CMS Strikes Out FDG for Infection Imaging

In the battle to get CMS to understand the value of diagnostic imaging, this month saw one gain, the decision not to limit CTA imaging, and one loss, a decision to continue national non-coverage of FDG PET for infection and inflammation imaging.

Explaining this decision, the CMS cited lack of interest in the FDG PET imaging by both orthopedic surgeons and infectious disease specialists as part of their determining factor.

Summing this up the CMS wrote: "This leads us to reasonably determine that the interest in the use of PET for these indications is narrow and does not apparently include the physicians who routinely manage the care of beneficiaries who have these conditions. Thus, we have determined that FDG PET is not reasonable and necessary for these indications."

In addition, the CMS still seems does not seem to understand the role of diagnostic imaging as they are still focusing on improved health outcomes as the deciding factor, stating:

"Based upon our review CMS has determined that the evidence is inadequate to conclude that FDG PET for chronic osteomyelitis, infection of hip arthroplasty and fever of unknown origin improves health outcomes in the Medicare populations and therefore has determined that FDG PET for chronic osteomyelitis, infection of hip arthroplasty and fever of unknown origin is not reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act ."

Although some FDG-PET studies for non-covered cancer applications are being reimbursed, when they are performed under certain study requirements, the CMS further determined that: "CMS has also determined that the request for coverage is not appropriate for the Coverage with Evidence Development (CED) paradigm."

This is a double blow to those working on imaging infection and inflammation with PET, because it will now be more difficult to collect the evidence needed to reverse the CMS non-coverage decision for this indication.