Wednesday, U.S. Senators Todd Young (R-Ind.) and Alex Padilla (D-Calif.) introduced the Ensuring Patient Access to Critical Breakthrough Products Act, bipartisan legislation that would enable millions of older Americans to receive quicker access to life-changing medical innovations.
Currently, seniors wait an estimated 5.7 years from when the Food and Drug Administration (FDA) authorizes a breakthrough technology until Medicare covers the technology. The legislation 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.
“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. Our bipartisan bill would streamline Medicare coverage of these advancements to better ensure patients receive timely access to breakthrough technologies,” said Senator Young.
“Timely access to lifesaving breakthrough medical advancements is essential to protect millions of patients in need,” said Senator 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. I will keep working across the aisle to support health care innovation and expand access to care for rural and underserved communities.”
More specifically, the Ensuring Patient Access to Critical Breakthrough Products Act would:
- Provide temporary Medicare coverage for medical devices and diagnostic tests approved or cleared under the FDA Breakthrough Devices Program.
- Allow technology developers to work with CMS during the temporary coverage period on a proposal for permanent Medicare coverage.
- 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 legislation builds on Senator Young’s continued efforts to improve access for Americans to innovative medical breakthroughs, including a letter he led to CMS earlier this year.
Full text of the legislation can be found here.
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