National Coverage Analysis (NCA) Tracking Sheet

Positron Emission Tomography (FDG) and Other Neuroimaging Devices for Suspected Dementia



Positron emission tomography (PET) is a non-invasive imaging procedure used for measuring the concentrations of positron-emitting radioisotopes within the tissue of living subjects. 2-[F18] fluoro-2-deoxy-D-glucose (FDG) is a radiopharmaceutical that is attracted to higher areas of metabolism. On December 15, 2001, CMS published a Decision Memorandum on a request for broad coverage (CAG-00065) of all oncological indications, heart disease, and neurological disorders. The December 15th decision memorandum stated that CMS had insufficient evidence to support coverage for the indication of Alzheimer's disease/dementia (AD).

On April 16, 2003 CMS released a Decision Memorandum stating that it would retain the previous noncoverage decision of PET for AD. The analysis concluded that the addition of an FDG-PET scan to the standard evaluation of AD does not result in improved patient outcomes. It was determined that the available evidence was adequate to conclude that an FDG-PET scan is not reasonable and necessary when used in the diagnosis and management of early dementia in elderly patients for whom the differential diagnosis includes one or more kinds of neurodegenerative disease.

CMS has received a new request from UCLA requesting a more restrictive coverage determination be made for the use of FDG PET to distinguish patients with AD from those with other causes of symptoms confounding the diagnosis of dementia or to assist with the diagnosis of early dementia in beneficiaries for whom the differential diagnosis includes one or more kinds of neurodegenerative disease, in cases where specific criteria have been met.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
University of California at Los Angeles (UCLA), School of Medicine. View Letter

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
10/07/2003 - 11/07/2003
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
06/15/2004 - 07/15/2004
Decision Memo Released


Lead Analysts
Samantha Richardson
Lead Medical Officers
Carlos Cano, MD

Medicare Benefit Category Determination Date

Actions Taken

October 7, 2003

CMS has accepted UCLA’s request for reconsideration of the previous non-coverage decision.

November 10, 2003

CMS has broadened the scope of review of FDG PET for AD to include neuroimaging for suspected dementias

December 4, 2003

CMS has previously committed to hold an expert panel meeting on the use of PET in diagnosing AD. We have begun discussions with the National Institutes on Aging (NIA) to convene a panel to assist in the review of this subject. We have also asked AHRQ to update the Technology Assessment (TA) that they produced for our previous NCD on PET for patients with AD.

January 7, 2004

CMS will extend the deadline until after the National Institute on Aging/CMS expert panel meeting that will occur April 5, 2004.

[Date entered in Expected Completion date field is an approximation.]

March 15, 2004

CMS is requesting input from the public regarding questions [PDF, 33KB] we have developed after reviewing the NCD request [PDF, 59KB] and the Alzheimer's Association statement [PDF, 100KB]. All comments received will be made public and will not be kept confidential. Responses requested by March 31, 2004.

May 25, 2004

Technology Assessment submitted to CMS by the Agency for Health Research Quality (AHRQ) is available for review.

The National Institute on Aging/CMS Expert Panel meeting Summary [PDF, 71KB] and Transcript [PDF, 548KB] has been posted.

June 7, 2004

Public comments in response to questions that were posted on March 15, 2004, can be reviewed here [PDF, 1MB].

June 15, 2004

CMS is posting a draft Decision Memorandum for a 30 day public comment period. Instructions for submitting public comments can be found at

July 26, 2004

Comments from the 30-day public comment period are now available for viewing [PDF, 274KB]

September 10, 2004

CMS met with representatives from NIA, FDA, AHRQ, academia and industry to discuss potential trial designs.

September 15, 2004

Final Decision Memorandum posted.

November 8, 2004

The AHRQ/CMS Clinical Trial meeting Summary [PDF, 11KB] and Transcript has been posted.