Budgeting for Clinical Trials from a Site Perspective
©CTNBP 2010
Kathy Kioussopoulos, RN, BSN
CTNBP SCAC
27 September 2010
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Budget Development: A Complex Process
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Navigating the clinical-trial budget process can be complicated and full of
compliance issues.
The slides in Part 1 address the compliance aspects to consider at your site.
The slides in Part 2 address the hidden costs of clinical research and provide
some budget terms language to consider asking for during the negotiation
process.
The slides in Part 3 focus on how to use the sample budget spreadsheet.
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Part 1:
Compliance Aspects
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Medicare Compliance Regulations
 There are currently 4 document regulations that govern how Medicare pays
for services provided during a research study. You and your organization
should understand that even though Medicare coverage rules may allow for an
item to be paid, the local fiscal intermediary may chose not to allow the
coverage depending on his/her assessment of medical necessity.
 This comes into play most often in the device-trial setting.
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Regulations Related to Clinical Trial Billing
 Pre-1995 Medicare Coverage Policy for Clinical Trials
 1995—Interagency agreement made between HCFA (now known as CMS)
and the FDA
 2000—CMS National Coverage Decision issued
 2003—Medicare Modernization Act
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Research Billing Compliance
 Understanding the regulations with regard to research billing can be
complicated and varies between regions in the U.S. Most hospital systems have
experts on staff who are familiar with National Coverage Decisions and should
be consulted as to whether a charge can be billed to Medicare/other payors or
if it should be included in the study budget.
 The process of this determination for the research budget is called: Medicare
Coverage Analysis (MCA) and should be part of each study you participate in.
See Sample Budget Worksheet, Tab 2.
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Research Billing Compliance
 Items to consider: Sites must consistently demonstrate “careful consideration”
with regard to whom they bill and how they bill for clinical trial services.
Medicare regulations do allow for payment of services related to a clinical
trial, but other payors may not.
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Part 2:
Hidden Costs
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Hidden Costs to Doing Clinical Research
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The typical clinical trial budget presented to sites by sponsors is done
in a “per subject” format.
Most sponsors assume that the site will deduct all study-related costs
from this amount.
This makes budgeting simple on their side; however, it can greatly
impact a site’s profitability and operational capacity.
The following slides illustrate some additional considerations for the
budget process.
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Miscellaneous Budget Items to Request
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Advance Patient Payment—Upon completion of regulatory documents and
contract, Sponsor will pay Institution a refundable advance payment in the
amount of 1 patient. This advance payment will be deducted from the next
patient payment made to the Institution. If Institution does not enroll at least 1
subject into the Study within 90 days of the date of receipt of Study Drug
and/or Site Initiation Visit, Institution shall refund to Sponsor Advance Patient
Payment.
Administrative Fee—Upon receipt of invoice, Sponsor will pay Institution a
non-refundable $3,000 administrative startup fee. This fee will cover the cost of
regulatory document preparation and training/staff time required to begin
enrolling in this trial.
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Miscellaneous Budget Items to Request
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IND Safety Reports—Upon receipt of invoice, Sponsor will pay Institution
$200 per 50 IND Safety Reports received from Sponsor and submitted to local
IRB for review.
SAE Reporting—Upon receipt of invoice, Sponsor will pay Institution $200
per completed SAE, Endpoint, and/or Clinical Events Committee report to
reimburse coordinator time for gathering all SAE information.
Patient Travel Reimbursement—Patients are reimbursed $25 for completed
study visit to reimburse travel costs. Patients who travel more than 100 miles
round trip are reimbursed at national reimbursement rate. We ask that standard
$25 reimbursement be built into budget and any amount over $25 be invoiced.
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Miscellaneous Budget Items to Request
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Local IRB Charges (pass-through cost)—Upon receipt of invoice, Sponsor will
pay Institution $2,000 for the pass-through cost from IRB for initial
submission/approval, and $750 for IRB annual review/approvals. (IRB requires all
studies to have a full review annually.)
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Administrative IRB Submission Fees—Upon receipt of invoice, Sponsor
will pay Institution $500 per annual review submission of protocol, protocol
amendments, Investigator Brochure revisions, and/or Sponsor-requested
revisions to Informed Consent Document.
Local Pharmacy Setup Fee—Upon receipt of invoice, Sponsor will pay
Institution $750 for pass-through cost from XYZ Hospital Pharmacy.
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Miscellaneous Budget Items to Request
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Re-consenting of Enrolled Study Subjects—Upon receipt of
invoice, Sponsor will pay Institution $50 per subject if re-consenting is
required due to amendment or Sponsor-requested change to any
Informed Consent Document (sub-study or main ICD).
Additional Coordinator Time Payments—If throughout the
duration of the trial the Sponsor requests additional information
and/or CRF pages for data that was not initially required, Institution
will invoice Sponsor for $50 per hour to compensate for additional
staff time.
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Miscellaneous Budget Items to Request
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Study Supplies—Sponsor will be responsible for supplying Institution all
supplies/equipment required to conduct the study. This includes, but is not
limited to, lab drawing and processing equipment and supplies, 3-ring binders
for regulatory and patient CRF storage, specialized equipment (e.g., ECG
machines), and any other equipment or supplies required to complete the study.
Storage Fees: Sponsor will pay the storage fees for study documents for the
duration of required storage as is stated in the study contract. These fees are
inclusive of all items charged to the study site for preparation and storage of
study documents. Once the study has ended and all documents have been sent
to storage, Sponsor will be invoiced annually for the storage fee. If at any time
the study documents must be retrieved from storage, such as for an audit,
Sponsor will pay the fees that are incurred for this action.
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Part 3:
How to Use Sample Budget
Worksheet
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How to use the sample budget worksheet
There are 2 tabs in the Excel worksheet:
 Tab 1—Overall Study Budget
 Tab 2—Required Testing/Billing Compliance
Worksheet
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Tab 1—Overall Study Budget
Items required to complete this page
1.
Full protocol
2.
Contract terms
3.
Budget offered by sponsor
4.
Study schema outlining clearly what
items need to be purchased from
institution
Items to consider
1.
Know your salary costs (precalculate).
2.
Know your institution’s charge rate
for tests and procedures.
3.
Know your physician’s professional
fees and where they are applied.
4.
Know your institution’s overhead
rate and what items it applies to.
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Tab 2—Required Testing/Billing Compliance
Purpose
1.
2.
Determine if sponsor
budget will cover the tests
and services required by the
protocol.
Determine if any of the
charges will be billable to
the subject or subject’s
insurance (Medicare or
private insurance).
1.
2.
3.
Considerations
Some protocols will require lab or
radiology studies that can be done a
variety of ways, e.g.. CBC with/without
different prices, MRI Brain –with
contrast/without contrast—price varies).
Bottom line is that you may need to speak
with sponsor /CRO to determine exactly
what they are looking for.
Some protocols require sending items out
to a central lab or core lab. Your
equipment may need to be validated or
you may need to show proof-of-service
records/logs.
These items should be calculated on a persubject/per-visit basis.
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