Transcription
Clinical Trials Billing FundamentalsTerry StoneResearch Billing Compliance ManagerBWPO/BWH Billing Compliance OfficeREV: 2014Q4TS
Objectives1. To provide a common understanding of clinical trials2. To give details of key billing concepts3. To explain patient care charges4. To supply the elements of trial budget development5. To clarify what it means to be a ‘qualifying’ clinical trial6. To describe overview of future state – Partners eCareand Epic functionality for researchPrimary Focus: Corporate sponsored clinical trials2
Why getting Research billing ‘right’ is important Medicare ‘double billing’ has been a focus and the subject ofnumerous OIG/DOJ investigations/settlements The 2009 OIG Work plan included Clinical Trial Billing in it’s topcompliance initiatives Not managing clinical research billing risks may lead to: Billing for services already paid for by the sponsor Billing for services promised free in the informed consent Billing for services that are for research only that are notallowable to bill under the CMS Clinical Trial Policy (CTP)3
What is a clinical trial?‘Although there are many definitions of clinical trials, they are generallyconsidered to be biomedical or health-related research studies inhuman beings that follow a pre-defined protocol. Interventionalstudies are those in which the research subjects are assigned by theinvestigator to a treatment or other intervention, and their outcomes aremeasured. Observational studies are those in which individuals areobserved and their outcomes are measured by the o/understand#types4
The trial SuppliesUsualCare(SOC)TestsProtocol(the sThe Goal - Sort through all components, figure out what’s billable toinsurance, determine a budget, then ensure that charges/cost getto the right place (insurance or study fund).5
Patient care and charges within the trialEvery clinical service provided to a patient/subject has apatient care charge: Each must be accounted for by billing to insurance orby charging to the study fund These charges are defined in the institution’s ratebook or charge master Most services have a hospital (technical) componentand a physician (professional) componentSometimes referred to as ‘patient care costs’ with regard toresearch, since ‘charging’ the study fund becomes an‘expense’.6
Preparation for budget development:Each PI should carefully review the protocol and define forthe patient population to be treated in the clinical trial: what is ‘usual and customary care’ ? what are ‘research specific’ services ?This will support and inform the MCA and budget work.7
Technical vs. Professional chargesFor clinical services provided in a hospital there aretypically two bills/claims for each service: The hospital ‘technical’ or facility component The physician ‘professional’ component8
More on charges For industry sponsored clinical trials:The budget incorporates both technical andprofessional charges.For federal sponsored clinical trials:Professional charges cannot be charged to astudy fund where investigator has effortassigned, but technical charges should becaptured appropriately.9
What is a Medicare Coverage Analysis? A study-specific billing summary that lists all items andservices to be provided as part of a qualifying clinicaltrial with notations of what should be billed to theresearch sponsor and what can be billed to Medicare. A Partners requirement since January, 2008 (BWH,Faulkner, Spaulding, and MGH). Required by the IRB before protocol activation will becompleted. Required for both industry sponsored andfederal/foundation sponsored qualifying clinical trials.10
Why an MCA is important Informs the PI / study staff of how to direct the patientcare charges.Becomes a tool for research billing compliance.Helps to avoid the risks of non-compliance.- Billing for services paid for by the sponsor fraud- Billing for services promised free in the informedconsent fraud- Billing for services that are specific to the researchprotocol, but not medically necessary fraud 11
Medicare requirement for patient care billingThe Centers for Medicare and Medicaid Services(CMS) Clinical Trial Policy (CTP) says that the studymust meet these criteria in order to bill Medicare forpatient care services related to a clinical trial:1. The study must meet the ‘qualifying’ requirement2. The services must meet the definition of ‘routine cost’3. Medicare must typically pay for those services whenprovided outside of the context of the clinical trial12
Sample Draft MCA2wksProcedureScreeningInf ormed consentNBThis service is research only and not billable toMedicare.Inclusion / ExclusionNBThis service is research only and not billable toMedicare.Vitalsn/aThis service is bundled with the physical exam andnot separately billable.Randomization3 mo6 mo9 mo12 mo15 moCommentsNBThis service is research only and not billable toMedicare.MGiven the patient's condition, a physicalexamination appears reasonable and necessary atwork-up to address signs and symptoms. A physicalexamination in follow-up and during unscheduledvisits appears appropriate to monitor and detect forcomplications related to the investigational item.Physical examMPregnancy testNBThis is not a covered service.MTTEMMMMMMMMWe assume that given the patient's presentingsymptoms and procedure performed that atransthoracic echocardiogram is reasonable andnecessary at this frequency to initially diagnose andthen monitor patient's condition. Coveragesupported by Massachusetts Medicare Part A LCDL441.Study drugICFICFICFICFICFICFStudy drug promised free of charge in informedconsent.Study drugadministrationMMMMMMIV administration of the investigational drug is acovered service under NCD 310.1.Adverse eventsFFFFFFThis involves filling out a form and this activity is notseparately billable to Medicare.Concomitant medsFFFFFFFThis involves filling out a form and this activity is notseparately billable to Medicare.SF 36NBNBNBNBNBNBNBThis service is research only and not billable toMedicare.13
Sample Final MCA – with PI inputProcedureScreeningInf ormed consentNBThis service is research only and not billable toMedicare.Inclusion / ExclusionNBThis service is research only and not billable toMedicare.Vitalsn/aThis service is bundled with the physical exam andnot separately billable.Randomization2 wks3 mo6 mo9 mo12 mo15 moCommentsNBThis service is research only and not billable toMedicare.MGiven the patient's condition, a physicalexamination appears reasonable and necessary atwork-up to address signs and symptoms. Aphysical examination in follow-up and duringunscheduled visits appears appropriate to monitorand detect for complicationsPhysical examMPregnancy testNBThis is not a covered service.MTTEMMMNBMMMNBWe assume that given the patient's presentingsymptoms and procedure performed that atransthoracic echocardiogram is reasonable andnecessary at this frequency to initially diagnose andthen monitor patient's condition. Coveragesupported by Massachuset PI has indicated 3 and15 mo are not usual and customary care at BWH.Study drugICFICFICFICFICFICFStudy drug promised free of charge in informedconsent.Study drugadministrationMMMMMMIV administration of the investigational drug is acovered service under NCD 310.1.Adverse eventsFFFFFFThis involves filling out a form and this activity is notseparately billable to Medicare.Concomitant medsFFFFFFFThis involves filling out a form and this activity is notseparately billable to Medicare.SF 36NBNBNBNBNBNBNBThis service is research only and not billable toMedicare.14
Charges/costs not allowable to bill to Medicare: Paid for by the research sponsor (double billing) Promised free in the informed consent Not ordinarily covered by Medicare Solely to determine trial eligibility or for datacollection/analysis15
What an MCA is not Not a reimbursement analysis Not quantitative (does not detail actual billing codes) Not a definition of coverage by private payers16
Non-qualifying trialsIf the clinical trial is determined to be non-qualifying underMedicare’s CTP – then: typically the study does not meet therequirement for therapeutic intent and/or is primarilyobservational in nature. A billing grid is not required to be created by PCRO. The IRB is informed that the MCA requirement for this studyhas been completed. Research-only procedures associated with the study maynot be billed to Medicare. Usual and customary care items or services provided aroundand during the trial may be billed to Medicare in the usualmanner.You should have a research service grid, in order to guidecharge processing.17
The clinical trial budget Comprised of administrative activities and clinical services as defined bythe protocol.Administrative activities (to be supported by the sponsor): Informed consentAssessing eligibility criteriaCapturing data required by the protocolPerforming Partners IRB requirementsTypically ‘priced’ for budget purposes based on timeestimates for salary and fringeClinical services/procedures (may be billable to third party payer orsupported by sponsor): Labs Radiology services Other tests/procedures/surgery/bed charges18
Draft Budget (typical industry)Procedure2 weeksScreeningInf ormed consent1001005050Inclusion / ExclusionVitalsincluded in physexam050RandomizationPhysical examUsual andcustomarycareUsual andcustomary care50Usual andcustomarycareUsual andcustomarycareUsual andcustomarycareUsual andcustomarycareUsual andcustomarycare65Pregnancy testTTETotal15 mo12 mo9 mo6 mo3 mo065Usual andcustomary care750Usual andcustomarycare7801,530Study dy drug administrationMMMMMM0Adverse events505050505050300Concomitant meds50505050505050350SF 3640404040404040280Patient parking25252525252525175Coordinator - crf completion, scheduling, administrativemgmt150125125125125125150925PI - crf signoff, study oversight, clinical mgmt ofpatients study 904404404401,2704,925Overhead @ 05501,5886,15619
Patient care charges flow in a clinical trialPer contracttermsSubmitinvoice toSponsorReceivepayment fromSponsorPatient CareCharges (Costs)SponsorPaymentsStudyFundResearch - clinical services: Outside of usual care/ ‘standard ofcare’ practiceResearch – administrative activities Informed consent Validating eligibility criteria CRF data entry Tracking visits20Medicare/InsuranceRoutine - clinical services: Usual / conventional care Administration of investigationalitem/service (per MCA) Detection, prevention andtreatment of complications(related to the investigationalitem/service)
To budget patient care effectively Understand the protocol Identify all the services in the protocol Determine what is usual care vs. a service required onlyfor the protocol Identify ‘where’ (physical location) services are beingprovided Price all clinical services using the CPT codes (ratebook, Budget Builder) Apply the institutional research discountsKeep in mind - some services are combinations of CPTcodes (‘bundled’)21
Charging to the study fund All patient care services provided specific to theresearch study protocol that will be charged to thestudy fund must be identified or ordered via the use ofan F number (Financial Medical Record Number). This number ‘defines’ the charge as research andprovides a means to direct the charge to the SpecialAccounting Department, where the research fund isexpensed. An F number needs to be in place before any patientcare services are ordered for a research subject.22
F number setup processIndustry sponsored clinical trial agreement – PCROFederal/foundation sponsored clinical trial agreement – RM The Post Award Grant Administrator within the Grants & ContractsDepartment in Research Management will initiate the F number setupprocess through Special Accounts. This will only occur if the IRBapproval for the protocol is in place. Once the F number has been assigned, Special Accounts will notifyyou and the Principal Investigator via email. After the account is set-up you will receive an embossed orange Fnumber card. This card should be in the possession of the Study Coordinator orPrincipal Investigator only, and never given to the research subject.23
Directing charges correctlyWhen ordering or scheduling services it must be clearwhich services will be billed to insurance and whichservices will be charged to the study fund.You should use the services grid or MCA as yourguide. If there is no MCA, meaning the trial is nonqualifying, then all research clinical services/chargesshould be directed to the study fund.24
Ordering research services to charge to thestudy fund: Paper requisitions should include the F number for theservices to be directed to the study fund Service Order Systems (i.e. Percipio) must includePI/Protocol/MRN/F number in the designated fields (perinstruction document)25
ReviewBilling to Medicare/3rd party payers If your trial is qualifying, PCRO will complete a Medicare coverageanalysis If your trial is non-qualifying, you should have a documented studyservices grid to assist with directing charges Services billed to insurance still require documentation for medicalnecessity Services not billed to insurance - to be charged to the study fund arerouted to the study fund by ‘tagging’ them with an F number26
Research Core Services have been created and areorganized to provide services to researchers, which help tofacilitate research activity. Review your protocol services requirements, then evaluate if a coreservice may be a more efficient delivery manner. Services have associated ‘user’ fees. Fees are invoiced to investigators monthly, then cross-charged tostudy spwww.bwhbri.partners.orgQuick Links: How do I Find a Core Facility?27
Documentation – Qualifying Clinical TrialsCMS requirements for billing to Medicare: ICD-9-CM Diagnosis Code V70.7 NCT number (added during claims creation)Indicates participation in a qualifying clinical trial.The V70.7 should always be a secondary diagnosisnoted on the subject’s encounters.28
Documentation – Qualifying Clinical TrialsCMS requires modifiers on outpatient claims forqualifying clinical trials. If outpatient claims have theV70.7, Finance will be identifying, in order to assign theappropriate modifiers.Q0 Modifier – A CMS outpatient modifier created toidentify trial related investigational items (devices anddrugs) and their administration in a qualifying trial.Q1 Modifier – A CMS outpatient modifier created toidentify routine trial related services in a qualifying trial.29
Documentation – Qualifying Clinical TrialsInpatient and Outpatient Documentation in LMR:When a research service is provided during orwith a ‘usual care’ stay or visit, an authenticatedphysician’s note is required which documents:“Patient participating in a qualifying clinicaltrial.”This will support the addition of the NCT#.30
IRB/QI ToolsResponsibility Log Include tasks specific to management/oversight ofresearch billingSubject Enrollment Log Include details of subject Page.htm31
Subject Enrollment LogEnhanced for Visit TrackingPrincipal InvestigatorPHRC Protocol #:Study Title:IRB-Approved Enrollment Target:Visit TrackingNSubjectIDMRNPer PHRC policy, a subject is considered enrolled once s/he signs the written informedconsent form, OR (with IRB approval) provides verbal or implied consent by completing aquestionnaire or participating in a focus group.EnrollmentTreatmentFollow upVisit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 Visit 8 Visit 9 Visit 10 Visit 11 Visit 1212345678910111213141532
Review and Reconciliation of the Study FundAlthough current systems impose some challenges, it isessential to monitor and reconcile the study fund on aregular basis. This is covered in the study coordinatororientation and training. Track services ordered specific to research Review statements from Finance and Insight fundstatementsThe fiscal ‘health’ of the study fund is the PI’s responsibility.33
Clinical Trial Process Flow / Life CycleEpicfunctionalitySTART Implementation RecruitmentIdentifyIdentifyresearchresearch Enrollment studyProvisionsubjectof services Initiation Idea/sponsordiscussion Contracting ExecutionPreAwardEND Study Close Scientific archclinicalservice(s)confirm compare topatient protocol/studyrelation- confirm chargedirectionship billing FinancialvalidationbillingManagementprocess bill toinsurance or Charging Expenses Sponsor Billingfund report to Collectionchargeinvestigatorreconcilia-tion review fundexpenses
Background of Research FunctionalityResearchModel Research Study Record Research Enrollment Record Manage Study RecruitmentCadence &PreludeHospital Billing &Professional BillingEpicCare Ambulatory,EpicCare Inpatient &Analytics Registries35 Appointment Scheduling Admission Scheduling Research Billing Calendars Charge Routing & Review Ambulatory andInpatient Documentation andOrdering Patient Identification forStudies
Epic Research Workflow36
SummaryImprovementsSupports recruitment Includes linking patient/subject clinical services to study Allows for identification of research study, research subjectand research clinical services (from clinical order entry orfinancial charge entry) Allows ability to compare to protocol and validate charges Allows for reporting to investigators and charge/fundreconciliation Supports billing compliance 37
Charge Questions/DiscrepanciesIf you experience any discrepancies in your research funddue to improper assignment of patient care charges, or ifyour research subject’s insurance carrier has been chargedfor services covered under the study protocol, pleasecontact us and we will provide instruction and/or assistancein how you should request the correction:Deborah A. Goodman, BWH Revenue Operations/PatientBusiness Systems, 617-732-5360dagoodman@partners.orgTerry Stone, BWPO/BWH Billing Compliance, 617-582-0091tstone@partners.org38
Questions/Issues:Terry StoneResearch Billing Compliance ManagerBWH/BWPO Billing Compliance OfficeCrosstown Center801 Massachusetts Avenue, Suite 610Boston, MA 02118Ph: 617-582-0091 / Fax: 617-582-009539
For industry sponsored clinical trials: The budget incorporates both technical and professional charges. For federal sponsored clinical trials: Professional charges cannot be charged to a study fund where investigator has effort assigned, but technical charges should be captured appropriately. 9
