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NaF-18 PET for Bone Metastasis

Guidance for 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).

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: March 05, 2020

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 Memos

 

On its website, CMS will maintain a list of all approved studies and facility locations on its website. A list of facility locations can be found here: /MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage

Registry Approvals:

Study Title: The National Oncologic PET Registry (NOPR)
Sponsor: American College of Radiology Imaging Network
ClinicalTrials.gov Number: NCT00868582
CMS Approval Date: 2/26/2010
Enrollment closed 12/14/2017

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