On June 25, 2007 the Centers for Medicare and Medicaid Services (CMS) opened a National Coverage Analysis (NCA) announcing they would formally consider coverage for FDG PET for infection and inflammation, specifically for the diagnosis of chronic osteomyelitis, infections associated with hip arthroplasty and fever of unknown origin, each in lieu of bone, leukocyte and/or gallium scintigraphy (CAG-00382N).
Subsequently, CMS recently issued a negative proposed decision memo on the coverage of FDG PET for infection and inflammation. CMS is asking for public comments that include any new evidence they have not reviewed in past considerations. Additionally CMS is asking for public comments as to the potential to provide limited coverage under coverage with evidence development programs (i.e. a registry).
The proposed decision memo was posted December 20, 2007 and public comments will be accepted for 30 days (see link below).
The CMS summary of the proposed decision memo is as follows:
“CMS proposes that there is inadequate evidence to conclude that FDG PET for chronic osteomyelitis, infection of hip arthroplasty and fever of unknown origin are reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act and therefore, we propose to continue our national noncoverage for these indications.
We are requesting public comments on this proposed determination pursuant to section 1862(1) of the Social Security Act. We are particularly interested in comments that include new evidence we have not reviewed here or in past considerations of this National Coverage Determination (NCD).
We are also interested in public comments as to the potential to provide limited coverage for any or all of these indications under the Coverage with Evidence Development (CED) paradigm. We solicit public comment as to the specific types of studies that would be appropriate under CED.
After considering the public comments and any additional evidence we will make a final determination and issue a final decision memorandum.”
The NCA calls for a final decision memo due date of March 19, 2008.
The full text of the proposed decision memo can be found at:
www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=207
Public comments may be submitted electronically at:
www.cms.hhs.gov/mcd/public_comment.asp?nca_id=207&basketitem
The tracking sheet for this NCA can be found at:
www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=207
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