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for officers and directors to trade theinternal controls, and include an assess-criminal penalties for document destruc-company’s securities during a “black-out”ment of those controls in the annualtion in federal investigations; (2) requiresperiod, and it requires employers to givereport. In turn, the auditor is required tothe maintenance of audit records for fiveemployees a 30-day written notice of aattest to, and report on, management’syears; and (3) provides for whistleblowerblack-out period. Moreover, this sectionassessment of internal controls. The Actprotections. For example, documentof the Act imposes an obligation onalso directs the SEC to review disclosuresdestruction and tampering are consideredlawyers practicing before the SEC tomade by public companies, including thenew federal crimes under the Act.report violations of the securities law andcompanies’ financial statements.Knowingly altering or destroying docu-breaches of fiduciary duty to the chiefments or records with the intent tolegal counsel or chief executive officer ofAnalyst conflicts of interest. In animpede, obstruct, or influence any exist-the company. If those persons do notattempt to limit the influence that invest-ing or contemplated federal investigationtake steps to remedy the problem, thement bankers have upon the securitiesor bankruptcy, is a crime punishable byattorney is required to report the inactionanalysts and their recommendations, thefines and up to 20 years of imprison-to the company’s audit committee.Act requires the SEC to adopt rulesment. The destruction of corporate auditrequiring each registered broker, dealer,records is a crime punishable by fines andEnhanced financial disclosure. Publicand securities analyst recommendingup to 10 years of imprisonment.companies must now disclose (1) anyequity securities in research reports andrequisite material adjustments identifiedpublic appearances to disclose any con-The Act also provides whistleblower pro-by the auditor; and (2) all material off-flicts of interest that were known or thattection for employees of publicly tradedbalance sheet transactions and othershould have been known at the time ofcompanies who provide evidence ofcompany relationships that could have athe report or recommendation.fraud. It provides for reinstatement, backmaterial impact on the company’s futurepay with interest, and compensation forfinancial statements or condition.Commission resources and authority.special damages resulting from any dis-The Act increases the SEC’s budget tocrimination they may face as a result ofThis section of the Act generally pro-enable it to conduct more investigationscoming forward. Defrauding the share-hibits public companies from makingand to review more filings. The SEC’sholders of publicly traded companies ispersonal loans to executive officers andauthority will grow along with theiralso a new crime that exposes violators todirectors. It requires officers, directors,budget. In addition to its previous pow-fines and imprisonment of up to 25 years.and significant shareholders to file state-ers, the SEC can now censure personsments of ownership with the SEC indi-and preclude them from appearing orWhite-collar crime penalty enhance-cating ownership, changes in ownership,practicing before the SEC.ments. The Act enhances certain existingand purchases and sales of the security-criminal penalties. Moreover, violationsbased swap agreements.Studies and reports. The Act commis-of the Act’s certification requirements aresions certain reports and studies. Amonga new federal crime. The key criminalThe Act also requires the SEC to issuethe study topics are: (1) consolidation ofimplications of the Act are: (1) mail andrules that require public companies topublic accounting firms; (2) credit ratingwire fraud offenses have been increaseddisclose whether (1) they have adopted aagencies; (3) investment banks; and (4)from a maximum 5-year prison term tocode of ethics for senior financial officers;enforcement actions regarding (a) viola-20 years; (2) penalties for ERISA-relatedand (2) they have at least one financialtions of the reporting requirements orviolations have increased from a $5,000expert on the audit committee.restatements of financial statements, andfine and a 1-year prison term to a(b) previous violations of the securities$100,000 fine and a 10-year prison term,Further, the Act requires public compa-act over the last five years.and the fines for corporate violations arenies to acknowledge in the annual reportincreased from $100,000 to a maximumthat its management is responsible forCorporate and criminal fraud account-of $500,000; and (3) false certificationsthe establishment and effectiveness of itsability. Generally, the Act: (1) outlinesContinued on page 75January 2003

January 20036A critical component of today’s drugbenefits program is the design andimplementation of an effective benefitplan and the use of benefit managementtechniques. These include such elementsas formulary management, a pharmacynetwork, intervention techniques, costsharing to encourage the use of formularyor generic drugs, and concurrent andretrospective review programs. The for-SPECIAL SPECIALINTERESTGROUPOIG The OIG identified three potential riskCompliancticalmanufacturers: (1) integrity of dataareas in the Draft Guide for pharmaceu-Guide for used by state and federal governments toPharmaceutical Manufacturers: A establish payment; (2) kickbacks anddefensive switch for health plans other illegal remuneration; and (3) compliancewith laws regulating drug sam-By Joel L. Michaelsples. From a health plan’s perspective,Editor’s note: Joel L. Michaels is a partnerin the law firm of McDermott Will & provide or arrange for health services toand particularly those who currentlyEmery, Washington, DC. He may be federal health care programs, the firstreached at 202/756-8000.two areas are the most relevant, and theissue of kickbacks and illegal remunerationis of particular concern.On October 3, 2002, the Departmentof Health and Human Services, Officeof the Inspector General (OIG) issuedits draft OIG Compliance Guidance forPharmaceutical Manufacturers in theFederal Register (hereinafter referred to asthe Draft Guide) seeking comments ofinterested parties. 1 Controlling fraudand abuse to limit the ever increasingcost of prescription drugs, particularlyfor federal health care programs, is agoal that managed health care plansendorse. For those health plans thatremain in the Medicare+Choice program, the offering of a prescriptiondrug benefit has often been akey distinctive feature and the ability toexpand this coverage to other Medicarebeneficiaries will depend, in part, on thecapacity of health plans to manage thebenefit.Nevertheless, given the potential scopeand breadth of the Draft Guide andthe current enforcement environment,additional clarification from the OIGis in order. Without it, an unintendedcloud may hinder legitimate efforts byhealth plans to effectively managedrug costs for their members andinsureds.Managing the drug benefitAs an introductory matter, it is importantto underscore that relationshipsbetween pharmaceutical manufacturersand health plans are not necessarilydirect or particularly uniform. A numberof health plans may have their ownarrangements with drug manufacturers,while others may contract with pharmacybenefit managers or “PBMs” who actas intermediaries between the healthplans and the drug manufacturers. ThePBMs may be either independent orhealth plan affiliated. For those PBMsthat are health plan affiliated, they maynot only provide services to the membersof their affiliated health plan, but toother health plans as well.PAYOR/ MANAGED CAREmulary, which is a list of preferred drugsfor treatment of specific illnesses, can beeither “open” or “closed.”In a closed formulary, the health planwill not cover non-formulary drugs,unless prior approval is obtained fromthe health plan or PBM. An open formularyuses a tiered co-payment structureto steer members and insureds topurchase generic drugs or formularybrand name drugs. The interventiontechniques may include therapeutic substitutionprograms, which involve utilizationreview and contacts with prescribingphysicians to increase andmaintain the use of formulary products.In view of the above, it is clear thatmanaging a drug benefit includes “steerage”and “switching”, concepts that arewell accepted in a managed care environmentbut may have other implicationswhen federal health care programsare at issue. These terms can representred flags to the OIG and other lawenforcement officials who often equatethem with being inapposite to the policiesbehind and the provisions of theFederal Anti-Kickback Statute, 42 USC§1320a-7b. This is particularly the casewhen they are accompanied by the paymentof rebates from pharmaceuticalmanufacturers.Although rebate arrangements withdrug manufacturers can vary significantly,there are two basic formats. The firsttype of rebate is a “flat” rebate or volumerebate. It is based on a fixed percentageof the number of units of thedrug that are purchased and dispensedto the health plan’s members. The secondtype of rebate is the “market-share”

SARBANES-OXLEY...continued from page 5or tiered rebate. This rebate is oftento know how their customers submitare a criminal penalty. Chief executivemeasured on a sliding scale according tothe number of units of the specific drugthat are purchased and dispensed to thehealth plan members as compared withthe manufacturer’s competitors in thatclass of medication. The more competitivethe marketplace is for a particulardrug, the more likely the market sharerebate is to be utilized. More importantly,from a health plan purchaser’s per-claims to the federal health care programs(e.g., whether the customer is amanaged care, cost-based, or chargebasedbiller).” How rebate arrangementsare to be reported by health plans tomany federal health care programsremains unclear. For example, under theMedicare+Choice program, there is nopolicy as to how health plans reportrebates in their Adjusted Communityofficers and chief financial officers whoknowingly violate the certificationrequirements can be held criminallyliable, fined up to $1,000,000, andimprisoned for up to 10 years. Willfulviolations of the certification requirementscan result in fines of up to$5,000,000 and imprisonment for up to20 years.spective, market share rebates often representmore material price concessionsfrom the manufacturer than do volumerebates. With these concepts in mind, aRate or “ACR” calculations.It is in the context of relationships withphysicians and other health care profes-Corporate tax returns. The Act recommendsthat a company’s chief executiveofficer certify the corporate tax returns.review of the relevant sections of theDraft Guide is in order.The Draft GuideThe first statement in the Draft Guideis the recommendation from the OIGthat “pharmaceutical manufacturerssionals where the Draft Guide describes“switching” in more ominous tones thatcould have a chilling effect on healthplan pharmacy rebate and prescribingphysician intervention activities. First,the OIG states that “switching” arrangementsor “product conversion” arrange-Corporate fraud and accountability.The Act: (1) generally prohibits peoplewho have been convicted of fraud fromserving as a company’s officer or director;(2) enhances penalties for record tamperingand for impeding investigations; andstructure their arrangements to fit in asafe harbor whenever possible.” One ofthe potentially relevant safe harbors listedby the OIG is the “discount” safeharbor, 42 C.F.R. § 1001.952(h). Thediscount must be in the form of areduction in the price of the good orservice based on an arms-length transactionand it must be given at the time ofsale or in certain cases set at the time ofsale even if finally determined subsequentto the time of sale (i.e., a rebate).Under the safe harbor, the “seller” or“offeror” of the discount has specificments are suspect under the Anti-kickbackStatute. Second, these arrangementsinvolve pharmaceutical manufacturersoffering pharmacies, PBMs,physicians or other prescribers cash paymentsor other benefits each time apatient’s prescription is changed to themanufacturer’s product from a competingproduct. While acknowledging thatthese more direct payment programsmay be permissible “in certain managedcare arrangements,” the Draft Guideindicates that the activity implicates thestatute and that manufacturers shouldreview any marketing practices utilizing(3) enhances individual penalties underthe Securities and Exchange Act of 1934from $1,000,000 to $5,000,000 andincreases the maximum term of imprisonmentfrom 10 years to 20 years.Corporate fines are increased from$2,500,000 to $25,000,000. The Actalso makes it a crime to retaliate againstany witness for providing law enforcementofficers any truthful informationrelating to the commission or possiblecommission of any federal offense. Thepenalties for retaliation are fines andimprisonment for up to 10 years.obligations that include (1) informing acustomer of any discount and of thecustomer’s reporting obligations withrespect to that discount and (2) refrainingfrom any action that would impedea customer’s ability to comply with the“switching” payments in connectionwith products reimbursable by federalhealth care programs very carefully.Finally, arrangements that “have theeffect of rewarding switching indirectlyPart II will address the implications ofthe Sarbanes-Oxley Act for health careproviders, and offer practical steps thatproviders can take in light of its provisionsand underlying themes. ■safe harbor. The Draft Guide goes onshould also be carefully reviewed.” Theto provide that “manufacturers will needContinued on page 81 P.L. 107-204.7January 2003

OIG PHARMA COMPLIANCE GUIDE...continued from page 7January 20038Draft Guide contains with the followingexamples of these arrangements :“Such arrangements include paymentsby pharmaceutical manufacturersto pharmacies, PBMs, or othersfor contacting patients or theirphysicians to encourage them tochange a prescription from anotherproduct to the company’s product,and discounts or rebates based onmovement of market share.”This particular section of the DraftGuide is far from the model of clarity asit relates to the operation of a manageddrug benefit plan. First, for those PBMsand health plans who negotiate rebatearrangements with manufacturers, it isunclear what is meant by “direct”arrangements. Does the reference to“each time” mean that the payment ismade concurrent with the so calledswitch? Second, is the reference to “certainmanaged care arrangements” thatmay be permissible limited only to thedirect payment context?Finally, the OIG fails to give examplesof what the parameters for permittedmanaged care arrangements may be. Arethese arrangements that have additionalsafeguards related to the quality of care?Is there a need to disclose to the planmembers the rebate arrangement? Whywouldn’t most managed care arrangements,where the health plan has thefinancial incentive to control the cost ofdrugs, be permitted?It is, however, the Draft Guide’s referenceto the indirect arrangements, thatis, discounts or rebates based on themovement of market share, coupledwith the encouragement by PBMs orothers through the contacting ofpatients or their physicians, that creates environment that exists, it is incumbentadditional ambiguity as to what activity upon the OIG to clarify the scope ofthe OIG considers suspect. It appears as what are the permitted managed careif market share rebates along with physicianand patient intervention techniques market share rebates, coupled with rec-arrangements and to recognize thatare problematic. This latter concern ognized intervention techniques, have adoes not appear to be limited to PBMs legitimate place in health plan efforts tonor is there even any reassurance that control the cost of drugs. ■certain managed care arrangements are1 The Draft Guide is set forth in the October 3,permissible when these factors are present.The resulting ambiguity could have2002 Federal Register, Vol. 67, No. 192, at62057. It follows the typical format for thea chilling effect on the ability of health“voluntary” programs that have been issued byplans or their PBMs to negotiate withthe OIG for other health care industry segmentsincluding hospitals, home health agen-drug manufacturers meaningful marketshare rebate arrangements.cies, Medicare+Choice organizations, and others.In this regard, the seven fundamental elementsthat are representative of these compli-The need for clarityThe need for additional clarity is further ance programs are also set forth in the DraftGuide. These elements include:underscored by the Federal government’songoing investigations of the• implementing written policies andproceduresPBM industry and the comments often• designating a compliance officer andmade by prosecutors responsible forcompliance committeeenforcement of federal fraud and abuse • conducting effective training and educationhealth care statutes. For example, it has • developing effective lines of communicationbeen suggested that it is problematic to • conducting internal monitoring and auditinghave switching arrangements of the kind • enforcing standards through well-publicizeddescribed above unless there is disclosureto patients and physicians of thedisciplinary guidelines• responding promptly to detected problemsand undertaking corrective actionfinancial interest at issue.Given the rather adverse enforcementCHC recipientsThe Healthcare ComplianceMiddleburg Heights, OHCertification Board (HCCB) ■ Lucia Lajcsak, CHC, Coudersport,announced that the following individualshave successfully completed the ■ John Little, CHC, Austin, TXPACertified in Healthcare Compliance ■ David J. Oberg, CHC, Santa Ana,Examination - Thus earning the CHC CAdesignation (Sept. 2002):■ Sandra Nutten, CHC, Lonia, MI■ Carla Wallace, CHC, Hopkinsville,■ Jean Boord, CHC, Brentwood, TN KY■ Sharon E. Eaton, CHC, York, PA ■ Kristen Wild, CHC, Cedarburg,■ Pamela S. Kormos, CHC,WI ■

By F. Lisa Murtha, J.D.Editor’s note: F. Lisa Murtha is ChiefAudit and Compliance Officer forChildren’s Hospital of Philadelphia, and amember of the HCCA Board of Directors.She may be reached at 215/590-9156 orby email at flmurtha@earthlink.net.Compliance Professionals thatwork in the provider area haveno doubt seen the plethora ofarticles and press releases around the topicsof clinical research and human subject protections.Unfortunately, human researchparticipants have been harmed from timeto time and some have even died.Research is not just a topic for those thatwork in Academic Medical Centers.Many practicing physicians and communityhospitals and other providers conductsome form of research every year. Assuch, it is incumbent on the ComplianceProfessional to be certain that clinicalresearch is included as an important areain the Compliance Monitoring Program.In early October, 2002, the HHSOffice of Inspector General (OIG),published compliance guidance forpharmaceutical manufacturers. Whilethe document is written from the perspectiveof the pharmaceutical manufacturer,there is much that is alsoapplicable to research institutes andinvestigators generally. This guidance isavailable on the OIG’s Website(www.oig.hhs.gov). These areas shouldalso be considered when developingyour monitoring plan for research.To begin, the Compliance Professionalmust assess what type of research is beingconducted in the institution. Is thereclinical research being done (i.e. researchon human beings)? Is there benchresearch being conducted (i.e. laboratorybasedresearch)? Is there just biostatisticalresearch being conducted? Finally, isresearch being conducted on animals?For purposes of this article, let’s assumethat the research enterprise conductsresearch in all of the above areas and let’sbuild a monitoring plan from there. Oncethe universe of the types of research hasbeen assessed, it is important to assess thelevels of risk that each area might carry. Forexample, which areas is the governmentfocusing on? Which areas have not beenaudited in some time? Which areas involvegovernment or other funding sources?Which areas involve little or no institutionaloversight? Which areas involve researchon humans and animals? Are there institutionalpolitical issues that must be considered?Consideration of all of these issueswill help you prioritize the risks in yourorganization.Once you have listed and prioritized theareas you might wish to monitor, youshould consider the relevant laws andregulations that must be followed forthose areas. The traditional source ofmany laws and regulations in research,one must consider the Food and DrugAdministration (FDA) regulations andthe National Institutes of Heath (NIH)and its Office for Human ResearchProtections (OHRP) regulations. Thereare many environmental health and safetyregulations to be considered and a newF. LISA MURTHAbody of law called “The Patriot Act”,that requires reporting of the use of certainbiologics and research agents to thegovernment. It is important to considerthe Anti-kickback Statute, and other traditionalfraud and abuse laws and regulations.These laws and regulations mayimpact research subject recruitment, giftsfrom pharmaceutical representatives, andother areas as well.OMB Circulars are another great sourcefor understanding government researchrules. In particular, OMB Circulars A-110 and A-21 detail the rules related touse of government funding in research. Itis also advisable to review sponsor contractsas well as technology transfer agreementsto make certain that you understandhow certain research is supposed tobe conducted.The Medicare Coverage Decision is alsoa great source of information. This documentoutlines certain types of researchtests, etc. that may be billed to theMedicare Program if they are also medicallynecessary for the patient. (This particulardocument is very detailed andsomewhat complicated and it is advisableto consult with competent legal counselon the intricacies of this rule.) TheContinued on page 109January 2003

COMPLIANCE MONITORING...continued from page 9Health Insurance Portability andAccountability Act (HIPAA) and itsPrivacy Rule detail how patient or protectedhealth information can be used forresearch. Finally, the OIG has publishedits guidance for pharmaceutical manufacturersand its annual Work Plan whichare great sources for areas to cover incompliance monitoring.Let’s begin with one of the more mundaneareas–research funding and the rules relatedto how to spend the government’s orother sponsor’s money for research. Whendealing with government money, the rulesare clear with regard to how governmentmoney must be tracked and spent. Areasthat you might want to consider in theCompliance Monitoring Plan include:■ Time and effort reporting■ Cost transfers■ Cost sharing■ Residual balances in clinical trials■ Research billingThe area of research billing has gottensome press over the last few years. Therules are clear that research sponsors(including the government) and payorsmay not BOTH be billed or charged forthe same item, procedure, or service. It iscritical that research enterprises have away to distinguish patients enrolled inresearch studies and those that are justreceiving clinical care. One approach tomonitoring in this area includes trackingseveral research studies or clinical trialsfrom the budget and following patientsthrough the organization’s system todetermine how the enterprise ensures thatonly appropriate charges get allocated tothe research and things that may be billedto insurance are billed appropriately.The area of residual balances in clinicalJanuary 200310trials is also very important. In somecases, the research will contemplate thatany money left over at the end of astudy, be returned to the sponsor. Inmost cases, the Principal Investigator willhave discretion as to how the residualfunding should be used. One thing theCompli-ance Professional should monitoris that residual balances attributableto a single investigator never grow toobig. Some research enterprises use thenumber of $25,000 as a guide. In otherwords, a single investigator may notaccumulate more than $25,000 as aresidual balance from his/her research.All excess funds should either bereturned to the sponsor or placed in aninstitutional fund for the benefit ofnumerous investigators and departments.Again, this is just a guide or place tobegin. Competent legal counsel shouldbe consulted with regard to how to dealwith this matter institutionally.The next area to contend with is HumanSubject Protections and InformedConsent Monitoring. There are a numberof areas to be considered. Some ofthe more obvious areas include:■ Methods of subject recruitment andpayments to subjects■ Informed consent and the process ofobtaining informed consent■ HIPAA authorization for using PHIfor research or waivers of the authorizationrequirement from theInstitutional Review Board (IRB) orPrivacy Board■ What is innovative care and what is“research” thus requiring a review byan IRB■ Investigator and institutional conflictsof interestCertain adverse events at the Universityof Pennsylvania and Johns Hopkins haveprompted a great deal of governmentintervention into Human SubjectProtections. Reading the literature andthe decisions on these cases provides awealth of information on how to monitorthese areas. For example, a ComplianceProfessional might desire to chooseone or more of the high dollar, high riskstudies and track them from start to finish.One would certainly review:■ The budget for the study■ The protocol as submitted to the IRB■ The minutes from the IRB meetingwhere the Protocol was considered■ How much time did the IRB spendin consideration of the protocol■ Was there a quorum at the IRBmeeting■ Is there the correct composition of theIRB members per the OHRP rules?■ How were conflicts of interestconsidered■ Did the informed consent documentreceive appropriate review andoversight■ Was there consideration of therecruitment method and recruitmentmaterials■ Are there informed consentdocuments signed for all researchparticipants■ Interviews will need to be conductedto determine how the subjects wereadvised of the risks of the research?Did they really understand what theywere getting into■ A search of investigators publishedworks should be conducted to determinewhether case studies or othertypes of articles really constitute“research” and thus subject to IRBscrutinyContinued on page 15

featurearticleThis interview of L. Stephan Vincze,J.D., LL.M., CHC, Ethics &Compliance Officer, TAP PharmaceuticalProducts Inc., was conducted by JohnSteiner, Esq., Corporate ComplianceOfficer, The Cleveland Clinic. Johntalked with Steve about the HCCACompliance Performance Initiative, hisexperiences as TAP’s Ethics & ComplianceOfficer, and the upcoming HCCACompliance Institute’s pharmaceuticalimmersion session.Meet L. Stephan Vincze,and Human Services. I report directlyto TAP’s President and Board ofDirectors, as well as chair TAP’s Ethics& Compliance Committee. I also serveas TAP’s Privacy Officer. I lead anEthics & Compliance team of five outstandingpeople who report directly tome and help me meet these responsibilitiesdaily.J.D., LL.M., CHCL. Stephan Vincze may be reached atsteve.vincze@TAP.com. You may reachJohn Steiner at 216/444-1709.JS: Hello, Steve. Could you firstplease tell us a little about your titleand your position at TAPPharmaceuticals?SV: Sure John. First, I’d like to thankyou and the HCCA for the honor ofbeing interviewed for ComplianceToday. My title is Ethics & ComplianceOfficer for TAP PharmaceuticalProducts Inc. I became the Ethics &Compliance Officer for TAP a littleover a year ago in September of 2001.As TAP’s Ethics & Compliance Officer,I am responsible for the design, implementation,and operations of TAP’sEthics & Compliance Program.I am also responsible for overseeingthe proper implementation ofTAP’s Corporate Integrity Agreementwith the Office of Inspector General(OIG) of the Department of HealthJS: Can you tell us a little about thetype and scope of TAP’s business?SV: Certainly. TAP is a pharmaceuticalcompany that produces a variety ofproducts, to include Prevacid andLupron, which are the leading productsin their respective classes. TAP hasapproximately 3,000 employees thatwork here in the United States.JS: What I would like to do then is totalk to you about TAP and your rolethere, but before I do that I understandthat you are the Chairman of a taskforce that is working under the auspicesof the HCCA that is intended to provideadditional guidance for complianceprograms and, more particularly,how to both create an effective complianceprogram and improve existingcompliance programs. Could you tellus a little bit more about that initiative?SV: Sure, I’d be happy to. This taskforce, whose full name is the HCCACompliance Performance MeasurementInitiative, is a task force that hasbrought together the leading healthcare compliance professionals andthought leaders in the country. I am,again, very honored and pleased toserve as the Chairman of the task force.Our goal has been to “think different”,to reach beyond the known boundariesof compliance as it is today and todevelop practical information and toolsto assist compliance professionals, theirorganizations, their senior management,and their board of directors totruly understand the added value thatcompliance programs bring and todevelop some way of empirically measuringthis added value to prove thatcompliance programs work.As you and I know, complianceprograms truly help not only toprevent and detect illegal conduct, butContinued on page 12January 200311

L. Stephan Vinczeunteers, because in the end, this effort isJanuary 200312it has been my experience, that they alsoserve to enhance the operational efficiencyand quality of a health care organization.Ultimately, improving health careservices to patients is the unifying missionof all health care professionals andwhy we as compliance professionals dowhat we do. Compliance is definitely notjust about staying out of trouble.Hopefully, this initiative will provideadded information and tools to verifythat.The Compliance PerformanceMeasurement Initiative was started overtwo years ago by the HCCA. I joined theinitiative as Chairman earlier this year aswe revamped and refocused it. We havebrought together compliance professionalsand thought leaders from across thecountry in both the public and privatesectors, to include representatives fromthe OIG and CMS, forming a SteeringCommittee, a Drafting Committee, andan overarching Task Force. Ultimately, allof these volunteers report to the HCCABoard of Directors. It has been a verycollaborative partnership that has produced,I believe, a true quality referencedocument in Phase I.The initiative is designed, atleast for now and we may adjust it as wego, to be a two-phased project. Phase I isintended to develop the foundation forthe specific practical measurement toolsthat Phase II is intended to produce.Phase I built upon the foundation of theU.S. Sentencing Commission’s sevenbasic elements for effective compliance aswell as the OIG compliance guidances.The multi-disciplined task force reviewedthese materials as well as the seminal academicwork, the Ph.D. dissertation oncompliance program effectiveness, of LoriRichardson Pelliccioni who did sometremendous empirical research on thissubject. So, taking all of these sourcesplus the collective experience and knowledgeof these thought leaders, I believewe have produced a reference documentthat pushes the edge of the envelopewhen it comes to providing clear, practicalunderstanding of the key elements orindicators of compliance program effectivenessand how to move to the nextstep of measuring the effectiveness ofthese indicators.JS: So, if you can tell us at this point, isthere a specific timetable for the referencedocument that you describe as Phase Iand perhaps define or describe briefly theobjectives of Phase II.SV: Certainly, John, I’d be pleased todo so. As we are speaking here today thePhase I reference document is currentlyavailable on the HCCA Website formembers for their review and comment.It will be available for a 45-day period.By the time this interview is published,the document should be finalized incorporatingthe comments received from themembership and reviewed and approvedby the HCCA Board of Directors. Wehope that will occur by the first of theyear, 2003. Having produced that referencedocument, we can then move to themore specific task of developing complianceperformance measurement tools,which I anticipate will require us to breakdown into various health care industrysectors, whether it be for hospitals, physiciangroup practices, nursing homes,pharmaceutical companies, etc.My sense is that each of thesesectors and others will require differentkinds of performance measurement tools.We’ll have to examine that and certainlywould welcome any comments and suggestionsfrom the membership. On thatpoint, we always want to encourage vol-done for the members of the HCCA.The more they can participate and lendtheir collective knowledge to the process,the better off all of us will be.We hope to have the performancemeasurement tools, at least in draftform, and it is hard to tell because this isuncharted territory and new ground, bythe end of next year. So, we anticipatethat each of these phases will take about ayear to complete. Not bad, I think, whenyou consider that some people suggestedit may take as long as seven years for justPhase I. The incredible dedication andteamwork provided by the Task Forcemembers have made whatever progresswe have achieved possible.JS: OK, thank you very much Steve,that was a very thorough explanation ofthe HCCA Compliance PerformanceMeasurement Initiative. Now moving on,the next topic that I’d like to cover in thisinterview involves your current workwith TAP. Perhaps you can recap for uswhen you began in your new positionand some of the steps that you haveeither completed or planned particularlyin the context of the Corporate IntegrityAgreement and what it was like for youpersonally to come into an organizationand have to implement the requirementsof the Corporate Integrity Agreement.SV: Sure, I’d be happy to John. As Imentioned, I started with TAP in lateSeptember of 2001 just prior to the signingof the Corporate Integrity Agreementon September 28th. Now people oftenjoke with me that I must be some kindof masochist for joining an organizationthat just signed the largest health carefraud settlement in U.S. history and thekind of organization that must be, especiallyas someone who previously served

as President and CEO of a successfulconsulting firm and who had been recommendedto be the next InspectorGeneral of HHS. Why would anyonerisk their reputation and associate themselveswith such horrible circumstances?Well, as a former combat arms Marine,to me, the position at TAP is “an opportunityto excel.”I believe in the five P’s - properpreparation prevents poor performance,and, I have to say that while doing mydue diligence prior to accepting the positionand certainly over the course of thepast year, that each step of the way, Ihave been thoroughly impressed with thecommitment and the leadership of thecurrent executive team at TAP and thatof our two corporate parents at AbbottLaboratories and Takeda Pharmaceuticals.TAP, for those who are unaware ofit, is a joint venture between AbbottLaboratories and Takeda Pharmaceuticals.Takeda is the oldest and largestpharmaceutical company in Japan andAbbott, of course, is one of the oldestand most respected pharmaceutical companiesin our country.One of the good things that Ifound, and that was, quite frankly, apleasant surprise, is the extent to which acompliance program had already existedat TAP. There had been a complianceofficer who preceded me, who had establisheda Code of Conduct, in-person livetraining, a Hotline, a ComplianceCommittee, and essentially, all of thebasic elements. So, for me, rather thanstarting completely from scratch, I inheriteda solid foundation. With the addedresponsibilities of implementing the CIA,TAP brought me on board to refine andenhance the program to ensure it met theOIG’s expectations and to turn into anindustry leader.I am pleased to say that overthe course of the past year we have significantlyenhanced every aspect of the program,to include revamping, redesigning,and reissuing the Code of BusinessConduct, implementing a state-of-the-artcomputer-based training program thatoutside reviewers have stated is the bestthey have seen, upgrading our Hotlineand expanding it into a Helpline with24/7 service with live operators, an internet-basedtracking and response system,posters and wallet cards and an OperationsManual that our Hotline vendorwants to use as an industry-wide model,creating an Ethics and Complianceintranet site with all of our compliancerelated documents for all employees,adding several written policies and procedures,implementing the PhRMA Codeon Interactions with HealthcareProfessionals, creating a one-stop-shoppingEthics & Compliance Manual as ahandy desk reference, and finally, addinghighly qualified and experienced staff tomanage and oversee compliance training,compliance auditing, ourHotline/Helpline and our overall administration.We have also changed the programfrom being strictly focused on complianceto one that leads with ethics.That is why we have adopted, “Acting onOur Values,” as the theme for our entireprogram, instilling the notion that valuesand ethics drive compliance and that, inthe end, what you do and the actionsthat you take are what count, and that atTAP, we strive to do what is right, notjust what is required. I have also tried toinstill a very positive, up-beat, and valueaddedapproach to ethics and complianceat TAP, seeking to show and prove eachand every day that “Good compliance isgood business.”JOHN STEINERIn the end, however, none ofthese enhancement to TAP’s complianceprogram would be possible without theunwavering and strong support TAP’sBoard of Directors, and especially of ourPresident, Tom Watkins. Tom has beentremendous in personally setting the tonethat Ethics & Compliance is a top companypriority that must be met. His supportand, really that of everyone at TAP,at all levels, made my transition assmooth and positive as possible.Finally, I have to add that on aday-to-day level, our senior legal counsel,Ken Greisman, has been a true partnerwho has been a tremendous source ofwise counsel and assistance. The bottomlinethat may shock the readers of thisinterview, especially if all they knowabout TAP is what they read in thepapers and what they hear at conferencesis that when it comes to Ethics andCompliance, the TAP that I know “getsit” better than any organization that Ihave ever seen, from top to bottom andeveryone in between. As a Marine, peopleknow me to say what I mean andmean what I say. So you can take this tothe bank. I have staked my professionalreputation and career on it, and if I hadto do it all over again, I would. Ofcourse, each day is a new day, and I amContinued on page 14January 200313

January 200316ALAN YUSPEHAlan Yuspeh, JD, MBAHCCA PresidentAlan Yuspeh is Senior Vice President,Ethics, Compliance, and CorporateResponsibility for HCA. HCA is headquarteredin Nashville. Mr. Yuspeh isresponsible for all corporate activities inthe areas of ethics, compliance withlaws and regulations, and corporatesocial responsibility. He is a member ofsenior management and an officer ofthe corporation. Alan Yuspeh is anationally recognized expert in the fieldof corporate ethics and compliance havingserved as Coordinator (executivedirector) of the Defense IndustryInitiative on Business Ethic andConduct (DII) from 1987 to 1997.AL W. JOSEPHSServing with Alan are:Al W. Josephs, CHCHCCA 1st Vice PresidentAl has been a member of the HCCABoard of Directors since 1999. Prior tojoining the HCCA Board he served asPresident of HCCAs Region VI. Al hasalso served on the HealthcareCompliance Certification Board andhas been active in the development ofthe certification exam for complianceprofessionals. He is Director ofCorporate Compliance for HillcrestHealthcare System in Waco, TX and isresponsible for the development andoperation of the compliance programfor all Hillcrest System entities.ODELL GUYTONOdell Guyton, Esq.HCCA 2nd Vice PresidentOdell is the Senior Corporate Attorney–Director of Compliance for MicrosoftCorporation, Redmond, WA. Odell hasbeen a member of the HCCA Boardsince 1998. Prior to joining MicrosoftCorporation he served as CorporateCompliance Officer for the Universityof Pennsylvania, Audit & Compliance.Mr. Guyton has many years of experiencein the areas of corporate compliance,corporate internal investigations,legal audit, federal and state grand juryrepresentation, and federal sentencingguidelines.ALLISON MANEYAllison Maney, CPA, CHCHCCA TreasurerAllison is the Compliance Officer forLovelace Health System in Albuquerque.Allison was elected to the HCCABoard of Directors in 2001. She is aCertified Public Accountant andCertified Healthcare Compliance.Allison Maney is responsible for implementinga system-wide ComplianceProgram for the Delivery System,Health Plan, and Physician Group, aswell as developing compliance trainingprograms and directing the performanceof internal and external audits.Daniel Roach, Esq.HCCA SecretaryDANIEL ROACH

Iowa■ Annie Kontos, Dr. Annie Kontos, PC■ Garry Leavell, Wellmark Blue Cross &Blue ShieldKentucky■ Elizabeth Hall, UK Chandler MedicalCenter■ Vicki Hood, Commonwealth HealthCorp.■ Linda Tribble, VAMC-LexingtonLouisiana■ Will Caillouet, Terrebonne GeneralMedical CenterMaryland■ Jack Arendale, Force 3, Inc.■ Joan Johns, University of MarylandMedical SystemMassachusetts■ Carolyn Gabbay, Hutchins, Wheeler &Dittmar■ William Hrubes, Fresenius MedicalCare■ Laurie Laporte, South BostonCommunity Health Center■ Earl Manz, Harvard Pilgrim HealthCare■ Marianne Murphy■ Susan Rodd, Tufts University School-Dental Medicine■ Donna StoneMichigan■ Coni Eller, Covenant Healthcare■ Shirlene Guikema, Pine Rest ChristianMental Health■ Laura Hovey, Cancer & Hematology ofWest MichiganMinnesota■ Linda Hall, McKesson MedicationManagement■ Nancy Payne, Allina Hospitals &Clinics■ Janine Stiles, UnitedHealth Group-Ovations■ Kenneth Treash, Ernst & YoungMississippi■ Margaret Owens, Children’s MedicalGroup, P.A.Missouri■ Sherdena Ward, BJC HealthcareMontana■ Carla Prinkki, Beartooth Hosp. &Health CenterNebraska■ Sara Juster, Nebraska Methodist HealthSystemNevada■ Richard Muhlhauser, Profit Line■ Paul Singleton, WHSNew Jersey■ Patricia Barnett, CardioNet, Inc.■ Michael Coceano, Catholic Charities■ Catherine Gorman-Klug, MeridianHealth System■ Robert Thompson, Cape May CountyM.I.S. Dept.New York■ Deb Baxter, Upstate Medical University■ Erika Benesch, Hebrew Home forAged/Riverdale■ James Brown, VCP of NYC, Inc.■ Rosemary D’Allessandro, IMPATH,Inc.■ Robert Fazzolari, Fidelis Care New York■ Joan Gage, The Kingston Hospital■ Eileen Garcia, Cornell University■ Robert Gundersen, AHRC - New YorkCity■ Gail Holtz, Our Lady of Consolation■ Mark Kovler, Empire State Group■ Anthony Lyons, Catholic Health System■ Walter Metz, Brookhaven MemorialHospital■ Susan Meyers, Schofield Residence■ Zameena Rasheed, Montefiore MedicalCenter■ Alan Strobel, North American Partners■ W. Mark Watson, Deloitte & ToucheLLPNorth Carolina■ Russell Lawrence, Profes. Mngmnt.Health Consult■ Joan McCanless, Med Cath, Inc.■ Paula Parke, St. Joseph of the Pines■ Bagayan Sundaram, InfoASAP.com.Inc.Ohio■ Christine States, Physician Staffing, Inc.Oklahoma■ Lavona Ashing, Hillcrest HealthCareSystemsOregon■ Laura Frazier, Health Future, LLC■ Kevin Johnston, PeaceHealth■ Patricia Southard, Oregon Health &Science University■ Regina Tipton, The Oregon ClinicPennsylvania■ James DiStefano, Healthcare ServicesGroup, Inc.■ Allona Ditlow, Lutheran Social Services■ Jane Domaracki, Marian CommunityHospital■ Ronald Levine, Post & Schell■ Rich Lobb, Conemaugh Health System■ John May, III, Penn State M.S. HersheyMed. Center■ David Murdoch, Caron Foundation■ Margo Opsasnick, Delta Medix, PC■ Carm Presogna, Millcreek CommunityHospital■ David Progar, St. Mary’s Home of Erie■ Edwin Sanchez, HGS Administrators■ Pamela Watkins, Pocono MedicalCenterRhode Island■ Rae-Scott Skinner, Blue Cross/BlueShield of RI ■January 200319

SPECIAL SPECIALINTERESTGROUPLarge tation including academic medicalHealth systems, non-profit, and investorSystem owned systems. The committeeSpecial consults monthly by conferenceInterest Group Updatecall. SIG members are encouragedBy Michael C. Hemsleyto contact any member of the committeewith their ideas and recommendationsas to how the SIG canThe Large Health System SpecialInterest Group, formed earlier this address member needs and interestsyear, now consists of 37 members. in its program. In its organizingA Steering Committee of volunteer conference call, the SteeringSIG members has been organized Committee approved without modificationthe charter on the missionto further the goals of the SIG inthe development of programs of statement for the group which is orinterest.will be posted on the HCCA’s website.The Committee is comprised of:■ Glenna Jackson, Vice President,Compliance MedStar Health,Glenna.s.jackson@medstar.net■ Michael Holper, Vice President,Organizational Integrity & AuditServices, Trinity Health,holperm@trinity-health.org■ Andi Bosshart, RHIA, AVP,Corporate Compliance Officer,Community Health Systems,Inc., andi_bosshart@hq.chs.net■ Michael C. Hemsley, VicePresident, Corporate Complianceand Legal Services, CatholicHealth East, mhemsley@che.org■ Suzan W. New, Director,Corporate Compliance, BaylorHealth Care System,suzann@baylorhealth.edu■ Alan Yuspeh, Ethics &Compliance Officer, HCA, Inc.,President, HCCA, alan.yuspeh@hcahealthcare.comThe Committee is diverse in itsrepresentation both geographicallyas well as in its provider represen-January 200320The immediate focus of theSteering Committee is implementingthe goals of the charter focusingon networking, education, andcommunication; each designed toaddress the operational and organizationalchallenges confrontingCompliance Officers at a systemlevel.The committee has set its immediatefocus on two areas: first–theupcoming HCCA ComplianceInstitute in April 2003 and second–thepreparation of commentsfrom the system perspective to thedraft report of the HCCACompliance PerformanceMeasurement Initiative.It is anticipated that there will be aCompliance Institute Pre-Conference on Sunday, April 27,2003 with tracks for SpecialInterest Groups. The SteeringCommittee is in the process ofdeveloping topics of interest ofLARGE HEALTH SYSTEMgroup members to be proposed tothe Institute Planning Committee.The approach in such presentationswill be the sharing of system practices,identified issues, and sharedlearning.On November 1, 2002, the HCCAissued a draft document–Phase I ofthe Performance Measure Initiativeentitled, “Evaluating and Improvinga Compliance Program.” Thedraft has been solicited to HCCAmembers for comments throughDecember 14, 2002. The SteeringCommittee is soliciting commentsfrom group members to be compiledinto a consolidated responseon behalf of Large Health CareSystems generally. The documentcan be found on the MembersOnly section of the HCCA websiteat www.hcca-info.orgHealth system interest group membercomments may be forwardeddirectly to HCCA at 5780 LincolnDrive, Suite 120, Minneapolis, MN55436 or through the SteeringCommittee.It is anticipated that in 2003,members will be able to avail themselvesof audio conferences focusedon compliance issues at the systemlevel; and to articles of interest inCompliance Today to complimentthe Compliance Institute pre-conferencesession in April. Speakers,authors, and volunteers are alwayswelcome.■

FORIOMreport onhealth carequality; HHSrespondsOn October 30, the Institute ofMedicine issued a new report,“Leadership by Example: CoordinatingGovernment Roles in ImprovingHealth Care Quality.” The IOMreport says that stronger federal leadershipis needed to reduce medicalerrors and improve care. “In theabsence of strong federal leadershipto address safety and quality concerns,progress will be slow,” saidcommittee chair Gilbert Omenn,professor of internal medicine,human genetics, and public health,University of Michigan HealthSystem, Ann Arbor. The IOM report,requested by Congress, follows twomajor studies on the quality of healthcare in the U.S.–the first documentingthe devastating extent of medicalerrors–the second calling for anational effort to improve safety andquality.HHS respondsAn HHS press release noted that theIOM report “emphasizes the need forgreater consistency in measuring theperformance of health care providersacross programs, ensuring that standardsare valid and reliable, standardizingperformance measure, andreporting information to consumersin a way that will help them makebetter choices about their care.”“Since arriving at HHS, I have madeimproving quality and safety a highpriority issue for the Department,”YOUR INFOsaid HHS Secretary Tommy G.Thompson in a press release. HHSfurther noted the following examplesof how HHS is working to promotequality improvement:■ CMS’ Medicare QualityMeasurement Program■ NIH’s National Kidney diseaseEducation Program■ AHRQ’s National HealthcareQuality Report■ CDC’s National Healthcare SafetyNetworkFor more on the IOM Report:http://www.iom.eduHHS: http://www.hhs.gov/newsMedical center settles fraudchargesA South Carolina medical center hasagreed to pay the government closeto $16 million to resolve allegationsof health care fraud. According to aNovember 1, 2002, U.S. Departmentof Justice press release, McLeodRegional Medical Center of the PeeDee, Inc. will pay $15,909,470 andhas entered into a corporate integrityagreement with HHS Office ofInspector General. This was originallya whistleblower suit, however,whistleblower Richard Rauh, a formerMcLeod employee waived allrights to recover a share of the recoveryor to recoup any attorney feesunder the False Claims Act inexchange for the U.S. and McLeodreleasing him from civil liability forhis own role in the conduct.The government alleged that McLeodsubmitted false claims to Medicare,Medicaid, and TRICARE by billingfor hospital and home health servicesordered by some physicians withwhom McLeod had an improperfinancial relationship. In addition,the government alleged that whenMcLeod purchased certain physicianpractices it agreed to pay doctorsassociated with those practices purchaseprices and salaries that farexceeded the fair market value of thepractices and services. It also allegedthat McLeod entered into thesefinancial relationships to induce andmaintain referral relationships withthose physicians. For more:http://www.usdoj.gov/opa/pr/2002/November/02_civ_634.htmCIAs updatedThe OIG updated the list of CIAs onits Website–for this listing:http://oig.hhs.gov/fraud/cia/index.htmlPfizer, two subsidiaries to pay $49millionOn October 28, the U.S.Department of Justice announcedthat Pfizer Corporation and its subsidiaries,Warner-Lambert and Parke-Davis agreed to pay $49 million tosettle allegations that the companyviolated the False Claims Act. Thegovernment alleged that the defendantsfraudulently avoided payingfully the rebates owed to the stateand federal governments under thenational drug Medicaid Rebate programfor the cholesterol-loweringdrug Lipitor. For more:http://www.usdoj.gov/opa/pr/2002/October/02_civ_622.htm ■21

22Editor:Margaret R. Dragon, Director of Communications, HCCA, 781/593-4924,mrdragon@ziplink.netPublisher:Health Care Compliance Association, 888/580-8373Consulting Editors:Alan Yuspeh, President, HCCA, 615/344-1005Roy Snell, CEO, HCCA, roy.snell@hcca-info.orgDesign & Layout:Robin Taliesin, Raven Creative, 781/631-4639, robint@raven2.comAdvertising:Erin O’Donnell, HCCA, 888/580-8373, erin.odonnell@hcca-info.orgHCCA Officers and Board of Directors:Alan Yuspeh, JD, MBAHCCA PresidentSenior Vice PresidentEthics, Compliance and CorporateResponsibilityHCAAl W. Josephs, CHCHCCA 1st Vice PresidentCompliance OfficerHillcrest Healthcare SystemOdell GuytonHCCA 2nd Vice PresidentDirector for ComplianceMicrosoft CorporationAllison Maney, CPA, CHCHCCA TreasurerCompliance OfficerLovelace Health SystemDaniel RoachHCCA SecretaryVP and Corporate Compliance OfficerCatholic Healthcare WestSheryl Vacca, CHCHCCA Imme. Past PresidentDirector, West Coast Compliance Practice,Deloitte & ToucheShawn Y. DeGroot, CHCCompliance OfficerUpper Midwest Network & VA Medical& Regional Office CenterSuzie Draper, BSN, RNCorporate Compliance Officer and PrivacyOfficer, Intermountain Health CareCEO/Executive Director:Roy Snell, CHCHealth Care Compliance AssociationRory Jaffe, MD, MBAChief Compliance OfficerU.C. Davis Health SystemVickie McCormickSpecial CounselHalleland Lewis Nilan Sipkins & JohnsonF. Lisa MurthaChief Audit and Compliance OfficerChildren’s Hospital of PhiladelphiaSteven OrtquistChief Compliance OfficerBanner Health SystemTeresa L. Mullett ResselDeputy Assistant SecretaryU.S. TreasuryJohn SteinerChief Compliance OfficerThe Cleveland Clinic Health SystemDebbie Troklus, CHCAssistant Vice President for Complianceand PrivacyUniversity of Louisville, School ofMedicineL. Stephan Vincze, JD, LL.M, CHCEthics and Compliance OfficerTAP Pharmaceutical Products, Inc.Greg WarnerDirector for ComplianceMayo FoundationCounsel:Keith Halleland, Esq.Halleland Lewis Nilan Sipkins & JohnsonCompliance Today (CT) (ISSN 1523-8466) is published by the Health Care ComplianceAssociation (HCCA), 5780 Lincoln Drive, Suite 120, Minneapolis, MN 55436. Subscription rateis $287 a year for non-members. Periodicals postage-paid at Minneapolis, MN 55436. Postmaster:Send address changes to Compliance Today, 5780 Lincoln Drive, Suite 120, Minneapolis,MN 55436. Copyright 2002 the Health Care Compliance Association. All rights reserved. Printedin the USA. Except where specifically encouraged, no part of this publication may be reproduced,in any form or by any means without prior written consent of the HCCA. For subscription informationand advertising rates, call HCCA at 888/580-8373. Send press releases to M. Dragon, POBox 197, Nahant, MA 01908. Opinions expressed are not those of this publication or the HCCA.Mention of products and services does not constitute endorsement. Neither the HCCA nor CT isengaged in rendering legal or other professional services. If such assistance is needed, readers shouldconsult professional counsel or other professional advisors for specific legal or ethical questions.PEOPLEEditor’s note: If you have receiveda promotion, award, degree, oraccepted a new position please let CTknow. Call or fax Margaret Dragon at781/593-4924, or email mrdragon@ziplink.net, or you maymail your news to Margaret Dragon, HCCA, P.O. Box 197,Nahant, MA 01908.➤ Cynthia L. Paes, has joined the County of San Diego’sHealth and Human Services Agency in San Diego, CA.She may be reached at 619/515-4243➤ Lori S. Richardson Pelliccioni has been named ChiefCompliance Officer for DaVita, Inc. Da Vita providesdialysis services for patients suffering from chronic kidneyfailure. It owns and operates kidney dialysis centers andhome peritoneal dialysis programs domestically in 32 statesas well as Washington, DC. Prior to joining DaVita, Ms.Pelliccioni was a partner in the Health Care Practice atPricewaterhouseCoopers. Lori serves on HCCA’sCompliance Performance Measurement Initiative TaskForce. She may be reached in Torrance, CA at310/792-2600. ■ATTENTION HCCA MEMBERS:HCCA Performance Measurement InitiativeOn November 1, the Health Care Compliance Associationplaced the DRAFT document–Phase I of the PerformanceMeasurement Initiative on the Members Only Section ofthe HCCA Website. This document is for review andcomment by our stakeholders and selected interest parties.HCCA has asked its members for their comments relatedto the Draft document.The comment period is open for 45 days–from November1, 2002 to December 14, 2002. Please review this documentand send your comments by December 14, 2002 toHCCA, Attn: Erin O’Donnell, 5780 Lincoln Drive, Suite120, Minneapolis, MN 55436. All comments must bemailed and received at the HCCA office in Minneapolis,MN by 5 PM on December 14. ■