Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging for Infection and Inflammation
MLN Matters Number: MM6099
Related Change Request (CR) #: 6099
Related CR Release Date: June 27, 2008
Effective Date: March 19, 2008
Related CR Transmittal #: R84NCD
Implementation Date: July 28, 2008
Provider Types Affected
Physicians, providers, and suppliers submitting claims to Medicare contractors (carriers, Fiscal Intermediaries (FIs), and/or Part A/B Medicare Administrative Contractors (A/B MACs)) for services provided to Medicare beneficiaries.
Impact on Providers
This article is based on Change Request (CR) 6099 instructing that the Centers for Medicare & Medicaid Services (CMS) is continuing its national non-coverage policy for the off-label indications of fluorodeoxyglucose (FDG) Positron emission tomography (PET) imaging for chronic osteomyelitis, infection of hip arthroplasty, and fever of unknown origin.
Background
CMS was asked to reconsider the current, de facto non-coverage for FDG PET imaging in the Medicare National Coverage Determinations (NCD) Manual (Section 220.6), for the following off-label uses (instead of bone, leukocyte, and/or gallium scintigraphy):
- Suspected chronic osteomyelitis in patients with:
- previously documented osteomyelitis with suspected recurrence, or
- 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 1 week of proper investigation.
Based upon its review, CMS 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 is not reasonable and necessary under the Social Security Act (section 1862(a)(1)(A) (See that provision at
http://www.ssa.gov/OP_Home/ssact/title18/1862.htm.)
Additionally, CMS determined that this request for coverage is not appropriate for the Coverage with Evidence Development (CED) paradigm.
Additional Information
The official instruction, CR 6099, issued to your carrier, FI, and A/B MAC regarding this change may be viewed at
http://www.cms.hhs.gov/Transmittals/downloads/R84NCD.pdf.
If you have any questions, please contact our Provider Contact Center at 1-888-828-2092.
Disclaimer
This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statement of their contents.