Medicare Lifts Its Coverage Limit On Alzheimer’s Disease PET Scans

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A decision memorandum from the Centers for Medicare and Medicaid issued last month lifts restrictions on coverage of Alzheimer’s disease diagnoses that measure beta-amyloid plaque in the brain. Excessive levels of plaque are considered an indicator of the presence of Alzheimer’s disease. Facilitating the reimbursement of diagnostic tests is critical in light of the recent approval of drugs aimed at reducing amyloid plaque. But questions remain about equitable access, as coverage decisions will now be made at the local level by Medicare Administrative Contractors.

Alzheimer’s disease is the most common cause of dementia, accounting for 60-80% of all cases in the United States. cognitive impairment which severely interfere with activities of daily living.

A pathological diagnosis of Alzheimer’s disease is possible after verifying the presence of beta-amyloid plaques in the brain tissue. Beta-amyloid is a natural protein. Abnormal levels of it clump together to form plaques that collect between neurons and disrupt cellular function, which in turn can lead to cognitive decline.

Thanks to several products launched a decade ago, there are diagnostic tools to assess the density of beta amyloid. In 2012, florbetapir 18F, marketed as Amyvid, became the first diagnostic agent to be approved by the Food and Drug Administration for positron emission tomography of the brain to assess plaque buildup. After two similar PET agents, flutemetamol 18F is florbetaben 18F were approved.

The knowledge gained from amyloid PET scans informs clinical decision-making to potentially prevent misdiagnosis and reduce the risk for patients of adverse effects of treatment.

But shortly after its approval, Medicare published a National Coverage Determination in 2013 that severely restricted coverage of these scans to patients enrolled in the so-called coverage with evidence development programs. In particular, patients should be part of an authorized clinical trial – preferably a randomized controlled trial – to examine “evidence gaps” in the use of such scans, particularly in terms of how they potentially improve health outcomes. . In addition, patients could only have one reimbursement for a beta-amyloid PET scan.

CMS’s decision in October to end coverage with the Evidence Development Program constitutes an improvement in access to amyloid beta imaging tools for Alzheimer’s patients.

It makes sense that CMS changed its policy given the recent approval of drugs that are designed to remove beta-amyloid plaque: Aduhelm (aducanumab) and Leqembi (lecanemab). Immediately following the regular approval of Leqembi by the FDA in July, CMS announced that it would cover much of the cost for most patients who are eligible for therapy. This includes patients with mild cognitive impairment or mild dementia with confirmed amyloid plaques.

To benefit from these biological therapies, patients must have beta-amyloid plaque present in their brain. It therefore seems imperative that Medicare beneficiaries prescribed, for example, Leqembi, are all provided with reimbursed access to multiple amyloid PET scans to assess possible reductions in plaque levels over time.

The need for universal access is amplified by the CMS requirement that Medicare beneficiaries taking Leqembi enroll in a patient record to gather more data on the drug’s safety and effectiveness. In turn, this collection of evidence will invariably include the widespread use of PET scans, not only for diagnosis, but also for follow-up care.

However, CMS now leaves coverage decisions to local reimbursement authorities called Medicare Administrative Contractors. Of course, in Medicare, most coverage decisions regarding prescription drugs, diagnostics and medical devices are made locally or regionally. But this can produce inequity in the system, since a significant variation in coverage can exist in different insurance carriers. With some ethnic groups like African Americans and Hispanics at higher risk of being diagnosed with Alzheimer’s, it is particularly important to minimize the discrepancy in the coverage of amyloid PET images.

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I am an independent healthcare analyst with over 24 years of experience in healthcare and pharmaceutical analytics. In particular, it will analyze the value (cost and benefits) of biologics and pharmaceuticals, patient access to prescription medications, the regulatory framework for drug development and reimbursement, and ethics regarding distribution of health resources. I have approximately 110 publications in peer-reviewed journals, in addition to hundreds of articles in journals and periodicals. I have also presented my work at numerous business, industry and academic conferences. From 1999 to 2017, he was a research associate professor at the Tufts Center for the Study of Drug Development. Before my Tufts appointment, I was a post-doctoral fellow at the University of Pennsylvania, and I completed my PhD in economics at the University of Amsterdam. Before pursuing my PhD, I was a management consultant at Accenture in The Hague, Netherlands. Currently, and for the past 6 years, I have been working freelance on a variety of research, teaching and writing projects.

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