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Eli Lilly Lawsuit Challenges CMS Coverage Standard For Alzheimer's Diagnostic

A lawsuit filed by Medicare beneficiaries with support from the manufacturer of an imaging agent approved to help evaluate adults for Alzheimer’s disease says diagnostic scans should not be required to show a change in disease management or outcomes to qualify for Medicare coverage. CMS limits coverage to the beta-amyloid plaque to use in clinical trials, and only one trial has been approved.

Medicare beneficiaries, supported byEli Lilly & Co., have filed a lawsuit that could have important repercussions for the Medicare coverage standard for diagnostics. The suit seeks to have a federal court reverse CMS’ policy to limit coverage of beta-amyloid positron emission tomography brain scans for helping diagnose Alzheimer’s to use only in clinical trials.

The Medicare agency singled out this kind of test in deciding that it must show an impact on disease management or outcomes – not just diagnosis – before it could...

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