The U.S. Centers for Medicare and Medicaid Services (CMS) has issued a final rule designed to speed up Medicare coverage of innovative devices that have undergone prioritized regulatory review.
The Medicare Coverage of Innovative Technology (MCIT) rule reduces the lag between U.S. Food and Drug Administration (FDA) marketing authorization and subsequent Medicare coverage for innovative medical devices. These devices run the gamut from implants to gene-based tests.
Under the program, Medicare can provide national reimbursement coverage for an innovative device simultaneously with FDA approval, up to a period of four years, CMS said. After four years, CMS will reevaluate the device based on clinical and real-world evidence to determine more permanent coverage. The timeline may incentivize manufacturers to develop additional evidence regarding the applicability of their products, the agency added.
Also, because of the four-year coverage period, MCIT will sync with the local coverage determination process to promote equal access for seniors regardless of where they live. Currently, under the local coverage process, 16 Medicare Administrative Contractors (MACs) make Medicare coverage decisions on the local level -- 12 for Medicare Parts A and B, and four for Durable Medical Equipment. That means that sometimes technology is covered in one area of the country but not another. Furthermore, medical device innovators are required to seek separate decisions from each of the MACs.
MCIT eliminates these hurdles by providing national coverage for four years, and innovators have the option to choose when they would like coverage to begin. Additionally, after the final rule takes effect, Medicare may cover devices that received FDA approval within two calendar years prior to MCIT's effective date.
MCIT also clarifies the standard CMS uses to determine whether Medicare should cover items and services, like devices and surgical procedures, defining what it deems reasonable and necessary.
The Medical Imaging and Technology Alliance (MITA) lauded the final rule and calls it "a major regulatory win."
Before the rule's finalization, MITA submitted comments supporting CMS's proposed changes and joined the Focused Ultrasound Foundation to publicly urge the agency to create the new Medicare coverage pathway.
