ASBA makes the Oral Appliance Case in the Halls of Congress

[Cannon House, Washington DC 20515]

Entrenched opinions in the medical community have a way of lingering well past their prime, and so it goes with the continuing bias in favor of continuous positive airway pressure (CPAP). Simple tradition conspires to keep oral appliance therapy underrepresented in the sleep apnea conversation.

In spite of the resistance, The American Sleep and Breathing Academy (ASBA) continue to make its voice heard at the highest levels. Recently, ASBA representatives spoke at the House Congressional briefing for the House Medical Technology Caucus in Washington, DC, September 27^th 2016.

Caucus Co-chairs

Hon. Anna G. Eshoo (D-CA), Co-Chair, Congressional Medical Technology Caucus

Hon. Erik Paulsen (R-MN), Co-Chair, Congressional Medical Technology Caucus

* List of congressional caucus members

The house congressional hearing was entitled “Innovations in dental sleep medicine to treat sleep disorders”. The Caucus is interested in researching and discovering new treatments for chronic conditions such as sleep apnea. Not only does healthcare innovation save and improve lives, but it also realizes significant cost savings and remains a driver of America’s workforce and economy.

The briefing was moderated by Dr. Elliott J. Alpher Director, the Alpher Center, ASBA Diplomate, ASBA Board of Governors and  Huffington Post Contributor. “As our nation is confronted with increasing healthcare costs, we must acknowledge the epidemic of sleep disorders in America, the huge economic cost to the nation and the role of dentists as a key part of the solution.”

Hearing testimony was provided by the following speakers:

i. TMD overview and its relation to Obstructive Sleep Apnea “OSA” - Dr. Richard Klein DDS, Michigan Head & Neck Institute

ii. What is Oral Appliance Therapy and how it works and Microrecorder to prove compliance in custom oral devices for OSA - Dr. Neal Seltzer, DMD Long Island Dental Sleep Medicine

iii. Working with NFL Greats across the Country - David Gergen, Gergens Orthhodontic Lab, President of the Pro Players Health Alliance

iv. Former NFL Player Personal Testimony – Roy Green, Wide Receiver, Arizona Cardinals

v. Personal Testimony from a Commercial Pilot – Bill Weimer

vi. Non‐surgical upper airway remodeling for OSA - Dr. G. Dave Singh D.Sc. PhD DMD Biomodeling Solutions

vii. Recap and close regarding “Advance Notice of Proposed Rulemaking on the “Evaluation of Safety Sensitive Personnel for Moderate-to-Severe OSA” - Dr. Kent Smith DDS Sleep Dallas

Acknowledging that it can be a painstaking process, ASBA officials are educating members of Congress in an effort to share the latest oral appliance facts. With help from Congressional allies, the goal is that Federal Motor Carrier Safety Administration (FMCSA) regulators will add language to an eventual proposed rulemaking document. If advocates get their way, that new comments explicitly endorse the use of oral appliances to treat sleep apnea in transportation workers.

By presenting and commenting on the Advanced Notice of Proposed Rulemaking (ANPRM) of the “Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea” [FMCSA-2015-0419] the ASBAs comments as an industry stakeholder will be placed in the ANPRM docket as part of the regulatory development process, with the objective being, every consideration will be given to the comments received.

“If we can get this information to trickle over to other governmental departments, and the transportation industry listens to us as well; that is our goal,” confirms Kent Smith, DDS, president of the ASBA and owner of Texas-based Sleep Dallas.

As it stands now, many of the larger trucking fleets are encouraging drivers to get tested—even mandating it in some instances. However, companies currently institute these rules on a volunteer basis.

With several high-profile fatal accidents connected to poor sleep, many experts believe a federal mandate governing sleep testing and treatment is all but certain. When that day comes, an acknowledgement of oral appliance validity in the text of a rule would be a major victory for transportation safety, as well as a boon to the business of oral appliance manufacturers and providers.

 A Necessary Step

ASBA CEO David Gergen admits that there are no guarantees in the mission to gain the attention of FMCSA bureaucrats, but the recent Congressional hearing was a necessary step in the right direction. The meeting took place thanks to Dr. Alpher’s regular communication with Rep Eshoo. Dr. Alpher serves on the board of the ASBA and is also on staff at George Washington University Hospital.

For the hard-charging Gergen, these connections represent an opportunity to get the word out at the highest levels of government. “Our next goal is to boost awareness at the U.S. Department of Transportation,” he says. “Again, we want to educate them about truckers and oral appliances.”

The connections help, but it’s the efficacy of oral appliances that catch the attention of all who care to listen. “We presented a study [at the Sept 27 hearing] that came out in 2015 that showed that if CPAP was used for a certain amount of time, and oral appliances were used for that same amount of time, the outcomes were identical,” says Gergen. “That was an eye opener for them. When you factor compliance into the equation, oral appliances should be a no-brainer for mild to moderate sleep apnea.”

Fortunately, Gergen believes the lawmakers clearly understood the message, even expressing surprise that oral appliance efficacy was not more widely known. “They were amazed at this information and how it has not been spread around the country,” muses Gergen. “They were shocked about the lack of information. I attribute that lack of information to the CPAP lobbyists.”

Groups such as the American Academy of Sleep Medicine (AASM) agree that oral appliances are excellent options for mild to moderate sleep apnea, and that agreement, along with ASBA’s considerable outreach efforts, are effectively sending the message.

Another part of that message is the power of celebrity, which the ASBA has been uniquely able to generate thanks to extensive connections, particularly within professional football, America’s most popular sport. Former NFL wide receiver Roy Green also testified at the recent Congressional hearing, and Green has joined other NFL greats in recent events designed specifically to boost awareness among the public and clinicians.

Ultimately, Kent Smith believes the message of oral appliance efficacy will resonate with regulators and legislators, primarily because proper sleep is necessary for public safety. “We must keep our citizens more awake on the roads, and the only way you do that is by giving them more refreshing sleep,” says Smith. “It amounts to a public health crisis, and it really needs to be fixed. Someone dies because of a sleepy driver every 70 minutes.

“This is very serious,” he continues. “Apart from surgery treatment to open the collapsing region, there are only two successful therapies for this—CPAP and oral appliances. If you ignore one of them, you’re putting a large portion of the population at risk. That was easy enough for lawmakers to understand, and I hope regulators will come to the same conclusion.”

To conclude, this campaign was initiated four years ago by Drs Alpher and Klein at a meeting in D.C. at Senator Debbie Stabenow’s (D-MI) office. This was followed up by a meeting with the Federal Motor Carrier Safety Association (FMSCA), which led to a further congressional meeting. This mission is ongoing and the ASBA will continue to helping level the playing field for OA'a with CPAP and BiPap.

* Congressional Medical Technology Caucus 2016

Source: ASBA publications