U.S. Sen. Todd Young (R-IN) on Nov. 20 led a bipartisan bill that would enable millions of older Americans to receive faster access to breakthrough medical devices under the Medicare program.
“Bureaucratic red tape is preventing millions of seniors in America from accessing medical advancements that have the potential to reduce health care costs, cure diseases, and save lives,” Sen. Young said. “Our bipartisan bill would streamline Medicare coverage of these advancements to better ensure patients receive timely access to breakthrough technologies.”
Currently, senior citizens wait an estimated 5.7 years from when the Food and Drug Administration (FDA) authorizes a breakthrough technology until Medicare covers the technology, according to a bill summary provided by Sen. Young’s staff.
If enacted, the Ensuring Patient Access to Critical Breakthrough Products Act of 2024, S. 5349, which Sen. Young sponsored alongside lead cosponsor U.S. Sen. Alex Padilla (D-CA), would create a faster pathway for the Centers for Medicare & Medicaid Services (CMS) to provide transitional coverage for certain new and emerging medical device innovations to Medicare beneficiaries, the summary says.
“Timely access to lifesaving breakthrough medical advancements is essential to protect millions of patients in need,” said Sen. Padilla. “This critical bipartisan legislation would ensure Medicare covers cutting-edge devices shortly after FDA authorization to better diagnose, prevent, and treat life-threatening illnesses.”
Specifically, S. 5349 would provide temporary Medicare coverage for medical devices and diagnostic tests approved or cleared under the FDA Breakthrough Devices Program, according to the summary.
Additionally, the bill would allow technology developers to work with CMS during the temporary coverage period on a proposal for permanent Medicare coverage, and grant CMS permission to immediately suspend or terminate Medicare coverage if subsequent clinical evidence demonstrates the technology causes harm or provides no clinical benefit to Medicare beneficiaries, the summary says.
The bill has been referred for consideration to the U.S. Senate Finance Committee.