CMS proposes Medicare PET coverage for Alzheimer's disease

The sale of PET/CT scanners in the U.S. could get a boost-possibly in the months ahead and almost certainly in the long term-if the Centers for Medicare and Medicaid Services carries through with its proposal to reimburse for the use of PET to evaluate Medicare patients suspected of having Alzheimer's.

CMS announced June 15 its intention to expand Medicare coverage for this indication. The agency will accept public comments on the draft decision memorandum for 30 days and will issue a final decision 60 days after that. But draft decisions such as this one are seldom reversed. And major vendors of PET systems are optimistic about its effects.

"This enables our customers to offer a broader range of applications: They can utilize the machines better, and that will certainly increase the market," said Markus B. Lusser, vice president of worldwide sales and marketing for the nuclear medicine division of Siemens Medical Solutions.

Vendors are divided, however, about the degree to which the market will increase and when it will happen. Jeffrey Kao, general manger of global PET/nuclear medicine, functional, and CT imaging at GE Healthcare, predicts that a positive decision by CMS regarding Alzheimer's could increase patient flow at PET and PET/CT sites by one to two patients per day. Those sites, however, are currently seeing only about three patients a day.

"The installed instrumentation has plenty of productivity left to handle the increased number of patients from Alzheimer's," he said.

Kao therefore predicts only a minimal effect on the sale of PET and PET/CT scanners in the short term, but he expects a rise in demand over the long haul. Ronald Nutt, Ph.D., president and CEO of CTI Molecular Imaging, disagrees. He predicts a short-term pop in sales due to the psychological effect of expanded PET coverage.

"People who are looking at buying PET/CTs are not looking at the next six months but further ahead," he said.

The coverage decision is the culmination of four years' work by the PET community to convince CMS that PET scans are valuable for patients suspected of having Alzheimer's. The agency found enough evidence in peer-reviewed literature and among expert medical opinions to support the use of PET, if certain conditions exist: a diagnosis of dementia or a documented six-month history of cognitive decline. There must also be reason to believe that PET will clarify the diagnosis or help guide treatment.

The CMS did not find enough support to cover patients diagnosed with mild cognitive impairment or early dementia. PET may be used in these patients, however, if they are enrolled in clinical trials that compare them with others who do not receive PET scans.

Contributing to the evaluation were experts from the National Institute on Aging, the Alzheimer's Association, the Agency for Healthcare Research and Quality, and other medical professional organizations. They have been split in their support of coverage for PET imaging for Alzheimer's. The Society of Nuclear Medicine and the National Electrical Manufacturers Association have endorsed the concept for several years. The Alzheimer's Association recently jumped on board, while the American Academy of Neurology and the American College of Radiology have not yet declared their positions.

Proponents have argued the need for more research to resolve unanswered questions. The draft memorandum written by CMS announced that the agency will help fund the development of clinical trials to evaluate PET's role in diagnosing mild cognitive impairment and early dementia. This decision signifies a major departure for the CMS, according to Michael Phelps, Ph.D., chair of molecular and medical pharmacology at the University of California, Los Angeles.

"This group has traditionally placed roadblocks in the development of medicine," Phelps said.

In the past, proponents of clinical PET have complained that CMS was micromanaging PET's approval process. In 2001, the agency granted coverage for the use of PET in oncology and cardiology, but provided no such coverage for neurological disorders.

A year later, the CMS specifically rejected coverage for PET imaging of patients with mild cognitive impairment or Alzheimer's disease, concluding that the peer-reviewed literature did not support use of the modality over traditional methods. Proponents submitted a new request in 2003 that clarified the evidence and called for the use of PET on a more specific patient population. The current draft decision by CMS is in response to that 2003 request.

How a positive decision will play out in the equipment market is unknown, not only from a sales timing standpoint but also as it will affect the type of equipment purchased. CT is important for both attenuation correction and the localization of PET scan data when performing oncological exams. But neither is required when scanning for Alzheimer's disease, which means a dedicated PET scanner would serve the purpose as well as a PET/CT. Lusser believes, however, that Alzheimer's will be factored into the decision to purchase equipment for use to assess other conditions such as cancer, heart disease, and dementia.

"Because they will be used in a mixed mode, a platform that can handle all these must be provided," he said.

Vendors may have to develop specialized software to optimize scans for dementia, said Kao. If this application becomes routine, the industry might even develop a brain scanner dedicated to this purpose.

"It would have a smaller field-of-view and would not include CT," he said. "We will learn about this over time and see how this transformation (to scanning for Alzheimer's) is going to happen."