Medicare generally does not cover experimental or investigational treatments for dementia, including Alzheimer’s disease, unless these treatments are provided within approved clinical trials or registries under a special provision called Coverage with Evidence Development (CED). This means that if a dementia treatment is considered experimental—lacking sufficient evidence of safety and effectiveness—Medicare will typically exclude it from coverage. However, Medicare may cover such treatments if they are part of an approved clinical study designed to gather more evidence about the treatment’s benefits and risks. This approach allows patients to access promising new therapies while ensuring that Medicare funds are spent on treatments with proven value.
To qualify for Medicare coverage under CED, the experimental dementia treatment must be administered within a clinical trial or registry that meets Medicare’s criteria. These criteria include having a clearly defined study protocol, enrolling appropriate patient populations, and collecting data systematically to evaluate the treatment’s impact on health outcomes. Physicians must document the clinical trial or registry details, including the trial name, number, and the specific drug or device used. This process helps Medicare balance patient access to innovative therapies with the need for rigorous evidence before fully endorsing new treatments.
For example, recent developments in Alzheimer’s treatments, such as drugs targeting amyloid plaques in the brain, have been covered by Medicare when patients participate in registries. One such drug, lecanemab, is covered if doctors enroll patients in a registry that tracks treatment outcomes and side effects. Medicare Part D caps the annual out-of-pocket cost for these drugs, making them more affordable for beneficiaries. This coverage under registry conditions reflects Medicare’s cautious but supportive stance toward new dementia therapies that show promise but require further evidence to confirm their long-term benefits and safety.
Medicare’s coverage decisions for dementia treatments also depend on whether the treatment is FDA-approved and whether it meets the definition of medical necessity. Medical necessity means the treatment must be reasonable and necessary for diagnosing or treating a specific medical condition. Experimental treatments often lack sufficient evidence to meet this standard outside of clinical trials. Additionally, Medicare requires that diagnostic tests related to dementia, such as biomarker tests for Alzheimer’s disease, demonstrate clinical utility—meaning the test results must influence patient management and improve outcomes—to be covered.
Prescription drug plans under Medicare Part D follow similar rules. They cover FDA-approved drugs for dementia but generally exclude experimental or investigational drugs unless exceptions are granted through prior authorization or coverage under clinical studies. Plans may require step therapy or other utilization management strategies to ensure appropriate use of dementia medication
