1. Managing Research Finances: Successful Strategies for Viability and Compliance July 29, 2006 M. Paul Wade, Jr., MS Financial and Contracts Compliance Officer

2. Elements of Clinical Research RegulatoryOperations Clinical

3. Operational Structure Directors/Principal Investigators Sub-Committee Budgeting Contracts Financial Set Up Clinical Delivery (Logistical) Billing Financial Tracking

4. Directors/P. I./Sub-Committee Study Procurement (P.I.s, Directors, Coordinators) Study Evaluation (Directors, P.I., Coordinator)  Determine Patient Population  Clinical Merits Multi-Disciplinary Sub-Committee Approval

5. Budgeting/Contracts/Financial Set-up Standard of Care (SOC) vs. Non-Standard of Care (nSOC) Review Budget Development Contract Review Budget/Contract Negotiations Financial Set-Up

6. Budgeting/Contracts/Financial Set-up Standard of Care (SOC) vs. Non-Standard of Care (nSOC) Review  Billing Compliance  P.I./Study Coordinator Review In September of 2000 CMS issued a final coverage decision for Medicare to cover the routine health care costs of beneficiaries in clinical trials. The rules for billing standard of care to research patients is subject to varying interpretations. Therefore, BE CONSISTENT IN YOUR PROCESSES.

7. Budgeting/Contracts/Financial Set-up Budget Development  Start-Up Costs (Administrative, Regulatory, etc.)  IRB Fees  Pharmacy Fees  Coordinator Time/Overhead  Device/Drug  CPT codes for nSOC Labs, Tests and Procedures  Screen Failures  Unpaid Insurance Claims  File Storage

8. Budgeting/Contracts/Financial Set-up Contract Review – Important Elements  Determine the parties  Study Description/Protocol Exhibit/FDA approval  Terms are well defined  Performed in strict compliance with the protocol  Anti-kickback, Anti-fraud language  Indemnification/Insurance/Adverse Outcomes  HIPAA  Mutual Confidentiality  Data Ownership  Publications  Inventions/Intellectual Property  Termination

9. Budgeting/Contracts/Financial Set-up Budget/Contract Negotiations  Allow enough time  Know your limits  Amicably negotiate

10. Budgeting/Contracts/Financial Set-up Financial Set-Up  Medicare Approval  Drug/Device Procurement  Process for getting IDE on the Bill  Set up Accounts

11. Clinical Delivery/Billing/Financial Tracking Clinical Delivery (Logistical) Billing Financial Tracking

12. Clinical Delivery/Billing/Financial Tracking Clinical Delivery (Logistical)  Communication (Depts., CRCs, Regulatory and Finance)  Drug/Device  Communicating Enrollments  Inter-office/facility communication (collaboration with outside entities)

13. Clinical Delivery/Billing/Financial Tracking Billing  Account Holds  Investigational Device Exemptions (IDEs) IDE Number in Item #23 on CMS-1500 QA Modifier for all services related to the IDE  Account Review  Coding Routine Costs QV modifier on line item level (outpatient only) Diagnosis code V70.7 reported as the secondary or subsequent diagnosis  Trial Name, Sponsor and Protocol number if applicable and requested  Periodic Audit for Billing Compliance

14. Clinical Delivery/Billing/Financial Tracking Financial Tracking  Database  Payment Modeling  Incoming Checks  Outgoing Checks Invoicing Process  Operational Analysis Revenue Expenses Statistics

15. QUESTIONS? M. Paul Wade, Jr. 95 Collier Road, Suite 5005 Atlanta, Georgia 30309 (404) 605-2372 paul.wade@piedmont.org