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by Kate Romanow & Steven C. White
A Medicare advisory committee has qualified a number of issues related to the effectiveness of cochlear implants for sensorineural hearing for further examination by the Centers for Medicare and Medicaid Services (CMS), which will use this information as it determines cochlear implant coverage for Medicare beneficiaries.
The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC)—a committee that provides advice and recommendations to CMS about Medicare coverage of items and services—met in May to examine evidence on cochlear implant (CI) outcomes. MEDCAC reviews the adequacy of scientific evidence to determine if items and services can be covered under the Medicare statute.
Medicare coverage for CIs is limited to unilateral cochlear implants for individuals who demonstrate limited benefit from amplification, defined as test scores of less than or equal to 40% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition. Medicare also may cover cochlear implantation for individuals with hearing scores of greater than 40% and less than or equal to 60% when the provider is participating in, and patients are enrolled in, either an FDA-approved category B investigational device exemption clinical trial or a CMS-approved clinical trial.
MEDCAC examined the evidence related to the effectiveness of bilateral CIs and CIs for individuals with test scores of greater than 40% and less than or equal to 60%. ASHA representative Richard Tyler, professor and director of audiology in the Department of Otolaryngology at the University of Iowa, spoke on the substantiated benefits of bilateral CIs. Other presenters included representatives from otolaryngology, audiology, and industry.
Two representatives from the Tufts Evidence-based Practice Center at Tufts University (funded by the Agency for Healthcare Research and Quality) presented their analyses of published outcome data. After reviewing the evidence and public presentations, the 11 MEDCAC panelists and two guest panelists (ASHA President Paul Rao and otolaryngologist John Niparko) voted on each issue presented by Medicare.
MEDCAC panelists rated each question on a scale from 1 (low confidence) to 5 (high confidence). Questions that receive a mean vote of at least 2.5 are given further consideration by CMS. Seven questions reached that score (percentages relate to open-set sentence recognition scores of the Medicare beneficiary candidate):
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