With genetic test spending under the microscope, CMS is asking labs to help shape future anti-fraud rules—before formal proposals are drafted.
Clinical laboratory leaders have a narrowing window to influence a major new federal anti-fraud initiative, as the Centers for Medicare and Medicaid Services (CMS) closes its March 30 comment period on its “CRUSH” request for information (RFI).
Published Feb. 27, the CRUSH (Comprehensive Regulations to Uncover Suspicious Healthcare) initiative signals CMS’s intent to pursue broader regulatory changes aimed at strengthening program integrity across Medicare, Medicaid, and Medicare Advantage. For laboratories, the RFI offers an early opportunity to weigh in before formal rulemaking begins.
CMS Targets Genetic Testing Spend, MolDX Oversight, and Advanced Analytics in Fraud Crackdown
A central focus is fraud tied to clinical diagnostic testing, particularly genetic and molecular assays. CMS cited recent federal data showing that while genetic tests accounted for just 5% of Medicare Part B test volume in 2024, they represented 43% of total lab spending—approximately $3.6 billion. The agency also pointed to ongoing enforcement actions and fraud alerts tied to laboratory testing as justification for heightened scrutiny.
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CMS is asking laboratories and other stakeholders to identify what new regulatory authorities, analytics tools, and data-driven approaches could improve detection and prevention of fraudulent billing. The agency’s questions suggest interest in expanding pre- and post-payment review, strengthening data analytics, and accelerating fraud detection earlier in the reimbursement claims lifecycle.
Another key issue for labs is CMS’s examination of the Molecular Diagnostic Services (MolDX) program. The agency is seeking feedback on whether MolDX registration reduces fraud risk and why some payers require participation even outside MolDX jurisdictions—raising the possibility of broader adoption or new requirements tied to molecular test oversight.
For laboratory executives, compliance leaders, and revenue cycle teams, the implications are significant. The RFI signals where CMS may tighten oversight next, particularly for high-cost, high-complexity testing. Policies affecting enrollment, documentation, payment review, and test validation could follow.
With the March 30 deadline approaching, laboratories still have time to submit operational insights and data to help shape future regulations.
—Janette Wider
