The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced an expedited pathway for Device Makers to potentially expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare. The Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway in an attempt to speed new devices through FDA’s regulatory process.

“FDA and CMS each play a critical role in getting new medical devices to patients, and they work most effectively when aligned sooner in that process,” said CMS Administrator Dr. Mehmet Oz. “The RAPID coverage pathway brings our two agencies together earlier, cutting red tape for innovators, and helping beneficiaries access new, life-changing health technology faster.”

“The American people deserve timely access to meaningful treatments without red tape or high costs,” said FDA Commissioner Marty Makary, M.D., M.P.H. “In this administration, FDA and CMS are functioning as a single team to deliver life-saving Breakthrough Devices to American patients as soon as we know they work,” said FDA Commissioner Marty Makary, M.D., M.P.H.

According to the CMS press release, the RAPID coverage pathway allows CMS and the FDA to work together, with innovators, earlier in the technology development lifecycle so that evidence generated for FDA review can also support Medicare coverage decisions. By aligning regulatory and coverage expectations in advance, the RAPID coverage pathway is designed to significantly reduce delays that have historically occurred between FDA market authorization and Medicare national coverage determinations.

See the full release at FDA