National Coverage Analysis (NCA) Tracking Sheet

Positron Emission Tomography (FDG) for Thyroid Cancer

CAG-00095N

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-D-glucose (FDG) is a radiopharmaceutical that is attracted to higher areas of metabolism. On December 15, 2000, HCFA 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 while several new indications for the use of FDG PET could be covered under Medicare, CMS, formerly known as HCFA, had insufficient evidence to support coverage for the management of thyroid cancer. However, it would reconsider the issue if documentation of new medical information was brought to our attention. Recently, CMS received a formal request for reconsideration of this issue from the American Thyroid Association, including new medical information suggesting the test's usefulness for several different indications in the management of thyroid cancer. CMS will review the new information to determine if Medicare's national coverage decision on FDG PET should be revised to include coverage of any, or all, of the proposed indications for thyroid cancer management.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
Susan Mandel, M.D., M.Sc. Chair, Standards of Care Committee The American Thyroid Association N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
06/13/2001
Expected NCA Completion Date
03/01/2003
Public Comment Period
07/13/2001 - 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
William Larson
Lead Medical Officers
Lawrence Schott, M.D., M.S.

Medicare Benefit Category Determination Date

Actions Taken

June 13, 2001

Request for reconsideration accepted by Coverage and Analysis Group, CMS.

September 10, 2001

Referred to the Agency for Healthcare Research & Quality for a technology assessment. Results of technology assessment due October 31. The technology assessment questions will be posted on this web site when finalized.

October 31, 2001

The 10/31/01 due date for receipt of the technology assessment will need to be extended in order to clarify the questions and complete the evidence review . We are working with the Agency for Healthcare Research & Quality (AHRQ) to determine what the revised due date will be. Tentatively, it will be the end of November.

December 5, 2001

CMS was notified by AHRQ that the final version of the technology assessment would not be received from the New England Medical Center Evidence-based Practice Center until January 7, 2002.

April 15, 2002

The technology assessment  has been received and is posted on website. CMS has 60 days to issue a coverage decision. The due date for the decision memorandum is June 14, 2002.

June 17, 2002

After exhaustive review of available literature, we have been unable to find adequate information to make an evidence-based determination. Therefore, we have decided to delay announcement of our determination until MCAC has reviewed and made recommendations on reviewing evidence for rare conditions.

November 1, 2002

The MCAC minutes have been received and are posted on website. CMS has 60 days to issue a decision. The due date is December 30, 2002

January 2, 2003

The decision is currently undergoing the CMS internal clearance process. Expected completion date is now January 30, 2003.

January 31, 2003

Due date extended 30 days to complete clearance process.

April 16, 2003