Media requests should be directed to:

Katy Riddick, Voices of Alzheimer’s Secretariat

Phone: +1 202 223 2027

FOR IMMEDIATE RELEASE

OUR MINDS. OUR LIVES. OUR CHOICES.
Two Steps Forward, One Step Back: Voices of Alzheimer's Applauds Medicare's Progress in Removing CED for Amyloid PET Scans but Calls Out its Failure to Ensure Expeditious and Equitable Coverage.

Washington, DC, October 16, 2023 – Voices of Alzheimer's, an advocacy organization led by people living with Alzheimer's disease and their care partners, supports the Centers for Medicare and Medicaid's (CMS) decision to end Coverage with Evidence Development for amyloid PET scans but remains disappointed in CMS's continued failure to unequivocally support expeditious and equitable coverage of this critical diagnostic tool. CMS's choice to fragment PET scan coverage decisions by passing that decision to regional Medicare Administrative Contractors (MACs) could delay and deny treatment for thousands of people living with Alzheimer's who do not have time to wait.

Jim Taylor, President of Voices of Alzheimer's and a long-time care partner, said, “This decision is two steps forward and one step back. It’s about time that CMS finally ends the CED, considering the overwhelming evidence in support of the value of PET scans in Alzheimer’s diagnosis and treatment. Yet, once again, the agency failed to heed the calls of people living with Alzheimer’s by transitioning to regional coverage decisions. Voices of Alzheimer’s and our partners will closely monitor the implementation of regional coverage and will raise flags if this transition complicates or delays care.”

We appreciate and support CMS's evolving stance in finally taking into consideration the evidence showing the immense benefit of ensuring broad access to amyloid PET scans. Since the 2013 CED determination, researchers have published considerable data showing that the knowledge gained from amyloid PET scans adds value to the management of patients, minimizes misdiagnosis, reduces the risk to patients of adverse treatment effects, and informs clinical decision-making. PET imaging is also equally important in ruling out people who do not have Alzheimer's disease since many other cognitive illnesses share symptoms with Alzheimer's. We hope today's decision to end CED for amyloid PET scans is a step toward broad and equitable access for people living with and at risk of Alzheimer's.

However, despite warnings in the public comment period from us and others in the Alzheimer’s community, CMS again fails in this decision to live up to its stated intent of ensuring broad coverage of FDA traditionally approved treatments for Alzheimer’s disease. The choice to transition coverage of amyloid PET scans to the discretion of Medicare Administrative Contractors will cause further delays in coverage for diagnostics and treatments and raises the possibility of varying coverage from region to region.

Researchers estimate that more than 3,000 people each day transition to a more advanced stage of Alzheimer’s, where they are no longer eligible for existing treatments. Months or even years of bureaucratic delays due to the regional coverage transition could cost hundreds of thousands of people the chance to access FDA-approved therapies. The agency must remain vigilant in ensuring local coverage commences without undue barriers or delays, and CMS still has the opportunity to issue a national coverage determination that provides consistent and clear coverage nationwide.

CMS's October 13th decision summary memo removes the restrictive national coverage determination (NCD) at § 220.6.20, ending coverage with evidence development (CED) for positron emission tomography (PET) beta-amyloid imaging, and permits Medicare coverage determinations for PET beta-amyloid imaging to be made by the Medicare Administrative Contractors (MACs). In August, Voices of Alzheimer's submitted public comments to CMS supporting its proposal to end the PET scan CED while urging the agency not to transition coverage decisions to Medicare Administrative Contractors.

About Voices of Alzheimer's

Voices of Alzheimer's is a non-profit organization dedicated to advocating for the rights and well-being of people living with Alzheimer's disease. Our mission is to empower people living with or at risk of Alzheimer’s and other cognitive illnesses, united by urgency, to drive equitable access to innovation in treatment and care. We are guided and led by those affected by Alzheimer’s but with a broad membership, including those individuals in the generation at risk. Our primary focus is to draw attention to the unmet medical needs of people with Alzheimer’s – especially to ensure the FDA and CMS get meritorious products approved and into the hands of patients.

Learn more on the Voices of Alzheimer’s website, and on social media through Facebook, Twitter, Instagram, and TikTok.

VoicesOfAD.com

@VoicesOfAlz

OUR MINDS. OUR LIVES. OUR CHOICES. Two Steps Forward, One Step Back: Voices of Alzheimer's Applauds Medicare's Progress in Removing CED for Amyloid PET Scans but Calls Out its Failure to Ensure Expeditious and Equitable Coverage.

OUR MINDS. OUR LIVES. OUR CHOICES.
Two Steps Forward, One Step Back: Voices of Alzheimer's Applauds Medicare's Progress in Removing CED for Amyloid PET Scans but Calls Out its Failure to Ensure Expeditious and Equitable Coverage.