Device makers and physicians alike were less than enthused about several features of the draft Medicare inpatient rule for fiscal year 2025, but thanks in part to support from the device industry, the final rule provides a new code that encompasses both left atrial appendage closure and ablation, a change that may reduce spending without dinging sales of these devices.
Cvrx Inc. secured U.S. FDA approval for magnetic resonance-conditional labeling for its Barostim system, a neuromodulator that improves symptoms of patients with heart failure. With the latest approval, patients with the implanted system can have magnetic resonance imaging (MRI) at 1.5T under the specified conditions.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Evidence does not back hearing loss screening for asymptomatics; Boston Scientific settles on mesh marketing; FDA says approval phase for Barostim Neo was 240 days.
Of all the things that irritate physicians about health insurance, prior authorization might be at the top of the list. That didn’t stop the U.S. Centers for Medicare & Medicaid Service (CMS) from imposing a prior authorization requirement for the implant of spinal stimulators and for cervical fusion with disc removal in the calendar year 2021 Medicare outpatient prospective payment system, however.
The Medicare inpatient draft is always an event due to its impact on medical technology. Now, several products soon may see their new technology add-on payments (NTAP) expire because of eligibility. The Centers for Medicare and Medicaid Services (CMS) said both Claret Medical Inc.’s Sentinel embolic protection device and Procept Biorobotics Corp.’s Aquabeam device have used up their NTAP eligibility, and hospitals may see lower rates for using those devices starting Oct. 1
