How to Submit Public Comment on Medicare Coverage of Anti-Amyloid Alzheimer's Drugs

Medicare is deciding whether to cover new anti-amyloid drugs like aducanumab, lecanemab, and donanemab for early-stage Alzheimer's. This decision affects whether you or your loved one can access these treatments. Your voice as a caregiver or patient can influence this policy. Here are concrete steps to submit a public comment that gets heard, including what to say, where to send it, and how to make your story count.

Key points

• Medicare's coverage decision for anti-amyloid drugs directly affects whether early-stage Alzheimer's patients can access these treatments.
• Public comments are a formal part of the CMS decision process and can influence the outcome when they are personal, specific, and respectful.
• Include both the benefits (slowed decline) and risks (ARIA) honestly to build credibility.
• Reference that CMS should accept FDA's safety/efficacy judgment, not re-litigate the science.
• Encourage other caregivers and patients to submit their own comments to amplify the message.
• Follow up with members of Congress and advocacy organizations to apply additional pressure.

Why Medicare's Decision Matters for You

Medicare's coverage decision for anti-amyloid drugs is not just a bureaucratic formality—it directly determines whether you and your loved one can access these treatments. These drugs, which include aducanumab (Aduhelm), lecanemab (Leqembi), and donanemab, are the first class of medications that actually target the underlying disease process by reducing beta-amyloid plaques in the brain, rather than just managing symptoms like older drugs such as donepezil (Aricept) or memantine (Namenda). Clinical trials have shown that lecanemab can slow cognitive decline by about 27% over 18 months in people with early Alzheimer's, and donanemab has shown similar benefits. However, these drugs come with significant risks, including brain swelling or micro-hemorrhages (ARIA) that require regular MRI monitoring, and they are expensive—potentially costing tens of thousands of dollars per year per patient. Medicare's decision will determine whether these costs are covered, making the difference between access and a financial burden that many families cannot bear.

How Public Comment Actually Works

When Medicare (specifically the Centers for Medicare & Medicaid Services, or CMS) proposes a national coverage determination (NCD) for a drug or treatment, it opens a public comment period. This is a formal window—usually 30 to 60 days—during which anyone can submit written comments that CMS staff must read and consider before making a final decision. These comments are not just symbolic; they are part of the legal record that CMS uses to weigh the evidence, including real-world patient experiences, caregiver perspectives, and expert opinions. CMS does not have its own neuroscientists or clinicians to re-evaluate the FDA's safety and efficacy findings—it relies on the FDA's judgment. But public comments can highlight practical considerations that clinical trials miss: how the drug affects daily life, what side effects feel like, and what it means for families when a treatment is or isn't available. Your story can tip the balance toward coverage, especially when combined with thousands of other voices.

What Anti-Amyloid Drugs Are and Who They Help

These drugs are approved by the FDA for people with mild cognitive impairment (MCI) or mild Alzheimer's disease—meaning the person is still living at home, managing most daily activities, but has noticeable memory or thinking problems. They are not for moderate or advanced stages. The drugs work by clearing amyloid plaques from the brain, which are a hallmark of Alzheimer's. However, they are not a cure; they slow progression, not stop or reverse it. The decision to take them is deeply personal and should be made with a neurologist or memory specialist who can assess whether the patient is a good candidate based on amyloid PET scans or cerebrospinal fluid tests, as well as overall health and willingness to undergo regular infusions (every two to four weeks) and MRI monitoring. As one expert noted, 'It comes down to what you believe in as a person'—some families feel the potential benefit is worth the time, cost, and risk, while others do not. Your public comment can advocate for keeping that choice available.

General caregiving information, not medical advice. Check medications and major care changes with your clinician.

Discuss with your clinician

Ask your neurologist: 'Is my loved one a candidate for an anti-amyloid drug based on their amyloid PET scan or spinal fluid results?'

Ask your doctor: 'What are the specific risks of ARIA (brain swelling or micro-hemorrhages) for my loved one, given their age, health, and other medications?'

Ask your clinician: 'How often would we need to come in for infusions and MRIs, and what is the monitoring schedule?'

Ask your pharmacist: 'What is the out-of-pocket cost if Medicare does not cover the drug, and are there patient assistance programs?'

Ask your primary care provider: 'Are there any contraindications with my loved one's current medications or conditions, such as blood thinners or a history of stroke?'

Related guides

• Involving people with dementia and caregivers in policy
• Understanding Contraindications for Anti-Amyloid Therapy (Lecanemab & Donanemab)
• Surgery decisions and informed consent for early-stage Alzheimer's
• caregiver leadership and self-advocacy
• Counting the Cost: A Financial Roadmap for Dementia Care
• Monitoring ARIA (Brain Swelling and Bleeding) with Anti-Amyloid Drugs
• Responding to repetitive, angry phone calls
• Apathy in Alzheimer's disease

Sources

• NICE
• PubMed
• PMC
• Alzheimer's Association
• Mayo Clinic
• aaic.alz.org
• Teepa Snow's Positive Approach to Care
• All Home Care Matters
• Dementia Careblazers
• Answers About Alzheimer's
• Dementia Caregiver Support For Christians
• Better Health While Aging