Fair Market Value (FMV) in Healthcare Compliance: Turning Regulatory Expectation into an Operational Capability

Fair Market Value (FMV) in Healthcare Compliance
Fair Market Value (FMV) remains one of the most scrutinised and operationally complex areas of healthcare compliance. For pharmaceutical, biotech, and medical device companies, FMV is not merely a pricing exercise, it is a core compliance control underpinning ethical engagement, anti-bribery and anti-corruption (ABAC) frameworks and transparency.

As global enforcement expectations continue to rise, regulators and self-regulatory bodies increasingly focus on how FMV is determined, documented, and applied in practice. While most large organisations have policies and structures in place, many small to medium size still struggle to translate FMV requirements into consistent, defensible, and scalable operational processes. The result is a persistent gap between written standards and day-to-day execution.

FMV in the Healthcare Context

FMV refers to the value agreed upon in an arm’s-length transaction between independent parties, where neither party can improperly influence the other. In healthcare, FMV applies when companies engage Healthcare Professionals (HCPs), Patients, Patient Representatives, members of the Public, Payers, for legitimate services such as advisory boards, speaking engagements, training, consulting, market research, scientific collaboration, etc.

The principle is clear: compensation must reflect the genuine value of services rendered and must never be linked, directly or indirectly, to inducement, prescribing, purchasing, or recommendation behaviour.

FMV therefore operates as a key safeguard within broader ABAC controls, helping mitigate risks under anti-kickback laws, bribery legislation, industry codes (EFPIA, MedTech Europe, local regulations), and global transparency and disclosure requirements.

Why FMV Is Under Heightened Scrutiny

Regulators now look well beyond the existence of an FMV policy. During audits, inspections, and investigations, organisations are expected to demonstrate:

  • Clearly defined and current FMV methodologies
  • FMV Tiering,
  • Consistent application across engagement types and geographies
  • Robust documentation, approval workflows, and audit trails
  • Alignment between FMV decisions and transparency disclosures

The critical question has shifted from “Do you have an FMV policy?” to “Can you clearly explain, evidence, and defend how this rate was determined?”

The Compliance and Business Impact

Poor FMV governance exposes organisations to regulatory findings, transparency discrepancies, reputational damage, and remediation costs. Equally, overly restrictive or impractical FMV approaches can hinder legitimate scientific exchange, frustrate internal stakeholders, and damage trusted relationships with HCPs.

Leading organisations are reframing FMV as an operational capability embedded within engagement, contracting, and transparency workflows. This shift requires:

  • Periodic review and recalibration of FMV methodologies
  • Clear governance aligned with ABAC and transparency frameworks
  • Strong documentation standards and approval controls
  • Integration into systems and processes used by the business

How Eunomia Supports FMV Governance and Delivery

Eunomia supports clients through clearly defined SOW-based engagements covering FMV framework design, benchmarking, governance, and operational implementation. Our services focus on building defensible FMV methodologies aligned with regulatory expectations while remaining practical for real-world use.
We assist with rate development and benchmarking, documentation standards, workflow design, exception handling, and audit readiness. Importantly, we help ensure FMV processes are aligned with transparency reporting and broader compliance programmes, including ABAC controls and third-party governance.

Conclusion

FMV is not about paying the lowest possible rate; it is about paying the right rate, for the right reason, and being able to demonstrate that decision with clarity and confidence. As expectations continue to rise, organisations must move beyond checkbox compliance and embed FMV as a transparent, well-governed, and operationally effective capability.

Eunomia partners with healthcare organisations to turn FMV from a compliance risk into a compliance strength—through structured, pragmatic, and audit-ready solutions.

Posted in Blog

Leave a Comment

Your email address will not be published. Required fields are marked *

*
*