The device industry is extraordinarily dependent on administrative activity where Medicare coverage is concerned, and this was exceptionally evident in 2024 when software and digital health coverage policies remained bogged down.

The U.K. Secretary of State for Health and Social Care, Wes Streeting, says that he wants people to see the national health service as a neighborhood health service as he works towards reimagining the health system and bringing care into people's homes. Data, he said, will be at the heart of the transformation. So too will be the deployment of science and medical technologies.

Medicare coverage of digital mental health therapies has traditionally been lacking, but the final Medicare physician fee schedule for 2025 added three new codes to deal with the coverage gap.

While the inpatient and outpatient final rules for 2025 are baked into the U.S. Medicare payment system, there are indications that Congress will consider legislation that would flatten rates across sites of service.

The U.S. Medicare outpatient final rule affirms several new devices for the new technology pass-through program, but one of the more significant findings is that CMS will use separate payment mechanisms for two renal nerve denervation devices, following the blueprint the agency employed for this question in the inpatient final rule.

FDA commissioner Bob Califf made it his mission to counter medical and food product misinformation, and described the dilemma as an emergency at an Oct. 28 public meeting.

Remote monitoring for patients with implanted cardiac electrophysiology devices may finally be coming of age in the U.K. thanks to a review of these systems by the National Institute for Health and Care Excellence.

Edwards Lifesciences Corp. made a splash recently with the U.S. FDA approval of the Evoque tricuspid valve replacement device, but is also pressing Centers for Medicare and Medicaid Services to provide a coverage framework for this class of devices.