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CMS Acts to Spur Innovation for America’s Seniors

Today the Centers for Medicare & Medicaid Services (CMS) announced the Medicare Coverage of Innovative Technology (MCIT) (CMS-3372-P) proposed rule, which would provide Medicare beneficiaries access to the latest medical technology faster than ever.

Under current rules, FDA approval of a device is followed by an often lengthy and costly process for Medicare coverage. The MCIT proposal would eliminate this lag time for both seniors and innovators. It would create a new, accelerated Medicare coverage process for innovative products that the FDA deems “breakthrough,” which FDA approves on an expedited basis and could include devices harnessing new technologies like implants or gene-based tests to diagnose or treat life-threatening or irreversibly debilitating diseases or conditions like cancer and heart disease.

Under the proposal, Medicare would provide national coverage simultaneously with FDA approval, for a period of four years. After that time, CMS may reevaluate the device based on clinical and real-world evidence of improvement in health outcomes among Medicare beneficiaries. This four-year timeline would 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.

Importantly, because the MCIT rule would provide national Medicare coverage for four years, it would streamline identical local coverage decisions (LCDs), promoting equal access for seniors and helping innovators focus on getting their devices to patients and clinicians.  Under MCIT, breakthrough devices are given automatic national coverage for four years, simultaneous with FDA approval, meaning innovators do not need to seek coverage from the MACs.

This proposed rule would also allow Medicare to cover eligible breakthrough devices the FDA has approved for use in 2019 or 2020, giving Medicare beneficiaries immediate access to these innovative and potentially life-saving devices.

Additionally, the MCIT proposed rule would clarify the standard CMS uses to determine whether Medicare should cover a product, like a drug, device, or biologic.

Today’s announcement also implements a major CMS effort to provide better customer service for innovators seeking Medicare coverage for their products.

In addition to the proposed rule and the internal changes, CMS is also announcing that, in an effort to ensure certainty and clarity for stakeholders, the agency has significantly reduced a backlog of requests for National Coverage Determinations (NCDs), some of which have been on a list awaiting approval since 2014. In 2019 there were 11 NCD applications waiting for CMS review. By the end of 2020, CMS will have addressed nine of those 11. One of the remaining two is being handled by local Medicare Administrative Contractors (MACs) and the second is undergoing additional clinical trials.

Public comments on the proposed rule will be accepted until November 2, 2020.

For the full announcement and links please visit: