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

概要

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system of records title, "Implantable Cardioverter-Defibrillator (ICD) System, System No. 09- 70-0548." National coverage determinations (NCDs) 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 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," Sec. 1862(a)(1)(A). CMS has determined that the evidence is adequate to conclude that an implantable cardioverter-defibrillator (ICD) is reasonable and necessary in several patient groups where certain criteria for these patients have been met. The reasonable and necessary determination requires that patients meet the ICD implantation criteria set f