© Huron Consulting Services LLC. All rights reserved. Aggregate Spend 101 March 5, 2009 L I F E S C I E N C E S A D V I S O R Y S E R V I C E S Manny Tzavlakis Director Life Sciences Advisory Services Huron Consulting Group (312) Marci Juneau Manager Life Sciences Advisory Services Huron Consulting Group (312)

Life Sciences Advisory Services 1 Current Regulatory Landscape  Industry relationships with healthcare professionals (“HCPs”) and healthcare organizations (“HCOs”) are under significant scrutiny by both Federal and state enforcement agencies.  Numerous life sciences companies have been investigated for matters related to their interactions with HCPs, including communications regarding the use of products, provision of gifts and hospitality, and compensation arrangements for services.  Several states have passed laws requiring the tracking and reporting of marketing and promotional spending on HCPs. Several additional state legislatures are discussing passing laws mandating manufacturer disclosure of spending and payments to HCPs, as is the Federal government with the proposed Physician Payments Sunshine Act.  With specific requirements by the FDA regarding financial disclosures for clinical investigators and numerous public inquiries into manufacturer relationships with HCPs, the simple perception of an inappropriate relationship could significantly harm a manufacturer’s reputation and market presence.  Result: the need for organizations to develop robust processes and systems to track and monitor spending on HCPs is a significant compliance requirement and a critical business need. Background on Aggregate Spend Tracking

Life Sciences Advisory Services 2 Enacted Legislation by State, as of 1/1/09 Gift Disclosure Laws: MA (Pending Final Rule), ME, MN, VT, WV, and DC File a report identifying the value, nature, and purpose of any gift, fee, payment, subsidy, or any other economic benefit greater than $25 (greater than $50 in MA) Prohibition & Disclosure Law: MN Prohibits certain gifts over $50 to any one HCP per year Requires disclosure of compensation and reimbursements valued at more than $100 Comprehensive Compliance & Reporting Laws: CA Establish annual, per-physician limits on gifts, promotional marketing materials and other items or activities (limits established by each company) Compliance with PhRMA Code and OIG Guidelines MA (Pending Final Rule), NV Adopt a written marketing code of conduct, a training program, identify a compliance officer, conduct annual audits of compliance with marketing code, and adopt policies for investigating non- compliance with the marketing code MN has Pending Legislation to Expand Current Law to Medical Device Manufacturers 9 states have enacted spend tracking / reporting laws; multiple state laws and the Sunshine Act are pending Current Regulatory Landscape

Life Sciences Advisory Services 3 Congressional Activity –Physician Payments Sunshine Act (pending) –Medicare Payment Advisory Commission (MedPAC) Recommendations to Congress –Senator Grassley (R-IA) and Senator Kohl (D-WI) inquiries Voluntary Disclosures –Charitable Donations and Grants Senator Grassley requested that several companies post their charitable donations and grants to medical organizations. Many of these companies have begun posting these transactions and others have stated they will begin posting in the near future. –Payments to Physicians Several companies will begin voluntarily posting payments to physicians in Corporate Integrity and Deferred Prosecution Agreements – Corporate Integrity Agreements (“CIAs”) Some recent CIAs require companies to publicly disclosure all customer payments. –Medical Device Deferred Prosecution Agreements (“DPAs”) DPAs mandate public disclosure of customer payments. Other Needs for Aggregate Spend Tracking Current Regulatory Landscape

Life Sciences Advisory Services 4  These aggregate spend tracking requirements necessitate the development of processes and systems to track aggregate spending at an enterprise level.  This is a significant business challenge for most life sciences companies, since very few organizations have systems and processes that are interoperable at the enterprise level.  Most systems are designed and implemented to meet very specific functional needs or departmental requirements (e.g., sales force automation, grants management, T&E, etc.). As a result, capturing all data necessary for state reporting represents a significant challenge for most life science organizations. So What Does this Mean for My Company? Aggregate Spend Reporting and Tracking

Life Sciences Advisory Services 5 Aggregate Spend Assessment – Getting Started  Status of Current Disclosure Activities –Who in your organization is currently making disclosures/certifications under the state laws? –Is the disclosure being made by each division of the company or for the entire company? –How is spend versus the declared cap being monitored under the California requirements?  Monitoring Efforts Regarding New State Disclosure Requirements –Is anyone within the company monitoring the status of current and pending state legislation to understand what is mandated by the existing and new disclosure laws? –Is there a Company-wide process for interpreting and implementing new state compliance or disclosure requirements? –Has the impact of the pending Federal Sunshine Act regarding payments to physicians that may ultimately preempt individual state laws been measured? –What is the Company’s plan to begin tracking for the Massachusetts law beginning 7/1/09?  Identification of HCP/HCO Spend –Which functions within the organization provide payments, gifts, or other items of economic value to healthcare professionals or healthcare organizations? –What systems are used to process or track these payments, gifts, or other items of economic value?  Tracking of HCP/HCO Spend –What is the Company doing to track spend in accordance with the existing state laws? Key Questions to Ask of Your Organization

Life Sciences Advisory Services 6 Aggregate Spend Assessment  Due to the previously mentioned issues, companies should consider evaluating individual aggregate spend situation.  To prepare for full compliance with state and pending federal disclosure requirements, companies should consider undertaking the following activities:  IMPLEMENTATION PROCESS  Customer Master Gain understanding of systems and processes Determine all channels where payments may occur Systems and Processes Identify touch- points with HCPs and HCOs across all key functional areas Develop complete inventory of activities and expenditure types Touch Points Map the touch- points to the current Business Systems and processes Mapping Identify notable gaps between the current process assessment and inventory Develop a vision for the company’s tracking Analysis Update/Acquire Customer Master so all HCPs can be uniquely identified and aggregated Customer Master Aggregate Spend Tracking & Reporting Activities

Life Sciences Advisory Services 7 Data Capture Issues for Honoraria Payments Aggregate Spend Assessment – Customer Master As part of the aggregate spend assessment, your company’s ability to allocate items to an individual HCP must be examined. This often includes reviewing the company’s existing customer master, or determining that one does not exist. –What is a customer master? A consolidated list of all HCPs, their credentials and their contact information. This includes a unique identifier for each HCP. –Why is this important? The goal of a company level customer master strategy is to identify unique HCPs at the time of the transaction or at a later time in order to facilitate tracking and reporting. The customer master allows the company to individually identify the actual recipient of spending. –Integration into Enterprise Systems Integrating an enterprise customer master into individual source systems will present unique challenges. Data is Key to a Successful Aggregate Spend Solution

Life Sciences Advisory Services 8 Aggregate Spend Assessment – Systems and Processes  Companies must understand all of their systems and processes through which HCPs or HCOs could receive value.  Each functional area within a company has a different need for tracking activities with physicians (e.g., sales, marketing, medical affairs, clinical, public relations, etc.).  Since the systems that support each of the functional areas tend to be developed for a specific need and do not generally interface with other systems across the company, capturing all data necessary represents a significant challenge. ERP System SFA System T&E System Grant Management KOL Tracking Clinical Trial Activity Designed for enterprise finance and logistic functions Designed to track sales force contacts Designed to accurately reimburse employees for expenses incurred Designed to track Medical Affairs contacts w/ KOLs and investigators Designed to track milestones and payments for investigator studies Designed to track grant payments and activity milestones Understanding Technical Requirements and Business Processes

Life Sciences Advisory Services 9 Aggregate Spend Assessment – Touch Points Field Sales (Non-Distributor) Field Sales (Non-Distributor) Medical & Clinical Affairs Marketing Third-Party Vendors Meals Gifts Grants Practice Aids Advisory Boards Consulting Services Publications & Speaking Medical Education Meals/Gifts Peer to Peer Meetings Advisory Boards Consulting Services Travel & Hospitality Service Fee Payments Consulting Services Sample Focus Areas Identifying HCP Spending Across Company  To fully comply with disclosure requirements such as those required under state marketing laws, manufacturers must first identify all of the circumstances under which healthcare entities are given payments, gifts or other economic benefits.  Manufacturers may find, however, that HCP spending is widely spread across the organization and is tracked in a variety of systems and manually updated spreadsheets by a multitude of departments. HCP/HCO Touch points

Life Sciences Advisory Services 10 Aggregate Spend Assessment – Mapping  After identifying all payment systems and spending types, companies should map the spending type touch-points and other spend identified to the current systems and processes in order to ensure that all necessary data is being captured. ERP System SFA System T&E System Grant Management KOL Tracking Clinical Trial Activity PaymentsMealsTravelGrantsLodgingDTC Ads Salary & Benefits Mapping Systems and Spend Types

Life Sciences Advisory Services 11 Aggregate Spend Assessment – Analysis  After completing all prior steps to understand the existing systems and processes, companies should identify notable gaps between the process assessment and activity inventory.  Companies must determine what their gaps are and how these can be filled in to complete the company’s aggregate spend tracking processes. Aggregate Spend Data Store Understanding Gaps in the Processes

Life Sciences Advisory Services 12 Aggregate Spend Assessment – Spend Reporting Implementation Spend Reporting Process/Tool Implementation  Using the aggregate spend assessment described in previous slides, companies can begin implementing a spend reporting process.  Addressing the key “front-end” processes and systems is critical to gathering the appropriate level of data necessary for aggregate spend tracking and reporting (including value, nature, and purpose of spend).  Without a robust data capture process for the “front-end” systems at the “point-of-entry”, organizing the data and structuring the transactions on the “back-end” will be a nearly impossible task.  Moreover, no aggregate spend tracking and reporting system will be capable of resolving issues of data completeness and accuracy related to “front-end” systems and processes.  Ultimately, the company may chose to either modify their existing processes and systems to capture and efficiently report on all necessary spend, or to purchase a comprehensive third-party software solution.  Several system vendors have developed wide-ranging solutions to capture, analyze, and report on expenditure data to HCPs. Your company will need to gain a thorough understanding of the current landscape of solution providers to select an appropriate technology solution if such a system is deemed appropriate. IMPLEMENTATION PROCESS

Life Sciences Advisory Services 13 Data Source 1 Data Source 2 Data Source 3 Data Source 4 ETL Process Operational Data Store Customer Master File Transaction Data Store w/ De-duping Functionality Rules Engine State Reporting Data Store Ad Hoc Reports Reporting Functionality State Disclosure Reports Company Systems Sample Aggregate Spend Systems Architecture Implementation of an Internal Tracking Mechanism Developing a Longer Term Vision for the Aggregate Spend Tracking System  Whether the company builds an aggregate spend tracking system or chooses a technology partner to build such a system, the development of business requirements to meet the requirements of tracking aggregate spend at an enterprise level will be necessary.  Note: the aggregate spend assessment described in the previous slides will allow companies to understand how their systems and processes fit into this picture.  Whether the company builds an aggregate spend tracking system or chooses a technology partner to build such a system, the development of business requirements to meet the requirements of tracking aggregate spend at an enterprise level will be necessary.  Note: the aggregate spend assessment described in the previous slides will allow companies to understand how their systems and processes fit into this picture.

Life Sciences Advisory Services 14 Proactive Compliance Management  As-Is / To-Be Strategy  Gap Analysis to determine issues across various division / functions in an organization  Roadmap created to blueprint next steps  Most effective use of commercial budget  Promotional Mix Optimization with rich “Reporting” data PHASE I: PLANNING “How do we determine spend?” PHASE II: REPORTING “How do we report spend?” PHASE III: PREDICTIVE “How do we spend more effectively?”  Business Process Analysis  Customer Touch Point Identification  Customer Master Integration  Aggregate Spend Reporting Tool Implementation  Sales & Marketing Decisioning  Commercial Data Center of Excellence (CoE) STEPS OUTCOMES  Transparency and Visibility for Ethics & Compliance  Seamless integration of tools needed for reporting processes  Scalability of solution to handle pending and future state and federal legislation An Aggregate Spend Reporting Roadmap

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