Local Coverage With Evidence Development Is Legit, CMS Says; But It May Be Rare
CMS issued its final guidance on the coverage-with-evidence-development program, two years following a draft. It is explicit that local Medicare contractors can employ CED in setting coverage policies in their jurisdictions, but it is not clear that the language will encourage significant use at the local level. The guidance also revises its approach on ending CED policies compared to what was stated in the 2012 draft guidance.
Medicare administrative contractors can incorporate coverage-with-evidence-development policies into local coverage determinations, CMS affirmed in a Nov. 20 final guidance on the CED program.
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.
Ellipsis said it will use its new funding to expand its AI-powered voice assistant Sage across health systems. Ellipsis is part of the global vocal biomarker market, which is expected to exceed $9bn by the end of 2033, according to a research market report.
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
