Medical groups press CMS for faster Medicare access to breakthrough technology

A coalition of health care and medical technology organizations is urging federal officials to create a streamlined pathway that would give Medicare patients faster access to breakthrough medical devices and diagnostics.

In a letter to Mehmet Oz, MD, administrator for the Centers for Medicare & Medicaid Services, the groups called on the agency to align more closely with the Food and Drug Administration to reduce delays in coverage for innovative technologies. They argued that unnecessary regulatory hurdles prevent seniors from benefiting from treatments that could improve or save lives.

“Patients should not be forced to wait the better part of a decade for access to safe and effective medical technology,” the groups wrote, citing a recent study that found it can take nearly six years between FDA authorization of a new technology and Medicare coverage.

The organizations highlighted the impact of medical technology in recent decades, noting that advances have shortened hospital stays, reduced deaths from breast cancer by 43%, and cut fatalities from heart disease and stroke by nearly half. Devices and diagnostics have also enabled earlier detection of conditions such as Alzheimer’s and Parkinson’s disease.

While CMS has programs such as the Transitional Coverage of Emerging Technologies initiative, the groups said those efforts fall short of delivering consistent, timely access to innovations. They urged the agency to consider adopting a framework modeled after the Medicare Coverage of Innovative Technology program, which was introduced under a prior administration but later repealed.

Such a policy, they argued, would provide automatic coverage for FDA-cleared breakthrough technologies and a clear timeline for CMS to gather additional evidence needed for permanent coverage decisions. Legislative proposals such as the Ensuring Patient Access to Critical Breakthrough Products Act have also sought to enshrine this approach.

The letter praised Oz for exploring options to improve the pathway but urged the agency to “take bold action” to ensure Medicare beneficiaries are not left behind as new treatments become available.

“This administration has a significant opportunity to course correct and make meaningful progress on improving American health,” the groups wrote.

The full letter and list of signatories is available here.