1 / 15

Managing Research Finances: Successful Strategies for Viability and Compliance

Managing Research Finances: Successful Strategies for Viability and Compliance. July 29, 2006 M. Paul Wade, Jr., MS Financial and Contracts Compliance Officer. Elements of Clinical Research. Clinical. Regulatory. Operations. Operational Structure. Directors/Principal Investigators

gary
Download Presentation

Managing Research Finances: Successful Strategies for Viability and Compliance

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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 Clinical Regulatory Operations

  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

More Related