MITA cites progress in the final Medicare coverage decision for beta amyloid PET, expresses disappointment in its narrow scope

The Medical Imaging & Technology Alliance (MITA) has issued the following statement in response to the Centers for Medicare & Medicaid Services' (CMS) final decision to cover beta amyloid positron emission tomography (PET) imaging under coverage with evidence development (CED) for patients enrolled in an approved clinical study.

"MITA appreciates CMS's attention to the serious concerns raised by the Alzheimer's disease community about the initial draft coverage decision and made progress in its final National Coverage Determination," said Gail Rodriguez, executive director of MITA. "We are grateful that CMS has initiated a pathway to make beta amyloid PET available to some Medicare beneficiaries under limited circumstances."

"However, we are disappointed that CMS will not provide coverage for beta amyloid PET imaging without CED to those Medicare beneficiaries with suspected dementia or Alzheimer's disease who meet specific appropriate use criteria," Rodriguez continued. "MITA is committed to working with CMS and their partners toward a substantive, feasible CED program for the purpose of efficiently generating clinical evidence that will support broader access for Medicare patients.

CMS's decision memo notes sufficient evidence that the use of beta amyloid PET imaging is promising in two scenarios: (1) to exclude Alzheimer's disease (AD) in narrowly defined and clinically difficult differential diagnoses, and (2) to enrich clinical trials seeking better treatments or prevention strategies for AD. However, the decision stops short of extending broad coverage for this scan in accordance with the appropriate use criteria developed by the Alzheimer's Association and the Society for Nuclear Medicine and Molecular Imaging (SNMMI).

PET imaging can detect the presence of beta amyloid plaque in the brain - a common indication of AD - and help physicians diagnose patients earlier, when there is more time for their family and caregivers to plan accordingly. The ability to rule out AD through beta amyloid PET imaging could also help physicians avoid prescribing inappropriate and unnecessary treatments.

MITA has encouraged CMS to adopt appropriate use criteria developed by a taskforce of dementia and imaging experts from the Alzheimer's Association and the SNMMI to guide physician utilization of amyloid PET imaging.

Approximately five million Americans have AD, and that number is expected to more than double by 2050 unless there is a significant medical breakthrough. In 2011, the National Alzheimer's Project Act (NAPA) was signed into law, requiring the creation of a national strategic plan to address the rapidly escalating Alzheimer's disease crisis and the coordination of Alzheimer's disease efforts across the federal government. Earlier this month, the U.S. National Institutes of Health announced $45 million in new Alzheimer's research, with most of the funding set aside for finding ways to prevent or delay onset of the disease.