CMS, CDC, and HHS Seek Public Input on Potential CLIA Updates
Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), and the Department of Health and Human Services...
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On May 29, Medicare announced it would expand coverage for genomic sequence analysis panels in the treatment of hematolymphoid diseases.
The local coverage determination (LCD) “provides limited coverage for genomic sequence analysis panels under specific clinical circumstances.” Specifically, these multi-gene panel tests would be used for diagnosis, risk stratification, and treatment planning for patients with hematolymphoid diseases, including newly diagnosed or relapsed/refractory acute myelogenous leukemia, myelodysplastic syndromes with nondiagnostic assessments, and myeloproliferative neoplasms requiring risk stratification or disease monitoring.
The College of American Pathologists applauded the proposed updates in a 2024 letter, expressing support for the decision to broaden coverage. According to CAP, the policy aligns with the National Comprehensive Cancer Network guidelines and the World Health Organization classifications.
The revision is effective for services performed on or after July 13, 2025.
Sources:
https://www.cap.org/advocacy/latest-news-and-practice-data/june-10-2025#story5
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