Fair Market Value & KOL Tiering
Appropriately tiering key opinion leaders (KOLs) and assigning fair market value (FMV) rates is a tedious process that is often prone to bias and human error.
To streamline this function and minimize your company’s risk of non-compliance with anti-kickback, anti-bribery and anti-corruption laws, our team of specialists have created fmvNOW® and kolNOW®.
Increasing scrutiny of engagements with KOLs
Life sciences companies frequently engage healthcare professionals (HCPs) and non-HCPs (e.g., reimbursement specialists) for consulting and advisory activities. When engaging with these key opinion leaders (KOLs), there are specific rules and regulations companies must follow to prevent and detect bribes and corrupt payments.
The Anti-Kickback Statue (AKS) makes it a crime to pay, offer, solicit or receive remuneration – directly or indirectly – to induce referrals or services of Medicare or Medicaid business. Further action under the Patient Protection and Affordable Care Act (PPACA) has expanded the AKS’ intent and specified that violations of the AKS may also trigger liability under the False Claims Act.
Payments made above established fair market value (FMV) rate thresholds can trigger a violation of the Foreign Corrupt Practices Act (U.S.), UK Bribery Act (U.K.), Clean Companies Act (Brazil) and Sapin II (France) among others.
Governing bodies are continuing to scrutinize these payments by ensuring KOLs are paid FMV for their services in accordance with their level of expertise. However, creating a defensible FMV rate card that establishes the amount KOLs should be compensated often tends to be time intensive, costly and subjective as there is minimal regulatory guidance on the methodology to employ.