SOMERSET, August 13 – For Oticon Medical, education and awareness-building among policymakers is critical to the securing continued coverage of bone anchored implants by the Center for Medicare and Medicaid Services (CMS). The company is working with otolaryngologists, audiologists and bone anchored implant users to increase understanding and appreciation of the value of bone anchored implants in advance of the proposed CMS changes to withdraw its current coverage policy for bone anchored hearing devices.
In a national outreach to healthcare and hearing care professionals, Oticon Medical cited the success achieved in 2005 when professional organizations, bone anchored hearing device providers and industry furnished Medicare policymakers with key clinical information, studies and other documentation on the benefits of bone anchored devices and why the technology is indeed a prosthetic device.
“As a result of that action and after a great deal of due diligence and lengthy consideration, CMS revised the Medicare Benefit Policy Manual to allow for coverage of osseointegrated implants like the Ponto System as prosthetic devices,” said Curt Gorman, President, Oticon Medical, LLC. “Since that time, numerous additional studies documenting substantial outcomes for bone anchored patients have been completed and published that further demonstrate the need and value of bone anchored implants to patients with conductive hearing loss and single sided deafness.“
A Call to Action
As the manufacturer of the Ponto System, Oticon Medical will take a leading role in submitting to CMS carefully detailed comments and information to explain why bone anchored devices should continue to be covered under Medicare as a prosthetic device. The company is also working to rally hearing healthcare professionals to reinforce the value of bone anchored hearing implants with policymakers during the comment period for the proposed rule. The comment period closes on Tuesday, September 2, 2014.
Daniel H. Coelho, M.D., F.A.C.S., Director of the Cochlear Implant Center at Virginia Commonwealth University Medical Center is among the concerned professionals who will share comments on the proposed CMS changes. Dr. Coelho has extensive experience with hearing implants and is the author of numerous peer-reviewed papers on implants and skull base surgery.
“Bone anchored implants have been a godsend for our patients - the overwhelming majority of whom are unable to wear conventional hearing aids,” he explained. “The proposed CMS drop in coverage threatens to eliminate what may be not only the best, but often the only option available for patients with severe conductive, mixed, or single-sided deafness. We as a community (doctors, audiologists, patients, professional organizations, and patient advocates) are strongly opposed to this proposal and the dramatic negative impact it would have on access to care for patients with hearing loss.”
Oticon Medical has also enlisted Ponto users to share their insights on the value and need for continued coverage for people with conductive hearing loss and single sided deafness who have limited to no benefit when it comes to alternative treatments. Bethany Geldmaker PhD, PNP is a vocal advocate for bone anchored implant technology and is using her more than 10 years’ experience in public policymaking to submit testimony to CMS.
“The proposed changes to coverage could mean effects for a much bigger population than just those who utilize Medicare and Medicaid,” said Geldmaker. “It’s likely that these implications would trickle down to third party providers too. If that happens, we would be undoing work on an incredibly important problem that we’ve just begun to address properly—one that we’ve just started to educate the public and providers on appropriately. So, I encourage people to speak out now.”
Decision May Have Implications Beyond CMS
This is not the first time that the CMS has reviewed its decision on bone anchored implants. Oticon Medical points out that the newest data only further supports the conclusion that bone anchored devices, like the Ponto system, are distinctive from traditional hearing aids because they are a prosthetic. A bone anchored device is surgically implanted where it osseointegrates and becomes part of the patient’s anatomy. The system components function by bypassing the ear canal and middle ear and stimulating the nerve directly through bone conduction, replacing the function of the middle ear. This meets the CMS definition for prosthetics of “replaces all or part of an internal body organ.”
“If adopted, the change proposed by CMS will be binding on all parts of the Medicare program,” explained Gorman. “It will eliminate coverage for Medicare patients and there is a real possibility that other non-governmental payers may use this as the rationale to revise their coverage policies and no longer provide coverage. As a result, patients will suffer due to limited access to this technology. Our goal is to continue to make bone anchored hearing solutions a viable and achievable option for all patients who can benefit from this life-changing technology.”
To register comments, log onto: http://www.regulations.gov/#!documentDetail;D=CMS-2014-0092-0002 and click the “Comment Now” button. Deadline for comments is September 2.