U.S. House Committee approves landmark medical technology legislation, with our site advocating for the inclusion of diagnostic test integration.
The MedTech Association has announced that Mike Mussallem, former chairman and CEO of Edwards Lifesciences, will receive the 2025 Lifetime Achievement Award at The MedTech Conference in San Diego. This recognition comes amidst a significant push for legislation that aims to provide Medicare coverage for FDA-designated and authorized breakthrough medtech.
The Ensuring Patient Access to Critical Breakthrough Products Act, recently passed by the U.S. House of Representatives Committee on Ways and Means, is one such legislation. It aims to ensure quicker access to safe and effective technologies for Medicare beneficiaries. The bill provides four years of coverage for designated devices authorized by the FDA under the Breakthrough Devices Program.
Scott Whitaker, president and CEO of the MedTech Association, has expressed support for this bill, as well as the bipartisan Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act. The RESULTS Act, introduced in both the U.S. House of Representatives and Senate, seeks to modernize laboratory testing services and improve Medicare reimbursement.
The diagnostics programming at The MedTech Conference 2025 is highlighted as an inflection point for IVD leaders due to regulatory modernization, reimbursement reform, and breakthrough technologies. Bobby Patrick, SVP of Government & State Affairs and Alliance Development at the MedTech Association, emphasized the importance of The MedTech Conference as a platform for building alliances that redefine healthcare.
In addition to these legislative efforts, the MedTech Association has also welcomed CMS' Rural Health Transformation Program, which aims to improve health outcomes for rural Americans by giving states access to the latest health care technologies. The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection (MCED) Screening Act (H.R. 842) has also been passed by the Ways and Means Committee, aiming to improve access to new, innovative cancer screenings among Medicare beneficiaries.
The MedTech Conference will also feature a town hall with FDA Center for Devices and Radiological Health (CDRH) Director Michelle Tarver and other CDRH senior leaders. This event provides an opportunity for industry leaders and regulators to discuss the future of medical technology and its impact on healthcare.
The MedTech Association has asked the US District Court for the District of Massachusetts to rule that independent sales agent (ISA) arrangements do not violate the Anti-Kickback Statute (AKS) in the Langer v Zimmer Biomet case. This ruling could have significant implications for the medtech industry.
In a separate development, the MedTech Association has also welcomed the CMS' efforts to modernize laboratory testing services and improve Medicare reimbursement. This includes the creation of a roadmap for additional evidence collection for the Centers for Medicare and Medicaid Services (CMS) to make a permanent coverage decision after the four-year period outlined in the Ensuring Patient Access to Critical Breakthrough Products Act.
As the MedTech Conference approaches, the medtech industry eagerly awaits these developments and the potential impact they could have on healthcare in the United States.
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