National Coverage Analysis (NCA) Tracking Sheet

Positron Emission Tomography (FDG) for Alzheimer's Disease/Dementia

CAG-00088N

Issue

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 at that time but would refer the issue to MCAC.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
Internally generated following University of California at Los Angeles (UCLA), School of Medicine initial request for broad coverage of FDG-PET N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
12/15/2000
Expected NCA Completion Date
07/14/2002
Public Comment Period
01/15/2001 - N/A
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
04/16/2003

Contacts

Lead Analysts
Samantha Richardson
Lead Medical Officers
Carlos Cano, MD

Medicare Benefit Category Determination Date

Actions Taken

February 15, 2001

CMS decided to refer for a technology assessment.

April 5, 2001

CMS met with the Agency for Health Research and Quality (AHRQ) to discuss the appropriateness and required features of a technology assessment.

May 8, 2001

CMS submitted a formal request to AHRQ to produce a technology assessment on the use of PET and other neuroimaging techniques in the diagnosis and management of dementia.

A Medicare Coverage Advisory Committee (MCAC) Executive Committee is scheduled to meet on June 14, 2001 to discuss problem formulation and analytic questions for the technology assessment to assist CMS in ensuring its relevance and usefulness.

August 27, 2001

AHRQ has selected The Center for Clinical Health Policy Research at Duke University as the evidence-based practice center (EPC) for this technology assessment. CMS expects to receive the finished technology assessment by the end of October and then present the issue to the MCAC Diagnostic Imaging Panel.

October 15, 2001

Posted Questions  for technology assessment.

October 19, 2001

University of California at Los Angeles (UCLA) has amended their original request to include coverage for FDG PET when used to assist with the diagnosis of early dementia in certain geriatric patients for whom the differential diagnosis includes one or more kinds of neurodegenerative disease. UCLA has submitted new evidence to support their request. The due date will remain unchanged.

December 21, 2001

Tech Assessment  received from AHRQ and posted on website. Will be presented to DI panel January 10, 2001.

January 10, 2002

The DI Panel  met and reviewed materials from UCLA and the technology assessment that was completed by Duke University. The Executive Committee of the MCAC will meet to review the DI panel recommendation on April 16, 2002.

April 16, 2002

The Executive Committee  of the MCAC met and ratified the DI panel recommendation. Minutes will be posted shortly. CMS has commenced writing the Decision Memorandum.

April 16, 2003