It’s final: Medicare doesn’t want to pay for people with Alzheimer’s disease

Earlier this month Medicare 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 fatal neurological disease that impacts more than 6 million Americans. And by finalizing this restrictive coverage policy, federal officials made it clear they intend to keep it that way.

Currently, Medicare pays just 16% 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, eating, and using the bathroom. Those are expenses the program doesn’t cover. Families must pay for a staggering 70% of overall costs. Medicaid picks up the remaining 14%, primarily for nursing home and related long-term care services.

The first signal that Medicare would likely limit access to the new treatment was in its August 2021 Medicare 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 October 2021, Medicare released a fact sheet asserting that increases in the 2022 Medicare Part B premium and deductible were due to the possibility of coverage for a “high cost Alzheimer’s drug.”

By January 2022, the “scope” of Medicare’s coverage plan to contain expenses for this Alzheimer’s drug became clear. The agency released a draft Medicare National Coverage Determination requiring “coverage with evidence development,” or 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 — in other words, drugs that have been proven to provide clinical benefits, such as slowing the decline in patients’ cognition and function — 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.

Consider the 2012 Medicare coverage decision for a cutting-edge heart disease treatment that provided a limited number of patients with an alternative to open-heart surgery, through a mandated patient registry under CED. In its 2019 reconsideration, Medicare officials claimed that the evidence collected in the CED registry was “insufficient for minority populations,” and used this as a justification to continue the restrictive coverage policy. Throughout the time this CED registry has been in place, utilization of this technology has been significantly lower in predominantly Black and Hispanic communities, according to a 2021 study published in JAMA Cardiology.

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, such as cancer, ALS, and rare diseases.

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. Instead, Medicare’s final coverage decision places the almighty dollar ahead of the inherent worth of people with Alzheimer’s disease.