federal_register: E5-6810
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| E5-6810 | Privacy Act of 1974; Report of a New System of Records | Notice | 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, as well as, evidence of a positive benefit of FDG PET for patients with several other cancers for which there is evidence of sufficient quality to warrant coverage. The purpose of this system is to collect and maintain information on Medicare beneficiaries receiving FDG PET scans for indications for when there is not sufficient evidence to reach a firm conclusion that the scan is reasonable and necessary unless they are enrolled in an approved study. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) to an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support constituent requests made to a Congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain health benefits programs. We have provided background information about the new system in the "Supplementary Information" section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period. | 2005-12-05 | 2005 | 12 | https://www.federalregister.gov/documents/2005/12/05/E5-6810/privacy-act-of-1974-report-of-a-new-system-of-records | https://www.govinfo.gov/content/pkg/FR-2005-12-05/pdf/E5-6810.pdf | Health and Human Services Department; Centers for Medicare & Medicaid Services | 221,45 | 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... |