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Medicare Coverage with Evidence Development: Cochlear Implantation

Guidance for the NCD for Cochlear Implantation (50.3), concluded that, effective for services performed on or after April 4, 2005, cochlear implantation may be covered for individuals meeting certain selection guidelines and with hearing test scores of greater than 40% and less than or equal to 60% 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 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.

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: January 30, 2020

The NCD for Cochlear Implantation (50.3), released by CMS in April 2005, concluded that,  effective for services performed on or after April 4, 2005, cochlear implantation may be covered for individuals meeting certain  selection guidelines (see below)  and with hearing test scores of greater than 40% and less than or equal to 60% 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 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.

Patient eligibility criteria for any of the above study types include individuals who meet all of these five selection criteria:

  1. Diagnosis of bilateral moderate-to-profound sensorineural hearing impairment with limited benefit from appropriate hearing (or vibrotactile) aids;
  2. Cognitive ability to use auditory clues and a willingness to undergo an extended program of rehabilitation;
  3. Freedom from middle ear infection, an accessible cochlear lumen that is structurally suited to implantation, and freedom from lesions in the auditory nerve and acoustic areas of the central nervous system;
  4. No contraindications to surgery; and
  5. The device must be used in accordance with Food and Drug Administration (FDA)-approved labeling.

Potentially, the results of trials may provide sufficient evidence of clinical utility that a future NCD on this topic will provide for the expansion of the current coverage of cochlear implantation.

 

Decision memo

Approved Studies

Study Title: MED-EL SYNCRONY Cochlear Implant System
Sponsor: MED-EL Corporation
ClinicalTrials.gov Number: NCT03236909
CMS Approval Date: 03/15/2018

Study Title: Cochlear Implantation in Adults with Asymmetric Hearing Loss Clinical Trial
Sponsor: Washington University School of Medicine
ClinicalTrials.gov Number: NCT03052920
CMS Approval Date: 05/26/2017

Study Title: Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults with Partial Deafness
Sponsor: Advanced Bionics
ClinicalTrials.gov Number: NCT02189798
CMS Approval Date: 09/12/2016

Study Title: Investigation of the FAST Sound Coding Strategy in Newly Implanted Adult Cochlear Implant Recipients
Sponsor: Cochlear Americas
ClinicalTrials.gov Number: NCT02698787
CMS Approval Date: 09/01/2016

Study Title: Evaluation of Revised Indications (ERID) for Cochlear Implant Candidacy for the Adult CMS Population
Sponsor: American Cochlear Implant Alliance
ClinicalTrials.gov Number: NCT02075229
CMS Approval Date: 07/30/2013

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