DOI: 10.1097/01.NT.0000433888.00676.73

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Issn Print: 1533-7006

Publication Date: 2013/08/15


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Medicare to Cover Florbetapir PET Scans in Clinical Trials Only

Gina Shaw

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Excerpt

The Centers for Medicare and Medicaid Services draft decision not to cover the florbetapir-f18 PET imaging agent for Alzheimer's disease outside of a clinical trial drew mixed response from Alzheimer's disease experts and advocates.
The US Centers for Medicare and Medicaid Services (CMS) have issued a draft coverage decision for the amyloid-tracking PET tracer Amyvid (florbetapir F-18), allowing Medicare to reimburse for florbetapir F-18-aided PET scans only when conducted as part of specific CMS-approved clinical trials (known as a Coverage with Evidence Decision).
The Food and Drug Administration had approved florbetapir F-18 for assessment of Alzheimer's disease (AD) in April 2012, but a CMS advisory panel in January of this year had concluded that there was, at least for now, insufficient evidence for the test's utility outside of a clinical trial setting. Moreover, it found that there was a dearth of data that it would improve health outcomes in suspected cases of AD. The panel gave florbetapir F-18 an average confidence rating of 2.2 out of 5, a lower rating. They indicated that more studies were needed in patients with mild cognitive impairment, and more evidence that the use of the scans could actually change patient management.
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