CMS Proposes Broadening Medicare Coverage for Cochlear Implants

In a National Coverage Analysis (NCA) Proposed Decision Memo, the Centers for Medicare & Medicaid Services (CMS) is proposing to broaden Medicare coverage of cochlear implants (CIs) by removing the requirement that individuals with test scores of 40%-60% be covered only under special circumstances. Instead, CMS says it may now have sufficient evidence that cochlear implantation should be covered for treatment of bilateral moderate-to-profound sensorineural (SNHL) hearing loss in individuals who demonstrate limited benefit from amplification. Under the new proposal, this would be defined as test scores of ≤60% correct in the best-aided listening condition on recorded tests of open-set sentence cognition.

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. 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. At that time, for individuals with hearing test scores of >40% and ≤60%, cochlear implantation were covered only when the provider was participating in a special FDA- and CMS-approved trial. 

According to CMS, the expansion of coverage is 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.

In its subsequent follow-up, CMS also identified nine clinical investigations that met their research inclusion criteria to ascertain if cochlear implantation is reasonable and necessary for treatment of adult Medicare beneficiaries with the conditions noted above.

In reviewing these nine studies along with the other research cited above, CMS believes the available data indicate that “many eligible individuals with pre-cochlear implant sentence recognition scores between 41% and 60% can improve their communication abilities with cochlear implantation and that this treatment would be reasonable and necessary…”

Further, CMS states:

“Therefore, we propose to expand the Medicare coverage criteria for cochlear implants to beneficiaries with 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 less than or equal to 60% correct in the best-aided listening condition on recorded tests of open-set sentence recognition…We also propose to eliminate the requirement that the speech tests be administered by tape recordings, as this represents old technology. However, we propose that sentence recognition testing must still be presented in recorded formats to avoid the variability of human voice.”

The Proposed Decision Memorandum described above was posted on July 6, 2022, and a 30-day public comment period now begins. Comments can be made on the proposed decision on the CMS Public Comment Page.