An FDA clearance and Medicare coverage are two different things, and for Alzheimer's blood tests only the first has happened. The FDA cleared the first blood test for aiding Alzheimer's diagnosis in May 2025, but Medicare has no national policy that pays for these branded tests, so many patients can face the full cash price.
FDA "clearance" is a marketing authorization that lets a test be sold and ordered. Medicare coverage is a separate decision about whether the program will pay. Understanding that gap explains why a test your doctor can now order may still land you a bill.
Medical information disclaimer: This article is for general educational purposes only and does not provide medical advice, diagnosis, or treatment. Always consult a physician or other qualified health professional about symptoms, medications, tests, or treatment decisions.
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Table of Contents
- What the FDA actually cleared
- Cleared does not mean covered
- Where you can actually get the test
- Why coverage stops at symptomatic patients
- What to check before you order
- The legislation that could change this
- Frequently Asked Questions
What the FDA actually cleared
On May 16, 2025, the FDA cleared Fujirebio's Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, the first blood test authorized to aid Alzheimer's diagnosis. The test detects amyloid plaques — sticky protein buildup in the brain linked to Alzheimer's — using a blood sample instead of a brain scan or spinal tap. The clearance is narrow.
It applies only to symptomatic adults aged 55 and older who are already being evaluated for memory problems. The FDA did not clear it as a screening tool for healthy people or as a standalone diagnosis. In the validation the FDA reviewed, the test matched brain-scan or spinal-fluid results in 91.7% of positive cases and 97.3% of negative cases. The agency stressed the result must be read alongside other clinical information, not used alone.
Cleared does not mean covered
fda clearance carries no promise that anyone will pay for the test. As the Association of Health Care Journalists explains, there is no Medicare National Coverage Determination for Alzheimer's blood biomarker tests, so payment decisions fall to regional Medicare Administrative Contractors — the private companies that process Medicare claims in each area. That regional structure creates geographic inconsistency.
A test paid for in one state may be denied in another, based on the local contractor's policy rather than a single national rule. For patients, the practical effect is a possible out-of-pocket bill. Labcorp's related three-part ATN Profile lists at $626, and the company said it was still negotiating reimbursement with insurers and Medicare — meaning beneficiaries can be charged the full cash price.
Where you can actually get the test
Availability has moved faster than coverage. On August 18, 2025, Labcorp announced nationwide availability of its FDA-cleared Lumipulse-based blood test, making the first cleared test broadly orderable by clinicians across the country. So a doctor can order the test almost anywhere.
Whether medicare or your insurer pays is a separate question that depends on your region and your clinical situation. There is a partial exception worth knowing. According to Neurology Today, some laboratory-developed plasma pTau217 assays — versions built and run by individual labs rather than the branded cleared kit — do get Medicare payment through the MolDX program. That coverage is limited to symptomatic patients being evaluated for cognitive impairment, not people seeking a screen while still healthy.
Why coverage stops at symptomatic patients
The line between symptomatic and asymptomatic testing is the heart of the coverage debate. Expert payer guidance recommends restricting coverage to symptomatic patients and to tests meeting published evidence thresholds until clinical utility for screening is proven. The reasoning is practical.
In someone already showing memory decline, an amyloid result helps a doctor confirm or rule out an Alzheimer's cause and plan care. In a healthy person, a positive amyloid result does not reliably predict when — or whether — symptoms will appear, and there is no proven action that changes the outcome. That is why current coverage, where it exists, targets people under evaluation for cognitive impairment. It is also why the test is not positioned as a routine checkup screen.
What to check before you order
A test that is cleared and available can still leave you paying. Before agreeing to one, work through a few questions: Ask for the specific billing code and an estimated cost in writing before the blood is drawn.
- Are you symptomatic and being evaluated for memory or thinking problems? Coverage, where it exists, generally requires this.
- Is the test a branded FDA-cleared kit or a lab-developed pTau217 assay? Some lab-developed versions have a Medicare payment pathway that the branded kits lack.
- Has your clinician confirmed with your regional Medicare contractor or insurer whether it will be paid?
- Are you prepared for a possible cash price in the hundreds of dollars if it is denied?
- Do you understand the result will be read alongside other findings, not treated as a final diagnosis?
The legislation that could change this
A pending bill could close the coverage gap, but it is not law today. In 2025 lawmakers introduced the bipartisan Alzheimer's Screening and Prevention (ASAP) Act to require CMS to create a Medicare coverage pathway for FDA-approved blood-based Alzheimer's detection tests.
The Alzheimer's Association describes it as still-pending legislation. Until it passes and CMS writes a rule, coverage remains a patchwork of regional contractor decisions — so treat any promise of guaranteed Medicare payment for these tests as premature.
Frequently Asked Questions
Can I get an Alzheimer's blood test just to screen myself while healthy?
The cleared test is authorized only for symptomatic adults 55 and older being evaluated for memory problems, and Medicare coverage does not extend to asymptomatic screening.
How much might I pay if Medicare denies the test?
Labcorp's related ATN Profile lists at $626, and beneficiaries can face the full cash price while reimbursement negotiations continue.
Does a positive result mean I definitely have Alzheimer's?
No. The FDA says the amyloid result must be interpreted alongside other clinical information and is not a standalone diagnosis.
