Medicare reimbursement delays for medical devices, which previously averaged five years, are set to shrink to two months under a new federal program. The initiative, announced by the FDA, aims to cut wait times for coverage of innovations like heart valve replacement devices and nerve-stimulating implants. This shift aligns with the Trump administration’s push to reduce healthcare costs ahead of the November elections. Medtronic and Johnson & Johnson, two major device makers, stand to benefit from faster access to the $1tn annual Medicare market, which covers 66 million Americans. Critics argue delays force patients to bear out-of-pocket costs, while industry advocates stress the economic and societal value of timely access to advanced treatments.

The program’s rollout reflects a rare bipartisan consensus. Democrats and Republicans have separately introduced bills to expedite device approvals, with filings showing Medtronic and J&J actively lobbying for such reforms. Professors like Marty Makary, FDA commissioner, defended the move as a correction of past “red tape,” though his agency faced backlash earlier this year for delaying approvals of rare disease drugs and a Moderna flu vaccine. The FDA’s dual role in safety and coverage decisions has sparked debates about regulatory efficiency.

$33.5bn in annual revenue for Medtronic and $33.8bn for J&J in medtech sales underscore the stakes. Experts note that faster reimbursement could spur innovation, as companies like these prioritize devices with quicker market uptake. However, the FDA’s credibility remains tied to its ability to balance speed with rigorous safety checks—a tension highlighted by recent controversies.

Why this matters: The US healthcare system’s reliance on outdated treatments costs billions in avoidable expenses. By aligning Medicare’s device coverage timelines with FDA approvals, policymakers aim to modernize a fragmented system. As one analyst put it, “If software took a decade to market, we’d still be using AOL.” The move signals a pivotal shift in how America funds medical progress—with implications for patients, innovators, and the economy.