Medicare Reconsiders Coverage of DCISionRT, Raising Stakes for Precision-Medicine Diagnostics

A proposed Medicare coverage policy could end payment for DCIS biomarker tests used to estimate recurrence risk and radiation benefit in women diagnosed with ductal carcinoma in situ (搜索)搜索该疾病 (DCIS), a decision that physicians and industry observers say could make treatment decisions more difficult and carry implications far beyond a single breast condition.

The Molecular Diagnostic Services Program (MolDX), a Medicare contractor program administered by Palmetto GBA (搜索)搜索该词条, has proposed ending coverage for certain DCIS biomarker tests, including DCISionRT (搜索)搜索该药品. The test analyzes biological characteristics of a patient's tumor and is used in patients with DCIS, sometimes referred to as Stage 0 breast cancer, to help estimate both 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. The condition consists of abnormal cells confined to the milk ducts; while some cases never become invasive, others can recur or progress into more serious disease.

The Radiation Dilemma in DCIS

Determining which patients are most likely to benefit from radiation therapy remains a challenge for doctors. "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 said.

DCISionRT (搜索)搜索该药品 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. The test measures seven proteins in tumor tissue and combines them with four clinical and pathological factors to estimate both recurrence risk and the potential benefit of radiation therapy.

That distinction matters clinically. A prognostic test asks how likely the disease is to recur, while a predictive test asks a different question: Is radiation likely to change that risk? Two patients with seemingly similar diagnoses may have very different risks based on tumor biology, according to Borgen.

Evidence of Two-Way Decision Changes

The strongest argument for the test is not that it helps women avoid radiation, but that it can move treatment decisions in either direction. In a 2024 clinical utility study, physicians recorded their radiation recommendations before and after receiving DCISionRT (搜索)搜索该药品 results for 2,007 women at 63 clinical sites. Recommendations changed in 38% of cases.

Among 1,425 women initially recommended radiation, 41% had that recommendation withdrawn after testing. Among 582 women initially not recommended radiation, 31% were subsequently advised to receive it. Borgen says his own practice sees the same two-way effect, which he considers significant because he helped develop the older Memorial Sloan Kettering approach that he now regards as inadequate for the decisions doctors face today.

Medicare's Evidentiary Standard

MolDX 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. Its draft policy points to several problems: limited direct comparisons with established risk tools, questions about how some Decision Score thresholds were analyzed, concerns about whether study populations represent Medicare patients, and gaps between clinical studies.

PreludeDx (搜索)搜索该词条 argues the evidence has moved since the draft was written. A head-to-head analysis of 926 patients comparing the seven-gene biosignature against several clinicopathologic criteria was published two weeks after MolDX posted its proposal. It found that a majority of women classified as low-risk by traditional criteria were reclassified as high-risk by the test, and that those women had a 10-year recurrence rate of 21.4% without radiation versus 6.4% with it.

Separately, NRG Oncology查看公司主页 and the National Cancer Institute查看公司主页 opened a randomized trial in April 2026 testing whether biosignature low-risk women can safely skip radiation.

A Governance Question in Precision Medicine

The dispute has become a governance question as much as a scientific one. At a July 2024 Contractor Advisory Committee (CAC) meeting, six of seven experts answered yes when asked whether sufficient clinical evidence supported biomarker testing to help determine which DCIS patients could forgo radiation. The committee was advisory, not binding, and MolDX's later draft characterized the discussion as more unsettled. The contractors are convening another advisory panel on October 13.

The federal government has already recognized DCISionRT (搜索)搜索该药品 in two other ways. The FDA granted it Breakthrough Device designation in 2025, and the Centers for Medicare & Medicaid Services (搜索)搜索该词条 (CMS) granted it Advanced Diagnostic Laboratory Test (ADLT) status in 2023, a classification for certain sole-source tests that provide new clinical diagnostic information. Neither recognition guarantees permanent Medicare coverage, and the mismatch is difficult to ignore: one part of the government can recognize a diagnostic as innovative while another concludes its evidence does not justify coverage.

That contradiction became sharper this year when CMS and FDA created a new pathway designed to accelerate Medicare coverage of certain breakthrough devices, yet explicitly excluded in vitro diagnostic products, including laboratory tests, directing them back through existing Medicare coverage channels.

Implications for Patients and Access

For PreludeDx (搜索)搜索该词条 President and CEO Dan Forche, the concern reaches beyond one test. Noncoverage, he said, "could be setting up to have a two-tier system" in which older women lose access while commercially insured patients may still get the information.

Kevin Thompson, CEO of 9i Capital Group, echoed that concern. "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," he said.

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," said Alex Beene, a financial literacy instructor for the University of Tennessee at Martin. "If the evidence supports that approach and Medicare expands coverage, beneficiaries could face fewer unnecessary treatments and lower out-of-pocket costs."

Medicare has not made a final determination on coverage. The outcome could help shape future coverage decisions involving precision-medicine diagnostics, and researchers are continuing to study whether women identified as low risk by DCISionRT (搜索)搜索该药品 can safely avoid radiation therapy.