21st Century Cures Act and Medical Device Regulation Departure from Principles or Catching the Wave

In the early years of the Medicare program, coverage policy had been made chiefly by the Medicare contractors at the local level.63 However, with the advances in expensive new medical technology in the 1970s, the Medicare program was faced with more issues on whether to cover new technologies which called for attention from the national office.64 In the early 1980s, CMS started promulgating national coverage determinations in the Federal Register.65 Decisions on whether Medicare covers an item or service are made by Medicare Administrative contractors (“MACs”) that administer the Medicare program at the local level.66 Many stakeholders, particularly the medical device industry, have been critical of the closed character of the MAC's coverage decision-making process.67 The U.S. Government Accountability Office (“GAO”) has been a persistent critic of CMS's coverage decision-making processes at both the national and local level.68 In January 1989, CMS (formerly the Health Care Finance Administration or HFCA) promulgated a proposed rule establishing procedures and criteria but never published a complete final rule.69 The proposed rule was to establish criteria and procedures for HCFA decisions as to whether, and under what circumstances, specific health care technologies could be considered “reasonable” and “necessary” in more open and streamlined procedures with increased public participation and expedited procedures for “new breakthrough” technologies.70 In recent years, CMS has placed great emphasis on assuring that coverage decisions are based on sound evidence.71 CMS did not have a formal, transparent and public process for making Medicare coverage determinations or appealing coverage decisions until 2000.72 CMS had proposed some administrative improvements.73 These improvements were insufficient from the perspective of manufacturers and they pressed for legislative reforms.74 In the late 1990s, the Republican-dominated House Ways and Means Committee pressured the then-HCFA to reform its coverage decision-making and appeals processes.75 The Committee's Health Subcommittee held several hearings on the coverage decision-making and appeals processes.76 In 2000, Congress enacted the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (“BIPA”) established statutory requirements for the national and local coverage decision-making processes.77 Basically, these requirements intended to make the coverage policymaking process more transpar