Medicare Update: Coverage Could Change for Breast Cancer Patients - Newsweek

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.

“None of our clinical pathological tools can predict which class of DCIS is in the patient in front of us,” breast surgeon Dr. 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If coverage of the tests is withdrawn, some older Americans could lose access to diagnostic tools that remain available to commercially insured patients.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.

“If the evidence supports that approach and Medicare expands coverage, beneficiaries could face fewer unnecessary treatments and lower out-of-pocket costs.”

DCIS consists of abnormal cells confined to the milk ducts. 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.

“The larger purpose is more personalized cancer treatment, but the key is making sure that any decision to eliminate radiation is supported by strong evidence rather than simply saving on costs,” Beene said.

The Medicare Molecular Diagnostic Services Program (MolDX), administered by contractor Palmetto GBA, reviewed dozens of studies and identified what it called limitations in the available evidence.

Those concerns included questions about study design, comparisons with existing risk-assessment methods and whether research populations accurately reflect Medicare beneficiaries.

The dispute will continue as Medicare advisers and outside experts review the evidence, and another advisory panel meeting is scheduled for October.

DCISionRT is a biomarker-based diagnostic test intended to help physicians personalize treatment recommendations for women diagnosed with DCIS.

The test differs from conventional prognostic tools because it attempts to answer not only whether cancer is likely to recur, but also whether radiation therapy is likely to reduce that risk.

That distinction can be important because two patients with seemingly similar diagnoses may have very different risks based on tumor biology, according to Borgen in the Forbes report.

“In this particular case, DCIS is becoming another avenue by which to question medical necessity and what Medicare is willing to cover,” Kevin Thompson, the CEO of 9i Capital Group and the host of the 9innings podcast, told Newsweek.

“The question surrounding how much evidence insurers need before reimbursing for services is bringing about a much larger conversation. This could be far-reaching across multiple areas of the Medicare system as costs continue to come into question.”

One 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 results were reviewed.

Among women who were initially advised to receive radiation, 41 percent had that recommendation withdrawn after testing. Among women who were not initially expected to receive radiation, 31 percent were later advised to undergo treatment based on the test results.

A separate study involving 926 patients found that many women categorized as low risk under traditional criteria were reclassified as high risk by the biomarker test. Researchers also reported lower recurrence rates among certain high-risk patients who received radiation therapy.

Medicare contractors reviewing the evidence concluded, however, that existing studies do not conclusively show that biomarker testing identifies patients who can safely skip radiation better than currently available clinical tools.

“There have been some breakthroughs under the current administration, particularly as it fast-tracks new pathways for medical devices and emerging technologies,” Thompson said. “But as some areas evolve, others are being pushed back into existing Medicare coverage channels.”

Medicare has not made a final determination on coverage.

A new advisory review is expected in October, and the outcome could help shape future coverage decisions involving precision-medicine diagnostics.

Researchers are also continuing to study whether women identified as low risk by DCISionRT can safely avoid radiation therapy.

“The bigger issue is noncoverage and the concern that older women could lose access to certain treatments while those with private insurance continue to have access,” Thompson said. “You could ultimately create a two-tiered system, leaving many older women on Medicare with fewer treatment options or without access to certain forms of care altogether.”

Contact Newsweek editors on this story: Jason Lemon and Geoffrey Rowland.