Coverage and Evidence Roundtables: Tricuspid Valve Interventions

Executive Summary

The Duke-Margolis Institute for Health Policy (Duke-Margolis) and the Heart Valve Collaboratory (HVC) jointly facilitated a Roundtable Series that demonstrates the value and opportunity of multistakeholder engagement to inform post-market evidence generation strategies to support coverage, patient access, and technology uptake. In particular, this Roundtable Series facilitated discussions of the coverage and evidence needs of emerging tricuspid valve intervention (TVI) devices and procedures. Stakeholders identified evidentiary gaps and outcome measures that would likely drive post-market data collection requirements to support Medicare coverage. Stakeholders also identified opportunities to improve data collection strategies, including using innovative real-world data collection methods to address challenges with provider burden, data quality, and completion. Finally, the series underscored the need to clarify expectations from payers and other key stakeholders to drive alignment on post-market evidence generation strategies. 

Patient access to novel technologies involves a series of major policy decisions, including regulatory approval payer coverage determinations, and physician adoption. In some cases, evidentiary gaps at the time of regulatory approval may lead to delays in coverage, as well as patient and provider adoption. The Centers for Medicare & Medicaid Services (CMS) issues Medicare coverage for products and services for which sufficient evidence exists to support “reasonable and necessary” use for Medicare beneficiaries. Current CMS initiatives to improve Medicare coverage processes for novel technologies aim to minimize the time between regulatory approval and Medicare coverage, and establish a timely, transparent, and predictable process with early, multistakeholder engagement to identify post-market evidence needs to support sustained patient access and better outcomes. Recent policy developments support these efforts, such as through the proposed Transitional Coverage for Emerging Technologies (TCET) Medicare coverage pathway and proposed guidance documents: updated Coverage with Evidence Development (CED)) guidance, guidance on National Coverage Analysis Evidence Reviews, and Clinical Endpoints Guidance: Knee Osteoarthritis.

The Roundtable series illustrates how early, multistakeholder engagement can help inform CMS and private-sector action to identify and advance the development for Medicare coverage and effective technology uptake in areas of innovation that may benefit from shared actions to address common challenges, including not only greater clarity about evidence needs and how to meet them efficiently, and steps to improve the infrastructure for developing such evidence in a way that makes post-market evidence development less costly, faster, and more relevant to stakeholder needs.  This report describes the processes and outputs of early engagement to support coverage for TVI procedures, which can be applied to other novel technologies that may require post-market evidence. generation to support Medicare coverage and sustained patient access.