FDA, CMS unveil rapid Medicare coverage pathway for critical medical devices
Federal healthcare agencies revealed a new program to speed up the timeline for when medical devices are eligible for Medicare coverage, cutting the timeline from years to months.
In an announcement, the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) revealed the new coverage pathway, which will expedite devices granted the Class II and Class III “Breakthrough” designation by the FDA.
Such devices are fast-tracked for clearance on the basis that they treat or diagnose life-threatening or debilitating conditions, making time a critical factor for intervention if a patient is to achieve optimal outcomes.
Prior to this change, announced Thursday, there was a significant delay, sometimes of a year or more, before cleared Breakthrough devices were eligible for Medicare coverage. Under this new Regulatory Alignment for Predictable and Immediate Device Pathway—or “RAPID”—developers that work with regulators could see their products receiving full reimbursement in as little as two months.
“Under this program, CMS will be able to provide coverage within 60 to 90 days of FDA approval across the Medicare population for new devices that offer promising therapies for individuals," CMS Deputy Administrator and Chief Policy and Regulatory Officer John Brooks said during a press conference.
"There's just going to be a lot more transparency for device manufacturers as they approach the FDA and CMS," he added, acknowledging that the previous process and erratic timelines were confusing to device manufacturers and providers alike.
New devices already in the RAPID pipeline
The FDA said it expects 40 devices in the Breakthrough program will be immediately eligible for rapid coverage approval. In the future, as a device is approved by the FDA, CMS will respond by making a national Medicare coverage decision immediately.
At that time, changes to new Medicare-eligible devices will be subject to a customary 30-day comment period from stakeholders, which includes providers and the broader public.
Once those hurdles are passed, clinicians could begin immediately implementing them into patient care plans, knowing they will be reimbursed by CMS.
“The American people deserve timely access to meaningful treatments without red tape or high costs," FDA Commissioner Marty Makary, MD, said in a statement. "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.”
Breakthrough devices could include numerous emerging technologies used to treat and diagnose cancers, heart failure, arrhythmias, and more.
The full announcement from the FDA and CMS is available by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.