Medicare and FDA propose granting rapid coverage for breakthrough radiology devices

Medicare and the U.S. Food and Drug Administration are proposing granting faster coverage for breakthrough devices in radiology and other specialties. 

The two agencies on Thursday announced the rollout of the Regulatory Alignment for Predictable and Immediate Device, or RAPID, coverage pathway. It’s designed to help expedite Medicare beneficiaries’ access to certain Class 2 and Class 3 Breakthrough devices. 

Experts note there is often a lag—at a median of nearly six years—between the FDA authorizing new devices and Medicare granting payment coverage. The new RAPID pathway aims to allow the two agencies to work together earlier in product life cycles, generating evidence to more rapidly support decisions. 

“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, MBA, said in a statement April 23. “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.”

With the new pathway, Medicare will now be part of earlier and more frequent engagement between the FDA and device makers. Authorities said the program change will link manufacturers with Medicare experts to help understand what clinical outcomes are most relevant to beneficiaries. This new coordinated approach will allow agencies to rely on early evidence to help inform premarket review and coverage decisions.

The RAPID program will establish predictable timelines for expediting Medicare coverage, authorities note. Under it, CMS will issue a proposed coverage decision the same day an eligible device earns market authorization. This will trigger a 30-day comment period. Streamlining the process, regulators hope, will enable more predictable coverage decisions and payments as soon as two months after authorization. This compares to about a year or more under the current pathway, Medicare estimated.

“The American people deserve timely access to meaningful treatments without red tape or high costs," FDA Commissioner Marty Makary, MD, MPH, said in the announcement. "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.” 

As part of the process, the administration is pausing the Transitional Coverage for Emerging Technologies (TCET) Pathway for new candidates. This will allow Medicare to focus on successful implementation of RAPID. CMS said it plans to apply lessons learned from other coverage pathways to help strengthen its processes over time.

AdvaMed, a trade group that represents device manufacturers, commented on the new program Thursday. 

“Today’s announcement is a positive step toward expanding Medicare beneficiaries’ access to the FDA-authorized, safe, and effective breakthrough medtech they desperately need,” President and CEO Scott Whitaker said in a statement. “As Dr. Oz and Dr. Makary have said publicly, more can and must be done for these patients who lack options and are suffering.”

“While we appreciate this first step toward improving coverage, it is critical that the implementation of such a proposal is effective,” he added. “Without meaningful timelines, accountability, and effective management of this program, patients are unlikely to see the full benefits of new technologies.”