{"database": "openregs", "table": "federal_register", "rows": [["E5-6808", "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 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 forth in the decision memorandum and are consistent with the trials discussed. Collection of these data elements allows that determination to be made. The purpose of this system is to provide reimbursement for ICDs and assist in the collection of data on patients receiving an ICD for primary prevention to a data collection process to assure patient safety and protection and to determine that the ICD is reasonable and necessary. 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 modified 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/E5-6808/privacy-act-of-1974-report-of-a-new-system-of-records", "https://www.govinfo.gov/content/pkg/FR-2005-12-05/pdf/E5-6808.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 system of records title, \"Implantable Cardioverter-Defibrillator (ICD) System, System No. 09- 70-0548.\" National coverage determinations (NCDs) are...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url", "agency_names", "agency_ids", "excerpts", "regulation_id_numbers"], "primary_keys": ["document_number"], "primary_key_values": ["E5-6808"], "units": {}, "query_ms": 29.676242964342237, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}