The Medicare hospital inpatient final rule gives new technology add-on payments to just two devices, Ellipse Technologies's Magec spinal bracing and distraction system, and Gore's Excluder iliac branch endoprosthesis. Two other requests were turned down, and another device was not FDA-approved in time.
Only two devices that applied for new-technology bonus US Medicare payments for fiscal year 2017 made the cut in the latest Medicare hospital inpatient final rule.
Of the five devices up for new technology add-on payments in the Centers for Medicare and Medicaid Services' April proposed rule, CMS granted two and denied two.(Also see "CMS...
Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.
The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.
A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.
