AdvaMed® Asks CMS to Give Seniors Access to Life-Saving Medical Breakthroughs through MCIT Rule

Millions of patients’ lives are improved every day because of advancements in medical technology. But too often, gaps in coverage and access prevent patients from benefiting from the safe, effective, and innovative technologies that can help detect disease earlier, improve treatment, and support better outcomes. 

That is why AdvaMed’s 2026 Patients First Agenda focuses on supporting policies that put patients at the center of health care. Across the country, AdvaMed works alongside patient advocacy group partners to help address gaps in access and coverage for critical medical technologies and bring innovative care to patients and families when they need it most.

Early Alzheimer’s blood tests are improving diagnosis, but access depends on policy. Learn how expanded Medicare coverage is changing patient outcomes.

The United States faces a maternal health crisis demanding urgent action. The U.S. has the worst maternal outcomes among high income nations. Our maternal mortality rates far exceed peer countries’, despite the highest per capita health care spending. Protecting mothers and improving birth outcomes provides an important opportunity for bipartisan priority leadership.

WASHINGTON—AdvaMed, the Medtech Association, the largest trade association representing medtech innovators, has long pressed for faster Medicare consideration of covering treatments using FDA-authorized breakthrough medtech. President and CEO Scott Whitaker made the following comment on a new initiative from FDA Commissioner Makary and CMS Administrator Oz on greater collaboration between the agencies to close the long gap — a median of nearly six years — between FDA authorization of breakthrough medtech and Medicare coverage. The new Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway would “expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare,” according to FDA.

AdvaMed’s® Comment Letter to ASTP/ONC, outlines concrete policy reforms across FDA oversight, CMS payment pathways, and HIPAA data-sharing rules to accelerate patient access to AI-enabled medical technologies. As AI-enabled medical devices transform patient care, outdated regulatory, coverage, and privacy frameworks are slowing the pace of adoption.

The 2026AdvaMed® Payment Policy Forum takes place May 28–29 in Washington, D.C. at Hogan Lovells Office. Registration is now open, and as always,AdvaMed® members receive preferred pricing.

WASHINGTON—AdvaMed, the MedTech Association®, today announced Melissa Torres is the new Executive Vice President of Technology and Regulatory Affairs. Torres succeeds Janet Trunzo, who retired after 30 distinguished, productive years withAdvaMed®. 

In a new video developed in partnership with Patients Rising, AdvaMed’s Peter Weems, Vice President of Imaging Government Affairs and Policy Strategy, explains why the Health Tech Investment Act is critical to expanding patient access to FDA-authorized AI-enabled medical devices.