Cochlear implant coverage
This article was originally published in The Gray Sheet
Executive Summary
CMS accepts Cochlear Corp. (Nucleus 24 contour implant system) request July 8 for consideration of expanded cochlear implant national coverage based on the firm's expanded labeling, granted by FDA in 2000. FDA allows implantation in patients with test scores of 50% or less, but CMS currently permits coverage for patients with demonstrated test scores of 30% or less. CMS requests that the public submit medical evidence and published literature detailing expanded use of cochlear implants in adults and children, patient selection criteria and the appropriate screening needed to qualify a patient for an implant. The agency expects to issue a decision by April 4, 2005...
You may also be interested in...
CMS Hears Earful From Supporters Of Cochlear Coverage Criteria Expansion
Advanced Bionics recommends that CMS tie coverage criteria for cochlear implants to FDA indications as an alternative to establishing specific cutoff criteria
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.