The Alzheimer's Association said it was "disappointed" by the government's tentative decision last week not to allow broad Medicare coverage for brain amyloid imaging.
The Centers for Medicare and Medicaid Services released a draft decision memo indicating that Medicare would pay for contrast-enhanced PET scans aimed at visualizing beta-amyloid protein plaques in patients brains only in the context of rigorous clinical trials, under the agency's "coverage with evidence development" (CED) policy.
"With 5 million Americans living with Alzheimer's and more than 15 million people providing care, the need to accelerate improved care and an early and accurate diagnosis today, when scientifically supported, is critical," the group said in a statement.
The Alzheimer's Association noted that, in the past, it has taken as long as 7 years for CMS to move from a CED designation for new medical technologies to full coverage.
"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 group's statement said.
Eli Lilly & Co., which sells the only currently approved PET contrast agent used for such scans, florbetapir (AmyVid), also said it was disappointed in the CMS's draft decision memo, as did the Medical Imaging and Technology Alliance, a trade group.
All three organizations pointed to "appropriate use criteria" published earlier this year by an expert panel that backed clinical use of the technology in select patient groups.
The panel, convened by the Alzheimer's Association and the Society for Nuclear Medicine and Molecular Imaging, said PET amyloid scans would be appropriate for patients with unexplained cognitive impairments, those with tentative Alzheimer's disease diagnoses who show unusual clinical presentations, and those with progressive dementia occurring before age 65.
In determining that the evidence of clinical benefit for such scans is currently insufficient -- even in these populations -- CMS followed a January recommendation by its Medicare Evidence Development and Coverage Advisory Committee (MEDCAC).
Panel members appeared to focus primarily on the role of positive scan results, even though the published guidelines put equal emphasis on the value of negative findings (which would rule out an Alzheimer's disease diagnosis).
The draft decision memo acknowledged that use of the scans "to exclude Alzheimer's disease in narrowly defined and clinically difficult differential diagnoses" is "promising."
Nevertheless, CMS insisted, "more evidence needs to be developed, including when the scan would replace, and when it would complement, other biomarkers, for particular patient subpopulations."
The Alzheimer Association and Lilly noted that the memo is currently open for public comment (through August 2) and that CMS could still decide to allow broader coverage.