On Friday, May 27, 2016, the FDA approved Axumin, a new PET agent for detecting prostate cancer metastatic lesions. The typical patient would have elevated recurring PSA (post definitive treatment), but the elevated PSA is of unknown anatomic origin. FDA press release here.
Clinical studies looked at the correlation between the Axumin image and biopsy/histopathology in 105 patients. A second study with 96 patients looked at the correlation between the Axumin image and Choline C11 PET imaging. Choline C11 was previously approved by the FDA as a PET agent for prostate cancer in September 2012 (here).
For CMS, in the hospital inpatient and outpatient setting, PET imaging agents (regardless of cost) are bundled as part of the base cost of the PET scan (after an initial two year cost pass-through period.) For Part B claims at freestanding centers, due to uncertainties in the Medicare regulations for pricing radioimaging agents, MACs have some discretion in pricing radiotracers (e.g. invoice or other methods).
Coverage for new FDA approved oncologic agents after March 2013 can be determined by MACs (see NCD 220.6).
- Effective for dates of service on or after March 7, 2013, local Medicare Administrative Contractors (MACs) may determine coverage within their respective jurisdictions for positron emission tomography (PET) using radiopharmaceuticals for their Food and Drug Administration (FDA) approved labeled indications for oncologic imaging.