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Centers for Medicare & Medicaid Services

View Public Comments for Positron Emission Tomography (CAG-00065R2)

Egge, Robert
Vice President, Public Policy
Alzheimer's Association

Jeffrey Roche MD, MPH
Stuart Caplan RN, MAS
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Bethesda, MD 21244

Re: National Coverage Analysis Reconsideration Request for Positron Emission Tomography (CAG-00065R2)

Dear Dr. Roche and Mr. Caplan,

The Alzheimer’s Association, the leading voluntary health organization in Alzheimer’s care, support and research, appreciates the Centers for Medicare and Medicaid Services’ (CMS) thoughtful reconsideration of the current National Coverage Analysis (NCA) of Positron Emission Tomography (PET).

Today, it is estimated there are more than five million Americans with Alzheimer’s disease. The vast majority of these individuals depend on the Medicare program for access to health coverage and services. Reconsideration of the NCA for PET is particularly relevant to the Alzheimer’s Association because its constituents include individuals that would be considered for use of amyloid radiopharmaceutical imaging agents. These amyloid imaging agents, one of which has been approved and others of which could be approved soon by the Food and Drug Administration, can be clinically useful but their appropriate use within a clinical examination has not been fully determined.

In response to key questions from CMS and other stakeholders regarding the appropriate use of the amyloid class of agents, the Alzheimer’s Association has joined with the Society for Nuclear Medicine and Molecular Imaging (SNMMI) to convene the Alzheimer’s Association-SNMMI Amyloid Imaging Taskforce.

The goals of the Alzheimer’s Association-SNMMI Amyloid Imaging Taskforce are the following:

  • Develop appropriate use criteria (AUC) and associated recommendations for clinical human amyloid imaging.
  • Conduct a review of pertinent medical evidence and form a consensus of expert opinion.
  • Aim specifically for F18 PET amyloid tracer AUC, but also consider C11 PIB evidence.
  • Characterize the appropriate population for testing, including factors such as age, duration of illness, clinical classifications or diagnoses, expertise of the referring physician, and prerequisite evaluations.
  • Assess current knowledge of the clinical implications of both positive and negative test results, and assess methods of disclosure.

The Alzheimer’s Association looks forward to reviewing the findings of the Alzheimer’s Association-SNMMI Amyloid Imaging Taskforce with CMS as soon it completes its work within the next several months.

We appreciate the opportunity to comment and we look forward to continuing to working with CMS on this issue. Please contact Rachel Conant (202-638-7121; if you have questions.


Robert Egge
Vice President, Public Policy