Medicare appears poised to reject widespread coverage of the latest test for detecting Alzheimer's disease; a brain scan that identifies the protein clumps believed to play a role in the development of the disease.
The Centers for Medicare and Medicaid Services (CMS) handed down a preliminary decision to limit coverage of the new PET scan for beta-amyloid plaques in the brain—regarded by many experts as a hallmark sign of Alzheimer's—to people participating in clinical trials.
With a final ruling from CMS expected to come in the early weeks of October, the debate over the utility of the test, as well as how it might benefit people with the disease and advance research efforts, is heating up.
Supporters of widespread coverage for the scan argue that putting the tool (which carries a price tag of about $3,000) within financial reach of elderly consumers would enable those with signs of dementia to seek a measure of clarity regarding the source of their cognitive impairment. Knowing specifically what disease they're dealing with could help families more effectively plan for the future.
Opponents contend that the unavailability of a successful treatment for Alzheimer's disease diminishes the value of a conclusive diagnosis. What happens after an Alzheimer's diagnosis when there are so few options available to manage it? Some also fear, given ongoing questions about the scan's accuracy and results, that the test could bestow a high number of devastating false positives.
Some experts land in the middle—arguing that Medicare should offer the scan for certain elders, but that strict guidelines should determine who qualifies for coverage.
Expert panel offers interesting Alzheimer's insights
Earlier this year, a group of neurological disease experts gathered to offer their opinions on the practicality of the PET amyloid scan in diagnosing and treating people with Alzheimer's disease. While in agreement over the benefits of early diagnosis of Alzheimer's disease, committee members were divided on how to achieve this goal.
The panel—formally called the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC)—gave the scan a mixed review. When asked to vote on the test's potential to alter the health outcomes of people experiencing cognitive decline, the experts settled on a paltry score of 2.17 (out of a possible five).
During the deliberations, the committee members expressed a few interesting insights about Alzheimer's disease that may help explain why the PET scan is surrounded by controversy:
- The cause of Alzheimer's is still unknown: Despite the push to develop drugs aimed at reducing or preventing beta-amyloid accumulation, the jury is still out as to whether the protein is really the number one enemy scientists should be focusing on. David Kuhlman, M.D., a neurologist and sleep medicine expert from Bothwell Regional Health Center, pointed out, "It is not known whether beta-amyloid is the cause of all causes of Alzheimer's disease, or even the cause of symptoms." Kuhlman feels the PET scan is of limited use, given that a positive result can't absolutely confirm an Alzheimer's diagnosis, and a negative result cannot rule out the possibility of the disease.
- Diagnosing Alzheimer's is tricky: Postmortem examination of brain tissue has led researchers to conclude that as many as one-in-five people diagnosed with Alzheimer's are misdiagnosed. These individuals likely have some other form of dementia, such as Lewy Body dementia, or frontotemporal dementia. Uncertainty over what causes Alzheimer's is the primary contributor to the inconsistency of available diagnostic tools. Elders often suffer from multiple chronic health issues, presenting physicians with a complex puzzle of cause and effect. Doctors must sift through a host of different factors in order to tease out the precise trigger(s) of an aging adult's cognitive issues. This is why a battery of tests is currently used to determine the source of a person's dementia, including mental functioning exams, biomarker analyses and neurological scans.
- Available Alzheimer's therapies are not risk-free: Alzheimer's medications carry side-effects such as nausea, vomiting, diarrhea, loss of appetite, and confusion. These side-effects are not serious but, given the rampant epidemic of polypharmacy among the elderly population, adding another medication to the list of an elder who may not actually need it could have a negative impact on their health.
- Beta-amyloid scans are hard to read: Rita Redberg, M.D., Chair Professor of Medicine at the University of California, San Francisco School of Medicine, pointed out the particular difficulty of interpreting PET scans for beta-amyloid. She cited research that uncovered a wide variation in the sensitivity of radiologists interpreting the scans, saying, "My radiology colleagues tell me that PET amyloid scans are among the hardest to read of all types of PET scans."
- An Alzheimer's diagnosis can affect insurance eligibility: Long-term care costs for an Alzheimer's sufferer can quickly skyrocket into the ten-of-thousands, regardless of whether they are cared for at home, or enter an assisted living or skilled nursing facility. Long-term care insurance is often suggested to help manage some of these costs, but receiving an Alzheimer's diagnosis automatically disqualifies an individual from purchasing this kind of protection. And, even if a person has a long-term care plan in place prior to diagnosis, their benefits may be altered by the new information.
Policymakers are torn between making the beta-amyloid PET scan more accessible so it can be used to enhance the lives of Alzheimer's sufferers and further research efforts, and acknowledging that the scan may not yet be useful enough to offset the many costs (both financial and otherwise) involved in offering coverage to the larger Medicare population.