CMS proposes faster Medicare coverage for breakthrough medical devices

Medicare coverage of some breakthrough medical devices would be accelerated under a Trump administration proposal released this month.

CMS published an Aug. 11 notice of proposed processes that would include issuing an initial national coverage determination (NCD) simultaneously with FDA authorization of an eligible device and finalizing Medicare coverage within three months of authorization. As is, nine to 12 months frequently elapse between authorization and completion of CMS’s coverage review, according to the notice.

As explained in a fact sheet, the Regulatory Alignment for Predictable and Immediate Coverage Device (RAPID) coordinated coverage pathway would apply to a narrow group of high-priority medical devices.

The new process would entail the involvement of CMS and the inclusion of Medicare beneficiaries in FDA’s investigational device exemption (IDE) clinical studies. Under current procedures, CMS typically does not evaluate whether Medicare coverage is appropriate until after FDA authorization.

Medicare-specific health outcomes would be established going into the IDE study, setting up FDA authorization and a proposed NCD in tandem. A final coverage determination then would take place within 60 or 90 days, depending on the device category. Coverage would remain contingent on the evidence and applicable Medicare standards.

In addition to lag time that can total a year or more, CMS says problems with current processes include inadequate representation of Medicare patients.

“To demonstrate the safety and effectiveness of a device as clearly as possible, studies may have exclusion criteria that disqualify individuals with characteristics that may make it harder to ascertain a device’s effects on populations with multiple comorbidities, such as Medicare beneficiaries,” the new notice states.

Comments on the proposed notice are due by Oct. 13 at regulations.gov.

Medical devices that would qualify for RAPID

Various criteria restrict which devices will be eligible for RAPID. For example, the device must be in one of the following FDA classifications:

• A Class II Breakthrough Device participating in FDA’s Total Product Life Cycle Advisory Program (TAP) and planning a de novo submission
• A Class III Breakthrough Device planning to submit a premarket approval application

Among other requirements, devices also must be at the IDE pre-submission stage and have separately payable status in Medicare.

The proposed notice explicitly excludes in vitro diagnostics (IVDs), as those coverage decisions are slated to remain under the purview of specialized Medicare administrative contractors.

How the RAPID Medicare coverage process would work

For devices meeting the criteria, the manufacturer could alert FDA that it wants to participate in RAPID. CMS would inform the manufacturer of Medicare-specific outcomes that need to be measured during the IDE study. A successful study would result in FDA authorization and a Medicare proposed NCD in tandem.

If evidence gaps emerge during the IDE study, the NCD could be issued under the Coverage with Evidence Development (CED) category, as applicable under current regulations. CED classification limits Medicare coverage to clinical trials or registries until sufficient evidence has been developed.

In the event of a CED designation, CMS says it would engage with FDA and the manufacturer before market authorization takes place, to ensure alignment between CED studies and any post-authorization studies required by FDA.

Devices in RAPID could receive priority clearance over other devices, per the proposed notice.

“Due to CMS’s commitment to issue proposed NCDs for devices in the RAPID coverage pathway on the same day as FDA market authorization, CMS proposes to prioritize the opening of RAPID NCDs over non-RAPID NCDs from the NCD Wait List if we are unable to address the total volume of NCDs within our available resources at any given time,” the proposed notice states.

RAPID would not change Medicare’s coverage standard

RAPID is intended to accelerate the coverage determination process but not to change the coverage standard for devices, CMS says in the notice. Medicare statutory requirements to deem a device reasonable and necessary would still apply.

The plan appears to be for RAPID to exist alongside, rather than replace, Parallel Review, a process that only two devices are listed as ever having completed.

In Parallel Review, FDA and CMS review the evidence concurrently but, unlike in RAPID, do not craft the evidence strategy together. There is no prescribed time frame for a final coverage decision along the lines of the 60- and 90-day windows in RAPID.

The newly published notice on RAPID announced the pause of the Transitional Coverage for Emerging Technologies (TCET), a Biden administration 2024 initiative to quickly establish CED classification for up to five breakthrough devices per year that have limited or developing evidence.

CMS says it instead wants to focus resources on implementing RAPID. The pause has taken effect immediately for future TCET candidates.

Manufacturers that already have begun the IDE process, thus rendering them ineligible for RAPID under the proposed notice, can explore other coverage mechanisms, including a traditional NCD application. The notice asks whether CMS should institute a temporary process allowing RAPID to accommodate certain devices that are already being studied in an IDE.