1 Budgeting for Clinical Trials from a Site Perspective ©CTNBP 2010 Kathy Kioussopoulos, RN, BSN CTNBP SCAC 27 September 2010 Kathy Kioussopoulos, RN, BSN CTNBP SCAC 27 September 2010

2 Budget Development: A Complex Process 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.

3 Part 1: Compliance Aspects

4 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.

5 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

6 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.

7 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.

8 Part 2: Hidden Costs

9 Hidden Costs to Doing Clinical Research 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.

10 Miscellaneous Budget Items to Request 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.

11 Miscellaneous Budget Items to Request 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.

12 Miscellaneous Budget Items to Request 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.) 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.

13 Miscellaneous Budget Items to Request 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.

14 Miscellaneous Budget Items to Request 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.

15 Part 3: How to Use Sample Budget Worksheet

16 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

17 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 (pre- calculate). 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.

18 Tab 2—Required Testing/Billing Compliance Purpose 1. Determine if sponsor budget will cover the tests and services required by the protocol. 2. Determine if any of the charges will be billable to the subject or subject’s insurance (Medicare or private insurance). Considerations 1. 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. 2. 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. 3. These items should be calculated on a per- subject/per-visit basis.