Padilla, Young Introduce Bipartisan Bill to Expedite Access to Innovative Medical Technologies
WASHINGTON, D.C. — U.S. Senators Alex Padilla (D-Calif.) and Todd Young (R-Ind.) 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.
“Timely access to lifesaving breakthrough medical advancements protects 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.”
“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 bill would streamline Medicare coverage of these advancements to better ensure patients receive timely access to breakthrough technologies,” said Senator Young.
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.
Senator Padilla has long been a leader in the fight to make health care more equitable, affordable, and accessible in the United States. Earlier this year, Padilla introduced the bipartisan Health Accelerating Consumers’ Care by Expediting Self-Scheduling (ACCESS) Act to improve digital health services by allowing patients to easily search for and book health care appointments online while protecting personal health information. Last year, Padilla, Senator Mazie Hirono (D-Hawaii), and Senator Cory Booker (D-N.J.) introduced the Health Equity and Accountability Act (HEAA) of 2024 to address health disparities among racial and ethnic minorities as well as women, the LGBTQ+ community, rural populations, and socioeconomically disadvantaged communities across the United States. Additionally, Padilla and Booker introduced the Equal Health Care for All Act, bicameral legislation that would make equal access to medical care a protected civil right to help address the racial inequities and structural failures in America’s health care system. He also recently joined Senator Bernie Sanders (I-Vt.) and over 100 lawmakers in reintroducing the Medicare for All Act, historic legislation that would guarantee health care as a fundamental human right to all people in the United States regardless of income or background.
Full text of the bill is available here.
###