Advisory Panel Examines Cochlear Implant Coverage

[Guest guest]

The ASHA Leader, a publication of the American Speech-Language-Hearing

Association - July 5, 2011

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Advisory Panel Examines Cochlear Implant Coverage

by Kate Romanow & 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 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 Rao and otolaryngologist 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 <http://www.cms.gov/faca/downloads/id58a.pdf> [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@...

C. White, PhD, CCC-A, director of health care economics and advocacy,

can be reached at swhite@....

cite as: Romanow, K. & White, S. C. (2011, July 05). Advisory Panel Examines

Cochlear Implant Coverage. The ASHA Leader.