Medicare: Eli Lilly spurns CMS refusal to cover PET scans with beta-amyloid agents

September 30, 2013 by Arezu Sarvestani

Medicare regulators reject reimbursement coverage for positron emission tomography beta-amyloid imaging, with exceptions for use in excluding Alzheimer's disease and in "clinically difficult differential diagnoses."

Medicare denies coverage for new PET agents

The Centers for Medicare & Medicaid Services ruled against new reimbursement coverage for beta-amyloid imaging agents in use with positron emission tomography scans with exceptions for certain indications.

The CMS ruling denied coverage for most PET Aβ scans, saying that there was "insufficient evidence" that such imaging is "reasonable and necessary" for the indications examined. The healthcare regulators granted 2 exceptions:

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  1. to exclude Alzheimer's disease (AD) in narrowly defined and clinically difficult differential diagnoses, such as AD versus frontotemporal dementia (FTD); and
  2. to enrich clinical trials seeking better treatments or prevention strategies for AD, by allowing for selection of patients on the basis of biological as well as clinical and epidemiological factors.

CMS agreed to cover 1 PET Aβ scan per patient in clinical studies that meet the agency's criteria. The rules for reimbursement, deemed "coverage with evidence development," include requirements that any potential studies receive approval from CMS, fit in CMS time-frames and that use of PET Aβ in such studies appears to improve health outcomes.

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