Fair Market Value & KOL Tiering
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.
To help with this tedious process and to free up your valuable time so that you and your team can focus on more important matters, our team of innovative specialists has created fmvNOW and kolNOW. With these two powerful, self-service tools, life sciences companies can have direct access to the FMV rates of millions of pre-tiered KOLs through an online dashboard and in downloadable reports.
To help you and your life sciences organization establish FMV rates for consulting and speaker program engagements, our fmvNOW tool is here to help. fmvNOW will provide your life sciences organization with FMV hourly rates, activity rates, and travel time compensation across different KOL tiers and countries.
To help streamline the tedious and costly process of tiering KOLs according to their level of expertise, our kolNOW tool is here to help. kolNOW will provide your life sciences company with access to an on-demand database of more than eight million pre-tiered HCPs and non-HCPs, removing any form of bias or human error.
Ensuring consulting payments to HCPs and non-HCPs are being made at FMV is one of the more powerful controls a company can establish to mitigate risk associated with global regulatory requirements. It is also a good business practice and allows your company to have more insight into how you are spending your money. Baker Tilly’s team of life sciences specialists can help your organization navigate these regulations and protect your company's and product portfolio’s value.