Doctors, patients, and families deserve to decide care, not faceless bureaucrats and automated claims systems. This piece looks at how a Biden-era Medicare policy has turned FDA approval into only half the fight, why private insurers follow the government’s lead, and how that harms Alzheimer’s patients, their families, and the broader economy.
Picture a diagnosis of Alzheimer’s and a doctor recommending a treatment tailored to keep you functional longer. It’s common sense that the final decision should rest with the patient, loved ones, and treating physician. Instead, an opaque approval process controlled by payers and regulators often blocks access to care that doctors believe is right.
If policymakers want fewer insurance denials, they should stop creating incentives for them.
Public frustration is real and bipartisan in its raw emotion, even if the policy debate falls along party lines. Recent polling shows overwhelming concern that doctors avoid prescribing tests or treatments because insurers won’t cover them and patients can’t afford to pay. Headlines about patients who improved with new therapies only to have coverage yanked have put a human face on a policy problem.
Lori Baetz is one of those faces: treatment brought her back to daily life, and when her insurer pulled coverage she steadily declined, at one point getting lost in her own neighborhood. Her neurologist, Dr. Cara Leahy, reports repeated denials for patients who respond to treatment. People see the clinical reality and wonder why paperwork and policy are stealing time and function from loved ones.
The answer is less about private spite and more about government design. After the FDA cleared a new generation of Alzheimer’s drugs, the Centers for Medicare and Medicaid Services imposed Coverage with Evidence Development, which limited Medicare reimbursement unless patients met extra conditions and enrolled in government-approved studies. That policy effectively created a second approval gate after the FDA had already done its job.
Once Medicare treated FDA clearance as insufficient, private insurers followed the same logic. Plans could point to Medicare’s extra requirements when they denied care, labeling FDA-approved therapies as “investigational/experimental” even as doctors recorded clinical improvements. The result is a system that rewards delay, paperwork, and narrow criteria over swift, individualized care.
The costs are enormous and painfully personal. Lifetime care for a person with Alzheimer’s exceeds $400,000 on average, with families shouldering roughly 70 percent of that through unpaid caregiving and out-of-pocket bills. At the same time Medicare and Medicaid are already spending tens of billions annually, and those totals will balloon as cases rise with an aging population.
There’s also an upside that policy is losing sight of. Research shows that earlier, effective treatment can add meaningful healthy years, reduce time in nursing homes by years, and cut medical spending substantially per patient. Keeping people independent longer means fewer family caregivers forced to quit jobs, less strain on long-term care budgets, and more productive, engaged Americans contributing to the economy.
Policymakers can change incentives without overturning the FDA. The FDA decides safety and efficacy; CMS should not create a policy architecture that treats approval as a starting line instead of a finish line. If Medicare stopped treating approval as optional and instead aligned reimbursement with clinical evidence and patient need, private insurers would follow and patients would win.
Practical fixes matter: simplify coverage rules, allow treating physicians more authority in real-world cases, and stop rewarding denials with bureaucratic shields. Political leadership that prioritizes patients over process can restore trust in the system and spare families needless decline and expense. “They just want to wear you down … so you just give up.”
Until that changes, Americans will continue blaming insurance companies for behavior government policy encourages.
