“Generative AI-enabled medical devices are poised to reshape the health technology landscape, and the FDA has an important responsibility to provide thoughtful leadership for this new era,” says radiologist Rick Abramson, MD. 

The federal payment program for seniors recently released a new fact sheet with details about its Regulatory Alignment for Predictable and Immediate Device, or RAPID, coverage pathway. 

The proposed changes are intended to help providers more accurately estimate the timing, circumstances and risks associated with patient release following treatment. 

Reps. John Joyce, MD, R-Pa., and Mike Thompson, D-Calif., recently reintroduced the latest iteration of the Medicare Access to Radiology Care Act, also known as MARCA. 

A broad coalition of doc groups has endorsed the measure, including the AMA, American College of Radiology and the American Society for Radiation Oncology. 

“Although notification laws may raise awareness, insurance coverage may be necessary to translate awareness into action,” experts charge in a new analysis.

According to the Wall Street Journal, providers scored $15B in payments last year through IDR, triple the figure for 2024, with CMS “actively working to clean it up." 

The updated law permits healthcare facilities to use alternative equipment-based radiation protection systems in place of lead aprons under specified conditions.

Currently, projectile incidents that occur within MRI suites are classified as “use errors.” This definition excludes such events from OEM reporting requirements.