The FDA Approved an Alzheimer’s Treatment, but 1 Million Americans Can’t Get It – Inside Sources

Seventy-nine percent of voters — including 78 percent of independents — support better access to coverage for Alzheimer’s detection and treatment. That’s according to a poll released in May. Eighty-nine percent say coverage restrictions from Medicare and private insurers are blocking patients from getting the drugs that their doctors want to slow the disease.

An equal number worry that doctors avoid Alzheimer’s tests and treatments because insurers might not cover them. They are right to worry. One million Americans qualify for FDA-approved treatments that can slow Alzheimer’s progression. Fewer than 15,000 have received them.

The FDA approved two drugs, lecanemab and donanemab, for Alzheimer’s disease in 2023 and 2024. What made them different was that they were the first treatments that could alter the course of Alzheimer’s disease. Previous therapies had managed symptoms. These newer drugs target and clear the toxic proteins that build up in the brain and drive the disease. They slow disease progression by 30 percent. That means the disease stays in a mild form for longer. It’s the difference between being able to live independently versus needing full-time memory care.

There are two problems, and both trace back to a Medicare coverage rule that was written in April 2022. The first is that the rule requires doctors who want to prescribe these Alzheimer’s treatments to enroll in a federal data registry and to submit patient information to a government portal several times over two years — a bureaucratic hurdle that most community physicians have not cleared. 

This means that for most people, access is limited to a few large academic medical centers. The second is that the rule was written when the only accepted methods for confirming a patient would qualify for treatment were either an invasive spinal tap or PET scan, a specialized imaging study that is not widely available across much of the country. We now have cheaper, better options. The rule has not caught up.

The 2022 coverage rule was reasonable given what was known and available at the time. It no longer reflects the best science. In 2024, the leading diagnostic criteria were formally updated to incorporate blood-based biomarker tests as sufficient on their own to diagnose Alzheimer’s disease.

In May 2025, the FDA approved the first blood test for Alzheimer’s diagnosis. It involves a simple blood draw. It’s dramatically less invasive than a spinal tap and a fraction of the cost of imaging. In July 2025, the Alzheimer’s Association published its first formal clinical practice guideline on the use of these blood tests.

In October 2025, the FDA cleared a second blood test, this one designed specifically for primary care settings. The medical community has done its job, but the coverage rule has not budged.

The practical consequence is that a blood test capable of identifying Alzheimer’s in virtually any clinical setting cannot be used to unlock Medicare coverage for treatment. Physicians who order this test, follow the most up-to-date clinical guidelines, and try to prescribe an FDA-approved treatment for an appropriate patient do so knowing the drug will not be reimbursed.

The good news is that no legislation is required to fix this. The Department of Health and Human Services can direct the Center for Medicare and Medicaid Services to update this coverage. The entire process would take 90 days. The scientific foundation — the updated diagnostic criteria, FDA-approved blood tests, a formal clinical practice guideline — is complete.

While legislation is not required to begin action, there is a legislative effort that is worth calling out. The bipartisan Alzheimer’s Screening and Prevention Act would allow Medicare to cover blood-based tests that can detect Alzheimer’s pathology before symptoms present, and would close a gap that has led to delayed diagnosis. It has strong support in both chambers of Congress. It is an important complement to addressing prescribing issues, but its passage should not be a barrier to moving forward on solving the coverage gap.

The FDA has done its job. So has the medical community. What remains is a coverage rule that was written for a world that no longer exists. The evidence and the authority to act both are in hand. One million Americans are waiting.