CMS Decision Could Prevent Physicians From Accurately Diagnosing Alzheimer's Disease

On July 3, CMS rejected coverage for amyloid PET imaging

By Greg Bengel, contributing writer

In a recently released proposed decision memo, CMS said it will reimburse Eli Lilly's Alzheimer’s diagnostic Amyvid only when patients taking it are in clinical trials.

In the memo, CMS says that “the evidence is insufficient to conclude that the use of positron emission tomography (PET) amyloid-beta (Aβ) imaging improves health outcomes for Medicare beneficiaries with dementia or neurodegenerative disease, and thus PET Aβ imaging is not reasonable and necessary under §1862(a)(1)(A) of the Social Security Act.”

Lilly strenuously objected to the decision. An article from pmlive.com includes a statement from the company saying CMS is “challenging the value of an adjunctive tool that can assist physicians in making a more informed diagnosis for patients with cognitive impairment.” Lilly also says the decision “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.”

It is notable that in May, Alzheimer’s experts and healthcare providers wrote a persuasive letter to CMS advocating coverage for amyloid PET imaging. Their arguments for the coverage confirm Lilly’s claim. “The foundation of good medical practice is based on accurate diagnosis,” they say. According to these experts, a large percentage of patients with cognitive impairment possibly due to Alzheimer’s disease do not receive an accurate diagnosis. “Amyloid PET is a major advance in the diagnosis and treatment of AD,” they continue. “Previously, we had to wait for a post-mortem examination to definitively diagnosis AD. Now, with amyloid PET, we are able to safely and reliably detect fibrillar forms of amyloid, one of the hallmarks of AD.”

The Alzheimer’s Association released a statement expressing disappointment and disapproval of CMS’s decision. In the statement, the association stresses the importance of improving care for Alzheimer’s disease. “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 statement says.

The fight is far from over. The statement from the Alzheimer’s Association emphasizes that CMS’s decision is not yet final. As such, they say they plan to continue working with healthcare communities and advocates to educate CMS on the need for amyloid imaging.