FDA, CMS propose new parallel review pathway for breakthrough devices

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel review program to expedite certain Class II and Class III breakthrough medical devices to market for Medicare patients called the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway.

On 23 April, FDA announced that breakthrough devices for unmet medical needs to treat Medicare patients may be eligible for the proposed RAPID pathway. The program will be available for Class III devices, as well as Class II devices participating in the Total Product Life Cycle Advisory Program (TAP), which was initiated as a pilot program under the Medical Device User Fee Amendments (MDUFA V). The agency said that products that go through the RAPID coverage pathway will also have to be part of an investigational device exemption (IDE) study that enrolls Medicare beneficiaries and studies clinical health outcomes determined by FDA and CMS.

"Through the RAPID coverage pathway, CMS will now be a part of the early and frequent engagement between the FDA and device innovators," said FDA in a statement. "The coverage pathway will link manufacturers to CMS experts early in development to understand what clinical outcomes are most relevant for Medicare beneficiaries.

"This coordinated approach allows CMS and the FDA to rely on premarket evidence to inform both the FDA premarket review and Medicare coverage processes," the agency added. "Aligning evidence expectations earlier reduces duplication, improves efficiency, and provides increased transparency to innovators."

FDA said the new pathway would allow for a more predictable timeline for the breakthrough products and more predictability in the regulatory and coverage process by better synchronizing the FDA's review process with CMS’s National Coverage Determination (NCD) process. The agency said products that go through the RAPID program would receive a proposed NCD the same day they receive FDA marketing authorization, triggering the statutorily required 30-day public comment period.

"This streamlined approach could enable predictable Medicare national coverage and payment as soon as two months after market authorization, compared to approximately a year or more under the current pathway, helping Medicare beneficiaries access new technologies sooner while increasing transparency, predictability, and cost savings for innovators and clinicians," said FDA.

FDA said CMS would soon publish the proposed RAPID coverage pathway in the Federal Register, after which stakeholders will have 60 days to comment on it. CMS will ultimately respond to the comments in a final notice, after which the new pathway is expected to go into effect immediately.

The industry group AdvaMed said that it has long pressed the federal government for faster Medicare coverage for FDA-authorized breakthrough products and added that the proposed RAPID pathway was a positive step.

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

“We also remain concerned about CMS’s recent proposal to repeal the New Technology Add-on Payments (NTAP) to hospitals that cannot afford to offer patients procedures involving FDA-authorized breakthrough medtech without these already-modest, temporary payments," he added. "We will continue to work closely with CMS to shore up the NTAP program and its critical role in serving Medicare beneficiaries."

Mark Leahey, CEO of the Medical Device Manufacturers Association (MDMA), was also optimistic about the new pathway.

“The RAPID coverage pathway holds significant promise to alleviate the problem of delayed access for Medicare beneficiaries to the newest medical devices and diagnostic tests, and to strengthen the United States’ position as the global leader in medical technology," he said.

Both groups said they look forward to working with FDA and CMS on the issue.

The proposed RAPID coverage pathway is reminiscent of the FDA’s Parallel Review Program, which began as a pilot in 2011 and was fully implemented in 2016. The program created a pathway that allowed FDA and CMS to simultaneously review pivotal clinical data and decrease the time between FDA's approval of a premarket application and the subsequent CMS national coverage determination (NCD).

FDA states on its website that as of December 2024, it has received 97 requests to participate in the Parallel Review Program, and only two devices have completed the program.

FDA announcement

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel review program to expedite certain Class II and Class III breakthrough medical devices to market for Medicare patients called the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway.

On 23 April, FDA announced that breakthrough devices for unmet medical needs to treat Medicare patients may be eligible for the proposed RAPID pathway. The program will be available for Class III devices, as well as Class II devices participating in the Total Product Life Cycle Advisory Program (TAP), which was initiated as a pilot program under the Medical Device User Fee Amendments (MDUFA V). The agency said that products that go through the RAPID coverage pathway will also have to be part of an investigational device exemption (IDE) study that enrolls Medicare beneficiaries and studies clinical health outcomes determined by FDA and CMS.

"Through the RAPID coverage pathway, CMS will now be a part of the early and frequent engagement between the FDA and device innovators," said FDA in a statement. "The coverage pathway will link manufacturers to CMS experts early in development to understand what clinical outcomes are most relevant for Medicare beneficiaries.

"This coordinated approach allows CMS and the FDA to rely on premarket evidence to inform both the FDA premarket review and Medicare coverage processes," the agency added. "Aligning evidence expectations earlier reduces duplication, improves efficiency, and provides increased transparency to innovators."

FDA said the new pathway would allow for a more predictable timeline for the breakthrough products and more predictability in the regulatory and coverage process by better synchronizing the FDA's review process with CMS’s National Coverage Determination (NCD) process. The agency said products that go through the RAPID program would receive a proposed NCD the same day they receive FDA marketing authorization, triggering the statutorily required 30-day public comment period.

"This streamlined approach could enable predictable Medicare national coverage and payment as soon as two months after market authorization, compared to approximately a year or more under the current pathway, helping Medicare beneficiaries access new technologies sooner while increasing transparency, predictability, and cost savings for innovators and clinicians," said FDA.

FDA said CMS would soon publish the proposed RAPID coverage pathway in the Federal Register, after which stakeholders will have 60 days to comment on it. CMS will ultimately respond to the comments in a final notice, after which the new pathway is expected to go into effect immediately.

The industry group AdvaMed said that it has long pressed the federal government for faster Medicare coverage for FDA-authorized breakthrough products and added that the proposed RAPID pathway was a positive step.

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

“We also remain concerned about CMS’s recent proposal to repeal the New Technology Add-on Payments (NTAP) to hospitals that cannot afford to offer patients procedures involving FDA-authorized breakthrough medtech without these already-modest, temporary payments," he added. "We will continue to work closely with CMS to shore up the NTAP program and its critical role in serving Medicare beneficiaries."

Mark Leahey, CEO of the Medical Device Manufacturers Association (MDMA), was also optimistic about the new pathway.

“The RAPID coverage pathway holds significant promise to alleviate the problem of delayed access for Medicare beneficiaries to the newest medical devices and diagnostic tests, and to strengthen the United States’ position as the global leader in medical technology," he said.

Both groups said they look forward to working with FDA and CMS on the issue.

The proposed RAPID coverage pathway is reminiscent of the FDA’s Parallel Review Program, which began as a pilot in 2011 and was fully implemented in 2016. The program created a pathway that allowed FDA and CMS to simultaneously review pivotal clinical data and decrease the time between FDA's approval of a premarket application and the subsequent CMS national coverage determination (NCD).

FDA states on its website that as of December 2024, it has received 97 requests to participate in the Parallel Review Program, and only two devices have completed the program.

FDA announcement