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CMS Expands Coverage of PET Imaging for Confirmation of Alzheimer Diagnosis
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The decision opens the door for greater access to PET imaging that can assist in timely diagnosis of Alzheimer disease and facilitate with appropriate treatment decisions.
Maria C. Carrillo, PhD
After proposing coverage determination earlier in the summer, the Centers for Medicare and Medicaid Services (CMS) announced they will cover PET imaging for the diagnosis of Alzheimer disease (AD), a major step toward ensuring access to novel treatments for patients who may be eligible.1
Specifically, CMS is removing its national coverage determination at §220.6.20, ending coverage with evidence development for PET amyloid-ß imaging and permitting Medicare coverage determinations for this imaging under §1862(a)(1)(A) of the Social Security Act (the Act). In its decision memo, the agency noted that appropriate patient selection is "key to ensuring benefits outweigh harms of newly developed drugs targeting amyloid."
The Alzheimer’s Association applauded the decision, noting that amyloid PET scans have become even more valuable in the diagnosis and eligibility of FDA-approved treatments.
"Amyloid PET scans are a proven tool and can be an important part of Alzheimer’s diagnosis and treatment,” Maria C. Carrillo, PhD, chief science officer of the Alzheimer’s Association, said in a statement.2 "Broader access to amyloid PET scans will enable earlier and more accurate diagnosis, and better care management. Their use can lead to better health outcomes for people living with Alzheimer’s or another dementia. This decision reflects the FDA’s confidence in this technology after many years of evaluation. It is essential that the MACs (Medicare Administrative Contractors) continue the CMS practice of covering PET scans in support of treatment."
The CMS policy to pay for amyloid PET scans beyond clinical trials also removes the current limitation of 1 scan per lifetime. Typically, out-of-pocket amyloid PET scans average $3000 per test or greater. In its coverage memo, CMS also noted that the harms of antiamyloid treatments would be avoided because the drug would not be given to patients that do not have brain amyloid and potentially stopped when brain amyloid was completely removed.
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New novel antiamyloid therapies like lecanemab (Leqembi; Eisai) require a diagnosis of mild cognitive impairment or mild AD that is supported by documentation of amyloid-ß in the brain. In accordance with CMS’ NCD, Medicare will cover lecanemab when physicians and clinical teams actively participate in collecting real-world evidence through a registry. In the proposed change, patients under the original Medicare will have a standard 20% coinsurance for the Medicare-approved amount of lecanemab that will be applied once Part B of their deductible is met.
"In the new era of treatment, amyloid PET scans become even more valuable as they are used to determine diagnosis and eligibility for FDA-approved treatments," Carrillo added.2 "Additionally, recent clinical trial results tell us it is also useful to track changes in a person's level of beta amyloid throughout the course of treatment because it may be possible to pause treatment, as the amyloid beta levels decrease."
The effects of amyloid PET scans have been shown in several research settings, including the Imaging Dementia – Evidence for Amyloid Scanning (IDEAS) study. The study, which comprised of 16,008 registered Medicare beneficiaries, used change in management between pre- and post-PET visits as the primary end point, assessed using a composite outcome that included AD drug therapy, other drug therapy, and counseling about safety and future planning.3
At the concluded of the trial, positive amyloid PET scans were found in 3817 patients with MCI (55.3%) and 3154 patients with dementia (70.1%). The composite end point changed in 4159 of 6905 patients with MCI (60.2%; 95% CI, 59.1%-61.4%) and 2859 of 4504 patients with dementia (63.5%; 95% CI, 62.1%-64.9%), significantly exceeding the 30% threshold in each group (P <.001). Notably, the etiologic diagnosis changed from AD to non-AD in 25.1% (95% CI, 24.3%-25.9%) and from non-AD to AD in 10.5% (95% CI, 10.0%-11.1%) of patients.
