UsAgainstAlzheimer’s, along with a coalition of leading advocacy groups, is calling for the Centers for Medicare and Medicaid Services (CMS) to appropriately cover the costs of blood tests helping to detect Alzheimer’s.

October 25, 2024 

Meena Seshamani, MD, PhD
Deputy Administrator and Director, Center for Medicare
Centers for Medicare & Medicaid Services

7500 Security Boulevard
Baltimore, MD 21244

Dr. Seshamani: 

RE: CY 2025 Clinical Laboratory Fee Schedule Preliminary Determinations: Category 1  CPT®[1] Codes and Assays for Fluid-Based Amyloid Beta and Tau Protein Biomarkers  

Alzheimer’s disease and related dementias are only diagnosed about half of the time. The  pathology is detected and diagnosed late in the disease progression, if at all, in Black and  Hispanic Americans. No diagnosis or late diagnosis robs these people of information they need  to consider new disease-modifying therapies, make lifestyle changes that might slow  progression, plan their lives or seek other appropriate therapy or clinical trials. 

Blood tests could provide a less expensive, easier-to-access means to obtain diagnosis for people  with Alzheimer’s disease. Increased access to a reliable test could be particularly important for  the health of rural Americans who often live far from an urban setting where a PET scan is  available. 

This revolution for people living with early Alzheimer’s and those who love them is threatened  by the proposed Clinical Laboratory Fee Schedule for next year. As we understand it, the  advisory panel recommended a reimbursement rate of $130 per test for beta-amyloid 1-40, beta amyloid 1-42, neurofilament light chain, total tau, and phosphorylated tau. However, your  proposed Fee Schedule would reimburse the labs who might perform these tests at $17, just over  10% of that amount, which may be less than what such a test would cost a laboratory to process  the test. As a result, as a practical matter, blood tests could simply not be used by physicians. As patient advocates, we are not experts in the costs of performing blood tests, but we expect  that your advisory panel is. If Medicare sets rates so much lower than they recommend, we  expect that many labs would simply not offer these crucial tests. This would be awful for people  living with dementia—particularly historically underserved populations. 

We cannot imagine that this is Medicare’s intention. 

The opportunity for someone with Alzheimer’s disease to access the medicines or make the  lifestyle changes that may improve their prognosis may be lost if patients are unable to get the  appropriate lab test because reimbursement rates are too low. 

The last few years have also made exciting new disease-modifying treatments available to  physicians and their Alzheimer’s patients – if a diagnosis can be made while the patient is still in  the early stages of the disease. The FDA has granted traditional approval to – and Medicare is  now covering, with restrictions under a CED – two drugs that slow both the cognitive and 

functional rate of decline that are the hallmarks of Alzheimer’s disease. Again, these drugs are  indicated only for people with mild cognitive impairment or early-stage Alzheimer’s dementia,  and anything that delays a diagnosis will mean that some patients will have advanced too far to  use these medications. 

Lack of access to these lab tests would exacerbate health inequities for Alzheimer’s disease that  hit traditionally underserved communities hard. Black Americans are twice as likely, and Latino  Americans are one and one-half times more likely, to develop dementia than White Americans.  More available and more affordable means of diagnosing Alzheimer’s disease could help these  groups of people. 

People living with Alzheimer’s disease waited more than two decades for new medications to be  approved by the FDA, and we now have the first two disease-modifying drugs ever. Evidence  about the effectiveness of lifestyle intervention is continually growing and becoming more  prescriptive. These are exciting developments – but their impact will be limited if people cannot  get affordable tests and early diagnosis. Please do not let blood test reimbursement rates create  yet another roadblock to effective treatment. 

As Medicare works to finalize its proposed reimbursement rate for blood tests, we urge you to  follow the advisory panel recommendations for tests for Alzheimer’s pathology and set an  appropriate rate. Setting rates that do not cover the laboratories’ cost of conducting the tests will  harm patients and their families. 

Please let us know if we can be helpful. 

Sincerely, 

• Alliance for Aging Research 
• Alliance for Patient Access 
• Alliance for Women's Health and Prevention 
• American Senior Alliance 
• Caregiver Action Network 
• Davos Alzheimer’s Collaborative  
• The Global CEO Initiative on Alzheimer’s Disease 
• Global Alzheimer's Platform Foundation 
• HealthyWomen 
• National Consumers League 
• National Grange 
• Partnership to Fight Chronic Disease 
• Society for Women's Health Research 
• UsAgainstAlzheimer’s 
• Voices of Alzheimer’s