1. 1 Preparing for Compliance with the New MA Pharmaceutical and Medical Device Code of Conduct Law January 23, 2008 Rupa M. Cornell Director, SEC Compliance and Corporate Counsel

2. Agenda Overview of Boston Scientific Corporation Compliance Challenges Approaches to Compliance Key Tactics for Compliance Summary

3. 3 Founded in 1979 with 38 employees and $2 million in sales Now a global leader in cardiovascular medicine and one of the world’s largest medical device companies Portfolio of approx. 13,000 products, many with market leading positions 25,000 Employees Over 2,000 in MA Dedicated marketing and sales force in more than 45 countries 37 manufacturing, distribution and technology centers worldwide Boston Scientific Corporation Profile Corporate HQ: Natick, MA Regional HQs: Paris, Tokyo, Singapore Website: www.bostonscientific.com The TAXUS® drug-eluting coronary stent was the most successfully launched product in the history of the industry Added Cardiac Rhythm Management Group through acquisition of Guidant Corporation in April 2006

4. 4 Boston Scientific’s mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical devices and procedures. Boston Scientific’s Mission Statement Boston Scientific’s Mission This is accomplished through the continuing refinement of existing products and procedures and the investigation and development of new technologies that can reduce risk, trauma, cost, procedure time and the need for aftercare.

5. 5 Sampling of Boston Scientific’s Product Portfolio Broad and Deep Portfolio of Over 13,000 Products StentsEmbolic Protection Balloons Catheters / Guidewires Ultrasound Imaging Lithotripsy Systems Stone Retrieval Enteral Feeding Embolics Biopsy Systems Pacemakers / ICDs Detachable Coils Ablation Peripheral Dilatation Neurostimulation

6. 6 Boston Scientific is Organized into Five Businesses Neuromodulation Cardiac Rhythm Management Electrophysiology Urology Gynecology Endosurgery Cardiovascular Business Group International Americas Europe/ Middle East/ Africa Asia / Pacific Japan Endoscopy Interventional Cardiology Peripheral Interventions Neurovascular

7. 7 MA Statute – Compliance Challenges Broad statutory language “Bona Fide Services,” “Covered Recipients” and “Health Care Practitioners” Clinical trials and R&D included as part of Sales and Marketing activities? Vague language Fifty dollar threshold in aggregate or per transaction? Discounts and rebates Incomplete regulations

8. 8 Possible Approaches Broad approach to overall Health Care Practitioner (HCP) compliance taking Federal, state, local level laws into account Focused MA-only approach

9. 9 BSC Approach – HCP Project Boston Scientific is approaching HCP compliance broadly HCP Project Team Focused on our policies, systems and processes involved in planning, approving, monitoring, controlling, compiling and reporting HCP payments/relationships To ensure compliance with legal requirements, as well as with desired standards of conduct Key to staff project with leadership and team, and identify and budget sufficient resources

10. 10 BSC Approach- HCP Project Comprehensive workplan that addresses near term HCP program requirements, and anticipates long term requirements Closely align required HCP project workflows with project teams, with defined objectives/deliverables Develop cross- functional teams, with subject matter experts, as well as those who use the systems, processes and policies on a day- to-day basis Develop a program that is compliant and works Smooth implementation for company and HCPs

11. 11 Key Tactics - MA Since regulations are not yet final and statute remains broad and vague, gather all possibly relevant data and refine once regulations are final Continue vigilant lobbying efforts until regulations are finalized

12. 12 Key Tactics - MA Information Technology is INTEGRAL & CRITICAL Information Technology Considerations: Identification of MA HCPs who fall within statutory requirements – consider outside vendor for databases Working across multiple business unit/payment systems, for consolidation or common data warehouse possibilities Systems to track travel and expenses and other spending sufficient detail captured to comply with MA statute System controls and tools to ensure compliance with requirements Online training for various groups across your organization

13. 13 Key Tactics – MA Define scope and elements of compliance, considering: US vs. Global application Identification of applicable ethical codes, Federal, state, local laws Anticipate future requirements to identify long term requirements/functionality that may be required Plan project and workflows Understand company’s current state Define expected end state Identify steps required to bridge from current state to expected end state Consider use of outside resources/advisors to assess current policies and procedures and recommended changes

14. 14 Key Tactics - MA Tee up key people and resources now Leadership Staffing Budget Develop appropriate cross-functional teams Legal Compliance Marketing Sales Communication Executive Management Clinical

15. 15 Key Tactics - MA Rolling Communication Plan Timing is critical Communicate on a high level now (e.g., National Sales Meetings) Be prepared to provide more specific communication as soon as the regulations are final Training Break-out sessions

16. 16 HCP Project Workflow Example of HCP Project Workflow Teams to address MA law or broader HCP initiative HCP Compliance Policies, Procedures & Work Instructions Management Processes & Controls Documentation Training & Communications Sustaining Compliance Federal, State & Local Requirements

17. Summary Be proactive – the time to act is NOW, even though regulations aren’t final Consider an approach that allows expansion/modification of MA compliance measures to meet other states, and likely Federal, law Communication and training are key

18. 18 Thank You Questions