The final Medicare coverage memo for transcatheter edge-to-edge repair for tricuspid valve regurgitation largely replicates the April 2025 draft, but cardiology centers will not have to bring an electrophysiologist to the patient’s care team to be permitted to practice these devices.
The U.K. Medicines and Healthcare Products Regulator Agency dropped a guidance for digital mental health technologies that clarifies several key points, such as when the DMHT qualifies as software as a medical device.
The House of Representatives passed H.R. 1, also known as One Big Beautiful Bill, which will restore personal income tax cuts that expired in 2022. However, the bill also restores research and development tax credits, a provision that drew immediate praise from industry.
The U.S. Office of Inspector General issued a report stating the Medicare program often pays for physician services that are not performed post-surgery, but the Centers for Medicare & Medicaid Services responded it is in no position to immediately begin tracking all excess payments under these global codes.
The U.S. Centers for Medicare & Medicaid Services posted the draft home health rule for calendar year 2026, which includes a proposal to subject continuous glucose monitors and insulin pumps to competitive bidding, but the agency is also considering a more rapid pace of replacement of these technologies.
The U.S. Department of Justice reported June 30 that several hundred defendants were charged with health care fraud of more than $14 billion, but the more important news may be that federal agencies are standing up a data sharing system that will make this kind of enforcement more effective.
The U.S. FDA finalized the latest edition of its premarket cybersecurity guidance, but the agency is of the view that any device with software is subject to the terms of the guidance even though the statute would seem to exempt device software that lacks connectivity.
The U.K. Medicines and Healthcare Products Regulatory Agency reported June 24 it joined a global regulatory network for AI that is part of the Health AI regulatory initiative – a program that will invite another nine regulatory agencies to take part in the initiative in the months ahead.
The U.K. National Health Service may or may not deploy transcatheter aortic valve replacement devices as widely as in the U.S., but the National Institute for Health and Care Excellence officially staked out the position the data are not yet compelling for anyone other than high risk patients.
Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes clear the FDA sees no compelling reason to issue such a report in every instance.
