Medical Design Briefs - January 2025 - 2

DON'T
WORRY!
Bipartisan Legislation Could
Fast-Track Breakthrough Medical
Devices
T
he U.S. Senate's bipartisan legislation to expedite Medicare
coverage of FDA-breakthrough-designated medical technologies
and diagnostic tests could significantly impact the
medical device industry and manufacturers, streamlining processes
for breakthrough devices, enhancing patient access, and
reducing barriers to market entry.
The legislation, " Ensuring Patient Access to Critical Breakthrough
Products Act, " introduced by Sens. Todd Young (RIN)
and Alex Padilla (D-CA), is similar to H.R. 1691, which the
U.S. House of Representatives Ways and Means Committee
passed on a bipartisan basis in June.
The legislation is designed to ensure that Medicare proInterpower®
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Interpower North American and international
hospital-grade cords are manufactured beyond
UL, CSA, and VDE standards such as the
" tough " UL 817 Abrupt Removal Test (UL 817,
18.2.4.1) and C22.2 No. 21-14 requirements
for hospital-grade cords.
" We test more than the standards require, "
Interpower Product Development Manager
Ron Barnett said. " We do so because it lends
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®
vides immediate or expedited coverage for devices designated
as breakthrough by the FDA. This reduces delays in reimbursement
that often impede patient access after regulatory
approval. Moreover, faster coverage could benefit underserved
populations, ensuring equitable access to cuttingedge
technologies.
By coordinating FDA approval and CMS coverage timelines,
manufacturers could experience less lag between obtaining
regulatory clearance and achieving reimbursement approval. A
streamlined pathway would likely encourage innovation by reducing
financial and administrative risks for companies developing
high-impact devices.
Knowing that there is a defined, expedited path to coverage
for breakthrough devices might provide clarity and confidence
to investors and stakeholders in the development process. In
the global market, enhanced incentives for U.S.-based device
development could bolster the country's position as a leader in
medtech innovation.
Such legislation has further implications for providers as well
because it would enable them to integrate innovative devices
into clinical workflows more quickly, enhancing care delivery
and outcomes.
The specifics of Medicare coverage and how private insur®
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2
ers respond will determine the real-world impact of this legislation.
In a statement from AdvaMed, the medtech association
noted that CMS was slow to finalize an option for
Medicare coverage of the procedures enabled through
breakthrough devices, and that when CMS finally offered an
option, the proposal was lacking, excluding diagnostics and
providing for only a handful of devices to receive approval
each year.
By creating a more cohesive and efficient ecosystem for
breakthrough device approval and reimbursement, the legislation
stands to transform patient care while fostering growth
and innovation in the medical device industry.
Sherrie Trigg
Editor and Director of Medical Content
The full text of the legislation can be accessed at https://www.
young.senate.gov/wp-content/uploads/Ensuring-Patient- Access-toCritical-Breakthrough-Products-Act-2024.pdf.
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Medical
Design Briefs, January 2025

http://info.hotims.com/87800-727 https://www.young.senate.gov/wp-content/uploads/Ensuring-Patient-Access-to-Critical-Breakthrough-Products-Act-2024.pdf https://www.young.senate.gov/wp-content/uploads/Ensuring-Patient-Access-to-Critical-Breakthrough-Products-Act-2024.pdf http://www.medicaldesignbriefs.com

Medical Design Briefs - January 2025

Table of Contents for the Digital Edition of Medical Design Briefs - January 2025