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The Centers for Medicare & Medicaid Services has introduced a new coverage pathway for Medicare beneficiaries to get expedited coverage for breakthrough medical devices.
On Thursday, CMS and the Food and Drug Administration released the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway to accelerate patient access to what the agencies called life-changing medical devices.
The RAPID coverage pathway allows CMS and the FDA to work together, with innovators, early during technology development so that evidence generated for FDA review can also support Medicare coverage decisions.
Aligning regulatory and coverage expectations in advance should reduce delays that historically occur between FDA market authorization and Medicare national coverage determinations, CMS said. CMS experts will have an early understanding of what clinical outcomes are most relevant for Medicare beneficiaries.
The expedited pathway is for FDA-designated Class II and Class III Breakthrough Devices. It is available for certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program (TAP) and Class III devices regardless of whether they are participating in TAP.
To be eligible, devices must be the subject of an Investigational Device Exemption (IDE) study that enrolls Medicare beneficiaries and studies clinical health outcomes agreed upon by the FDA and CMS.
The RAPID coverage pathway establishes a predictable timeline and process that can expedite Medicare coverage for eligible Class II and Class III Breakthrough Devices by better synchronizing FDA market authorization with CMS' National Coverage Determination (NCD) process.
Under the RAPID coverage pathway, CMS would issue a proposed NCD the same day an eligible device participating in this pathway receives FDA market authorization, triggering the statutorily required 30-day public comment period.
Payment could be made as soon as two months after market authorization, compared to approximately a year or more under the current pathway.
"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," said CMS Administrator Dr. Mehmet Oz. "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 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," said FDA Commissioner Dr. Marty Makary.
Email the writer: SMorse@himss.org