One morning in 2012, my wife Geri looked in the mirror and failed to recognize her own face. Our neurologist diagnosed Geri, a former health care executive and nurse, with early dementia (also known as mild cognitive impairment) but could not confirm if she had Alzheimer’s disease or give us a clearer diagnosis.
Over the next two years, we lived with the gnawing uncertainty of not knowing the cause of Geri’s memory loss or the best medical options to combat it. A clinical trial of an experimental Alzheimer’s drug at Yale University, a two-hour drive from our home, looked like it might help. To see if she qualified to take part in the trial, Geri had to undergo a scan called positron emission tomography (PET). It uses special chemicals injected into the bloodstream to help “light up” brain tissue with amyloid plaque, the telltale sign of Alzheimer’s disease.
The amyloid PET scan confirmed that she did, indeed, have these plaques, allowing physicians to definitively diagnose her with the disease. That changed things for Geri, allowing her to qualify to begin receiving experimental medication as she continued developing coping strategies to better manage her disease.
Had Geri not entered the clinical trial and received that critical amyloid PET scan, we might still not have a definitive diagnosis. While an Alzheimer’s diagnosis is never easy, she and I no longer have to struggle with uncertainty about her disease.
Most other people with mild cognitive impairment or dementia aren’t as fortunate as Geri. Although the FDA approved the amyloid PET scan that she received in 2012, the Centers for Medicare and Medicaid Services (CMS) decided the following year not to cover these scans except in the case of specialized research studies or in circumstances in which the scans can be used to “exclude” Alzheimer’s disease in a “narrowly defined and clinically difficult differential diagnoses.”
Since that decision, however, new evidence supports the utility of amyloid PET imaging for people with cognitive impairment. In 2019, researchers published results from the IDEAS study, which analyzed the use of these scans among more than 11,000 people with various forms of cognitive impairment. Researchers found that amyloid PET imaging led to improvements in disease management in more than 60% of the cases. The trial’s lead investigator, University of California, San Francisco, neurologist Gil Rabinovici, told MedPage Today that the research demonstrated “that the availability of amyloid PET imaging can have a significant impact on how physicians care for patients with memory loss and cognitive impairment.”
A successor trial, New IDEAS, is now underway and aims to focus on a more racially and clinically diverse group of Medicare beneficiaries.
But since CMS reimburses facilities less than the cost of the scan — meaning they lose money on each one they perform — it remains to be seen how many hospitals will actually participate in the new study.
That will become an even bigger problem if drugs that work against Alzheimer’s disease come on the market. The FDA is supposed to make a decision on aducanumab, a medication that appears to slow the cognitive decline of Alzheimer’s disease, by June 7. And there are several other exciting treatment possibilities close behind.
If these medications are approved, people with cognitive impairment or dementia will still face the hurdle of first confirming their Alzheimer’s diagnosis to qualify to receive them. More than 6 million Americans are estimated to be living with Alzheimer’s in the United States, about half of whom have not yet been diagnosed with it. If the amyloid PET scans required to definitively diagnose someone with the disease — and to make them eligible for these medications — aren’t covered by Medicare, most people won’t be able to afford the high out-of-pocket costs associated with scans, increasing the likelihood of not only a missed diagnosis but also a missed opportunity to receive treatment and important social services. And few hospitals or medical centers will perform them.
This lack of coverage will only deepen health disparities faced by women, those in minority groups, and low-income individuals. Women account for nearly two-thirds of all Americans with Alzheimer’s. Black seniors are nearly twice as likely to develop Alzheimer’s compared with their white counterparts. And Alzheimer’s is more prevalent among elderly Americans with lower levels of education and income.
Congress can help Americans with cognitive impairment address these access disparities and encourage hospital systems to perform PET scans for Alzheimer’s by introducing legislation that establishes higher, more financially feasible payment for this imaging through the Medicare program. Reintroduction and passage of legislation similar to the Medicare Diagnostic Radiopharmaceutical Payment Equity Act from last Congress would help providers better manage the costs associated with diagnostic PET imaging procedures while still delivering more targeted and cost-efficient care.
As science advances potential treatments for Alzheimer’s disease, we owe it to people with this disabling condition to make sure diagnostic coverage and payment policies also advance.
Jim Taylor is a retired financial analyst and care partner to his wife, Geri. Together, they have spoken to more than 10,000 people about Alzheimer’s since 2015. They have received travel reimbursements and honoraria from Biogen, Takeda, and Lilly for speaking with employees about clinical trial participation, all of which were donated to dementia support organizations.