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Medicare’s Proposed Rule to Eliminate Funding for Bone Anchored Solutions

Anthony Manna

August 25, 2014
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Interview with Anthony Manna, President, Cochlear Bone Anchored Solutions


Carolyn Smaka:  Thanks for your time today, Tony.  I wanted to discuss the urgent issue regarding Centers for Medicare and Medicaid Services’ (CMS) proposal to eliminate Medicare coverage for osseointegrated implants.  Can you explain the situation – why would they do that?

Tony Manna: Thank you for having me, and I will do my best to explain the issue.  As a result of their normal process of investigating coverage, CMS issued a proposal in July that would reclassify osseointegrated implants as hearing aids.  That proposed rule would reverse CMS’s own coverage position that has been in place since 2006.  In 2006, CMS correctly classified an osseointegrated implant system as a prosthetic per their definition of a prosthetic.  A prosthetic device is one that replaces the function of an organ in the body.  A cochlear implant, for example, replaces the function of a cochlea, and therefore is considered a prosthetic.  An osseointegrated implant system replaces the function of the middle ear and cochlea.

If CMS reclassifies osseointegrated implants, they will classify them as hearing aids rather than prosthetic devices.  Hearing aids are not covered by Medicare.  As you know, osseointegrated implants are clearly not hearing aids.  In fact, for most patients who receive osseointegrated systems, hearing aids are either contraindicated, and many patients have failed a hearing aid trial prior to obtaining their osseointegrated system.  Unlike a hearing aid which can be self-selected by the patient, requires no medical procedures and is not permanent, these systems are prescribed and surgically implanted by a physician to replace the function of the middle ear or the cochlea.   

CMS has issued this proposal to allow interested parties time to comment – you can make comments here.  The comment period is typically 60 days, and in this case will conclude on September 2nd.  Then, CMS will review the information and comments and make a final ruling.  The final ruling will likely be made by the end of October, and go into effect on January 1. 

Carolyn:  Who would be affected by this ruling, if osseointegrated systems were reclassified as hearing aids?

Tony: If the ruling goes into effect and reclassifies osseointegrated systems as hearing aids, it would affect anyone who is on Medicare; anyone 65 years of age and older would lose coverage for an osseointegrated implant system.  If they fail a hearing aid trial and their only option to hear is an osseointegrated implant system, they would not have coverage under Medicare.

In addition, private insurance companies typically follow the lead of CMS.  So if CMS decides that osseointegrated devices are no longer considered prosthetic and therefore not covered, over time, a majority of people who are candidates for this modality would lose access.  This would include children as well as adults.  If the proposed CMS ruling goes into effect, it would limit access almost immediately to people of Medicare age and then gradually limit access to osseointegrated implants to many who are covered by private insurance. 

Carolyn:  I’m thinking about children with syndromes like Treacher Collins, where microtia and atresia often prohibit the use of hearing aids.  Even these children with private insurance could be affected? 

Tony: That’s right – if the proposal were accepted and private insurance companies followed suit, it would limit access to those covered by private insurance, including children.

Carolyn: Would the osseointegrated systems from all manufacturers be impacted by this proposal, were it to be accepted?

Tony: Yes.  There are currently two manufacturers of osseointegrated systems, Cochlear and Oticon Medical, and the systems from both manufacturers would be affected.

Carolyn: If this proposal were accepted, how it would it impact people on Medicare who already have an osseointegrated device?

Tony: They could lose access to future technologies.  They could lose access to coverage for maintenance on their current system like repairs, and would have to pay for those themselves.  It is not clear if Medicare would cover upgrades for people on Medicare who are current recipients of osseointegrated devices, if the proposal were accepted.  It is unlikely that they would cover the upgrades going forward, but it is not clear. 

Carolyn: You mentioned that CMS is seeking comments on this proposal.  How do those comments impact the outcome, and how can people make comments?

Tony: The comments allow people to provide input as to why or why not this is a good proposal.  In meetings we and others have had with CMS, CMS has made it clear that they are looking for input, which is provided through the written comments.  Since our professionals understand how this technology differs from hearing aids and since they have seen the amazing results that this technology can have, we are asking professionals to submit written comments to CMS.  These are the patients you see in your office.  They need the care.  For many of them, hearing aids are contraindicated.  We’re asking professionals to submit written comments to CMS indicating how this would limit access to care for their patients. 

Carolyn:  If this proposal were accepted, would it be realistic that patients could pay for their own osseointegrated systems? How much does an osseointegrated device cost, including surgery?

Tony:  An osseointegrated device, including surgery, is approximately $20,000, a figure that most people cannot afford.  If CMS’ proposal were accepted, it would significantly limit access to this modality for people who need it.

It would not save CMS a significant amount of money to limit access to these systems for Medicare recipients. Osseointegrated implants have been available since the mid-90s in the United States, yet there are only about 6,500 Medicare recipients who currently have them.

Carolyn:  So if Medicare no longer covered these systems, it would not be a significant cost savings for CMS, but it would be a significant cost barrier for patients who need the systems to hear.

Tony:  Yes.  And because of the trickle down effect to private insurance, it could limit access to osseointegrated implants for almost everyone. 

Carolyn: Tony, you mentioned that osseointegrated systems have been available in the U.S. since the mid-1990s.  I know there is a very large evidence base of their efficacy and benefits.

Tony:  That is correct.  The first patient was implanted with an osseointegrated system in the late 1970s in Sweden, so it is almost 40 years that these systems have been available globally.  More than 100,000 people have been implanted worldwide. The U.S. FDA approved osseointegrated systems in August 1996.  There are more than 300 published clinical papers regarding the efficacy of osseointegrated systems. If the new proposal were accepted, the United States would be one of very few industrialized nations not to cover this life-changing technology.

We’re asking professionals, current and prospective users and their loved ones, and patient advocates to voice their dissatisfaction with the proposed rule so these systems can continue to be covered by Medicare.  Here is the link to leave comments to CMS – the comment period is closing on September 2nd: http://www.regulations.gov/#!submitComment;D=CMS-2014-0092-0002

In addition, people seeking more information can visit www.HelpNowHearAlways.com.

Carolyn: I left a comment today and it only took about 2 minutes – I urge everyone reading this to do the same.  Thanks for your time and we’re hoping for a positive resolution to this issue. 

2019 NIHL Series | 4 advanced-level live webinars | June 5, 12, 19, + 26 | 12:00 pm EDT | Guest Editor: Brian J. Fligor, ScD, PA


Anthony Manna

President, Cochlear Bone Anchored Solutions

Anthony Manna is President, Cochlear Bone Anchored Solutions.