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, "Anti-Cancer Chemotherapy for Colorectal Cancer (CRC) System, System No. 09-70- 0554." 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) section 1869(f)(1)(B). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage. Moreover, with limited exceptions, the expenses incurred for items or services must be "reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member" (section 1862(a)(1)(A). Under authority of section 1861(t)(2) of the statute, Medicare provides coverage for Food and Drug Administration (FDA) approved indications for anticancer chemotherapeutic agents and for other indications that are in the specific approved compendia listed below. Increased understanding of the biology of cancer and emerging techn