CMS Expands Medicare Coverage for Cochlear Implants

The Centers for Medicare & Medicaid Services (CMS) is expanding its coverage for cochlear implants, broadening the patient criteria to individuals with hearing test scores of >40% and ≤60%. It has concluded that sufficient evidence exists that “cochlear implantation may be covered for treatment of bilateral pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss in individuals who demonstrate limited benefit from amplification.”

As reported by HearingTracker in July, CMS at that time issued a National Coverage Analysis (NCA) proposing the change. It appears the final decision is identical to CMS’s previous proposal.

The new criteria for Medicare coverage for cochlear implants requires that patients receive limited benefit from amplification, which is defined by test scores of less than or equal to 60% correct in the best-aided listening condition on recorded tests of open-set sentence cognition. Additionally, to qualify for a CI, patients would need to meet all of the criteria below:

• Diagnosis of bilateral moderate-to-profound sensorineural hearing impairment with limited benefit from appropriate hearing (or vibrotactile) aids;
• Cognitive ability to use auditory clues and a willingness to undergo an extended program of rehabilitation;
• 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;
• No contraindications to surgery; and
• The device must be used in accordance with Food and Drug Administration (FDA)-approved labeling.

CIs were first covered for adult Medicare beneficiaries in October 1986 and extended to children in 1992. In 2005, CMS determined that among other criteria, cochlear implantation was reasonable and necessary for treatment of bilateral pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss in individuals who demonstrate limited benefit from amplification.

At that time, limited benefit from amplification was defined by test scores of ≤40% correct in the best-aided listening condition on tape-recorded tests of open-set sentence recognition. However, for individuals with hearing test scores of >40% and ≤60%, cochlear implantation was covered only when the provider was participating in a special FDA- and CMS-approved trial.

CMS changes policies due to evidence on moderate-to-profound losses

In its National Coverage Analysis issued in July, CMS said the expansion of coverage was due to a formal request letter from Teresa A. Zwolan, PhD, at Michigan Medicine and Craig A. Buchman, MD, at the Washington University School of Medicine who asked for reconsideration of the national coverage determinations (NCDs) for cochlear implants. NCDs are made by CMS through a formal evidence-based process, with opportunities for public participation. In the letter, Zwolan and Buchman cited the results from a 2020 systematic review and consensus statement by 32 experts in CIs.

In this consensus paper, several statements related to the effectiveness of CIs were agreed upon, including:

• Cochlear implants significantly improve overall and hearing-specific quality of life (QOL) in adults with severe, profound, or moderate sloping to profound bilateral SNHL.
• Adults who are eligible for cochlear implants should receive the implant as soon as possible to maximize postimplantation speech recognition.
• Adults with hearing loss can be substantially affected by social isolation, loneliness, and depression; evidence suggests that treatment with cochlear implants can lead to improvement in these aspects of well-being and mental health.
• There is an association between age-related hearing loss and cognitive or memory impairment.
• The use of cochlear implants may improve cognition in older adults with bilateral severe to profound SNHL.
• Hearing loss is not a symptom of dementia; however, treatment of hearing loss may reduce the risk of dementia.

Zwolan and Buchman also cited results of two 2020 studies (Buchman et al and Wick et al) involving Cochlear Ltd’s Nucleus CI532 device that together suggest cochlear implantation in older adults is safe and effective and may facilitate the concept of healthy aging in adult hearing aid users with and without mild cognitive impairment (MCI).

Additionally, in its initial comment period during March 2022, CMS received 32 comments, with 29 expressing support for the expansion of the cochlear implantation patient criteria.

Team effort by ACI and other organizations

The change was high on the agenda of several organizations in hearing healthcare and was an early initiative of the newly organized American Cochlear Implant Alliance (ACI) with a multi-center study to explore and document outcomes in older adults who had more residual hearing than was currently allowed under Medicare coverage criteria. According to the organization, ACI approached CMS, requesting that they partner and allow Medicare expanded coverage for individuals who were part of the ACI Alliance study. Principal investigators Drs. Zwolan and Buchman, as well as the late John Niparko, MD, led the multi-center study effort. “Their thoughtful leadership over a sustained timeframe led to this important outcome,” says the Alliance.