Several advocacy groups and professional societies are criticizing a tentative decision by the Centers for Medicare & Medicaid Services not to cover a new Alzheimer's diagnostic tool in all but a few cases in clinical studies.
In a draft of rules set to be finalized in October, after public comment, CMS said it would only pay for a beta-amyloid positron emission tomography (PET) imaging test for patients in an Alzheimer's clinical trial -- a decision that's dismayed both the Alzheimer's Association and the Society for Nuclear Medicine and Molecular Imaging, as well as the company that developed it, Eli Lilly subsidiary Avid Radiopharmaceuticals.
The roughly $3,000 imaging process highlights beta amyloids in the brain that are associated with plaques related to Alzheimer's and dementia, although the company has noted that a scan "does not diagnose Alzheimer's Disease or other thinking or memory disorders" but rather helps doctors make a diagnosis in tandem with other tests.
CMS said in its draft that it would cover limited PET amyloid-beta scans in "narrowly defined and clinically difficult differential diagnoses," such as in determining whether the disease is Alzheimer's or
frontotemporal dementia in clinical trials and in 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 said it will cover one PET amyloid-beta scan per patient through the "coverage with evidence development" framework, a policy first applied by the agency in 1995 and formalized in 2006.
The Alzheimer's Association, though, thinks that's much too narrow an offering, considering the impacts of the disease, with some 5 million Americans already living with it and many more likely to develop it in the coming decades.
The Alzheimer's Association said it "understands that CMS' evaluation of the impact of brain amyloid imaging on health outcomes is ongoing, however the needs of Alzheimer's community are acute...Neither families directly impacted by the disease, nor our federal government, can afford to wait as much as seven years for a final decision about national coverage, as was the case with the National Oncology Patient Registry and the evaluation by CMS of FDG PET coverage," the association said said, referring to the agency's drawn-out decision with coverage with evidence development, or CED, to cover post-therapy fluorodeoxyglucose-enhanced PET scans for tracking tumors in cancer patients.
"Seven years ago, this brain amyloid imaging technology did not even exist. The timeframe at which CMS has conducted CED processes is wholly unsuited and unacceptable to both the pace of scientific and technological innovation in the Alzheimer's field, and more importantly, the rapidly increasing needs posed by the escalating Alzheimer's epidemic."
The Society of Nuclear Medicine and Molecular Imaging concurred, arguing that "more than adequate evidence exists for Medicare to cover without additional onerous steps." The coverage with evidence development framework "is not appropriate for this test, which the U.S. Food and Drug Administration has already approved, noting its clinical utility," the society said.
Meanwhile, the company that developed the scan -- and there been others in the past rejected by CMS, as well as others working on new ones -- said the decision may stifle industry interest in developing new diagnostics.
"CMS appears to be challenging the value of an adjunctive tool that can assist physicians in making a more informed diagnosis for patients with cognitive impairment," said Daniel Skovronsky, M.D., the CEO of Eli Lilly's Avid Radiopharmaceutical.
"Restricting coverage could hinder a timely and accurate diagnosis, which is in conflict with the advice of Alzheimer's disease experts and with the administration's National Alzheimer's Project Act," he said.