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

This article was originally published in The Gray Sheet

Executive Summary

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.

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