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Centers for Medicare & Medicaid Services

View Public Comments for Positron Emission Tomography (CAG-00065R2)

Gelovani, Juri
World Molecular Imaging Society
August 8th, 2012
Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd., Mail Stop C1-09-06
Baltimore, MD 21244

Re: National Coverage Analysis (NCA) Tracking Sheet for Positron Emission Tomography (CAG-00065R2)

Dear Dr. Jacques:

On behalf of World Molecular Imaging Society (WMIS), we appreciate the opportunity to submit public comments to the Centers for Medicare & Medicaid (CMS) in support of the reconsideration of the non-coverage language in Section 220.6 of the Medicare National Coverage Determinations Manual for PET scans.

WMIS is the foremost and authoritative society in molecular imaging. Since the inception of Positron Emission Tomography PET, the society (formerly known as the Academy of Molecular Imaging) has participated in all major coverage and payment determinations and educational activities related to PET. WMIS is the sponsor of the National Oncologic PET Registry (NOPR). Additionally, we are a cosignatory for the Formal Request. Given our experience and involvement with PET and our objective viewpoint which comes from our academic roots, we would like to again reiterate our support for a lifting the national non-coverage language for new FDA approved PET diagnostic radiopharmaceuticals. Our clinical and scientific rational is as follows:

Since first reviewing PET imaging in the late 1990s, the technology is now widely recognized in the medical communityas an important diagnostic modality. For more than a decade now, significant data has been accumulated to demonstrate the clinical accuracy of FDG-PET and its impact on patient management. In light of the robust NOPR data collected since 2009, we are now convinced that there remains no clinical need to continue CED data collection for FDG-PET oncologic indications.

Based on the past review of FDG-PET, and now NaF-18, we strongly believe that future FDA approved imaging agents should not be non-covered by Medicare following FDA approval. In the next decade we expect to see the commercialization of a new generation of highly targeted radiopharmaceuticals. Furthermore, we believe that the improvements in the FDA approval process for new radiopharmaceuticals have led to the evolution of significant protocols and rigor to evaluate and determine the safety and efficacy of these new agents. Obviously, the final determination for CMS purposes is whether new FDA approved agents meet the "reasonable and necessary" criteria for coverage of the Medicare specific population. We believe that the most appropriate framework for the next generation of PET tracers in oncology, neurology (Dementia, Alzheimer’s disease), and cardiology would be the elimination of the overly restrictive national non-coverage language. Coverage could be reviewed through the local contractor process and when appropriate through a national coverage analysis framework.-.

We look forward to working with you in the future both on issues relating to the NOPR as well as new imaging technologies. Thank you.

Best Regards,

Juri Gelovani