Device Congress

1. Device Congress Track B: Reimbursement How to Convince the Medical Director Your Product is Special Michael Becker, GM Global Reimbursement, GE Healthcare Michael Bihari, MD, Health Care Consultant March 29, 2007

2. Key Questions We Will Address Today • What are the do’s and don’ts in convincing the payers’ medical directors that your product is worth covering and reimbursing? • What are medical directors looking for? • How do they make decisions? • And what are some strategies one successful medical company uses?

3. Before We Start . . . • What is your Reimbursement Strategy? • Where does discussion w/Medical Director fit in your overall reimbursement strategy? • Medical Director is just one stakeholder • Medical Director may influence coverage decisions . . . don’t forget about coding & payment

4. GEHC Reimbursement Program

5. Reimbursement Objectives • Accelerate reimbursement for new products • Respond to customer needs for existing products • Develop & advocate public health policies favorable to GEHC products

6. Reimbursement Objective #1 Reduce cycle time from product launch to customer paid & patient access Regulatory Approval $ Customer Paid + Improved Health Outcomes Existing Procedure Existing Coding/Coverage/Payment New Code (15 mos. min) New Payment (1-2 yrs) New Procedure Expanded Coverage (1-5 yrs) 0-7years

7. Creating “Surround Sound” With Key Stakeholders Coding • AMA • CMS Coverage Payment • CMS • Priv Payers • Legislature • CMS • Priv Payers

8. Objectives of Payer Focus We Will Be Successful, If We Can Create Positive, Ongoing Dialogue With Payers • Understand coverage & payment policy processes (decision makers, influencers, requirements, timing, communication) and where we can influence • Gather payer input into product reimbursement strategies: clinical trial design, reimb. tactics to support coverage • Collaborate with payers to accelerate coverage for new technology, where appropriate

9. We Will Be Successful, If We Can Create Positive, Ongoing Dialogue With Payers Objectives of Payer Focus • Develop relationship w/ major payers for open communications when favorable/unfavorable policy changes made (coverage, payment, utilization) • Gather payer input on product development– how to meet their needs (VBM/P4P data, pricing transparency; reducing medical errors; linking claims data w/ pt. history; provider accreditation) • Identify opportunities to collaborate on major health policy initiatives (IT initiatives, VBM/P4P, Quality)

10. Preparing for the meeting Meeting With Medical Director • Inventory payer relationships • Select target payers • Research target payer policies/positions • Assemble clinical value story (WIIFM) • Assess existing evidence

11. Preparing for the meeting Meeting With Medical Director • Assess provider & professional society support • Prepare agenda & presentation • Determine/secure meeting participants • Modify Reimbursement Strategy accordingly • Maintain dialogue with payer

12. Who should attend the meeting? Meeting With Medical Director • Practicing physician • Technical expert • Clinical trials design expert • Senior company representative • Consultant / Facilitator • No Sales & Marketing

13. Meeting Agenda Meeting With Medical Director • Objectives – what is your ask? • Disease overview • Procedure/technology overview • Evidence review & clinical trial plans • Specific questions for payer • Next Steps

14. Do’s • Must be part of overall reimbursement strategy • Be prepared • Be clear & consistent • Be careful what you ask for • Treat Medical Director as Customer

15. Don’ts • Over commit • Raise the evidence bar • Blow smoke • Overstate outcome of meeting to commercial teams

16. Medical Director Perspective

17. Medical Device Companies • Capital • Personnel - researchers & medical workers • Disease expertise - knowledge of disease states from device development process • Clinical expertise - insights & outcomes from clinical trials • Influence - tools & techniques to influence patients & providers • Devices - clinical therapy

18. Things You Need to Know About Your Target Health Plans • Structure of plan – local/regional/national impacts the message • Who is at risk and for what – capitation/P4P • Radar screen diagnoses and # lives • Key decision makers – bottom up vs. top down • Competitive environment • Political environment • Coverage/Tech Assessment Process

19. Clinical vs. Reimbursement Usually separate process with clinical decision made first, BUT may vary with plan In most plans, a medical director chairs clinical committee process As part of process most plans use outside assessment companies (BCBS, Hayes, ECRI) Criteria: FDA approval of technology/device Documentation of safety Must be as efficacious as current treatment Improves health outcomes Independent scientific evidence Coverage/Tech Assessment Process

20. Outside Requests Most often from network providers Consumer Groups Patients Manufacturers Health plan staff Large employer “Squeaky Wheels” Process Initiation Will benefit health plan members Technology related to high utilization service or disease Will significantly reduce other health care costs And, I need to know that it’s important! Coverage/tech Assessment Process – What Kick-starts the Medical Director?

21. Things to Do: • Appreciate the role of the medical director – I’m your customer! • Take the time to provide me with evidence-based information and tools to help me make an appropriate decision • Make sure what you say to me is consistent with what you say to physicians and consumers • KNOW YOUR STUFF!

22. More Things to Do: • GET TRAINED! • It is important that you understand how health plans function • Learn the roles of key staff and what keeps them up at night • Excellent training companies are available that have had extensive experience in the pharma industry

23. What Not to Do: • Don’t nag me, I’m busy. I do care but I’m juggling multiple projects • Don’t waste my time – KNOW YOUR STUFF! • Don’t do anything that is not consistent with industry standards and ethical and legal business practices.

24. How to Influence Me Appropriately • Surround Sound – increase the noise level • Key opinion leaders • Local influential physicians • Clinical practice guidelines • National society evidence-based protocols • Non-branded disease awareness: increase the size of the pie—benefits all patients • Practicing physician awareness: publish, present, via specialty societies • Work with employers and employer groups

25. How to Influence Me Appropriately • Develop a relationship with me based on trust and mutual respect • Learn best ways to communicate with me • Be dedicated to my organization: research and know my plan • Get involved in plan initiatives • Provide “value-added” services that benefit the plan, providers, patients • Measurement tools to assess performance of care and services in health plans • Disease management tools • Focus on appropriate outcomes – such as quality, utilization, cost, and satisfaction

26. Partner with Me • Early involvement in product development, launch, and promotion • Algorithms to support appropriate use • Educational pieces • Phase 4 trials • Joint promotion of preferred devices • Collaborative initiatives with plans, providers & employers