The Centers for Medicare & Medicaid Services (CMS) on Wednesday issued a final ruling that evidence provided was inadequate to determine that the use of FDG-PET imaging for chronic osteomyelitis, infection of hip arthroplasty and fever of unknown origin improves health outcomes in Medicare populations.
For that reason, CMS reported that it has decided to continue its national noncoverage of FDG PET for these indications. CMS has also determined that the request for coverage is not appropriate for the “Coverage with Evidence Development paradigm,” according to the CMS final decision memorandum.
The final ruling follows a CMS Proposed Decision Memorandum in December 2007 that also declined reimbursement for these FDG-PET procedures.
CMS reviewed individual study results in making the determination. According to CMS, the evidence presented showed significant limitations in the body of evidence including heterogeneity of cases, lack of consistent comparators, small sample sizes, missing data (or lack of data reporting), and poor methodological structure, with one study in particular (Bleeker-Rover 2006) leading to an overestimate of the test performance of FDG PET. In addition, most studies were case series which are useful for hypothesis generation, but did not show causality, according to the CMS memo.
Although chronic osteomyelitis and hip replacement are commonly managed by orthopedic surgeons, CMS noted the marked “paucity of expressed interest on this issue by practicing orthopedic surgeons or their professional societies as well as the lack of expressed interest from those physicians, generally infectious disease specialists, who would routinely be asked to consult in cases of fever of unknown origin.”
CMS said the lack of interest indicated narrow use of PET for these indications and did not apparently include the physicians who routinely manage the care of beneficiaries who have these conditions.
“The evidence reviewed does not support a finding that FDG PET reliably informs physician management or improves patient centered outcomes for these indications,” CMS noted.