Ensuring Continued Access to Breakthrough Devices through Evidence Generation

Medicare coverage determination processes involve reviewing the clinical evidence available on the health outcomes of Medicare beneficiaries. This applies to all technologies including FDA-designated breakthrough devices. A recent attempt to implement a new coverage pathway, known as Medicare Coverage for Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” (CMS-3372-P), would have streamlined Medicare’s coverage, coding, and reimbursement processes for breakthrough devices by providing immediate national Medicare coverage for a period of four years post-FDA approval. Under the framework for this pathway, once the MCIT period concludes, Medicare can decide whether to continue coverage permanently, or even potentially to non-cover the device. However, the future of this new pathway is unclear. On September 13, 2021, CMS proposed to repeal the rule. There are also attempts to establish a coverage pathway with similar intents through the 21st Century Cures Act, released on June 22, 2021. These are ongoing policy discussions; however, they underscore the need to develop real world evidence for breakthrough devices that address the needs of Medicare beneficiaries. For new technologies, including breakthrough devices, manufacturers are responsible for generating evidence to satisfy Medicare’s coverage criteria. Providers already face many data collection requirements to satisfy quality and performance metrics under other quality and payment frameworks. Data requirements for regulatory and coverage decisions is also oftentimes siloed between stakeholders, resulting in duplicative efforts for providers. Further, data collection is costly, particularly if the onus is on one stakeholder to set up. In this session, panelists will discuss opportunities to encourage additional data collection, consider how to align data collection that can inform both regulatory and coverage decisions, and strategize how costs to support data collection could be shared across stakeholders.