By Terry Wilcox, Patients Rising
Originally published in RealClearHealth.
President Trump has challenged Republicans to lead on health care by cutting red tape, holding insurance companies accountable, and putting medical choice back in the hands of patients.
Nowhere is this relief needed more than among people with early-stage Alzheimer’s disease whose private health insurance plans are using an obscure Biden-era policy as an excuse to deny coverage for critical medicines.
Dan Jaworski had private insurance and was diagnosed with Alzheimer’s disease at 54. He was determined to continue living well for as long as possible. That included continuing to compete in Iron Man competitions, following a Mediterranean diet, and taking an FDA-approved Alzheimer's treatment. Despite his doctor’s prescription and proof that the medicine has changed the lives of similar patients, his insurer denied the claim, writing that the drug was not “medically necessary.”
My organization has identified nine health insurers, including one national plan and multiple Blue Cross plans, that have written medical policies for FDA-approved Alzheimer’s medicines that categorize them as “experimental” or “investigational” and, as a result, won’t cover them.
These Alzheimer’s medicines are not experimental; they are FDA-approved and supported by more than a decade of clinical trials. But the insurers say the medicines are experimental because the Biden administration mandated that, to get coverage, each patient and his or her doctor had to participate in a special study known as Coverage with Evidence Development, or CED — an extra requirement that makes it look like the medicines are still in the testing phase.
CED was created to allow Medicare to cover innovative medical devices while the government collected additional data on safety and effectiveness, creating a temporary bridge to cutting-edge care while science caught up. However, in practice, the program has tied up numerous breakthrough devices in more than a decade of red tape before being allowed to leave the program. Most devices never leave the program. And when FDA approved the first-ever monoclonal antibody treatment for Alzheimer’s disease – a breakthrough in treatment – the Biden administration expanded CED to tie up the entire new class of drugs.
Imposing regulations designed for medical devices on drugs has never made sense. FDA-approved drugs have already met the highest evidentiary standard in medicine, supported by more than a decade of clinical trials with the highest standards. When Medicare treats FDA-approved Alzheimer’s drugs as unsettled science, it sends a misleading signal to private insurers that the treatments are still experimental and gives them an excuse to deny coverage.
Using this program to delay or deny seniors access to the first Alzheimer’s therapies shown to improve patients’ lives is not only unjustified—it is quietly producing devastating consequences for patients and families. For some families, a coverage denial will mean watching their loved one fade away.
And insurance companies do not stop at treatment denial -- they can also impede early diagnosis. Once a patient is diagnosed with Alzheimer’s disease, insurers face downstream obligations: specialist referrals, advanced testing, ongoing monitoring, and potentially expensive therapies. Insurers know that by delaying or obstructing diagnosis itself, they can limit those obligations before they arise. As a result, insurers create barriers to diagnosis, requiring prior authorizations, secondary visits, or behavioral health pre-certifications to get cognitive assessments.
The chilling effect on early diagnosis cannot be ignored. An estimated 90% of early cognitive decline goes undiagnosed. Fewer than 20% of seniors receive routine cognitive screening. Patients are diagnosed late when interventions are least effective and costs are highest.
Each year of delayed Alzheimer’s diagnosis adds roughly $18,500 in lifetime care costs per patient as unmanaged decline accelerates disability and institutionalization. Multiplied across millions of Americans, dementia is projected to cost more than $1 trillion over the next five years.
The human cost is harder to measure. Patients lose time. Families lose loved ones. Physicians lose the ability to practice according to settled science rather than payers’ preferences.
For families watching a loved one fade away, CMS’s demand for more evidence does not feel like prudence. It feels like abandonment. Ending the Biden administration’s CED policy for Alzheimer’s drugs is an immediate way the Trump administration can restore patient choice, realign insurer incentives, and reopen access to both diagnosis and treatment. It would be a decisive win for the millions of families who know the challenge of Alzheimer’s firsthand—and proof that Republican leadership on health care is more than a slogan.
Published in RealClearHealth.
Terry Wilcox is cofounder and chief mission officer of Patients Rising.
