CMS accelerates Medicare coverage for breakthrough medical devices

A new Medicare coverage pathway will shorten the reimbursement timeline from a year or more to just two months for certain breakthrough medical devices.

CMS and FDA jointly announced on Thursday the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway for some Class II and Class III Breakthrough Devices.

FDA-designated breakthrough devices provide more effective treatments or diagnoses for life-threatening or irreversibly debilitating diseases, delivering significant advantages over existing alternatives. The voluntary program helps accelerate the development, assessment and review of medical devices, such as Alzheimer’s disease pathology assessment tests and AI-based cancer detection software.

Securing Medicare coverage is a significant challenge for innovative medical devices, contributing to the "valley of death" in which approved devices struggle to secure funding and commercialize. Many medtech companies end up waiting five to seven years for coverage.

The RAPID coverage pathway will reduce that time to as soon as two months and provide a more "predictable pathway for coverage," CMS stated.

Under this coverage pathway, CMS will issue a proposed national coverage determination on the same day an eligible device receives FDA market authorization, triggering a statutorily required 30-day public comment period.

"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, M.D., said in the announcement. "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."

The new coverage pathway will only apply to FDA Breakthrough Devices that address unmet medical needs among Medicare beneficiaries. It will be available for these Class II devices participating in the FDA Total Product Life Cycle Advisory Program (TAP) and Class III devices, regardless of TAP participation.

Eligible devices will also have to undergo an investigational device exemption study that enrolls Medicare beneficiaries and studies clinical health outcomes set by the FDA and CMS.

While both agencies ramp up the RAPID coverage pathway, they will pause the Transitional Coverage for Emerging Technologies Pathway for new candidates.

The agencies will set an effective date for the new pathway after publishing the final notice following a 60-day comment period.

Jacqueline LaPointe is a graduate of Brandeis University and King's College London. She has been writing about healthcare finance and revenue cycle management since 2016.