KOL Fair Market Value and Aggregate Spend umentation Tracking

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KOL Fair-Market Value and Aggregate Spend: Documentation,
Tracking and the Sunshine Act

Description:    Establish and maintain compliant fair-market value (FMV) physician fee schedules and prepare for
                imminent regulatory changes. This study showcases processes and strategies for determining FMV
                compensation and it provides step-by-step guidance for implementing a world-class documentation
                system for aggregate spend tracking.

                Comprehensive, easy-to-read tables and charts show the actual hourly rates and flat fees paid to
                KOLs for their services. Examine current FMV benchmark data for specialists, subspecialists,
                primary care physicians, mid-level providers and allied health professionals. Use accompanying
                content to understand changes that companies have implemented in their FMV development

                Cutting Edge Information is the industry leader in fair-market value benchmarking. Since 2006, we
                have pioneered the study of physician fee schedules, with a special focus on legislative and policy
                changes. Our extensive knowledge base allows us to pinpoint the effects of past policy changes and
                make strategic recommendations that will help prepare teams for the future of thought leader

                Prepare for The Sunshine Act

                Since the 2009 study on KOL fair-market value compensation, the United States has passed
                legislation to regulate all payments made by life sciences companies to physicians. The impact of
                the Sunshine Act is already being felt as pharmaceutical, biotechnology and medical device
                companies invest millions of dollars to implement aggregate spend tracking systems. These
                systems are critical components in remaining compliant and meeting the requirements laid out in
                the Sunshine Act. Our study reveals the most sought-after characteristics of a top-notch
                documentation system and the best practices for implementing one that will stand up to regulatory

                Over the past few years, other changes have altered the KOL landscape. KOLs themselves are
                beginning to push back against the increased scrutiny surrounding their industry relationships. In
                addition, legislation resulting in increased transparency has caused the overall KOL pool to shrink.
                These factors raise new challenges:

                - How are companies navigating these regulatory hurdles?
                - What are they doing to find and cultivate successful KOL relationships?
                - What are the most effective activities for which to utilize KOLs?

                Chapter 1: Trends Impacting KOL Compensation

                Chapter Benefits:

                - Prepare for the Sunshine Act’s requirements by understanding how your FMV compensation
                strategy will be impacted.
                - Implement tracking systems to meet Sunshine Act requirements
                - Navigate the regulatory changes with succinct analysis.
                - Organize and centralize your KOL compensation efforts.
                - Learn how disclosure requirements (both federal- and state-level) will impact your KOL
                - Approach rising star thought leaders with different strategies than established KOLs to attract
                their services.
                - Understand how KOLs are reacting to disclosure/transparency requirements and pushing back on
                life sciences companies.
                - Understand how companies are managing the restrictions placed on KOLs by academic institutions
                and medical publications.
- Segment your KOLs appropriately to avoid conflicts of interest with external restrictions, such as
at certain hospitals.
- Learn how to maintain valuable KOL relationships in a rapidly shrinking KOL pool.
- Compete for top KOLs’ services by offering attractive scientific opportunities.

Chapter Metrics:

15 charts primarily showing data on the benchmarks for the number of thought leader relationships
per company:
- Total number of primary care physician relationships per company
- Total number of mid-level provider relationships per company
- Total number of allied health professional relationships per company
- Average hourly rates for top-tier KOLs by year
- Average number of specialist relationships per company per year
- Number of companies with more than 1,000 KOL relationships per year
- Total number of specialist relationships per company
- Average primary care physician relationships per company

Chapter 2: Calculating Fair-Market Value

Chapter Benefits:

- The FMV process is not set in stone. Learn the best practices companies have implemented to
arrive at fair-market value for services.
- Understand how legal and compliance teams fit into the process and how they should influence
the FMV process.
- Build flexibility around FMV levels to attract top KOLs while continuing to remain compliant.
- Provide executives with tools to negotiate KOL compensation and resolve FMV conflicts.
- Avoid over-analyzing fair-market value and arrive at a reasonable fee schedule.
- Establish a system to identify and segment KOL targets that includes.
- Establish criteria to define KOLs.
- Target different KOLs based on company size and specific activity.

Chapter Metrics:

5 charts focused on the types of KOLs that companies target:
- Percentage of companies that target each KOL type to build a relationship:
- Percentage of Top 25 companies that target each KOL type
- Percentage of Top 50 companies that target each KOL type
- Percentage of Top 100 companies that target each KOL type
- Percentage of Device and Diagnostic companies that target each KOL type

Chapter 3: Documenting Thought Leader Compensation

Chapter Benefits:

- Understand the detailed requirements outlined in the Sunshine Act.
- Create a database for storing and tracking records of KOL payments.
- Implement best practices for documentation, which is an emerging and key trend in KOL
compensation compliance.
- Establish procedures for documentation as they will be more important to compliance than actual
FMV payments.
- Understand corporate integrity agreements and their implications to avoid pitfalls.
- Coordinate KOL compensation practices across the board to ensure compliance
- Build an FMV database using the steps outlined in this chapter.
- Learn how to make your FMV database useful to the key functions across the organization.
- Centralize fair-market value compensation information and setup appropriate access points to it.
- Manage compensation limits
- Learn how to compensate for travel expenses.

Chapter Metrics:

24 charts focused on compensation limits, the types of activities that companies pay for and travel
- Top 50 pharmaceutical companies with corporate integrity agreements in place
- Percentage of companies with annual caps on KOL compensation by company size:
-- Top 25 companies
-- Top 50 companies
-- Top 100 companies
-- Device and Diagnostic companies
- Actual annual compensation limits for individual thought leaders
- Percentage of companies whose annual caps cover specific activities:
-- Commercial/marketing
-- Research and development
-- Medical publications
-- Speaker programs/medical education events
-- Thought leader development
- Percentage of companies that cover associated costs:
-- Preliminary work
-- Accommodations during travel
-- Travel method
- Percentage of companies that pay for travel separate from payment for services (by company
- Method of payment for KOLs’ travel expenses
- Average flat rates for travel time (when applicable)
- Method companies use to calculate KOLs' travel time (when applicable)
- Percentage of companies that pay for KOLs' out-of-pocket expenses while traveling (when
- Percentage of companies that pay premiums for KOLs' international travel (when applicable)

Chapter 4: Compensation for Clinical Development KOLs

Chapter Benefits:
- Recruit and manage clinical KOL relationships.
- Understand why clinical consulting and advisory services will be equally scrutinized compared to
commercial/promotional activities and, therefore, subject to FMV procedures.
- Benchmark duration of clinical and commercial activities.
- Benchmark clinical compensation (flat and hourly rates).
- Learn how companies identify appropriate KOLs for clinical work.
- Implement best practices to invest in interpersonal networking to reach more clinical KOLs
- Learn how to manage clinical KOLs
- Identify additional KOLs through existing clinical relationships.
- Attract KOLs by offering top-notch scientific opportunities.

Chapter Metrics:

23 charts focused on the differences in compensation for clinical vs. commercial activities:
- Average duration of clinical and commercial activities
- Average hourly rates and flat fees for clinical activities by provider type:
-- Specialists
-- Subspecialists
-- Primary care physicians
-- Mid-level providers
-- Allied health professionals
- Premium increase for top-tier clinical KOLs
- Percentage of companies that rely on experts/KOLs from various academic institutions:
-- Harvard
-- California system
-- UPenn
-- Tufts
-- Columbia
-- Stanford
-- Wash. Seattle
-- Dana-Farber
-- Wash. St. Louis
-- MD Anderson
--   Princeton
--   Yale
--   Duke
--   Michigan
--   MIT
--   Purdue
--   Vanderbilt

Chapter 5: Analysis of Aggregate FMV Payment Data

Chapter Benefits:
- Benchmark fair-market value rates:
-- By KOL type
-- By company size
-- By activity
- Benchmark both hourly rate and flat fee payments.
- Understand the compensation tendencies and trends of different companies in different situations.
- Learn how to compensate different KOLs at fair-market value.
- Adjust your fee schedule based on the decreases in FMV compensation benchmarked by Cutting
Edge Information.
- Analyze FMV payments by KOL type, by company size and by activity.

Chapter Metrics:

44 charts focused on actual FMV payment benchmarks:
- Average duration of clinical and commercial activities
- Method of payment for KOL services by company type:
- Average duration of KOL activities:
-- Participating in an advisory panel
-- Leading an advisory panel
-- Delivering a promotional speech
-- Delivering an educational speech
-- Commercial consulting engagements
-- Clinical consulting engagements
- Average base hourly and base flat rates
-- by KOL Type:
-- By Company Size
-- By Activity

Appendices: Fair-Market Value Benchmarks

Chapter Benefits:
- Average hourly rates and flat fees
- Median hourly rates and flat fees
- Minimum hourly rates and flat fees
- Maximum hourly rates and flat fees

Furthermore, the data are broken down by:
- Company size
-- Top 25
-- Top 50
-- Top 100
-- Device and diagnostic companies
- KOL type
-- Specialists and subspecialists
-- Cardiologists
-- Endocrinologists
-- Hematologists
-- Neurologists
-- Oncologists
-- Surgeons
-- Primary care physicians
-- Family/general practitioners
            --   Internists/hospitalists
            --   Pediatricians
            --   Preventive medicine providers
            --   Mid-level providers
            --   Nurse practitioners
            --   Physician assistants
            --   Allied health providers
            --   Nurses
            --   Pharmacists
            --   Activity
            --   Clinical consulting engagements
            --   Commercial consulting engagements
            --   Delivering a promotional speech
            --   Delivering an educational speech
            --   Leading an advisory board
            --   Participating in an advisory board

Contents:   Executive Summary
            - Profiled Companies
            - Specialty Areas of Focus
            - Study Methodology
            - Study Definitions
            - Key Findings and Recommendations

            Trends Impacting KOL Compensation
            - The Impact of Disclosures on KOL Compensation
            - Restrictions at Academic Institutions and Medical Journals
            - KOL Experience Level Affects Engagement and Pushback
            - Managing Relationships in the Shrinking KOL Pool

            Calculating Fair-Market Value
            - The FMV Process
            - Segmenting and Organizing Thought Leaders
            - Outsourcing

            Documenting Thought Leader Compensation
            - Compensation Limits
            - Travel Compensation

            KOL Compensation for Clinical Development
            - Clinical Consulting Versus Commercial Consulting Compensation
            - Differentiation of Clinical KOL Types
            - Recruiting and Managing Clinical KOL Relationships
            - Diversifying KOL Relationships Across Academic Institutions

            Analysis of Aggregate FMV Payment Data
            - Fair-Market Value Payments for Individual Activities
            - Fair-Market Value Payments by Company Size

            - Aggregate Fair-Market Value Benchmarks for All KOLs
            - Aggregate Fair-Market Value Benchmarks for Select Specialists
            - Aggregate FMV Benchmarks for Primary Care Physicians, Mid-Level Providers and Allied Health

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                                       the Sunshine Act
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