National Coverage Analysis (NCA) Tracking Sheet

Positron Emission Tomography (FDG) for Soft Tissue Sarcoma (STS)

CAG-00099N

Issue

The requestor asked that Medicare cover FDG-PET for soft tissue sarcomas. 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.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
David Kaplan (private party) N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
10/18/2001
Expected NCA Completion Date
03/01/2003
Public Comment Period
11/19/2001 - 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
JoAnna Baldwin
Lead Medical Officers
Mitchell Burken, MD

Medicare Benefit Category Determination Date

Actions Taken

October 18, 2001

Letter sent to requestor accepting the formal request to develop a national coverage determination (NCD).

December 10, 2001

Referred issue to technology assessment. CMS expects to receive the completed assessment in mid-February 2002.

February 19, 2002

Expected receipt date of the technology assessment has been extended, CMS now expects completed assessment in late March.

April 8, 2002

CMS has received the final technology assessment.

June 7, 2002

The due date for this request has been extended to July 8, to allow for additional review.

June 24, 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 any determination until MCAC has reviewed and made recommendations on reviewing evidence for rare conditions.

November 4, 2002

CMS received the minutes from the September MCAC meeting on November 1. CMS has 60 days following the receipt of the formal Medicare Coverage Advisory Committee (MCAC) recommendations to issue a decision memorandum. The minutes are publicly posted on our website.

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

April 16, 2003