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Centers for Medicare & Medicaid Services

National Coverage Analysis (NCA) Tracking Sheet for Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease (CAG-00431N)

PET is a minimally-invasive diagnostic imaging procedure used to evaluate normal tissue as well as in diseased tissues in conditions such as cancer, ischemic heart disease, and some neurologic disorders. An injected radioactive tracer gives off subatomic particles, known as positrons, as they decay. PET uses a positron camera (tomograph) to measure the decay of these radioisotopes. The rate of tracer decay provides biochemical information on the tissue being studied. Certain tracers allow for imaging of beta-amyloid plaques in the brain of patients with cognitive impairment who are being evaluated for possible Alzheimer's disease or other causes cognitive decline.

Section 220.6 of the National Coverage Determination Manual identifies ammonia N-13, fluorodeoxyglucose F-18, rubidium Rb-82 and sodium fluoride F-18 as the only nationally covered radioisotopes for certain defined uses in PET. Certain uses of PET with these radioisotopes are covered only when performed under Coverage with Evidence Development (CED) in clinical studies. All remaining uses of PET are nationally noncovered.

CMS is reconsidering Section 220.6 of the National Coverage Determination (NCD) Manual pursuant to a request from the Eli Lilly and Company that coverage for PET tracers be expanded to include those agents that image beta-amyloid plaques in the context of the diagnosis of dementia.

CMS is soliciting public comment relevant to this request. We are particularly interested in comments that include scientific evidence.

Diagnostic Tests (other)
Requestor Name(s)Eli Lilly and Company
Requestor Letter(s)View Letter
Formal Request Accepted and Review Initiated10/09/2012
Expected NCA Completion Date10/01/2013
Public Comment Period10/09/2012 - 11/08/2012
Proposed Decision Memo Released07/03/2013
Proposed Decision Memo Public Comment Period: 07/03/2013 - 08/02/2013 
Decision Memo Released09/27/2013
Comments for this NCA:View Public Comments
Lead Analyst(s)
Lead Medical Officer(s)
  • Joseph Hutter, MD, MA

October 9, 2012

CMS opens this reconsideration of Section 220.6 of the NCD on Positron Emission Tomography as it relates to beta-amyloid imaging in the context of the diagnosis of dementia. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the "Submit A Public Comment" webpage.

July 3, 2013

September 27, 2013

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