CMS Approves Extremely Limited Coverage for Alzheimer’s PET Test

Advocates for Medicare coverage of PET amyloid-beta imaging to confirm or rule out Alzheimer’s Disease had hoped for broad coverage, but in the end, the draft CMS decision memo only approved the test as part of coverage with evidence development (CED), a narrowly defined type of coverage that will take time to implement. According to the July 3 memo, Medicare will pay for one brain beta-amyloid imaging test per patient in two possible scenarios. The first is if the test is needed to rule out Alzheimer’s disease in order to prevent patient harm from the patient being given the wrong treatment. The example CMS cited is when Alzheimer’s cannot be distinguished from frontotemporal dementia. Certain drugs used to ease Alzheimer’s symptoms (cholinesterase inhibitors and memantine) have been shown to exacerbate symptoms in some patients with frontotemporal dementia, and telling the two diseases apart without imaging the brain is very difficult. However, CMS had already been covering the test in this situation, so it was not really an expansion of coverage. The second scenario was if the test was needed as part of a CMS-aproved clinical research study using an FDA-approved radiopharmaceutical for the PET amyloid-beta scan. This is coverage with evidence development (CED), a narrowly defined type of coverage that stops well short of the broad coverage advocates for the test had wanted. The Society of Nuclear Medicine and Molecular Imaging (SNMMI) expressed its disappointment in an official statement emailed to the press. “SNMMI believes that sufficient evidence exists to support immediate coverage, which would change patient management, leading to better health outcomes for patients and assisting families making care decisions,” the statement read. However, proving that a diagnosis of Alzheimer’s Disease using PET amyloid-beta brain imaging improves outcomes is tricky absent a treatment for Alzheimer’s Disease that can either significantly slow or reverse the disease. In the end, CMS decided that there was simply not enough evidence yet to show that the test -- which can run between $3,000 to $10,000 -- makes a big positive difference in patient outcomes. Advocates for the test are not giving up, however. The decision memo is in draft form and CMS will accept comments on it until August 2. Eli Lilly, the developer of Amyvid, the only FDA-approved radiopharmaceutical for PET amyloid-beta imaging so far, may be among those submitting comments on the draft. "Lilly remains steadfast in our request for Medicare coverage of beta-amyloid imaging agents for the appropriate patient population without Coverage with Evidence Development, as recommended by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging," said Wei-Li Shao, senior director, Alzheimer's Business Division, Eli Lilly and Company, in an official statement.   In addition, Daniel Skovronsky, M.D., Ph.D., president and CEO, Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Eli Lilly and Company, and vice president, Tailored Therapeutics at Eli Lilly and Company, warned in the statement that such a narrow decision that “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" could both prevent a timely diagnosis for patients and discourage researchers from investigating ways to improve Alzheimer’s diagnosis in the future.