Combining TECHNOLOGIES - Dental Sleep Practice · However, disruptive change is already un-der way...

SUMMER 2016

Supporting Dentists Through PRACTICAL Sleep Apnea Education

Thoughts on the Current and Future

Practice of DSM by Gilles Lavigne, DMD, MSc, FRCD, PhD

From A to ZQuiet®

The Unforgettable Story of Dan and Trina Webster

by Lou Shuman, DMD, CAGS

PLUS

TECHNOLOGIESfor Successful Outcomes with Innovations Like i-CAT, Ez Sleep, Night Shift and Apnea Guard®

Combining

Airway, Bruxism and Craniofacial Pain

Cross-Codingby Rose Nierman, RDH

Do you find yourself wondering sometimes ‘What’s all the fuss about how dental sleep medicine is so complicated?” Do you think that you’ve been doing pretty good supplying MAD and

gathering reports of improved symptoms? Is the ‘dirty secret’ that it’s not really all that difficult?

Do you like what you are reading in DSP? Do you have ideas you want to share about what works in your practice? I would be happy to consider essays from any reader! Don’t be shy – we’ll help polish your ideas and spread the wisdom of Practical Sleep Education. Contact me at [email protected].

Take this seriously

Technology serves

the doctor-patient

relationship, not the

other way around.

Steve Carstensen, DDS

Diplomate, American Board of

Dental Sleep Medicine

If that’s you, do not read Dr. Gilles Lavigne’s article. He challenges all of us to embrace the complexity that is medicine, the need to engage with the whole of our patients – thinking of ‘phenotype’ as a frame-

work for identifying, diagnosing, treating and managing patients. If you want things to carry on simple, you will not be comfortable with this essay.

Dr. Lavigne is at the pinnacle of dentists who influence research, define practice, and reveal physiologic connections between sleep disordered breathing and other signs and symptoms in our patients. In this issue, he calls all doctors (and not just dentists) to action to embrace Precision Medicine – the framework for knowing your patient so well that you can apply just what is needed to alleviate their diagnosed problems. This challenge is echoed by commentary from Dr. John Remmers, who named “Obstructive Sleep Apnea’ and continues innovation to this day, and Dr. Rob Rogers, founder of Sleep Disorders Dental Society (later AADSM).

Technology allows us to approach our patients with more knowledge and a great-er sense of collaborative care. When we ask our patients to bring us reports from their smartphone app or FitBit, we involve them. When we show them their own anatomy on a big screen, we involve them. When

we use a scanner to take photos of their teeth to create an appliance, in-

stead of ‘data’ or ‘records’, they see themselves.

Nothing we can do replaces a commitment by our patients to take up the MAD and manage their own disease. We can offer the right solu-

tion, the precise treatment aimed at their individual problem, but our fas-cination with technology, our focus on the things we use to document, pro-

duce, and deliver oral appliance ther-apy must never take precedence over the personal connection. Technology serves the doctor-patient relationship, not the other way around.

Our offices have a culture – you choose how you are perceived by your patients, your colleagues, your medical peers. It’s how your office looks, how it feels, how you approach managing your patient’s health. Is your cul-ture everything it should be?

Dr. Lavigne lays it out for us. We have a challenge. We need to employ every means we have to meet this worthy goal and make our communities healthier. If we are going to make a serious difference, we need to be serious parts of the health care team. If you think dental sleep medicine is pretty simple, think deeper.

INTRODUCTION

1DentalSleepPractice.com

Cover Story

Combining Technologies for Successful Outcomesby Todd Morgan, DMD, ABDSM

Predicting outcome and

gaining confidence.

614

Origin Stories

From A to ZQuiet®


Getting problems solved fast is

the mission of this company.

38

Future Focus

Thoughts on the Current and Future Practice of DSMby Gilles Lavigne, DMD, MSc, FRCD, PhD

Perhaps the most important article you

will read this year.

28 Practice Management

Airway, Bruxism and Craniofacial Pain Cross-Codingby Rose Nierman, RDH

Medical insurance is the key for treatment

acceptance and smooth office success.

4o Technology Update

Consumer-Driven Sleep Technologiesby Ping-Ru Teresa Ko, MDEveryone loves electronics. Are they useful for us?

56 Meaningful Conversation

The Precision Medicine Paradigm for DSMby Pat Mc Bride, Sleep ClinicianCommittment to patient outcomes means paying attention to many details.

72 Team Focus

The Use of Technology in a Dental Sleep Practice by Glennine Varga, AAS, RDA, CTAYour team may be more comfortable with technology: maximize the advantage.

74 Legal Ledger

Stark Law and Anti-Kickback Statuteby Ken Berley, DDS, JD, and Jayme Matchinski, JDThink again about your relationship with your referring providers.

Todd Morgan, DMD, ABDSMCo-Inventor of Apnea Guard®,researcher and author

2 DSP | Summer 2016

CONTENTS

4 DSP | Summer 2016

12 Education Spotlight

Foundation for Airway Health

26 Medical Insights

Airway, Bruxism and Craniofacial Pain: What’s the Connection? by Mayoor Patel, DDS, MS

31 Product Spotlight

Is Apnea Guard®… becoming the New Normal to work with MDs?by Todd Morgan, DMD, ABDSM

33 Clinical Focus

How to Read a Sleep Study by Jamison Spencer, DMD, MSThere may be no standard report, but there is common data.

43 Starting Early

The Healthy Start System Provides an Effective Treat-ment for the Root Cause of Sleep Disordered Breathing...No one should endure years of poor breathing just because they are young!


Don’t Make Your Patients Wait!

47 Adjunctive Care

Dental Sleep Medicine: Beyond Oral Appliance Therapyby Drs. Richard Drake and Craig SchwimmerDentists can do more with the palate than just look at it.

50 Practice Management

The Four Pillars for Dental Sleep Medicine Successby Gy Yatros, DMDThere is much more to success than fitting acrylic.


A Story of Progress and Adapt-ation: the Panthera D-SAD


OravanOSA: Sleep Appliances with a Truly Open Anterior Design


Avoid the cost of missing desaturation events or having to repeat an overnight study

66 Inside the Lab

Retrofitting Crowns Under Sleep Appliancesby Deborah Curson-VieiraSimplifying a common problem for dentists.

68 Choosing Appliances

Is Selecting the Appropriate Sleep Device for You and Your Patient Important?by Dr. David “Trey” Carlton III

Case report series illuminates differ-

ences in patient outcomes.

80 Sleep Humor

Financial Focus

Living with the choices we make by Tony Robbins and Tom ZgainerRetirement plan fees affect your future.

10CONTENTS

Summer 2016

Publisher | Lisa [email protected]

Editor in Chief | Steve Carstensen, [email protected]

Managing Editor | Lou Shuman, DMD, [email protected]

Editorial AdvisorsSteve Bender, DDS Ken Berley, DDS, JD Ofer Jacobowitz, MD Christina LaJoieSteve Lamberg, DDS, DABDSM Dale Miles, DDS Amy Morgan John Remmers, MD Rob Rogers, DMD Sarah Shoaf, DDS, MSDBruce Templeton, DDS, MS Jason Tierney Glennine Varga, AAS, RDA, CTA

National Account Manager | Adrienne Good [email protected]

Creative Director/Production Manager Amanda Culver [email protected]

Website Manager | Anne Watson-Barber [email protected]

E-media Project Coordinator | Michelle Kang [email protected]

Front Office Manager | Theresa Jones [email protected]

MedMark, LLC15720 N. Greenway-Hayden Loop #9Scottsdale, AZ 85260Tel: (480) 621-8955 Fax: (480) 629-4002Toll-free: (866) 579-9496

www.DentalSleepPractice.com

Subscription Rates1 year (4 issues) $79* 3 years (12 issues) $189* *plus shipping

©MedMark, LLC 2016. All rights reserved. The publisher’s written consent must be obtained before any part of this publication may be reproduced in any form whatsoever, including photocopies and information retrieval systems. While every care has been taken in the preparation of this magazine, the publisher cannot be held responsible for the accuracy of the information printed herein, or in any consequence arising from it. The views expressed herein are those of the author(s) and not necessarily the opinion of either Dental Sleep Practice magazine or the publisher.

Combining

6 DSP | Summer 2016

COVERstory

for Successful Outcomeswith Innovations Like i-CAT, Ez Sleep, Night Shift and Apnea Guard®

by Todd Morgan, DMD, ABDSM

Introduced in 1995 by Harvard Univer-sity professor Clayton Christensen, the the-ory of disruptive innovation has proven to be a powerful way of thinking about inno-vation-driven growth. The medical device industry, especially PAP-based technology, has enjoyed stability, strong growth, and good financial return over the last 35 years. However, disruptive change is already un-der way and the future of the industry will be different as patients seek and demand in-dividualized approaches to their problems. Enter disruptive technologies, like Oral Ap-pliance Therapy, positional therapy, Pharma approaches, gastric and nerve stimulation surgical modalities, as well as self-help tech-nology like oropharyngeal exercise, to name only a few! But how does this disruptive technology get to patients and then lead to a personalized approach to care?

Technological Advancements that Help the Dentist

Change requires not only innovation but getting folks to think differently. That isn’t

easy, especially when the existing technolo-gy works so well. CPAP works, and, it works great. Our patients are savvy and they are requesting treatment choices based on sto-ries from their friends and family, and what they’ve researched on the Internet.

I was fortunate enough to begin my career in DSM among an elite and forward-think-ing group of sleep docs at Scripps Clinic in La Jolla, California. My participation was interesting to them, and over time they be-

“Targeted and disruptive technologies” is the space where Dental

Sleep Medicine dentists have always lived. Whether we know it

or not, we have been all about disruptive innovation in the med-

ical device field, and more specifically within the field of sleep medicine. Positive Airway Pressure, introduced by Collin Sullivan in 1981, would

become the treatment of choice for decades. But always close by were the

dentists with their hunks of acrylic swimming in saliva, making up ground

slowly, deliberately.

Dr. Todd Morgan is board certified in Dentistry and Den-

tal Sleep Medicine. Dr. Morgan graduated from the Wash-

ington University School of Dental Medicine in 1985,

promptly returned to his hometown San Diego and began

his practice in 1986. Dr. Morgan is internationally recog-

nized as an expert in the field of Dental Sleep Medicine and has completed several clinical research studies and

published many scientific papers on the treatment of snoring, sleep apnea, and headache with dental devices. Dr. Morgan is a co-inventor of the Apnea

Guard. He has no ownership interest in EZ Sleep and receives no royalties

from sales of Apnea Guard.

COVERstory


gan to see the benefits of my expertise. We came to agree to invest some time and resources into a formalized study that pro-duced a sentinel clinical trial on the “Jaw Advancement Device. But even after show-ing very good outcomes, OAT remained little more than a curiosity for my docs, a rescue, a small possibility. But just as they said in the old Virginia Slims commercials: “You’ve come a long way way, Baby!” Back in the day, I could not have imagined the impact a digital workflow would have on my practice. Digital dentistry is here to stay and has spilled over into the DSM world with the advent of computer-guided appli-ance fabrication, such as the Narval and MicrO

2 sleep appliances. Kudos to ResMed

Inc. and MicroDental Laboratory for ad-vancing this disruptive technology – a sure game-changer.

Another game-changer that I have come to count on for evaluation and thoroughness in my patient consultation and work-up is CBCT technology. I like that the i-CAT tech-nology in particular has the least radiation exposure for my patients, and incredible im-aging software abilities. In my observations of the images over the last two years, I have come to recognize traits that help me predict outcomes and what combination of thera-pies may be most helpful to that individual patient. The strongest impact is with patient education and helping the patient grasp an understanding of their condition and “own” the problem. They can then share ownership in the treatment as well.

One of the greatest weaknesses of OAT is difficulty predicting when patient suc-cess may be expected, and so far there is no reliable predictive model or phenotype. Then there’s the problem of our definitions: What is a successful outcome? An AHI that drops below 5? Below 10? Whichever of these is your treatment goal, (and we’ll save that argument for later) treatment with oral appliances all too often falls short of ex-pectations. The dedicated clinicians must ask themselves: What else can I do to help my patient?

Maximizing Outcome Through Titra-tion Strategies

Although titration strategies are becom-ing more refined, finding the right starting

position of the mandible at the beginning re-mains critical. Relief from apnea can actual-ly be facilitated very early in the therapy. In one novel and scientifically validated tech-nique, the dentist may use a trial oral ap-pliance called the Apnea Guard to correctly determine the starting position for a custom appliance. The Apnea Guard protocol takes both vertical and protrusive variables into account to correctly predict the most effica-cious position of the jaw through a propri-etary algorithm. Since the Apnea Guard has proven outcome equivalency compared to a custom appliances, the device provides the dentist and the sleep physician an added op-portunity to accurately identify responders to OAT before a custom appliance is offered to a patient. This system has the added ben-efit of providing the patient with immediate treatment of their sleep disordered breathing while the patient waits for the weeks neces-sary for the custom MAD.

Having the ability to correctly predict which patient will respond to therapy is an astounding breakthrough for skeptical phy-sicians and unsure patients. Never before have we had a scientifically proven, inex-pensive, trial device to identify the ideal jaw position for effectiveness that also provides immediate treatment for our drowsy patients. CPAP therapy has always been quick to ini-tiate; Apnea Guard allows OAT to progress from testing to therapy almost immediately as patients leave the sleep center.

i-CAT CBCT airway images

Apnea Guard

DSP | Summer 2016

COVERstory

8

Deploy Additional Therapies When Expectations Aren’t Met

So what is the trained, caring dentist to do next? What therapies can be added to our Oral Appliance in order to improve results? Well, we have more options than you may think. And it all started with a tennis ball…

Positional TherapyPositional therapy was first formally

studied by Cartwright and others, who used biofeedback to keep folks off their backs when they slept. Feedback came from a tennis ball sewn into the back of the night-shirt. They demonstrated successfully that positional-dependent patients improved their AHI with the tennis ball shirt by elim-inating supine sleep. Fantastic! So, would it help the dentist to add positional therapy when their patient has residual apnea while supine and wearing their appliance? One would think so.

The good news about positional therapy is that it’s not so dependent on full coopera-tion. People can be encouraged to behave in their best interest, by sleeping on their sides, with a simple ‘reminder’ device worn on the body that gently prods the patient out of su-pine sleep. The Night Shift is a comfortable, electronic trainer that vibrates quietly to prompt a turn, kind of like a bed partner, but without the elbows! The Night Shift has been carefully validated and FDA cleared for use by every member of the sleep health team, including dentists. The vibration produced is similar to your cell phone, does not diminish sleep efficiency, and reduces supine sleep to lower AHI.

Tongue Push-ups?It is reasonably well understood now

that there are two primarily important medi-

ators of airway collapse in sleep: Anatomical deficiency and/or an inadequate neuromus-cular response. Oral appliances, like CPAP or surgery address anatomical narrowing by enlarging the retro-glossal or velopharyn-geal spaces. The chief difference that most likely accounts for the superior effects of PAP over other treatments is that pneumatic inflation eliminates any need for airway di-lation muscles to function. Other treatments that improve airway caliber still rely on the patient’s muscle tone to defend against the challenge of airway collapse, a function that is commonly lost in OSA patients. Can that response be rehabilitated? The answer is most likely yes.

Enter the myofunctional therapist. If you haven’t explored this field and made friends with a local therapist yet, you should con-sider it. The myofunctional therapist can play an important role in helping the DSM dentist reach success through rehabilita-tion of muscle strength, and a restoration of proper resting tongue posture. There is good evidence to support its use either as a stand-alone therapy in the correctly selected pa-tient, or as an adjunct to OAT.

ConclusionIn summary, the DSM dentist has more

tools than ever to help them succeed, by whatever definition you choose. First of all, seek out a reliable clinical approach driven by evidence clinical approach and made practical by convenience. Secondly, be pre-pared to supply adjunctive therapies that push your results into that winning zone. And third, partner with a disruptive Home Sleep Testing Company like Ez Sleep to com-bine technologies that can enable you to reach successful outcomes. Build your repu-tation around versatility and achieving great results every time. Stay disruptive!Night Shift

COVERstory


The good news

about positional

therapy is that

it’s not so

dependent on

full cooperation.

People can be

encouraged to

behave in their

best interest...

A startling statistic is that in a recent sur-vey by the AARP, nearly 70% of participants in 401k plans believe they are paying no invest-ment-related expenses or that their employer absorbs these fees. Nearly 40% of plan spon-sors, the business owners bearing the fiducia-ry liability of the plan, who have chosen the providers and investments in the plan, do not know the average expense ratios of the funds in the plan. Both figures are truly astonishing.

A review of your own 401k fees and in-vestment options should be a near-term ac-tion item. Plan sponsors are required by the Department of Labor to compare their current plans against alternatives on a regular basis to be sure all fees are reasonable and pru-dent. With the proliferation of lawsuits that exist — many very high-profile — recently in the news brought on by plan participants and almost always related to excessive fees or the use of proprietary funds in the 401k plan, it makes all sense to have a document-ed process and report of your findings in case a DOL examiner knocks on your door.

We’ve made it easy for you to get a quick check to see how your plan compares to industry averages here: http://americasbest 401k.com/medmark. A couple of pieces of information are all we’ll need to complete the analysis. You’ll know right away if the path your retirement plan is heading is a place you’ll want to end up — or if a change will do you, and your employees who are counting on you, a world of good.

Nothing is more important regarding your money than knowing how much you have, where it is, and if it is invested, how the costs of those investments will affect your future. Consider taking these steps for you, your family, and those you employ, who most likely do not even understand how your choices affect their future.

Living with the choices we make by Tony Robbins and Tom Zgainer

As this article was written, the presidential campaign had

officially started with the Iowa caucus now completed. In each of our states, we’ll soon enjoy the great individ-

ual privilege of choosing who we think will be the most suitable

candidate in each party. When November 9 rolls around, and

the results of the previous day’s election are confirmed, we’ll then have to live with the choices we made, or did not make,

for the next 4 years.

When it comes to our retirement planning, the choices we make today related to our investment options and their associated fees need to be made with a much longer time horizon in mind. Twenty to thirty years of life after active work has completed is now the norm. And if we intend to work an-other 10-25 years, the opportunity for the positive effects of compounding growth in your retirement savings will make all the difference in the quality of life we might enjoy in retirement.

Different from what you might choose for yourself, be it a presidential candidate or a particular investment, if you are the sponsor of a retirement plan, your employees are counting on your decisions, and the ramifications of those choices good or bad. You are choosing for them, as they generally have no say so in the matter. And yet it’s their money, their future. It is a very significant responsibility often overlooked.

We review hundreds of 401k plans per month, and while the employ-ers are certainly well intentioned, so little is often understood regarding the effect of investment-related fees over time. A recent study found that the av-erage total cost for a small business retirement plan declined to 1.46% over the past year, and that within this amount, the investment-related expenses typically borne by participants average 1.37%. This particular study defined small plans as those with 50 participants or $2.5 million in assets.

However, if you own or work for a business that has fewer than 50 par-ticipants or less than $2.5 million in plan assets, odds are you’re paying a substantial amount more in 401k fees. Plans in this demographic are defined as “micro” plans. It is not uncommon for the underlying investments in these plans to have expense ratios averaging between 1.50% and 2.50%. This has a major impact on retirement savings over time that can be difficult to decipher.

Why is this important to you? While 1.00% may sound insignificant, the costs of your investments can have a staggering effect on your retirement savings over time. According to the Department of Labor (DOL), paying just 1 percentage point more in expenses over the course of 35 years could re-duce a worker’s retirement savings by nearly 28%. For example, Bob is a participant in a plan offered by his employer with a 401k balance of $25,000 that earns 7% over the next 35 years. If Bob paid 0.50% in fees, even if he stopped making new contributions, his account would grow to $227,000 at retirement. But if he paid fees totaling 1.5%, the savings would rise to only $163,000, or 28% less.

10 DSP | Summer 2016

FINANCIALfocus

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fROM Positional tHERAPY with Night Shift.

- Innovative Combo-Treatment Device for Improving Oral Appliance Therapy Results

- Wearable Device Improves Efficacy Across a Wider Range of Patients

- Alternative Therapy for Non-Compliant CPAP Patients with OSA

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TM

Foundation for Airway Health

Please accept our

invitation to help

craft and deliver the

airway message

The Mission of the Foundation for Air-way Health is to help people realize their maximum potential by championing the recognition, diagnosis and treatment of air-way related disorders through collaboration, awareness, research, education and access to care.

Healthcare thought leaders, academies, educational organizations, and companies are invited to collaborate on our the mes-sage and address a prevalent, unrecognized and unmet public health problem: under- identified compromised airway.

Do you understand the important role air-way structure and function plays in health, function, performance and well-being? You are invited to participate and help craft our Foundation message and will be listed as a resource for the many who will seek care.

We are in a public health crisis of epic proportions, and it has been steadily worsen-ing. It affects the bodies, minds and spirits of young and old and can be measured in the percentage of the population with obesity, diabetes, heart disease, dementia, cancer, as well as ADHD, anxiety and depression. It can be measured in the dollars spent on health-care, developmental and learning problems, and in the volume of medications prescribed – often for the expression, but not addressing the underlying cause – for all of the above conditions. When these diagnoses are driven

by airway/sleep/breathing disorders, treating airways has to be part of the solution.

Do you know? • More than 50% of U.S. adults suffer

from sleep disorder breathing (SDB)• 50% of Americans snore. One in five

has mild to moderate apnea• One in 15 has moderate to severe apnea• Even today only 15% of patients with

airway/sleep disorders (ASD) are diag-nosed. In spite of new research, news stories, and conferences, this has not changed much in the past five years.

• The list of airway disorders and their comorbidities is growing

This is not a new healthcare problem that requires years of research to find a cure. There are already treatments that are successful and effective. The challenge is getting the message to the 85% in need and providing resources for screening, diagnosis and treatment.

The Foundation believes the dental community is in a unique position to take the lead, halting and reversing the epidem-ic of airway-driven chronic illness. So often the airway obstruction involves the tongue and other oral architecture. More and more thought leaders, organizations, laboratories and corporations are recognizing the role of airway health in chronic illness. Every week new approaches and treatments, instrumen-tation and products are introduced and mar-keted. But as noted, the percentage of cases that gets diagnosed has hardly changed.

The Foundation envisions a future where no child will be denied the opportunity to reach his or her potential because of an un-recognized airway/sleep problem. For every-one, of any age, we envision a future where the incidence of inflammatory and chronic illnesses falls, not rises.

Do you represent an organization, a healthcare company or are you a passionate and concerned practitioner? Please accept our invitation to help craft and deliver our airway message and serve as a resource for those discovering that there is hope for a fuller, happier life.

For more information, contact us at [email protected].


EDUCATIONspotlight

The Foundation for Airway Health will host an “Airway

Summit”, September 15, 2016 at the El Conquistador Hotel

in Tucson, Arizona. We’re calling it a “White Flag Event.”

Why “white flag”? Because we’re asking you to momentarily set aside the focus on competition in the marketplace and serve

patients by and articulating a unified airway health message.

September 15, 2016

Airway SummitHilton El Conquistador Resort

Tucson, Arizona

For this “White Flag Event,” we’re asking

you to momentarily set aside the focus on

competition in the marketplace and serve

patients by articulating a unified airway

health message. Only 15% of airway/sleep

disorders are diagnosed. Help address this

major unrecognized public healthcare crisis

by joining thought leaders, academies,

organizations and corporations to create

and bring a unified message to the public.

[email protected]

www.foundationforairwayhealth.org

This paper presents some personal thoughts, none of

which should be taken as final pronouncements at this

stage. My hope is to spark further thinking, open discus-

sions and relevant research in the field, as well as collaborations

with other healthcare professionals.

Thoughts on the Current and Future Practice of Dental Sleep Medicine

by Gilles Lavigne, DMD, MSc, FRCD, PhD

Currently, we are coping with major challenges in dental sleep medicine. We must be able to:

1. be aware of the complexity of sleep- disordered breathing (SDB) in order to make accurate screening or differ-ential diagnoses while taking into ac-count the impact of comorbidities on management planning (see Table 1).

2. understand the principles of precision medicine, a comprehensive, patient- centered approach.

3. improve access to healthcare, from prevention and screening to diagnosis

and treatment, in order to address this critical public health issue.

4. balance information obtained from evidence-based medicine and den-tistry with guidelines for daily clinical practice.

5. translate sleep society guidelines into practice and develop efficient up-dating strategies for the fast-moving world of sleep medicine.

The prevalence of SDB has risen dramat-ically over the past two decades, from 14% to 55%, depending on the patient group, i.e., age and gender who are also critical factors (Peppard PE et al, Am J Epidemiol 2013). Pre-vention and early detection of SDB are crit-ical due to the health consequences, which frequently begin in adolescence and peak in adulthood. These consequences include met-abolic alterations (higher fasting insulin and, blood glucose plus insulin resistance) as well as higher risks for cardiovascular morbidity and mortality, and accidents due to sleepi-


FUTUREfocus

ness (Bhushan B et al, Int J Pediatr Otorhinolar-yngol. 2015; Mukherjee S et al, American Jour-nal of Respiratory and Critical Care Medicine, 2015; Peppard PE et al, Am J Epidemiol 2013). Fortunately, dental sleep medicine is making continuous advances in terms of knowledge and technology.

Unlike my usual publications, this is not a report of a randomized clinical trial, an exper-imental trial, or a systematic meta-analysis. My intention was to gather together some recurrent thoughts arising from lectures I have delivered to dental and medical practitioners in various parts of the world. These thoughts have been inspired by your comments and questions as well as my own reading and ongoing research. I have cho-sen to publish this paper in a nonacademic style journal in order to reach an audience of dentists in clinical practice.

The Challenges of Dental Sleep MedicineThe dentist’s role in sleep had been primari-

ly for sleep bruxism management but about 30 years ago it strongly emerged for sleep disor-dered breathing with the development of a few oral appliances that were designed to reduce snoring and help preserve airway patency during sleep. Clinicians and scientists in dentistry and medicine began sharing their experiences, questions, and visions in an unprecedented way. Sleep medicine became a shining example of an integrated, interdisciplinary health domain. Of course, not everything is perfect, and much progress is needed before optimal dental care can be provided to the greatest number of SDB patients in need.

FUTUREfocus


Gilles Lavigne, DMD (U Montreal, Canada), PhD (U Toronto, Canada) and FRCD (oral medicine, Georgetown U,

USA) completed a postdoctoral training on the neurobiology of pain at NIH, Bethesda. He received a Doctor ho-

noris causa from the Faculty of Medicine, University of Zurich (April 2009). He currently holds a Canada Research

Chair in Pain, Sleep & Trauma and is Dean of the Faculty of Dental Medicine at the Université de Montréal. He is

the Past President of the Canadian Sleep Society and currently the president elect of the Canadian Pain Society. He

is the co-founder and past director of the 3 research networks in Oral Health, Pain and Placebo Mechanisms of the

Fonds de la Recherche en Santé du Quebec and the Canadian Institutes of Health Research (CIHR). He was also

the co-director of the training grant Pain M2C of the CIHR. Internationally recognized for his experimental and clinical researches

on sleep bruxism and the interactions between sleep, pain and breathing disorders, Dr Lavigne is conducting studies on: 1) the role

of sleep on placebo analgesia, 2) the influence of airway on sleep of teenagers with craniofacial malformations and, 3) sleep and pain in brain injury patients.

Conflict of Interest: No Commercial Share; Royalties received for book publications (Quintessence and IASP Press); Research grant and salary (governments of Canada and Quebec: CIHR, CFI, CRC, FRQS), oral appliances provided free of charge for research

protocols (ResMed; Somnodent).

Adapted from Mayer P et al, Chest, 2015

Table 1: A nonexhaustive list of conditions to screen for in dental sleep medicine

Sleep Disorders that may overlap in your patients:

Snoring

Sleep-disordered breathing, such as obstructive sleep apnea, apnea-hypopnea syndrome, respiratory ef-

fort-related arousal (RERA), etc.

Periodic limb movements with or without waketime restless leg syndrome

REM behavior disorder (RBD) with risk for severe neurological disease

Sleep epilepsy, which may be concomitant to tooth grinding in some patients

Sleep gastroesophageal reflux, observed in both sleep bruxism and sleep-disordered breathing patients

Sleep walking (somnambulism )

Sleep talking, sleep enuresis (a triad with sleep bruxism in children)

Headache: sleep-related (e.g., associated with sleep apnea or bruxism), hypnic, cluster, tension, or migraine

Orodental

Sleep tooth tapping, which is most frequently idiopathic. You may need to exclude sleep epilepsy and RBD.

Sleep bruxism, frequently reported during the night. Observed or measured jaw movements that most of us confuse with sleep bruxism are mainly rhythmic (i.e., repeated rhythmic masticatory muscle activity episodes over the sleep period).

Waketime tooth clenching. In this case, the patient is aware of clenching.

Reactive tic or habit such as frequent non-functional tooth contact during waketime (it is not considered

clenching, due to the low force used) or tongue pushing

Waketime nail or object biting, another oral tic or habit

Large tonsils or adenoids (in the latter case, they cannot be seen with a simple mouth inspection)

Large tongue with or without scalloping

Small oral box (small upper or lower jaw or retrognathia, flat palate, or deep and narrow palate)

Other conditions

Sleepiness during the daytime (while at work, driving, reading, watching TV, etc.)

Cognitive alterations, including mood, memory, and other behavioral changes

Temporomandibular disorders and orofacial pain

Allergies

Attention deficit hyperactive disorder (ADHD)

Addiction

Parkinson’s disease, oromandibular dystonia-dyskinesia

Other conditions under investigation

16

Some clinicians continue to view dental sleep medicine as a jackpot field. More ratio-nally, most of us realize that sleep medicine is a demanding domain of dentistry. Patients with sleep disorders have special needs and specific expectations that require a different approach than the usual dental-tooth-periodontal care. In restorative dentistry, we focus on the

immediate outcome. In other words, we fix problems that we can see in front of us. In contrast, SDB management requires us to shift this modus operan-di to pursue a more long-term objec-tive of patient wellbeing. In SDB, the patient is the central figure, and we inform and guide patients according

to their expectations, beliefs, and medi-cal and socioeconomic situations. In sleep medicine, improved health ap-

pears to be better achieved by: 1. active patient involvement in manage-

ment, such as diet, exercise, and sleep hygiene

2. high patient compliance in the use of mechanical tools such as oral applianc-es and continuous positive airway pres-sure (CPAP) or sleep position devices

3. in some cases, physical or myofunc-tional therapy and psychology, such as cognitive behavioral therapy (CBT), or nerve stimulation to open the airway, or corrective surgery on the nose, maxil-lary, or upper airway.

So far, no medications have been recog-nized or approved as treatments for managing SDB, except for patients who are living at high altitudes.

Oral appliances, albeit considered the second choice after traditional CPAP devices for SDB management, have been suggested to be equally effective in the long term for re-ducing morbidity and mortality (Young D and Collop N, Curr Treat Options Neurolo 2014; Anandam A et al, Respirology 2013; Bratton DJ et al, JAMA 2015). However, this signifi-cant finding needs to be replicated to reassure those who remain skeptical about the benefits. As scientists, we are skeptical by nature and by training.

The fact that both oral appliances and CPAPs are mechanical methods that work by improving airway function during sleep raises questions in my mind. Are they not only the best but also the only effective methods for pre-venting or improving SDB, including the conse-

quences for health? The future of these devices in sleep medicine remains an open question, and particularly when we consider the substan-tial burden of SDB in terms of health and med-ical costs. Simple cases need to be identified early in life (i.e., in children), and preventive ac-tions need to be taken to avoid more extensive care in adults with high medical risks or those who hold decision-making positions requiring alertness and fully cognitive functioning, such as aircraft pilots, finance investors, surgeons and... politicians. Children with craniofacial syndromes such as Pierre Robin or with recur-rent infections or metabolic syndromes should receive comprehensive early treatment (Tan HL et al, Sleep Med Review, 2015).

Moreover, the value of orthodontics and preventive or corrective surgery to treat ob-structive sleep apnea in children is debat-able. Most children with retrognathia and narrow palate appear to benefit from palatal expansion and improved airway. However, adenotonsillectomy is not a panacea for all children. It was recently shown to improve obstructive sleep apnea in only 25% of chil-dren, and in only 10% of obese cases (Koren D et al, CHEST, 2015). This finding suggests that certain phenotypes (i.e., physical and bio-chemical characteristics and their interactions with genetics and the environment) need to be identified to predict best outcomes in a given SDB population. This approach is called preci-sion medicine (PM), as described below.

Precision medicine in dentistry: From a one-size-fits-all paradigm to an advanced decision-making process

In the last three decades, the dentistry field has introduced innovations that are at once amazing and polarizing. They include im-plants, aesthetic dentistry, 3D imaging, elec-tronic aids, and restorative dentistry tools such as periodontal biomaterials. Gene and im-mune mediators for diagnosis and therapeu-tics are also gaining ground, and although it is generally recognized that they cannot resolve all issues, they have opened up promising ave-nues for future interventions.

It is well known that patients differ in terms of biological and environmental risk factors. Hence, more integrated and intelligent phe-notyping (e.g., morphology, familial history, health status and life style, genetic and im-mune biomarkers) is needed to help estimate the probability that cluster risk and predicted

DSP | Summer 2016

FUTUREfocus

success factors are associated with the highest outcome probability.

Wikipedia currently defines Precision Medicine (PM) according to the National Re-search Council’s vision, as follows: Precision Medicine refers to the tailoring of medical treatment to the individual characteristics of each patient. It does not literally mean the creation of drugs or medical devices that are unique to a patient, but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular dis-

ease, in the biology and/or prognosis of those diseases they may develop, or in their response to a specific treatment. Preventive or therapeutic interventions can then be concentrated on those who will benefit, sparing expense and side effects for those who will not. Although the term ‘Personalized Medicine’ is also used to convey this meaning, that term is sometimes misinterpreted as implying that unique treatments can be designed for each individual (https://en.wikipedia.org/wiki/Precision_medicine).

Bearing this in mind, dentists may tend to do what they feel is best based on their own beliefs. However, beliefs and convictions are not supposed to be

the modus operandi of medical professionals, and decision making in dentistry should not involve gambles. Healthcare decisions should be based on the best available evidence and assessments of the benefits and risks for the patient as well as the patient’s capacity. In this case, capacity refers to the patient’s medical condition, age, and socioeconomic situation. It does not mean the dentist’s capacity to say, “I think so,” or “I’m telling you!” In PM, a growing number of tools are available for use by doctors, not as disinterested technicians, but in order to make decisions in collabora-tion with the patient.

These tools include molecular diagnostics (currently under development; e.g., Nizan-kowska-Jedrzejczyk A et al, J Clin Sleep Med 2014; DeLuca Canto G et al, Sleep Medicine 2015), imaging (already used to improve air-ways, with brain imaging developments ex-pected), and analytical software (see a prelimi-nary model in Trenaman et al, Sleep Breathing, 2015). Algorithm-based analytical software will allow sharing information stored in large databanks to help fine-tune tools such as phe-notyping for decision making. This approach

also raises new ethical issues to consider, and patients’ consent will be required.

It is worth repeating here that the use of an apnea-hypopnea index (AHI) alone is insuffi-ciently reliable or predictive of the health risks when selecting a treatment and assessing out-comes. This index should be used as a guide, and not a hard-and-fast rule. If assessments of hypoxia and autonomic activity along with the patient’s risk factors and medical and familial history are missing, we may find ourselves in a blurry situation of maybe yes, maybe no. I call this the gray area of patient assessment. Other challenges include too many false negatives in at-risk cases, too much variability in one-night recordings due to AHI fluctuations over time in mild cases, and lack of interest in the role of intermittent hypoxia on morbidity and mor-tality (Cairns A et al, J Clin Sleep Med, 2014; Punjabi NM et al, PLOS 2009; Punjabi NM, CHEST 2015).

We also need to gain a deeper understand-ing of phenotyping. We must be aware that certain psychosocial, anatomical, biological, and clinical risk factors are frequently clus-tered in certain population subgroups. This calls for more precise diagnostic and treat-ment decisions. For instance, a recent study on the benefits of PM found that patients with re-sistant hypertension showed a better response (i.e., reduced blood pressure) when treated with a CPAP within a cluster of patients hav-ing 3 (plasma) mRNA (Sanchez-de-la Torre, M et al., J Am Coll Cardiol, 2015).

Dentistry cannot progress without embrac-ing modern biotechnologies that incorporate our clinical examination findings, are valid, and are accessible. If they are too costly, they will not be accessible. Furthermore, no ma-chine can replace the dentist’s role in patient diagnosis, or the personal input required to manage treatments and to inform, reassure, comfort, provide relief to, and follow the pa-tient. A sleep recording device can assist in the decision-making process and help guide management planning. We can look forward to more precise methods and tools in the fu-ture as well. Nevertheless, most methods and tools involve an inherent degree of uncertainty. Based on my experience, I expect from 5 to 30% false positives or negatives with any new approach. For example, a large population study on patients who underwent screening and portable recording suggests the need for personal attention to patients with a history of


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insomnia, stroke, and/or lung disease and with a low apnea-hypopnea index (Cairns A et al, J Clin Sleep Med, 2014). Although oral applianc-es are used in combination with more precise monitoring tools to manage SDB, the patient’s medical history and any new medical events should always be taken into consideration.

Evidence-based and Management Approaches

It is a no-brainer that dentists should select the best management approach. This could include screening, a physician’s diagnosis, or treatment with an oral appliance, CPAP, or surgery, always based on the strongest avail-able evidence.

In the presence of SDB, recent guidelines recommend that sleep physicians should pre-scribe oral appliance therapy administered by a qualified dentist (Ramar K et al, J Cli Sleep Med, 2015). This recommendation is based on the literature and consensus between the phy-sician and dentist. However, although consen-

sus guidelines are great tools that help us share a common language and strat-egies, they are not completely free of bias, and their relevance may have a short shelf life as new evidence emerges. They are meant as guides, and not definitive prescriptions for

SDB management. It is important to re-tain a critical stance in order to select the

best treatment in a professional manner. It is where PM and evidence based medicine

are coming important.What is more, recent guidelines are silent

on what to do when patients present oth-er dental conditions or comorbidities. In the presence of sleep bruxism alone, that is, with no evidence of SDB or insomnia, we must assess the role of bruxism in pain or head-ache onset or recurrence, tooth damage, and quality of life. At that point, we may have to decide that a referral to a sleep physician is or is not necessary. But what if you suspect that SDB, sleep bruxism, insomnia, or tooth tapping (which is a sign of potential sleep- related epilepsy or RBD, a neurodegenerative condition)? Incidentally, the so-called inter-relationship between sleep bruxism and SDB needs further corroboration, as concluded in a recent review (Mayer P et al, Chest 2015).

Although a randomized control trial design is the strongest method for initial assessment of the effectiveness and advantages of new

treatments, we should remember that in the case of medications, most trials are run by pri-vate firms in the aim of obtaining government approval, and they do not necessarily address actual clinical settings. Before adopting a new clinical procedure, it is essential to get a phy-sician’s professional opinion. We need to bal-ance the freshness of a new discovery with common sense. When a medication or device gets approved, data are provided to convince healthcare decision makers that there is a rea-sonable efficacy–safety ratio for a given popu-lation. However, only time and real-world fol-low-up will confirm the appropriateness and effectiveness of new treatments. Effectiveness studies are also known as pragmatic studies: they “examine interventions under circum-stances that more closely approach real-world practice, with more heterogeneous patient populations, less-standardized treatment pro-tocols, and delivery in routine clinical set-tings” (Singal AG et al, Clinical and Transla-tional Gastroenterology, 2014). These studies provide the most convincing evidence, but they take years to complete, and multicentre collaboration is needed to get enough subjects to participate for shorter periods. Should we wait years? Of course not! We have to decide on the best management strategy now, based on the patient’s condition, capacity (physical, psychological, and economic), and needs. I should remind you here that the government approval process for oral appliances differs from that for medications. It is much less rigor-ous. But again, we have to wait for long-term follow-up studies on effectiveness. Time is therefore a major limiting factor.

Comorbidities: Screening and Diagnosis Many dentists are surprised to find out that

we actually do not cure bruxism. Instead, we manage or reduce the consequences, includ-ing tooth damage, grinding sounds, pain, and headache. In this respect, it is similar to SDB management. However, patients frequently have comorbidities. So what should we do?

Some of your patients may have sleep breathing disorders that are associated with sleep bruxism or temporomandibular disor-ders (TMD). These may be coincidental, due to the patient’s age. This is known as interesting epidemiology. For example, children and teen-agers tend to grind their teeth, middle-aged women have a higher probability of TMD, and older patients have higher probabilities of

DSP | Summer 2016

FUTUREfocus

22

snoring and sleep apnea. We need to identify the patient’s phenotype (i.e., morphological, environmental, or genetic), comorbidities, and other risk factors. And we should keep in mind that no definitive causal associations have been found in the interactions between sleep breathing disorders and either TMD or bruxism. Do not fall for an attractive one-size-fits-all paradigm.

As dentists working in dental sleep medi-cine, we are responsible for being competent to provide a sound sleep medicine screening

and, when indicated, differential di-agnosis. We have the expertise to di-agnose sleep bruxism, orofacial pain, and TMD. Physicians, for their part, can diagnose other conditions such as SDB, insomnia, RBD, the causes of sleepiness and cognitive alterations during daytime, unstable hyperten-sion, unexplained headache, and so on. However, we should be able to recognize these conditions, screen for them, and request referrals for a final diagnosis. Table 1 presents a list of co-morbidities that you may come across. Please note that this list is not exhaus-tive. For instance, it does not include all the craniofacial syndromes.

Because not all physicians have expertise in sleep medicine, we are also responsible for referring patients to trained sleep physicians when there are potential risk factors (e.g., obesity, hypertension, sleepiness, retrognathia, mood and/or cognitive alterations, craniofa-cial syndrome). The screening tools that den-tists use are generally based on history, dental and oral examinations, questionnaires (Ep-worth for sleepiness, or Stop-Bang for apnea), or a combination (exam and questionnaire) with or without type 3 (three–four-channel) or 4 (one-channel) recording devices. Type 3 re-cording devices are economical and easy to use at home to monitor sleep breathing and jaw or leg muscle activity when a breathing disorder, bruxism, or periodic limb move-ments are suspected. They include just a few channels (for breathing, muscle activity, ox-ygen, and sometimes brain activity) and use intelligent software to guide the examiner to make a diagnosis. Nevertheless, no machine is perfect, nor can it replace a human health-care professional. The diagnosis falls within the doctor’s purview, and when SDB is at is-sue, the diagnosis should be made by a trained

sleep physician. Type 4 devices use one mus-cle channel (leg or jaw) or finger oximetry re-cording. This is fine for first-line detection and for rapid, low-cost CPAP or oral appliance monitoring. However, oximetry alone cannot discriminate central from obstructive sleep ap-nea, nor can identify the apnea or hypopnea events occurring in the absence of oxygen desaturation. For atypical and moderate-to-se-vere cases (mainly if a medical comorbidity is present, or if sleepiness or cognitive alterations are reported), a full sleep laboratory or home polysomnography system (type 1 or 2) under medical supervision is the ideal tool for scor-ing and diagnosis. Moreover, each time you collect biological signals with these recording devices, you are responsible for ensuring that the data are carefully read and interpreted by an expert in the field.

There has been much debate recently about the need for more and better SDB diagnosis and management, presaging a move from the expert physician-only paradigm to a more open approach, including minimally sleep-trained family physicians and nonphysicians. This possible change, if it ever happens, should take place in an organized fashion so as to im-prove early prevention and care for simpler cases (Phillips B et al. Am J Respir Crit Care Med. 2015). Again, this does not mean a free-for-all. Instead, this calls for the development of professional collaborations. Solo performances are counter-indicated in sleep medicine.

To improve your expertise in patient screening, I suggest the following:

• Take formal continuing education cours-es in sleep medicine, and not just in den-tistry, and attend medical sleep meetings to keep abreast of new developments.

• Join independent dental sleep academies.• Join a study club where dentists, phy-

sicians, and other sleep-related pro-fessionals (psychologists, respiratory technicians, etc.) can share their expe-riences and ideas.

• Fine-tune your expertise in recognizing comorbidities.

• Move on from the traditional silo den-tistry model and build a collaborative network. It will benefit both you and your patients in terms of health and quality of life.

N.B.: References cited and related abstract are available at: http://www.ncbi.nlm.nih.gov/pubmed/.

DSP | Summer 2016

FUTUREfocus

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Ignore the “M.D.” behind my name; in spirit I am a dental scientist devoted to dental sleep medicine. My heart and soul are focused on the massive public health problem we face in the epidemic of sleep disordered breathing (SDB). My advice: Read This

Article By Gilles Lavigne. It’s the best analysis of our current status and challenges, and it is clad in beautiful prose with touches of pure poetry. Don’t miss a word of it.

The article grapples with all of sleep medicine, traditional medical and dental. The thesis is deceptively simple, namely: practice “precision medicine”. To this end, we should “classify individuals to subpopulations that differ in their response to a specific treatment... so that therapeutic interventions can then be concentrated on those who will benefit, sparing expense and side for those who will not.” This is the gospel according to Gilles, and what a message it is, provocative and compelling.

The author spares no one and trucks no sacred cows. He asserts, for instance, that: AHI is a flawed parameter that pretends that oxyhemoglobin saturation is unimportant; that guidelines are guides, not laws, established by committee members with vested in-terests; and we have not established a causal link between bruxism or TMD and SDB. Heavy stuff and so right!

The article ends with sage advice for the practitioner: “move on from the traditional silo dentistry model and build a collaborative network”. Let’s get on with precision medicine.

Dental Sleep Medicine at a CrossroadsCan we seize the moment and join the precision medicine movement? by John E. Remmers, MD

This paper presents some personal thoughts, none of

which should be taken as final pronouncements at this

stage. My hope is to spark further thinking, open discus-

sions and relevant research in the field, as well as collaborations

with other healthcare professionals.

Thoughts on the Current and Future Practice of Dental Sleep Medicine

by Gilles Lavigne, DMD, MSc, FRCD, PhD

Currently, we are coping with major challenges in dental sleep medicine. We must be able to:

1. be aware of the complexity of sleep- disordered breathing (SDB) in order to make accurate screening or differ-ential diagnoses while taking into ac-count the impact of comorbidities on management planning (see Table 1).

2. understand the principles of precision medicine, a comprehensive, patient- centered approach.

3. improve access to healthcare, from prevention and screening to diagnosis

and treatment, in order to address this critical public health issue.

4. balance information obtained from evidence-based medicine and den-tistry with guidelines for daily clinical practice.

5. translate sleep society guidelines into practice and develop efficient up-dating strategies for the fast-moving world of sleep medicine.

The prevalence of SDB has risen dramat-ically over the past two decades, from 14% to 55%, depending on the patient group, i.e., age and gender who are also critical factors (Peppard PE et al, Am J Epidemiol 2013). Pre-vention and early detection of SDB are crit-ical due to the health consequences, which frequently begin in adolescence and peak in adulthood. These consequences include met-abolic alterations (higher fasting insulin and, blood glucose plus insulin resistance) as well as higher risks for cardiovascular morbidity and mortality, and accidents due to sleepi-


FUTUREfocus

After more than a quarter century, the field of dental sleep medicine is expanding and evolving at light-ning speed. We dental sleep medicine practitioners

are now granted the luxury of improved technology, recog-nition by physicians and third-party insurance carriers, and acceptance by patients.

So now what?The article by Dr. Gilles Lavigne leverages the unique

intellect and experience of one of our finest researchers, educators and thinkers. By choosing to publish this paper in a non-academic style journal, he steps slightly out of charac-ter but offers us a wonderful glimpse into our fast-changing field. He urges us focus on what he considers some major challenges such as the complexities of sleep disordered breathing, understanding the principles of a patient-cen-tered approach (Precision Medicine), improved access to address critical public health issues, balancing guidelines with evidence-based medicine and updating strategies for a fast-moving sleep medicine world.

He notes that sleep medicine has become a shining ex-ample of an integrated, interdisciplinary health domain but progress is needed before optimal oral appliance therapy can be provided to the greatest number of sleep-disordered breathing patients. As a jumping-off point, effective manage-ment of sleep-disordered breathing requires a shift from fix-

ing what’s in front of us to a longer-term objective of focusing on patient well-being.

Regarding treatment, Dr. Lavigne speaks of the impor-tance of identifying cases early in life and preventative actions needing to be taken to avoid more extensive care in adults. But when adults do need to be treated, the need to identify certain phenotypes to predict best outcomes in a given pop-ulation. Becoming known as precision medicine or personal-ized medicine (PM), he urges us to move from a one-size-fits-all paradigm to an advanced decision-making process.

The article goes on to underscore the reality that an ap-nea-hypopnea index (AHI) alone is insufficiently reliable or pre-dictive of health risks when selecting a treatment and assessing outcomes. Absent a keen understanding of hypoxia and auto-nomic activity along with other risk factors we are likely to land in a place he describes as “the gray area of patient assessment”.

The contemporary need for more and better sleep-disor-dered breathing diagnosis and management seems to be giv-ing rise to a move from the expert physician-only paradigm to a more open approach including minimally sleep-trained family physicians and non-physicians (dentists, for instance). Dr. Lavigne points out that this does not mean a free-for-all and suggests that integrity and responsibility must prevail through the development of professional collaborations.

Are we up for the challenge?

Commentary on “Thoughts on the Current and Future Practice of Dental Sleep Medicine” by Robert R. Rogers, DMD, DABDSM


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The majority of dentists are not well versed in sleep medi-

cine and related disorders. Studies have shown that many

dentists were not able to recognize the risks of sleep ap-

nea, let alone manage patients with oral appliances.1 By un-

derstanding the connection and interrelationship between the

airway, bruxism and craniofacial pain, you open your practice

to more areas of diagnosis and treatment that will help your pa-

tients live healthier, happier lives.

A Look at Sleep Disordered Breath-ing (SDB) – the Airway

Dental practices are in a unique position to identify patients at risk for SDB. Intra oral findings can be highly suggestive of such a condition (see figure). Once testing has been completed to evaluate a suspect compro-mised airway, the diagnosis may contain a combination of diagnostic details. A respi-ratory effort related arousal (RERA) is scored

when a series of breaths with an ever-in-creasing respiratory effort against a narrowed upper airway terminates with arousal from sleep before criteria for a true apnea or hypo-pnea event are met. Upper airway resistance syndrome (UARS) is the condition of exces-sive sleepiness associated with 10 or more RERAs per hour. Obstructive apneas and hypopneas are characterized by repetitive periods of complete (apnea) or partial (hypo-pnea) airflow reduction. The events must be at least 10 seconds in duration in association with respiratory efforts, and they usually end with arousal from sleep.

Understanding BruxismBruxism is a term used to describe gnash-

ing and grinding of the teeth that occurs with-out a functional purpose.2 Whether it is due to a nervous habit, stress or with no known cause, bruxism can cause a lot of damage to your patient’s teeth. In 2005, sleep bruxism

Airway, Bruxism and Craniofacial Pain: What’s the Connection? by Mayoor Patel, DDS, MS


MEDICALinsight

was categorized as a sleep related movement disorder and defined as an oral parafunction-al activity characterized by tooth grinding or jaw clenching during sleep, which is usual-ly associated with sleep arousals.3 Repeated episodes of bruxism produce microtrauma in associated structures. Dentists, of course, deal with the consequences: breakage of dental restorations, tooth damage, induction of temporal headaches and temporomandib-ular joint disorders (TMD).

Craniofacial PainCraniofacial pain covers a wide spectrum

of symptoms reported in many areas of the head and neck. Problems involving facial pain can include TMJ discomfort, muscle spasms in the head, neck and jaw, cluster or frequent headaches, or pain in the teeth, face or jaw. The majority of craniofacial pain complications can be associated with TMD.

As an essential part of the routine dental examination for all patients, the gold stan-dard for the diagnosis of TMD is based on the evaluation of history, clinical examination, and appropriate imaging.4 The Journal of the American Dental Association states 44% to 98% of TMJ problems are caused by trau-ma, with microtrauma hypothesized to be a cause of TMD because of its sustained and repetitive adverse loading of the masticatory system that occurs with sleep bruxism.5

The Connection and InterrelationshipThe connection between sleep disordered

breathing (airway issues), Bruxism, and TMD (craniofacial pain) is no longer a question of ‘if’. It is a question of proper evaluation and diagnosis by the dental and medical teams. However, it is essentially up to the dental cli-nician to determine this because it is the den-tist who is in the optimum clinical position to evaluate, refer, and possibly manage these issues that impact such a large percentage of the population.

With an evident relationship, we look to understand that clenching or grinding of one’s teeth may be a way for the brain to protect itself from suffocation during sleep. The screening process is important in help-ing us identify bruxism as either a cause of TMJ/Craniofacial Pain or a protective mech-anism – even though research is ongoing to fully link these findings. By keeping this link between the three conditions in mind as we

diagnose our patients, we can properly man-age each disorder without thinking of them as fully distinct.

It has become increasingly clear that den-tists involved in either sleep apnea, TMD or bruxism treatment should be knowledgeable in all three areas because the connection is evident.

1. Bian, Hui. “Knowledge, opinions, and clinical experience of general practice dentists toward obstructive sleep

apnea and oral appliances.” Sleep and Breathing 8, no. 2 (2004): 85-90.2. Bader G, Lavigne G. Sleep bruxism; an overview of an oromandibular sleep movement disorder. Sleep Med

Rev. 2000;4:27–43

3. Sleep related bruxism. In: International classification of sleep disorders: diagnosis and coding manual. 2nd ed.

Westchester, IL.: American Academy of Sleep Medicine; 2005:189-92.

4. McNeill, Charles, Norman D. Mohl, John D. Rugh, and Terry T. Tanaka. “Temporomandibular disorders: di-

agnosis, management, education, and research.” The Journal of the American Dental Association 120, no. 3

(1990): 253-263. 5. Camparis, Cinara Maria, and J. T. T. Siqueira. “Sleep bruxism: clinical aspects and characteristics in patients

with and without chronic orofacial pain.” Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology 101, no. 2 (2006): 188-193.

MEDICALinsight


Dr. Mayoor Patel has taken well over 1400 hours of postgraduate education courses in the area of Sleep Medicine, Craniofacial Pain, Sleep disorders and Ortho-

dontics. Since 2003, he has limited his practice to the treatment of TMJ Disorders, Headaches, Facial Pain, Sleep Apnea and Snoring.

Airway Airway management is the most predica-

ble in dental to medical cross-coding. Most medical insurers reimburse for the HCPCS code E0486 for a custom appliance to re-duce upper airway collapsibility when paired with the ICD code for Obstructive Sleep

Apnea (OSA), G47.33. It is import-ant to know what coverage criteria and documentation various medical insurers require supporting medical necessity; This criterion is in the med-ical insurer’s medical policies (clini-cal policy bulletin, local coverage determination, etc.), which are typi-cally located on their main website on their providers page. Criteria for medical necessity coverage can vary; for example, various commercial car-riers are now following the guidelines set by the Pricing, Data Analysis, & Coding (PDAC) contractor (currently Noridian Healthcare Solutions) for E0486. Because Medicare DME has

required PDAC approval for custom-made oral appliances for OSA for some time now, you will often hear this referred to as the “Medicare approved appliances.” What this means is that some commercial insurers re-quire appliance PDAC approval to be billed as E0486. The list of devices are on PDAC’s website, www.dmepdac.com. The current

criteria to meet PDAC approval as stated in the Medical LCD for Oral Appliance for OSA is below:

1. Have a fixed mechanical hinge (see below) at the sides, front or palate; and,

2. Be able to protrude the individual beneficiary’s mandible beyond the front teeth when adjusted to maxi-mum protrusion; and,

3. Incorporate a mechanism that allows the mandible to be easily advanced by the beneficiary in increments of one millimeter or less; and,

4. Retain the adjustment setting when re-moved from the mouth; and,

5. Maintain the adjusted mouth position during sleep; and,

6. Remain fixed in place during sleep so as to prevent dislodging the device; and,

7. Require no return dental visits beyond the initial 90-day fitting and adjust-ment period to perform ongoing mod-ification and adjustments in order to maintain effectiveness (see below)

A fixed hinge is defined as a mechanical joint, containing an inseparable pivot point. Interlocking flanges, tongue and groove mechanisms, hook and loop or hook and eye clasps, elastic straps or bands, etc. (not all-in-clusive) do not meet this requirement.

What does ABC (Airway, Bruxism, and Craniofacial Pain) have to do

with cross-coding from dental to medical insurance? Services for

two of these are typically reimbursed by health insurance and one

of them may be paid under certain circumstances.

Airway, Bruxism and Craniofacial Pain Cross-Codingby Rose Nierman, RDH CEO Nierman Practice Management

Items that require

repeated adjustments

and modification beyond

the initial 90-day fitting

and adjustment period

in order to maintain

fit and/or effectiveness

are not eligible for

classification as DME.


PRACTICEmanagement

Rose Nierman has been at the forefront of educating dental

practices on medical billing in dentistry, cross-coding and

the expansion of patient services for over 26 years. She is

the creator of DentalWriter™ Software and a CE provider

for CrossCoding; Unlocking the Code to Medical Billing

in Dentistry™. Contact Nierman Practice Management

at 1-800-879-6468 or www.NiermanPM.com.

Items that require repeated adjustments and modification beyond the initial 90-day fitting and adjustment period in order to maintain fit and/or effectiveness are not eligi-ble for classification as DME. These items are considered as dental therapies, which are not eligible for reimbursement by Medicare un-der the DME benefit. They must not be coded using E0486.”

That brings us to Bruxism Billing for a bruxism appliance to medi-

cal insurance will very likely be reclassified as “dental treatment” – not as a medical necessity. There are two bruxism ICD codes to consider: G47.63 for “Sleep-related bruxism” and F45.8 for “Other somatoform disorders”, which include bruxism. Recent medical policies show that a “bruxism” diag-nosis may be reimbursed for Botox when the patient has “painful bruxism”. For example,

Aetna’s general medical policy titled “Botuli-num Toxin” states that:

“OnabotulinumtoxinA (Botox Brand of Botulinum Toxin Type A): Aetna considers onabotulinumtoxinA (Botox) medically necessary for any of the following condi-tions: V. Painful bruxism”

Craniofacial Pain Cross-CodingThe biggest barrier dental practices en-

counter in TMD/craniofacial pain reimburse-ment is the absence of a narrative report of medical necessity, written by the dentist, and sent with the claim or the preauthorization. A well-written narrative report based on a detailed history taking and exam is a key to TMJ treatment reimbursement. Another fac-tor that will make or break a TMD claim is the selection of an International Classifica-tion of Diseases (ICD) diagnosis code that is covered based on the medical policies. While there are many ICD codes pertain-ing to a patient suffering from craniofacial pain to represent symptoms and conditions like facial pain, myalgia, headaches, tinni-tus, etc., most insurers will only consider the ICD codes that represent Temporoman-dibular Disorders (TMD) as the primary di-agnosis. These TMD diagnosis codes range from M26.60-M26.69. Thirdly, think about your language when calling for a “benefits check” and in your narrative report. Medical carriers want to see the medical necessity for TMJ disorder indicating, perhaps, a disc derangement diagnosis with head and facial pain to ensure that the treatment is medical in nature instead of a bruxism appliance to protect teeth.

The fact that over 35 states mandate TMJ treatment coverage under medical plans im-proves access to care. When TMJ services are covered, an exam, a panorex, the orthotic and follow-up visits are typically reimburs-able. A TMJ appliance is referred to as an “orthotic” or “jaw repositioning appliance” to treat the condition, not a bite “guard or an occlusal splint” designed to protect the teeth.

Incorporating Airway, Bruxism and Cranio- facial Pain services increases the services your practice offers. Learning the latest trends in successful reimbursement helps your practice, but more importantly, your patients with life-changing treatments.

The biggest barrier dental

practices encounter in

TMD/craniofacial pain

reimbursement is the

absence of a narrative

report of medical

necessity, written

by the dentist,

and sent with the claim

or the preauthorization.


PRACTICEmanagement

The Apnea Guard has greatly improved, and changed the way I work with physicians. An evidence-based approach to medicine is the cornerstone of the clinical medical prac-tice, and the Apnea Guard provides a way to interface with my medical colleagues on this level like never before. Thanks to the solid clinical evidence from our validation studies showing equivalency of the Apnea Guard to a custom appliance, the hurdles I used to encounter with my docs have begun to come down. In a short period of time I have gained their total trust now by proving OAT will work before ordering a custom ap-pliance. Many docs who were skeptics about Oral Appliances before have now been con-vinced by the logic of “pre-qualifying” their patients for OAT! As you might guess, the Apnea Guard has become a bridge for me to physicians (and insurance carriers). Last year I made Apnea Guard an integral part of my MD outreach program.

I was asked recently asked what I be-lieve are the strongest benefits of the Ap-nea Guard System. That’s easy. First and foremost, the Apnea Guard was built to be a trial oral appliance, and this is its biggest strength. Our original plans for AG included the hospital where it could be fitted to OSA patient emerging from general anesthesia – a time of heightened risk for those patients. That is why the Apnea Guard was designed to be fitted easily by any healthcare worker so that we could reach those patients at spe-cial risk. As soon as it came to market, we realized it added value by providing dentists with a precision immediate treatment AND accurate treatment planning. Precision in the sense that the dentist can find the correct po-sition of the jaw for the most effective and rapid outcome possible, and that treatment can start now. Accurate in the sense that a responder to OAT can be identified immedi-ately using simple tests like HST while wear-

Is Apnea Guard®… becoming the New Normal to work with MDs?by Dr. Todd Morgan

“That’s fantastic! You can do that?” These were the

words of my physician colleague when he learned

that I could use the Apnea Guard trial appliance to

tell AHEAD OF TIME whether a custom oral appliance would

work for his patients. Now he is my number one referral for Oral

Appliance Therapy!

Apnea Guard catalyst scoop Retention materials mixed Retention material added to tray Material distributed evenly in tray

PRODUCTspotlight


ing the Apnea Guard on night one: BTW: One more new opportunity to cement the DDS and MD relationship, and AG has done that for me.

What do I love the most about the Apnea Guard in my hands? First of all, it’s easy, and I’m done fitting it in about 10 minutes. I love that I can capture a precise and predictable bite and jaw position, and then transfer that proven position without hassle to the cus-tom device in a simple lab process. I love that the Apnea Guard system, thanks to EZ Sleep In-Home Testing, is totally seamless to incorporate into your practice routines. And, since their program includes 2 nights of test-

ing each time they study a patient at home, you’ll have blended data that is more reflec-tive of true sleep patterns and best practices. All of their studies are interpreted by Board certified sleep docs so you get the real deal. In fact, if you use all of their DSM tools to identify, test and treat the OSA patient in your practice, it’s really hard to fail.

I love teaching my students how to use the Apnea Guard because I know it will mean success, whether they are new to DSM or more advanced, saving time, appoint-ments spent on titration, and overhead dol-lars. It makes the apnea conversation with your patient easier, too. Because of a special offer from EZ Sleep, there’s very little to lose in offering a no-cost AG Trial to your patients. My final thought almost always returns to the awesome ability to help my most desperate patients feel better NOW. “Mrs. Jones, I think we can begin helping you with your apnea starting tonight,” and as I wait for the smile to happen.

For more information on incorporat-ing an Apnea Guard trial appliance pro-tocol to increase your MD referrals, case patient acceptance and treatment outcomes, please contact EZ Sleep In-Home Testing at [email protected] or [email protected].

Dr. Todd Morgan is board certified in Dentistry and Dental Sleep Medicine. Dr. Morgan graduated from the Washington University School of Dental Med-

icine in 1985, promptly returned to his hometown San Diego and began his practice in 1986. Dr. Morgan is internationally recognized as an expert in the

field of Dental Sleep Medicine and has completed several clinical research studies and published many scientific papers on the treatment of snoring, sleep apnea, and headache with dental devices. Dr. Morgan is a co-inventor

of the Apnea Guard. He has no ownership interest in EZ Sleep and receives no royalties from sales of Apnea Guard.

The dentist can

find the correct

position of the

jaw for the

most effective

and rapid

outcome

possible, and

that treatment

can start now.

Adjustment Apnea Guard fitting Log settings Finishing in water


PRODUCTspotlight

Is it an in lab test, a home sleep test, or are you looking at the CPAP titration?

The first thing you need to determine is what type of study report you are looking at. You want to be looking at a baseline study, not the CPAP (continuous positive airway pressure) titration. Here are the different types of studies:

1. Inlab polysomnogram, or PSG. This is the gold standard test and is performed with the patient going to a sleep lab, getting wired up, and spending the night in the lab while a technician at-tends the study.

2. A “home sleep test” or “out of center sleep test” (OCST). These are small devices that are usually sent home with the patient or sometimes mailed to them. They usually consist of a pulse-oximeter, 1 or 2 strain gauges, and a nasal cannula. Some home test units can also measure brainwaves or have another means to determine if the patient is actually asleep or not (most home units only assume the patient is asleep…making them less accurate).

3. A “split night study.” This is an inlab PSG where the first part of the nightis the diagnostic phase, and then, IF the patient shows significant sleep apnea, the patient is awoken and placed on CPAP. The rest of the night is used to find the optimal CPAP pressure to treat the sleep apnea.

4. CPAP titration study. This is an inlab PSG where the entire night is used to adjust the CPAP. Usually in these re-

ports there will be an initial sentence about what the baseline PSG showed.

Once you know that you are looking at the baseline PSG or OCST, here are the things you want to look for:

1. AHI: What was the overall Apnea/Hypopnea Index (AHI)? The AHI is the measure of how bad the patient’s sleep apnea is. The scale of AHI is:• < 5 = normal in an adult. (In a

child > 1.5 indicates clinically sig-

nificant sleep apnea)• 5-15 = mild• 15-30 = moderate• > 30 = severe

Now, let’s take this AHI number and break it down a bit. Obstructive apneas and central apneas are added together to get the “A” in the AHI. Central sleep apnea is where the brain doesn’t tell the person to try to breathe. [As a brief note, pure central sleep apnea is very, very rare, BUT if you ever see a patient with a high percentage of central sleep apnea, instead of obstructive, you will want to review the goals of oral appliancet herapy with their physician, as oral appli-ance therapy typically will not affect central sleep apnea — neither does CPAP.] Hypo-

pneas are the “H.” A hypopnea is a reduction in ventilation by at least 50% that also results in a decrease of the O

2 saturation by 4% or

more. In other words, a hypopnea is shallow

by Jamison Spencer, DMD, MS

Sleep study reports come in a lot of variety. Some reports will be “just the facts.” Others will have TONS of data. Here are the things that are important for us to review as dentists, and what we should point out to our patients.

How to Read a Sleep Study Report

CLINICALfocus


So why do we care?

I believe it is

important to show

the patient what

is going on with

them so that they

better understand

their problem.

34

breathing that results in desaturation. These are usuallyo bstructive in nature, like partly kinking a hose, but not completely blocking the flow.

I enjoy showing the patient the difference between an apnea and a hypopnea by draw-

ing on the back of one of the forms. I say, “in the sleep lab, or in you rhomestudy, you had a nasal cannula in your nose. Normally when you see these things they are to givesomeone extra oxygen. In this case, the cannula was measuring your breathing in and out. On the computer screen it would look like this:

I’ll tell the patient that this, an apnea, happened “X number of times” throughout the whole night. This number will usually, but not always, be in the report. This is not the “index” but the actual number of obstructive and central apneas that occurred throughout the night. If the number of apneas is not specified in the report, then you can’t show this.

I will then show the patient what a hypopnea would look like on the computer screen in the sleep lab:

I’ll tell the patient that this, a hypopnea, occurred “X number of times” throughout the whole night.

By showing the patient the difference between an apnea and a hypopnea, it helps them to understand their problem better, and makes the severity of their sleep apnea make more sense… because the AHI does not tell the whole story.

Speaking of story, here’s a little mathe-

matical story problem for you:Patient A’s study shows that he had 60

obstructive apneas throughout the night. He had 30 hypopneas throughout the night. He slept 6 hours total. Therefore his AHI is (60 + 30) / 6 = 15.

Patient B’s study shows that he had 30 obstructive apneas throughout the night. He had 60 hypopneas throughout the night. He slept 6 hours total. Therefore his AHI is (30 + 60) / 6 = 15.

Wait a second! They both have an AHI of 15 eventhough one had half as many actual episodes of stopping breathing? Yep!

Now let’s take this to the extreme. What is the AHI if the patient had 180 apneas for the night, 0 hypopneas for the night, and slept 6 hours? (180 + 0) / 6 = 30.

What is the AHI if the patient had 0 apneas for the night (literally NEVER stopped-

breathing), 180 hypopneas for the night, and slept 6 hours? (0 + 180) / 6 = 30.

What? So BOTH of these patients have“ severe sleep apnea,” even though the second one NEVER stopped breathing?! That’s correct.

So why do we care? I believe it is import-ant to show the patient what is going on with them so that they better understand their problem. If you are told that you have severe sleep apnea and that you stop breathing 30 times per hour, but your wife of 20 years says that she has only rarely noticed you stopped breathing, are you going to believe the report? Probably not. So it is important to explain to the patient that even though they have been told that they “stop breathing X times per hour” (which is what they will think the AHI is) that they don’t actually completely stop breathing all of those times (unless of course they have 0 hypopneas throughout the night).

It’s also important for us to look at this as I believe, through experience, that we tend to have an easier time treating patients with more hypopneas than apneas. That doesn’t mean that we don’t treat people with lots of apneas, but it just means that we might “low-

er their expectations” a little of oral appliance therapy completely resolving their apneas.

Jamison Spencer, DMD, MS is the Director of the Center

for Sleep Apnea and TMJ in Boise Idaho, and the Director

of Dental Sleep Medicine for the 24 practices of Lane and

Associates Family Dentistry in North Carolina. He is adjunct

faculty at Tufts University, University of the Pacific, and the University of North Carolina at Chapel Hill. Dr. Spencer

teaches mini-residencies in Dental Sleep Medicine at Tufts and UOP, and

lectures around the world on Dental Sleep Medicine and TMD. He is a Dip-

lomate of the Board of Dental Sleep Medicine, a Diplomate of the Board

of Craniofacial Pain, the inventor of an FDA approved oral appliance, and

recently launched the “Spencer Study Club“ as an online education and

mentoring resource to help dentists take Dental Sleep Medicine and TMD

to new levels in their practices. For more information go to www.Jamison-

Spencer.com, or email Dr. Spencer at [email protected].

DSP | Summer 2016

CLINICALfocus

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36

2. Sleep Position: In conjunction with the AHI you will also usually find in-

formation about sleep position and the AHI when the patient is sleeping supine versus on their side. For most peopletheir obstructive sleep apnea is worse on their back (supine). For some people you will notice that their prob-

lem almost exclusively occurs when they sleep supine. When you notice this, you should talk to the patient about this fact and encourage them to sleep as much as possible on their side, including once they get their oral appliance.

3. O2 Saturation: What is the O

2 satu-

ration nadir (lowest point), and how much time didthe patient spend with an O

2 saturation below 90%?

This is a pretty obvious one to us as to why it is important. However, most patients will not realize what the O

2 saturation means. Ex-

plain to them that our blood O2 levels, atthis

elevation, should be above 95% most of the time. Explain that if they were in a hospital and their O

2 level went below 90, alarms

would go off! Then tell them that their O2

level dropped to a low of X and was below 90 X% of the night.

4. Sleep Stages: How much time the patient spent in the different levels of sleep during the study. Non REM sleep stages are referred to as N1, N2 and N3. Here are the“ ideal” percentages:• N1 is “light sleep” or “transitional

sleep.” This should only account for about 5-10% of the total sleep time.

• N2 is “restful sleep.” This should be about 45-55% of the total sleep time. When people have reduced deep sleep and REM sleep, they usually have increased N1 and N2 sleep.

• N3 is “deep sleep” or “slow wave sleep.” This should beabout 10-20% (much more in children, and becomes less as we get older).

• REM is Rapid Eye Movement sleep, or “dreamsleep.” We should have about 20-25% of our sleep be REM sleep. In REM sleep the muscles have much less tone (some will say paralyzed), and as such obstructive sleep apnea tends to be worse in REM sleep.

While there are a lot of things that are fascinating about how sleep works, here are the simple things you need to know and share with your patients.

First, if they have reduced deep sleep (N3) they will feel physically tired. They may also have muscle pain, or even “fibromyal-gia” type symptoms.

Second, if they have reduced REM sleep they will feel mentally tired. They may also have memory problems and a “clouded intellect.”

For some of our patients youwill be the first one to go over the baseline sleep study with them. For many of our patients it was months or years ago that their doctor re-

viewed their sleep study with them, so they have likely forgotten much of the informa-

tion. Going over this information with the patient will help them, and you, to under-stand their problem much better and make them, in my opinion, more likely to stick with treatment.

Each sleep lab and sleep doctor will present their data a little different, but you should be able to find the above information in all sleep studies and help the patient to understand it.

We DO NOT base our appliance selec-

tion on any of this information. ALL oral appliances work the same way… they keep the mandible from falling back, or keep it slightlyf orward. The data WILL help us to know how bad the patient’s obstructive sleep apnea is so that we will better know how to treat them and how important it will be for them to return to their physician for objective follow up and adjustment of the oral appli-ance in the sleep lab.

Follow Up Sleep StudyI believe that ALL patients should be re-

ferred back to the referring physician (the one who wrote the prescription for the oral appliance) for consideration of a follow up sleep study with the oral appliance in place. IF the physician does decide to have a follow up sleep study, I also believe that it is ideal to have the appliance adjusted in the sleep lab by the sleep techs (you will normally need to teach them how to do this and have written protocols for this).

When comparing a baseline study to a follow up study, make sure that you compare apples to apples, and look for:

DSP | Summer 2016

CLINICALfocus

For some of our

patients you will

be the first one

to go over the

baseline sleep

study with them.

• PSG to a PSG is apples to apples, buto How long has it been since the

last PSG?o Were both studies at the same lab?o Were both studies read by the

same doctor?• PSG to HST, or HST to PSG = not

apples to apples = tough to make conclusions

• HST to HST maybe apples to apples, buto How long since the last HST?o Is the same HST device being used

(if not, probably not apples to apples)?

Once you understand the differences between the technical aspects of the baseline study versus the follow up study, look for the following things that may be different from the baseline study to the follow up study:

• How long has it been since the base-

line study? Sleep apnea usually gets worse as we get older.

• Has there been any weight gain? Sleep apnea usually gets worse with weight gain.

• Different sleep posture? Sleep apnea is usually worse in the supine position.

• Look at more than just the AHIo Was there a change in the number

of apneas?o Was there a change in the number

of hypopneas?o Was there a change in the average

O2 saturation? The nadir?

I have had several patients that prior to me referring them back to the physician for consideration of a follow up sleep study with adjustment of the appliance in the sleep lab, the patient reported feeling fantastic and hav-

ing a major improvement of their snoring. However, when they went in for the follow up sleep study the report came back that they didn’t do as well as I would have liked. In almost all of these cases I was able to com-

pare the baseline study to the follow up study and find the reasons that we didn’t see a big change in the AHI, eventhough the patient felt much better. The most common things I’ve seen that made the follow up study num-

bers not a sgood as I would have liked were:• It had been 5 or more years since the

baseline study.

• The patient had gained significant weight.

• The patient slept mostly non-supine on their baseline study, and mostly on their back on their follow up study.

The bottom-line is that it is important for us as dentists to understand what is present-ed in sleep study reports AND when follow up studies are completed to make sure that we compare the follow up study to the base-

line study, and make sure that our objective data appears to be consistent with the sub-

jective data of what the patient is reporting to us.

CLINICALfocus


The Unforgettable Story of Dan and Trina Webster

From A toreadily available and known by the consumer community. Dan never would have had to go through the unsuccessful surgery in the first place. Dan and Trina decided to embark on a personal mission to investigate snoring appliances, become more aware of the best options, and then focus on educating con-sumers like them. They found that there really wasn’t an easy-to-use, affordable option avail-able and decided to create their own. In 2008, working in conjunction with a renowned rep-utable dental sleep practitioner, an engineer, and using Dan’s own background as a gifted sculptor, the ZQuiet consumer appliance was born along with their company, Sleeping Well LLC. Money was raised, a patent was secured, and FDA clearance was granted.

Seven years later, ZQuiet is the leading consumer brand in snoring treatment. Dan and Trina’s mission of educating the con-sumer community on the concept of Oral Appliance Therapy has been realized through TV, radio, and social media, reaching mil-lions of Americans.

But the story does not end there!Recognizing the correlation between

snoring and sleep apnea and its association with numerous medical risks, a new mission arose. It’s hard to believe, but an estimated 22 million consumers suffer from sleep apnea, and a whopping 85% are undiagnosed.

Working in conjunction with John T. Herald, DDS, a 20-year veteran in sleep dentistry, Sleeping Well, LLC entered the dental sleep medicine market with a custom oral appliance created to treat both snoring and sleep apnea, obtained FDA 510k clear-ance, and the ZQuiet Pro Plus was launched. Now Dan and Trina could communicate the correlation between snoring and sleep apnea to their formidable customer base as well as the consumer community as a whole. They could not only encourage these people to be screened and tested for sleep apnea, but also extend their trusted line of appliances, keep-ing it all in the family.

To assist Dental Sleep Practitioners increase the number of sleep cases and grow their

Dan and Trina Webster understand the torment felt by sleep- deprived people. Dan’s incessant snoring resulted in sleepless nights for Trina, and the couple’s frustration

escalated dramatically when their first daughter, Hannah, was born. The old cliché “banned to the living room couch” be-

came a nightly routine, and the baby and new mom’s sleep still were disturbed by his snores even a room away. Dan’s personal journey resulted in an unforgettable story. While looking for a solution for the Webster family, the couple have become true leaders in the sleep appliance marketplace. Now, each night more than a half a million consumers place their ZQuiet sig-

nature snoring appliances in their mouths, transforming their nights from incessant intolerable snoring to a world where, “all through the house, not a creature is stirring not even a spouse!”

Dan’s quest for a resolution was first to visit his primary care physician in the small Vermont town where they lived – and on to a specialist who recom-mended elective airway surgery. The recovery was lengthy and painful. Since the surgery was not covered by insurance, it was also very expensive. But what hurt the most was after a few weeks, the snoring returned – just as badly as before.

The family was at a loss about what to do next. Determined to find a solu-tion, Dan learned about oral appliance therapy, tried a mandibular advance-ment device, and the Webster’s lives literally changed overnight! Dan and Trina were surprised that this simple straightforward option wasn’t more



ORIGINstories

practice, they are creating a national dentist locator. This patient marketing program will fully leverage the expansive consumer reach ZQuiet has with snoring – they have over a half million existing customers – by listing trained sleep dentists on their website. Webster notes, “For us, it’s simple. We want to get as many people screened, tested, and treated as possi-ble. Connecting consumers with trained dental sleep medicine practitioners is further helping our mission of better sleep and better health.”

Recognizing the importance of providing a complete continuum in oral appliance ther-apy, Dan continued to develop appliances to meet the diverse needs of the individual patient and the preferences of the dental sleep practitioner. Beyond the introductory, interim device, ZQuiet offers a complete line of professional lab-fabricated custom appli-ances: ZQuiet Pro-Plus, ZQuiet Pro Herbst, and ZQuiet Pro Flex.

The ZQuiet S.A. Interim Appliance is a breakthrough product. It is highlighted on page 46 in DSP’s product spotlight section.

As Webster states, “The innovative ZQuiet S.A. offers a temporary but immediate solu-tion to both the newly diagnosed and those currently in treatment. Our goal in develop-ing the ZQuiet S.A. was to provide a prod-uct that fills the important need of offering immediate relief for patients as part of a con-tinuum of uninterrupted patient care in their treatment protocol.”

The ZQuiet S.A.’s open tray design requires no boiling, molding, forming, or impressions, requiring virtually no chair time, which cre-ates efficiency in the practice and time to see more patients. The device retention is cleverly created by the resilient hinging, which gently keeps it in contact with the dentition. Webster notes, “The beauty of the device’s simplicity is that it doesn’t compete or take the place of the custom appliance so there is no risk of losing the sale of the custom appliance. Dentists appreciate the health value of using a temporary appliance to provide immediate patient relief. Additionally, the price point is so low, they don’t even hesitate to fold the cost of the device into the treatment, provid-ing a nice value-add to the patient.”

Regarding the ZQuiet Pro-Plus, Pro Herbst, and Pro Flex

“We researched the market and deter-mined that the traditional dorsal fin and

Herbst style devices were the most popular and preferred appliances by both the prac-titioners and patients alike. With the ZQuiet Pro Plus and the ZQuiet Pro Herbst, we now offer both of these popular appliances in our product line at a very competitive price.” Both are available in hard or soft linings and can be customized to meet the dentist’s per-sonal build specifications. The ZQuiet Pro Flex is the lightest and thinnest lab appliance available and is nearly invisible when worn. The advanced thermoplastic is stronger than acrylic which allows the appliance to be built with minimal bulk, and it is stain and odor resistant.

The tried and true designs of the ZQuiet Pro Plus and ZQuiet Pro Herbst devices are not unlike the appliances dentists may be ordering currently. The biggest differ-ence is that ZQuiet widely markets OAT to consumers through national TV, radio and Internet marketing programs. Dental profes-sionals can leverage the awareness created by ZQuiet to provide custom OAT devices where they are prescribed.

Final ThoughtsAs the Managing Editor of Dental Sleep

Practice magazine, and as the founder of the Pride Best of Class Technology Awards, I am exposed to hundreds of dental com-panies every year. Every once in a while, a company comes along that really gets it right. One that is driven to make a differ-ence; that is totally dedicated to its products and its cause. One that makes you proud to be a customer. Such a company is ZQuiet, and more specifically, Dan and Trina Web-ster. Their appliances are well thought out and beautifully constructed combining science with the esthetic eye of a sculptor. They stand by their work and their untir-ing mission to improve the quality of life of their customers. They are not a billion dollar company with a sleep appliance line, nor a multinational public company. They are the kind of company that is totally dedicated to its dentists, and one any of us would be proud to be involved in. If you are attending AADSM, drop by booth 412, or pick up the phone and call Dan or Trina. Then you will understand how fortunate we are to have them as part of our dental community and how much they have added to the famous ending “to all a good night.”

ZQuiet S.A.: Interim Appliance for dental sleep medicine practitioners who have a responsibility to keep a patient’s airway open while the new oral appliance is being made or repaired. ZQuiet S.A. is indi-cated to treat simple snoring and/or mild to moderate OSA under FDA Clearance: #K140777.

ZQuiet Pro-Plus: A patient-friendly, dorsal-style appliance. The two-piece construction provides lateral jaw movement enabling the patient to open and close normally with less bulk and less stress to the temporomandibular joint.

ZQuiet Pro Herbst: The well-proven appliance consists of 2 acrylic splints which are bilaterally connected via an adjustable tele-scoping Herbst mechanism. Since the device is E0486 approved, it is frequently used for Medicare cases.

ZQuiet Pro Flex: The lightest and thinnest lab fabricated dorsal-style appliance available. Made from a proprietary flexible partial mate-rial that is 10 times stronger than acrylic and virtually stain and odor resistant.

ORIGINstories


Consumer-Driven Sleep Technologiesby Ping-Ru Teresa Ko, MD

With an estimated 50-70 million U.S. adults having a sleep or wakefulness disor-der,4 it is little wonder that sleep trackers and other consumer-driven sleep technologies have gained a significant marketing pres-ence. These devices have a fascinating range of purported applications, from tracking sleep duration and quality, to self-guided sleep as-sessment and education, to entertainment and health-driven social interaction. To this end, sleep technologies take on a sometimes dizzying variety of forms.

Sleep specialists and other healthcare professionals are increasingly exposed to these unregulated sleep technologies via their patients, families, or friends, and may be asked to try to interpret the data from these devices. In this article, we will review some of the more popular or illustrative technologies. We will categorize them into four main spheres: mobile apps and other software, wearables, mattress-embedded de-vices, and nightstand devices. This article is not meant to be a comprehensive review of all available sleep technologies, but aims to encourage reflection and discussion on cur-rent popular and emerging consumer-driven sleep technologies.

Fitness and sleep trackers entered the market in 2010 and

have exploded in sales over the last 5-6 years. Nearly 33

million of these devices have been purchased in the United

States alone as of the end of 2015.1 Worldwide, it was estimated

that approximately 8.5 million units were sold in the U.S. in

2015, leading the global market, followed by estimated sales in

Western Europe and the Asia-Pacific region of 7.1 and 4.9 mil-lion units in 2015, respectively.2 It is predicted that 60 million

fitness trackers will be in use globally by 2018.3


TECHNOLOGYupdate

Mobile Apps and SoftwareMobile applications, or “apps,” and sim-

ilar software which run on computer-based operating systems such as Android OS, Ap-ple iOS, or Microsoft Windows, can be run on smartphones, tablets, or other electronic devices. Many are free; features-enriched ver-sions generally cost no more than a few dol-lars. Some apps are simple sleep logs, or noise generators with white noise, nature sounds, hypnosis recordings, or other vocal tracks or light displays which claim to aid in sleep in-duction. Apps such as Sleep Cycle (Android OS, iOS)5, SleepBot (Android OS, iOS)6, Sleep As Android (Android OS)7 claim to work as sleep trackers, assessing sleep quality and duration. The apps often require the mobile device to be placed on the bed mattress next to the user, and use accelerometer technolo-gy available on many smart mobile devices to monitor sleep. Using proprietary algorithms, many of these apps claim to differentiate deep from light sleep, and employ a “smart alarm” that try to wake sleepers during a period of light sleep rather than deep sleep, ostensibly avoiding excessive grogginess upon awak-ening. Another novel feature employs task-based alarm systems, requiring the user to complete arithmetic or motor-based tasks, or forcing the user to get out of bed, walk, and scan a QR barcode located in another part of the physical environment, thereby guaran-teeing a certain degree of wakefulness before the alarm will shut off. An app called GO! to Sleep (iOS)8, developed by the Cleveland Clinic Sleep Disorders Center, uses a standard questionnaire for sleep hygiene, self-reported sleep duration, and other factors to derive a sleep score, and offers daily sleep tips and trivia. SnoreLab (iOS)9 records snoring inten-sity; it also provides advice to improve snor-ing and allows users to track efficacy of these therapies by trending their “Snore Scores.” Expanding into Internet-based resources, on-line interactive websites such as Sleepio10 and SHUTi11 provide customizable cognitive be-havioral therapy for insomnia via multimedia modules for a time-based fee. Free software such as SleepyHead,12 available on most ma-jor desktop operating systems, provides ac-cess to CPAP usage data for end-users.

WearablesOne of the trendier spheres of consumer-

driven sleep technologies, wearables in-

clude sleep tracker bracelets, necklaces, smart watches, or other technologies which can be attached directly to users or to their clothing. These bear similarities to conven-tional actigraphy, and often use three-dimen-sional accelerometer technology to track exercise as well as sleep. Certain devices even employ heart rate, perspiration, and temperature sensors to aid in sleep monitor-ing. Popular examples of wearables include Fitbit,13 Jawbone,14 Android Wear watches,15 and Microsoft Band.16 Apple Watch17 also supports several apps to track sleep; howev-er, the high battery consumption rate of the Apple Watch typically necessitates night-ly recharging, which may limit its use as a sleep tracker. Other examples of wearables include baby clothing with built-in sen-sors to monitor sleep quality, position, and temperature for infants; and hats and other clothing accessories that claim to track and improve sleep.

It is predicted

that 60 million

fitness trackers

will be in use

globally by 2018.3

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TECHNOLOGYupdate


Mattress-Embedded DevicesSleep mattresses such as Sleep Number’s

IT,18 Kingsdown Sleep Smart Intuitive,19 and Molten Corp’s Leios mattress,20 as well as mattress covers like Luna’s Eight,21 use em-bedded sensors to measure sleep activity, heart rate, breathing rate, temperature, and even ambient humidity, light, and noise. These technologies often communicate with an accompanying mobile device app to re-port sleep quality and duration, and offer sleep advice. Some of these devices may even automatically adjust mattress firmness, temperature, and elevation of the head or foot of the bed to optimize comfort.

Nightstand DevicesSeveral sleep and bedroom sensor stand-

alone monitors can be placed on the night-stand, but often pair with mobile devices placed on the mattress to track sleep and oth-er environmental factors. Smart bulb tech-nology such as the Philips Wake-Up Light22 can be programmed to turn on at a certain time and gradually increase in light intensi-ty over 30 minutes, simulating sunrise and aiming to wake the user gently. Users can also program the color and intensity of smart light bulbs to minimize blue wavelength exposure near bedtime, which may help enforce a normal circadian rhythm.

ConclusionAs a general rule of thumb, very few of

these consumer sleep technologies are med-ically validated, and even fewer have been robustly tested. For many of these technol-ogies, the algorithms used to derive sleep quality and duration are proprietary. Until further research is done, data from these de-vices cannot be reliably interpreted and re-quests for medical interpretation must be ap-proached with caution. When encountering

these technologies, one must question how data is collected, what artifact may be in-troduced (for instance, for mattress-derived sensors, the degree to which sensor artifact from sleep partners, pets, and different mat-tress textures may affect results), and the lev-el of quality of sleep education and informa-tion that is offered by the device or that may be shared through social media or other po-tentially un-validated sources. In addition, one must consider how these media-rich devices may be negatively impacting sleep through noise and light pollution. Howev-er, these technologies are exciting glimpses into potential future tools for sleep evalua-tion and sleep health, and even in their nov-elty and entertainment value can entice the average consumer to think more about their sleep – and ultimately fall to sleep, and in love, with healthy sleep practices.

1. “Year-Over-Year Wearables Spending Doubles, According to NPD.”

NPD. Online: https://www.npd.com/wps/portal/npd/us/news/press re-

leases/2016/year-over-year-wearables-spending-doubles-according-to-

npd/ Published: Feb 1, 2016. Accessed: March 14, 2016.

2. “Forecast unit sales of health and fitness trackers worldwide from 2014 to 2015 (in millions), by region.” Statista.com. Online: http://www.

statista.com/statistics/413265/health-and-fitness-tracker-worldwide-unit-sales-region/ Published: 2016. Accessed: March 14, 2016.

3. Sullivan, Mark. “Fitness tracker sales will triple by 2018, then smart-

watches take over (report).” Venturebeat.com. Online: http://venture-

beat.com/2014/11/25/fitness-tracker-sales-will-triple-by-2018-then-smartwatches-take-over-report/ Published: Nov 25, 2014. Accessed:

March 14, 2016.

4. “Insufficient Sleep Is a Public Health Problem.” Centers for Disease Control and Prevention. Online: http://www.cdc.gov/features/dssleep/

Published: Sept 3, 2015. Accessed: March 14, 2016.

5. Sleep Cycle. Online: http://www.sleepcycle.com/ Accessed: March

14, 2016.

6. SleepBot. Online: https://mysleepbot.com/ Accessed: March 14, 2016.

7. Sleep As Android. Online: https://play.google.com/store/apps/details?

id=com.urbandroid.sleep&hl=en/ Accessed: March 14, 2016.

8. “Go! to Sleep.” Online: https://itunes.apple.com/us/app/go!-to-sleep/

id450775914?mt=8 Accessed: March 14, 2016.9. SnoreLab. Online: http://www.snorelab.com/ Accessed: March 14, 2016.

10. Sleepio. Online: https://www.sleepio.com/ Accessed: March 14, 2016.

11. SHUTi. Online: http://shuti.me/ Accessed: March 14, 2016.

12. SleepyHead. Online: https://sourceforge.net/projects/sleepyhead/ Ac-

cessed: March 14, 2016.

13. Fitbit. Online: https://www.fitbit.com/ Accessed: March 14, 2016.14. Jawbone. Online: https://jawbone.com/ Accessed: March 14, 2016.

15. Android Wear. Online: https://www.android.com/wear/ Accessed:

March 14, 2016.

16. Microsoft Band. Online: https://www.microsoft.com/microsoft-band/

Accessed: March 14, 2016.

17. Apple Watch. Online: http://www.apple.com/watch/ Accessed: March

14, 2016.

18. Sleep Number IT.” Sleep Number. Online: http://itbed.sleepnumber.

com/it. Accessed: March 14, 2016.

19. Colon, Alex. “PCMag Review: Kingsdown Sleep Smart Intuitive.”

PC Magazine. Online: http://www.pcmag.com/article2/0,2817,

2476614,00.asp Published: Feb 20, 2015. Accessed: March 14, 2016.

20. Bolton, Adam. “Sleep smart: Japanese mattress adjusts air pressure for

better rest.” Published: January 15, 2016. Accessed: March 14, 2016.

21. “Eight.” Online: https://www.eightsleep.com/ Online: March 14, 2016.

22. “Philips Wake-up light.” Philips. Online: https://www.usa.philips.

com/c-m-li/light-therapy/wake-up-light/latest Accessed: March 14,

2016.

These technologies

are exciting glimpses

into potential future

tools for sleep

evaluation and

sleep health, and

even in their novelty

and entertainment

value can entice the

average consumer

to think more about

their sleep...


TECHNOLOGYupdate

Ping-Ru Teresa Ko, MD is a pediatric neurologist who

trained at Children’s Hospital of Oakland and the Uni-

versity of Washington, and completed a sleep medicine

fellowship at the University of Washington. She currently

works at Kaiser Permanente in Santa Clara, CA. She is

highly interested in medical technology and sleep tech-

nology in particular, and potential applications of tech-

nology in the fields of sleep medicine and neurology.

The Healthy Start System Provides an Effective Treatment for the Root Causeof Sleep Disordered Breathing and Straightening Teeth Without Braces

Sleep Disordered Breathing in children is a much more critical and common problem that what has

previously been thought. SDB can manifest itself in a variety of symptoms that can be easily over-

looked, misdiagnosed, and most unfortunately left untreated. The Healthy Start system educates the

dental community to identify the symptoms, understand the underlying root cause, and create a treat-

ment plan that both cures the breathing disorders and corrects the orthodontic condition.

Early intervention is critical when addressing sleep issues. The optimal age for a Healthy Start patient is as soon as the problem is identified. Any age from 2-12 might be best for any indi-vidual patient – the first step in identifying SDB symptoms is with the Healthy Start Sleep Ques-tionnaire. The Healthy Start requires a parent to assign a frequency number to Sleep Disordered Breathing symptoms apparent in their child:

1. Day or nighttime mouth breathing2. Snoring 3. Talking in sleep4. Tooth grinding5. Difficulty listening / often interrupting6. Allergic symptoms including eczema7. Fidgeting with hands8. Waking up at night9. Restless sleep10. ADHD11. Excessive sweating while asleep12. Bed wetting13. Hyperactivity14. Excessive daytime sleepiness15. Nightmares / night terrors16. Lack of focusing17. Difficulty with school subjects of math,

science, and spelling

18. Falling asleep during the day19. Headaches in the morning20. Speech problemsA recent study of 501 Healthy Start patients

from the ages of 2 to 19 found that nine out of ten children display at least one symptom of Sleep Disorder Breathing. Previous research found SDB occurring in only 1% to 3% of children from the ages of 5 to 13 yeas of age, however, the findings of this study provides evidence that SDB is much more common affecting 90% of children and the SDB symp-toms can be seen in children as young as 2 years of age. (Stevens, 2016)

Conclusions of this recent study found:1. Mouth breathing and snoring are com-

monly associated with more SDB symp-toms than the other symptoms studied.

2. The four most commonly occurring symptoms are: Mouth breathing at night, snoring, talks in sleep, and teeth grinding.

3. 90% of the sample had one or more symptoms commonly associated with SDB.

4. 60% of the sample had four or more symptoms.

STARTINGearly



STARTINGearly

5. Between 4 and 12 years of age, 92.6% of symptoms did not self correct while 30% worsened with age.

6. The dentist is well positioned to be able to utilize appliances that can modify the common symptoms.The implications of this study are essen-

tial in finding a way to improve the health of children today. Observations of these SDB symptoms can be seen as early as two years of age. Treating early not only allows the Healthy Start system to take advantage of growth and development and promote proper oral habits but to also ensure a healthier life for children (Stevens, 2016).

TrainingProfessionals interested in gaining a

greater understanding of SDB and how the Healthy Start System addresses both the sleep and orthodontic conditions can participate in a three-day course. The first two days of this course provide the necessary information for both Dr. and staff to identify, evaluate, and understand the treatment protocols. The third day is a hands-on day with patients and par-ents. Please visit www.TheHealthyStart.com for upcoming dates and more information.

TreatmentThe Healthy Start System is a non-

invasive, non pharmaceutical, natural form of treatment that uses a series of specially designed appliances to promote proper breathing habits. The Healthy Start addresses mouth breathing, open-bite, crossbite, narrow palate, speech dif-ficulties, sucking and swallowing problems. The Healthy Start System also treats orthodontic prob-lems such as crowding, overbite, overjet, gummy smiles, and class lll corrections. The Healthy Start system uses the natural forces of eruption to guide incoming teeth so natural fiber bundles develop and anchor these newly erupted permanent teeth into a perfectly created occlusion.

The sequence for this case is typical: a sleep questionnaire filled out by parent rating their child’s symptoms on a scale indicated the degree of risk. Finding an open-bite condition usually represents a tongue thrust, improper swallow, and mouth breathing. The Healthy Start system was introduced with the first of a three-appli-ances series given to address the habit and breathing issues for a period of three months. The second appliance was issued when the first tooth was lost and was used only at night to guide the incoming dentition and ensure proper

habits. The third and final appliance was given as the laterals began to erupt and continues to guide the incoming teeth into the correct posi-tion. The natural eruptive forces will expand the arches and allow more space for the tongue to be forward and out of the airway.

FAQQ: What is the ideal age to begin Healthy

Start treatment?A: The earlier the better. Ideally every child

should have a comprehensive exam by a Healthy Start Provider by the age of two (2). Healthy Start dentists and their staff have received special training to ensure that the overall health and wellbeing of every child is carefully evaluated and taken into consideration when formulating a treatment plan.

Q: What are the benefits of the Healthy Start system?

A: The Healthy Start addresses health issues in children as well as straightening teeth without braces. Nine out of ten children present with at least one symptom of Sleep Disorder Breathing. Healthy Start looks at the root cause of these symptoms: a compromised airway, a narrow arch which compromises the proper tongue position, and mouth breathing. The Healthy Start addresses the root issues while straighten-ing the teeth.

Q: How long will the Healthy Start System for kids prevention technique take when done at this young age?

A: Since treatment in young patients occurs as the adult teeth erupt, the process will need to last until all permanent teeth have come in. This is not as daunting as it may seem since the appliances may be worn passively at night or for brief peri-ods during the day. Our devices work to ensure the jaw and teeth fit and work properly together, therefore allowing the achieved results to be stable for life. Typically, the child is completely finished by 12 years of age.

Q: Can you predict at age 5 what a child’s teeth are going to look like at 12 years of age?

A: Yes. Actually, many aspects of maloc-clusions (overbite, jaw relationship, cross-bite, crowding, and overjet) are predictable by 2 years of age. Left untreated, at best they stay the same but in over 75% of individuals, the problems become more severe while the child suffers from breathing problems every night from age 5 to 12 – years of development they’ll never get back.

1. Stevens, B. (2016). The Incidence of Sleep Disordered Breathing

Symptoms in Children from 2 to 19 Years of Age. Journal of the

American Orthodontic Society, 24-28.

Before Healthy Start

After Healthy Start

Mayoor Patel, DDS, an Atlanta, GA dental sleep practitioner and educator, doesn’t think your patient should wait. “Patients usually do not want to wait 3 to 4 weeks to get their cus-tom device in order to begin treatment,” said Patel. He uses the ZQuiet S.A., a new device specifically created to meet the needs of patients waiting for a custom device, allow-ing them to begin oral appliance therapy or maintain treatment while a device is repaired.

“As an educator of Dental Sleep Medi-cine, I explain to clinicians the importance and benefits of having a cost effective option that can be used in clinical situations as a temporary appliance or a trial device,” noted Patel. “I have incorporated the ZQuiet S.A. for many different clinical situations and see great patient satisfaction as a result.”

ZQuiet cofounder, Dan Webster, recounts, “The ZQuiet S.A. was developed as a product that fills an important treatment need. The new appliance offers immediate relief for patients and provides a continuum of uninterrupted patient care in the treatment protocol.“

Brock Rondeau, DDS, DADSM of London, Ontario is pleased with the interim appliance option. “I particularly like to use the ZQuiet S.A. temporary appliance for OSA patients who have lost or damaged their oral appliance.”

The ZQuiet S.A.’s open tray design requires no boiling, molding, forming, or impressions, requiring virtually no chair time which creates more efficiency in the practice to see more patients. The device retention is cleverly created by the resilient hinging which gently keeps it in contact with the dentition. “The beauty of the device’s simplicity is that it doesn’t replace or compete with a custom appliance so there is no risk of losing the sale of the custom appliance. Dentists appreciate the health value of using a temporary appli-ance to start immediate treatment or main-

tain interim treatment. Additionally the price point is so low, they don’t even hesitate to fold the cost of the device into the treatment, providing a nice value add to the patient.”

The ZQuiet SA is available in four protrusive sizes allowing the practitioner to pro-vide temporary advancement at a clinically appropriate level. Each appliance is pack-aged individually with a storage case for easy dispensing to the patient.

Practitioners nationwide have embraced the new device, incorporating the tempo-rary appliance in their treatment protocol. “I always doubted the need for a temporary appliance in my sleep practice, but after using the ZQuiet S.A. I am now a believer. Every patient with an appliance repair gets one, and my new cases benefit from immediate relief while their appliance is fabricated,” says Brian Shuman, DMD of South Burlington, VT.

Webster, along with his wife Trina, founded Sleeping Well, parent company of the ZQuiet brand of snoring and OSA treat-ment solutions, after their struggle to treat his snoring. “We know first-hand how snoring disrupts families and impacts relationships,” said Webster. The couple is passionate about providing education that can help consumers recognize the health dangers of OSA, and reaches millions of consumers through media campaigns offering treatment and support for anyone struggling with snoring and OSA. “Trina and I started ZQuiet because of our commitment to help people get better sleep and live healthier, happier lives. We see this same passion from the dental sleep practi-tioners we have met.”

Dr. Rondeau agrees. “We have a respon-sibility to keep a patient’s airway open while the new oral appliance is being made or repaired. Otherwise, in my opinion, we are practicing below the standard of care.”

Your patient is sitting in the chair, ready to move forward with oral appliance therapy. His bed partner is desperate

for relief, and he fully understands that treating his apnea is critical to his health and his quality of life. Why spend weeks waiting for his custom appliance and delay beginning treatment that is necessary today?

Don’t Make Your Patients Wait!

Trina and I started

ZQuiet because of

our commitment

to help people get

better sleep and

live healthier,

happier lives.


PRODUCTspotlight

With real-world CPAP compliance rates as low as 35%, many patients simply need better treatment options. Over the past 10 years, dental sleep medicine has played an increasingly vital role because Oral Appli-ance Therapy (OAT) has proven efficacy and is better tolerated than CPAP. More and more dentists are educated about what sleep ap-nea is and help their patients with custom oral appliances. In fact, independent health-care business analysts Frost and Sullivan recently reported that they anticipate a five-

fold increase in the number of dental devices made in the US over the next 5 years.

But is OAT all we have to offer? As a den-tist, what can you do for your patient who can’t tolerate OAT? What about those who refuse to wear a dental device? Or those patients for whom OAT offers partial, but incomplete relief? What else can we do for these patients?

The Pillar Procedure is another tool you can use to better meet the needs of your snoring and sleep apnea patients.

First approved by the FDA in 2002, the Pillar Procedure has been used to treat over 50,000 patients with snoring and mild-to-moderate sleep apnea. The Pillar Procedure is a minimally invasive technique, performed chair-side, that works by inserting small woven sutures into the soft palate (see diagram). Performed under local anesthesia in about 10 minutes, it has been shown to significantly reduce snoring (bed-partner sat-isfaction rates average around 80%),1,2 and to effectively treat mild-to-moderate sleep apnea (approximately 80% of patients expe-rience significant reduction in AHI).3,4

Dental Sleep Medicine:

Beyond Oral Appliance Therapy

by Drs. Richard Drake and Craig Schwimmer

Sleep disordered breathing continues to plague millions of

Americans. Our traditional way of managing patients has

been inconvenient, intrusive, and ultimately offered solu-

tions most patients simply don’t want (CPAP or surgery). Be-

tween the high cost and inconvenience of in-lab sleep studies,

and the aversion that most people have to the idea of sleeping

with a CPAP device or having “half their throat ripped out”,

most people with sleep apnea have never even been diagnosed.

Perhaps more telling is the fact that most people who have been

diagnosed currently go untreated!

ADJUNCTIVEcare



ADJUNCTIVEcare

Stiffening the soft palate has been a pri-mary method of procedural sleep apnea treatment for over 40 years. The Uvulo- Palato-Pharyngo-Plasty (UPPP) was first in-troduced in the 1970s as a treatment for

OSA, and remained the stan-dard surgical treatment for many years. Over the years, the technique has been modi-fied numerous times, but even now remains an extremely in-vasive and painful procedure.

In contrast, the Pillar Procedure does not require the removal or destruction of any soft tissue. The Pillar Procedure stiffens the soft palate by stimulating a foreign body re-action. In response to the placement of the palatal implants, the patient’s natural fibrot-ic response stiffens the soft palate, thereby decreasing palatal flutter. So instead of an invasive, painful surgical procedure, it is a simple, essentially painless chair-side pro-cedure that allows patients to immediately return to normal diet and activities.

OK, but what does the Pillar Procedure have to do with dentistry? Simple, as a den-tist, you can perform the Pillar Procedure. While most Pillar Procedures performed to date have been done by ENT physicians, the FDA authorizes trained dentists to perform this procedure. Eager to offer their patients more than just OAT, an increasing number of dentists are adding the Pillar Procedure to their practices. In the dental setting, the Pillar Procedure has been shown to augment the efficacy of OAT, reducing the amount of protrusion required to achieve a desired end point. The theory is that the two techniques work synergistically, because airway stabili-zation is accomplished both retro-palatally and retro-lingually. It also allows a dentist to help patients for whom OAT is not an option.

Performing the procedure: The patient is typically given ibuprofen 800 mg po, and then asked to rinse with an antiseptic solu-tion immediately prior to the procedure. The palate is anesthetized topically, and then in-jected with approximately 3 cc of a short act-ing local anesthetic (with epi). The implants are then placed approximately 2 mm apart and parallel, with the first implant inserted along the midline raphe. The entry point for the delivery device is the junction of the hard and soft palate, allowing the implants to be placed as close to that junction as possible. The implants are placed 2mm apart and par-allel (see illustration). Typically, 5 implants are placed per patient.

Fifteen minutes later, the patient is driving back to work. Post operatively, most patients experience very little discomfort, typically

It is a simple, essentially

painless chair-side procedure...

Dr. Craig Schwimmer is a practicing ENT from Dallas, TX, who has per-

formed thousands of Pillar Procedures, and serves as Chief Medical Officer of Pillar Palatal, LLC. He can be reached at [email protected]

Dr. Richard Drake is a practicing dentist in San Antonio, TX, and co-founder

of Dental Sleep Solutions and DS3 software. He routinely utilizes the Pillar

Procedure in his dental office.

ADJUNCTIVEcare


Good for Your Patients. Good for Your Practice.

www.pillarprocedure.com | 214-369-2347

Proven Palatal Stiffening

PatientsTreated*

ZERO

Serious Adverse Events Reported*

**Neruntarat C. Eur Arch Otorhinolaryngol. 2011 *Manufacturer’s data on file

10Minutes to Perform

$1,300 Average Profit*

50,000

Long Term Reduction in AHI**50%

Long TermSatisfaction**80%

managed with ibuprofen and cold liquids. It takes several weeks for the scar tissue in the soft palate to form, and to integrate with the implant material. Therefore, patients are advised not to expect clinical improvement for at least two weeks, and that maximal improvement can take up to three months. Decreasing palatal flutter in this way can di-rectly decrease snoring and apnea, and (an-ecdotally) it can also synergistically augment the effect of OAT, thereby providing the assist that some dental devices need to get to the end zone. Over 50,000 patients have been treated with the Pillar Procedure, and not a single significant complication has been re-ported. The most commonly reported com-plication is “partial extrusion” of one or more of the implants. This occurs in between 1 and

2% of patients, and is managed by removing the exposed implant.

Pillar Procedure courses are offered throughout the year and sometimes in con-junction with Dental Sleep Solutions. You can get more information by calling Pillar’s manufacturer at 214-369-2347 or by visiting www.PillarProcedure.com.

1. Long-term Results of Palatal Implants for Primary Snoring. Maur-er JT, Verse T, Stuck BA, Hormann K, Hein G. Otolaryngol Head

Neck Surg. 2005; 132: 125-132.

2. Patient Outcomes After Soft Palate Implant Placement for Treat-

ment of Snoring. Rosenberg B, Alsaffar H, Kandessamy T. Journal

of Otolaryngol Head Neck Surg. 2010; 39:323-328.

3. Extended Follow-up of Palatal Implants for OSA Treatment.

Walker RP, Levine HL, Hopp ML, Greene D. Otolaryngol Head

Neck Surg. 2007; 137:822-827.

4. One-year Results: Palatal Implants for the Treatment of Obstruc-

tive Sleep Apnea. Norgard S, Hein G, Stene BK, Skjostad KW,

Maurer JT. Otolaryngol Head Neck Surg. 2007; 136: 818-822.

The Four Pillars for Dental Sleep Medicine Success

I’ve been providing Oral Appliance Ther-apy (OAT) for a long time and at one time or another, I’ve experienced each of the above frustrations. How do you identify patients, ensure they get properly diagnosed, treat them appropriately, and get paid for your potentially life-saving therapy? Welcome to the Four Pillars necessary to successfully implement and sustain DSM production in your practice; Screening, Testing, Treating, and Billing. Each of these must be a part of a firmly established system in your practice if you are going to attain success.

Pillar 1 – Screening Sleep Disordered Breathing (SDB) affects

greater than 35% of our adult population and as many as 1 in 5 adults have Obstructive Sleep Apnea (OSA). Still, less than 10 % of patients know they have this serious disor-der. They are in your waiting room right now. We’re remiss if we assume that someone else is broaching this issue with them. Their phy-sicians have packed schedules and are un-likely to have a dialogue about sleep with them. That assumes it’s even on their radar. It is time that we step up to the plate and boost awareness. Compared to our patients’ other medical care givers we spend more time an-nually with our patients and we are more fa-miliar with cranio-facial anatomy which can put patients at risk for SDB and OSA.

How do you identify patients that suffer from OSA and may benefit from OAT? Our

by Gy Yatros, DMD

In the spirit of full disclosure, I need to tell you that I own a

dental sleep medicine implementation company. Because

of that, I have my finger on the pulse of what is on the mind of other dentists that have entered the burgeoning field of Dental Sleep Medicine (DSM). Our Member Support team

fields calls every day from dentists that proclaim some ver-sion of the following:

• “I want to practice DSM more, but I just don’t have the patients.”

• “I send patients to the sleep lab, but they all just get slapped with a CPAP.”

• “I just don’t know which appliance to use and I heard this can change bites.”

• “I have treated a few patients and it went well but insurance won’t pay for it.”


PRACTICEmanagement

Patient screening

team fields some iteration of this question frequently. Should I advertise on radio, buy billboards or what? Screening your existing patients is where it all begins.

Most dental offices routinely do oral can-cer screenings. Have you considered why? Is it because we were told to do so, that oral cancer occurs in the mouth, to avoid litiga-tion or because we care about our patients’ well-being? All are good reasons and the same can be said for screening our patients for SDB. How many oral cancers do most of-fices find in a year? One or two per year? Yet, we still do it because it is an important service and we care about our patients. Screening for SDB takes no more time than screening for oral cancer while the number of our patients with airway problems far exceeds the number of oral cancer patients we will encounter.

The first pillar requires launching a sys-tem to quickly identify at-risk patients. This can easily be accomplished through readily available sleep screening questionnaires. An ideal questionnaire should include questions about Excessive Daytime Sleepiness (EDS), snoring, sleep quality, witnessed apneas/gasping while sleeping, morning headaches and difficulty in maintaining sleep. The ques-tionnaire should also include common OSA co-morbidities such has hypertension, diabe-tes, weight gain, GERD, and cardiac prob-lems. The Screener should be comprehensive and easy to complete by the patient.

Identifying these patients is a step in the right direction. What do you do next though? You need to be educated and prepared to discuss these results with patients. You AND your team need to have a defined approach to handling these conversations. You need to be passionate and caring as you help patients understand their risks. The goal is to have an informed and sincere conversation with pa-tients about their risks, and ultimately, move forward to the next pillar of DSM: a sleep test.

Pillar 2 – TestingThe goal of sleep testing is to objectively

determine if the patient has an airway prob-lem. It is paramount to note that dentists can-not make the diagnosis for OSA but we can facilitate testing and work closely with the patient’s other health care providers to treat this serious problem.

Sleep testing is one of the many areas of DSM that has become significantly more “dentist friendly” over the past few years.

Years ago, the only option was to refer our patients to a sleep lab where the patients would spend the night for a Polysomnogram (PSG). If their OSA was severe enough, they were likely given a CPAP and the dentist never heard back about the patient’s status. Now many patients can be tested in the comfort of their own home with a Home Sleep Test (HST).

Our job is to build a pillar to support sleep testing for all of our patients. The last thing we want is to identify an at-risk patient with a need to be tested and then drop the ball. Again, to successfully establish this pillar, it’s imperative that a system is firmly established. To shore up this DSM pillar we most certain-ly need to also provide ways for our patients to be home sleep tested. There are currently three ways this can be accomplished. First, the dental office can work with local medical professionals (PCPs, ENTs, sleep MD’s, etc.) to whom they can refer their patients for HST.

The other two methods of obtaining HST are a bit more ambiguous. There is debate in the medical community about whether dentists should be directly involved in fa-cilitating sleep testing. Furthermore, federal and state laws may regulate or prohibit our offices from these practices. With that said, some practices order HST from third parties that provide these services directly for their patients. These companies have sleep spe-cialists who provide an interpretation and diagnosis while billing the patient directly. This protocol reduces the dentist’s capital ex-penditure and also introduces significant effi-ciency to the process. Other dentists directly provide their patients with an HST and sub-

Dr. Gy Yatros has been practicing dental sleep medicine for

over a dozen years and is a well-respected international lec-

turer in the field of sleep-disordered breathing and dental sleep medicine. He has offices in Bradenton, Sarasota and Tampa, Florida devoted exclusively to the treatment of sleep

disordered breathing. He is a Diplomate of the American

Board of Dental Sleep Medicine (ABDSM), past president of the Manatee Dental Society and is an Affiliate Assistant Professor of the Department of In-

ternal Medicine with the University of South Florida, College of Medicine. He

is a Co-Founder of the Dental Sleep Solutions system.

PRACTICEmanagement


HST testing

mit the data to sleep specialists who provide the interpretation and diagnosis.

Regardless of how we build this DSM pillar we need a foundation that will work for all of our patients and we should always include the patient’s PCP in the process. This can easily be done through a phone call or auto-generated correspondence through your DSM practice management software.

Pillar 3 – TreatingTreating is the DSM pillar with which

dentists are most familiar. Oftentimes, we get calls from dentists that just want to know which device to use without any thought de-voted to the first two pillars. While it’s under-standable because appliances fall within our wheelhouse, this view is a disservice to the patient and the process.

It is of utmost importance that a diag-nosed patient be treated properly with an effective modality with which they will be compliant. Doing nothing is simply not an option. There are several treatment options for patients diagnosed with OSA including PAP therapy, surgery, and OAT.

The most common therapy, positive air-way pressure such as CPAP, has a high level of efficacy but generally low compliance. Depending on whose statistics you read, the compliance rate is approximately 50%. Sur-gery can be very helpful but with it comes significant risk. OAT, namely Mandibular Advancement Devices (MAD) is very effec-tive and has been demonstrated to have high compliance rates through myriad studies over the past few years. It can also create some minor complications. Dr. Keith Thornton, in-ventor of the TAP family of MAD, once said that “Effectiveness = Efficacy X Compliance.” I think this is a useful algorithm to consider

when weighing treatment options with your patients and their other healthcare providers.

Treatment shouldn’t be done without col-laborating with other health care profession-als – namely boarded sleep physicians. Over the years, oral appliances have become more widely accepted as an integral part of SDB therapy. This pillar is made sound through education, readily available online or at meetings, and within each practice, led by the dentist and the ‘sleep ambassador’ team member. Take some courses. They are avail-able from different organizations, labs, and device manufacturers.

Pillar 4 – BillingThis is the pillar we receive the most calls

about and the one I encounter most in my lectures. It’s understandable. We have to be paid for our services. With that said, it may also be the most difficult to navigate. It’s cli-ché but medical billing truly is a different beast than dental billing. There is no way around that. It simply is. Over the years, I’ve seen the following situation play out hun-dreds, if not thousands of times.

A dentist decides to begin offering DSM services but the pillar is not firmly estab-lished. She tasks a team member with sub-mitting claims. Seemingly easy enough? The claim is faxed to the payer with some support-ing documentation and after countless hours navigating voice prompts, the dentist angrily exclaims that insurance doesn’t pay for OAT and she ceases to offer this valuable service.

This is unfortunate for the patients, the practice, and the profession.

This is a medical problem. Dental insur-ance will not cover OAT under any circum-stances. This leaves fee-for-service or medical insurance as payment options. Fee-for-service

Screener result Device selection

You need to be

passionate and

caring as you

help patients

understand

their risks.


PRACTICEmanagement

may seem like a no-brainer. Think again. This choice is typically unknown in medi-cal care. Patients don’t expect to pay for medical services out of their own pockets and our medical colleagues are dumbfounded when they learn that we’ve asked pa-tients to pay up front. Addi-

tionally, most insurance companies require a pre-authorization of benefits before treatment, which means even if you provide patients with a properly completed form, they may not get any insurance payment at all because it wasn’t filled out prior to the date of service. It’s easily understandable why this model can translate into patients declining treatment, physicians opting not to refer to dentists, and a lack of OAT production in the dental practice.

Fortunately, there is another option. Uti-lize a third party biller. Use your DSM prac-tice management software to transmit the claim along with the supporting documenta-

tion directly to them. Their core competency is getting dentists reimbursed for OAT. They are masters of navigating voice prompt purga-tory, deciphering payers’ jargon, and getting you paid. Hiccups may still arise because you are a dentist billing medical, probably doing it out of network, and you’re submitting an unfamiliar code. However, outsourcing your billing will increase the likelihood of maxi-mum reimbursement while empowering your team to do the jobs you’ve hired them to do. There are several third party billers. Do a web search. Ask for references. Inquire about their services and fee structures.

DSM provides us with amazing rewards unseen in any other facet of dentistry. We can save lives and realize significant reve-nues doing it. DSM is a phenomenal way for a practice to differentiate itself from others in the area while serving the community. To do this effectively and efficiently requires a solid foundation on which to erect these 4 pillars. Build your team. Establish these pillars and change the world one breath at a time.

Billing


PRACTICEmanagement

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Developing the software system enabled Panthera Dental to adapt the appliance effectively and develop it according to the needs of its customers. This year Canadian customers can now benefit from the Braebon DentiTrac integrated in the Panthera D-SAD (awaiting FDA approval for the US market). With this sensor, dentists and physicians can now track the compliance of their patients and also monitor the position in which they sleep. This is a game changer for unions and the transport industry.

However, the greatest addition to the design software application this year is its compatibility with intra-oral scanning. There is no need for regular dental impressions any-more. With intra-oral scanning, we improve the customer experience while increasing the accuracy and the quality of our product. Indeed, we avoid bubbles and porosity in plaster models, which are common and may cause issues regarding the fit of the device.

The Panthera D-SAD is available world-wide and comes with a 5-year warranty, the longest warranty available on the market for dental sleep appliances.

The Panthera Digital – Sleep Apnea Device (Panthera D-SAD) is the sec-ond-generation of the world’s first CAD/CAM appliance. Jean Robichaud,

R.D.T., is the genius behind this invention. In 2006, with his company Biocad, he created the world’s first software to design dental sleep apnea devices. In 2012, Jean Robichaud’s two sons, Bernard and Gabriel, designed a new software application using the latest technology in order to offer an improved version of the first-generation oral appliance. Thanks to this advanced design tool, the Panthera D-SAD offers more options than ever regarding the design of bands and plates for occlusal contact. Moreover, the design of the first- generation device was greatly improved with a new patent-pending mech-anism that connects the retentive rods to the appliance so that they never disengage during sleep. These rods are supple yet resistant, so they are also suitable for patients with bruxism. Another advantage of the new software is a better control over the retention of the splints. Instead of determining the retention over a group of teeth, the new software calculates it for each tooth, thus making the appliance suitable for a broader range of patients.

The appliance is manufactured using an industrial 3D printer and made of an incredible material. The type 12 organic polyamide is a biocompatible hydrophobic nylon. Polyamide possesses a distinctive feature: it remains very resistant to failure of every kind, even when very thin.

A Story of Progress and Adaptation: the Panthera D-SAD

PRODUCTspotlight


Electronic health records (EHR) – already a mainstay of medical practice will soon be mandated for the dental practitioner. Patient portals must be opened for access to records requiring seamless correspondence back and forth between physician, dentist, laboratory and patient. Moving a general dental prac-tice into one that includes a medical model can be overwhelming when one takes into consideration balancing the dental aspects of the practice with the demanding needs of medical patients. When a practice partners with and relies upon community physicians to care collectively for patients, a compre-hensive precision medical system must be carefully established. Don’t question wheth-

er a small practice just starting to treat sleep can “afford” to implement a medical system, it is the future of medical management and treatment for SDB is medical. You simply cannot afford not to.

SF Bay Area based Mike Selleck, DDS, DABDSM began his sleep medicine practice years ago the way many of our colleagues have… with the tragic loss of a friend who pulled a C-PAP mask off in the night and died. Devastated, he looked for answers and his journey towards establishing an airway dental/medical model began. Initially day-to-day logistical documentation and com-munications with physicians was frustrating and “detached.” Shocking many local physi-cians and colleague dentists, he threw cau-tion to the wind and kicked down as many MD doors as he could to gain acceptance in one of the most forward thinking hospital based pulmonology systems in the area. To do this he set out to fully incorporate “their” hospital-based EHR into his solo practice. Anyone who knows what a hospital based

The Precision Medicine

PARADIGM for Dental Sleep Medicine

by Pat Mc Bride, BA, RDA, CCSH, Sleep Clinician

True partnership between medicine and dentistry

must exist if we are to make any headway treating the

exponential increase in breathing disordered sleep.

The days where a one page medical history in a pa-

per chart sufficed are long gone. It has been replaced by behemoth electronic/cloud based systems with digital

forms compiling massive amounts of patient health data;

all of which must be carefully reviewed prior to definitive diagnosis and treatment planning.


MEANINGFULconversations

EHR looks like understands that no one in their right mind who is NOT connected with the hospital directly would ever consider the idea. According to Mike, “It didn’t take long to realize that without a two-way means to connect us directly with the physicians, labs, ...and patients, systematic care provision and management was going to be chaotic. Yes, it was a nightmare to get it all going, but the level of communication, quality of care and clinical outcomes have risen substan-tially. The patient’s perceptions of the quality of care and concern they receive have dra-matically improved. Understanding what it means to the patients we serve and the won-derful relationships established with local medical community now, we’d do it all over again in a minute. It has been so worth the effort. We have become a 100% physician referral source for the kind of care manage-ment we offer firstly because we serve the underserved, and secondly because we have the ability to move seamlessly back and forth through the system to serve patients effec-tively and efficiently.”

Gilles Lavigne’s brilliant placement of the Wikipedia definition of Precision Medicine in his recent article states that it is the tailoring of medical treatment to the individual char-acteristics of each patient (https://en.wikipe-dia.org/wiki/Precision_medicine), taking into consideration genetic predisposition, health status, lifestyle, culture, race, sex, biological and environmental risk factors. It is an ad-vanced decision making process.

In other words, precision medicine takes into account individual differences in the genes, environments, and lifestyles of people allowing the design of targeted disease inter-ventions from the start. What does this mean? In conventional medicine, our patients are more often than not treated with the same therapies that everyone else with the same disorder gets. Individual differences get over-looked. One cannot know which therapies will work and have fewer side effects for one set of patients over another. Precision med-icine uses health information technology to integrate medical history into patient centric approaches, improve health, and treat dis-ease, all while focusing on targeted longitudi-nal care outcomes. This individualized meth-odology actually requires a population-based perspective. Primary is learning what works and does not work for a person while at the

same time knowing that causality cannot be inferred on one person at a time. The informa-tion gathered from individuals must be com-pared against that of large numbers of other people in order to recognize individual char-acteristics that are important and identify rel-evant population subgroups that are likely to respond differently to treatment. Allowing for large data sets that include all strata of patient affords less bias and unreliable disease pre-diction models. Precision medicine’s current focus is on treatment; the exciting future plan gives attention to early detection and disease prevention.

Understanding the complexity of SDB and attendant comorbidities is essential for the dentist partnering with physicians. With-in the EHR are numerous areas where patient data regarding health status, medications, lifestyle and comorbidities are noted. Care-ful review of this information aids tremen-dously in definitive diagnosis and treatment

planning. As an example, when the dentist reviews data prior to patient intake he/she may note not one, but two or three medica-tions for hypertension on board. What that tells us before we ever see this patient with diagnosed OSA is that they also have a level of brain damage resultant of the OSA. That

Precision medicine takes into account individual

differences in the genes, environments, and lifestyles

of people allowing the design of targeted disease

interventions from the start.



Pat McBride, BA, RDA, CCSH, has spent 35 years as a

full time clinician in the fields of dentistry, respiratory medicine, and dental sleep medicine. Her extensive ex-

perience in clinical, laboratory and educational arenas led to the development of interdisciplinary care model delivery systems used by physicians and dentists across the globe. She sits on the Board of Directors for the Academy of Dental and Physiological Medicine in New

York. Pat continues to work as hands on with patients while lecturing interna-

tionally on subjects relating to sleep medicine, dentistry, and protocol devel-opment to best serve patient populations. Serving the underserved remains a priority and passion for her. She has one grown daughter, a teacher in Spain.


brain damage acts to perpetuate the OSA syndrome and the patient ends up with high set point hypertension, which is medication resistant. Treatment for this patient may re-solve the OSA with C-PAP or combination therapy but not always. If they are PAP re-sistant/fail your treatment plan of oral ap-pliance must include assessment and man-agement of the hypertension as well as the OSA by monitoring the patient’s BP at every visit, asking whether they have taken their medications regularly and if necessary refer-ring them back to PCP if it remains too high. But, you also must be completely informed as to what the BP norms for this patient are by age, sex, and comorbidity factor. During treatment, significant resolution of the respi-ratory disturbance index numbers (RDI) can be achieved, but could hit a “stopping point” where the dial simply refuses to move; the OSA damaged brain just cannot cope with anything else. This is where the impact of the comorbidity factors in, and you as the care provider need special understanding of just how far you can take a patient with a partic-ular therapy.

All patients... child or adult, man or wom-an presents differently with inspiratory flow limitation (IFL), upper airway resistance syn-drome (UARS) or OSA. The factors mitigating and influencing treatment selection will be precise to each age group and their partic-ular sets of accumulated data. Information recently published by Dr. Harper and col-leagues at UCLA notes that SDB patients are routinely deficient in Magnesium and Thia-mine, especially if they sweat in their sleep. Understanding, monitoring and treating nu-trient deficiency is well within the treatment paradigm for sleep disordered therapy. Ergo these levels must be reviewed and adjusted throughout therapy. A strong understanding and partnership with the patient’s MD can make this a much easier process. Stasha Gom-inak, MD’s work on D3 deficiency in SDB and neurology patients is groundbreaking,

and should be foundational in assessment and treatment for sleep patients. D3 plays an important role in sleep. The pacemaker cells of the brainstem appear to directly impact the timing of sleep. Most people walk around these days vitamin D3 deficient simply be-cause we don’t go into the sun like we used to. For good sleep, levels should be 60-80 ng/ml. Most of our OSA patients tested with levels well under 30 ng/ml. If a patient takes a statin drug it further blocks what little vita-min D3 the body gets from the sun. Correct-ing D3 levels can substantially improve sleep and the attendant daily headaches, digestive issues (GERD), initiation and maintenance of sleep. Additionally, if that same patient is de-ficient in thiamine and magnesium, takes a statin, and has leg cramp/muscle issues, can you contact the prescribing MD through an EHR and discuss changing the dosing time of day to help alleviate the leg cramps, and improve sleep fragmentation. Often mov-ing a dose to a few hours earlier in the day allows the patient to “walk off” the cramp/twitch side effects. If there is communication with the MD regarding the collective comor-bidities and presentation complaints, these issues are easily handled and quality of clini-cal outcome improves. This access and open line communication is a hallmark of preci-sion medicine and centers on patient need based on presentation and symptomology criteria. Having scientific knowledge of and evidentiary support to share with your physi-cians always advances your cause and helps your patients. Constant vigilance is required with regard to obtaining education regarding new data and therapy discoveries. These are just a few examples of the global diagnosis and treatment thought process required of the dentist who embarks upon treating the SDB population. Definitive testing and MD diagnosis of the disorder is always required prior to embarking on alternative/adjunctive therapy for the SDB patient.

There is no way treating the SDB commu-nity of patients can be a turnkey or cash cow revenue producing operation. Besides, in my experience, a turnkey is only ever as good as the person turning the key. Anything quick and easy will never factor in longitudinal health outcomes, tends not to be patient cen-tric or participatory, does not provide pub-lic education or address the health concerns of the underserved. There must be access to

Understanding, monitoring and treating

nutrient deficiency is well within the treatment

paradigm for sleep disordered therapy.



care for every level of the economic strata, and specific treatment paradigms established to ensure that care is provided at the highest level with utmost efficiency.

Being patient centered should be a core value for all physicians and dentists. If we are to look at a metric design for care pro-vision in this manner we must start with the clinician first. Does he or she have specific curiosity regarding the patient’s disease pro-cess and the four dimensions of the “illness experience?” Our job when a patient either presents or is referred into our care is to first establish rapport. We must both elicit and understand the patient’s feelings about their diagnosis, their actual level of understand-ing of what is wrong with them, the impact the disorder has on their ability to function during the day, and finally their expectations as to what should or can be done. Critical is the ability and desire to understand the pa-tient as a whole person. Longitudinal treat-ment success can only be achieved if the dentist and patient can find common ground regarding the management of the disorder. Common ground incorporates patient educa-tion and participation in the entire process of walking towards wellness. This doesn’t mean that the patient directs the care, but rather that the dentist operates in an realm where they can respond fully to the unique needs of the patient, and address appropriately issues as they come up during treatment. When the patient is placed at the center of the care paradigm and perceives a common ground with the dentist, they accept recommended treatment options more readily, cooperate with referral out of the DDS setting into an adjunctive therapist or MD providers prac-tice for associated care willingly, participate in the process directly and take responsibil-

ity. It is after all their health being cared for. They need to own the process. We are just the facilitators to that end. Patients who have providers who actively promote precision medicine report feeling better faster, have higher levels of care satisfaction, have few-er complications and report improved health and emotional status overall.

Whether you have been treating the SDB patient for a long time, or are just starting out, expanding into a medical model that places the patient at the center of the para-digm is essential. Use technology and a pre-cision medical model to improve the level of care you provide your dental patients as well. Whatever it takes to turn your vision to the future to improve the emotional and overall health status of your patients is time, effort and money well spent. Educate your-selves as to what options exist for your prac-tice and demographic of patient. Dentistry has so much to offer the medical communi-ty in terms of supportive care and concern for the patients. It needs to be diligent in its mission to join the medical community ful-ly engaging the sleep-disordered patient in a management model where patient needs are addressed as fully as possible. What dentistry absolutely does not want is for the medical community of peers to view us as cavalier or myopic in our understanding of the seriousness of this issue. There are mil-lions of unscreened and as yet to be diag-nosed people suffering. Make it your goal to reach out and touch as many of these people as you can, if only to screen them and make them aware. You may never treat them with an appliance, orthodontics, sur-gical therapy for sleep or other dental thera-py, but you may educate them and perhaps save their life.

1. Water Exchange across the Blood-Brain Barrier in Obstructive Sleep Apnea: Sleep. 2008 Jul 1; 31(7): 967–977.

2. Brain Structural Changes in Obstructive Sleep Apnea. Paul M. Macey, PhD, Rajesh Kumar, PhD, Mary A. Woo, DNSc, Edwin M. Valladares, BS, Frisca L. Yan-Go, MD, and Ronald M.

Harper, PhD, Jose A. Palomares, Sudhakar Tummala, Danny J.J. Wang, Bumhee Park, Mary A. Woo, Daniel W. Kang, Keith S. St Lawrence, Ronald M. Harper andRajesh Kumar*. Article

first published online: 29 AUG 2015 DOI: 10.1111/jon.122883. The World Epidemic of Sleep Disorders is Linked to Vitamin D Deficiency. S.C. Gominak, East Texas Medical Center, Neurologic Institute, Tyler, TX, USA; W.E. Stumpf, University of North

Carolina, Chapel Hill, NC, USA

4. The Impact of Patient-Centered Care on Outcomes. Moira Stewart, PhD; Judith Belle Brown, PhD; Allan Donner, PhD; Ian R. McWhinney, OC, MD; Julian Oates, MD; W. Wayne Weston,

MD; John Jordan, MD

5. Preparing for Precision Medicine. Reza Mirnezami, M.R.C.S., Jeremy Nicholson, Ph.D., and Ara Darzi, M.D. N Engl J Med 2012; 366:489-491 February 9, 2012 DOI: 10.1056/NE-

JMp1114866

6. Resistant Hypertension and Obstructive Sleep Apnea. Akram Khan, Nimesh K. Patel, Daniel J. O’Hearn, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science

University, Portland OR & Portland VA Medical Center, 3181 SW Sam Jackson Park Road, UHN67, Portland, Oregon 97239-3098, USA; and Supriya Khan, Division of Nephrology and

Hypertension, Oregon Health & Science University, Portland OR & Portland VA Medical Center, Portland, OR 97239, USA.Received 28 February 2013; Revised 21 April 2013; Accepted

27 April 2013

7. Vitamin D3 Effects on Lipids Differ in Statin and Non-Statin-Treated Humans: Superiority of Free 25-OH D Levels in Detecting Relationships. Lynn Kane, Kelly Moore, Dieter Lütjohann, Daniel Bikle, and Janice B. Schwartz. J Clin Endocrinol Metab. 2013 Nov; 98(11): 4400–4409. Published online 2013 Sep 12. doi: 10.1210/jc.2013-1922


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Ivan Stein, DDS, a NJ based dental sleep practitioner, is the proud inventor of the Ora-van and Oravan Herbst. “After many years of practicing sleep medicine, I was frustrated with the lack of comfort my patients were facing with other appliances as well as the amount of extra chair time having to refit and adjust them,” said Stein. He has incorporated the Oravan and Oravan Herbst devices in his practice and is astounded by the results.

“The results have been excellent and documented. Our patients have only rave reviews and actually use these appliances every night. By eliminating the anterior and incisal coverage, patient comfort is maxi-mized and the tongue protrudes naturally. Patients tell us all the time how great they are sleeping, how they have more energy during the day and how their partner no lon-ger is up all night listening to them snore. The appliances are easy to seat, and I never need to worry about anterior cosmetic work being a problem.”

Mandibular advancement of these appliances are easy to do and can be accomplished in very small increments for best results. Oravan can be advanced 0.1mm at a time, with 6mm of advancement. Oravan Herbst can be advanced 0.0625mm at a time, with 5mm of advancement.

OravanOSA introduced its dorsal fin appliance, Oravan, at the 24th AADSM conference in Seattle last year. Daniel Stein, CEO of OravanOSA said, “We’ve really come a long way. After receiving such amazing feedback on the Oravan, we knew we had to offer this treatment option to as many patients as possible. Obtaining Medicare approval on the Oravan Herbst last December was a huge step. We look forward in continuing to part-ner with more dentists to get this incredible treatment option to their patients.”

The company takes pride in not only providing the highest quality products, but also ensuring the best in customer service. “We specialize in sleep and understand how important it is to work with our dentists in meeting individual patient needs. We will do everything in our power to tailor the appli-ances to the doctor’s request for maximum effectiveness,” Daniel said. OravanOSA offers various design features on the Oravan such as a 90 degree wing to keep the mandible forward when the patient opens their mouth or an angled wing for those patients who may have difficulty acclimating to the initial forward position.

“I have been using OravanOSA sleep apnea appliances exclusively to treat my patients with sleep apnea,” stated James Andrews, DMD, of South Carolina. “The appliances are quick and easy to deliver with minimal adjustment. Patient compliance is great as they are very comfortable and patients tell us how much more alert and better they feel after wearing the appliance. This is the appliance that I personally wear and do not sleep without it.”

Recent estimates show that 80-90% of patients with Obstructive Sleep Apnea remain undiagnosed. With this evidence, it is clear that there is no other disease or disorder as life threatening as sleep apnea that is undi-agnosed and untreated to this level. As oral appliance therapy continues to gain popu-larity as a leading treatment option, Orava-nOSA is excited in helping more patients get the sleep they deserve. After all, everyone deserves to Sleep with the Best!

The Oravan and Oravan Herbst sleep apnea devices by

OravanOSA encourage natural protrusion of the tongue,

maximum patient comfort and less clinical chair time at

the fitting session.

OravanOSASleep Appliances with a Truly Open Anterior Design

“Patient compliance is great as they

are very comfortable and patients tell

us how much more alert and better

they feel after wearing the appliance.”

Oravan™ Herbst

Oravan™


PRODUCTspotlight

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1. Weaver T, Chasens E. Continuous positive airway pressure treatment for sleep apnea in older adults. Sleep Med Rev. 2007; 11:99–111.

2. Ferguson KA, Ono T, Lowe A, et al. A randomized crossover trial of an oral appliance vs nasal-continuous positive airway pres-sure in the treatment of mild-moderate obstructive sleep apnea. Chest.1996;109:1269-1275.

3. Menta A, Qian J, Petocz P, Darendeliler MA, Cistulli PA. A random-ized, controlled study of a mandibular advancement splint for obstruc-tive sleep apnea. Am J Respir Crit Care Med. 2001;163:1457-1461.

4. AADSM Protocol for Oral Appliance Therapy for Sleep Disordered Breathing in Adults: An Update for 2013, American Academy of Dental Sleep Medicine, 2013. AASM Clinical Guidelines for the Use of Unattended Portable Monitors in the Diagnosis of Obstructive Sleep Apnea in Adult Patients: Portable Monitoring Task Force of the American Academy of Sleep Medicine, JCSM Journal of Clinical Sleep Medicine, Vol. 3, No. 7, 2007.

5. Nonin Technical Bulletins and study data on file.

When buying a pulse oximeter to pre-screen for OSA and verify the

effectiveness of OAT, look for an accurate, easy-to-use, cost-effective device

Avoid the cost of missing desaturation events or having to repeat an overnight study

What costs more – multiple sleep tests to find out if the therapy is working or missing the problem altogether? There may be no clear answer, but there is a product

that helps the sleep dentist with both of these expensive problems. Continuous positive airway pressure (CPAP), the treatment of

choice of most physicians, is unfortunately abandoned by more than half of all patients within a year due to discomfort.1 Oral appliance therapy (OAT) is often deployed by dentists working with referring sleep physicians. Studies have shown that patients are more compliant with OAT than with CPAP,2 but the mandibular advancement devices do not have a performance or compliance smartcard. The physicians and the dentists need to know whether the airway problem is being solved. Repeat PSG? Not covered. HST? Patients may find them complicated and unreliable.

Overnight pulse oximetry monitoring is essential in pre-confirming the effectiveness of OAT for treating OSA

The American Academy of Sleep Medicine / American Academy of Dental Sleep Medicine 2015 guidelines recommend oral appliances as a first line treatment option for many OSA patients.3 According to the AADSM and the AASM, overnight pulse oximetry has been shown to be an effective sleep screening tool used to evaluate the response to OAT prior to sending patients back for follow-up polysomnography (PSG) testing at a sleep lab.4

Pulse oximeters are noninvasive medical devices used for measuring pulse rate and blood oxygen saturation (SpO

2). There are many FDA-cleared brands

on the market, but it’s important to understand that not all FDA-cleared pulse oximeters and sensors perform alike. Accurate readings are crucial to avoid missing desaturation events or having to repeat sleep studies.

Obtain Reliable SpO2 Results the First Time

Engineered with proven PureSAT® SpO2 technology, Nonin Medical’s

WristOx2® Model 3150 wrist-worn pulse oximeter provides accurate, con-

tinuous oxygen saturation and pulse rate monitoring during overnight sleep studies. Nonin PureSAT SpO

2 technology is clinically proven accurate in the

most challenging patients and settings – even in patients with poor circulation or dark skin, or with excessive motion.5 It’s little surprise, then, that 90% of PSG manufacturers use Nonin pulse oximetry!

Designed for pediatric and adult patients, the WristOx2 is comfortable to

wear and easy to use. Patients simply attach the WristOx2 like a watch, put

their finger in the soft sensor and go to sleep. The device turns on automati-cally when a finger is inserted and turns off when the finger is removed.

And the best part? Dental sleep practitioners save valuable training time and minimize the risk of patient set-up errors by pre-programming the device before it goes home with patients.

Nonin Medical’s WristOx2 3150 pulse oximeter and soft sensor


PRODUCTspotlight

Using digital crown and bridge technol-ogy, Dental Prosthetic Services (DPS) has developed a protocol for retrofitting a new restoration under an existing sleep appli-ance, allowing your patient, in many cases to continue wearing his or her appliance, and

avoid the cost of a new appliance. This process also helps you build value in your practice. Patients like knowing their dentist is state of the art, designing the crown and ap-pliance to work together instead of just “making it fit.”

“From a clinical and patient sat-isfaction perspective, the ability to retrofit a crown under an existing appliance saves time and expense,” said Dr. Laura Fauchier of Marion Dental. “I recently had a patient who needed a restoration under her appliance. She was concerned about purchasing another appli-ance because this one would be out of pocket. It was a relief to her to know that we would be able to make the restoration work with her current appliance.”

The process begins with the clinician us-ing PVS bite material to fill the area in the sleep appliance where the tooth is being re-stored, creating a “positive” of the existing dentition. Enough material to fully capture the tooth and tissue around the tooth being restored should be used. After the material sets up, remove it from the appliance and

send it along with the prescription, impres-sion of the crown prep, pre-operative study models, and bite. If the patient is having multiple crowns done, it may be necessary to send the sleep appliance to the lab.

“For the best outcome, in addition to the positive of the tooth being restored, we require a pre-operative study model of the arch. If the appliance is not well adapted to the tooth because of undercuts or ball clasps, it is difficult to achieve a good fit with just the positive. We use both the model and the pos-itive in our digital design and manufacturing process to mimic the existing dentition,” said David Stricker, Research and Development Specialist for DPS.

The fit of the appliance on the new crown may be more passive than the previous fit. The crown is designed to fit under the ap-pliance, but not fully engage it. Just as you would not want a pontic to bear the full oc-clusal load on a bridge, you do not want the new crown to bear the majority of the reten-tion of the appliance. “If the tooth that is be-ing restored is the primary source of retention for a quadrant of the sleep appliance, the ret-rofitting process is not ideal and I generally recommend a new appliance,” said DPS’s Dental Sleep Medicine Supervisor, Colleen Digmann.

Due to retention concerns, the retro-fitting process is indicated for single tooth restorations only. Stricker also suggests that monolithic crowns, like zirconia, work best under oral appliances, “Because we are mill-

by Deborah Curson-VieiraDirector of Customer Care, Dental Prosthetic Services

The relationship patients have with their sleep appliances is well docu-

mented. Patients have come to rely on their particular appliance and when

they need a crown made, they are hesitant to give up their appliance, let

alone have a new one made. In some cases, dentists can adjust the existing

appliance to fit the crown, however not all appliances are easily adjusted.

Retrofitting Crowns Under Sleep AUsing Crown and Bridge Technology in the Dental Sleep World


INSIDEtheLAB

The retrofitting process

can be used with almost

all sleep appliances.

ing solid crowns and not hand-stacking por-celain, the monolithic crowns tend to have a more consistent fit.”

The retrofitting process can be used with almost all sleep appliances. However, those appliances that have more room for adjust-ment work best.

By using advanced crown and bridge technology to retrofit crowns under sleep appliances, your patient does not have to be without his or her appliance while a new crown is being made, nor do they have the expense of purchasing another appliance, saving them frustration and continuing to build value for the service you provide with oral appliance therapy.

rowns Under Sleep Appliances:

INSIDEtheLAB


The analysis of data was conducted on patients whom I treated over about a three year time period. I reviewed data from one group of patients treated for a sleep breathing disorder with a popular dorsal fin appliance titrated with a jack screw mechanism, called Population 1. The second group of patients reviewed, population 2, was treated with a twin fin CAD/CAM sleep appliance, titrated using combinations of splints. Within Popula-tion 1, 17 cases that were diagnosed between the dates of April 2013 and April 2014 and consecutively completed treatment were ana-lyzed. Within Population 2, 20 cases that had been diagnosed between the dates of Octo-ber 2014 and November 2015 and consecu-tively completed treatment were chosen.

“Consecutively completed treatment” is defined as patients who had an initial poly-somnogram (PSG), followed the treatment protocol with the delivered sleep appliance, followed up with a final home sleep test (HST) and had reported significant improve-ment in symptoms and quality of sleep. The patients who fell within these populations but did not follow up with a final HST or have not reached a conclusion in their treatment were not included in the data for this report. Additionally, patients who started treatment with one sleep device and then chose to use a different sleep appliance will be discussed in detail in a separate communication.

The technique for capturing the bite for all of the patients in both Populations 1 and 2 was consistent over the 3 year span. A physi-ologic approach utilizing TENS (Transcutane-ous Electrical Neural Stimulation) to prepare the patient for the bite and determining the

Is Selecting the Appropriate Sleep Device for You and Your Patient Important?

by Dr. David “Trey” Carlton III

Recently, I gathered patient data to take a retrospective

look at the performance of two sleep breathing applianc-

es I was using to treat patients. I suspected that one of the

sleep appliances was out performing the other in overall prac-

tice efficiency and in patient outcomes.

68

CHOOSINGappliances

DSP | Summer 2016

bite position as taught at the Las Vegas Insti-tute (LVI, Las Vegas NV) was used for all the patients treated with sleep devices. Any vari-ation to patient treatment was subject to pa-tient compliance and their schedule, but the plan typically was as follows in Table 1.

For steps 1 and 2, patients presented with symptoms which ultimately lead to Obstruc-tive Sleep Apnea (OSA) screening, diagnosis and treatment. The Epworth Sleepiness Scale and an OSA assessment worksheet were used in these populations to help understand pa-tient symptoms in terms of pain and overall wellbeing. I worked closely with physicians in my area to treat CPAP intolerant patients and patients whom the physicians believe were good candidates for oral appliance therapy (OAT). Specifics of Steps 1 and 2 were not included in this report as this was widely variable due to insur-ance plans, required documentation for acceptance and sleep physician ap-pointment availability. Details of Step 3, capturing the patient’s physical re-cords for appliance fabrication and or-dering, was also not included. For this analysis, data regarding the patients in the two populations begins with Step 4, the appliance delivery appoint-ments and continued through Step 6, once the final HST report showed that the patients sleep breathing disorders were “treated”.

Technically, a “treated” patient is described as having a 50% reduction in AHI or achieving an AHI of less then 10, with the goal of complete treatment at an AHI of less than 5. Oftentimes, patients will complete their own treatment, vis-a-vis by feeling significantly better and/or they stopped seeing the need for further appointments. Of course, our goal as doctors is to achieve the best possible outcome by encouraging patient follow through and completion.

In Population 1, there were 17 patients overall, with an average age of 57.0 +/- 10.4 years, an average BMI of 31.4 +/- 7.1, an av-erage starting PSG AHI score of 33.5 +/- 22.7 In Population 1, there were 11 Females and 6 Males. All patients in Population 1 were treat-ed with the SomnoDent® Lingual-less Sleep Device (Aurum Labs, Las Vegas NV) shown in Figure 1A and 1C. Population 2 consisted of 20 patients with an average age of 54.1 +/- 12.0

David Carlton III, DDS, is a graduate and Fellow

of the Las Vegas Institute for Advanced Dental

Studies (LVI). He has taken over 100 hours of

training in Dental Sleep Medicine and treats pa-

tients at his Center for Dental Sleep Solutions in

Alexandria, LA.

Table 1: Patient Path

Step Activity

1 Symptom Discovery and OSA Screening in office

2 PSG consult referral and MD OAT Prescription, Insurance Coordination and

Documentation

3 Appliance Selection and Patient Records

4 Appliance Delivery and Education

5 2-4 week Follow Up for Symptom Review and Initial Calibration/Titration

6 Final HST and additional Follow Up as needed

Figure 1A Figure 1B

Figure 1C Figure 1D

years, an average BMI of 32.4 +/- 5.9, start-ing with an average PSG AHI score of 35.6 +/- 23.1. This group had 14 Females and 6 Males. All patients in Population 2 were treated with the MicrO2™ Sleep Device (MicroDental Labs, Dublin, CA) shown in Figure 1B and 1D.

Figures 2 and 3 show the initial diagnostic PSG AHI data in blue for each patient and

CHOOSINGappliances


the final HST AHI data for each patient in red. Table 2 shows a summary of the differ-ence between the average outcomes based on AHI results between the two populations, with Population 2 having a greater than 27% improved AHI average of 9.0 compared to that of 11.9 for Population 1. The table also shows that the change (delta) from initial AHI to final AHI for Population 2 compared to Population 1 is about 11% greater for all patients with a reduction in AHI, except for 4 patients in Population 1 who had an increase in AHI vs. 1 patient in Population 2. Table 3 further compares the success in treating each population. Using the standard guidelines previously discussed, 85.0% of Population 2 were successfully “Treated” compared to 58.8% of Population 1. Those who did not meet the guidelines, but still had a significant change in AHI outcome were classified as “Patient Responded.” Those patients who re-vealed no change or a negative change (AHI actually increased with OAT) were classified as “Not Treated”.

Table 4 reveals data regarding practice efficiency. The data here includes all patient

appointments during treatment steps 4, 5 and 6 in which clinical notes in the patient charts described fitting/delivering the appliance, ti-trating the appliance, adjusting the acrylic to the appliance, and/or responding to a patient concern about the appliance comfort or pain possibly due to OAT.

It is important to note the differences in titration modalities of the two appliances to help understand and analyze practice effi-ciency. The SomnoDent oral appliance uti-lizes a jack screw with a 0.1mm titration per turn which is a standard adjustment type in some sleep devices. Titrations for this appli-ance was as few as 1 to 3 turns as commonly taught in the sleep appliance arena. The Mi-crO

2 sleep device Series A used offered 1mm

adjustments, therefore I titrated my patients at those increments. Not only did my patients tolerate those adjustments well, they moved to a successful treatment position more quick-ly. This is easily seen in the number of ap-pointments and treatment duration. Typically for either appliance I would make the initial titration and educate the patients to do their own subsequent titrations. Patients respond-ed well and easily titrated the MicrO

2 Sleep

Devices. However, for the jack screw adjust-ments, some patients could not easily manage the adjustment process due to age, dexterity or simply making adjustment mistakes. This added to the number of clinical appointments for Population 1.

The patients in Population 2 showed 30% fewer overall patient appoint-ments from 7.8 to 6.0 and even more significant reduction in overall treat-ment duration, from an average of 10.3 months for Population 1 to 3.8 months for Population 2.

Using standard

guidelines 85.0% of

Population 2 were

successfully treated

compared to 58.8%

of Population 1.

Table 2: Comparison of average PSG outcomes for Populations 1 and 2

Population AVG Initial PSG AVG Final HST AVG Delta AHI

1 33.5 +/- 22.7 11.9 +/- 8.9 24.9 +/- 16.3

2 35.6 +/- 23.1 9.0 +/- 8.6 27.8 +/- 21.1

Figure 2: Pop. 1 PSG-HST data Figure 3: Pop. 2 PSG-HST data

Table 3: AHI Comparison of successfully treated patients in Populations 1 and 2

Population AHI<5 AHI<10 AHI Reduced 50% Patient Responded Not Treated % Treated

1 5 3 2 3 4 58.8%

2 8 5 4 2 1 85.0%


CHOOSINGappliances

The data shows that Populations 1 and 2 had very acceptable outcomes with both groups having over 58% treatment success. The discussion comes as to why there are outcome differences between the Popula-tions and to what the success and efficiency in treating OSA with specific Oral Devices can be attributed? I believe that proper de-vice selection is paramount in the success seen in the above data. Specifically, a device that is fabricated into a sleek profile, low vol-ume design and allows as much space for the tongue as possible. Both the lingual-less SomnoDent and the CAD-CAM MicrO

2 oral

appliances provide significantly more space for the tongue than most appliances on the market, with the MicrO

2 Sleep Device pro-

viding even more room. You can see in com-paring Figure 1C to 1D that the MicrO

2 Sleep

Device has significantly less material behind the anterior teeth and overall less bulk. In my opinion, this specific feature may be the rea-son for the high treatment success of 85.0% for this group. It also contributes to what may be the most important aspect of treatment success, patient comfort and compliance.

Another specific feature that differenti-ates these two appliances is the angle de-gree of the dorsal fins. The SomnoDent oral appliance features a 70-degree fin vs. the 90-degree fin on the MicrO

2 Sleep Device.

It is hard to identify specific reasons for treat-ment success, but I believe the design of the 90-degree fin does in fact maintain better protrusion during the full range of mouth po-sitions during sleep. In my observation, there have been no negatives to this feature and could be one more explanation to the im-pressive results of Population 2 when com-pared with Population 1.

The difference in the titration modalities definitely contributed to the “ease of use” of the appliances in Population 2. More patients struggled with the jack screw mechanism than they did placing the MicrO

2 Sleep De-

vice splints. The extra appointments needed by some patients in Population 1 prolonged treatment time contributing to delayed health outcomes and potentially added to decreased patient follow through. Addition-ally, it would make sense that the smaller in-crements of titration used for the first popula-tion also contributed to prolonged treatment. Both the simplicity of the MicrO

2 system and

the increased titration increments has led to

quicker resolutions of patient symptoms and faster patient treatment completions. I sus-pect that more positive patient experiences and increased patient referrals also resulted with this appliance therapy.

In summary, I believe proper oral appli-ance selection has delivered two very im-portant outcomes: Impressive results showing lowered AHI scores matched with patient reports of better sleep quality, increased day-time energy and an overall better sense of well-being. Additionally, patients required fewer appointments and less time to treat-ment objectives, resulting in greatly enhanced practice efficiency. I believe these factors are important when it comes to patient satisfac-tion and overall sleep practice success.

Table 4: Comparison of Appointment Efficiency for Populations 1 and 2

Population Treatment Appointments Treatment Duration Months

1 7.8 +/- 3.6 10.3 +/- 7.0

2 6.0 +/- 3.0 3.8 +/- 2.9

Before you hire a firm to help you implement a dental sleep medicine program, talk to us…

• Low month-to-month program costs that include the newest Philips Respironics home sleep testing equipment

• Low startup/training fees including 6 CE credits for every dentist and hygienist on your team

• Dedicated dentist-friendly sleep physician and sleep tech team for you and your patients – we bring the sleep doc to you!

• Everything you need to start screening, testing and

treating patients immediately

Find us online at www.sleeptreatmentsolutions.com

Email us at [email protected]

Or call us at 303-390-1217Visit us at the AADSM Booth #411

CHOOSINGappliances


sleep. Identification of the site of obstruction and pattern of upper airway changes during sleep is a key point to guide therapeutic ap-proaches of OSA. What is really exciting is the work of Zephyr Sleep Technologies. Zephyr is the only company evaluating the ideal position of the mandible for maximum airway patency during sleep. The MATRx system is patient specific and is available for dentists to use at many sleep labs. Keep your eye on this company as technology is con-stantly advancing (www.zephyrsleep.com).

Since seeing is believing, any time a pa-tient can experience what is happening with their own airway during sleep, it’s a winner! Wearable technology is becoming the norm and the average consumer can get a pretty good idea of the quality of sleep he or she is experiencing. This technology is very new and only has room to improve. Some of these products include: Fitbit to track movement and hours slept, the Oura ring is specially de-signed for sleep to measure data and provide textual message flow showing trends, details and changes over time (Ouraring.com). Even one of the largest gaming companies in the world wanted to watch us sleep – Nintendo had plans to release a bedside sensor that tracks sleep and sends data up to the cloud for analysis that would provide suggestions for better sleep. Sadly, the project came to a halt in February 2016 but may be revived anytime. Products like inclining beds and cooling pillows are all the rage in the sleep market. These tools are great to amp the awareness of sleep quality!

The app technology is providing some great tools for a dental sleep practice. Recent-ly, Dr. Gail Demko, Dental Director of Sleep Apnea Dentists of New England pointed out a couple great apps for patients regarding posi-tional therapy. She was excited that the Som-

noPose app used for iPhones and the Apnea Sleep Position app used for Android phones

by Glennine Varga, AAS, RDA, CTA

In the past few years there have been some wonderful techno-logical advances in sleep research and sleep observation and even more amazing advances are on the horizon. Any dental

team member can get excited about something that will en-hance the job at hand making it fun and rewarding. Technology can play a big role and has its place in a dental sleep practice.

Let’s reflect on the history of technology in the dental field. Prior to 1896, we had no way of viewing the inside of a tooth or the integrity of its structure. However, in 1924 the bitewing radiograph gave us this ability. Now we have cone beam technology making it possible to see a 3D image of our patients’ teeth and airway structures. We have seen dental offices transition from pa-per charts to digital charts allowing electronic charting for every encounter. We have seen intra-oral cameras evolve to magnify small structures so pa-tients can visually experience what is being evaluated. In some offices we’ve seen the transition from articulating paper to the use of digital bite recording with T-scan to measure timing versus force and electro-diagnostic equipment to measure muscle activity, jaw tracking and joint vibration analysis (JVA). The dental profession has evolved to scanning impressions instead of the use of impression material. These advances play a significant role in educating patients to move forward with treatment, help dentists get a full picture of their patient’s dental and musculoskeletal health and enhance the ability of dentists and dental team members.

In the sleep industry the technological advances have also evolved to help practitioners glean what is occurring during a night of sleep. The first electro-encephalogram (EEG) of man was recorded in 1929 to help understand brain function during sleep. In 1953 the same technology was used to identify sleep stages REM and NREM and in 1970 the first sleep lab was established. Today the sleep industry has several different types of Home Sleep Apnea Testing (HSAT) units to work with and several new wearable technology pieces are available to the average consumer. Let’s evaluate sleep technology currently on the market and what is on the horizon and how it can play a role in a dental sleep practice.

An educated patient will make educated decisions. Patient education is a fundamental staple in any dental practice offering dental sleep medicine. Ed-ucational videos and presentations are great especially if the information is illustrating the patient’s specific condition. The use of cone beam technology and 3D images are a fascinating way to educate patients because patients are able to see their own airway and how it can be affected with mandible position. The procedure Drug-Induced Sleep Endoscopy (DISE) is also a great advancement in technology, unfortunately is used only by otolaryngologists, not dentists. DISE is the closest thing to evaluating a collapsing airway in real


TEAMfocus

The Use of

Technology in a Dental Sleep Practice

Glennine Varga is a certified TMD assistant and educa-

tor with an AA of sciences. She is a certified TMD assis-tant with the American Academy of Craniofacial Pain. She has been employed in dental education for over 19 years. Glennine has been a TMD/Sleep Apnea trainer and speaker with emphasis on medical billing and doc-

umentation for over ten years and has tried the use of electrodiagnostic equipment for five years. Glennine is

CEO of Dental Sleep Medicine Boot Camp and Co-Founder or Dental Sleep Medicine Interactive Team Training with Jan Palmer offering Administrative Aspect of DSM courses across the country. For more information, visit www.dsmbootcamp.com, www.dsmitt.com or email [email protected].

can monitor a patient’s position during sleep. These apps sound alarms to alert the patient to get off their back. Check out the many sleep apps available today like SnoreLab, Sleep- Cycle, SleepBot and Sleep Time. They use your phone’s accelerometer to record sleep habits and sleep cycle theory to wake you up at the right time to ensure optimal rest. Of course there are a slew of apps providing soothing soundtracks and white noise to help the on-

set of sleep like Pzizz, White Noise and Sleep Genius. Mediation for sleep apps like Relax & Sleep Well Hypnosis and dream journal apps like Awoken may be helpful for some patients.

These types of technology will only help the dental sleep medicine industry as along as we (dental professionals especially TEAM) take advantage of them! Ask your patients if they have ever purchased any such technol-ogy, keep a sleep diary or use any type of sleep app. Your patients may not want to bring up consumer products with your doctor, but they’ll be happy when you are willing to ex-

plore with them. Talk with your doctor and possibly suggest apps or ancillary products to

your oral appliance therapy that will help your patients get the best night’s sleep possible.

This Sleep Team Column will be dedicated to the team and provide practical tips and re-

sourceful information. Let us know your spe-

cific issues by email to: [email protected], while we can’t respond to every indi-vidual. Your feedback will help us create the most useful Sleep Team Column we can!

September 15-17, 2016Hilton El Conquistador Resort | Tucson, Arizona

www.aapmd.org

30+ Speakers

Focused

Workshops

Networking

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AAPMD Airway SummitBuilding a Collaborative Community for Optimal Health

TEAMfocus


Stark Law and Anti-Kickback StatuteKey Issues You Should Consider to Protect Yourself and Your Practice

by Ken Berley, DDS, JD, and Jayme Matchinski, JD

Investigations, audits, and indictments related to the Stark Law and Anti-Kickback Statute violations in the dental sleep com-munity are likely to become more common place in the near future. Sadly, most dentists who are at risk of violating these federal laws may not even know these laws exist. In this article, we will discuss these statutes and outline the types of patient referrals that are prohibited under the law. Additionally, we will explain the risk associated with violating these federal statutes and the civil and crimi-nal penalties that could be imposed.

Why should dentists and dental prac-tices be concerned about the Stark Law (SL) and the Anti-Kickback Statute (AKS)? Many dentists and dental practices are making deals with physicians to get referrals for Oral Appliance Therapy. The SL and AKS were

enacted to ensure that health care profes-sionals do not enter into prohibited referral agreements and to prevent overutilization of health care services. If a dentist or dental practice is considering entering into a quid pro quo agreement and arrangement with physicians to get referrals, proceed forward cautiously and ensure that any agreements are in full compliance with the federal SL and AKS, as well as any applicable state reg-ulations regarding patient referrals and pay-ment terms between providers.

Any time a dentist and physician enters into an agreement where the dentist expects to receive referrals and the physician receives some type of benefit, the SL and AKS are most likely triggered. The federal SL and AKS only apply if providers provide services to patients who are beneficiaries of a govern-ment program, including but not limited to, the Medicare and Medicaid programs. Therefore, if you do not accept Medicare, Medicaid, Tricare or other federally funded plans, these statutes may not apply to you. However, most states have their own ver-sions of the SL and AKS and some states, for example Florida, are more restrictive than

In this issue, I have asked Jayme Matchinski, Attorney at

Law, to join me in writing this important article. Jayme has

many years of experience in healthcare law and is consid-

ered an expert in the field. I am truly grateful for her input and expertise in researching and writing of this article.


LEGALledger

Dr. Ken Berley is a practicing general dentist with over 30 years of private practice experience focusing on com-

plex reconstruction and 20 years of experience as an attorney licensed to practice law in Arkansas and Texas. He

has extensive experience as a litigator and was a full partner in Travis, Borland and Berley, Attorneys’ at Law before

moving to Northwest Arkansas. Dr. Berley is a Diplomate of the American Sleep and Breathing Academy and a

Diplomate for the ABDSM. He lectures in the area of sleep medicine risk management. He has provided TMD

treatment for many years and has incorporated Sleep Medicine in his office for the last 3 years.

Jayme Matchinski, JD, concentrates her private law practice on health care and corporate law. She works with

physicians, as well as not-for-profit and for-profit health care systems in the licensure, certification, legal structure and reimbursement structuring of post-acute venues of care, including sleep disorder centers, rehabilitation hos-

pitals, ambulatory surgery centers, long term acute care hospitals, skilled nursing facilities, among others. She is

the former vice president of a national health care consulting firm. Jayme is a member of the editorial advisory board of Sleep Diagnosis and Therapy Journal, and an advisory member of the board for the Sleep Center Man-

agement Institute in Atlanta, Georgia. She serves as the Chair of the National Council for Valparaiso University

School of Law. Jayme serves on the Board of Directors of Volunteer Optometric Services to Humanity (VOSH) Illinois Chapter.

the federal statutes. Therefore, make sure you check your state’s statutes before you enter into any agreements for the provision of oral appliance therapy.

During the past few years, several dental organizations have emerged that are signing up dentists and selling the “right” to imple-ment their dentist/physician referral program within certain zip codes. These organizations and dentists are recruiting physicians to par-ticipate in patient screening programs where the dentist get referrals for oral appliance therapy. In these organizations, dentists pro-vide physicians with a dental sleep employee to work in the physician’s office to screen all patients for Obstructive Sleep Apnea (“OSA”). When a potential OSA patient is identified, the physician then orders a Home Sleep Test (“HST”). The HST equipment is supplied by the dentist without cost to the physician. The physician is then paid by the patient’s med-ical insurance or Medicare for the HST and OSA diagnosis. After the diagnosis of OSA, the physician then rewards the dentist with a referral for oral appliance therapy. After oral appliance therapy is completed, the patient returns to the physician’s office for a final HST to confirm efficacy. The physician is again paid for an HST by the patient’s health insurance.

Overview of the SL and AKS

The SL (Ethics in Patient Referral Act) pro-hibits physicians from referring Medicare patients for “designated health services”

(“DHS”) to any facility or other entity with which the referring physician (or any of his or her immediate family members) has any financial relationship, unless an exception in the SL or related regulations is satisfied.1 Furthermore, the entity providing the DHS would be prohibited from billing Medicare for the services. The SL also prohibits the entity from presenting, or causing to be presented, claims to Medicare (or billing another individual, entity, or third party payer) for those referred services. The SL establishes a number of specific exceptions and grants the Secretary the authority to cre-ate regulatory exceptions for financial rela-tionships that do not pose a risk of program or patient abuse.

The original SL (Stark I) applied only to Medicare referrals for clinical laboratory services. Stark II, enacted in August 1993, expanded the prohibition to apply to an addi-tional list of DHS and to referrals to Medicaid as well as Medicare patients. Under Stark I and Stark II, prohibited financial relation-ships include: ownership or investment interests through equity, debt or other means and include indirect ownership interests through other entities, as well as compen-sation arrangements including virtually any form of remuneration. Possible sanctions for violation of the SL include: civil monetary penalties, exclusion from the federal health care programs (including Medicare and Medicaid) and forfeiture of all improperly collected amounts.

The False Claims

Act offers whistle-

blowers an effective

way to expose and

stop kickbacks in

the health care

system.

LEGALledger


The following are some DHS prohibited by Stark II :

• Physical therapy, occupational ther-apy, and speech-language pathology services;

• The professional and technical com-ponents of radiology and certain other imaging services, including MRIs, CT scans and ultrasound services, but excluding nuclear medicine and cer-tain other procedures;

• Durable medical equipment and supplies;

• Prosthetics, orthotics and prosthetic devices and supplies;

In general, a “referral” is a physician’s request for, ordering of (or certifying or recer-tifying the need for), any DHS for Medicare patients, including a consultation request and tests or procedures ordered, performed or supervised by the consulting physician or the physician’s request or establishment of a plan of care involving Medicare DHS. In addition, a physician who directs or controls referrals by others is deemed to be a “referring physi-cian”. A financial relationship includes own-ership, investment interest, and compensa-tion arrangements. (42 U.S.C. 1395nn(h)(5).)

Durable medical equipment includes oral appliance therapy, and referrals for and the provision of DME between providers, including physicians and dentists, and trig-gers analysis under the SL to ensure that such referrals would not be a prohibited referral between the parties.

Penalties for Violation of the SL include: • Denial of payment for the DHS

provided; • Refund of monies received by phy-

sicians and facilities for amounts collected;

• Payment of civil penalties of up to $15,000 for each service that a per-son “knows or should know” was provided in violation of the SL, and three times the amount of improper payment the entity received from the Medicare program;

• Exclusion from the Medicare program and/or state healthcare programs including Medicaid; and

• Payment of civil penalties for attempt-ing to circumvent the SL of up to $100,000 for each circumvention scheme.

The consequences for non-compliance with the SL are the denial of payment or recoupment of overpayment. Specifically, the SL states, “no payment may be made” for DHS provided in violation of the physician self-referral statute and that “if a person col-lects any amounts that were billed in viola-tion of the statute, the person shall be liable to the individual for, and shall refund on a timely basis to the individual, any amounts so collected.” Sanctions for violating the statute are often severe and sometimes lead to disproportionally large damage amounts compared to the severity of the violation. Because all claims associated with the pro-hibited referrals for DHS, even if medically necessary, are not payable, providers who submit such claims are subject to significant overpayment liability. The statute’s overpay-ment sanction creates a significant potential financial burden on health care providers.

Federal Anti-Kickback StatuteThe Federal AKS was enacted to protect

patients and federal health care programs from fraud and abuse by prohibiting the use of money, remuneration, either directly or indirectly, to influence health care deci-sions. The AKS specifically provides that any-one who knowingly and willfully accepts or offers remuneration of any sort and in any manner intended to influence the referral of Medicare and Medicaid services can be held accountable for a felony.

The AKS, 42 U.S.C. § 1320a-7b(b), pro-hibits any person or entity from making or accepting payment to induce or reward any person for referring, recommending or arranging for the purchase of any item for which payment may be made under a feder-ally funded health care program. The statute not only prohibits outright bribes, but also prohibits offering inducements or remu-neration that has as one of its purposes the inducement of a physician to refer patients for services that will be reimbursed by a fed-eral healthcare program. The statute ascribes liability to both sides of an impermissible kickback relationship.

Any person, including a dentist, physi-cian, or other third party or entity, who is involved in making or accepting payment to induce referrals may be indicted. Illegal remuneration includes bribes and rebates, gifts, above or below market rent or lease

Sanctions for

violating the statute

are often severe and

sometimes lead to

disproportionally

large damage

amounts compared

to the severity of

the violation.


LEGALledger

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arrangements, discounts, supplying ser-vices or equipment for free or at above- or below-market rates, cash of any kind, whether they are paid directly or indirectly. Almost anything bought by or between med-ical providers can be characterized as remu-neration, if given with the intent to influence medical decision making. If a dentist is pro-viding an employee to a physician to screen the physician’s patients for free or is provid-ing equipment (HST) free or below market rates, the AKS may be triggered.

The federal AKS incurs a criminal viola-tion charge because by definition it requires a specific intent to induce referrals or orders for services. Anti-Kickback violations are pun-ishable by up to five years in prison, with the potential for additional criminal fines up to $25,000, and administrative civil money pen-alties reaching as much as $50,000 per occur-rence. Additionally, the Department of Health and Human Services’ Office of Inspector General may commence administrative pro-ceedings to prohibit anyone convicted of an Anti-Kickback violation from participation in federal and state health care programs or impose civil monetary penalties for fraud, kickbacks, and other prohibited activities.

To assist the federal government in policing the referral process, federal whistleblower statutes have been promulgated where employees of health care practitioners or other knowledgeable parties can initiate federal or state investigations into referral or kickback violations. The False Claims Act offers whistleblowers an effective way to expose and stop kickbacks in the health care system. Kickbacks, which are hidden finan-cial arrangements between doctors and hos-pitals or other healthcare providers or com-panies, are one of the most complicated and troubling aspects of the health care system. Qui tam lawsuits are a type of civil lawsuit whistleblowers bring under the False Claims Act, a law that rewards whistleblowers if their qui tam cases recover funds for the government. Under the False Claims Act, a private citizen or employee may sue an indi-vidual or a business that is defrauding the government and recover funds on the gov-ernment’s behalf. The qui tam lawsuit is filed “under seal,” meaning that it is kept secret from everyone but the government to give the Justice Department time to investigate the allegations. Even the person or entity

being accused of fraud is not told about the qui tam case. The qui tam lawsuit and sup-porting documents should provide the gov-ernment with detailed information about the fraud. Under the Affordable Care Act and its False Claims provision a party with general knowledge or suspicion of fraud or violation can act as a whistleblower. As an incentive, whistleblowers receive a per-centage of the funds recovered from wrong- doers. Therefore, any disgruntled employee or a dentist practicing next door can take his evidence to an attorney and sue you as a federal whistleblower. Consider the potential risk exposure. Any party with knowledge of a referral scheme could potentially act as a federal whistleblower, including employees and competing providers.

Conclusion

Don’t get me wrong, I am sympathetic to any dentist trying to get a dental sleep prac-tice established. I am not trying to rain on your parade. I am aware that it is difficult to establish a referral network! We are all trying to develop relationships with referring phy-sicians and there is nothing innately wrong with that. However, contracting with phy-sicians for referrals is too risky for me. DO NOT give a physician anything of value for a referral! If you are sued by a whistleblower attorney, it could be financially devastating. All it takes for you to get into trouble is for you to make a staff member mad enough for her or him to contact a whistleblower attor-ney. The employee could initiate the lawsuit and still be working for your office since the relater is undisclosed and unidentified. Ultimately, the employee could be paid a portion of any recovery. Sadly, even if you win the case you will lose financially. I don’t want to be the dentist who has to defend this in court. “If you are currently participating in some type of arrangement with a physician where you receive referrals, I strongly urge you to consider hiring a good health care attorney and have him review your protocol and any agreements (contracts) that you have with physicians. “If in doubt, Get Out!”

1. Section 1903(s) of the Social Security Act, 42 U.S.C. Section

1396b(s), expanded the SL to cover Medicaid by denying fed-

eral payment to states for DHS resulting from prohibited refer-

rals. While CMs has not yet issued regulations on Medicaid

referrals, we recommend that all Medicaid DHS referrals sat-

isfy the same standards as Medicare referrals.


LEGALledger

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