Julie Calahan, CCRP

Clinical Trials Budget Analyst

Health System Contracts Office

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CRC Basic 2.0Budgeting for

Industry-Sponsored Clinical Trials

Clinical Trials Contracts OfficeAnnie Wong – Health System Contracts Director

Signatory and Director of Clinical Trials unitAnnie Wong – Health System Contracts Director

Signatory and Director of Clinical Trials unit

Erick Jenkins – Clinical Trials OfficerSupervises Clinical Trials unit, negotiates new and complex clinical

trial agreements and assists in negotiation of UCOP master agreements, liaison with UC Office of the President and CTSC

Erick Jenkins – Clinical Trials OfficerSupervises Clinical Trials unit, negotiates new and complex clinical

trial agreements and assists in negotiation of UCOP master agreements, liaison with UC Office of the President and CTSC

Andrew Jones – Clinical Trials AnalystNegotiates agreements under master clinical trial

agreements and some new agreements

Andrew Jones – Clinical Trials AnalystNegotiates agreements under master clinical trial

agreements and some new agreements

Lorie Dilts – Clinical Trials AnalystNegotiates amendments and confidentiality agreements,

office and database management

Lorie Dilts – Clinical Trials AnalystNegotiates amendments and confidentiality agreements,

office and database management

Julie Calahan – Clinical Trials Budget AnalystAssists departments with budget development and negotiation, develop clinical trial budgeting policy

Julie Calahan – Clinical Trials Budget AnalystAssists departments with budget development and negotiation, develop clinical trial budgeting policy

Objectives Roles of coverage analysis and internal budget

Components of a clinical trial budget

Budget template and examples

Budget negotiation tips and tactics

Resources and questions

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What is a clinical trial?

(for the purposes of application of 26% indirect rate*)

The controlled, clinical testing in human subjects of investigational new drugs, devices, treatments, or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions and/or outcomes.

*This rate applies to the Total Direct Cost, and no budgeted item is excluded from the application of indirect. This rate applies regardless of whether a Clinical Trial is based on sponsor -initiated, or an investigator-initiated protocol.

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Industry Sponsored Clinical Trial Approval Process

Receive Sponsor Packet (Protocol, CTA &

Budget)

Send Sponsor Packet to Clinical Trial Budget Analyst and Research

Abstractor

PI Interest

Research Team Drafts Internal Budget (UBT) 1)Gather information from

- Research Team Members (CRC, PI)- Quantim- Investigational Drug Services- Other Depts (CCRC, Radiology, Pathology)

2) Use Research Query Tool for current research prices3) Complete Coverage Analysis

Negotiate Budget &

Payment Terms w/Sponsor

(External Budget)

Negotiate Budget &

Payment Terms w/Sponsor

(External Budget)

Assistance provided by Research Abstractor and Budget Analyst

Send packet to Chair for Approval

& SignatureTabled

Clinical Trial Contract Packet Forwarded to Dean’s Office for

Signature

CT Contracts Office- Negotiates Contract Language - Signs Off on Final Budget

Research Team determine feasibility:-Scientific Merit-Financial Soundness-Pt Accrual

NoYes

The role of Coverage Analysis (CA) and internal budget (UBT)

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Coverage Analysis Works To Create Accurate Budget

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How can I use Coverage Analysis?

• Use to create an accurate budget• Provides a list of study events in a Billing Grid• Early analysis will:

• Identify all procedures• Identify CPT codes for research costs• Identify policies limiting insurance coverage• CTSC Coder provides assistance

• Obtain research costs by CPT code • Cost Query Tool

• Accurate costs=accurate budget• Accurate budgeting useful for feasibility, negotiations with sponsors,

patient billing, invoicing

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Use the BG to prepare internal budget•Look up clinical trial costs by CPT code in Cost Query Tool•Base External budget on internal budget•Negotiate with sponsors•Billing, CTA, Consent Form match

Study Procedure/Labs CPT Code Q0/Q1

Screening

C1 C2 C3 C4 C5 C6 C7 C8 C9 C10 C13 C16

C19 C22

C25

EOT

Short-term FU

Long-term FU

Notes

Complete Physical Examination (includes vital signs/height/weight at screening)

99201-99205, 99211-99205

Q1 P P

Complete physical exam at screening and end of treatment are reasonable and necessary for work-up prior to treatment and for assessment of potential complications upon completion of treatment.

Physical Examination(includes vital signs/weight)[SOC]

99201-99205, 99211-99205

Q1 P P P P P P P P P P P P P P Physical exam each cycle is reasonable and necessary for assessment of potential complications and/or clinical signs of disease progression during treatment.

Vital Signs/Weight 99211 Q1 P Vital signs prior to treatment with study medication is

reasonable and necessary for patient safety.

ECOG Performance Status N/A N/A S S S S S S S S S S S S S S S S SThis is a data collection activity and is payed for by the sponsor.

MUGA Scan (or ECHO if MUGA not available)

78472 (93306) S S S S S S S Sponsor to pay for this activity. MUGA not billable to 3rd party for screening purposes and in the absence an abnormal ECG (LCD L28246 01/01/2010).

Medicare National Clinical Trial Policy

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• Coverage Analysis is a UC requirement for all studies with patient care services billed through UCDMC

• At UC Davis we can determine when a clinical trial meets national policy guidelines by performing a Coverage Analysis

• NCD explicitly defines coverage of clinical trial services

What does sponsor pay for?What does 3rd party (Ins co) pay for?

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Conventional Care Costs

Expanded costs

Research costs

Sponsor

Insurance/Medicare/Pt Acct needed to clinically manage pt care

Insurance/Medicare/Pt Acct services pt receives if not in CT but part of protocol – SOC

Billing Grid continued…

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• Tool to create an accurate budget• Identify the study events• Lists study events in the form of a CPT code• Research Costs can be found by CPT code• Lists who will be billed (sponsor or insurance billing)• Tool to reconcile billing statements

Components of a clinical trial budget

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Protocol-related tasksBudget-related tasksIRB DocsTrainingPharmacy communicationCommunications w/Sponsor

Start Up Close Out Invoicables Per Patient

AdvertisementOffice suppliesPharmacy start-up, inventoryTranslation of Informed Consent

Categories of tasks

FEES

Complete Feasibility Questionnaire from Sponsor

Review protocol & study flow

Review by Scientific Review Committee (Cancer Ctr)

Preparation and return of Sponsor/Site documents

Pre-Study Site Selection visit, prepare for & attend

Prepare, distribute, collect and copy financial disclosures

Obtain and copy CV's

Preparatory Research

CMS determination

Tasks

Start-up Costs

Close Out Costs

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Closeout Report Complete QueriesBox up Study RecordsTransport Study Records for storageCloseout Visit, Prepare for & AttendRegulatory close with IRBClose out study account w/Extramural (incl.payroll transfer)

Close out invoicingProducing addtl information after study close out

Start Up Close Out Invoicables Per Patient

Tasks

Invoicable Costs

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Adverse events x 8Monitoring Visits x2Screen Failure x4Annual Report x1IRB Docs x1Admin/Correspondence x1

Start Up Close Out Invoicables Per Patient

Categories of Tasks

Mods to Reg Documents

Regulatory Binder, Maintain

IRB, Communicate Modifications, incl 1572

Contracts, Communicate Modifications

Invoicables may or may not happenEach category multiplied by the number of occurrencesMust include to come up with the total budget

Per Patient Costs

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Start Up Close Out Invoicables Per Patient

Unified Budget Template

(UBT)

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Internal Budget (UBT) Summary Shows anticipated revenue residuals/loss assuming full enrollment of patients completing entire study

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Factors impacting budgets• Composition of research personnel

• The type, phase, and complexity of the protocols involved

• Screen failure rates

• The actual time it takes to perform the work

• Given the organization of clinical trial research services within the research unit

• Anticipated complications

• Sample processing and/or shipping logistics• Patient treatment logistics and scheduling challenges• Data management in busy studies• Time limits on patient accrual reporting and data query resolution

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Start-up Costs

If you don’t ask for it, you won’t get it

Start-up fees should always be non-refundable

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Close-Out and Other Invoicables

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Per Patient Costs – Study Procedures/Labs

Per Patient Costs - Other

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Per Patient Costs - Study Activities

Per Patient Costs

Salary Calculator -linked to all costs throughout the budget

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Completed UBT

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Budget Negotiations

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Budget negotiations……• Sponsor’s initial budget is STARTING POINT for negotiations

(perform a thorough analysis of the specific protocol)

• Keep in mind ……all sponsors and CROs have a business plan to make money

• Communicate resources available to conduct trial• Expertise• Facilities• Access to large patient population

• Remain neutral…establish that you represent the University and are negotiating the budget on behalf of the study team

• A break-even point and bottom line should be determined

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Budget negotiations (con’t)…..• Keep the PI in your corner

• Keep him/her informed• Ready to intervene• Ready to remind sponsor of the benefits of having UCD as a site

• Keep momentum going if negotiations are moving quickly

• Don’t let aggressive CROs push you around

• Remain calm and exercise some patience

• Reach out to resources within the UCD research community for advice

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Budget negotiations (con’t)…..

Payment Terms

REVIEW, REVIEW, REVIEW!!!

• Advance vs. start-up

• Interim Payments

• Payment Withholding

• Final Payment

• Screen Failures

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Resources

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Resources

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•Clinical Trials Website•UCD Clinical Research Guidebook•Process Maps

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Research Costs - UCDHS Query Tool

B6 FIN to provide cost data for clinical trial billing codes

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CPT Codes - Quantim

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Questions ??