News | March 17, 2015

CMS Opens Comment Period for Reconsideration of NaF-18 PET National Coverage Determination Manual

Agency seeking feedback on data collection requirements for use of PET in finding bone cancer metastasis

NOPR, CMS, PET, NaF-18, comment period, bone metastasis

March 17, 2015 — The National Oncologic PET Registry (NOPR) Working Group submitted a formal request to the Centers for Medicare and Medicaid Services (CMS), to end the prospective data collection requirements under Coverage with Evidence Development (CED) for use of NaF-18 PET (CAG-00065R) imaging in intended patient management. CMS has initiated its review of this request.

Positron emission tomography (PET) is a minimally invasive imaging procedure used to assess metabolic activity and perfusion in various organs or tissues. Images are obtained by processing of emissions from positron-emitting radioisotopes that are usually administered intravenously. Sodium fluoride F-18 (NaF-18) is a radioisotope commonly used in oncologic PET imaging procedures to detect bone metastasis in cancer and is the focus of this national coverage analysis.

The rate of NaF-19 uptake provides information on the tissues being studied. NaF-18 PET evaluation can indicate the probable presence or absence of bone metastasis based upon observed differences in biologic activity of adjacent tissues.

Section 220.6.19 of the National Coverage Determination (NCD) Manual establishes the requirement for prospective data collection under CED for NaF-18 PET for bone metastasis in cancer.

At this time, CMS is soliciting comments on the NOPR's request. The public comment period will be open for 30 days, until April 16, 2015. PET facilities participating in the NOPR are encouraged to provide comments (which can be entered directly online on the CMS website at this link). Additionally, PET facilities are encouraged to ask referring physicians who frequently use NaF-18 PET in the care of their patients to submit comments to CMS indicating how NaF-18 PET has helped with patient management. Comments that cite scientific evidence (including unpublished data), including the full range of uses of NaF-18 PET in oncology and the uses of NaF-18 PET in benign bone and joint diseases, will be particularly valuable to CMS.  

For more information: www.cms.gov

Related Content

MIM Software Inc. Receives FDA 510(k) Clearance for Molecular Radiotherapy Dosimetry
Technology | Nuclear Imaging | January 16, 2019
MIM Software Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for molecular radiotherapy...
Videos | SPECT-CT | December 12, 2018
This is a walk around of the new Spectrum Dynamics Veriton SPECT-CT nuclear imaging system introduced at the 2018 ...
Spectrum Dynamics Sues GE for Theft, Misappropriation of Trade Secrets and Unfair Competition
News | SPECT Imaging | December 06, 2018
Single-photon emission computed tomography (SPECT) cardiac imaging company Spectrum Dynamics filed a lawsuit Dec. 6,...
Subtle Medical Receives FDA Clearance, CE Mark for SubtlePET
Technology | PET Imaging | December 05, 2018
Subtle Medical announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SubtlePET. Subtle...
Mirada Medical Joins U.K. Consortium Exploring Healthcare AI
News | Artificial Intelligence | December 04, 2018
Mirada Medical, a leading global brand in medical imaging software, will form part of an artificial intelligence (AI)...
GE Healthcare Recalls Millennium Nuclear Medicine Systems
News | Nuclear Imaging | November 15, 2018
GE Healthcare announced it is recalling its Millennium Nuclear Medicine Systems due to an incident in which the the top...
Artificial Intelligence Predicts Alzheimer's Years Before Diagnosis
News | Neuro Imaging | November 14, 2018
Artificial intelligence (AI) technology improves the ability of brain imaging to predict Alzheimer’s disease, according...
Researchers Awarded 2018 Canon Medical Systems USA/RSNA Research Grants
News | Radiology Imaging | November 13, 2018
The Radiological Society of North America (RSNA) Research & Education (R&E) Foundation recently announced the...
Subtle Medical Showcases Artificial Intelligence for PET, MRI Scans at RSNA 2018
News | Artificial Intelligence | November 13, 2018
At the 2018 Radiological Society of North America annual meeting (RSNA 2018), Nov. 25-30 in Chicago, Subtle Medical...
University of Missouri Research Reactor First U.S. I-131 Supplier in 30 Years

MURR is the only supplier of I 131 in the United States and the first U.S. supplier since the 1980s. Image courtesy of University of Missouri

News | Radiopharmaceuticals and Tracers | November 13, 2018
The University of Missouri Research Reactor (MURR) recently shipped its first batch of Iodine-131 (I-131), a...