Medicare Coverage for Breast Cancer Patients Could Change
核心洞察
Medicare (搜索)'s Molecular Diagnostic Services Program, run by contractor Palmetto GBA (搜索), has proposed ending coverage for certain DCIS biomarker tests including DCISionRT (搜索).
MolDX reviewed 57 publications and found no convincing evidence that current DCIS biomarker tests identify patients who can forgo radiation better than existing tools.
A 2024 study of 2,007 women found physician recommendations changed in 38 percent of cases after DCISionRT (搜索) results were reviewed.
Medicare (搜索)'s Molecular Diagnostic Services Program (MolDX), administered by contractor Palmetto GBA (搜索), has proposed ending coverage for certain biomarker tests used in ductal carcinoma in situ (搜索) (DCIS), including the DCISionRT (搜索) test. The test measures seven proteins in tumor tissue and, analyzed alongside other clinical and pathological factors, is intended to estimate recurrence risk and the potential benefit of radiation therapy. DCIS accounts for more than 60,000 new diagnoses among U.S. women annually, according to the American Cancer Society.
MolDX reviewed 57 publications and concluded there is no evidence convincingly showing that current DCIS biomarker tests identify who can forgo radiation better than existing tools. The concerns cited included study design, comparisons with existing risk-assessment methods, and whether research populations accurately reflect Medicare (搜索) beneficiaries. A 2024 study published in the National Library of Medicine examined 2,007 women across 63 clinical sites and found physician recommendations changed in 38 percent of cases after DCISionRT (搜索) results were reviewed; among women initially advised to receive radiation, 41 percent had that recommendation withdrawn, while 31 percent of those not initially expected to receive radiation were later advised to undergo treatment. A separate study of 926 patients found many women categorized as low risk under traditional criteria were reclassified as high risk by the biomarker test.
Medicare (搜索) has not made a final determination. Another advisory panel meeting is scheduled for October, and the outcome could shape future coverage decisions for precision-medicine diagnostics. Researchers are continuing to study whether women identified as low risk by DCISionRT (搜索) can safely avoid radiation therapy.