Our previous national coverage NCDs on PET scans (§50-36 of the Medicare Coverage Issues Manual) provided coverage for limited uses of FDG-PET. Further, it requires that the scans for these more limited indications be performed with a camera that has either been approved or cleared for marketing by the FDA to image radionuclides in the body.
In our consideration of a public request for expanded coverage of FDG-PET scans (# CAG-00065, decision memorandum dated 12/15/00), the majority of literature submitted was derived from imaging studies using full ring bismuth germanate (BGO) PET scanners. There were also published studies showing that some other scanner types may miss clinically important malignant lesions. Thus, in the new coverage decision we announced our intention to limit the new indications (described in the 12/15/00, decision memorandum) to high performance PET scanners with specific structural features.
It has come to our attention that there may be additional PET scanner systems with performance "equivalent to" or "better than" the scanners to which we are limiting the new indications. We have, therefore, internally generated a formal coverage request to examine the comparative performance of all system types approved for marketing by the FDA as PET scanners. This request will allow us to develop a uniform and appropriate quality standard for imaging systems that will be eligible for Medicare reimbursement for all covered uses of FDG-PET.
Information collected up until March 23, 2001, had illustrated a potentially greater gap in system performance than recognized as of December 15, 2000, between dedicated PET and gamma camera systems. Further, it is clear that no single design specification (i.e. crystal thickness) can differentiate a quality cut-off but, in fact, may require a performance-based standard. We are now exploring the magnitude and clinical importance of differences in image quality and acquisition time between dedicated full ring PET and camera-based systems.
On March 23, 2001, industry coupled with various academicians provided a substantial number of additional scientific studies that purportedly address the above concerns. Receipt of this new material has required us to extend until May 4, 2001, the finalized version of the National Coverage Determination on the gamma camera issue.
