Privacy Act of 1974; Report of a New System of Records

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In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, "Fluoro-Deoxy Glucose (FDG) Positron Emission Tomography (PET) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, Testicular and Other Cancers (PET 6), HHS/CMS/OCSQ, System No. 09-70-0549." National Coverage Determinations (NCD) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Social Security Act (the Act) Sec. 1869(f)(1)(B). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained in Part A or Part B, and must not be otherwise excluded from coverage. In our review of the other cancer indications, we found sufficient evidence to determine that PET scans are no longer experimental. However, the evidence was insufficient to reach a conclusion that FDG PET is reasonable and necessary in all instances. A sufficient inference of benefit, however, can be drawn to support limited coverage if certain safeguards for patients are provided. This inference is based on both the physiological basis for FDG PET usefulness in cancer