The Centers for Medicare & Medicaid Services (CMS) will continue to cover auditory osseointegrated implants (AOIs) as a Medicare benefit, the agency announced, retreating from its previous proposal to classify the devices as hearing aids, which are excluded from Medicare coverage.
“We believe AOIs that provide focused stimulation to the temporal bone structures, through an implant that is physically integrated into the bone of the skull, to the cochlea are outside the scope of the hearing aid exclusion,” CMS said in a final rule released Oct. 31.
Osseointegrated implants have been payable by Medicare as prosthetic devices that replace the function of the middle ear since Jan. 1, 2006. Given the device's history of coverage, safety, and efficacy for a patient population with no auditory alternative, the hearing healthcare community was surprised and concerned by the CMS proposal published in July.
“CMS felt that the implanted device did the same function as a bone-conduction hearing aid because they both transmit sound via bone conduction,” said Lisa Satterfield, MS, director of healthcare regulatory advocacy for the American Speech–Language–Hearing Association (ASHA).
“They were failing to realize the benefits of having it implanted into the mastoid process, which include better attenuation and better sound quality, and the device doesn't need to include amplification like a hearing aid would.”
The proposal not only would have restricted access to auditory osseointegrated implants among future Medicare recipients who need them, such as those who have single-sided deafness or are not able to wear a hearing aid because of congenital conditions like microtia or atresia, but also likely would have affected patients with private insurance, as these payers usually take their cue from CMS. Hearing healthcare professionals were also concerned that such a policy change would have put maintenance and upgrades out of reach for current implant recipients.
In response to the proposal, providers, patients, and members of industry joined to raise awareness and encourage others to voice their support for maintaining coverage of these devices.
Cochlear Americas posted a petition on change.org to continue coverage of its Cochlear Baha Implant System, and representatives from the Academy of Doctors of Audiology, the American Academy of Audiology, the American Academy of Otolaryngology–Head and Neck Surgery, ASHA, HIA, and consumer organizations met with CMS to discuss why they objected to the proposal and how its adoption would affect patients.
CMS ultimately received about 2,635 public comments on the proposal that argued these major points:
- An auditory osseointegrated implant is a prosthetic device that replaces the function of the outer and middle ear.
- Candidates for AOI devices typically have no other reasonable option for hearing assistance or restoration, and they do not benefit from hearing aids.
- Auditory osseointegrated implants have made a profound difference for people with hearing loss, significantly improving their quality of life.
These comments and the efforts of the hearing healthcare community worked, with CMS deciding not to withdraw coverage.
“Cochlear devices, brainstem implants, and AOIs are invasive devices and are significantly different than the hearing devices in existence at the time the Medicare coverage exclusion for hearing aids was enacted,” CMS said in the final rule. “We therefore do not consider them to be the hearing aids or technological refinements of the hearing aids excluded from the program in 1965 and after 1965.”
The hearing healthcare community has applauded the final decision.
“We were thrilled to work with our congressional hearing health champions as they urged CMS not to pull coverage for devices and procedures that had been covered for eight years with good reason,” said HIA Executive Director Andy Bopp.
“We're thrilled to see that CMS gave it another look and, in our opinion, did the right thing.”