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CMS opens the door for the possible use of FDG PET for the evaluation of infection and inflammation

As we reported earlier this month, the Calendar Year 2022 Medicare Physician Fee Schedule (MPFS) proposed rule published by the Centers for Medicare and Medicaid Services (CMS) brought some good news about the prospects of greater Medicare coverage for additional positron emission tomography (PET) services. In the 2022 proposed rule, CMS announced its intention to remove "exclusionary language" from the national coverage determination (NCD) for PET services, largely leaving coverage decisions for non-oncologic PET indications to the discretion of local Medicare Administrative Contractors (MACs). 

CMS began that NCD removal process for PET services in the Calendar Year 2021 Medicare Physician Fee Schedule final rule (85 FR 84472, December 28, 2020). This month, CMS published Transmittal 10888 to provide notice that – effective for dates of service on or after January 1, 2021 – local MACs may determine coverage within their respective jurisdictions for the use of Fluorodeoxyglucose (FDG) PET to evaluate patients with infection and inflammation (formerly NCD 220.6.16). 

Prior to the removal of this NCD, CMS had determined that there was inadequate evidence to conclude that FDG PET improved health outcomes in Medicare populations when the test was used to evaluate chronic osteomyelitis, infection of hip arthroplasty, and fever of unknown origin. As a result, CMS had determined that using FDG PET to test for these conditions was not reasonable or necessary. CMS has now removed that determination. 

With the removal of that NCD, coverage determinations about the use of FDG PET for the evaluation of patients with infection and inflammation can be now made by the Medicare Administrative Contractors.

The Centers for Medicare & Medicaid Services (CMS) acknowledges the advances relating to the assessment of diagnostic performance and patient safety, as pioneered by the FDA in its regulatory policies and guidelines for diagnostic PET imaging agents and systems during the past decade. We note for completeness that local coverage cannot be in conflict with NCDs or other national policies.


health care & life sciences, medicare, positron emission tomography, payment