Auditing Clinical Trial Billing: A Real-World Approach
3/13/2019Auditing Clinical Trial Billing:A Real-World ApproachHCCA Compliance InstituteApril, 2019Cynthie Lawson, Kelly Willenberg and Associates, LLCWendy Portier, Kelly Willenberg and Associates, LLC.2Disclaimer No legal advice is provided. Please seek legal representation to have your questions clarified or discussed.1
3/13/20193Objectives Conduct hands on review of clinical trials related claims and relate thereview to the clinical trial billing rules Understand how to apply the coverage analysis in a clinical trial billingaudit Review claims submitted on clinical trials that were denied andunderstand whyIdentifying essentials of researchbilling compliance assurance2
3/13/20195Clinical Trial Billing Compliance ‐Synchronous Work Flow is Key Vetting & Feasibility Analysis Coverage Analysis & Billing Plan Budgeting, Pricing & Contracting IRB Approval Enrollment & Informed ConsentCompliantBilling Identification, Registration, Scheduling &Tracking Authorization & Documentation forMedical Necessity Charge Capture Charge Segregation Claims Submission6Clinical trial revenue continuumFront End ProcessStartCoverageyAnalysisBudgetContractStudy AccountpSetupCoverage DocumentsConsentSite InitiationDrugs/Biologics vs. Devices vs. CEDCharge Captureand Bill HoldCoding, Billinggand Study AccountClose OutBack End Process3
3/13/20197What Does It Take to Get Clinical Trial BillingCompliance Right? A broad understanding of many fragmented, disconnectedprocesses and systems An appreciate of many events that take place before and afterbilling Correctly debiting a study account and billing a third party(insurance, patient, etc.) Four main reasons for incorrect billing:1. Technological error2. Human error3. Training4. AwarenessThe most basic basics!4
3/13/20199Clinical trial billing compliance:Primary rules*, 1“Clinical Trials Policy”: National Coverage Determination 310.1 Defines qualifying clinical trials and types of routine servicesInvestigational Device Guidelines Defines device and routine service billing requirements*Other laws, regulations, rules also are relevant but are largelycaptured by 310.1 and claims requirements10Clinical trial billing compliance:Primary rules*, 2Medicare claims processing rules Research‐specific and non‐research‐specific: all relevant rules to be met Federal payers follow Medicare; Medicaid may have specific alterationsFalse Claims Act protects federal taxpayers from overpayment for servicesprovided: Overpayments result from false claims made by federal service providers In health care billing, an overpayment occurs when a federal insurer pays for aclinical service that was not allowable Rules stipulate requirements for reporting and correcting overpayments*Other laws, regulations, rules also are relevant but are largely captured by310.1 and claims requirements5
3/13/201911NCD 310.1: What is a Qualifying Clinical Trial?12NCD 310.1: What are Routine Costs? “Items or services that are typically provided absent a clinical trial(e.g., conventional care);” “Items or services required solely for the provision of theinvestigational item or service (e.g., administration of a non‐covered chemotherapeutic agent), the clinically appropriatemonitoring of the effects of the item or service, or the preventionof complications; and” “Items or services needed for reasonable and necessary carearising from the provision of an investigational item or service‐‐inparticular, for the diagnosis or treatment of complications.”6
3/13/2019Research billing compliance assurance13Although there are many nuances, in a nutshell: Do not bill patient/insurance for services that are: Not medically necessary Otherwise not allowable / non‐covered services Promised by the sponsor (contract) / budget Promised by the consent form Apply the Medicare‐specified research modifications as applicable Follow all other (many) Medicare rules, for example: Medicare Advantage patients in qualifying non‐IDE studies routinecharges revert to Traditional Medicare National Coverage Determinations (NCDs) Medicare Administrative Contractor Local Coverage Determinations(LCDs) Non‐covered benefits14Areas to watch in research billing and finance Inadequate financial accounting Research subjects not identified Document non‐concordance: Protocol,Coverage Analysis, Budget, Contract, ICF Charge capture/billing for researchrelated services and routine costs, studydrugs and devices No monitoring of billing inquiries Poor budget process, lack of properaccounting and invoicing to Sponsors Claims lack proper research coding: dx,modifiers, CCs, and NCT # on claim Charge segregation occurring betweenresearch and payer or Medicare andMedicare Advantage Communication on denials managementnot thorough or lack of attention to detail7
3/13/201915Research billing audit goalsAlthough there are many nuances, and scope dependsupon specific institutional goals, in a nutshell: Identify system or human error in research billing Make repayments if overpayments are found, followingrequired timelines Identify underpayments and invoice as possible Correct process errors or gaps Educate users as applicable Conduct follow‐up review to assure sufficient remediation Document quality assurance diligenceCharge segregationexercise8
3/13/2019Common audit findings18Auditing clinical trial billing and finance:common findings, 1 Non‐employed physician group not notified of clinical trial / subject Under budgeting Lack of fund accounting Excessive residual balances and no residual funds policy Claims submission errors Misdirection of charges – double billing Denials For example: pre‐authorization, investigational article Coding errors and mismatches IDE, NCT numbers on claim no CC or Q‐modifiers IV administration with no study drug on claim No follow‐up on denials; write‐offs9
3/13/201919Auditing clinical trial billing and finance:common findings, 2 Charges not posted in billing systems; “Off the books” researchactivities Billing of professional (pro) and technical (tech) charges notcoordinated. For example, pro charge is billed: to insurance and tech charge is billed to sponsor/research to Medicare and tech charge is billing to MedicareAdvantage with clinical trial coding but the tech charge lacks coding Patient reimbursements held or not paidAudit scope and planning10
3/13/2019Areas to understand prior to audit testing21 Operations Charge segregation Registration Charge Capture Billing ComplianceManagement Investigations &Monitoring Training Financial Management Budgeting, Pricing,Contracting AccountsReceivable Professional Fees Personnel Roles &Responsibilities CommunicationWhat areas at your organizations do you understand fully?22Before audit can be planned, identifystandards1. Audits are designed to track and evaluate existing processes andtheir results2. In order to identify audit scope, need to have evaluated thepotential failure of existing process(es) to provide intended results:risk assessment of entire process3. In order to evaluate existing processes, need to compare tominimum necessary to achieve compliance assurance: regulations,other external requirements, and organizational policiesWhat does clinical research billing compliance assurance require?11
3/13/201923Three types of clinical trial billing audits1. Process / Internal Control2. Study Level (Document Concordance & Coverage Analysis Validation)3. Patient Level (Claims)Audit scope: preliminaries24Stakeholders and auditors, internal and external Depends upon the content scope Skill set to be parallel to content: e.g., denialsreview requires person with denials experience Do internal audit or compliance departments haveauthority? Is Office of General Counsel to be consulted? Decision to go external may be related to riskassessment results12
3/13/2019Audit scope: preliminaries25Time span Are you auditing a process improvement? Do you want to see before and after or just after? Are you performing it for cause and need a specific time point?Sample size Determining significant sample Unless reviewing a process only, number of studies? If conducting billing review, number of patients, number of claims?Interviewees and assistants Depends upon the content scope Will involve those according to assigned operational tasks Leadership channels to be consideredAudit scope: one or all of the following, 126Coverage analysis Is the coverage analysis concordant with study documents?(protocol, ICF, budget, contract, coverage analysis) Does the study qualify for billing? Do the justifications support billing the subject’s insurance? Were all costs included?Document concordance Are all study documents concordant? (protocol, ICF, budget,contract, coverage analysis) Do study documents contain clear language?13
3/13/2019Audit scope: one or all of the following, 227Subject identification Are the subjects identified “flagged” in the systems? Was the “flag” applied timely?Claims review Did the claim go to the appropriate payer? (Medicare,Medicare Advantage, Sponsor, Commercial Insurance, etc.) Does the claim contain correct coding? (Z00.6, Q1, Q0,CC30, IDE#, Rev Code 256/624, NCT#, etc.) Does the medical record documentation support medicalnecessity?Audit scope: one or all of the following, 328Payer selection Audit Medicare/Medicaid only or include commercialpayers? If commercials payers to be included, do you want A different sample size? A subset of them?Invoicing Did invoicing occur? Was invoicing timely? Was the proper amount billed? Was overhead included?14
3/13/2019Audit scope: one or all of the following, 429Denials Are research related denials identified? What causes research related denials? Who manages research denials?30Summary: how to audit a clinical trial, 1 Take the standard steps: Risk assessment Objectives: what are we trying to achieve? Scope: what and who are to be included in the audit? Approval(s) required: Identify necessary authorities, advisors,stakeholders Create an audit plan What is the objective of each step? Does the step tie to the overall audit objective?15
3/13/201931Summary: how to audit a clinical trial, 2 Conduct sample selection Request and review documents Study Level – protocol / study documents, ICF, CTA, budget, CA,IND/IDE Patient Level – UBs/1500s, EOBs, study accounts, subject calendars,EMR Perform interviews and testing Documentation Work papers Data collection Write a reportDocument ConcordanceAuditing16
3/13/201933Term alert: document concordanceWe use “document concordance” to refer to a keyand complex practical requirement in research billing: theconsistency and accuracy of all study‐initiation andcontinuation documents relevant to billing for protocol‐specified clinical servicesWithout concordance,accurate billing is impossible( – or accidental)34Example: document concordance andcontent reviewCompare key documents ContractBudgets (Internal and External)Informed Consent Form (ICF)Coverage AnalysisProtocolAre there any discrepancies between the documents?Were there any discrepancies on the Coverage Analysis?Did the budget contain invoiceable items?Were there any additional regulatory issues identified? Did the contract or ICF contain language the violate the Medicare Secondary PayerRule? Did the ICF contract Medicare Advantage language for drug trials?17
3/13/2019Sample checklistIRB #: 12-00000Study Name: XYZ StudyPI Name: MDConsistency Checklist Date:IssueAgreement /Budget DateA. ConfidentialityDescribe how data or information will be shared between INSTITUTION, or sites and the research sponsor.ICF Version/Date:N/AYESProtocolYESB. Benefits of Taking Part in the StudyDescribe benefits of participating for the subject and/or others in the context of therapeutic intent.XXXXXXYESN/AXXXN/AD. Additional CostsSubjects will be required to bear additional costs beyond those associated with their conventional care as aresult of participating in the study.N/AN/AXXXE. Subject CompensationSubjects will be compensated for agreeing to participate in the trial.N/AN/AN/AXXXF. Research Related InjuryIdentify the individual or entity responsible for the costs of any research-related injuries to subjects.N/AN/AN/AXXXG. Future Use Of DataAre subjects asked or expected to donate data, materials, samples etc. to databases or tissue repositoriesand if the sponsor receive any future rights to the data or materials collected in the course of the study?N/AYESYESXXXC. Research vs. Conventional CareThe procedures that will be performed during the course of the trial that are considered to be part of thesubjects’ conventional care and that would be performed anyway notwithstanding the research study aredifferentiated from the procedures that will be performed during the course of the study that are forresearch purposes only.36ReviewerN/A35H. Study is registered at clinicaltrials.gov and statement is in the ICF(Input Registration Number)XXXI. Medicare Advantage statement included in the ICFXXXBilling grid/sponsor budget reviewExerciseWhat’s missing/incorrect?S Sponsor PaidM Medicare/ 3rd Party PayerGreen billing grid; Blue sponsor budgetProcedure/EventMRI BRAIN STEM W/O& W/DYECBCChemo AdminChemo Study DrugProcedure/EventMRI BRAIN STEM W/O& W/DYECBCVenipunctureChemo AdminChemo Study DrugCPT/HCPCS CodesBilling Designation70553S85025, 8502796413SSJ9999SCPT/HCPCS CodesAmount Paid7055385025, 850273641596413J99991131279429018
3/13/2019Insurance claims review &exercisesSummary: Medicare requirements – drug trials38Claim TypeTechnicalUB-04(CMS1450)Coding Requirements-ProfessionalCMS1500--Location on ClaimZ00.6 – Secondary DiagnosisModifier Q0 & Q1 as needed(Outpatient Only)- Q0 – Investigational ClinicalService (Drug)- Q1 – Routine CostsCondition Code 30 “Qualifying ClinicalTrial”Rev Code 256 – Drug TrialNCT # (www.clinicaltrials.gov)-Field 66Field 44-Field 18 - 28Field 42Field 39; D4 & Value Code 8 digit NCT#Z00.6 – Secondary DiagnosisModifier Q0 & Q1 as needed- Q0 – Investigational ClinicalService- Q1 – Routine CostsNCT # (www.clinicaltrials.gov)-Field 21Field 24.D – Modifier-Field 19 (Use CT pre-fix on paper claimonly)19
3/13/201939Summary: Medicare requirements – device trialsClaim TypeTechnicalUB-04(CMS1450)Coding RequirementsLocation on Claim-Z00.6 – Secondary DiagnosisModifier Q0 & Q1 (Outpatient Only)Q0 – Investigational Clinical Service (Procedure)Q1 – Routine CostsCondition Code 30 “Qualifying Clinical Trial”Condition Code 53 – Free Devices (Outpatient only)NCT # (www.clinicaltrials.gov)Value Code FD (Free Device as part of a trial, Outpatient Only)Rev Code 0624 – Device TrialDevice charge – list as non-covered (token) charge if deviceis provided at no costRev Code 278 – Medical/Surgical Supplies: Other ImplantsIDE NumberCategory B IDE device HCPCS code, as applicableGenerally, Category A not reported on institutional claim. FollowMedicare’s specific instructions for the trial-Field 66Field 44-Field 18 - 28Field 18 - 28Field 39; D4 & Value Code 8 digitNCT#Field 39; Credit amount for deviceField 42Field 47 & 48-Field 42Field 43Field 44-Field 21Field 24.D – Modifier-Z00.6 – Secondary DiagnosisModifier Q0 & Q1 as neededQ0 – Investigational Clinical Service (Procedure)Q1 – Routine CostsNCT # (www.clinicaltrials.gov)--IDE Number-Field 19; Use CT pre-fix on paperclaim onlyField 23-ProfessionalCMS150040Medicare Q&A 2014Mandatory Reporting of NCT# Identifier on Medicare -Clinical-TrialIdentifier-Number-QsAs.pdf20
3/13/2019Billing grid/claim Exercise41What’s missing/incorrect?S Sponsor PaidM Medicare/ 3rd Party PayerGreen billing grid; Blue Facility ClaimProcedure/EventMRI BRAIN STEM W/O &W/DYECPT/HCPCS CodesBilling Designation70553SVenipunctureCBC3641585025, 85027SSChemo Admin96413SChemo Study DrugJ9999SCPT/HCPCS CodesAmount Paid7055385025, I BRAIN STEM W/O &W/DYECBCPort DrawChemo AdminChemo Study DrugClaims review exercisedrug study21
3/13/2019Denials review exerciseInvoicing review22
3/13/2019Example: invoiceable items45Review contracts, budgets, coverage analysis for invoiceable itemsIdentify activities that are invoiceable Conduct a process audit Conduct internal control testing For example: External vendor invoices – PEAR* groups Items/services performed for specific cases Was overhead included?* Pathology, Emergency, Anesthesia, RadiologyData collection & error rates23
3/13/201947Data collection during a claims review auditGeneralDocumentation requirements Subject identifier Payer Type – Primary, Secondaryand TertiaryAmount billed and amount paid Visit #, DOSOverpayments / Underpayments Calculate overpaymentsClaim Information Claim type Encounter Number Calculate underpayments Calculate error rates Claim Number Item / Service Description CPT/HCPCS Codes Coding: NCT#, Modifiers, Dxcode, IDE#, CC 30 , CC5348CMS error rate data – A/B MACsImproper Payment Rate Scores/Rankings: 10.0% - 3.9% (Oh Yeah!) 24.0% - 7.9% (Getting Better) 38.0% - 11.9% (Tighten Up) 4 12.0% - 15.9% (Processes?) 5 16.0% and above (Uh-OH!)Source: ibutionData.html24
3/13/2019Error rate calculations ‐ examples49Payment Error Rate Total dollars paid in error / total dollars paid EX: 195,000 / 500,000 39% payment error rateClaim Error Rate Total # of claims billed to the incorrect payer / Total # of claims reviewed EX: 90 / 500 18% claim error rateLine Item Error Rate Total # of line items billed to incorrect payer / Total # of line items reviewed EX: 975 / 5000 20% line item error rateCoding Error Rate Total # of claims billed to correct payer, incorrect coding / Total # of claimsreviewed. Coding errors count as 1 error per claim. EX: 200 / 500 40% coding error rateWrapping up25
3/13/201951Not to be a broken record, but Audit planning effort cannot be underestimated! Scope and objectives follows responsible risk assessment Thorough knowledge of billing regulations and rules, as well asinstitutional policies, is crucial Matching audit to auditors and interviewees is key to planning Did we mention that audit planning is really important?52Contact usWendy Portier, MSN, RN, CHRC, CHC, CCMConsultantKelly Willenberg and Associates, e Lawson, BSM, CPC, CHRCConsultantKelly Willenberg and Associates, LLCcynthie@kellywillenberg.com208‐321‐463826
Conduct hands on review of clinical trials related claims and relate the review to the clinical trial billing rules . audit Review claims submitted on clinical trials that were denied and understand why 3 . “Clinical Trials Policy
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5. The batch will close and so will the OPIE Billing application. 6. To return to OPIE Billing, create a new batch. Get Started in Billing - Set up Global Settings in Billing Admin Rights in OPIE are required to access Billing Settings. 1. Log into OPIE Billing, go to the top left part of the Window to the menus: File, Windows, Help and click .
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