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National Coverage Determination (NCD) for FDG PET for Infection and Inflammation (220.6.16)

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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:

  1. 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),
  2. Investigation of patients with suspected infection of hip prosthesis, and,
  3. 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.)


Transmittal Number

84

Revision History

06/2008 -CMS reconsidered the current, de facto non-coverage for FDG PET imaging for off-label indications chronic osteomyelitis, infection of hip arthroplasty, and fever of unknown origin, each in lieu of bone, leukocyte, and/or gallium scintigraphy. CMS determines it will continue its national non-coverage policy for FDG PET for the requested indications. Effective date: 03/19/2008 Implementation date: 07/28/2008 (TN 84) (CR6099).

03/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/07/2013 Effective date: 10/1/2014. (TN 1199) (TN 1199) (CR 8197)


National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

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