July 5, 2011 News

Advisory Panel Examines Cochlear Implant Coverage

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):

  • How confident are you that there is adequate evidence to determine whether or not a unilateral (i.e., first) cochlear implant improves health outcomes for adults with hearing loss who have demonstrated a test score of >40% and ≤50%? (voting member average: 2.73)
  • How confident are you that a unilateral (i.e., first) cochlear implant improves health outcomes for adults with hearing loss who have demonstrated a test score of >40% and ≤50%? (voting member average: 2.91)
  • How confident are you that thereis adequate evidence to demonstrate whether or not the use of bilateral cochlear implants as compared to a unilateral cochlear implant improves health outcomes? (voting member average: 2.91)
  • How confident are you that the use of bilateral cochlear implants as compared to a unilateral cochlear implant improves health outcomes? (voting member average: 2.82)
  • How confident are you that there is adequate evidence to determine whether or not a simultaneous bilateral cochlear implantation as compared to a unilateral cochlear implantation improves health outcomes for adults with hearing loss who have demonstrated a test score of ≤40%? (voting member average: 3.09)
  • How confident are you that a simultaneous bilateral cochlear implantation as compared to a unilateral cochlear implantation improves health outcomes for adults with hearing loss with test score of ≤40%? (voting member average: 2.82)
  • How confident are you that these conclusions are generalizable to:
    • The Medicare patient population? (voting member average: 3.64) 
    • Community-based settings? (voting member average: 2.73)

To see all the questions and voting results, visit the Centers for Medicare and Medicaid's website [PDF]. 

CMS will deliberate the MEDCAC findings and may make a decision regarding bilateral cochlear implant coverage in 2011.  

Kate Romanow, JD, director of health care regulatory advocacy, can be reached at kromanow@asha.org

Steven C. White, PhD, CCC-A, director of health care economics and advocacy, can be reached at swhite@asha.org.

cite as: Romanow, K.  & White, S. C. (2011, July 05). Advisory Panel Examines Cochlear Implant Coverage. The ASHA Leader.

  

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