Considering changes to CMS's national coverage decision process: Applying lessons learned from FDA as a regulator of access to healthcare technology

摘要

During the 2000 presidential campign, both candidates supported adding some form of prescription drug benefit to Medicare. Although the details of the plan continue to be debated in Congress, this appears to be good news for seniors. Many new drugs currenfiy on the market, or expected to be available within the next several years, will have the ability to profoundly affect the quality of life and clinical outcomes of patients with acute and chronic diseases, many of which primarily afflict the eldefiy--a demographic group that is increasing disproportionately to the rest of the population. Included among these are such diseases as cancer, coronary heart disease, and stroke. The agency charged with the important work of administering Medicare (the Centers for Medicare & Medicaid Services (CMS)), the government entity that likely will be responsible for deciding which drugs will be available under the new benefit, has been the subject of increasing criticism, especially with regard to the processes that it uses to render national coverage decisions for new technology? Among these concerns is the level of CMS responsiveness to the needs of Medicare beneficiaries and the physicians who care for them and that the CMS bureaucracy is overly complex, unaccountable.