The Centers for Medicare and Medicaid Services (CMS) proposed a new rule on July 11 that would effectively end coverage for people who need bone anchored hearing solutions—systems that have traditionally been covered by Medicare.

The proposed rule change seeks, in part, to “clarify the statutory Medicare hearing aid coverage exclusion and specify devices not subject to the hearing aid exclusion.” Hearing aids are not eligible for Medicare reimbursement based on a specific exclusion included in the original legislation of 1965. CMS is proposing that it now classify bone-anchored hearing solutions (ie, osseointegrated hearing implants) as “hearing aids” instead of “prosthetic device” as cochlear implants are classified.

Adoption of the rule would affect the thousands of people in the United States who have found traditional hearing aids to be ineffective in treating hearing problems, such as single-sided deafness, microtia, atresia, and other kinds of conductive losses. Importantly, not only would some people be out of luck when it comes to obtaining a bone-anchored hearing device, but current users who wish to update or replace their current system would also be left wanting.

Additionally, this would have a profound effect on a vast range of implant devices (available now and also in the future), including middle ear implants, dental-anchored systems, and other bone-conduction devices.

CMS’s argument. CMS says that hearing aids provide assistance or “aid” to hearing that already exists via a functioning ear, whereas the cochlear implant was the first hearing device not considered a “hearing aid” and instead met the benefit category of a “prosthetic device”—devices (other than dental) which replace all or part of an internal body organ. CMS contends that a cochlear implant differs fundamentally from a hearing aid because it is surgically implanted to directly stimulate auditory nerve fibers. Both cochlear implants and auditory brain stem implants (ABI) create the perception of sound rather than aid hearing that already exists.

CMS states in Section VII of the proposed rule: “We interpret the statute as excluding devices that provide aid to extant hearing (or hearing aids) rather than devices that create the perception of sound and hearing, given that devices with technology that utilize either air or bone conduction via mechanical stimulation to aid extant hearing were primarily utilized when the statute was written. Moreover, we believe that prosthetic hearing devices are not ‘hearing aids’ given that such devices do more than ‘aid’ in hearing and instead replace the function of an internal body organ (ie, a part of the ear).”

Rallying the troops. Manufacturers, clinicians, and patients are leading the charge to oppose the rule change. “In 2006, CMS correctly classified the Baha Implant System as a prosthetic device that replaces the function of the middle ear and cochlea,” said Anthony Manna, president of Cochlear Bone Anchored Solutions in a press statement. “If the new proposal is accepted, the United States would be one of the very few industrialized nations not to cover this life changing technology.”

Oticon Medical issued a statement pointing out several problems with the proposed rule: “Equally disturbing,” says Oticon, “is the potential ripple effect this proposal will have on non-governmental private payers and state Medicaid policies. These groups routinely look to Medicare as the standard for their policies and use Medicare coverage guidelines for justification of coverage, or removal of coverage for treatment options. It is not overstating a concern to say, if this proposal passes, coverage for everyone using a bone-anchored system is threatened.”

Similarly, Sonitus Medical CEO Amir Abolfathi states, “At Sonitus, we believe that single-sided deafness is a medical condition that needs to be treated. We believe that patients with single-sided deafness suffer from significant disability and as such deserve the right to choose their treatment from among proven technologies like the SoundBite. We believe that these are medically necessary treatments that should be covered by Medicare…And we disagree with the proposal and join the chorus of clinicians, patients, and innovators in [opposing the rule change].”

Comments needed! All three companies above have urged clinicians and their patients to submit comments at!documentDetail;D=CMS-2014-0092-0002 or at the Web site Cochlear established to facilitate commentary at A petition at entitled “Continue coverage for the Cochlear Baha Implant system, a life changing hearing solution” was also established.

The comment period ends on September 2, and the final ruling by CMS is expected sometime around November 1.