A dispute over Medicare coverage of a breast cancer diagnostic test is raising concerns among some doctors. Medicare's Molecular Diagnostic Services Program (MolDX), administered by Palmetto GBA, has proposed ending coverage for certain DCIS biomarker tests, but some doctors argue that losing access to the tests could make treatment decisions more difficult for women diagnosed with early-stage breast cancer. The DCISionRT test analyzes biological characteristics of a patient's tumor and is used in patients with ductal carcinoma in situ (DCIS), sometimes referred to as Stage 0 breast cancer.
This can help estimate both recurrence risk and the potential benefit of radiation therapy. Ductal carcinoma in situ accounts for more than 60,000 new diagnoses among U.S. women annually, according to the American Cancer Society. Using the diagnostic tool in question could help doctors avoid unnecessary treatments while identifying patients who may need more aggressive care, though critics say there is not enough evidence to justify continued Medicare reimbursement.
Patrick Borgen told Forbes. The DCISionRT test can measure seven proteins in tumor tissue and, when analyzed alongside other clinical and pathological factors, can help predict recurrence risk and the benefits of radiation therapy, according to the Forbes report. MolDX, however, has reviewed 57 publications and concluded that there is no evidence to convincingly show that current DCIS biomarker tests identify who can forgo radiation better than existing tools.
The outcome of the dispute over the diagnostic test could determine how Medicare approaches coverage for other emerging precision-medicine technologies designed to tailor treatments to individual patients. If coverage of the tests is withdrawn, some older Americans could lose access to diagnostic tools that remain available to commercially insured patients. The issue is particularly significant because DCIS is one of the most commonly diagnosed forms of noninvasive breast cancer.
"The real question is whether Medicare should pay not only for radiation treatment but also for a test that could help determine which breast cancer patients actually need it, potentially allowing some women to avoid treatment that offers them little additional benefit,” Alex Beene, a financial literacy instructor for the University of Tennessee at Martin, told Newsweek. While some cases never become invasive, others can recur or progress into more serious disease. Determining which patients are most likely to benefit from radiation therapy remains a challenge for doctors.
The DCISionRT test analyzes proteins in tumor tissue. Unlike traditional risk assessment methods, the test seeks to measure the biological behavior of a patient's tumor. Medicare is reevaluating whether the available evidence supports coverage of the test for beneficiaries, and a new proposed policy would stop payment for certain DCIS biomarker tests, including DCISionRT.
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