The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would create an accelerated pathway in the Medicare coverage process for products, including tests, that the U.S. Food and Drug Administration (FDA) approves on an expedited basis as part of its Breakthrough Devices Program, according to CMS.
The goal of the FDA’s breakthrough program is to speed the process of premarket approval, 510(k) clearance, and De Novo marketing authorization for products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Under the proposal from CMS, Medicare would provide national coverage for four years on the same day as the FDA approves a breakthrough product. After that time, CMS said “it may reevaluate the device based on clinical and real-world evidence of improvement in health outcomes among Medicare beneficiaries.” CMS said the four-year time horizon would encourage manufacturers to develop real-world evidence supporting the benefits of their products to seniors.
This proposed rule would also allow Medicare to cover eligible breakthrough devices the FDA already has approved for use in 2019 and 2020.
Under current CMS rules, FDA approval of a device is followed by a process in which devices are approved for Medicare coverage by 16 Medicare Administrative Contractors (MACs), which decide whether to grant Medicare coverage for the device. Each MAC’s decision applies only to that MAC’s jurisdiction, meaning that manufacturers go through a cumbersome process to win approval for their products across the country.
