The Advanced Medical Technology Association released a policy proposal for AI in medical devices that took the U.S, FDA to task for its guidance for predetermined change control protocols for AI, stating that the guidance is “inconsistent with the statutory authority” for PCCPs.
The U.S. Centers for Medicare & Medicaid Services decided to peel back a series of local coverage determinations for skin substitute grafts that provoked a vigorous response from stakeholders.
The American Medical Association’s CPT editorial panel will meet May 1-3 to consider codes for several devices and services, but the most important of these might be the code for cardiac contractility modulation.
The Center for Medicare and Medicaid Innovation was founded with the objective of reducing Medicare spending, but many of the associated programs will be stood down by the end of this year thanks in part to a 2023 report detailing a significant increase, rather than a decrease, in spending associated with CMMI programs.
The U.S. Medicare draft inpatient rule for fiscal 2026 discusses a number of coding proposals, although the agency seems disinclined to go along with a proposal to increase payment rates for TAVR devices by switching the procedures to a different diagnostic-related group.
The new technology add-on payment for the TAG thoracic branch endoprosthesis is likely coming to an end, but the device’s manufacturer, Gore Medical Inc., petitioned CMS to reassign the procedure to a new diagnostic-related group that would more accurately reflect the costs of the related procedure.
The U.S. Centers for Medicare & Medicaid Services (CMS) issued a draft coverage memo for transcatheter edge-to-edge repair for the tricuspid valve (T-TEER), which is a development that promises accelerated competition for this anatomical space.
A late 2024 CMS proposal to include obesity drugs like Novo Nordisk A/S’ Wegovy (semaglutide) and Eli Lilly and Co.’s Zepbound (tirzepatide) under Medicaid and Medicare didn’t make it far under the new U.S. administration. A final rule, set to be published in the Federal Register April 15, will not include the provision that would have added obesity drugs to Part D coverage beginning in 2026.
Mehmet Oz won the U.S. Senate’s nod as the administrator of the Centers for Medicare & Medicaid Services. Oz brought in 53 aye votes to 45 nays in the Senate’s April 3 confirmation tally, and inherits a complicated task as the Medicare breakthrough devices coverage program continues to face substantial challenges.
Mehmet Oz, the Trump administration’s pick to lead the U.S. Centers for Medicare & Medicaid Services (CMS), appeared for a second time in the Senate for the CMS administrator’s job.
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