On Monday, November 2, the Alliance for Aging Research submitted feedback to the Centers for Medicare and Medicaid Services (CMS) on the Medicare Coverage for Innovative Technology and Definition of “Reasonable and Necessary” proposed rule. CMS proposes to provide an initial Medicare coverage of up to four years for “breakthrough devices” immediately upon market approval from the Food and Drug Administration (FDA). The agency also proposed to revise and codify the definition of “reasonable and necessary” services, which is used in evaluating procedures and products for coverage in the Medicare program.
Key points in the comment letter include:
- Support for CMS’s proposal to align Medicare coverage with FDA approval for devices designated as “breakthrough,” i.e. that provide a treatment option when no clear alternatives exist or that have significant advantages over existing treatments
- Advising CMS to withdraw the proposed revision and codification of the definition of “reasonable and necessary.” CMS’s proposal would allow Medicare coverage determinations to incorporate considerations of decisions made by commercial insurers. However, Medicare coverage has historically provided greater coverage than commercially available plans.
About the Alliance for Aging Research
The Alliance for Aging Research is the leading nonprofit organization dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. The Alliance believes advances in research help people live longer, happier, more productive lives and reduce healthcare costs over the long term. For more than 30 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the National Institutes of Health and Food and Drug Administration; built influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers. For more information, visit www.agingresearch.org
Vice President of Communications