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NaF-18 PET for Bone Metastasis

This national coverage determination (NCD) was issued on February 26, 2010.  It establishes specific clinical indications under which CMS will cover NaF-18 Positron Emission Tomography (NaF-18 PET).  The NCD concluded that NaF-18 PET scans are reasonable and necessary under Section 1862(a)(1)(E) of the Social Security Act in the context of Coverage with Evidence Development (CED).

Prospectively under CED, NaF-18 PET imaging must lead to:

  • A change in patient management to more appropriate palliative care; or
  • A change in patient management to more appropriate curative care, or
  • Improved quality of life; or
  • Improved survival

The clinical research study also must adhere to certain standards of scientific integrity and relevance to the Medicare population.

 

Decision memorandum: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=233

 

On its website, CMS will maintain a list of all approved studies and facility locations.  There are approximately 2200 facilities participating in the clinical research study for NaF-18 PET.  A list of facility locations can be found here: http://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage

 

The following study has been approved by CMS: The National Oncologic PET Registry (NOPR)

 

Information on the clinical study may be found at: http://www.clinicaltrials.gov/ct2/show/NCT00868582?term=PET+Academy+of+Molecular+Imaging&rank=2

The protocol for FDG PET for Solid Tumors was amended to include a second clinical research study to include this NCD.