupporting this information shall be available to OIG , upon request);4. the follow ing information regarding each type of training required bySection 1II.C:

a. a description of such training, including a summary of the topicscovered, the length of sessions and a schedule of training sessions;andb. the number of individuals required to be trained, percentage ofindividuals actually trained, and an explanation of any exceptions.

A copy of all training materials and the docum entation supporting this information shallbe available to OIG, upon request.5. a description of any changes to the Focus Arrangements Databasesrequired by S ection 1II.D.1 a ;6. a description of any changes to the internal review and approval processrequired by S ection 1II.D.1 e;


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7. a description of any changes to the tracking and monitoring proceduresand other Arrangements Procedures required by Section 1II.D.1;8. a complete copy of all reports prepared pursuant to Section III.E, alongwith a copy of the IRO's engagem ent letter (if applicable);9. UHHS' response and corrective action plan(s) related to any issuesraised by the reports prepared pursuant to Section 1II.E;10. a summ ary and description of any and all current and priorengagements and agreements between UHHS and the IRO, if different from what w assubmitted as part of the Implementation Report;11. a certification from the IRO regarding its professional independenceand/or objectivity with respect to UHHS;12. a sum mary of Reportable Events (as defined in Sec tion 111.1) identifiedduring the Reporting Period and the status of any corrective and preventative actionrelating to all such Reportable Events;13. a report of the aggregate Overpayments that have been returned to theFederal health care programs. Overpayment amounts shall be broken down into the

following categories: inpatient Medicare, outpatient Medicare, Medicaid (report eachapplicable state separately, if applicable), and other Federal health care programs.Overpaym ent amounts that are routinely reconciled or adjusted pursuant to policies andprocedures established by the payor do not need to be included in this aggregateOverpayment report;14. a summary o f the disclosures in the disclosure log required by Section1II.F that: (a) relate to Federal health care programs; (b) allege abuse or neglect ofpatients; or (c) involve allegations of conduc t that may involve illegal remunerations orinappropriate referrals in violation of the Anti-Kickback Statute or Stark law;15. any changes to the process by which UH HS fulfills the requirements ofSection 1II.G regarding Ineligible Persons;16. the nam e, title, and responsibilities of any person who is determined to


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be an Ineligible Person under Section 1II.G; the actions taken by UHHS in response to thescreening and removal obligations set forth in Section 1II.G; and the actions taken toidentifjr, quantifjr, and repay any overpaym ents to Federal health care programs relatingto items or services relating to items or services furnished, ordered or prescribed by anIneligible Person;

17. a summary describing any ongoing investigation or legal proceedingrequired to have been reported pursuant to S ection 1II.H. The summary shall include adescription of the allegation, the identity of the investigating or prosecuting agency, andthe status of such investigation or legal proceeding;18. a description of all changes to the most recently provided list of UHHS 'locations (including addresses) as required by Section V.A. 15; the corresponding name

under which each location is doing business; the corresponding phone numbers and faxnumbers; each location's M edicare Provider number(s), provider identificationnumber(s), andlor supplier number(s); and the name and address of each Medicarecontractor to which U HH S currently submits claims; and19. the certifications required by Section V.C.

The first Annual Report shall be received by OIG no later than 90 days after theend of the first Reporting Period. Subsequent Annual Reports shall be received by OIGno later than the anniversary date of the due da te of the first Annual Report.C. Certifications. The Implem entation Report and Annual Reports shall include acertification by the UH HS Com pliance Officer that:

1. to the best o f his or her knowledge, except as otherwise described in theapplicable report, UHHS is in compliance with all of the requirements of this CIA;2. to the best of his or her know ledge, UHH S has implemented proceduresreasonably designed to ensure that all Arrangements do not violate the Anti-KickbackStatute and S tark Law, including the Arrangem ents Procedures required in Section 1II.Dof the CIA;3 . to the best of his or her knowledge, UHHS has h lfilled the requirementsfor New and Renewed Focus A rrangements under Section III.D.2 of the CIA;


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4. he or sh e has reviewed the Report and has made reasonable inquiryregarding its content and believes that the information in the Report is accurate andtruthful; and5. UHH S has complied with its obligations under the SettlementAgreem ent: (a) not to resubm it to any Federal health care program payors any previouslydenied claims related to the Covered Conduct addressed in the Settlement Agreem ent, andnot to appea l any such denials o f claims; (b) not to charge to or otherwise se ek paymentfrom Federal or S tate payors for unallowable costs (as defined in the SettlementAgreem ent); and (c) to identify and adjust any past charges or claims for unallowablecosts.

D. Designation of Information. UHHS shall clearly identify any portions of itssubmissions that it believes a re trade secrets, or information that is commercial orfinancial and privileged or confidential, and therefore potentially exempt fiom disclosureunder the Freedom of Information Act (FOIA), 5 U.S.C. 5 552. UHHS shall refrain fiomidentifying any information as exem pt from disclosure if that information does not meetthe criteria for exemption from disclosure under FOIA.VI. NOTIFICATIONSND SUBMISSIONFREPORTS

Unless o therwise stated in writing after the Effective Date, all notifications andreports required under this CIA shall be subm itted to the following entities:m: Administrative and Civil Remedies BranchOffice of Counsel to the Inspector GeneralOffice of Inspector GeneralU.S. Department of Health and H uman ServicesCohen Building, Room 5527

330 Independence Avenue, S.W.Washington, DC 2020 1Telephone: 202.6 19.2078Facsimile: 202.205.0604UHHS: Cheryl Forino WahlVice Presiden uchief C ompliance OfficerUniversity Hospitals Health System , Inc.


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10524 Euclid Avenue, S uite 1100Cleveland, OH 44 106Telephone: 216.983.1024Fascimile: 216.983.1057

Unless otherwise specified, all notifications and reports required by this C IA may bemade by certified mail, overnight mail, hand delivery, or other means, provided that thereis proof that such notification was received. For purposes of this requirement, internalfacsimile confirmation sheets do not constitute proof of receipt.VII. OIG INSPECTION,AUDIT, ND REVIEWRIGHTS

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 UHHS'books, records, and other documents and supporting materials andlor conduct on-sitereviews of any of UHH S' locations for the purpose of verifjing and evaluating: (a)UHH S' compliance with the terms of this CIA; and (b) UHHS' compliance with therequirements of the Federal health care programs in which it participates. Thedocum entation described above shall be made available by UH HS to OIG or its dulyauthorized representative(s) at all reasonable times for inspection, audit, or reproduction.Furthermore, for purposes of this provision, O IG or its duly authorized representative(s)may interview any of UHH S' employees, contractors, or agents wh o consent to beinterviewed at the individual's place of business during normal business hours or at suchother place and time as may be m utually agreed upon between the individual and OIG.UHHS shall assist OIG or its duly authorized representative(s) in contacting andarranging interviews with such individuals upon OIG's request. UHHS' employees mayelect to be interviewed with or without a representative of UHHS present.VIII. DOCUMENTND RECORD RETENTION

UH HS sha ll maintain for inspection all documents and records relating toreimbursem ent from the Federal health care programs, or to compliance with this CIA, forsix years (or longer if otherwise required by law ).IX . DISCLOSURES

Consistent with HH S's FOIA procedures, set forth in 45 C.F.R. Part 5, OIG sha llmake a reasonable effort to n ot ifj UH HS prior to any release by OIG of information


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submitted by UHHS pursuant to its obligations under this CIA and identified uponsubmission by UHH S as trade secrets, or information that is comm ercial or financial andprivileged or confidential, under the FOIA rules. With respect to such releases, UH HSshall have the rights set forth at 45 C.F.R. $ 5.65(d).X. BREACH ND DEFAULTROVISIONS

UHH S is expected to h l l y and timely comply with all of its CIA obligations.A. Stipulated Penalties for Failure to Comply with Certain Obligations. As acontractual remedy, UHH S and O IG hereby agree that failure to comply with certainobligations as set forth in this CIA m ay lead to the imposition of the following monetarypenalties (hereinafter referred to as "Stipulated Penalties") in accordance with the

following provisions.1. A Stipulated Penalty of $2,500 (w hich shall begin to accrue on the dayafter the date the obligation became due) for each day UHHS fails to establish andimplement any of the following obligations as described in Section 111:

a. a UHHS C ompliance Officer or Hospital Compliance Officer;b. an Audit Committee or Compliance Oversight Committee;

c. a written Code of Conduct;d. written Policies and Procedures;e. the training of Covered Persons;f. the A rrangements Procedures and/or Focus A rrangementsRequirements described in Sections 1II.D.1 and III.D.2;g. a Disclosure Program ;h. Ineligible Persons screening and removal requirements; andi. Notification of Governm ent investigations or legal proceedings.


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2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the dayafter the date the obligation became due) for each day UHHS fails to engage an IRO , asrequired in Section 1II.E and Appendix B.

3 . A Stipulated Penalty of $2,500 (w hich shall begin to accrue on the dayafter the date the obligation became due) for each day UHHS fails to submit theImplementation Report or the A nnual Reports to O IG in accordance with therequirements of S ection V by the deadlines for submission.4. A Stipulated Penalty of $2,500 (w hich shall begin to accrue on the dayafter the date the obligation became due) for each day UHHS fails to submit the annualFocus Arrangements Review or Unallowable Cost Review Report in accordance with the

requirements o f Section 1II.E.5. A Stipulated Penalty of $1,500 for each day UH HS fails to grant accessto the information or documentation as required in Section VII. (This Stipulated Penaltyshall begin to accrue on the date UHHS fails to grant access.)6. A Stipulated Penalty of $5,000 for each false certification submitted byor on behalf of UHH S as part of its Implementation Report, Annual Report, additionaldocumentation to a report (as requested by the OIG), or otherwise required by this CIA.7. A Stipulated Penalty of $1,000 for each day U HHS fails to comply h l l yand adequately with any obligation of this CIA. OIG sha ll provide notice to UHHS,stating the specific grounds for its determination that UH HS has failed to com ply fullyand adequately with the CIA ob ligation(s) at issue and steps UHHS shall take to complywith the CIA. (This Stipulated Penalty shall begin to accrue 10 days after UHHS receivesthis notice from OIG o f the failure to comply.) A S tipulated Penalty as described in thisSubsection shall not be dem anded for any violation for which OIG has sought aStipulated Penalty under Subsections 1-6 of this Section.

B. Timely Written Requests for Extensions. UHHS may , in advance of the duedate, submit a timely written request for an extension of time to perform any act o r fileany notification or report required by this CIA. Notwithstanding any other provision inthis Section, if OIG gran ts the timely written request with respect to an act, notification,or report, Stipulated Penalties for failure to perform the ac t or file the notification orreport shall not begin to accrue until one day after UHHS fails to meet the revised


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deadline set by OIG . Notwithstanding any other provision in this Section, if OIG deniessuch a timely w ritten request, Stipulated Penalties for failure to perform th e act or file thenotification or report shall not begin to accrue until three business days after UHH Sreceives O IG's written denial of such request or the original due date, whichever is later.A "timely w ritten request" is defined as a request in writing received by OIG at least fivebusiness days prior to the date by which any act is due to be performed o r any notificationor report is due to be filed.

C. Paym ent of Stipulated Penalties.1. Demand L etter. Upon a finding that UHHS has failed to com ply withany of the obligations described in Section X.A and after determining that StipulatedPenalties are appropriate, OIG shall notifl UHHS of: (a) UHHS' failure to comply; and

(b) OIG 's exercise of its contractual right to demand payment of the Stipulated Penalties(this notification is referred to as the "Demand Letter").2. Response to Demand L etter. Within 10 days after the receipt of theDemand Letter, UHHS shall either: (a) cure the breach to OIG 's satisfaction and pay theapplicable S tipulated Penalties; or (b) request a hearing before an HH S adm inistrative lawjudge (ALJ) to dispute OIG 's determination of noncompliance, pursuant to the agreedupon provisions set forth below in Section X.E. In the event UHHS elects to request anALJ hearing, the Stipulated Penalties shall continue to accrue until UHHS cures, to O IG'ssatisfaction, 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 breachof this CIA and shall be grounds for exclusion under Section X.D.3 . Form of Payment. Paym ent of the Stipulated Penalties shall be made bycertified or cash ier's check, payable to: "Secretary of the Departm ent of Health andHuman Services," and submitted to OIG at the address set forth in Section VI.4 . Independence from Material Breach Determination. Excep t as set forthin Section X.D. 1 c, these provisions for payment of Stipulated Penalties shall not affect orotherwise set a standard for O IG's decision that UHH S has m aterially breached this CIA,which decision shall be made at OIG's discretion and shall be governed by the provisionsin Section X.D, below.


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D. Exclusion for Material Breach of this CIA.1. Definition of Material Breach. A m aterial breach of this CIA means:

a. a failure by UHH S to report a Reportable Event, take correctiveaction, an d make the appro priate refunds, as required in Section 111.1;b. a repeated or flagrant violation of the obligations under this CIA,including, but not limited to, the obligations addressed in SectionX.A;c. a failure to respond to a Demand Letter concerning the paymentof Stipulated Penalties in accordance with Section X.C; ord. a failure to engage and use an IRO in accordance with Section1II.E.

2. Notice o f Material Breach a nd Intent to Exclude. The parties agree thata material breach of this CIA by U HH S constitutes an independent basis for UH HS'exclusion from participation in the Federal health care programs. Upon a determinationby O IG that UHH S has materially breached this CIA and that exclusion is the appropriateremedy, OIG shall noti@ UHH S of: (a) UH HS' material breach; and (b) OIG's intent toexercise its co ntractual right to impose exclusion (this notification is hereinafter referredto as the "Notice o f Material Breach and Intent to Exclude").

3. Opportunity to C ure. UHH S shall have 30 days from the date of receiptof the Notice of M aterial Breach and Intent to Exclude to demon strate to O IG'ssatisfaction that:a. UH HS is in compliance with the obligations of the CIA cited byOIG a s being the basis for the material breach;b. the alleged material breach has been cured; orc. the alleged material breach cannot be cured within the 30-dayperiod, but that: (i) UHH S has begun to take action to cure thematerial breach; (ii) UH HS is pursuing such action with due


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diligence; and (iii) UHHS has provided to O IG a reasonabletimetable for curing the material breach.4. Exclusion Letter. If, at the conclusion of the 30-day period, UH HS failsto satisfy the requirements of Section X.D.3, OIG may exclude UHHS from participationin the Federal health care programs. OIG shall notify UHH S in writing of itsdetermination to exclude UH HS (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 UHH S' receipt of the ExclusionLetter. Th e exclusion shall have national effect and shall also apply to all other Federalprocurement and nonprocurement programs. Reinstatement to program participation isnot automatic. After the end of the period of exclusion, UHHS may apply forreinstatement by submitting a written request for reinstatement in accordance with the

provisions at 42 C.F.R. $5 1001.3001-.3004.E. Dispute Resolution

1. Review Rights. Upon OIG's delivery to UHHS of its Demand Letter orof its Exclusion Letter, and as an ag reed-upon contractual remedy for the resolution ofdisputes arising under this CIA, UHHS shall be afforded certain review rights com parableto the ones that are provided in 42 U.S.C. $ 1320a-7(f) and 42 C.F.R. Part 1005 as if theyapplied to the Stipulated Penalties or exclusion sought pursuant to this CIA. Specifically,OIG's determination to dem and payment of Stipulated Penalties or to seek exclusion shallbe subject to review by an HHS ALJ and, in the event of an appeal, the HHSDepartmental Appeals Board (D AB), in a manner consistent with the provisions in 42C.F.R. fj 1005.2-1005.21. Notwithstanding the language in 42 C.F.R. $ 1005.2(c), therequest for a hearing involving S tipulated Penalties shall be made within 10 days afterreceipt of the Dem and Letter and the request for a hearing involving exclusion shall bemade w ithin 25 days after receipt of the Exclusion Letter.

2. Stipulated Penalties Review. Notwithstanding any provision of Title 42the United States Code or Title 42 of the Code o f Federal Regulations, the only issuesa proceeding for Stipulated Penalties under this CIA shall be: (a) whether UH HS wasin full and timely compliance with the obligations of this CIA for which OIG demandspayment; and (b) the period of noncompliance. UHH S shall have the burden of provingits full and timely compliance and the steps taken to cure the noncompliance, if any. OIGshall not have the right to appeal to the DAB an adverse ALJ decision related toStipulated Penalties. If the ALJ agrees with OIG with regard to a finding of a breach of


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this CIA and o rders UHHS to pay Stipulated Penalties, such Stipulated Penalties shallbecome due and payable 20 days after the ALJ issues such a decision unless UHHSrequests review of the ALJ decision by the DAB . If the ALJ decision is properlyappealed to the DAB and the DAB upholds the determination of O IG, the StipulatedPenalties shall become due and payable 20 days after the DAB issues its decision.

3. Exclusion Review. Notwithstanding any provision of Title 42 of theUnited States Code or Title 42 of the Code of Federal Regulations, the only issues in aproceeding for exclusion based on a material breach of this CIA shall be:a. whether UHHS was in material breach of this CIA;b. whether such breach was continuing on the date of the ExclusionLetter; andc. whether the alleged material breach could not have been curedwithin the 30-day period, but that: (i) UHHS had begun to takeaction to cure the material breach within that period; (ii) UHHS haspursued and is pursuing such action with due diligence; and (iii)UHH S provided to OIG within that period a reasonable timetable forcuring the material breach and UH HS has followed the timetable.

For purposes of the exclusion herein, exclusion shall take effect only afteran ALJ dec ision favorable to OIG, or, if the ALJ rules for UHHS, only after a DABdecision in favor of OIG. UHH S' election of its contractual right to appeal to the DABshall not abrogate OIG's authority to exclude UHHS upon the issuance of an ALJ'sdecision in favor of OIG. If the ALJ sustains the determination of OIG and determinesthat exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issuessuch a dec ision, notwithstanding that UHHS may request review of the ALJ decision bythe DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, theexclusion shall take effect 20 days after the DAB decision. UHHS shall waive its right toany notice of such an exclusion if a decision upholding the exclusion is rendered by theALJ or DAB. If the DAB finds in favor of UHHS, UHH S shall be reinstated effective onthe date o f the original exclusion.4 . Finality of Decision. The review by an ALJ or DAB provided for aboveshall not be considered to be an appeal right arising under any statutes or regulations.Consequen tly, the parties to this CIA agree that the DAB'S decision (or the ALJ's


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decision if not appealed) shall be considered final for all purposes under this CIA.XI. EFFECTIVEND BINDING GREEMENT

Consistent with the provisions in the Settlement Agreem ent pursuant to which thisCIA is entered, UHHS and OIG agree as follows:A. This CIA shall be binding on the successors, assigns; and transferees of UHHS;B. This CIA shall become final and binding on the date the final signature isobtained 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 ag ree to a suspension of UHHS' obligations under the CIA in theevent of UHH S' cessation of participation in Federal health care programs. If UHHSwithdraws fiom participation in Federal health care programs and is relieved of its CIAobligations by OIG, UHHS shall noti@ OIG a t least 30 days in advance of UHH S' intentto reapply as a participating provider or supplier with any Federal health care program.Upon rece ipt of such notification, OIG shall evaluate whether the CIA should bereactivated or modified.E. The undersigned UH HS signatories represent and warrant that they areauthorized to execute this CIA. The undersigned OIG signatory represents that he issigning this CIA in his official capacity and that he is authorized to execu te this CIA.


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Thomas F. Zcnty IIIPresidenVCEO

Ctx.e@lForirloWablVicc Presidenuchief Co~nplianceOEcerWnivei-sityHospitals I-Tealth System, Inc.

Roger S.Goldmant a tham & ~ a t k i n s ,LPCounsel for University HospitalsHealth System, Inc.

DATE

OXBEK41,P OFTHE OFFICE OF NSPECTORGEKE'~WLOFTHE DEPA;RThTENrf'OF HEALTI~NDHUBTAiVSERVICES

Gregory E. DernskeAssistant Inspector General for :LegalA.ffairsOffice aInspector GeneralU. S. DepartmentofHealth and Human Services

-

DATE


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ONBEHALFF UHHS

Thomas F. Zenty I11PresidentICEOUniversity Hospitals Health System, Inc.DATE

Cheryl Forino WahlVice PresidentIChief Compliance OfficerUniversity Hospitals Health System, Inc.DATE

~~pRoger S . GoldmanLatham & Watkins, LLPCounsel for U niversity HospitalsHealth System, Inc.

DATE

O N BEHALF OF THE OF FICE OF INSPECTOR GENERALOF THE DEPARTMENTF HEALTH ND HUMAN ERVICES

Gregory E. Demske DATEAssistant Inspector General for Legal A ffairsOffice of Inspector GeneralU. S. Department of Health and Human Services


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Thomas F. Zenty TI1President/CEOUniversity Hospitals Health System, Inc.DATE

Cheryl Forino WahlVice PresidentIChief Com pliance OfficerUniversity Hospitals Health System, Inc.

Roger S. GoldmanLatham & Watkins, LLPCounsel for University HospitalsHealth System, Inc.

DATE

F//C / d 6DATE

ON EHALF OF THE OFFICE OF SPECTO TOR GENERALOFTHE DEPARTMENTF HEALTH AND HUMANERVICES

Gregory E. DemskeAssistant Inspector General for Legal AffairsOffice of Inspector GeneralU. S.Department of Health and Human Services

DATE


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APPENDIX AFOCUS ARFtANGEMENTS DATABA SES

UHH S shall create and maintain two Focus A rrangements Databases to track all new,renewed, and existing Focus Arrangements in order to ensure that each FocusArrangement does not violate the Anti-Kickback Statute and Stark Law. The FocusArrangement Databases shall contain certain information to assist UHHS in evaluatingwhether each Focus Arrangement violates the Anti-Kickback Statute and S tark Law.A. The Focus A rrangements Database tracking contractual transactions shall contain atleast the following information:

1. Each party involved in the Focus Arrangement;2. The type o f Focus Arrangement(x,hysician employment contract,medical directorship, lease agreement);3. The term of the Focus Arrangement, including the effective and expirationdates and any automatic renewal provisions;4. . The amount of compensation to be paid pursuant to the Focus A rrangementand the means by which compensation is paid;5 . The m ethodology for determining the compensation under the FocusArrangements, including the methodology used to determine the fair market valueof such compensation;6 . Whether the am ount of compensation to be paid pursuant to the FocusArrangement is determined based on the volume or value of referrals between theparties;7. Whether each party has h lfil led the requirements of Section III.D.2; and8. Whether the Focus Arrangement satisfies the requirements of an Anti-Kickback S tatute safe harbor and/or a Stark Law exception or safe harbor, asapplicable.


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B. The Focus Arrangements Database tracking non-contractual transactions subject to 42C.F.R.5 4 11.357(k) shall contain at least the following information:1. Each party involved in the Focus A rrangement;2. The type of Focus Arrangement(=,he type of non-contractualtransaction);3. The aggrega te value of all non-contractual transactions with each entity orindividual during the Reporting Period;4. Whether the am ount of compensation to be paid pursuant to the FocusArrangement is determined based on the volume or value of referrals between theparties; and5 . Wh ether the Focus Arrangement satisfies the requirements of an Anti-Kickback Statute safe harbor and/or a S tark Law exception or safe harbor, asapplicable.


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APPENDIX BINDEPENDENT REVIEW ORGANIZATION

This Appendix contains the requirements relating to the Independent ReviewOrganization (IRO) required by Section 1II.E of the CIA.A. IRO Engagement.

UHHS shall engage the IRO(s) that possesses the qualifications set forth inParagraph B, below, to perform the responsibilities in Paragraph C, below. The IRO(s)shall condu ct the review in a professionally independent and/or objec tive fashion, as setforth in Paragraph D. Within 30 days after OIG rece ives written notice of the identity ofthe selected IRO(s), OIG will notify UHHS if the IRO(s) id are u nacceptable. Absentnotification from OIG that the IRO is unacceptable, UHHS m ay continue to engage theIRO.

If UHHS eng ages a new IRO during the term of the CIA, this IRO shall also meetthe requirements of this Appendix. If a new IRO is engaged, UHHS shall subm it theinformation identified in Section V.A.11 to O IG within 30 d ays of engagement of theIRO. Within 30 days after OIG receives written notice of the identity of the selected IRO,OIG will notify UHHS if the IRO is unacceptable. Absent notification from OIG that theIRO is unacceptable, UHHS may continue to engage the IRO.B . IRO Qualifications.The IRO shall 1 ) assign individuals to conduct the Focus Arrangem ents Review andUnallowable Cost Review engagement who have expertise in the subject matter of thereview(s) the IRO is being engaged to perform and in the general requirements of theFederal health care program(s) from which UHHS seek s reimbursement; and 2) havesufficient staff and resources to conduct the reviews required by the CIA on a timelybasis.

C. IRO Respo nsibilities.The IRO shall:

I . perform each Focus Arrangements Review and Unallowable Cost Review inaccordance with the specific requirements of the CIA;


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2. follow all applicable statutes, regulations, laws, rules, and reimbursementguidelines in making assessm ents in the Focus Arrangements Review and UnallowableCost Review;

3. if in doubt of the application of a particular Medicare policy or regulation,request c larification from the appropriate authority(a,iscal intermediary or carrier);4. respond to all OIG inquires in a prompt, objective, and factual manner; and5. prepare tim ely, clear, well-written reports that includ e all the informationrequired by Section 1II.E.

D. IRO Independence/Objectivity.The IRO m ust perform the Focus Arrangements Review and Unallowable Cost Review ina professionally independent and/or objective fashion, as appropriate to the nature of theengagement, taking into account any other business relationships or engagem ents thatmay exist between the IRO and UH HS.E. IRO Removal/Termination.

1. Provider. If UHHS terminates its IRO during the course of the engagem ent,UH HS m ust subm it a notice explaining its reasons to OIG no later than 30 days aftertermination. UH HS must engage a new IRO in accordance with Paragraph A o f thisAppendix.

2. OIG Rem oval of IRO. In the event OIG has reason to believe that the IRO doesnot possess the qualifications described in Paragraph B, is not independent and/orobjective as set forth in Paragraph D , or has failed to carry out its responsibilities asdescribed in Paragraph C , OIG may, at its sole discretion, require UHH S to engage a newIRO in accordance with Paragraph A of this Appendix.Prior to requiring UHHS to engage a new IRO, OIG shall no tif j UHHS of itsintent to do so and provide a w ritten explanation of why O IG believes such a step isnecessa ry. To resolve any concerns raised by O IG, UHH S may request a meeting withOIG to discuss any aspect of the IRO's qualifications, independence, or performance ofits respons ibilities and to present add itional information regarding these matters. UHHS


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shall provide any additional information as may be requested by OIG under thisParagraph in an expedited manner. OIG will attempt in good faith to resolve anydifferences regarding the IRO with UHHS prior to requiring UHHS to terminate the IRO.However, the final determination as to whether or not to require UHHS to engage a newIRO shall be made at the sole discretion of OIG.


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APPENDIX C

OVERPAYMEN T REFUND-TO BE CO MPLETED BY MEDICARE CONTRACTORDate:Contractor Deposit Control # Date of Deposit:Contractor Contact Name: Phone #Contractor Address:Contractor Fax:

TO BE COM PLETED BY PROVIDER/PHYSICIAN/SUPPLIERPlease complete and forward to Medicare Contractor. This orm, or a similar document containing the ollowinginformation, should accom pany every voluntary refund so td t receipt of check is properly recorded and applied.PROVIDERIPHYSICIANISUPPLIERN~~EADDRESSPROVIDERPHYSICIANISUPPLIER CHECK NUMBER#CONTACT PERSON: PHONE # AMOUNT OF CHECK$ CHECK DATE

REFUND INFORMATIONFor each Claim, provide the following:Patient Nam e HIC #Medicare Claim Number Claim Amount Refunded $Reason Code for Claim Adjustment: (Select reason code fiom list below. Use one reason per claim)

(Please list & claim numbers involved. A ttach separate sheet, if necessary)Note: IfSpec lJic Patient/HIC/C laim #/Claim Amount data not available or all claims due to Statistical Sampling,please indicate methodology and formula used to determine amou nt and reason foroverpayment:For Institutional Facilities Only:Cost Report Year(s)(If multiple cost report years are involved, provide a breakdown by amoun t and corresponding cost report year.)For OIG Reporting Requirements:Do you have a Corporate Integrity Agreement with OIG? Yes NoReason Codes:BillindClerical Error MSPIOther Paver Involvement Miscellaneous01 - Corrected Date of Service 08 - MSP Group Health Plan Insurance 13 - Insufficient Documentation02 - Duplicate 09 - MSP No Fault Insurance 14- Patient Enrolled in an HMO03 - Corrected CPT Code 10 - MSP Liability Insurance 15 - Services Not Rendered04 - Not Our Patient(s) 11 - MSP, Workers Comp.(Including 16 - Medical Necessity05 - Modifier AddedlRemoved Black Lun 17 - Other (Please Specify)06 - Billed in Error 12 - Veterans ~ cf ki st ra ti on07 - Corrected CPT Code

university hospitals health system inc 08172006 corporate integrity agreement oig medicare

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