News | January 07, 2009

CMS to Expand Coverage for PET

January 7, 2009 - The Centers for Medicare & Medicaid Services (CMS) proposed a national coverage determination (NCD) to expand coverage for initial diagnostic testing with positron emission tomography (PET) for many Medicare beneficiaries who are being treated for cancer.

Under Coverage with Evidence Development (CED) program, CMS had issued a national coverage determination in 2005 that tied Medicare coverage of PET scans to the collection of clinical information about the effect of the test on the beneficiary's cancer care. This information was obtained through the National Oncologic PET Registry (NOPR) observational study. Without CED, these tests would not have been covered by Medicare.

The purpose of CED is to develop evidence on the utilization and impact of the item or service evaluated in an NCD, so that Medicare can a) document the appropriateness of use of that item or service in Medicare beneficiaries under current coverage; b) consider future changes in coverage for the item or service; c) generate clinical information that will improve the evidence base on which providers base their recommendations to Medicare beneficiaries regarding the item or service.

The sponsors of NOPR submitted a formal written request to reconsider the 2005 coverage determination to CMS, based on the evidence they had collected and published. Medicare uses a formal evidence based process when it reconsiders past NCDs. This proposed expansion in coverage is the first time that CMS has reviewed medical evidence arising from its CED program.

"We are pleased with these first results of the Coverage with Evidence Development program and look forward to patients gaining greater access to new technologies while enhancing the evidence physicians use to make treatment recommendations," said CMS Acting Administrator Kerry Weems.

This proposed decision would remove a significant part of the CED requirement for PET scans in cancer and allow coverage for one PET scan to guide the initial treatment strategy. CED will still be required for PET scans for subsequent treatment strategies, as CMS believes that the current evidence is not adequate to provide coverage for PET scans in guiding subsequent treatment.

CMS proposes some cancer-specific exceptions to these broad requirements, which are listed in the proposed decision memorandum.

CMS will accept public comments on the entire proposed decision through February 5, 2009 and will issue a final national coverage determination in April 2009. CMS invites public comments on its proposed decision at www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=218.

For more information: www.cms.hhs.gov

Related Content

Study Demonstrates First Human Application of Novel PET Tracer for Prostate Cancer

Transaxial 11Csarcosine hybrid PET/CT showed a (triangulated) adenocarcinoma in the transition zone of the anterior right prostate gland on PET (A), CT (B), and a separately obtained T2?weighted MR sequence (C) with resulting PET/MRI registration (D). Image courtesy of M. Piert et al., University of Michigan, Ann Arbor, Mich.

News | Radiopharmaceuticals and Tracers | August 16, 2017
In the featured translational article in the August issue of The Journal of Nuclear Medicine, researchers at the...
PET/CT Tracer Identifies Vulnerable Lesions in Non-Small Cell Lung Cancer Patients

Example of a patient with an upper left lung NSCLC: A: FDG; B: FDG PET/CT; C: Planning radiotherapy based on FDG (66Gy) with BTVm (GTV), CTV and PTV; D: PET FMISO E: FMISO PET/CT; F: boost based on the FMISO PET (76Gy) with BTVh (biological hypoxic target volume) and PTV boost. Credit: QuantIF – LITIS EA 4108 – FR CNRS 3638, Henri Becquerel Cancer Center, Rouen, France

News | PET-CT | July 14, 2017
July 14, 2017 — Fluorine-18 (18F)-fluoromisonidazole (FMISO) is a positron emission tomography (PET)...
Novel PET Tracer Detects Small Blood Clots

PET images (MIP 0-60 min) of three Cynomolgus monkeys. Strong signals are detected at the sites where inserted catheters had roughened surfaces. Almost no other background signal is visible. Only accumulation in the gallbladder becomes visible at the bottom of the image. Credit: Piramal Imaging GmbH, Berlin Germany.

News | PET Imaging | July 07, 2017
July 7, 2017 — Blood clots in veins a
A 77-year-old male with recurrent lymph node and pulmonary metastases detected by Ga-68 PSMA PET/CT but not by conventional imaging

A 77-year-old male with recurrent lymph node and pulmonary metastases detected by Ga-68 PSMA PET/CT but not by conventional imaging. Graphic courtesy of the Department of Nuclear Medicine, Royal North Shore Hospital, Sydney

News | Prostate Cancer | June 15, 2017
An estimated one in seven American men will be affected by prostate cancer in their lifetime. Prostate-specific...
Dual-labeled PSMA-inhibitors for the diagnosis and therapy of prostate cancer

IMAGE OF THE YEAR: Dual-labeled PSMA-inhibitors for the diagnosis and therapy of prostate cancer. Technology of dual-labeled PSMA-inhibitors for PET/CT imaging and fluorescence-guided intraoperative identification of metastases. This work might help to establish a new treatment regimen for more precise and sensitive pre-, intra- and post-therapeutic detection of prostate cancer.

Credit: Courtesy of A. Baranski, M. Schäfer, U. Bauder-Wüst, M. Roscher, J. Schmidt, E. Stenau, L. Maier-Hein, M. Eder, K. Kopka, German Cancer Research Center, Heidelberg, Germany; T. Simpfendörfer, B. Hadaschik, U. Haberkorn, Heidelberg University Hospital, Heidelberg, Germany; PET-image: Afshar-Oromieh et al., EJNMMI 2013; 40(4); STED-image: J. Matthias, German Cancer Research Center.

This study was supported by the VIP+ fund, Federal Ministry of Education & Research (BMBF), Germany.

Scientific Paper 531: “Preclinical evaluation of dual-labeled PSMA-inhibitors for the diagnosis and therapy of prostate cancer.” A. Baranski, M. Schäfer, U. Bauder-Wüst, M. Roscher, J. Schmidt, E. Stenau, L. Maier-Hein, M. Eder, K. Kopka, German Cancer Research Center (DKFZ), Heidelberg, Germany; T. Simpfendörfer, B.  Hadaschik, U. Haberkorn, University Hospital, Heidelberg, Germany. Presented at SNMMI’s 64th Annual Meeting, June 10-14, 2017, Denver, Colo.

News | Prostate Cancer | June 15, 2017
In the battle against metastatic prostate cancer, the removal of lymph node metastases using image-guided surgery may...
Axial fused 89Zr-5B1 antibody PET/CT image demonstrates focus of uptake in the liver (arrow). Focus of uptake correlates with increased liver metastasis seen on diagnostic CT (red arrow) performed 2 weeks prior

Axial fused 89Zr-5B1 antibody PET/CT image demonstrates focus of uptake in the liver (arrow). Focus of uptake correlates with increased liver metastasis seen on diagnostic CT (red arrow) performed 2 weeks prior. Image courtesy of Christian Lohrmann, Jason Lewis, Wolfgang Weber, Memorial Sloan Kettering Cancer Center; MabVax Therapeutics

News | PET-CT | June 14, 2017
Pancreatic cancer is associated with bleak five-year survival rates and limited treatment options, but new research is...

While subject No. 1 (left) was judged as positive for both the neuronal injury and the amyloid load biomarker, both Alzheimer's disease biomarkers were negative in subject No. 2 (right). Image courtesy of Henryk Barthel et al., University Hospital Leipzig, Leipzig, Germany

News | PET Imaging | June 14, 2017
More people die of Alzheimer's disease than prostate and breast cancer combined. Identifying the disease before major...
PET/CT
News | PET-CT | June 12, 2017
Philips announced that it will be showcasing molecular imaging solutions highlighting Philips’ commitment to innovation...
News | PET-CT | June 12, 2017
Siemens Healthineers has announced that the Food and Drug Administration (FDA) has cleared Biograph Horizon Flow...
Overlay Init