I will keep pushing until patients in Indiana and across the country can get the care they need without unnecessary delays.
Keep pushing to improve Medicare coverage and access to FDA-designated breakthrough medical devices for seniors in Indiana and across the country.
Occurrences
Evidence
Congressman Rudy Yakym led a bipartisan letter with Reps. Blake Moore, Suzan K. DelBene, Terri Sewell, Lori Trahan and Gus Bilirakis urging HHS Secretary Kennedy and CMS Administrator Mehmet Oz to take action on improving Medicare coverage for FDA-designated breakthrough medical devices. The release says the letter was signed by 82 Members of Congress and that Yakym will keep pushing until patients in Indiana and across the country can get the care they need without unnecessary delays.
CMS and FDA announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, described as a new pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare. CMS said the pathway will link manufacturers to CMS experts early in development to understand outcomes relevant for Medicare beneficiaries.
Assessments
Yakym made a concrete federal effort within his current House term by leading a bipartisan 82-member letter urging HHS and CMS to improve Medicare coverage and access for FDA-designated breakthrough medical devices. CMS and FDA then announced the RAPID coverage pathway, which directly advances the promised access goal, but the record does not establish that Yakym caused the agency action or that Medicare coverage/access has been fully improved for seniors. This supports partial fulfillment with clear effort, not full delivery.