by Envoy Medical Staff Member, on October 4, 2022
On September 26, the Centers for Medicare & Medicaid Services (CMS) published details on their final decision to expand coverage for cochlear implants under Medicare. This expansion provides a significant improvement in access to care for older adults who may be struggling with their hearing aids but did not meet the eligibility requirements to receive a cochlear implant previously under Medicare's previous and more strict guidelines.
A cochlear implant is an inner ear implant designed to bypass damaged portions of the inner ear and directly stimulate the auditory nerve. Cochlear implants are typically recommended for individuals who are receiving limited benefits from their hearing aids particularly when it comes to speech understanding. The CI audiologist and implant surgeon use specific audiometric testing and medical evaluation to determine if an individual meets candidacy.
Cochlear implant criteria from CMS were more stringent than the FDA guidelines that were followed by most health insurance plans. FDA expanded their criteria several times over the years as clinical evidence demonstrated patients (including those over age 65) with more pre-operative hearing/speech understanding were benefiting from cochlear implantation.
However, Medicare patients that were getting a limited benefit from their hearing aids and decided to get a cochlear implant evaluation would meet the FDA criteria, but not Medicare's more strict coverage criteria.
This resulted in millions of Medicare beneficiaries being unable to access the benefits of cochlear implants that could help them remain active, engaged, and healthy.
Both the FDA and CI audiologists incorporated the expanded criteria into their best clinical practices as evidence-based studies continued to demonstrate good benefit under these expanded guidelines. When it came to patients with Medicare, despite clinical candidacy being met, audiologists were forced to base their clinical decision-making on labeling and coverage instead of evidence-based clinical outcomes.
A group of professionals in the Industry created American Cochlear Implant Alliance (ACIA), an organization committed to eliminating barriers to cochlear implantation by sponsoring research, driving heightened awareness, and advocating for improved access to Cochlear Implants for patients of all ages across the U.S. This group sought a change early on and in 2014 designed 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.
ACIA completed the study with favorable results which were published in October 2020 by JAMA Otolaryngology. The study helped ACIA formally request a reconsidering of criteria under a formal process through CMS called a National Coverage Determination (NCD).
CMS reviewed the study and ultimately published their final decision in which coverage was expanded (effective immediately) allowing for the treatment of bilateral, sensorineural, moderate to profound hearing loss in individuals who demonstrate limited benefit from amplification.
"Limited benefit" was expanded to test scores of less than or equal to 60% correct in sentence recognition tests. All criteria that must be met can be viewed here.
If you are on Medicare and getting a limited benefit from your hearing aids you may want to schedule a cochlear implant evaluation.
More needs to be done to provide better access to treatments that improve hearing health for those with moderate to severe hearing loss including for those that don't want or qualify for a cochlear implant and would be better serviced by a middle ear implant or hearing aid.
Medicare has had a "hearing aid exclusion" since 1965 that prevents even attempting insurance coverage for hearing aids, middle ear implants, or alternative treatment options. The best way to get private insurance companies on board is to change Medicare.
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The “hearing aid exclusion” within Medicare has denied many older adults with hearing loss access to hearing technologies and healthcare services that can help them remain healthy, connected, and able to care for themselves.
Envoy Medical Asks You to Urge Your Members of Congress to Support H.R. 1118, the Medicare Hearing Aid Coverage Act of 2021 to provide better access to treatments that improve hearing health.
Click here to request a letter template
