CMS releases final rule on covering emerging medical technologies

January 13, 2021
Keith A. Reynolds

The rule is aimed at getting Medicare patients faster access to the latest medical technologies and devices.

The Centers for Medicare & Medicaid Services (CMS) has released a final rule aimed at giving beneficiaries faster access to the latest medical technologies and devices.

According to a news release, the Medicare Coverage of Innovative Technology (MCIT) final rule is aimed at smoothing the Medicare coverage pathway for innovative medical technologies by eliminating the lag time between a device or technology’s approval by the Food and Drug Administration (FDA) and their coverage under Medicare.

“Government processes have slowed beneficiaries’ access to innovative treatments,” CMS Administrator Seema Verma says in the release. “Despite being deemed safe and effective by the FDA, Medicare beneficiaries have not had predictable, immediate access to innovative breakthrough devices. In an ever-evolving health care marketplace, CMS remains committed to transforming the health care delivery system through initiatives like MCIT that focus on results, removing government barriers to advancing innovations, fostering competition, and ensuring quicker access to the most advanced therapies for Medicare beneficiaries while providing them with better value and outcomes.”

The rule creates a new, accelerated Medicare coverage pathway for innovative products deemed “breakthrough” by the FDA and approved on an expedited basis. It allows Medicare to provide national coverage simultaneous to FDA approval for a period of up to four years, the release says.

After this coverage period concludes CMS will reevaluate the device based on clinical and real-world evidence in health outcomes among beneficiaries to determine more permanent coverage, according to the release.

The rule also clarifies the standard used by CMS to determine Medicare coverage for items and services by stating the program can only cover those which are “reasonable and necessary,” the release says.

More information on the rule can be found here.