California Life Sciences Responds to RAPID Coverage Pathway Announcement

SOUTH SAN FRANCISCO, Calif., April 23, 2026 — California Life Sciences (CLS), which represents more than 1,300 pharmaceutical, biotechnology, medical technology, and academic research institutions, responded today to the announcement of the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new initiative from the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) designed to accelerate Medicare coverage of FDA-authorized Breakthrough Devices.

Mike Guerra, President and CEO of California Life Sciences, issued the following statement:

“We appreciate CMS and FDA taking steps to address the long-standing gap between FDA authorization and Medicare coverage for breakthrough medical devices—a delay that often leaves patients without access to technologies their doctors have determined they need. The RAPID pathway shows promise, but implementation must include clear timelines and meaningful accountability to make a meaningful difference in the lives of patients. California is home to many of the companies developing breakthrough technologies, and we are committed to working with CMS and FDA process to ensure this pathway delivers real, timely access for Medicare beneficiaries—not just on paper, but in practice,” said Mike Guerra, President and CEO of California Life Sciences.

CLS will actively engage in the forthcoming public comment period and continue working with policymakers to ensure patients can access the breakthrough technologies they need without delay.

###