The Centers for Medicare & Medicaid Services (CMS) removed the national non-coverage decision for PET for FDA-approved oncologic applications. However, CMS stopped short of including cardiac and neurologic applications in the decision.
“[U]nless there is a specific national coverage determination, local Medicare Administrative Contractors may determine coverage within their respective jurisdictions for PET using radiopharmaceuticals for their FDA-approved labeled indications for oncologic imaging,” CMS wrote in a March 7 decision memo.
The decision removes the national non-coverage determination for FDA-approved labeled oncologic uses of radiopharmaceuticals that are not more specifically determined nationally, according to CMS.
Several organizations, including the American Society of Nuclear Cardiology, the American College of Radiology, the American College of Cardiology and Society of Nuclear Medicine and Molecular Imaging, had lobbied for CMS to expand the proposal to cover all areas.
The Medical Imaging & Technology Alliance (MITA) responded with a statement. “MITA is concerned that CMS stopped short of our complete request, which called for local coverage of all PET tracers that are newly approved by the FDA, not just oncologic tracers. PET procedures inform medical decision making in the specialties of cardiology and neurology, as well as oncology. We are disappointed that these applications were not included in the decision memorandum and believe that the consideration of coverage for PET tracers should be no different than for other items and services.”
MITA urged CMS to continue to evaluate the evidence and “avoid lengthy, bureaucratic reviews.”