Trump administration moves to speed up Medicare coverage for breakthrough cardiology devices
The U.S. Centers for Medicare and Medicaid Services (CMS) and U.S. Food and Drug Administration (FDA) have proposed a new coverage pathway that would dramatically change how Medicare beneficiaries gain access to certain “breakthrough” medical devices. The goal is to get the two agencies on the same page and speed up the process through which medtech companies receive Medicare coverage for these devices after already securing FDA approval.
The new Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway was developed to help Medicare patients—and the clinicians who treat them on a daily basis—gain access to medical devices that have previously received the FDA’s breakthrough device designation. When those devices receive FDA approval, it will now trigger a 30-day public comment period before any final decisions about Medicare coverage are made.
According to the agencies, the RAPID pathway will help CMS release National Coverage Determinations for breakthrough devices in a matter of months as opposed to the year-plus it currently takes for those policies to be finalized.
“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,” CMS Administrator Mehmet Oz, MD, said in a statement. “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,” added FDA Commissioner Marty Makary, MD, MPH. “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.”
New pathway brings added value to FDA's Breakthrough Devices Program
The FDA’s Breakthrough Devices Program is reserved for medical devices that meet an unmet need. The program helps these devices make it through the approval process faster than they would otherwise by creating an open line of communication between the FDA and the device manufacturer. In addition, any future regulatory submissions for devices that receive this designation are prioritized instead of going to the back of the line.
When devices that have previously received the FDA’s breakthrough device designation go on to gain a full approval, they have always had to secure Medicare coverage like any other device. Now, however, this new pathway significantly speeds up that process.
Cardiology has the most devices in the Breakthrough Devices Program out of all the medical specialities, with close to 250 devices.
Industry stakeholders have argued for years that there is too much red tape involved with securing these various approvals and coverages. This proposal certainly suggests the Trump administration agrees.
A full proposed procedural notice is expected to be published in the Federal Register in the days ahead. The public will then have 60 days to provide comments.
CMS did emphasize that this new pathway only applies to “certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare.” Click here for additional information.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.