The College of American Pathologists is urging CMS to avoid broad anti-fraud policies that could unintentionally harm compliant clinical laboratories.
In comments submitted to CMS related to its proposed CRUSH initiative, CAP said it supports efforts to combat healthcare fraud, including inappropriate self-referral arrangements, kickbacks, and medically unnecessary testing. However, the organization warned that overly aggressive oversight policies could create operational and reimbursement risks for even honest laboratories, particularly those performing molecular and genetic testing.
The letter noted, “We respectfully ask CMS to ensure any policy responses distinguish between documented fraud schemes and the broader field of molecular diagnostics, which has become an integral part of modern evidence-based care.”
The CRUSH initiative (Comprehensive Regulations to Uncover Suspicious Healthcare) signals a broader federal push to expand fraud prevention and enforcement authority across Medicare and Medicaid. CMS is considering potential changes involving provider enrollment, payment suspensions, pre-payment reviews, ownership disclosure requirements, and broader utilization management tools.
For laboratory professionals, the proposal could carry implications for reimbursement workflows, compliance programs, and access to advanced diagnostics. CAP specifically cautioned CMS against policies that blur the distinction between fraudsters and laboratories operating within established clinical guidelines and medical necessity standards.
Concerns grow around molecular testing oversight
The CAP comments arrive amid continued federal scrutiny surrounding molecular diagnostics and genetic testing. Industry groups have warned that broad payment suspensions or expanded pre-payment review requirements could delay reimbursement and increase administrative complexity for legitimate laboratories already navigating staffing shortages and margin pressures.
In an article from Dark Daily published in February, we noted Medicare Part B spending on clinical laboratory testing rose to $8.4 billion in 2024, a 5% increase over the previous year, according to the Department of Health and Human Services’ Office of Inspector General (OIG)
CMS has also signaled growing interest in using artificial intelligence, expanded data analytics, and enhanced provider screening tools to identify suspicious billing patterns. Additional proposals under consideration include stricter ownership disclosure rules, expanded fingerprinting requirements, and broader oversight authority tied to Medicare Advantage and Medicaid claims.
CAP said anti-fraud efforts should remain targeted and evidence-based rather than relying on broad policies that could reduce patient access to necessary laboratory services. The organization also emphasized the importance of distinguishing between intentional fraud schemes and legitimate high-volume or specialized testing operations.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
