We are seeing a long‑anticipated and important policy inflection point. 

By now you might have heard that Congress passed the Nancy Gardner Sewell Medicare Multi‑Cancer Early Detection (MCED) Screening Coverage Act, creating a pathway for Medicare to cover FDA‑approved MCED tests. The landmark, bi-partisan legislation resolves a gap that had previously prevented Medicare from covering these tests—even as evidence continued to mature along with increasing patient demand.  

The law authorizes Medicare to treat MCED tests as a covered screening benefit once those tests secure Food and Drug Administration (FDA) approval and clear the hurdle of demonstrating clinical benefit. Until now, MCED tests fell into a policy “twilight zone,” i.e., as screening tools without a statutory benefit category supported by the United States Preventative Services Task Force (USPSTF)—leaving Medicare without any mechanism to pay for the tests even if clinicians and patients were willing to use them. 

The law’s signing coincides closely with GRAIL’s late January announcement that it had completed submission of the final module of its premarket approval (PMA) application to the FDA for Galleri^®, its commercially available MCED blood test. The submission includes data from more than 25,000 participants in Grail’s U.S.‑based PATHFINDER‑2 study, as well as approximately 140,000 participants enrolled in the randomized NHS‑Galleri trial in the United Kingdom. Galleri FDA approval, when and if it comes, will represent the true kickoff for Medicare coverage development under the new law.  

What the law actually does. 

The law establishes MCED as a recognized Medicare screening benefit category. This is important to highlight, because Medicare requires statutory authorization to cover screening tests (think colorectal and breast cancer screenings).  

CMS will now be able to cover FDA‑approved MCED tests through an evidence‑based framework, under a National Coverage Determination (NCD). CMS will need to determine eligibility, testing frequency, and medical necessity criteria. For clarity, the statute does not mandate coverage of any specific test. It creates a pathway, not a guarantee.  

Who is affected—and how broadly? 

The most direct initial winners will be Medicare and Medicare Advantage beneficiaries. The benefits will extend beyond Medicare to commercially insured individuals also. While private insurers are not bound by Medicare policy, they frequently align their benefit designs once Medicare establishes a precedent. MCED screening has the potential to be a real game changer, reshaping referral patterns across the entire patient journey that will require clinician and health system stakeholders to put patient navigation and care coordination optimization front and center.  

Why this matters for our US healthcare system. 

It is a game changer, because for MCED tests that demonstrate clinical utility, early detection could effectively shift diagnoses for numerous cancers toward earlier stages when a patient’s disease is highly treatable, gives them the best opportunity for long term survival, and can offer an improved quality of life.  

MCED uptake does present challenges with payers that regularly grapple with managing short‑term spending vs. obtaining long‑term value from novel diagnostics technologies. As with other screening modalities, up‑front spending includes the test itself and any downstream diagnostic activities, while potential savings accrue over time through reduced late‑stage cancer treatment costs.  

For health systems, positive MCED results will result in diagnostic confirmation and consultation but without triggering unnecessary procedures that may further strain resources already near capacity in some cases (such as imaging and specialty practices). 

Meanwhile, FDA approval of one or more MCED tests would accelerate an increasingly competitive, multi‑vendor market. Differentiation will hinge on having strong validation performance but also on cancer‑signal origin accuracy and the operational burden placed on clinicians and patients.  

The hurdles ahead. 

Despite the momentum, several challenges will shape MCED adoption over the long term. FDA review of population screening tests is complex, and approvals will depend on robust trial data, including real‑world evidence. CMS coverage decisions will then set precedents around eligibility, frequency, and required follow‑up that could either accelerate or constrain uptake.  

The risk of false positives and indeterminate results underscores the need for standardized diagnostic pathways and strong patient navigation. Without them, costs may rise without commensurate benefit, and patient anxiety may increase. Patient out of pocket costs and utilization management policies will also influence whether clinicians are willing to use MCED tests.  

Finally, guideline endorsement carries a lot of weight. Over time, specialty society recommendations and USPSTF grades will shape both coverage and patient expectations. Demonstrating not just stage shift, but eventual mortality reduction, will be critical.  

What is the bottom line? 

The Nancy Gardner Sewell MCED Coverage Act represents the missing policy link between innovation and access. It does not guarantee widespread adoption, nor does it resolve questions of evidence, equity, or economics on its own. What it does is move MCEDs out of legislative limbo and into the clinical, regulatory, and operational arenas where those questions can finally be answered. 

The first FDA approval—whether Galleri or another MCED test—will mark the transition from policy “promise” to a real‑world multi-cancer screening opportunity at population level. Successful companies will be those that follow science with rigor, use well defined evidence pathways, and seek to partner closely with patients, providers, payers, health systems, government, specialty societies, and patient advocacy groups to create equitable access strategies that will bring more people to screening. 

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ADVI Health offers expert advice and influential solutions, informed by data and guided by a clear vision of the complex intersection of life sciences and healthcare innovation, economics, policy, and patient impact. ADVI supports diagnostics innovators with an integrated FDA, CMS coverage, and market access strategy to help ensure MCED technologies are positioned for approval, reimbursement, and sustainable adoption. As Medicare operationalizes the new screening benefit, get in touch to receive insights from our precision medicine team.