Currently, CMS covers only one FDG-PET study during initial treatment. The groups believe that this limits clinical practice under certain circumstances.
The communiqué presents CMS with three scenarios in which a second initial FDG-PET scan would be necessary for optimal patient care.
The first example is when PET is used for the diagnosis or staging of a tumor and the course of treatment is determined to be radiation therapy. In certain circumstances, a second PET scan may be needed for successful radiation therapy planning.
The second example comes in the event that PET used to evaluate a suspicious lesion came back with false-negative results and the patient is later diagnosed with cancer; a second PET scan is needed for initial staging before treatment.
A third scenario applies to patients with newly diagnosed cancer who had to delay treatment due to reluctance on their own part or because of another medical illness that needed immediate attention. It may be medically necessary for that patient to undergo another PET scan to evaluate the disease after that prolonged period of time.
By presenting CMS with new supporting bodies of evidence, including studies that were not yet available during the original consideration period, the groups hope CMS will open the decision for reconsideration and extend coverage to two FDG-PET scans for those certain clinical scenarios.
If CMS decides to reconsider this issue, the agency will begin a standard regulatory review process, with a final decision likely in more than 90 days.
The letter is signed by the leadership of the National Oncologic PET Registry (NOPR) Working Group, Academy of Molecular Imaging, American College of Nuclear Medicine, American College of Radiology, American Society for Radiation Oncology, Institute for Molecular Technologies, and SNM.
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