Nearly a decade after approving coverage for auditory osseointegrated implants, the Centers for Medicare & Medicaid Services (CMS) proposedhttp://www.regulations.gov/#!documentDetail;D=CMS-2014-0092-0002 a reversal that would classify the devices as hearing aids, making them ineligible for Medicare coverage.
“The announcement came as a surprise to many of us,” said John Niparko, MD, professor and chair of the Department of Otolaryngology–Head & Neck Surgery at the Keck School of Medicine of the University of Southern California. “We had felt that the support of this technology by CMS was providing a critical opportunity for a small subpopulation of patients who require this approach in order to restore hearing.”
Under current regulations, which have been in place since Jan. 1, 2006, osseointegrated implants are payable by Medicare as prosthetic devices that replace the function of the middle ear.
According to the new proposal published July 11, however, the agency reevaluated the scope of Medicare's hearing aid coverage exclusion after getting requests to consider additional implanted and non-implanted auditory devices as prosthetic devices, and came to this conclusion:
“The hearing aid exclusion encompasses all types of air-conduction and bone-conduction hearing aids (external, internal, or implanted). Osseointegrated devices such as the BAHA [bone-anchored hearing aid] are bone-conduction hearing aids that mechanically stimulate the cochlea; therefore, we believe that the hearing aid exclusion applies to these devices and propose that Medicare should not cover these devices…”
Because osseointegrated implants are surgically inserted, it “defies common sense” to call them hearing aids, said Andy Bopp, executive director of the Hearing Industries Association.
“It does replace a body part—a human function—and it's placed by a doctor.”
The American Academy of Audiology (AAA) also disagrees with the proposal, said AAA president Erin Miller, AuD, and that position is shared across the hearing healthcare community, from providers and manufacturers to patients.
“The osseointegrated implant is a prosthetic device,” Dr. Miller said, speaking on behalf of the Academy. “It actually does replace the function of the middle ear, and it should continue to be covered.”
CMS's proposal does not affect brainstem and cochlear implants, which would continue to be covered as devices that directly stimulate the auditory nerve, replacing the function of the inner ear.
A bone-anchored hearing device was first implanted in 1977 in Sweden and received U.S. Food and Drug Administration approval in 1996.
“This isn't a new intervention,” Dr. Miller said. “It has a proven track record.
“The current regulation prohibits people from providing this particular device unless it's the only device option available to the patient. These are patients who couldn't receive benefit from any air-conduction and/or other bone-conduction device, and they've likely tried those because osseointegrated implants aren't a first step.
“There would be a population of patients who would not receive the services they need to communicate effectively, so it's very concerning for the consumers whom we treat.”
Candidates for osseointegrated implants, such as Cochlear's Baha Implant System and Oticon Medical's Ponto Bone Anchored Hearing System, may not be able to wear a hearing aid because of congenital conditions like microtia or atresia. In patients with single-sided deafness, osseointegrated devices pick up sounds from the deaf side and send them through the bone to the hearing ear.
Currently, Medicare pays for Cochlear's osseointegrated devices in a bundled payment that covers the cost of the device and operating room time, said a Cochlear Americas representative.
The national average bundled rate for hospital outpatient treatment is $9,732, and the national average for an ambulatory surgical center is $7,987. Medicare beneficiaries typically are responsible for a deductible and coinsurance for each service provided, the Cochlear representative added.
According to CMS, the proposal “would not have a significant fiscal impact on the Medicare program because the Medicare program expenditure for BAHA paid under Medicare during the period CY [calendar year] 2005 through CY 2013 was less than 9,000,000 per year.”
If approved, however, CMS's decision would likely affect many more patients.
“These consequences are far beyond the Medicare proposal,” said Shannon Weinberg, senior manager of marketing strategy for Cochlear Americas. “Private payers typically follow the lead of CMS, so they really are setting the tone across the industry.”
In general, a bone-anchored implant surgery costs a patient who does not have insurance coverage for the procedure $15 thousand to $25 thousand, said Alan Raffauf, vice president of marketing for Oticon Medical.
Hearing healthcare providers and patients also have raised concerns about how withdrawal of coverage would affect people who already have an osseointegrated device and need maintenance and upgrades.
“I would be up a creek if I were not able to continue advancing in the technology,” said Dan Nettler, who was diagnosed with single-sided deafness in 1971 and received his first osseointegrated hearing device in 2005. Mr. Nettler is a Cochlear volunteer speaking from his own experience, he said.
“I would not be able to afford out-of-pocket coverage for this type of device. I would constantly have to seek some sort of repair and, hopefully, not return one day to having single-sided deafness. That scares me more than you could imagine.”
COMMUNITY COMES TOGETHER
The hearing healthcare community has been raising awareness about the CMS proposal and encouraging providers and patients alike to show their support for continued coverage of osseointegrated devices.
Cochlear Americas posted a petition to that effect on change.org https://www.change.org/petitions/centers-for-medicare-medicaid-services-dept-of-health-human-services-continue-coverage-for-the-cochlear-baha-implant-system-a-life-changing-hearing-solution. Additionally, representatives from the Academy of Doctors of Audiology, the American Academy of Audiology, the American Speech–Language–Hearing Association, and consumer organizations met with CMS Aug. 5 to outline why they disagree with the proposed hearing aid designation.
“It didn't go as well as I'd originally hoped it would,” said Lisa Satterfield, AuD, the director of healthcare regulatory advocacy for ASHA, speaking on behalf of the association. “We set up our argument to prove that the osseointegrated implant was a prosthetic device because it replaces the function of the outer and middle ear.
“We haven't changed their minds with those arguments. They feel that the device is a hearing aid because it conducts sound mechanically and not electronically like a cochlear implant.”
However, the meeting was not the be-all and end-all, Mr. Bopp said, expressing hope that congressional support and formal commentshttp://www.regulations.gov/#!docketBrowser;rpp=25;po=0;dct=PS;D=CMS-2014-0092, which were due Sept. 2, would help CMS come around.
“I have not heard any argument from outside of CMS in support of this rule change,” Dr. Niparko said. “There's a patient population who depends solely on this technology for connectivity to the hearing world, and I think it would be a really, really unfortunate situation if CMS were to change its position and withdraw support for this particular technology.”