ECRI advocates for evidence-based safeguards for proposed Medicare RAPID coverage pathway
ECRI submitted recommendations to the Centers for Medicare & Medicaid Services (CMS) regarding the proposed Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, which aims to reduce the gap between FDA authorization and Medicare coverage for Breakthrough Devices.
ECRI supports the pathway’s overall goal of accelerating access to Breakthrough Devices but emphasized that coverage decisions must remain grounded in evidence demonstrating meaningful clinical benefits and safety for Medicare beneficiaries. ECRI’s comments urge CMS and FDA to align evidence expectations while maintaining rigorous standards for coverage decisions.
Among its recommendations, ECRI called for requiring studies supporting RAPID eligibility adequately represent older adults and patients with comorbidities, mandating a defined post-market and active surveillance infrastructure, and incorporating human factors engineering into the evidence framework for Breakthrough Devices. ECRI also highlighted the importance of addressing healthcare accessibility and equity as part of the pathway's implementation.