Meet Cynthia Boyd & Ryan Meade - Health Care Compliance ...

Volume EightNumber FiveMay 2006Published MonthlyMeet Dr. Cynthia Boyd and Ryan Meadeand Learn Details of the RushClinical Trials Billing SettlementDr. Cynthia BoydChief Compliance Officer andDirector of the Medical Staff OfficeRush University Medical CenterRyan MeadePartnerMeade & Roach, LLP

May 200614featureEditor’s note: F. Lisa Murtha of HuronConsulting conducted this interview withCynthia Boyd, MD and Ryan Meade inlate March 2006 about the Rush settlement,the lessons learned during theprocess, and about their projects onphysician Medicare education. RyanMeade may be reached by telephoneat 773/472-3975 or by e-mail atrmeade@meaderoach.com. Cynthia Boydmay be reached by telephone at 312/942-5496. F. Lisa Murtha may be reached bytelephone at 215/497-0713 or by e-mailat lmurtha@huronconsultinggroup.com.BackgroundIn December 2005, Rush University MedicalCenter entered into a landmark settlementwith the federal government related toMedicare and Medicaid overpayments forcancer clinical trial services. At the conclusionof the settlement, the U.S. Departmentof Health and Human Services Office ofInspector General (OIG) called the Rush settlementa “model resolution” to a complianceissue and took the unusual step of publiclycomplimenting Rush on its compliance program’sefforts to tackle clinical trials billingcompliance.Cynthia Boyd is the Chief ComplianceOfficer for Rush and director of the MedicalStaff Office at Rush. She guided Rush’sefforts to investigate and resolve its researchbilling compliance issues. Dr. Boyd is also anassistant professor of medicine at Rush. RyanMeade served as legal counsel for Rush duringRush’s internal investigation, voluntarydisclosure, and settlement process. He is aarticleF. Lisa Murtha interviews Cynthia Boyd, MD,MBA and Ryan Meade, JD, on the RushClinical Trials Billing Settlementpartner in the law firm of Meade & Roach,LLP and the consulting firm, Meade RoachConsulting, LLP. He is an assistant professorat Rush University and also teaches at LoyolaUniversity Chicago School of Law’s Institutefor Health Law & Policy.LM: What was unique about Rush’srecent settlement? Also, please tell us how itcame about.RM: To start with, this is the first settlementsolely associated with Medicare’sNational Coverage Decision (NCD) onClinical Trials which is a very misunderstoodbilling rule—not the least because it is filledwith so many ambiguities.CB: During the settlement process, Rushhad a number of meetings with the government,including meetings at the OIG inWashington, DC and with CMS inBaltimore. CMS clarified a number of issuesin the Clinical Trials NCD and I think thiswill help the industry better understand howto comply with the research billing rules.LM: What was the basic issue involved inthe Rush settlement and how did Rush discoverthe compliance issue?CB: The compliance issue that Rush discoveredinvolved an operations problem inincorporating clinical trials coverage informationinto the billing process.RM: Many providers who do researchHealth Care Compliance Association • 888-580-8373 • www.hcca-info.orghave had a difficult time developing complianceprocesses to meet the expectations ofthe Clinical Trials NCD. In order to billproperly under the Clinical Trials NCD,there needs to be coordination of theresearch study protocol’s schedule of events,the contract with the sponsor of the trial,and the financial disclosure of the study’sIRB-approved informed consent. At manyproviders, different departments are responsiblefor managing each of these documents.Rush has been very open that its billingerrors were because communication aboutthese study documents were not in sync andthere was a disconnect between the processesthat managed clinical trials and the processesthat billed for services.CB: When the suspected billing errorswere brought to the attention of theCompliance Office in the summer of 2003,we undertook an internal investigation. Tobe frank, we were working in a vacuum. Noone seemed to have gone through this publiclybefore; the billing rules were only a coupleof years old and there was there wasalmost no government commentary or guidanceto rely on. The Clinical Trials NCD issurely one of the most complicated billingrules Medicare has, even though it is only afew pages long. Though we did not know allthe details at first, what Rush initially discoveredwas that in its cancer division, coverageinformation about clinical trial services was

issues like this arise. We followed our protocolsand acted very quickly. Within 10 daysof discovering the problem, Rush placed abill hold on all cancer clinical trial services.This didn’t mean that patients stoppedreceiving services, just that Rush held thebills until they could be scrubbed to determinewhich services should be billed andwhich shouldn’t. Within 30 days of beginningthe investigation, Rush voluntarily disclosedthe compliance issue to the federalgovernment through our legal counsel.not being communicated to the billingprocess. We knew when we saw this that itcreated compliance exposure for Rush. Youcan’t bill for services during medical researchwithout making a concentrated effort to figureout what is or isn’t billable. At first theproblem looked like it was focused on billingMedicare for services that were also paid forby the sponsor. As the internal investigationpeeled back the onion, we realized this alsoinvolved not analyzing the clinical trial servicesto see which ones met the definition of“routine costs” under the NCD and it alsoinvolved promises in the informed consentto provide services free that were billed.There was never any indication that anyonebilled something purposefully wrong, butlots of indications of a process that had notevolved with Medicare’s rules.LM: What did Rush do when it discoveredthe billing problem?CB: Luckily, the Compliance Office hasdeveloped processes that we follow whenLM: Making the decision to voluntarilydisclose can be one of the toughest decisionsa provider has to make. There are usuallymany people who need to be convinced thatit is the right thing to do. Ryan, what didyou do to convince your client that a voluntarydisclosure was needed?RM: I didn’t have to do much! From thebeginning, Rush’s senior leadership was100% committed to getting to the bottomof this issue and to self-disclose the overpaymentsto the government. Rush had beenthrough the voluntary disclosure processbefore and had a favorable experience andthere was never any doubt that the matterwas going to be self-disclosed. The Rush settlementshows the importance of involvingleadership in compliance, particularly forclinical trials compliance. Research billingcompliance in a hospital setting is a verycomplex matter because it touches just aboutevery part of the hospital, from the registrationprocess to the hospital’s ancillary departmentssuch as pharmacy and the lab. Andimportantly, it touches on the prestige of thephysicians doing research. A lot of departmentsand people need to be pulled togetherfor a research billing compliance initiativeand without senior leadership support, Idon’t think it can be done. Rush is fortunateto have a Chief Operating Officer (CEO)who takes compliance very seriously. TheCEO, Dr. Larry Goodman, not only lent thesupport of his office to the internal investigation,but he personally chaired the twiceweeklycorrective action meetings. Dr.Goodman also went twice to the federal governmentwith us to help explain the issueand Rush’s resolution.LM: So what was the corrective actionRush implemented? Many providers whoconduct research are trying to figure out howto do this and it sounds like Rush came upwith a unique solution.CB: When you step back and look at thenew processes Rush put in place, it boilsdown to three things. First, Rush centralizedmanagement of clinical trials billing. Rushestablished a new office that is responsible foranalyzing all clinical trials for Medicare coverage.This office develops the billing tools thatare used throughout the institution to communicateinstructions to the people who areentering services into the charge capture system.Second, Rush mandated that all proposedclinical trials must be routed throughthe new central office and all clinical trialsmust receive a Medicare coverage analysis.This ensures consistency in approach andfacilitates the necessary communicationamong departments. Communicating whichservices are billable and which services are notbillable is essential for research billing compliance.And third, the Compliance Officedeveloped an auditing and monitoringprocess that audits both the accuracy of thecoverage analysis billing tools and the accuracyof how the billing tools are used.LM: This sounds like it was a lot ofwork. How did Rush get it all done andwhat have you learned in this process?CB: There’s no question it was-and still isalot of work to get into compliance with, andContinued on page 16Health Care Compliance Association • 888-580-8373 • www.hcca-info.org15May 2006

The Rush Clinical Trials Billing Settlement ...continued from page 15stay in compliance with the Clinical TrialsNCD. Working without models is always difficultand filled with stops and starts andthings that work and things that don’t work.The key was a commitment to comply and acommitment to think outside the box. Like alot of academic medical centers, Rush’sresearch operations were decentralized. Thisneeded changing. A lot of people from differentparts of the organization had to worktogether who had never worked togetherbefore. This was a good thing. The days whenhospital departments can function independentlyare over. There is too much informationthat needs coordinating in order to keep compliantand too much risk for a hospital to havepeople and departments doing their ownthing. In Rush’s corrective action, there neededto be standardization of an approach tobilling for clinical trial services.LM: During the course of the settlement,Rush took an unusual approach of assemblinggroups of representatives from Rush togive presentations to the OIG inWashington, DC and to CMS officials inBaltimore. How did this come about?RM: Well, I think it was only unusualbecause providers don’t take advantage of askingfor such meetings and presentations. Wefound the government very open to hear aboutthe complexities of how to live with theClinical Trials NCD. We also pressed for clarificationsfrom CMS on the ambiguities in theClinical Trials NCD. If Rush was going todevelop a corrective action and an auditingprocess, it needed answers on how to interpretsome very difficult parts of the NCD. Thesemeetings came about through continuous dialoguewith the government. The settlementprocess began normally enough. As counsel, Imet frequently with the local U.S. Attorney’sOffice in Chicago and provided regular updateson the internal investigation and overpaymentcalculation. After the basic overpaymentmethodology and figures were worked out, theOIG had to determine if they were going toask Rush to sign a corporate integrity agreement(CIA). We asked for a meeting with theOIG decision makers in Washington to give apresentation on all the work that Rush haddone along with the innovative solutions Rushhad come up with. Along with myself, sevenRush officials, including the CEO, the chief ofthe cancer division, and Dr. Boyd gave a twoand-a-halfhour presentation on Rush’s complianceprogram to make the argument that aCIA was not warranted because Rush’s complianceprogram was effective. Because OIG doesnot deal with policy interpretations of Medicarerules, we next pressed on for a meeting withCMS. Again, a group of Rush representativesand myself met with eight CMS officials anddiscussed the nuances of the Clinical TrialsNCD and asked for clarifications.LM: What were the results of these meetingswith the government?RM: The results were that Rush did notreceive a CIA, but rather entered into aCertification of Compliance Agreement withOIG, which is considerably better than a CIA.With a CCA, the provider needs to annuallycertify for three years that its compliance programremains effective. The provider alsomust file an annual report that chroniclesoverpayment refunds during the year. Theprovider can also do its auditing and monitoringinternally and needn’t retain anIndependent Review Organization. The resultof the CMS meeting was some much neededclarifications on the Clinical Trials NCD. Themeeting with CMS was refreshing because itput an end to a lot of head scratching aboutcertain parts of the billing rule. It didn’tresolve all of the ambiguities but it went along way to helping Rush roll-out its new centralizedapproach to clinical trials billing.LM: Dr. Boyd, what did you learn fromthese meetings with the government?CB: First and foremost, it put a humanface to the self-disclosure process. I would liketo think that our meetings benefited bothsides. Government officials need to understandthe difficulties in putting together operationalprocesses to comply with the words ofthe rules. But getting specific, I think the eyeopenerfor all of us at Rush was how muchCMS defers to the local Medicare contractor’smedical director for coverage decisions aboutindividual claims and even whether a researchstudy has sufficient therapeutic benefit tomeet the criteria for a “qualifying clinicaltrial.” CMS told us to get to know our localMedicare medical director because he ultimatelymakes the first-line decisions aboutwhether services are “reasonable and necessary”for this or that circumstance. We alsolearned that if you don’t ask for clarifications,you aren’t going to get them!LM: What were some of the clarificationsRush received about clinical trials billing?CB: There were several. One that hasreceived a lot of industry discussion is whatconstitutes a “qualifying clinical trial.” Only“routine costs” during “qualifying clinical trials”are eligible for Medicare coverage. TheClinical Trials NCD lists 10 criteria for aqualifying clinical trial but is filled with confusinglanguage about how these criteriainteract with each other. Many providersbelieve that because a research study is fundedby a government agency, such as NIH[National Institutes of Health], that thestudy is a qualifying clinical trial. This isn’ttrue. CMS clarified that just because a studyis funded by the government does not makeit a qualifying clinical trial. These types oftrials are “deemed” to automatically meetseven of the 10 criteria but they must alsohave three other independent requirements,most importantly the study must evidencethat the trial is designed with therapeuticMay 200616Health Care Compliance Association • 888-580-8373 • www.hcca-info.org

intent. Medicare isn’t going to pay for serviceswhich aren’t done to help a patient.RM: The therapeutic intent requirementis very important for providers who are doingPhase 1 drug trials or have their own investigator-initiatedtrials because if the study isdesigned just to test the safety or toxicity ofthe investigational item or service, or to simplystudy the disease or some biological phenomenon,then the study may not be a qualifyingclinical trial and then none of the servicesduring the trial are billable to Medicare.LM: The Clinical Trials NCD is certainlya difficult billing rule for providers to operationalize.Are their upsides to the ClinicalTrials NCD?CB: Yes, many. Most importantly, if astudy is properly analyzed for Medicare coveragebefore a provider has decided whetheror not to do the study or accept a sponsor’scompensation offer, the provider can determinewhether the study makes financial sensein the context of the provider’s goals fordoing medical research. Conducting a coverageanalysis can also give a provider importantdata in order to negotiate a better compensationarrangement with the sponsor.This is an instance when complying with theMedicare rules can actually help improveresearch management.LM: I understand that out of the experienceof the Rush settlement, both of youhave been doing quite a bit of education onclinical trials billing compliance as well asbasic Medicare education. And there is evena book and video involved in this, I hear?CB: What we identified during the Rushsettlement is that physicians need more educationon Medicare. As a physician myself, Inever received even one lecture on the structureof Medicare during my medical educationand residency. Once I began managingmy own practice, I was too busy taking careof patients to even know what I didn’t knowabout Medicare. It wasn’t until I becameRush’s Chief Compliance Officer that Ibegan to really learn about Medicare andappreciate the need for physicians to understandthe basics. It is ironic that physiciansknow so little about how Medicare is structuredconsidering that for most physicians,Medicare is their largest single source ofreimbursement. I think many physicians justgive up trying to understand Medicarebecause the language seems so confusing andthe rules are so voluminous. While physiciansshould stay focused on treating patientsand definitely should seek experts for administrativematters beyond their competence,they nevertheless should know some of thebasics of Medicare. A little knowledge can goa long way in mitigating a physician’s frustrations.For instance, many physicians takemedical necessity denials as a person affrontto their clinical competency—but physiciansneed to understand that when Medicaremakes medical necessity decisions, it is notmaking the decision like a clinician wouldmake it or even making the decision as apublic health program, rather claims processingdecisions are made by Medicare in theirrole as a third-party payor. Most physicianshave no idea that some things that Medicaredoes not pay for are determined by Congressand other things are determined by the localMedicare medical director.When I became Chief ComplianceOfficer, I realized that one of the things thatwas causing me confusion was that Medicareuses clinical terms-language I was used to asa physician-in ways not related to their clinicalorigin. I ended up taking Ryan’s lawschool course on Medicare in order to understandMedicare better. In fact, the book weare writing, “Explaining Medicare toPhysicians,” really came out of my takingRyan’s course and realizing that the languageof Medicare and the language of medicineare often in conflict. The book attempts togive physicians an overview of the basic languageand structure of Medicare. Recently,Ryan and I did a video for the Health CareCompliance Association called Bridging theGap between Medicare Compliance andMedicine. The video is designed for physicianoffices as an introduction to the basicsof Medicare. Steve Ortquist, the ChiefCompliance Officer for Tenet Healthcareinterviews us on some of the issues on whichwe focus in the book. Kim Brandt, theDirector of Program Integrity at CMS, alsoappears in the video giving insights from theCMS.LM: Ryan, from your perspective as a lawprofessor, what is your take on the need formore Medicare education in the health careindustry?RM: It amazes me that Medicare is thelargest body of federal law and the largestfederal program—bigger on its own than allmilitary spending—yet there is so littleknowledge about the basics of Medicare inthe health care industry. A lot of peopleknow a lot about the minutia of Medicarebut don’t know anything about the basicstructure. Local Coverage Determinations(LCDs) are a good example. Not manyproviders, even very sophisticated providers,know that LCDs exist or that providers canhave influence in their creation. For many,the big picture of Medicare remains a mystery-butthere is a logic to Medicare.LM: I understand Rush is taking thisneed for physician education to heart andsponsoring a local symposium for physicianson Medicare.CB: Yes, on May 22, Rush is sponsoring asymposium mainly geared to Chicago-areaphysicians to provide some basic background onclinical trial billing compliance and also providesContinued on page 32Health Care Compliance Association • 888-580-8373 • www.hcca-info.org17May 2006

Corporate ethics starts at the top ...continued from page 31Feature article ...continued from page 17should embrace the values and standardscontained in the code of conduct.Management should develop the code andtrain employees on complying with its standardsof conduct.When assessing honest and ethical behaviorin an organization, ask:■ Are employees required to obey the laws,regulations and policies to which theorganization is subjected?■ Are all verbal and written communicationstruthful and honest?■ Are patients and insurers properly chargedfor services?■ Are records prepared accurately and honestly?■ Are mistakes corrected in a timely manner?■ Are compliance violations reported togovernment agencies?■ Are conflicts of interest properly disclosed?■ Are transactions for personal gain or privatebenefit avoided?■ Are records maintained as required andnot prematurely destroyed or altered?■ Is confidential information properly protectedand not inappropriately disclosed?■ Are gifts and gratuities to induce referralsor business avoided?■ Are patients treated with honesty andrespect?■ Are employees encouraged to report complaintsor improprieties without fear ofretaliation?The top individuals in an organization setthe tone for its code of ethics. But theresponsibility to do the right thing belongsto the top, the bottom, and everyone inbetween. Corporate ethics are much morethan the paper on which they are written.They are the organization’s core values thatrepresent the expected honest and ethicalconduct of everyone concerned. ■them a chance to meet the local Medicaremedical director. I think the format could bereplicated in any region as long as the localMedicare medical director is willing to participate.LM: Any last thoughts or “lessonslearned” from the Rush settlement?CB: I’ll say two things to close. First, if Ihad to give one piece of advice to providerswho do research, I’d tell them to do an assessmentof their clinical trials billing practices. Aprovider needs to understand what it is doingright and what it is doing wrong and thendevelop a system to coordinate clinical trialcoverage information. Every clinical trialneeds a coverage analysis. There really isn’tany way out of that. If a provider is not doingcoverage analyses it may be sending in erroneousclaims-and the provider also probablydoes not have control of the financial realityof doing research. The second and last thing Iwill say is to offer encouragement.Compliance can be done. ■• SAVE THE DATES •PHYSICIAN PRACTICECOMPLIANCE CONFERENCEOctober 1–3, 2006Renaissance Parc 55 HotelSan Francisco, CAMay 200632Health Care Compliance Association • 888-580-8373 • www.hcca-info.org