Bipartisan Support Secures MCED Coverage in Medicare

As this issue of Evidence-Based Oncology (EBO) went to press, those of us focused on early detection of cancer were voicing support for HR 842/S 339, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act. This legislation will rapidly accelerate access to blood-based tests that can detect multiple cancers from a single, noninvasive sample.

Increased cancer screening is often cited as a major reason why cancer mortality rates have plummeted over the past generation; the National Cancer Institute estimates that screenings for breast, cervical, prostate, colon, and, recently, lung cancer account for 80% of the 6 million deaths averted between 1975 and 2020.

However, 70% of cancer deaths occur in cancers with no screening, and continuing to screen for cancers one at a time is impractical. Screening for multiple cancers through a single blood test would increase the chances of catching rare cancers and those, such as pancreatic cancer, that show few symptoms until they reach later stages.

MCED is a remarkable confluence of circulating tumor DNA (ctDNA) and artificial intelligence technologies merging to potentially transform the way we diagnose, treat, and hopefully cure cancer. Data with MCED tests continue to be impressive. The PATHFINDER 2 study (NCT05155605) demonstrated a 62% positive predictive value for the Galleri MCED test (GRAIL), whereas Cancerguard (Exact Sciences) reported 68% sensitivity for high-mortality cancers. MCED tests can identify cancers that currently have no standard screening, with 73% of detected cancers in one study having no existing screening, and over half being Stage I or II. Another study found that in cases with a detected signal, 87% accurately predicted the cancer type.

The MCED legislation, led by US Reps Jodey Arrington (R, Texas) and Terri Sewell (D, Alabama), was included in the Fiscal Year 2026 appropriations bill, which President Donald Trump signed February 3, 2026.

Many lawmakers played a role in the bill’s passage, including US House of Representatives members Richard Hudson (R, North Carolina), Raul Ruiz (D, California), and Mariannette Miller-Meeks (R, Iowa). In the US Senate, leaders on MCED funding were Mike Crapo (R, Idaho), Michael Bennet (D, Colorado), Tim Scott (R, South Carolina), and Ron Wyden (D, Oregon).

Supporters of funding MCED coverage in Medicare understand that ctDNA technology for early detection has rapidly evolved, that methylation and fragmentomics are really helping, and that data continue to support its use. This will be a remarkable advance in early cancer detection and better outcomes.

New MCED screenings are emerging that hold the potential to detect dozens of forms of cancer with a single test. At present, it could take a decade for Medicare to cover screenings once the FDA approves them.

The legislation speeds up this process by authorizing CMS to cover blood-based MCED tests, starting in 2028. Future methods will be funded once they receive FDA approval and are shown to have clinical benefit. The aim is to complement, not replace, existing screenings and use an evidence-based process to determine coverage.