Legal Independent Review Organization (IRO) Services Under (or Outside) a Corporate Integrity Agreement

Episode Date: October 19, 2022

In this episode of Stark Integrity, Bob Wade (“Captain Integrity”) explores the role of Legal Independent Review Organizations (IROs) and how they function in the context of Corporate Integrity Agreements (CIAs) and broader Stark Law compliance.

Bob walks through what IROs do, when they are required, and how organizations can effectively use them—not only when mandated, but also as a proactive compliance tool.

What Is an Independent Review Organization (IRO)?

Bob explains that an IRO is an independent third party responsible for evaluating an organization’s compliance with healthcare laws and regulatory requirements.

These reviews often include:

• Physician financial arrangements
• Claims and billing practices
• Compliance systems and controls

IROs are intentionally independent to provide objective, unbiased assessments of an organization’s practices.

IROs and Corporate Integrity Agreements

A major focus of the episode is how IROs are typically used within Corporate Integrity Agreements.

Bob explains that:

• CIAs are often required as part of settlements involving the False Claims Act or Stark Law issues
• They impose ongoing compliance obligations on organizations
• IROs are commonly required to perform periodic independent reviews

These agreements are designed to strengthen compliance programs and prevent future violations.

IRO Services Outside of a CIA

A key insight from the episode is that IRO services are not limited to organizations under a CIA.

Bob emphasizes that:

• Organizations can voluntarily engage IROs
• Independent reviews can identify issues early
• Proactive use of IROs can reduce compliance risk

In this way, IROs can be used as a preventive tool, not just a corrective measure.

Independence Matters

Bob highlights that the defining feature of an IRO is its independence.

He notes that:

• The IRO must not have conflicts of interest
• It should provide objective analysis based on facts
• Independence enhances the credibility of findings

At the same time, the relationship does not have to be adversarial—IROs can work collaboratively while still maintaining objectivity.

Who Selects the IRO?

Bob explains that the selection of an IRO depends on the situation:

• In a CIA, the organization typically proposes an IRO
• The Office of Inspector General (OIG) may review or approve the choice
• Selection should be based on expertise, credibility, and independence

Choosing the right IRO is critical because their work will be closely scrutinized by regulators.

Scope and Depth of Review

Another important topic is how the scope of an IRO review is determined.

Bob explains that:

• The scope depends on the specific compliance risks involved
• It may include claims reviews, arrangement reviews, or system evaluations
• The level of detail can vary based on the agreement or regulatory expectations

For example, some CIAs require detailed statistical sampling and reporting, while others may focus on specific high-risk areas.

IROs as a Compliance Asset

Bob encourages organizations to view IROs as more than just a requirement.

He explains that:

• IRO findings can improve internal processes
• Reviews can strengthen documentation and controls
• Organizations can use feedback to enhance compliance programs

Rather than being seen as a burden, IROs can become a valuable compliance resource.

Practical Takeaways

The key takeaway from this episode is that IROs play a critical role in both reactive and proactive compliance strategies. Organizations should:

• Understand when IROs are required under CIAs
• Consider using IROs proactively to assess risk
• Ensure independence and credibility in IRO selection
• Clearly define the scope of reviews
• Use IRO findings to strengthen compliance programs

Final Thoughts

Bob Wade’s discussion highlights that Independent Review Organizations are a cornerstone of modern healthcare compliance.

Whether required under a Corporate Integrity Agreement or used voluntarily, IROs provide objective insight into compliance risks and performance, helping organizations navigate the complexities of the Stark Law, FCA, and broader regulatory landscape.

Click here to listen to this Stark Integrity Podcast Episode:
https://podcasts.apple.com/us/podcast/legal-independent-review-organization-iro-services/id1588939373?i=1000583107875&l=fr-FR