United States House Committee approves landmark medical technology legislation, encouraging incorporation of diagnostic tests in the bill.
The U.S. Congress has been actively pursuing legislation aimed at ensuring quicker access to safe and effective medical technologies for beneficiaries. One such bill, the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act, has been introduced in both the House of Representatives and the Senate.
This bill, if passed, would create a roadmap for additional evidence collection for the Centers for Medicare and Medicaid Services (CMS) to make a permanent coverage decision after a specified period. Notably, the legislation is called the Ensuring Patient Access to Critical Breakthrough Products Act, H.R. 5343.
Another significant development is the U.S. House of Representatives Committee on Ways and Means' passage of legislation providing Medicare coverage for FDA-designated and authorized breakthrough medtech. This move is a long-sought victory for the medtech association, which has consistently advocated for Medicare coverage of FDA-authorized breakthrough medtech.
In addition to these, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection (MCED) Screening Act (H.R. 842) has been passed by the Ways and Means Committee. This bill aims to improve access to new, innovative cancer screenings among Medicare beneficiaries.
The medtech association has also expressed concern about the proposed Medicare Durable Medical Equipment Competitive Bidding Rule, citing potential issues with patient safety, fewer treatment options, and increased costs. They have urged CMS to address these 'serious flaws' in the rule.
On a positive note, the medtech association has welcomed CMS' Rural Health Transformation Program, which gives states the chance to access the latest health care technologies that best suit their needs to improve health outcomes for rural Americans.
The medtech association's efforts extend beyond Congress. They have 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.
The medtech association's advocacy work is also evident in events like #MTC25, where Bobby Patrick, the SVP of Government & State Affairs and Alliance Development, has highlighted the event as a crucial platform to witness the power of coalitions in action.
Moreover, the medtech association's Dx has stated that this year's diagnostics programming at The MedTech Conference comes at an inflection point for IVD leaders. The conference will also feature a town hall with FDA Center for Devices and Radiological Health (CDRH) Director Michelle Tarver and fellow CDRH senior leaders.
Lastly, Mike Mussallem, former chairman and CEO of Edwards Lifesciences, will receive the 2025 Lifetime Achievement Award at The MedTech Conference, scheduled to take place in San Diego from Oct. 5-8.
These developments underscore the ongoing efforts to ensure access to innovative medical technologies and the role of the medtech association in advocating for these changes.
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