The new pathway aims to cut red tape and bring predictability to Medicare coverage for Breakthrough devices.
The Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. The initiative aims to expedite access to certain FDA-designated Class II and Class III Breakthrough devices for Medicare beneficiaries.
The RAPID pathway allows CMS and the FDA to work with innovators earlier in the technology development lifecycle. By aligning regulatory and coverage expectations in advance, the agencies intend to reduce delays that historically occur between FDA market authorization and Medicare national coverage determinations.
“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,” says Mehmet Oz, CMS administrator, in a release. “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.”
Early Evidence Alignment
Through the new pathway, CMS will engage with the FDA and device innovators early in the development process. This allows manufacturers to understand which clinical outcomes are most relevant for Medicare beneficiaries.
The RAPID pathway is available for certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program (TAP) and Class III devices, regardless of TAP participation. To be eligible, devices must be the subject of an Investigational Device Exemption study that enrolls Medicare beneficiaries and evaluates clinical health outcomes agreed upon by both the FDA and CMS.
“The American people deserve timely access to meaningful treatments without red tape or high costs,” says Marty Makary, FDA commissioner, in a release. “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.”
Predictable Coverage Timelines
The RAPID pathway synchronizes FDA market authorization with the CMS National Coverage Determination (NCD) process. Under this approach, CMS will issue a proposed NCD the same day an eligible device receives FDA market authorization.
This triggers a 30-day public comment period. The streamlined process could enable Medicare national coverage and payment within two months of market authorization, compared to the current average of a year or more. This shift is intended to increase transparency, predictability, and cost savings for innovators and clinicians.
Impact on Existing Pathways
CMS will continue to offer standard processes for national coverage determinations. However, the Transitional Coverage for Emerging Technologies (TCET) pathway will be paused for new candidates as the agency focuses on the implementation of the RAPID pathway. CMS plans to apply lessons learned from various coverage models to improve Medicare processes over time.
A proposed procedural notice for the RAPID pathway will be published in the Federal Register, followed by a 60-day public comment period. The pathway is expected to become effective upon the publication of a final notice in the Federal Register.
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