Investigator Grant Payments are Not Just a Site Concern Anymore February 8, 2011

1. Investigator Grant Payments are Not Just a Site Concern AnymoreFebruary 8, 2011

2. Presented by:Kevin T. Williams, MBA/MSVice President – Corporate Development & Marketing

3. Agenda • Industry Review • Site Perspective • Sponsor Perspective • Key Issues & Challenges • Sunshine • Fair Market Value • Operations • Sponsor & Site Impact • Final Thoughts • Questions

4. Industry Review

5. The Site Concerns…

6. “…providing/receiving grant payments is the single most inefficient activity in study conduct.” - ACRP White Paper (survey of 1100 clinical research professionals)

7. Source: CenterWatch 2005-2009 Survey of Investigative Sites in the U.S.

8. Source: CenterWatch Survey of 953 Investigative Sites, 2010

9. Sponsor Concerns…

10. Physician Payments Sunshine Provision (PPSP) Summary • Included in the Patient Protection and Affordable Care Act of 2009 • Signed into law on March 23, 2010 • Regulated by Centers for Medicare & Medicaid Services (CMS) which is under Health and Human Services • Requires drug and medical device manufacturers to publicly report gifts and payments made to “covered recipients” • Defined as Physicians and Teaching Hospitals • Thresholds for payments or transfers of value • Anything with a value of $10 or greater must be reported • Anything with a value less than $10 must be reported if the covered recipient received more than $100 in value during the year

11. PPSP Timeline Updated Timeline • December 19, 2011 CMS Issued Guidance • February 24, 2012 Comments are Due to CMS • Final Publication of Rule (TBD) Following Comments Collection of required data for reporting in 2013 to begin 90 days after publication of the final rule (date TBD)

12. Challenges with Aggregate Spend Reporting for Trials A/P System CTMS System PPSP requires reporting that integrates this data A/P System has financial details of payment CTMS System has physician details These systems are typically not integrated which makes grant reporting especially challenging

13. Penalties & Responsibilities Penalties for Non-Compliance • $1K to $10K for each payment not reported • Maximum penalty is $150K • $10K to $100K for each payment intentionally not reported • Maximum penalty is $1MM Responsibilities • Requirement to submit signed attestation as to accuracy of data • Records can be audited up to 5 years after the date of payment

14. Fair Market Value (FMV) Where Did it Come From? • 2003 Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers (U.S. Department of Health and Human Services) • OIG report emphasized that payments for research services should be FMV for legitimate, reasonable, and necessary services. • Unfortunately, “FMV” was never actually defined??? Goal and intent of FMV compensation is to reduce the apparent conflict of interest What does it mean? • Need well-documented processes for developing grant budgets • Controls & exception processes for negotiations

15. Operational Challenges • Contracts & Protocols not set up with payments in mind • Lack of robust technologies • Grants calculated in MS-Excel or MS-Access with no integration into A/P • *Major Issue for Sunshine Reporting* • CTMS systems generally not equipped to handle complex configurations • Inefficient payment approval process • Many handoffs/approvals • Manual, paper based A/P process • Lack of invoices hinders A/P automation • Paper checks • Limited supporting documentation

16. Operational Challenges • Global Challenges • International Tax Issues VAT, GST, Stamp • Invoicing required due to tax requirements • De-Centralized Process • Spread across multiple subsidiaries or CROs • Currency and exchange issues • Consolidated reporting difficult • Electronic Funds Transfer standards • Standards require banking network • iACH, Wires • Global Transparency Initiatives on the Horizon • US Aggregate Spend (Sunshine Compliance) • Requirements are challenging existing processes • May discourage participation in research • HCP reporting not limited to R&D

17. Grant Payment Impact

18. Sponsor Impact • Increased costs • Inefficient processes require additional resources or overworking existing resources (impacts turnover) • Enrollment goals can be delayed • Unable to realize full potential of EDC • Unable to comply with latest compliance standards • Limited visibility to cash flow • Difficulty with site recruitment • CFS Survey: 90% of Site Respondents indicated “Receiving Faster Payment would be a Significant Factor in Selecting a Sponsor I want to Partner with”

19. Site Impact • Project accounting difficult • Lack of focus/resources • Funds potentially go uncollected…or just really late • Negatively impacts viability • Cash flow • *60% of private research sites have less than 3 months of operating cash *Site Solutions Summit 2010 Survey (Christine Pierre – RX Trials) • Reimbursement timing impacts negotiations • Requests for advances & start-up • Rapid payment provides negotiation leverage • Discourage future interest in participating in clinical research

20. Final Thoughts…

21. Industry Trends with PaymentsWhat we are seeing… • Pay more frequently to stimulate investigator relationships • Monthly Payments – Shift from Quarterly • Pay from Unmonitored Data via EDC • Minimizes accrual management • Enhanced Cash Flow Management • Transparent Reporting • High focus due to compliance requirements • Standardization for consistency internally and externally  Branding

22. Maximize EDC Value Sites Populate eCRF

23. Contractual Considerations

24. Questions?

25. Thank You! Kevin T. Williams, MBA/MSVice President – Corporate Development & MarketingClinical Financial Services, LLCkwilliams@clinicalfinancialservices.com