National Coverage Analysis (NCA) Tracking Sheet

Cochlear Implantation

CAG-00107R

Issue

Currently, CMS has a National Coverage Determination (NCD 50.3) covering cochlear implantation for treatment of bilateral pre-or post-linguistic, sensorineural, moderate-to-profound hearing loss in individuals who demonstrate limited benefit from amplification. Limited benefit from amplification is defined by test scores of = 40% correct in the best-aided listening condition on tape recorded tests of open-set sentence cognition. For individuals with hearing test scores of > 40 % and = 60 %, CMS covers cochlear implantation only when the provider is participating in and patients are enrolled in a clinical study.

CMS received a complete, formal request to reconsider the NCD. This NCD analysis will align with the scope of the request and focus on individuals with hearing test scores of > 40% and ≤ 60 %, for whom coverage is available only when the provider is participating in and patients are enrolled in a clinical study.

CMS is soliciting public comment on this topic. We are particularly interested in any peer-reviewed literature that describes the sentence recognition of individuals who experience bilateral pre-or post-linguistic, sensorineural, moderate-to-profound hearing loss within the boundaries of pre- implantation hearing test scores of > 40 % and ≤ 60 %.

National Coverage Determinations

Benefit Category

Prosthetic Devices

Requestor Information

Requestor Name Requestor Letter
Terry Zwolan, Ph.D., CCC-A, Director of Audiology, Clinical Professor Emerita, Michigan Medicine Otolaryngology, Head & Neck Surgery View Letter
Craig A. Buchman, MD, FACS, Lindburg Professor and Chair, Department of Otolaryngology-Head & Neck Surgery, Washington University School of Medicine N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
03/01/2022
Expected NCA Completion Date
10/04/2022
Public Comment Period
03/01/2022 - 03/31/2022
Proposed Decision Memo Due Date
Proposed Decision Memo Released
07/06/2022
Proposed Decision Memo Public Comment Period
07/06/2022 - 08/05/2022
Decision Memo Released
09/26/2022
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Kimberly Long
kimberly.long@cms.hhs.gov
410-786-5702
Lead Medical Officers
Susan Miller, M.D.

Medicare Benefit Category Determination Date

Actions Taken

March 1, 2022

CMS initiates this national coverage analysis for Cochlear Implantation. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

To submit a comment, please use the blue "Comment" bubble at the top of the page. Enter comments directly into the “Submit A Public Comment” webpage.

July 6, 2022


September 26, 2022