21st Century Oncology, Inc. Corporate Integrity Agreement

by 21st Century as well as for any reporting obligationscreated under this CIA.Any noncompliance job responsibilities of the Chief Compliance Officer shall belimited and must not interfere with the Chief Compliance Officer’s ability to perform theduties outlined in this CIA.21st Century shall report to OIG, in writing, any changes in the identity or positiondescription of the Chief Compliance Officer, or any actions or changes that would affectthe Chief Compliance Officer’s ability to perform the duties necessary to meet theobligations in this CIA, within five days after such a change.2.Regional Compliance Officers. 21st Century has appointed RegionalCompliance Officers, which at a minimum shall comprise of the same proportion ofRegional Compliance Officers as 21st Century currently maintains and shall maintainRegional Compliance Officers for the term of the CIA. The Regional ComplianceOfficers shall be responsible for maintaining and implementing policies, procedures, andpractices designed to ensure compliance with the requirements set forth in this CIA andwith Federal health care program requirements for the applicable regions, and shallmonitor the day-to-day compliance activities for the applicable regions. The RegionalCompliance Officers shall report to the Chief Compliance Officer and shall be membersof the Compliance Committee. The Regional Compliance Officers shall make periodic(at least quarterly) written reports regarding compliance matters directly to the ChiefCompliance Officer, and shall be authorized to report on such matters directly to theCompliance Committee, the Chief Compliance Officer, and the Board of Directors at anytime. The Regional Compliance Officers shall make periodic (at least quarterly) visits to21st Century practices in order to fulfill the obligation of this Section.21st Century shall report to OIG, in writing, any changes in the identity or positiondescription of the Regional Compliance Officers, or any actions or changes that wouldaffect the Regional Compliance Officers’ ability to perform the duties necessary to meetthe obligations in this CIA, within five days after such a change.2.Compliance Committee. Within 90 days after the Effective Date,21st Century shall appoint a Compliance Committee. The Compliance Committee shall,at a minimum, include the Compliance Officer and other members of senior managementnecessary to meet the requirements of this CIA (e.g., senior executives of relevantdepartments, such as billing, clinical, human resources, audit, and operations). The621st Century Oncology, Inc. CIA

Compliance Officer shall chair the Compliance Committee and the Committee shallsupport the Compliance Officer in fulfilling his/her responsibilities (e.g., shall assist inthe analysis of 21st Century’s risk areas and shall oversee monitoring of internal andexternal audits and investigations). The Compliance Committee shall meet at leastquarterly. The minutes of the Compliance Committee meetings shall be made availableto OIG upon request.21st Century shall report to OIG, in writing, any changes in the composition of theCompliance Committee, or any actions or changes that would affect the ComplianceCommittee’s ability to perform the duties necessary to meet the obligations in this CIA,within 15 days after such a change.3.Board of Directors Compliance Obligations. The Board of Directors(or a committee of the Board) of 21st Century (Board) shall be responsible for the reviewand oversight of matters related to compliance with Federal health care programrequirements and the obligations of this CIA. The Board must include independent (i.e.,non-executive) members.The Board shall, at a minimum, be responsible for the following:a.meeting at least quarterly to review and oversee 21stCentury’s compliance program, including but not limited tothe performance of the Compliance Officer and ComplianceCommittee;b.submitting to the OIG a description of the documents andother materials it reviewed, as well as any additional stepstaken, such as the engagement of an independent advisor orother third party resources, in its oversight of the complianceprogram and in support of making the resolution belowduring each Reporting Period; andc.for each Reporting Period of the CIA, adopting a resolution,signed by each member of the Board summarizing its reviewand oversight of 21st Century’s compliance with Federalhealth care program requirements and the obligations of thisCIA.721st Century Oncology, Inc. CIA

d.for the first and fourth Reporting Periods of the CIA, theBoard shall retain an individual or entity with expertise incompliance with Federal health care program requirements(Compliance Expert) to perform a review of the effectivenessof 21st Century’s Compliance Program (Compliance ProgramReview). The Compliance Expert shall create a work plan forthe Compliance Program Review and prepare a written reportabout the Compliance Program Review. The written report(Compliance Program Review Report) shall include adescription of the Compliance Program Review and anyrecommendations with respect to 21st Century’s complianceprogram. The Board shall review the Compliance ProgramReview Report as part of its review and oversight of 21stCentury’s compliance program. A copy of the ComplianceProgram Review report shall be provided to OIG in eachAnnual Report submitted by 21st Century. In addition, copiesof any materials provided to the Board by the ComplianceExpert, along with minutes of any meetings between theCompliance Expert and the Board, shall be made available tothe OIG upon request.At minimum, the resolution shall include the following language:“The Board of Directors has made a reasonable inquiry into the operationsof 21st Century’s Compliance Program including the performance of theCompliance Officer and the Compliance Committee. Based on its inquiryand review, the Board has concluded that, to the best of its knowledge, 21stCentury has implemented an effective Compliance Program to meetFederal health care program requirements and the obligations of the CIA.”If the Board is unable to provide such a conclusion in the resolution, the Boardshall include in the resolution a written explanation of the reasons why it is unable toprovide the conclusion and the steps it is taking to implement an effective ComplianceProgram at 21st Century.21st Century shall report to OIG, in writing, any changes in the composition of theBoard, or any actions or changes that would affect the Board’s ability to perform theduties necessary to meet the obligations in this CIA, within 15 days after such a change.821st Century Oncology, Inc. CIA

4.Management Certifications. In addition to the responsibilities setforth in this CIA for all Covered Persons, certain 21st Century employees (CertifyingEmployees) are specifically expected to monitor and oversee activities within their areasof authority and shall annually certify that the applicable 21st Century department is incompliance with applicable Federal health care program requirements and with theobligations of this CIA. These Certifying Employees shall include, at a minimum, thefollowing: Chief Executive Officer, Chief Financial Officer, Chief Medical Officer,Regional Compliance Officers, Senior Vice Presidents for Operations, and the executivesresponsible for business development and marketing, if a separate individual is identifiedas responsible for business development and marketing. For each Reporting Period, eachCertifying Employee shall sign a certification that states:“I have been trained on and understand the compliance requirements andresponsibilities as they relate to [insert name of department], an area undermy supervision. My job responsibilities include ensuring compliance withregard to the [insert name of department] with all applicable Federal healthcare program requirements, obligations of the Corporate IntegrityAgreement, and 21st Century policies, and I have taken steps to promotesuch compliance. To the best of my knowledge, the [insert name ofdepartment] of 21st Century is in compliance with all applicable Federalhealth care program requirements and the obligations of the CorporateIntegrity Agreement. I understand that this certification is being providedto and relied upon by the United States.”If any Certifying Employee is unable to provide such a certification, the CertifyingEmployee shall provide a written explanation of the reasons why he or she is unable toprovide the certification outlined above.Within 90 days after the Effective Date, 21st Century shall develop and implementa written process for Certifying Employees to follow for the purpose of completing thecertification required by this section (e.g., reports that must be reviewed, assessments thatmust be completed, sub-certifications that must be obtained, etc. prior to the CertifyingEmployee making the required certification).921st Century Oncology, Inc. CIA

B.Written StandardsWithin 90 days after the Effective Date, 21st Century shall develop andimplement written policies and procedures regarding the operation of its complianceprogram, including the compliance program requirements outlined in this CIA and 21stCentury’s compliance with Federal health care program requirements (Policies andProcedures). The Policies and Procedures also shall address:a.42 U.S.C. § 1320a-7b(b) (Anti-Kickback Statute) and 42U.S.C. § 1395nn (Stark Law), and the regulations and otherguidance documents related to these statutes, and business orfinancial arrangements or contracts that generate unlawfulFederal health care program business in violation of the AntiKickback Statute or the Stark Law; andb.the requirements set forth in Section III.D (Compliance withthe Anti-Kickback Statute and Stark Law).The Policies and Procedures shall be made available to all Covered Persons.Throughout the term of this CIA, 21st Century shall enforce its Policies and Proceduresand shall make compliance with its Policies and Procedures an element of evaluating theperformance of all employees.At least annually (and more frequently, if appropriate), 21st Century shall assessand update, as necessary, the Policies and Procedures. Any revised or new Policies andProcedures shall be made available to all Covered Persons.All Policies and Procedures shall be made available to OIG upon request.C.Training and Education1.Covered Persons Training. Within 90 days after the Effective Date,21st Century shall develop a written plan (Training Plan) that outlines the steps 21stCentury will take to ensure that all Covered Persons receive at least annual trainingregarding 21st Century’s CIA requirements and Compliance Program and the applicableFederal health care program requirements, including the requirements of the AntiKickback Statute and the Stark Law; and that all Arrangements Covered Persons receiveat least annual training regarding: (i) Arrangements that potentially implicate the Anti 1021st Century Oncology, Inc. CIA

Kickback Statute or the Stark Law, as well as the regulations and other guidancedocuments related to these statutes; (ii) 21st Century’s policies, procedures, and otherrequirements relating to Arrangements and Focus Arrangements, including but notlimited to the Focus Arrangements Tracking System, the internal review and approvalprocess, and the tracking of remuneration to and from sources of health care business orreferrals required by Section III.D of the CIA; (iii) the personal obligation of eachindividual involved in the development, approval, management, or review of 21stCentury’s Arrangements to know the applicable legal requirements and the 21stCentury’s policies and procedures; (iv) the legal sanctions under the Anti-KickbackStatute and the Stark Law; and (v) examples of violations of the Anti-Kickback Statuteand the Stark Law.The Training Plan shall include information regarding the following: trainingtopics, identification of Covered Persons and Arrangements Covered Persons required toattend each training session, length of the training sessions(s), schedule for training, andformat of the training. 21st Century shall furnish training to its Covered Persons andArrangements Covered Persons pursuant to the Training Plan during each ReportingPeriod.2.Board Member Training. Within 90 days after the Effective Date,each member of the Board of Directors shall receive at least two hours of training. Thistraining shall address the corporate governance responsibilities of board members, andthe responsibilities of board members with respect to review and oversight of theCompliance Program. Specifically, the training shall address the unique responsibilitiesof health care Board members, including the risks, oversight areas, and strategicapproaches to conducting oversight of a health care entity. This training may beconducted by an outside compliance expert hired by the Board and should include adiscussion of the OIG’s guidance on Board member responsibilities.New members of the Board of Directors shall receive the Board Member Trainingdescribed above within 30 days after becoming a member or within 90 days after theEffective Date, whichever is later.3.Training Records. 21st Century shall make available to OIG, uponrequest, training materials and records verifying that Covered Persons, ArrangementsCovered Persons, and Board members have timely received the training required underthis section.1121st Century Oncology, Inc. CIA

D.Compliance with the Anti-Kickback Statute and Stark Law1.Focus Arrangements Procedures. Within 90 days after the EffectiveDate, 21st Century shall create procedures reasonably designed to ensure that eachexisting and new or renewed Focus Arrangement does not violate the Anti-KickbackStatute and/or the Stark Law or the regulations, directives, and guidance related to thesestatutes (Focus Arrangements Procedures). These procedures shall include the following:a.creating and maintaining a centralized tracking system for allexisting and new or renewed Focus Arrangements (FocusArrangements Tracking System);b.tracking remuneration to and from all parties to FocusArrangements;c.tracking service and activity logs to ensure that parties to theFocus Arrangement are performing the services requiredunder the applicable Focus Arrangement(s) (if applicable);d.monitoring the use of leased space, medical supplies, medicaldevices, equipment, or other patient care items to ensure thatsuch use is consistent with the terms of the applicable FocusArrangement(s) (if applicable);e.establishing and implementing a written review and approvalprocess for all Focus Arrangements, the purpose of which isto ensure that all new and existing or renewed FocusArrangements do not violate the Anti-Kickback Statute andStark Law, and that includes at least the following: (i) a legalreview of all Focus Arrangements by counsel with expertisein the Anti-Kickback Statute and Stark Law, (ii) a process forspecifying the business need or business rationale for allFocus Arrangements, and (iii) a process for determining anddocumenting the fair market value of the remunerationspecified in the Focus Arrangement;f.requiring the Compliance Officer to review the FocusArrangements Tracking System, internal review and approval1221st Century Oncology, Inc. CIA

process, and other Focus Arrangements Procedures on at leastan annual basis and to provide a report on the results of suchreview to the Compliance Committee; andg.implementing effective responses when suspected violationsof the Anti-Kickback Statute and Stark Law are discovered,including disclosing Reportable Events and quantifying andrepaying Overpayments pursuant to Sections III.J and III.Kwhen appropriate.2.New or Renewed Focus Arrangements. Prior to entering into newFocus Arrangements or renewing existing Focus Arrangements, in addition to complyingwith the Focus Arrangements Procedures set forth above, 21st Century shall comply withthe following requirements (Focus Arrangements Requirements):a.Ensure that each Focus Arrangement is set forth in writingand signed by 21st Century and the other parties to the FocusArrangement;b.Include in the written agreement a requirement that each partyto a Focus Arrangement who meets the definition of aCovered Person shall complete at least one hour of trainingregarding the Anti-Kickback Statute and the Stark Law andexamples of arrangements that potentially implicate the AntiKickback Statute or the Stark Law. Additionally, 21stCentury shall provide each party to the Focus Arrangementwith a copy of its Stark Law and Anti-Kickback StatutePolicies and Procedures;c.Include in the written agreement a certification by the partiesto the Focus Arrangement that the parties shall not violate theAnti-Kickback Statute and the Stark Law with respect to theperformance of the Arrangement.3.Records Retention and Access. 21st Century shall retain and makeavailable to OIG, upon request, the Focus Arrangements Tracking System and allsupporting documentation of the Focus Arrangements subject to this Section and, to the1321st Century Oncology, Inc. CIA

extent available, all non-privileged communications related to the Focus Arrangementsand the actual performance of the duties under the Focus Arrangements.E.Review Procedures1.General Description.a.Engagement of Independent Review Organization. Within 90days after the Effective Date, 21st Century shall engage anentity (or entities), such as an accounting, auditing, law, orconsulting firm (hereinafter “Independent ReviewOrganization” or “IRO”), to perform the reviews listed in thisSection III.E. The applicable requirements relating to theIRO are outlined in Appendix A to this CIA, which isincorporated by reference.b.Retention of Records. The IRO and 21st Century shall retainand make available to OIG, upon request, all work papers,supporting documentation, correspondence, and draft reports(those exchanged between the IRO and 21st Century) relatedto the reviews.c.Responsibilities and Liabilities. Nothing in this Section III.Eaffects 21st Century’s responsibilities or liabilities under anycriminal, civil, or administrative laws or regulationsapplicable to any Federal health care program including, butnot limited to, the Anti-Kickback Statute and/or the StarkLaw.2.Arrangements Review. The IRO shall perform an ArrangementsReview and prepare an Arrangements Review Report as outlined in Appendix B to thisCIA, which is incorporated by reference.3.Claims Review. The IRO shall review claims submitted by 21stCentury and reimbursed by the Medicare and Medicaid programs, to determine whetherthe items and services furnished were medically necessary and appropriately documentedand whether the claims were correctly coded, submitted and reimbursed (Claims Review)1421st Century Oncology, Inc. CIA

and shall prepare a Claims Review Report, as outlined in Appendix C to this CIA, whichis incorporated by reference.4.Independence and Objectivity Certification. The IRO shall includein its report(s) to 21st Century a certification that the IRO has (a) evaluated itsprofessional independence and objectivity with respect to the reviews required under thisSection III.E and (b) concluded that it is, in fact, independent and objective, inaccordance with the requirements specified in Appendix A to this CIA. The IRO’scertification shall include a summary of all current and prior engagements between 21stCentury and the IRO.F.Risk Assessment and Internal Review ProcessWithin 90 days after the Effective Date, 21st Century shall develop and implementa centralized annual risk assessment and internal review process to identify and addressrisks associated with Arrangements (as defined in Section II.C.1 above) and 21stCentury’s participation in the Federal health care programs, including but not limited tothe risks associated with the submission of claims for items and services furnished toMedicare and Medicaid program beneficiaries. The risk assessment and internal reviewprocess shall require compliance, legal and department leaders, at least annually, to: (1)identify and prioritize risks, (2) develop internal audit work plans related to the identifiedrisk areas, (3) implement the internal audit work plans, (4) develop corrective actionplans in response to the results of any internal audits performed, and (5) track theimplementation of the corrective action plans in order to assess the effectiveness of suchplans. 21st Century shall maintain the risk assessment and internal review process for theterm of the CIA.G.Disclosure ProgramWithin 90 days after the Effective Date, 21st Cent

1395nn(h)(5)) to 21st Century for designated health services (as defined at 42 U.S.C. § 1395nn(h)(6)). 2. “Focus Arrangements” shall include: a. every Arrangement that: i. is between 21st Century and any actual source or recipient of health care business or referrals to 21st Century and