ACLA Secures Critical Changes to Medicare Local Coverage Determination for Cancer Genetic Tests
Washington, D.C.— The American Clinical Laboratory Association (ACLA) is pleased to announce significant changes to a coverage policy that was poised to disrupt broad access to genetic testing for Medicare beneficiaries with cancer. Medicare Administrative Contractors (MACs) Novitas and First Coast Service Options (FCSO) have finalized their “Genetic Testing for Oncology: Specific Tests” Local Coverage Determinations (LCDs), incorporating ACLA’s core recommendation to eliminate a provision that would have automatically denied coverage for any genetic test not included in at least one of three identified third-party “knowledgebases.”
In 2023, ACLA, along with 44 other key stakeholders, submitted a letter urging the MACs to reevaluate their coverage policies and ensure access to genetic testing services for oncology patients. The letter underscored the importance of coverage that reflects the rapid advancements in genetic testing, which are vital for accurately diagnosing and tailoring treatment for various cancers. It also highlighted that restrictive LCDs could hinder access to essential testing, thereby impacting personalized treatment plans and patient outcomes.
“We are grateful for the positive outcome and that Medicare beneficiaries will continue to have access to these vital tests,” said ACLA President Susan Van Meter. “Genetic testing plays a critical role in diagnosing and treating cancer, and it is essential that patients have access to the most advanced testing options available.”
The narrowed down finalized LCDs now include only a limited number of positive or negative coverage decisions for specific molecular tests without broadly impacting access to other genetic tests. This outcome reflects years of dedicated advocacy by ACLA in collaboration with dozens of leading patient and provider organizations, ensuring continued access to clinically appropriate genetic testing for Medicare beneficiaries.
ACLA recently released its 2025 advocacy agenda, which promotes policy priorities in the areas of reimbursement, regulation, and preparedness and infrastructure. Learn more here.
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The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.
