Medicare beneficiaries now have immediate access to innovative medical technology approved by the U.S. Food and Drug Administration (FDA), rather than having to wait for it to clear additional bureaucratic hurdles before coverage is approved.
The Medicare Coverage of Innovative Technology (MCIT) final rule issued this week eliminates the time and cost innovators were formerly required to navigate to seek Medicare coverage after the FDA approves a product. The new process accelerates seniors’ access to “potentially lifesaving technologies,” according to a news release issued by the Centers for Medicare & Medicaid Services (CMS).
“Government processes have slowed beneficiaries’ access to innovative treatments,” said CMS Administrator Seema Verma. “Despite being deemed safe and effective by the FDA, Medicare beneficiaries have not had predictable, immediate access to innovative breakthrough devices.”
MCIT removes government barriers to advancing innovations, fosters competition, and ensures quicker access to the most advanced therapies, Verma explained.
The rule applies to products that the FDA deems as “breakthrough,” which are approved on an expedited basis. Examples include implants or gene-based tests to diagnose or treat life-threatening or irreversibly debilitating diseases or conditions such as cancer and heart disease. For such innovations, Medicare national coverage begins simultaneously with FDA approval. Manufacturers can choose the date coverage begins to better align with market availability.
There is a catch. The products are only covered for a period of four years.
“After the coverage period is over, CMS will reevaluate the device based on clinical and real-world evidence of improvement in health outcomes among Medicare beneficiaries to determine more permanent coverage,” the release stated. “This four-year timeline may incentivize the manufacturers of these breakthrough devices to develop additional evidence regarding the applicability of their products to the Medicare population, so they might continue Medicare coverage beyond the initial four years.”