Imaging Groups Disappointed By CMS’ Final Beta Amyloid PET NCD
This article was originally published in The Gray Sheet
Agency’s final national coverage determination for beta amyloid positron emission tomography to diagnose dementia confirms that Medicare will cover the procedure only in clinical trials. On the positive side, it may offer a bit more flexibility in trial design.
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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.
Medical imaging manufacturers and professional societies echoed Eli Lilly’s criticism of the CMS proposal to cover beta-amyloid PET for use in patients suffering from dementia and neurodegenerative disease.
“Improvement in health outcomes” standard would interpret “the statute to require both diagnosis and treatment,” Lilly says about CMS’ recent evaluation of beta-amyloid positron emission tomography in dementia and neurodegenerative disease.