CMS Seeks Comment on Faster Approval Process for Breakthrough Medical Devices

On August 7, the Centers for Medicare and Medicaid Services (CMS) issued a proposed procedural notice outlining a process to align CMS and the Food and Drug Administration’s (FDA) evidence requirements, with the goal of establishing a more expedited pathway for manufacturers to obtain coverage for new devices. The announcement initiates a 60-day comment period.

• The Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway would align CMS and FDA evidence requirements in advance to shorten the time for the FDA to issue market authorization and for Medicare to issue a national coverage determination (NCD). This means a proposed NCD could be issued the same day as the FDA market authorization. CMS and the FDA first announced the new RAPID Medicare coverage pathway in April via a joint press release.

• The RAPID coverage pathway applies to FDA-designated Breakthrough Devices that address unmet medical needs for Medicare beneficiaries. Eligible products include all Class III devices and certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program (TAP). The Breakthrough Devices Program was established by Congress in the 21st Century Cures Act of 2016. The program is designed to accelerate the development, assessment, and review of novel devices with the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

• The agency has outlined a process in which CMS and the FDA would continue to use their existing processes but would closely engage and coordinate. The FDA would use the proposed Investigational Device Exemption (IDE) studies conducted by the manufacturer to assess clinical outcomes. CMS would review the IDE plan before the study launches, and the FDA would share the final IDE report and other information with CMS to inform the NCD process. It is expected that the device would receive FDA market authorization on the same day that CMS posts a proposed NCD.

• There will be a 30-day public comment period for the proposed NCD. Under the proposed plan, CMS would issue the final NCD approximately days after FDA market authorization for Class II devices and 90 days for Class III devices.

CMS Sunsets Supplemental Payments for Breakthrough Devices

While the agency is issuing a notice and seeking comments on a faster approval process for breakthrough devices, it is raising the bar for these devices to receive supplemental payments. To qualify for a Medicare New Technology Add-on Payment (NTAP), an applicant must satisfy three core statutory and regulatory criteria: newness, cost, and substantial clinical improvement. Currently, FDA Breakthrough Devices can qualify for NTAP without demonstrating substantial clinical improvement, provided they meet the standard cost and newness criteria.

In recently issued payment rules, CMS is phasing out the alternative pathway for new technology add-on payments for breakthrough devices in 2028. Moving forward, breakthrough devices will need to meet the traditional criteria of being new, costly, and demonstrating substantial clinical improvement over existing options. Stakeholders have raised concerns that this could reduce access to breakthrough devices.

For more information and questions, please contact:

Sheila Madhani

Madhani Healthcare Consulting

Email: smadhani@madhani-health.com

Tel: (202) 679-2977