1. Finance and Contract Pre-Award Process Rachel Sheppard Regulatory Director, OCRSS

2. Protocol solicitations No standard methods NDA Site questionnaire Synopsis

3. Site Qualification Sponsor evaluation of site Tour of facilities Meeting with personnel Know processes and timelines Sometimes by phone

4. Feasibility Formal review Get all information Be prepared (document review) Schedule of Events Inclusion/exclusion Budget template ICF template CTA Lab/imaging manuals Real logistics

5. Billing Compliance Table Billing plan Specifies the coverage of procedures Providers use to bill for procedures performed Must match with contract, budget and ICF

6. Billing Plan Development How do you determine standard of care? a. PI determination b.Review of previous orders c. NCD/LCD d. Sponsor proposed

7. Budget Development Price requests from hospitals/clinics CPT codes Professional fees Associated charges Detailed descriptions Time estimation Coordinator time PI time Internal budget grid

8. Best practices Assume that the budget template is incomplete Base all fees on actual activities/costs Involve clinical and regulatory in analysis

9. Budget Negotiation Most are negotiable A game Know when to change tactics Information is power Have standard methods/rationale

10. Contract Review Process Submit TRIA early Report all non-U of L personnel Be detailed Communicate with stakeholders Hospital offices Negotiator Sponsor

11. References OIG Compliance Program Guidance for Third-Party Medical Billing Companies (1998) eXL Pharma