CMS Approves Medicare Coverage for PET Scans To Detect Alzheimer’s
CMS on Thursday announced that Medicare will begin covering an "expensive" brain scan -- called a positron emission tomography, or PET, test -- to help determine whether beneficiaries have Alzheimer's disease, the Washington Post reports. CMS' decision memo states that the agency will only cover PET scans for beneficiaries whose symptoms of "social disinhibition, awkwardness and difficulties with language" are "more prominent than their memory loss" -- which could indicate one of several rare brain conditions collectively known as "fronto-temporal dementia," rather than Alzheimer's disease (Weiss/Brown, Washington Post, 9/17).
The current method of Alzheimer's detection involves a series of cognitive tests, which can be ineffective in detecting the early stages of the disease, Dow Jones/Wall Street Journal reports (Dow Jones/Wall Street Journal, 9/17). According to the CMS memo, PET scans are "reasonable and necessary" for beneficiaries who have had mental decline for at least six months. However, such scans are not medically necessary for beneficiaries who "simply have early dementia," according to the memo, the Post reports. To receive coverage for the PET scan, Medicare beneficiaries first would have to undergo a full physical exam, two mental status examinations over six months, and the usual laboratory and imaging tests done to diagnose dementia.
CMS said it had no official estimate of the cost or number of eligible beneficiaries for PET scans under the new rules (Washington Post, 9/17). The scans can cost as much as $2,000, and each PET machine costs about $2 million for a hospital or clinic to install. About 4.5 million U.S. residents have Alzheimer's disease, and the number is expected to rise to as high as 16 million by 2050 as the population ages, according to experts (Heavey, Reuters/Boston Globe, 9/17).
CMS' decision "caps a four-year struggle" by PET scan makers to gain Medicare approval to pay for scans of beneficiaries suspected of having Alzheimer's, the Post reports. The agency decided to narrowly cover the scans because of "the absence of convincing evidence that PET scans can, by themselves," detect Alzheimer's.
CMS last year rejected an application to reimburse PET scans as a general test for Alzheimer's, which can only be "made with certainty" upon examining the brain after death, the Post reports. Fronto-temporal dementia conditions can mimic Alzheimer's enough that it can be difficult to distinguish the diseases, and early detection can be important because rare forms of dementia tend to progress more rapidly, according to the Post.
PET scans track injected radioactive chemicals in the blood stream to identify areas where metabolic processes are out of balance (Washington Post, 9/17). The technology can show plaque build up in the brain, which researchers believe contributes to the onset of Alzheimer's (Dow Jones/Wall Street Journal, 9/17). Doctors have said the scans, which Medicare already covers for cancer and heart testing, also could help show the efficacy of Alzheimer's drugs (Reuters/Boston Globe, 9/17).
CMS, along with PET providers and the National Institute on Aging, will sponsor a "large study" on the use of PET scans in patients who may have early Alzheimer's, the Post reports. The study would include at least 1,000 patients who would be enrolled in 30 to 50 medical centers, according to CMS Chief Medical Officer Sean Tunis. Tunis added that although the specific design of the study has not been finalized, it likely would randomly assign some patients with early dementia to receive PET scans in addition to the usual medical examinations (Washington Post, 9/17).
CMS Administrator Mark McClellan said, "The technology is promising for patients with early dementia but is only reasonable and necessary in the context of a peer-reviewed clinical trial." McClellan added that the trial would help determine the efficacy of PET scans.
Dr. Edward Coleman, head of nuclear medicine at Duke University Medical Center, said CMS' approval, which could lead to increased coverage and general use of PET scans, "is an extremely important step for diagnosis" (Reuters/Boston Globe, 9/17).
After CMS in June opened up the matter for public comment, "[s]everal doctors and other medical professionals wrote to oppose coverage, fearing that once PET was approved for a narrow use, it would be marketed more broadly as a diagnostic test for Alzheimer's generally," the Post reports.
Sheldon Goldberg, president of the Alzheimer's Association, which supported the approval but expressed reservations, said, "It is important to reiterate that unnecessary PET scanning has a number of potentially serious consequences, including unnecessary exposure of patients to radiation, misdiagnosis and unnecessary use of medical resources" (Washington Post, 9/17).