New Initiative for Faster Medicare Coverage of Innovative Devices

The Centers for Medicare and Medicaid Services (CMS) have announced a new initiative to expedite Medicare beneficiaries' access to groundbreaking medical technologies. In collaboration with the Food and Drug Administration (FDA), the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway aims to simplify the introduction of innovative medical devices.

This collaborative approach allows CMS and the FDA to engage early in technology development, ensuring that FDA review data can inform Medicare coverage decisions. By aligning regulatory and coverage expectations, the agencies seek to reduce delays often occurring between FDA approval and Medicare coverage determinations.

The RAPID coverage pathway specifically targets FDA-designated Class II and Class III Breakthrough Devices. Class II device eligibility is limited to those participating in the FDA Total Product Life Cycle Advisory Program (TAP), while Class III devices are eligible regardless of TAP involvement. These devices must also be part of an Investigational Device Exemption (IDE) study involving Medicare beneficiaries, focusing on clinical health outcomes agreed upon by the FDA and CMS.

By aligning FDA market authorization with CMS’ National Coverage Determination (NCD) process, this initiative establishes a defined timeline for expediting Medicare coverage of eligible devices. Under this pathway, CMS plans to issue a proposed NCD the same day a device achieves FDA market approval, initiating a 30-day public comment period as required by statute. This process could enable payments to begin two months post-market authorization, significantly reducing wait times that can extend beyond a year.

Dr. Mehmet Oz, CMS Administrator, highlighted the significance of the collaboration, stating, “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. 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.”

FDA Commissioner Dr. Marty Makary added, “The American people deserve timely access to meaningful treatments without red tape or high costs. 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.”