Washington, D.C. (August 16, 2023) – Yesterday, UsAgainstAlzheimer’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 to just one in a person’s lifetime.

UsAgainstAlzheimer’s applauded CMS for considering providing Alzheimer’s patients with additional coverage for PET scans. The full public comment can be read below:

We are immensely grateful for the opportunity to comment on the Center for Medicare and Medicaid Services’ (CMS) proposed National Coverage Determination (NCD) reconsideration for Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegenerative Disease.

At UsAgainstAlzheimer’s, we welcome CMS’s proposal to eliminate the highly-restrictive NCD at § 220.6.20, effectively ending coverage with evidence development (CED) for PET beta amyloid imaging. 

The proposed decision to allow Medicare coverage determinations for PET beta amyloid imaging to be made by the Medicare Administrative Contractors (MACs) under § 1862(a)(1)(A) of the Social Security Act (the Act) is an important step in the right direction, but we urge you to make an affirmative, national decision that amyloid PET scans should be covered. Beneficiary access to this important diagnostic and monitoring tool should not vary from region to region or plan to plan. 

Our organization had previously submitted detailed comments on July 15, 2022, in response to CMS’s NCD Analysis for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease. In those submissions, we presented a compelling case for CMS to reconsider this NCD and provide coverage without CED for the FDA-approved use of an Aß PET scan.

Since that time, the case for taking this long-overdue action has only strengthened. On July 6th of this year, Leqembi, one of the class of monoclonal antibodies targeting amyloid, received traditional FDA approval due to trial data demonstrating clear clinical benefit and a meaningful slowing of the disease's progression. In response, CMS provided broad coverage for all eligible beneficiaries through a registry. As CMS acknowledges in the proposed decision, a diagnosis through PET amyloid-beta (Aß) imaging is one likely path for a patient to receive Medicare coverage of the drug. 

We recognize that national coverage of PET will have cost implications for Medicare, and we are taking steps through our Blood-based Biomarker Initiative to advance lower-cost diagnostic and monitoring tools. 

USAgainstAlzheimer’s commends CMS for reevaluating this NCD, and we eagerly anticipate the elimination of the CED requirement. We stand ready to collaborate in our unwavering commitment to ending this dreaded disease, which has already devastated too many American lives.

Sincerely,
George Vradenburg
Chairman and Co-Founder
UsAgainstAlzheimer’s

About UsAgainstAlzheimer’s

UsAgainstAlzheimer’s is engaged in a relentless pursuit to end Alzheimer’s, the sixth leading killer in America. Our work centers on prevention, early detection and diagnosis, and access to treatments – all regardless of gender, race, or ethnicity. To achieve our mission, we give voice to patients and caregivers while partnering with government, scientists, the private sector, and allied organizations -- the people who put the “Us” in UsAgainstAlzheimer’s.