The Centers for Medicare and Medicaid Services (CMS) has convened this meeting for the panel to review the evidence on health outcomes attributable to unilateral and bilateral cochlear implantation for its beneficiaries.
A cochlear implant device is an electronic instrument, part of which is implanted surgically to stimulate auditory nerve fibers, and part of which is worn or carried by the individual to capture, analyze, and code sound. Cochlear implant devices are available in single-channel and multi-channel models. The purpose of implanting the device is to provide awareness and identification of sounds and to facilitate communication for persons who are moderately to profoundly hearing impaired.
In 2005, CMS published National Coverage Determination (NCD) for Cochlear Implantation (50.3). This NCD establishes Medicare's criteria for coverage of cochlear implantation. Among other criteria, the patient must derive limited benefit from current means of sound amplification. Limited benefit is defined by 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.
For those patients who demonstrate hearing test scores of greater than 40% and less than or equal to 60% (and who meet Medicare's other coverage criteria), NCD 50.3 states that cochlear implantation may be covered, but only when the provider is participating in, and patients are enrolled in, either an FDA-approved category B investigational device exemption clinical trial as defined at 42 CFR 405.201, a trial under the Centers for Medicare & Medicaid (CMS) Clinical Trial Policy as defined at section 310.1 of the National Coverage Determinations Manual, or a prospective, controlled comparative trial approved by CMS as consistent with the evidentiary requirements for National Coverage Analyses and meeting specific quality standards. Since the 2005 NCD was published, we are unaware of any new clinical trials that adequately address the impact of cochlear implantation in patients who demonstrate hearing test scores of greater than 40% and less than or equal to 60%.