Presentation on theme: "Budgeting for Clinical Trials"— Presentation transcript:
1 Budgeting for Clinical Trials Carolyn Strickland, RN, BSN, CCRCResearch Billing Services ConsultantOffice of Contracts ManagementMy BiosketchBasic overview of budget negotiationInformal, Interactive, ask questionsReview budget development, review examplesAvailable after session for off topic questions
2 Objectives Review basics of a clinical trial budget Review “PriceChecker” on StarbriteProvide tips on the most common mistakes we see in OCMJust review don’t discuss
3 Lack of knowledge re use of CRC space & fees Most Common Budget Mistakes With Budgets for Industry-Initiated ProjectsMissing IDS feesMissing IRB feesLack of knowledge re use of CRC space & feesAccounting for full staff effortVUMC indirect costsStart-up FeeReimbursement for protocol proceduresAnnual cost increase for budget itemsArchive fees
4 Purpose of a Budget Understand the cost Identify who will pay for what Documentation of costInformed decisionHow much will the study cost?Who will pay for each procedure and staff effort? Insurance, the sponsor,Good documentation assists with negotiation and decreases delaysShould you open this trial?
5 Getting Started Carefully review protocol Input from investigator, coordinator, sponsorKnow institutional requirements- finance, compliancePrice quotesFeasible?Staff- Need additional staff? Training?Reasonable? Will patients with memory loss have to complete a daily electronic diary entry? Are blood draws daily over several hours for many days? Is the pt NPO for an extended period? Is the data due within 24 hrs of visit?Compatible? Conflict with other studies- compete? Is it in line with work department is already doing? Some dept have a committee to review research studiesDo you see these pts in your clinic? Competitive enrollmentGet price quotes and estimate cost of staffDept of Hospital Finance Billing Compliance - researchratesrus
6 Developing Budget List study events and staff time Identify hidden costsAccount for institutional indirect-industry sponsored 29%Identify standard of care (Routine Care) and research costsEvents should mimic x-pageReconcile x-page with protocol, lab manual, CRFs
7 Routine CarePrinciple investigator and coordinator must carefully identify usual and customary care procedures vs. research specific proceduresUsual and customary care procedures would probably be performed if the patient were not on the studyRoutine care tests and results may be used for researchUsual and customary or SOC is unique to the institution.Ask the question- would I perform this procedure/service if the subject were not on a study? Is it reimbursable?Physician must assist and agree- physician word most important during an audit or court case.Medicare- is trial eligible? Is item eligible? LMRP site- Star panel- “Inf resources” CPT & ICD-9 check compliance-Third party payor
8 Research CostsResearch specific procedures would probably not be performed if the patient were not on a studyCan not bill insurance for any item that is reimbursed by sponsor
9 Schedule of Events example ScreeningDayInitiationDay 1+/-3DaysMO123456+/-3Days or ET*Unsched.visitVisit 1Visit 2Visit 3Visit 4Visit 5Visit 6Visit 7Visit 8XXXX-STUDYAssessmentsClinical Exam√Prednisone use HXMMMMTQMGMG-ADLSF-36IgAIgGAchRPregnancy testBUNCreatininePT/PTTCBC/DiffLFTExaminaton of XXXX site√ (Teach)√ (Refresher Course)AECon MedsSTUDY VISIT FLOW CHART*ET=Early Termination
10 Start-up Costs Protocol review Staff training Budget preparation Site selection/initiation visitInvestigator meetingsDevelopment of study toolsAdministration (budget)RegulatoryAlso known as the site initiation costs/fee- incurred before the first patient is enrolledTools- data collection and patient educationStaff time for meetingsFile set up and internal paperwork
11 Start-up Costs Nonrefundable Up front Average start-up fee $10,000 National Conference range- $5,000- $15,000Local fee standard $7500
12 Fixed CostsIRB fees- Institutional charge for IRB review, amendments, annual reviewArchive feesPharmacy review; set-up fee, annual fee, close-out feeExternal audit feeRadiology set-up feeLab set-upClose out activitiesPass through feesLine itemDon’t forget to add 29% indirectMay be a one time fee
14 Study Subject CostsAssessments- medical history, physical exam, adverse eventsMedical procedures- radiology, cardiologyProfessional feesOffice visits/facility feesLab workMedical and/or lab suppliesHospital bedVICTR/Clinical Research CenterScreen FailuresResearch discountsMany procedures have professional fees- EKG, CXR, Cat scan
15 Administrative Costs Office supplies Telephone or fax charges Pager VoicComputerPostage/ShippingDepartment overhead not covered in the 29% indirectGet Sponsor billing number for shipping
16 Payment terms Critical Negotiated by the department Advance payment Payment triggerPayment scheduleOne time expensesDesigned to assist with cash flow.Advance should be paid upon contract execution; pt advance is credited towards future payment. 20% or 2 ptsTrigger- CRF completion? Monitor visit and pulled data?Quarterly or lessMilestones may be ok if payment still made quarterly and prorated for pts enrolledOne time- remittance within 30 days or with next quarterly payment
17 Payment terms Prorated payment Annual cost adjustment Payment adjustmentsHoldback-Per institution policy holdback can not exceed 20%Annual cost adjustment- 5-10%Ask for more money if needed
19 Sponsor BudgetExhibit B – Clinical Study Financial Terms $5000 Investigator Fee $3750 IRB Fee $5000 Lab Fee $700 Per patient Fee (estimate 150 patients) estimate $1,050,000 $118,750 Estimated Total (based on 150 patients) $17, % payable upon IRB Approval (Institution will invoice Sponsor) $12, Per month for six months after first patient enrolled. Total $77, $23, At close out based on 150 patients Institution will invoice Sponsor in writing Any patients over 150 forecasted billed at $700 /per patient Any patients under 150 deducted at $700/per patient IRB amendments and continuing reviews will be an invoiceable pass-through cost at $500 each amendment, $750 each continuing review. All payments made pursuant to this Agreement shall be made payable to Vanderbilt University Medical Center and directed to the following address: Attn: Stephen Todd Associate Director Department of Finance Academic and Research Enterprise Vanderbilt University Medical Center Dept AT Atlanta, GA Each payment voucher should reflect IMI’s name, Protocol Number, and the Principal Investigator’s name. Institution’s Federal Tax Identification Number is____ _______.
20 Negotiation Budget process requires negotiation Documentation ConfidenceIdeal vs. bottom lineCompromiseMutual agreement
25 Most Common Budget Mistakes With Budgets for Industry-Initiated Projects Missing IDS fees – 4 fees including: Initial submission - ~$2000-$3000; Annual fee - ~$1650 (varies); Close-out - ~$650; Dispensation of drug – varies. Always get an IDS quote.Missing IRB fees – 3 fees including: Initial submission - $2250; Amendments each $500; Continuing Review - $750.Lack of knowledge re use of CRC space & feesAccounting for full staff effortA misunderstanding or lack of knowledge re VUMC indirect costs(continued next slide)
26 Most Common Budget Mistakes With Budgets for Industry-Initiated Projects (continued) Failure to obtain Start-up FeeInadequate or no reimbursement for protocol procedures; use tools such as Price-Checker; i.e. pathology fees for tissue samplesFailure to build in annual cost increase for budget itemsArchive fees
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