The U.K. National Institute for Health and Care Excellence (NICE) endorsed the use of the Orbit system by Mindtech Ltd. as a treatment for tics and Tourette syndrome.
Physicians aren’t the only ones who see prior authorization (PA) practices as a significant problem, but John Brooks, deputy administrator at CMS, told a med tech audience that a renewed focus on Medicare Advantage plans’ use of PA will not yield tangible results overnight.
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 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 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.
Diopsys Inc. agreed to pay $14.25 million to settle allegations it violated the False Claims Act (FCA) in encouraging the unnecessary use of the company’s Nova device for retinal testing.
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.
Medicare beneficiaries in the U.S. diagnosed with chronic obstructive pulmonary disease (COPD) may soon be covered for positive pressure ventilation in the home per a draft coverage memo from CMS.
Allurion Technologies Inc. is cleared by regulators in France to resume sales of its swallowable gastric balloon to treat obesity, in the country. Last summer, the company withdrew the Allurion Balloon from the French market amid concerns about the safety of the weight loss device. The greenlight to relaunch the product is good news for Allurion given that France represents a sizeable portion of its market.
Ziwig SAS, which leads the race for a simple diagnostic for endometriosis, picked up the pace with a fast-track reimbursement decision in France for its Endotest, the first saliva-based diagnostic assay for endometriosis.
