Seven medical imaging groups wrote a joint letter to the Centers for Medicare and Medicaid Services (CMS) to formally request coverage of two fluorodeoxyglucose (FDG) positron emission tomography (PET) scans for a patient during the initial treatment evaluation. Currently, CMS covers only one FDG-PET study during initial treatment, a limitation that the groups believe is contrary to good clinical practice under certain circumstances.
“It is absolutely critical for CMS to reconsider this decision,” said Michael M. Graham, Ph.D., M.D., president of SNM and director of nuclear medicine at the University of Iowa Carver College of Medicine in Iowa City. “It is unacceptable to have reimbursement for only one scan when you need two in order to assess efficacy of treatment.”
The letter—which was signed by the leadership of the National Oncologic PET Registry (NOPR) Working Group, the Academy of Molecular Imaging, the American College of Nuclear Medicine, the American College of Radiology, the American Society for Radiation Oncology, the Institute for Molecular Technologies and SNM—presents CMS with three practical 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.
Second, 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. Finally, the third scenario applies to patients with newly diagnosed cancer who had to delay their treatment either because of reluctance on their own part or because of another medical illness that needed to be addressed first. 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—such as studies that were not yet available during the original consideration period—the groups are hoping that 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, it will have to go through the standard regulatory review process, and a final decision may not be made for more than 90 days.
The groups that submitted the letter comprise clinicians, academicians, researchers and nuclear medicine providers who use molecular imaging technologies. They have been working closely with CMS over the past several years to increase beneficiary access to PET/CT though the development of NOPR.