Media requests should be directed to: 

Katy Riddick, Voices of Alzheimer’s Secretariat  

E-mail: kriddick@highlanterngroup.com 

Phone: +1 202 223 2027 

FOR IMMEDIATE RELEASE 

OUR MINDS. OUR LIVES. OUR CHOICES. 
VoA's Official Public Comment On CMS's Broader PET Scan Coverage Proposal

Washington, DC, August 16, 2023 – Yesterday, Voices of Alzheimer’s submitted their official public comment to the Centers for Medicare and Medicaid Services (CMS) on eliminating its current policy of limiting Medicare coverage of PET scans for people living with Alzheimer’s.

Voices of Alzheimer’s supported CMS proposals to expand coverage of PET scans while raising concerns about transitioning coverage decisions to Medicare Administrative Contractors. The full public comment can be read below:  

Submitted to CMS on August 15th, 2023 - Voices of Alzheimer's, an advocacy organization led by people living with Alzheimer's Disease and caretakers, supports action by the Centers for Medicare & Medicaid Services (CMS) to end Coverage with Evidence Development (CED) requirements for beta-amyloid PET in Dementia and Neurodegenerative Disease. We also support the CMS proposal to lift PET scan coverage limits, which currently cover virtually no scans, as patients are only eligible for one scan in their lifetime if participating in a CMS-approved clinical trial. There is only one such trial today.

While we applaud these proposals, we remain concerned that the transition to coverage at the discretion of Medicare Administrative Contractors (MACs) will result in uncertainty, confusion, and delays in coverage. We urge CMS to end CED and remove the limit on scan coverage while issuing a national coverage determination of beta-amyloid PET to ensure consistent, broad access.

Existing CED requirements and limits restrict the ability of people living with Alzheimer’s disease to access testing that is crucial in making decisions that shape their fight against the disease. Beta-amyloid PET imaging plays a vital role in the most critical care decisions, including determining a diagnosis of Alzheimer’s disease, deciding whether an individual is eligible for disease-modifying therapies, monitoring treatment response, and determining when to stop treatment. PET imaging is also equally important in ruling out people who do not have Alzheimer’s disease since many other dementias share symptoms with Alzheimer’s.

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 [1]. Further, since 2013, the FDA has granted traditional approval to the first-ever approved disease-modifying therapy for the treatment of Alzheimer’s disease, making access to diagnostic tools more important than ever. In light of these developments, Voices of Alzheimer’s could not agree more with the CMS statement that “appropriate coverage of amyloid PET scans will greatly reduce provider and patient burden from the existing requirements and test limitation.”

To avoid delays in coverage, confusion, and uncertainty for the millions of Americans living with Alzheimer’s, we urge CMS to reconsider its proposal to transition coverage of amyloid PET scans to the discretion of Medicare Administrative Contractors and instead end CED and the limit on scans while maintaining national coverage. Given the progressive nature of Alzheimer’s disease, the uncertainty and delay caused by the transition to coverage at the discretion of Medicare Administrative Contractors (MACs) and Medicare Advantage (MA) plans will result in poor patient health outcomes and inequitable access.

Every day, it is estimated that more than 3,000 people transition to a more advanced stage of Alzheimer’s, where they are no longer eligible for existing treatments. Even in the best-case regional coverage scenario for people with Alzheimer’s, where MACs decide to cover PET scans, establishing final Local Coverage Determinations (LCDs) could take several months. Then, once a final LCD is issued, it does not go into effect for 45 days. These bureaucratic delays could cost hundreds of thousands of people the chance to access FDA-approved treatments. CMS can altogether avoid this outcome by issuing a national coverage determination that provides consistent and clear coverage nationwide.

Furthermore, in staying with CMS’s stated intent of ensuring broad coverage of FDA traditionally approved treatments for Alzheimer’s disease, the agency should not transition to coverage at the discretion of MACs. Currently, CMS requires that patients who are candidates for treatment with anti-amyloid therapies receive a diagnostic test for amyloid identification under the National Patient Registry Portal. Without national coverage, if specific regions do not provide adequate coverage for amyloid PET scans, people living with Alzheimer’s who are eligible for treatment could be effectively barred from receiving the diagnostic tests required to initiate treatment.

Voices of Alzheimer's, on behalf of our members living with Alzheimer’s and related neurodegenerative diseases, appreciate and support proposals by CMS to ensure broad access to beta-amyloid PET. We urge CMS to move forward with its proposals to end CED and the coverage limits on amyloid PET scans and call on the agency to maintain national coverage of beta-amyloid PET to avoid the delay and uncertainty that could harm hundreds of thousands of people living with these diseases.

Sources:

[1] E.g., Hattori N, et al. J Alzheimer Dis Rep. 2020. Ceccaldi M, Jonveaux T, Verger A, et al. Alzheimer's Dement. 2018;14(3):293-305. doi:10.1016/j.jalz.2017.09.009 

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 ensuring 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. 
 

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