How the Biden Admin's Refusal to Cover New Alzheimer's Drugs Hurts 'Underserved' Americans and Costs Taxpayers Billions

'The tragedy of Alzheimer's disease is exacerbated by inaction of policymakers,' University of Chicago prof says

Getty Images
June 12, 2023

The Biden administration is imposing strict Medicare coverage requirements on a new FDA-approved Alzheimer's treatment, a move that experts say is hurting low-income patients and costing taxpayers billions of dollars.

The Centers for Medicare and Medicaid Services—a federal agency within the Department of Health and Human Services that administers Medicare—is, in almost all cases, refusing to cover an Alzheimer's treatment that research shows can reduce cognitive decline by 27 percent. The decision, a new University of Chicago study argues, could cost Americans up to $546 billion in private and public spending, as patients who deteriorate without the drugs require additional health care spending that Medicare does cover.

In addition to the sizable burden on taxpayers, the administration's refusal to cover the new treatments outside of selective clinical trials contradicts the health department's self-described commitment to "health equity." The Centers for Medicare and Medicaid Services on Wednesday and Thursday held its first ever "Health Equity Conference," which aimed to highlight and address "health disparities" in rural and "underserved communities." Those communities, however, are often unable to participate in clinical trials, which typically take place in heavily populated areas that include universities or large medical centers. 

The University of Chicago study's co-author, professor Tomas Philipson, criticized the administration for creating "barriers to care" that "not only deny patients innovative relief but also hope."

"Millions of Americans are all too familiar with the human cost of Alzheimer's, but this study makes clear the personal and financial suffering caused by red tape that withholds potentially life-altering relief from patients," Philipson said. "The tragedy of Alzheimer’s disease is exacerbated by inaction of policymakers. We hope lawmakers will heed this report’s findings outlining the lost opportunity and harm caused by onerous regulations."

In 2021, the Food and Drug Administration granted accelerated approval for amyloid plaque-targeting treatment in Alzheimer’s patients, which studies have shown delays cognitive decline caused by the disease. In April of 2022, however, Biden's health department implemented a coverage restriction that limited Medicare coverage for the treatment to those who participate in certain clinical trials. As a result, patients who are prescribed the treatment outside of a clinical trial have to pay out of pocket, and it may take as long as 17 years to reverse the restriction, according to the University of Chicago white paper.

In December, the national Alzheimer’s Association formally requested the Centers for Medicare and Medicaid Services reconsider its coverage determination, citing clinical studies the association said "clearly demonstrate a meaningful clinical benefit" of the plaque-targeting treatments for Alzheimer patients. Even the Food and Drug Administration says the treatment has shown "statistically significant treatment effects."

In addition to the two groups, a bipartisan coalition of nearly 100 members of Congress in February wrote Biden's health secretary, Xavier Becerra, to call for the coverage restriction to be removed, arguing that the restriction could bring "irreversible disease progression for beneficiaries living with Alzheimer's." 

"Patients, families, and caregivers living in rural and underserved areas should have the same opportunity for access to treatment," the letter says. "It is an enormous physical and financial burden for Medicare beneficiaries to spend countless hours traveling to limited research institutions that host the trials."

The Food and Drug Administration is expected to weigh traditional approval for one plaque-targeting drug in the coming weeks. But even if the drug does get the okay, Medicare and Medicaid will only cover it "when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry."

The development of a registry can take many years, Philipson noted in his study, causing the coverage restriction that prevents patients from getting treatment to persist, despite full federal approval.

"With this approach, only the privileged few with access to clinical trials have access to treatment," the Alzheimer's Association stated in a press release. As a result, the association said, the Biden administration policy "exacerbates and creates further health inequities among those who are already disproportionately impacted by this fatal disease."

The Centers for Medicare and Medicaid Services told the Washington Free Beacon it would "continue to look carefully at the evidence and wait for the FDA’s decision on whether to grant traditional approval."

"CMS is committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for Alzheimer’s disease," senior communications adviser Sara Lonardo said. "If the FDA grants traditional approval CMS is prepared to ensure anyone with Medicare who meets the criteria is covered," Lonardo concluded. 

Thomas McKenna contributed to this report.