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Episode 118 ·

Volume or Value Conundrum

Send us Fan Mail The Volume or Value Restriction under the Stark Law is a conundrum. In this episode, Captain Integrity Bob Wade breaks down how to approach compensation under the Stark Law. Hear why aggregate compensation can vary, why you can use the same analysis under the safe harbors under the Anti-Kickback Statute (AKS), why you should keep your compensation determination process separate, how volume and value are determined, and when to use volume or value. Learn more at CaptainIntegrity.com

  • Anti-Kickback Statute
  • Stark Law

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Volume or Value Conundrum

Episode Date: April 3, 2024

In this episode of Stark Integrity, Bob Wade (Captain Integrity) tackles one of the most complex and frequently misunderstood elements of Stark Law compliance:

The Volume or Value standard.

While the concept appears straightforward on its face, the practical application is anything but. This discussion breaks down how to think through compensation structures while avoiding arrangements that improperly take into account the volume or value of referrals.

What Is the Conundrum?

The core issue is simple:

Compensation cannot take into account the volume or value of referrals.

However, the challenge arises when:

  • Compensation varies based on productivity or performance
  • Financial outcomes are indirectly tied to referrals
  • Models are designed with multiple moving parts

This creates what Bob Wade describes as a conundrum:

Where is the line between permissible compensation and prohibited referral-based incentives?

“Varies With” vs. “Determined In Any Manner” — A Critical Distinction

A key technical point emphasized in this episode is the difference between two regulatory standards:

  • “Varies with” → Used only in the Indirect Compensation definition
  • “Determined in any manner” → Used in Stark exceptions

This distinction is critical.

“Varies With”

  • Applies specifically to indirect compensation arrangements
  • Focuses on whether compensation fluctuates based on referrals
  • Requires a more direct relationship between referrals and payment changes

“Determined In Any Manner”

  • Applies broadly across Stark exceptions
  • Is a much stricter standard
  • Prohibits compensation that is influenced by referrals in any way—directly or indirectly

The takeaway:

“Determined in any manner” casts a much wider net than “varies with.”

Even if compensation does not explicitly fluctuate with referrals, it can still fail compliance if:

  • Referral data influenced the design of the formula
  • Downstream revenue was considered in setting compensation
  • The structure reflects referral value indirectly

Why This Matters

This distinction is where many organizations get into trouble.

They assume:

  • If compensation does not visibly change with referrals → it must be compliant

But under Stark:

The real question is whether referrals influenced the compensation at all.

This means organizations must look beyond:

  • Outputs (how compensation behaves)

And focus on:

  • Inputs (how compensation was determined)

Aggregate vs. Per-Unit Analysis

Another key concept explored in the episode is how to evaluate compensation:

  • At the aggregate level
  • Or at the individual component level

Certain arrangements may:

  • Appear compliant when viewed in total
  • But raise concerns when broken into components

This reinforces:

How you analyze compensation matters as much as the compensation itself.

Separate the Analysis

One of the most practical takeaways is the need to:

Keep the Volume or Value analysis separate from FMV and Commercial Reasonableness.

Each addresses a different question:

  • FMV → Is the amount appropriate?
  • CR → Does the arrangement make sense?
  • Volume/Value → Was compensation influenced by referrals?

Blending these analyses creates risk and confusion.

Can Compensation Vary?

A common question addressed in the episode is whether compensation can change over time.

The answer:

Yes—but only for the right reasons.

Permissible variation:

  • Productivity tied to personally performed services
  • Legitimate quality or value-based metrics

Prohibited variation:

  • Compensation tied to referral volume
  • Payments based on downstream financial impact

The key distinction:

Variation itself is not the issue—referral influence is.

Practical Compliance Considerations

From an operational standpoint, organizations should:

  • Examine how compensation formulas are designed—not just how they function
  • Identify any inputs tied to referral patterns or revenue streams
  • Ensure documentation reflects independence from referral considerations
  • Separately analyze Volume/Value, FMV, and CR

Because in enforcement:

The structure—and the reasoning behind it—will both be examined.

Key Takeaways

  • “Varies with” and “determined in any manner” are not the same — the latter is broader and stricter
  • The Stark exceptions use the more expansive standard — capturing indirect influence
  • Compensation can comply in form but fail in design — if referrals influenced the structure
  • Volume/Value analysis is separate from FMV and CR — each must be independently satisfied
  • Permissible variation exists — but not when tied to referrals
  • Focus on inputs, not just outputs — how compensation is set matters as much as the result

Final Thoughts

This episode highlights one of the most nuanced—and consequential—interpretations in Stark Law:

It’s not just whether compensation changes with referrals—it’s whether referrals influenced it at all.

That distinction shifts the analysis from:

  • Observing outcomes

To:

  • Understanding intent, structure, and methodology

For healthcare organizations, this means:

Compliance is not just about what the model does—it’s about how and why it was built.

Because in practice:

The difference between “varies with” and “determined in any manner” can determine the outcome of an entire arrangement.

Click here to listen to this Stark Integrity Podcast Episode:
https://podcasts.apple.com/us/podcast/volume-or-value-conundrum/id1588939373?i=1000651258752&l=fr-FR