Benefit Category
Diagnostic Tests (other)
Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.
Item/Service Description A. General
The Centers for Medicare & Medicaid Services (CMS) received a formal, complete request to reconsider the current, de facto non-coverage for FDG PET imaging for the following off-label uses, each in lieu of bone, leukocyte, and/or gallium scintigraphy:
- Suspected chronic osteomyelitis in patients with: (a) previously documented osteomyelitis with suspected recurrence, or, (b) symptoms of osteomyelitis for more than 6 weeks (including diabetic foot ulcers),
- Investigation of patients with suspected infection of hip prosthesis, and,
- Fever of unknown origin in patients with a febrile illness of >3 weeks duration, a temperature of >38.3 degrees Centigrade on at least two occasions, and uncertain diagnosis after a thorough history, physical examination, and one week of proper investigation.
Indications and Limitations of Coverage B. Nationally Covered Indications
N/A
C. Nationally Non-Covered Indications
The CMS is continuing its national non-coverage of FDG PET for the requested indications. 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.
D. Other
The CMS has also determined that the request for coverage is not appropriate for the Coverage with Evidence Development (CED) paradigm.
(This NCD last reviewed March 2008.)
