A proposed change to Medicare’s reimbursement of hearing aids could leave patients on their own when they need the a specific type of bone-anchored hearing aid implant, according to device maker Cochlear Ltd. (ASX:COH).
The new rule would withdraw Medicare coverage of bone-anchored hearing implants, a measure that the agency said wouldn’t affect coverage for cochlear implants or brain stem implants, which are not considered hearing aids. That’s bad news for Cochlear’s Baha implant system, a bone-anchored device, which would be excluded from typically covered Medicare benefits.
The Baha system was previously classified as a prosthetic device, and rightly so according to Cochlear. Cochlear implants were the 1st hearing devices not classified under the "hearing aid" category for Medicare purposes, having been given the "prosthetic" label because it replaces the function of the cochlea. Unlike traditional hearing aids, which help support a patient’s existing hearing capability, cochlear implants simulate hearing through mechanical means.
Cochlear implants were also the 1st hearing device covered with Medicare payment for adult beneficiaries, a measure that took effect in 1986, according to the memo issued this month by the Centers for Medicare & Medicaid Services. The agency has clarified its definition of "hearing aid" several times since then and the new proposal would shift more hearing devices into the "hearing aid" category.
"We propose to interpret the term ‘hearing aid’ to include all types of air or bone conduction hearing aid devices, whether external, internal, or implanted, including, but not limited to, middle ear implants, osseointegrated devices, dental anchored bone conduction devices, and other types of external or non-invasive devices that mechanically stimulate the cochlea," according to the proposed rule. "We believe, based on our understanding of how such devices function, that such devices are hearing aids that are not otherwise covered as prosthetic devices, in that they do not replace all or part of an internal body organ."
The agency names the Baha device in particular as an osseointegrated bone conduction device that would be subject to the hearing aid exclusion rules.
"To date, the Baha Implant System has helped well over 100,000 people across the world and thanks to the coverage CMS has provided, it has benefited thousands in the U.S. alone," Cochlear bone anchored solutions president Anthony Manna said in prepared remarks. "If the new proposal were to be accepted, the U.S. would be one of the very few industrialized nations not to cover this life changing technology for patients in need, for many of whom there is no alternative treatment option and access to Baha Implant System technology is most critical."
Cochlear asked all interested parties to join its petition on Change.org, which already has nearly 1,900 signers as of this article’s publication.
CMS said in its proposal that the reclassification of the bone-anchored hearing aids wouldn’t mean much to the agency’s bottom line, calculating that CMS paid less than $9 million in total for the devices from 2005 through 2013.