budgeting for industry sponsored clinical research...invoiceable charges (invoiced and paid...
TRANSCRIPT
Budgeting for Industry Sponsored
Clinical Research
Sarah Bernardo
Senior Financial Analyst, MCA Specialist
Partners Clinical Trials Office
Elements of Successful Budgeting
Analyze research or protocol activities
Delineate usual and customary care from research
Comply with federal & state laws for clinical trial billing
Institutional considerations
Pricing
Direct and indirect costs
Clinical research / trial agreement
Policies, processes, contacts and resources
Negotiation
PI-initiated
Company-initiated
Direct Costs
Costs specific to a sponsored project, may include:
Salary and fringe for investigators and other
research professionals (clinical research
coordinator/nurse, statistician, co-Investigator)
Procedure costs (x-rays, lab tests)
Supplies
Advertising
Pharmacy costs
Indirect Costs
Costs incurred for common or joint objectives not
identified specifically with a particular project
Research administration
Legal/financial review for sponsored agreements
General accounting
IDC for industry sponsored clinical trials at Partners is
30% TDC
Obtain institutional policies regarding eligibility for
clinical trial indirect rates and details regarding
application
Example:
Sponsor offer is $4K per patient including
overhead and IRB fee
Screening - $700
2 week, 6 mo, 9 mo, 12 mo - $275
3 mo and 15 mo - $1100
How to evaluate a sponsor proposal?
Identify Research Activities
Create billing grid from study schedule
Follow federal and local guidelines governing billing
on clinical trials – Medicare Clinical Trial Policy
(CTP) local and national coverage decisions to
identify items to be billed to patient’s insurance
Understand institutional policies/processes regarding
research billing compliance as applicable
Medicare Clinical Trial Policy
Only allows coverage of routine costs during a qualifying
clinical trial
Conventional care
Detection, prevention and treatment of complications
Administration of investigational item
Medicare will not cover routine costs that are:
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 data collection/analysis
https://www.cms.gov/clinicaltrialpolicies/
Identify Research Activity
Procedure Screening 2 wks 3 mo 6 mo 9 mo 12 mo 15 mo
Informed consent Research
Inclusion / Exclusion Research
Vitals UCC
Randomization Research
Physical exam UCC UCC UCC UCC UCC UCC UCC
Pregnancy test Research
TTE complete UCC Research UCC Research
IND Research Research Research Research Research Research
IND administration UCC UCC UCC UCC UCC UCC
Adverse events Research Research Research Research Research Research
Concomitant meds Research Research Research Research Research Research Research
SF 36 Research Research Research Research Research Research Research
Per patient - fixed
Fixed costs for every subject to complete each portion of
the trial
Industry trials generally paid by visits completed
Company initiated trials typically pay by completed electronic
case report forms
Obtain institutional research rates for research ancillary
items/services and consider inflation and length of study
Estimate time for staff related procedures, factor in
appropriate salary/fringe
Price Out Ancillaries
Hard costs:
Identify CPT code(s) for each identified research
ancillary procedure (consult with ancillary
department billing contacts to identify accurate
codes as needed)
Obtain institutional research rates (including
professional fees for tests requiring a read)
Account for inflation
Internal Pricing
FY17
Full tech
fee
FY17
Research
tech rate
FY17
Full pro
fee
FY17
Total cost
FY18
Inflation
FY19
Year 2
TTE Complete $1,533 $436 $249 $685 $719 $755
Serum
pregnancy $172 $37 $37 $39
Build in Ancillary Costs
Procedure Screening 2 wks 3 mo 6 mo 9 mo 12 mo 15 mo
Informed consent Research
Inclusion / Exclusion Research
Vitals UCC
Randomization Research
Physical exam UCC UCC UCC UCC UCC UCC UCC
Pregnancy test $65
TTE UCC $775 UCC $800
IND Research Research Research Research Research Research
IND administration UCC UCC UCC UCC UCC UCC
Adverse events Research Research Research Research Research Research
Concomitant meds Research Research Research Research Research Research Research
SF 36 Research Research Research Research Research Research Research
Staff time and other fixed patient costs
Staff reimbursement:
For each research non-ancillary procedure directly related to the patient, identify who performs and how long does it take?
Determine hourly salary and include institutional fringe
Assign estimates for reimbursement
Fixed patient study costs:
Parking
Room Charges
Staff & Other Costs
Procedure Screening 2 wks 3 mo 6 mo 9 mo 12 mo 15 mo Total
Informed consent $100 $100
Inclusion / Exclusion $50 $50
Vitals UCC 0
Randomization $50 $50
Physical exam UCC UCC UCC UCC UCC UCC UCC 0
Pregnancy test $65 $65
TTE complete UCC $775 UCC $800 $1,575
IND sponsor sponsor sponsor sponsor sponsor sponsor 0
IND administration UCC UCC UCC UCC UCC UCC 0
Adverse events $50 $50 $50 $50 $50 $50 $300
Concomitant meds $50 $50 $50 $50 $50 $50 $50 $350
SF 36 $40 $40 $40 $40 $40 $40 $40 $280
Patient parking $25 $25 $25 $25 $25 $25 $25 $175
Coordinator - crf completion, scheduling,
administrative mgmt $150 $125 $125 $125 $125 $125 $150 $925
PI - crf signoff, study oversight, clinical mgmt of
patients study related $175 $150 $150 $150 $150 $150 $175 $1,100
Subtotal $655 $490 $1,215 $440 $440 $440 $1,290 $4,970
Apply Indirects Procedure Screening 2 wks 3 mo 6 mo 9 mo 12 mo 15 mo Total
Informed consent $100 $100
Inclusion / Exclusion $50 $50
Vitals UCC 0
Randomization $50 $50
Physical exam UCC UCC UCC UCC UCC UCC UCC 0
Pregnancy test $65 $65
TTE complete UCC $775 UCC $800 $1,575
IND sponsor sponsor sponsor sponsor sponsor sponsor 0
IND administration UCC UCC UCC UCC UCC UCC 0
Adverse events $50 $50 $50 $50 $50 $50 $300
Concomitant meds $50 $50 $50 $50 $50 $50 $50 $350
SF 36 $40 $40 $40 $40 $40 $40 $40 $280
Patient parking $25 $25 $25 $25 $25 $25 $25 $175
Coordinator - crf completion, scheduling,
administrative mgmt $150 $125 $125 $125 $125 $125 $150 $925
PI - crf signoff, study oversight, clinical mgmt of
patients study related $175 $150 $150 $150 $150 $150 $175 $1,100
Subtotal $655 $490 $1,215 $440 $440 $440 $1,290 $4,970
Overhead @ 30% $197 $147 $365 $132 $132 $132 $387 $1,491
Total $852 $637 $1,580 $572 $572 $572 $1,677 $6,461
Per Patient - Variable
Screen fail terms
Price of full screening visit including IDC
Watch/negotiate proposed ratios
% of screening visits
Subject travel reimbursement (airfare, lodging,
meals)
SAE reports
Sub-studies
Study Costs – Fixed & Variable
Administrative Start-Up (IRB submission,
initial study team meetings)
IRB fees – initial, continuing reviews
Clinical Trial Office fee
Pharmacy
Advertising
Storage
Monitor Visits
Sample Language
Non-refundable one time fees (payable upon contract execution)
IRB fee – initial (overhead exempt) $3,500
Administrative Start-up $5,000
Medicare Coverage Analysis (overhead exempt) $1,500
Clinical Trial Office Fee (overhead exempt) $5,000
Invoiceable charges (invoiced and paid quarterly)
Advertising $4,000
Screen fails
to be paid for procedures completed including
coordinator & PI time plus 30% overhead
IRB fee - continuing review (overhead
exempt) $1,000 per
Pharmacy charges $2,000
SAE reports $200 per
Importance of the Clinical Research Agreement
Budget is tied to the agreement
Term and termination
Compensation and Budget Exhibits
Provision of drug/device/equipment
Deliverables tied to payment triggers
Importance of payment terms and language
Compliance Issues
Industry – Fair Market Value (FMV) - Exchange of services rendered (contract deliverables) vs. reimbursement received (budget)
Don’t go above list price for services
Cannot accept sponsor reimbursement for any item/service billed to insurance – “double billing”
Be aware of institutional payment policies regarding incentive (i.e. no incentive payments tied to specified enrollment within a certain timeframe or “bonus” payments after certain # of payments received) – inclusion of pro-rated language
Company initiated
Company generates contract/budget proposal, distributes protocol/consent
Usually large multi-center studies
Selects investigators and sites for participation
Contract and budget negotiation after contract distributed to sites
Payment by automated crf for patient costs, invoice for variable costs
10-20% withhold of subject payments common until final datalock and resolution
May use CRO for negotiation
PI initiated
PI generates budget estimates
Pitches proposals to companies
Negotiation prior to contracting
Deliverables may include submission of final manuscript as trigger for final payment
Generally fewer automatic payments, more invoicing based on payment milestones
Single center vs multi-center. If multi-center, be sure to understand how institutional IDC policy affects subcontract costs, other work related to the trial (i.e. protocol development, core labs, etc.)
Contact institutional budget approval contacts for review prior to sponsor submission
Negotiation Tips
Good deals can take time and effort
Always try to negotiate
Consider fiscal health of your study - work to negotiate a budget that will cover your anticipated costs
If you are not covering your costs approach the sponsor for amendments
Provide justification for your costs - sponsors may want copies of policies or costs to document
Review all financial language carefully
When in doubt, contact your assigned CTO FA
Questions?