1. January 12-13, 2010 Washington, D.C. ExLPharma’s Tracking & Reporting Aggregate Spend Highlights

2. Why is Training Critical to the Success of Accurate Data Capture and Reporting? One of the 7 Elements of a Compliance Program Process is not intuitive to many areas of business…especially commercial Data systems in most organizations weren’t designed to be integrated CRM Accounting Speaker Bureau Grants Effective training reduces organizational risk Understanding state restrictions and accurate reporting is a shared responsibility of all employees Understand the restrictions and data entry process Follow the guidance Seek advice when necessary Shared Responsibility

3. When is the Right Time to Train on State Laws and Reporting Requirements? Integrate into existing training process New employee orientation and new rep sales schools Ongoing training Live training at meetings, e.g. brand team or sales meetings Position throughout the year – “learning through repetition Manager training Must have understanding and “buy in” from the top down Develop specific training applicable to managers Refresher training Sessions at meetings Prior to events, e.g. American Academy of Physicians, American Society of Hospital Pharmacists Booth Training for national meetings

4. Comprehensive Training and Communication Critical Elements to the Success of Accurate Data Capture and Reporting Compliance Officers Policy & Procedures Leadership Computer Based Client Live Training Compliance Training Newsletters Webex Training Tools Internal Website

5. Who Should be Trained on State Laws and Reporting Requirements?Training by Business Areas

7. Management

8. Employees in High Engagement Areas

9. Operations

10. Administrative Support

11. Third PartiesMedical Affairs R & D Corporate Shared Service (e.g. Public & Government Affairs)

13. Management

14. Employees in High Engagement Areas

15. Operations

16. Administrative Support

17. Third PartiesMedical Directors MSLs Med Info Grants Office Biostatistics Consultant Engagements

18. Focused Training for State Laws and Reporting Requirements Benefits of Focused Training: Relevance Retention Considerations for focused training: Who within the department interacts with health care professionals? Does the department affect the calculation and reporting of HCP payments and meals? Risk areas identified in audits Resource Considerations: Do you have the resources (internal/external) to develop focused training? Do you have a training platform than can support focused training assignments?

19. Comprehensive Training and Communication Critical Elements to the Success of Accurate Data Capture and Reporting Compliance Officers Policy & Procedures Leadership Computer Based Client Live Training Compliance Training Newsletters Webex Training Tools Internal Website

20. Considerations for Training Senior Management Organizational implications of aggregate spend gaps…spending or reporting Training Venue Look for existing meetings that include many of the key personnel Sr. Staff Meeting Executive Leadership Committee Corporate Compliance Committee Content: Make it relevant Identify the most likely instances in which Sr. Management might encounter state restrictions Headquarter and satellite locations Congresses International meetings involving U.S. HCPs

21. Considerations for Training Senior Management Engage the administrative staff Administrative staff manage calendar and travel…and can provide reminders prior to travel Administrative staff frequently handle expense data and can help change old behaviors. Reminder of internal meal caps Reminder of information needed in order to complete data entry Reminder of state restrictions/prohibitions Leverage existing meetings of Executive Assistants

22. Comprehensive Training and Communication Critical Elements to the Success of Accurate Data Capture and Reporting Compliance Officers Policy & Procedures Leadership Computer Based Client Live Training Compliance Training Newsletters Webex Training Tools Internal Website

23. Training for State and Federal Reporting Where should you focus your training efforts? Is this an Allowable Expense under state Regulations? How should the data be recorded? Expense Reports Tracking System CRM Law Rules Restrictions Yes Policy Process

25. VideoLive Webex Conference Call

26. Effective Training of State Laws and Reporting Requirements Consider phases of training: Phase I—Self study and completion of web-based training Phase II—Live participation Face to face meeting Webex Conference call Phase III—Refresher training Sessions at departmental or annual meetings Prior to events

27. Effective Training of State Laws and Reporting Requirements Case studies are an effective way to engage employees to actively participate in the training session Tailor the case study to the audience (when possible) Provide scenarios that include “shades of gray” Leverage manager’s influence Develop Case Studies (with a trainer guide) for use by the manager Remediation of improper data entry-WIIFM Involvement of manager in retraining Manager’s role in expense

28. Comprehensive Training and Communication Critical Elements to the Success of Accurate Data Capture and Reporting Compliance Officers Policy & Procedures Leadership Computer Based Client Live Training Compliance Training Newsletters Webex Training Tools Internal Website

29. Monitoring an Aggregate Spend System We’ve Got an App for That

30. What Data Is in an Agg Spend System 19 Potentially: Field sales spend on HCPs (meals/items) Displays/exhibits Speaker program spend (meals, speaker fees, expenses) Speaker training Home office meals with HCPs Consultant payments Advisory boards Investigator payments/Trial costs Grants (educational, sponsorship, IST) Charitable contributions Advertising costs (media, DTC)

31. Risks of a Robust System 20 We’ve Got an App for That What you have MORE of: Data From more sources In more detail Flexibility (being in one system) Greater ability to analyze data What you may NOT have more of: IT headcount to continue development Operational headcount to monitor data explosion Headcount/expertise to analyze data What may outside (OIG/AG) expectations be?

32. Monitoring: What, Who, When, How? 21 What are you monitoring? Accuracy & completeness of data Potential policy violations Who is responsible for monitoring? Individuals who ‘spend’ Business units & departments who own or manage the spend Corporate Compliance (or Dept. that reports spend) When Should monitoring be ‘scheduled’? How Making monitoring user-friendly

33. Opportunities for Improved Compliance 22 Monitoring The low hanging fruit Aggregate spend on individual HCP across the company Dine & dash (view data by rep – multiple lunches/same day) Value of items/textbooks (internal policy limits) Meal policy infractions (limits, venue, prohibitions) Speaker program policy infractions (attendees, venue, etc.) Speaker or consultant use across all departments More challenging Matching product detailed to HCP specialty. Requires robust customer master data Potential Conflicts of Interest Identifying agg. spend across related entities (HCP/HCO)

34. Auditing an Aggregate Spend System

35. Importance of State Law Knowledge in Designing Audits 24 Who, What, Where and When Who is the covered? doctors, nurses, managed care, hospitals What is covered? Meals, consultants, clinical trials, speakers, government pricing Where? Offices, hospitals, CME, conventions, When? Monthly, semi annual, yearly, calendar vs other time period Was this ever audited before and by whom? How often? Auditor experience Internal and external resources

36. National Verses Individual State Samples 25 Does the national sample suffice for a state? Products Employees Field sales vs HQ Location HQ vs Regional Office vs R&D vs Manufacturing Cost of national audit sample is much lower than sampling by state 100% vs some reasonable sample population PhRMA Code vs State Laws

37. Types of Spend to Audit & the Controls 26 What is covered? Meals, consultants, clinical trials, speakers, government pricing Controls Policies and procedures Control documents invoices, contracts, expense reports, payroll expenses, accruals Review and approval Automated (computer generated) vs manual (signature of manager) Monitoring Exception Reports Warning notices Audits

38. Audit Reports 27 Executive Summary Scope and objective Sample size Procedures Detailed observations Recommendations Management response; who and when

39. System Involvement 28 Types General ledger T&E Speaker Grants R&D spending Consultant Payroll Seamless and transparent Reconciliation Audit trails Reporting capability

40. Pharmaceutical and Medical Device Manufacturer Conduct

41. Regulations: Purpose Seeks to identify and minimize potential financial conflicts of interest. Seeks to ensure transparency around industry payments to health care practitioners without compromising legitimate and beneficial industry-health care practitioner interactions. Seeks to place pharmaceutical and medical device manufacturers on equal footing with respect to the specific requirements of Chapter 111N. Specifically incorporates requirements from the PhRMA and AdvaMed Codes of Conduct as mandated by Chapter 111N.

42. Regulations: Process Proposed regulations presented at December 2008 PHC meeting for informational purposes. Two public hearings in January 2009. Comment period closed on January 19, 2009. Oral and written commentary summarized and reviewed by the Department. Final regulations presented at March 2009 PHC meeting for approval.

43. Who Submitted Comments? Consumer advocacy groups and individual consumers Pharmaceutical, Biotech and Medical Device Industry Trade Groups Individual Pharmaceutical, Biotechnology and Medical Device Manufacturers Health Care Practitioners Visitor Industry Charitable Organizations Payors, Pharmacy Benefit Managers and Purchasers of Drugs, Biologics or Medical Devices

44. Balancing the Interests In depth analysis of testimony received. Clarified the regulations where necessary. Made substantive changes with 3 goals in mind: To limit industry interactions with health care practitioners that may influence prescribing patterns and/or affect the care patients receive. To increase transparency surrounding industry payments to covered recipients. To not unduly restrict beneficial industry interactions with health care practitioners/other covered recipients that increase access to advances in the diagnosis, treatment and prevention of disease.

45. Code of Conduct Restrictions

46. Who is Subject to the Code of Conduct Restrictions? Pharmaceutical or Medical Device Manufacturing Companies (“PMDMC”) that employ or contract with pharmaceutical or medical device manufacturer agents, and: Are engaged in the production, preparation, propagation, compounding, conversion or processing of prescription drugs, biologics, or medical devices, either directly or indirectly or Are directly engaged in the packaging, repackaging, labeling, relabeling or distribution of prescription drugs, biologics or medical devices. Does not include health care practitioners (“HCPs”), physician practices, hospitals, clinics, home health agencies or retail pharmacies.

47. Who is Affected by the Code of Conduct Restrictions? Persons who: Prescribe prescription drugs for any person, and Are licensed to provide health care in the Commonwealth Partnerships or corporations comprised of such persons, or their agents. Does not include bona fide employees or boardmembers of PMDMC, acting in their capacity as such.

48. Code of Conduct Prohibited Activities

49. General Marketing Prohibitions Entertainment or recreational items of any value; Payments in cash or cash equivalents either directly or indirectly except as compensation for bona fide services; The provision of complimentary items such as pens, coffee mugs, gift cards, flowers, etc; and Grants, scholarships, subsidies, consulting contracts, or educational items in exchange for prescribing or disbursing prescription drugs or medical devices.

50. Prohibited Meals Meals that are part of an entertainment or recreational event; Meals that are offered without an informational presentation made by a pharmaceutical or medical device marketing agent; Meals outside of a HCP’s office, hospital, academic medical center or specialized training facility; and Meals provided to a HCP’s spouse or other guest.

51. Prohibited Payments: CME, Conferences and Meetings Financial support for the cost of travel, lodging, attendance or other personal expenses of non-faculty HCPs; Direct payment of an HCP’s meals; Sponsorship of CME where the sponsorship is not compliant with the commercial sponsorship standards established by ACCME or other equivalent standards.

52. Code of Conduct Permissible Activities

53. Permissible Meals Modest and occasional meals in conjunction with informational sessions in specified clinical training settings. Sponsorship of meals at third-party scientific, educational or charitable conferences or professional meetings. Meals pursuant to a written consulting agreement for bona fide services, sponsored genuine research or clinical trials.

54. Permissible Payments to Health Care Practitioners Reasonable compensation for substantial professional and consulting services of an HCP for a genuine research project or clinical trial. Reimbursement of reasonable costs necessary for technical training on a medical device if subject to a written agreement for purchase of the device. Charitable donations. The provision of price concessions, such as rebates or discounts in the normal course of business. Payments for bona fide services.

55. Payments Permitted for “Bona Fide Services” Research, Consulting, Advisory Board Participation, Speaker’s Bureau Participation Participation in company-sponsored training and education

56. Permissible Payments: CME, Conferences and Meetings Permissible payments: Compensation and reasonable expenses of conference faculty. Sponsorship - where the payment is made directly to the conference or meeting organizers.

57. Institutional Disclosures How do we prepare company leadership for increased institutional disclosure requirements in advance of federal disclosure? Follow-up: How do we prepare HCPs for increased institutional disclosure requirements in advance of federal disclosure? How are institutional disclosure requirements reshaping pharmaceutical Marketing? Follow-up: How are institutional disclosure requirements reshaping Compliance? Who are the company stakeholders in the institutional disclosure debate? Follow-up: Who is the ultimate decision maker? How do we assess the potential impact of institutional disclosures to the company? Follow-up: To HCPs? To the institution?

58. Will trade associations continue to be involved? How will AdvaMed, PhRMA, BIO and similar organizations continue to be proactive? The legislative arms of these groups have worked to educate legislatures to defeat bills and, in states like MA, to amend the bills to better enable compliance. Can industry through the trade groups gain more participation from medical and patient groups? The question about physician interest in these laws keeps coming up, but are doctors put off by the prospect of aligning with the pharma industry? Will the trade groups continue to be most involved before laws pass or will they sue again (consider the success or failure of the ongoing litigation in Vermont) What is the role of other less formal groups, like the Ad Hoc Compliance group counseled by King & Spalding or the consortium of companies updated by Hogan & Hartson on reporting laws (among other disclosure or transparency laws)?

59. Still have any questions? For additional information on ExLPharma’s Tracking & Reporting Aggregate Spend Conferences, please visit www.exlpharma.com