Medicare doesn’t want to pay for people with Alzheimer’sJun 28, 2022 10:43AM ● By Sue Peschin, MHS
Medicare recently announced it will effectively refuse to cover Aduhelm, the first FDA-approved Alzheimer’s disease treatment in two decades.
For years, the program has gotten away with paying only a fraction of the costs for this disease that impacts more than six million Americans. And by finalizing this restrictive coverage policy, federal officials intend to keep it that way.
Currently, Medicare pays just 16 percent of lifetime costs for a person with Alzheimer’s. The price tag for Medicare is so low because, without treatments, expenses are primarily for non-medical services, such as at-home help with bathing.
The first signal that Medicare would likely limit access to the new treatment was in its August 2021 Board of Trustees report to Congress, which stated, “The scope of Medicare coverage for this drug [Aduhelm] is unknown...Because of these uncertainties, actual program experience could be worse than projected in the high-cost scenario.”
In January 2022, the “scope” of Medicare’s coverage plan to contain expenses for Aduhelm became clear. The agency released a draft Medicare National Coverage Determination requiring “coverage with evidence development” (CED).
Under CED, Medicare covers FDA-approved treatments on a very limited basis, and under the condition that beneficiaries must enroll in a clinical trial or patient registry.
In the agency’s final Medicare coverage policy, the CED requirements vary depending on how an Alzheimer’s treatment is approved by the FDA. If the FDA approves a therapy under “accelerated approval”—a pathway designed to give patients earlier access to medicines that are likely, though not yet fully proven, to be clinically beneficial—Medicare will require beneficiaries with Alzheimer’s to enroll in randomized control clinical trials. Such studies will take years to complete, and patients will have to risk receiving a placebo rather than treatment.
For drugs approved under the FDA’s traditional pathway, Medicare will require beneficiaries to enroll in a patient registry.
The idea of a mandated patient registry may sound good on paper. But in practice, these types of registries have historically exacerbated health disparities.
In reality, Medicare is using CED as a rationing tool to deny expensive care to people suffering from Alzheimer’s. Many patients with the disease are dually eligible for Medicare and Medicaid, and this decision goes out of its way to be especially harsh on them. The likelihood that any full-benefit dually eligible beneficiaries will be able to access these FDA-approved treatments is extremely low.
The impact of this final decision will be felt far beyond Alzheimer’s patients and their caregivers. Federal officials will be able to use it as a precedent to further undermine FDA’s authority and restrict access to future drugs for other serious and life-threatening conditions.
Our older family members and neighbors paid into Medicare to provide care for those before them. We should honor their contributions by ensuring they now receive the coverage they deserve.