CRUSH and Genetic and Molecular Laboratories: A Potential Shift in Medicare Oversight

Genetic, molecular, and reference laboratories are closely watching a new Medicare concept known as CRUSH- short for Comprehensive Regulations to Uncover Suspicious Healthcare. While CRUSH is often discussed as a major anti‑fraud initiative, it is important to understand its current status.

CRUSH is not yet a finalized regulation or active enforcement program.
It is a proposed framework under consideration by the Centers for Medicare & Medicaid Services (CMS), introduced through a public Request for Information (RFI) that could inform future rulemaking.

Understanding why CMS is exploring CRUSH, and what it could mean for genetic and molecular laboratories, requires looking at recent Medicare laboratory spending trends.

Why CMS Is Exploring CRUSH

Recent federal analysis shows that Medicare Part B spending on clinical laboratory tests increased in 2024, reaching approximately $8.4 billion, even as fewer Medicare beneficiaries received laboratory testing.

From a Medicare policy perspective, this combination raises important questions:

• What types of tests are driving spending growth?
• Are costs increasing because tests are becoming more complex and expensive?
• Is spending concentrated in specific testing categories or laboratory types?

CMS has signaled that CRUSH is intended to explore how Medicare might respond to these trends before they translate into larger program‑integrity challenges.

The Role of Genetic and Molecular Testing

The data CMS is reviewing shows that genetic and molecular testing plays a significant role in recent spending growth.

In 2024:

• Genetic testing represented a large share of total Medicare Part B laboratory spending
• Total spending on genetic tests reached several billion dollars
• Spending growth in genetic testing outpaced other laboratory categories

At the same time, spending on traditional reference laboratory services, such as routine chemistry and hematology testing, declined. This shift reflects Medicare dollars moving away from high‑volume, low‑cost testing and toward lower‑volume, higher‑cost molecular diagnostics.

For CMS, this trend does not imply that genetic or molecular testing is inappropriate. Instead, it highlights why these services are central to discussions about future oversight approaches.

Concentration Is Part of the Policy Conversation

Another factor CMS is examining is concentration.

A relatively small number of laboratory tests account for a large share of total Medicare laboratory spending, and many of those tests are genetic or molecular in nature. Similarly, Medicare spending on genetic testing is concentrated among a smaller number of laboratories, often large genetic, molecular, and reference labs.

Concentration alone is not a compliance issue. However, from a policy standpoint, it increases visibility and raises questions about how Medicare should monitor utilization patterns in high‑cost, high‑complexity testing categories.

What CRUSH Is and What It Is Not

CRUSH is not a finalized rule, payment policy, or enforcement action.
Instead, it represents CMS’s effort to gather input on questions such as:

• How should Medicare evaluate laboratory utilization patterns at scale?
• How can CMS distinguish appropriate high‑complexity testing from potential overuse?
• What tools should be available to address risk earlier in the payment process?
• How can oversight protect patients and taxpayers without limiting access to innovation?

Any future CRUSH‑related requirements would need to go through formal rulemaking, including additional public notice and comment.

What This Means for Genetic, Molecular, and Reference Labs

Although CRUSH is still under consideration, it provides insight into how CMS is thinking about the future of laboratory oversight.

For genetic, molecular, and reference laboratories, this suggests increased policy attention to:

• Utilization patterns, not just individual claims
• Medical necessity at the population level
• High‑cost tests with rapidly increasing spend
• Standardized panels, standing orders, and reflex testing
• Marketing and referral relationships tied to testing volume

Importantly, CRUSH is about exploration and feedback, not immediate enforcement.

The Bottom Line

CMS is signaling that laboratory spending growth, particularly in genetic and molecular testing, is an area of active policy review. CRUSH represents a potential future direction for Medicare oversight, not a settled outcome.

For genetic, molecular, and reference laboratories, this is an opportunity to:

• Understand how Medicare views emerging spending trends
• Evaluate how testing practices may appear in population‑level data
• Participate in shaping future policy before it is finalized

Labs that engage early and thoughtfully will be best positioned if CRUSH evolves into formal regulation.

Public Comment Opportunity: March 30, 2026 Deadline

CMS is currently accepting public comments on the CRUSH concept as part of its Request for Information process.

Comment deadline: March 30
Who should consider commenting:

• Genetic, molecular, and reference laboratories
• Ordering providers and health systems
• Medicare beneficiaries, patient advocates, payers, states, and technology companies

Public comments give stakeholders a meaningful opportunity to influence how CMS approaches future laboratory oversight and to ensure that any eventual rules reflect the realities of high‑complexity diagnostic testing.

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Stacey Gilbert, MPH, MBA
Director, Precision Medicine