Baker Tilly’s life sciences consulting practice delivers proven methodologies, based on objective survey data, to develop FMV rates and related tiers for compensating HCPs and non-HCPs. Our solution is flexible and global, and our documented methodology is defensible to any inquiring regulatory body.

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    fmvNOW™

    Establishing FMV is not always an easy task. To help you and your life sciences organization establish FMV rates for engagements with healthcare professionals (HCPs), as well as non-HCPs, our fmvNOW™ tool is here to help. fmvNOW™ aids in protecting your company’s and product’s value through a variety of unique features with our novel application.

    Non-HCP related FMV

    Global regulatory focus is not just on payments to HCPs. FMV enforcement has expanded to include non-HCP related activities. Baker Tilly provides FMV analysis and methodologies to address these areas as well, including:

    • Bona-fide services fees (BFSF) related to fee-for-service arrangements with channel partners
    • IIS/IIT grants
    • Clinical trial FMV

    KOL tiering

    It is appropriate to compensate certain individuals at a higher FMV rate than others based on an objective assessment of individual expertise. Categories of expertise to be evaluated can include, but may not be limited to:

    • Employment experience
    • Publications
    • Involvement in clinical trials
    • Speaking and advisory engagements
    • Association and journal affiliations

    Depending on the level of expertise in each category, an individual can be assigned as a National/International Thought Leader, Regional Thought Leader or Local Thought Leader. This process is important to the overall methodology and in mitigating risk as it ensures that FMV rates are correctly applied across the thought leadership tiers. For example, if a regional thought leader is assigned the FMV rate for a national/international thought leader, this could result in an overpayment of more than 100% depending on the specific specialty and country.

    Baker Tilly can help

    Ensuring payments to HCPs and other non-HCP related services are being made at FMV is one of the more powerful controls a company can do to mitigate risk associated with the Anti-Kickback Statute and False Claims Act. It is also good business practice and allows your company to have more insight into how you are spending your money. Baker Tilly’s team of Value Architects™ can help your organization put this in place and protect your company's value.

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    Jan. 24, 2023

    Life sciences industry forecast for 2023 and beyond

    Join us for our second annual Life Sciences Industry Forecast event where we will explore developments from this past year, discuss the current state of the environment and look at trends and challenges shaping the industry in 2023 and beyond.