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Patient Protection and Affordable Care Act upheld by US Supreme Court

June 29, 2012 SleepDT Leave a comment

In a landmark 5 to 4 decision, the US Supreme Court upheld the majority of President Obama’s signature health-care reform legislation, which was signed into law in March 2010. In the ruling delivered Thursday morning, the Supreme Court upheld the central and most controversial element of the law, the minimum coverage provision, popularly known as the “individual mandate.” It was ruled that the federal government may use its taxation authority to impose penalties on those who do not purchase insurance meeting minimum federal standards. Another less-discussed provision of the health-care reform law, the expansion of the Medicaid program, was also upheld. However, the federal government is limited in the penalty amount they can impose on states that choose not to expand their Medicaid program.

Read full details of the decision, visit Supreme Court website.

Stay tuned for commentary from Sleep Diagnosis and Therapy on how the health-care reform law will affect Sleep Medicine.

The Affordable Care Act Became Law in March 23, 2010

On March 23, 2010, President Obama signed the Affordable Care Act. The law put in place comprehensive health insurance reforms that will roll out over four years and beyond, with most changes taking place by 2014.

Use this timeline to learn about what’s changing and when at Healthcare.gov

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Game Changer – Why Sleep Labs are Shifting the Way They Operate and Why Those that Aren’t, Should

June 7, 2012 SleepDT Leave a comment

Natalie Morin
President & CEO, Sleep Strategies

Examine the evolution of sleep record outsourcing and you will gain some key insights into the changing operational practices of sleep labs and hospitals. What began as a strategy to alleviate sleep study backlogs and prevent year-long-plus wait times for patient diagnosis, has now morphed into an ongoing, virtual partnership. Perhaps the most revealing indication of this once niche industry’s recent maturation is how it has performed throughout the economic crisis. “Where so many industries have had to make cutbacks in the last three to four years, our business has been on the rise. It comes down to the fact that ours is one of those rare companies that actually help our partners save money in very concrete, immediate ways,” says Natalie Morin, President and CEO of Sleep Strategies Inc.

Morin is encouraged by the resilience of sleep record outsourcing— an industry she helped found over 12 years ago. Forecasts indicate that what began as an economically-driven shift in business practices is likely here to stay. “It might have taken a recession to motivate sleep lab managers to con sider novel budget cutting measures, but now that they see how sleep scoring quality can improve while overhead is reduced, it just makes sense to make the change permanent,” explains Morin. Prior to the economic crisis, sleep record outsourcing was certainly on the rise. “But at a slower pace,” says Morin, going on to explain, “Hospitals were acknowledging that they needed expertise they didn’t have in-house, specifically with finding qualified staff. Then the economic crisis comes along, and many sleep labs are forced to change their business practices by cutting labour costs and increasing efficiencies. So we saw a real spike in late-2008 and again in 2009 and then once again in 2010. At this point, it feels like the onslaught of new business is here to stay.”

The concept is simple. Companies like Sleep Strategies house a large team of RPSGTs—who are all certified specialists in the scoring of sleep studies, which facilitate the accurate diagnosis of sleep disorders. With the ongoing rise of sleep disorders, the demand for quick turnaround of these studies is essential. Many sleep labs and hospitals are opting to keep their operations patient focused—attending to the collection of data through overnight sleep monitoring—while diverting the analysis of data to trusted external partners like Sleep Strategies. The beauty of this arrangement is that it’s mutually beneficial. The use of third-party scoring companies with certified technologists allows sleep labs to reduce recruitment, hiring, training and several other overhead costs. It’s also become so widely adopted because the sole-focus nature of this sector leads to improved accuracy and efficiency, which ultimately allows these labs to improve patient care.

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According to Morin, the trend should continue as hospitals realize that investing in training and locating qualified staff has begun to dominate operational budgets. An informal survey conducted by Sleep Strategies of lab managers indicates they are increasingly focused on business growth and patient care in what is a lingering recession. So if sleep record outsourcing is so widely considered the de facto method to streamline processes and get sleep labs back in the black, the obvious question remains: why isn’t it universally accepted?

Chad Doucette, VP of Sales and Marketing at Sleep Strategies attempts to make sense of what some see as barriers to fully embracing sleep record outsourcing. “If we forget for a moment the natural reluctance to change that exists in most large organizations, we can see that some sleep labs don’t outsource their scoring because they falsely believe that in-house anything is more cost-effective. Truth is, there are a number of hidden costs with in-house scoring,” explains Doucette.

Locating, training and retaining qualified staff consume a surprising amount of monetary and human resources. The hiring process alone entails spending money for recruitment advertising, time on testing, interviews and other screenings. Then of course there is the training and supervision of new hires, not to mention the overhead on such concrete items as office furniture, supplies and space. This is all before salary, worker’s compensation and medical insurance comes in the picture, as well as additional employee benefits such as vacation, sick days, personal days, maternity leave and pension, among others. All of these details need to be calculated into the total cost of retaining in-house staff what could easily be performed externally.

“It’s difficult to focus on core competencies when you have to spend so much more time on the management side of a sleep lab,” Morin says, providing one of the prime reasons for why larger sleep labs should recognize the benefits of sleep record outsourcing. Doucette knows that even obvious solutions are sometimes hard to accept. “We can see that part of the reluctance to embrace sleep record outsourcing on the part of those sleep labs who are defying the trend comes from a desire to keep the status quo and from inaccurate cost forecasting. There are also some legitimate concerns,” Doucette goes on to explain. He’s not afraid to admit that there are certain risks to outsourcing.

“There is a shady side to the sleep medicine industry that no one wants to talk about,” Doucette confesses. The reality is that there are questionable sleep labs operating with untrained staff members who have very little knowledge of sleep medicine. According to Doucette, “There exists a segment of our industry—usually offshore operators—who conduct business without liability insurance, without trained or certified technologists, with little or no clinical or HIPAA knowledge or experience and at heavily discounted rates.” The risks that come from partnering with such sleep scoring outfits far outweigh the benefits. These risks also help to explain why some hospitals and labs remain trepidatious.

“I understand the hesitation. In fact, I encourage it. The more diligence sleep lab managers’ conduct in their selection of a sleep record outsourcing partner, the more likely these questionable operations are to go out of business. That hesitation shouldn’t lead these same managers to write the industry off wholesale,” explains Doucette.

So, how exactly can a hospital based sleep lab ensure that a suitable service provider has been selected? To begin with, sleep labs should make themselves aware of the industry leaders. Alternatively, they should determine who the preferred suppliers of local or well-known sleep labs are. Secondly, they should evaluate the industry standard when it comes to cost-pertest. “When a sleep lab contacts us to engage our services and the first question they ask is “how much?” I can pretty much guarantee that this relationship will not be long-term,” says Doucette. “While cost effectiveness is key, it should never be your main reason for engaging this business model.” The reason offshore operations have flourished is because they severely undercut their competitors. Yes, there are many freelance scoring techs offering scoring for well below this amount, but remember, these freelancers are not a full-service operation with policies, procedures, a quality assurance department, general liability and errors and omissions insurances, expertise and scalability,” explains Doucette.

It would appear that sleep record outsourcing works best when it is viewed as a virtual extension of an existing sleep lab. In other words, it should be seen as a long-term partnership, not a hasty solution. When properly integrated, a sleep scoring service can ensure that mangers are doing what they are supposed to be doing—managing a sleep lab. Daytime scoring positions normally revolve around performing other tasks such as MSLTs or general office duties that can take them away from scoring. Having a service to specifically address this task will only improve overall productivity.

The sleep medicine landscape is changing and labs looking to stay on top need to adapt. “If you look around at the largest and leading sleep labs you will see that the majority have moved to sleep record outsourcing. They have successfully incorporated scoring services and realize the important benefits to such a degree that to discontinue the use of this service would cause a major disruption to their daily operations,” says Morin. As the industry matures, specialists emerge. What most medical directors of sleep labs acknowledge is that fewer errors and guaranteed short-term turnaround times come from those who do sleep scoring best—that is, sleep record outsourcers.

Leading the way in Sleep Scoring Services – Sleep Strategies is the Go-to-Company for Hospitals and Sleep Labs Looking to Cut Costs

Sleep Strategies has become the leader in sleep scoring services because of the stable corporate culture it has developed. For many scoring companies their only focus is on hiring any technologist to score the studies. With some of the most rigorous hiring practices in the industry, Sleep Strategies prides itself on hiring the best of the best. Our HR practices supersede those of any hospital or sleep lab. For many sleep labs if a technologist is an RPSGT then they are hired. The reality is that many RPSGTs have been night techs for the majority of their careers and their ability to score accurately is questionable. Sleep Strategies hiring involves scoring several test studies, conducting inter-rater reliability comparisons, online multiple choice testing and previous employment references. With a minimum of 5 years requirement as a clinical experience RPSGT, Sleep Strategies requirements for experienced techs has raised the standards for other scoring services. When

you are a scoring technologist at Sleep Strategies you can say you are the best of the best.

But having the best RPSGTs is just one of the pillars at Sleep Strategies. Our internal quality assurance department ensures that our clients are receiving the highest quality of sleep scoring available in the industry. Our quality assurance department is an industry first and remain unmatched by other scoring services. This team of seasoned RPSGTs oversee our team of scoring technologists and ensure that they remain top of their game. But it doesn’t stop there – Sleep Strategies has put in place an executive team that is visionary in the growth and customer service it needs to maintain in order to ensure that it remains on top. Running a successful scoring company is very complex. It involves a seamless integration for a sleep disorders centre from the onset. Sleep Strategies has developed a flawless integration process so a centre can easily transition to our scoring services with no interruption to the sleep facility. “Making the change to a scoring service can be very daunting for many sleep labs. The sheer thought can make a lab manager change their mind. Not knowing how to transition is one of the mysteries that Sleep Strategies helps its clients’ solve. The reality is bringing on a scoring service can happen seamlessly and with minimal stress. Our staff, from our sales to our technical department to our physicians to our quality assurance personnel makes it as quick and effortless as possible.

Sleep Strategies scores thousands of sleep studies each month making it the largest scoring service in the industry. Our clients are the sleep medicine industries leading hospitals and sleep labs, who have realized that partnering with Sleep Strategies has enabled them to cut operational costs, improve efficiency and maintain the highest level of scoring of their sleep studies.

When a sleep lab signs on with Sleep Strategies they are signing on with the industry’s top scoring techs and industry experts – they are not just hiring techs to score studies – they are hiring a team of sleep medicine experts that can assist on numerous aspects of improving the operation of a sleep lab. The reality is once a sleep lab realizes not only the cost benefits but the quality that we provide we will rarely see a sleep lab bring the scoring back in-house.

Sleep Strategies has grown tenfold in the last few years as sleep labs look for ways to streamline operations. As well, the growth of at-home sleep studies is fuelling the company’s marketing share as the demand for the scoring of these studies surges. Sleep Strategies has signed on some national accounts with some of the largest homecare companies to service the growing at-home market segment.

Our mission is to become the sleep medicine industry’s go to company for all sleep scoring needs. The sheer number of clients and studies we score per month, coupled with the recognizable client roaster and industry renowned medical directors attesting to our services speaks volumes. It is one thing to believe you as a company are providing the highest quality of service but it is another thing to have our clients tell us it on a regular basis.

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Fisher and Paykel’s Long-Awaited Pilairo Set to Debut at SLEEP

June 7, 2012 SleepDT Leave a comment

http://www.fphcare.com/

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Partners In Compliance Management

June 7, 2012 SleepDT Leave a comment

INTRODUCING THE PARTNERS IN COMPLIANCE MANAGEMENT WEBSITE

As homecare providers, clinicians, and sleep lab staff deal with the challenges of tracking patient compliance and managing their patients’ compliance requirements, they are turning more and more to manufacturers for products, knowledge, and services. With that in mind, Philips Respironics recently launched the Partners in Compliance Management website which is designed for healthcare team members involved in patient compliance management. The site can be accessed at: www.sleepapnea.com/picm

WHAT INFORMATION CAN BE FOUND ON THE WEBSITE?

The website has three focused areas: a Resource Center, Best Practices and Protocols, and Training. Educational and product- oriented videos, documents, and tools have been posted to the website in easy-to-access sections.

If a customer is interested in learning more about the EncoreAnywhere patient management system, the System One therapy device, or our available modem solutions, materials can be found within the resource center. If a customer wants more information on reimbursement coding and coverage, or wants to learn details about topics such as our bi-level rescue program or motivation enhancement therapy, documents are located within our “Best Practices & Protocols” section. These documents are designed to help customers achieve a simplified, systematic approach to managing their patients’ compliance requirements, and help increase staff efficiency.

The Training section of the website offers webinars, audio tutorials, and videos that help walk customers through the specific capabilities of the EncoreAnywhere web-based patient compliance system in order to maximize the efficiency of tracking patient compliance.

NEW TOOLS TO HELP WITH PATIENT COMPLIANCE MANAGEMENT

Three training videos that walk a patient through the process of setting up a modem with a therapy device in the home were recently added to the Training section of the website. Another new tool, an interactive modem calculator, also was recently added to the Resource section. The videos guide a patient through the process of setting up an in-home wired or wireless network connection, or a pulse oximetry connection to the therapy device.

The interactive calculator offers customers an easy method for assessing the savings that can be achieved when modems are used to transmit patient data from a therapy device. New tools and materials will be added to the website on an ongoing basis as they are developed.

WHAT ARE SOME OF THE BIGGEST CHALLENGES IN PATIENT COMPLIANCE MANAGEMENT?

One of the biggest challenges is simply being able to validate if patients are being compliant with their sleep therapy. Other challenges include knowing when reimbursement criteria has been met and facilitating staff efficiency while maintaining a viable patient compliance management program. As an ally and resource to our customers, we offer products, technologies, and solutions such as the Partners in Compliance Management website, to help meet these challenges.

The Partners in Compliance Management website can be accessed at: www.sleepapnea.com/picm

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Web-Based Data Management and Monitoring System for Sleep Apnea Evaluation in the Home

June 7, 2012 SleepDT Leave a comment

Paul Venizelos, M.D. ,¹ Siarhei Ramaniuk,¹ Theodore Bellezza, RPSGT,² Sarah Weimer, BME,² Joseph Lamont, RPSGT,² Michael Papsidero, M.D., FACS² and Hani Kayyali, MS, MBA²

¹West Region Sleep Center, 15805 Puritas Rd, Cleveland, Ohio 44135.
²CleveMed, 4415 Euclid Avenue, Cleveland, Ohio 44103.

Abstract

Study Objective: to assess the feasibility and accuracy of a web-based home sleep testing (HST) system for sleep apnea evaluation in the home.

Introduction: Sleep Disordered Breathing (SDB) affects more than 40 million patients with serious health and economic costs. Overcrowded sleep labs, patient resistance to sleep outside of their homes, and long-term disease management emphasize the need for a simple and cost effective solution for home sleep assessment.

Methods: The technology consists of a web portal (e-Crystal PSG) that allows users such as administrators, registered technologists and interpreting physicians to schedule studies, upload monitor data from any PC, and access raw data for scoring and interpretation irrespective of their physical location. Workflow is further streamlined via email notifications alerting users of the various stages of study progress: scheduled, device programmed, data uploaded, scored, interpreted, and finalized. The web portal interfaces to a seven (7) channel HST monitor (SleepView) that follows AASM channel set guidelines. To assess feasibility, the system was tested on 6 patients at a local sleep center; each patient underwent two (2) studies: in-lab full PSG on the first night followed by at-home SleepView study. The following day, the patient returned the equipment. Data from the SleepView and morning questionnaire were uploaded to the web portal, scored by a Registered Polysomnographic Technologist (RPSGT), interpreted and electronically signed by a sleep physician.

Results: All 6 studies generated high fidelity recordings with no loss of data or replacement to the sensors. All patients were able to hook themselves up, successfully. The ability to detect Obstructive Sleep Apnea (OSA) via SleepView matched in-lab PSG studies (Cutoff, AHI>5). To assess disease severity (normal, mild/moderate, severe), both in-lab and at-home studies showed identical evaluations except for one patient who was diagnosed as severe in the lab (AHI=44) and mild/moderate in the home (AHI=20).

Conclusions: a new web-based study management solution that permits streamlined expansion of HST was developed and tested successfully. Data from the SleepView monitor was of high quality when compared to in-lab PSG, and its ease-of-use facilitated self-administration in the home. The flexibility of the system may be particularly suited for HST deployment in large geographical areas where a streamlined process is required.

Introduction

Obstructive Sleep Apnea (OSA) occurs when the upper airway collapses during the night, which fragments sleep and leads to excessive daytime sleepiness. The mechanism for airway occlusions is not yet fully understood; however, it is widely accepted that reduced neck muscle tone combined with abnormal pharyngeal anatomy and excessive fat tissue make the airways vulnerable to collapse during negative inspiratory drive. A report by the National Commission on Sleep Disorders Research (1) shows that 12-20 million Americans suffer from OSA leading to more than 200,000 car crashes per year and 1/3 of fatal trucking accidents due to fatigue. The financial cost impact is also staggering. Estimated direct annual cost for OSA is $16 billion.2,3 OSA has also been linked to cardiovascular and cerebrovascular implications making the disorder even more alarming than originally thought.4 In a study by Dyken et al., sleep apnea was five times as frequent in patients with ischemic or hemorrhagic strokes.5 Therefore, sleep disorders in general and OSA in specific present a serious national healthcare concern.

One of the most important and widely used indicators of OSA severity is the Apnea Hypopnea Index (AHI), which is defined as the average number of apneas and hypopneas episodes per hour based on a minimum of 2 hours of recorded sleep. New regulations by the Center of Medicare and Medicaid Services (CMS) allowed the use of total recording time instead of total sleep time for ambulatory home studies since portable monitors do not typically record sleep state. In that case, the resultant output is named the Respiratory Disturbance Index (RDI). Typically, AHI (or RDI) > 30 indicates severe OSA, while mild to moderate OSA patients show AHI (or RDI) between 5 and 30. AHI < 5 suggests normal breathing and is typically a target for successful OSA therapy. According to AASM 2007 guidelines, apnea is defined as total cessation of airflow for at least ten seconds, while hypopnea is defined as a drop of 30% or more in airflow or thoracoabdominal effort for at least ten seconds combined with oxygen desaturations of 4% or more. Therefore, the proper calculation of AHI requires the measurement of multiple parameters: airflow, respiration effort, and saturation level.

Home Sleep Testing per AASM Guidelines

A task force assigned by AASM concluded that home sleep testing can indeed facilitate and improve patient care provided that HST is done properly, which includes the acquisition of the appropriate type of physiological signals. The parameters recommended by the task force are: pulse oximetry, heart rate, airflow (cannula), and respiratory effort using Respiratory Inductive Plethysmography (RIP). Additionally, the AASM strongly recommends the use of another airflow sensor (thermistor) for oral breathing and apnea confirmation. Due to the complexity of the disease, the AASM guideline also requires qualified interpretation of the HST study by a sleep physician. These guidelines have been adopted as the basis for HST reimbursement by the Center for Medicare and Medicaid Services (CMS) and many other insurance carriers. Therefore, fulfilling these recommendations is important for proper medical evaluation as well as to meet many insurance requirements.

Fig. 1. Screen shots of the web portal (e-Crystal PSG), which is a sleep study management software that facilitates many aspects of HST deployment.

Although business models and care pathways that can best utilize HST remain in flux, the adoption of HST is expected to dramatically expand in the US. Therefore, technologies that offer high quality information combined with efficient workflow for patients, providers and payers, especially on a large scale, will be needed in the future.

Methods

The new technology consists of two components (manufactured by CleveMed): a web portal (e-Crystal PSG), and a wearable patient monitor (SleepView). E-Crystal PSG (Figure 1) is a web-based data management software that streamlines the various operations of HST including scheduling, device data upload, study archival, upload of additional data such as morning questionnaires, scoring and interpretation, all via the internet. To further streamline the workflow, e-Crystal PSG sends email notifications to users alerting them of study progress status. For example, once the study has been uploaded, a notification is sent to the assigned scorer for action, and once scoring is completed a similar notification is sent to the interpreting physician.

By internet-enabling the entire operation, the system opens up HST usage to more qualified resources allowing them to conduct various aspects of the workflow at different times and from various locations, thus improving overall efficiency. This can be useful for HST deployment for wide area coverage. For instance, national or even regional implementation by a healthcare provider may require study scheduling to happen in an administration center, device preparation and data upload by a nurse at a practice close to the patient (like a Primary care Physician Practice), scoring by RPSGT in a sleep laboratory, and interpretation by a sleep physician in his/her clinic.

The other component of the system is SleepView (Figure 2), which measures 7 parameters: pulse ox, chest effort (respiratory inductive plethysmography), airflow (pressure), airflow (thermistor), body position, snore, and heart rate. The patient hooks themselves up with the pulse ox, cannula, thermistor, and wraps the belt around their chest (the belt is already connected to the SleepView). The remaining signals are measured internally (do not require external sensors): body position measured by an accelerometer, snore is derived from airflow pressure, and heart rate is measured from pulse oximetry. Light indicators check the proper sensor attachment. Improper sensor connection will light up the respective indicator alerting the patient to adjust the sensor. The unit was pre-programmed to be turned on and off based on the patient’s typical sleep schedule.

Fig. 2. Above – SleepView patient unit. Below – SleepView worn by a patient illustrating the hookup.

More extensive testing of the system that covers many sites will be done at a later date; however, in order to gain early feedback and assess feasibility and accuracy, the system was tested in a community based sleep laboratory environment.

Clinical Protocol – 6 patients diagnosed with OSA at West Region Sleep Center were recruited for next night at-home testing. After describing the study and obtaining consent, the patient was instructed on device use and given the SleepView monitor including a hookup instructions sheet. Next day, the patient returned the equipment to the sleep lab with a completed questionnaire regarding system’s ease-of-use. Data were uploaded to the web portal, and scored by the same registered sleep technologists who scored the in-lab PSG’s. All studies (6) were interpreted by the same board-certified sleep physician.

Results

The web portal was found to be very useful by the technologist and interpreting physician. Some recommendations to improve the workflow were made including expanding email notifications and availing the sleep report to the ordering physician.

2 of 6 patients were male (33%). Age ranged from 26 to 55 years old (average was 43 years old). All recordings (6/6) were completed successfully; no sensors fell off or needed replacement. All patients were able to hook themselves up using the attached instructions and a brief training in the sleep lab.

A typical recording is shown in Figure 3, which displays episodes of obstructive hypopnea, and central apnea. The at- home system showed an identical ability to detect the disease when compared to the lab studies using a cutoff AHI = 5 (sensitivity of 100% and specificity of 100%). To assess disease severity (normal < 5, 5 = mild/moderate < 30, severe = 30), both in-lab and at-home studies showed identical evaluations except for one patient who was diagnosed as severe in the lab (AHI=44) and mild/moderate in the home (AHI 20).

Fig. 3. Home sleep recordings using SleepView showing central apnea (left) and obstructive hypopnea (right).

Discussion

A web-based data management software that interfaced to a 7 channel HST monitor was developed and tested in an in-lab environment successfully. More extensive research that tests the system in a national HST deployment is underway elsewhere. In this study, the software was used to facilitate HST evaluation of the SleepView monitor and to provide early feedback about the feasibility and functionality as viewed by a community-based sleep laboratory. The web-based operation functioned as expected and was able to conduct the necessary evaluation.

The finding that in-home studies generated very high accuracy in detecting the presence of OSA when compared to in-lab PSG is not surprising because the SleepView monitor utilizes a channel set and measurement methodology that is identical to that used in sleep laboratories, which is a channel set that is also recommended by the AASM. What is more revealing behind at-home and in-lab comparisons, however, relates to other factors that may influence signal quality, particularly the sensor hookup. The high accuracy of this study confirms the reliability of the sensor hookup process in Sleep View and the simplicity of its self-administered nature. Finally, disease severity findings showed one in six home recordings with lower severity than the in-lab diagnosis. This is not surprising as underestimation of disease severity is typical in HST because RDI is calculated based on total recording time, not total sleep time, which lowers the overall index.

This research, while preliminary, supports the use of a new simplified and effective home technology for sleep apnea evaluation. We believe the future expansion of HST will require three core competences: 1) reliable and easy to use home technology that avoids duplicative and costly in-lab confirmation, 2) improved workflow efficiency among the various stakeholders that are expected to participate in HST such as national sleep management companies, out-of-center operations and other healthcare providers, and 3) a continued central role of the sleep physician in supervising and managing the disease. The SleepView / e-Crystal PSG system provides the necessary infrastructure for these core competencies.

Acknowledgements
This development effort was funded by grants from the National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS).

Literature Cited
1. Wake up America: A National Sleep Alert. Report of the National Commission on Sleep Disorders Research, 1993
2. Frost and Sullivan Marketing Report, 2001, A071–56
3. Feedback Research Services, Sleep Screening and Testing Markets, Marketing report, August 2001
4. Kryger, “Principles and Practice of Sleep Medicine”, Third Edition, Saunders, 2000
5. Dyken et. al., “Investigating the relationship between stroke and sleep apnea”, Stroke 1996;27: 401–407

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Pondering the Paradigm

June 7, 2012 SleepDT Leave a comment

Could oral appliances someday supplant CPAP as a first-line defense against obstructive sleep apnea? The idea seems unlikely in 2012, but paradigm shifts in medicine are usually stealthy.

Change is slow because clinicians demand rigorous evidence before traditions are jettisoned. If that evidence continues to build, will physicians continue to embrace CPAP as the “gold standard,” or could the paradigm shift in this decade?

The fact remains that CPAP-intolerant patients are piling up, and dentists who specialize in sleep medicine want to help. Paying little attention to turf wars, tradition, or pondering paradigms, a growing number of sleep-focused dentists are working with primary care and sleep physicians to spread oral appliances to patients who need them.

Some sleep physicians simply have a bias against oral appliances, and that some are even content to refer patients for surgery before contemplating oral appliances. The American Academy of Sleep Medicine does not share that stance,” says Kent Smith DDS, a Dallas-based dentist who owns 21st Century Dental along with a sleep arm of the business called Sleep Dallas. “They suggest oral appliances prior to surgery. But it’s a fact that there are some sleep physicians who will never think of oral appliances—even for mild patients or primary snorers who would not qualify for CPAP.”

For Smith, it all comes down to: Will patients actually use the therapy? “I want the appliance with the best compliance,” says Smith. “And I would hope that at some point in the near future all of the different health professions will learn to work together to truly get the patient treated, without being as territorial as we seem to be right now. If we truly have the patients’ best interests in mind, we will educate them about all of the different therapies, and we will find what is best for each patient.”

What Really Works?

If dentists and sleep physicians are going to commit to oral sleep appliances, they want to know what works with some objective certainty. Executives at Dallas-based SomnoMed understood this desire and supported the development of SomnoMed MATRx™ (now FDA cleared) by Zephyr Sleep Technologies. Ralf Barschow, Global CEO of SomnoMed, touts the device as nothing less than a revolutionary breakthrough in the prediction of efficacy for the SomnoDent Mandibular Advancement Splint (MAS).

A typical MATRx scenario starts with a sleep physician who then refers the patient to a SomnoMed dentist to perform an oral examination and prepare the custom overnight oral appliance. From there, patients take the overnight appliance to a sleep lab, a sleep technician will titrate the patient’s mandibular position during the study, in response to apneas and hypopneas, with a goal to eliminate these events during REM sleep in the supine position.

To conduct a study with SomnoMed MATRx, the overnight appliance is attached to a small motor (50 grams) that is remotely controlled by a sleep technician. “Using this process, sleep technicians can clearly see whether the patient is a responder or non-responder to SomnoDent therapy,” says Barschow, who also serves as president of SomnoMed North America. “The MATRx is analogous to a CPAP titration. For the first time, we are providing a means of predicting whether patients are suitable for an oral appliance. If they are, we can help determine optimal protrusive distance for their SomnoDent once they are returned to their SomnoMed dentist for further titrations.”

Oral Appliances Here to Stay

Respect for oral appliance therapy has reached a greater acceptance. “After Seattle and San Antonio, Minneapolis was the third time SomnoMed had a strong presence at APSS,” said Anthony White, vice president, SomnoMed Marketing & Academy. “Sleep lab managers and sleep physicians came and said, ‘the MATRx is the missing link here. The ability to prospectively predict which patients would be appropriate for SomnoDent therapy in a polysomnographic environment means we can, with confidence, provide patients that cannot tolerate or adhere to CPAP a second chance at therapy.”

White believes clinicians will continue to embrace oral appliance sleep apnea therapies, but only patient-focused and evidence- based ideas will succeed. “Our products are backed by independent clinical studies validating their use,” adds White.

MAS Fosters Compliance

Loyal customers are already familiar with SomnoMed’s MAS treatments, each with different clinical indications aimed at OSA sufferers. These include the SomnoDent® Classic, SomnoDent® Flex, and SomnoDent® Edent for the Edentulous patient.

The SomnoDent® is a custom-designed oral device that has been the subject of numerous stringent, independent, evidence- based studies that satisfy the need for safe and effective OSA treatment. The SomnoDent® has a number of design features such as a streamlined design with minimal bulk, which maximizes lingual space, reduces gagging, and offers a comfortable treatment with a compliance rate of over 87% all night (Am J Respir Crit Care Med Vol 163. Pg 1457-1461, 2001).

The company touts an excellent fit in both upper and lower arches with anterior and posterior contact for a stable occlusion, which prevents tooth movement and minimizes temporomandibular joint (TMJ) discomfort and injuries.

The SomnoDent is constructed in two separate pieces that allow patients to open and close their mouth. This allows clear speech, yawning, and drinking without requiring patients to remove the appliance. The ability to communicate clearly while wearing the device is particularly appreciated by patients and their partners.

For more information visit www.somnomed.com

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Small Company, Big Expertise

June 7, 2012 SleepDT Leave a comment

Larger accreditation agencies may view The Compliance Team (TCT), Spring House, Pa, as a thorn in their side. Sandra Canally, RN, president of TCT, does not mind the thorn comparison, because she is only interested in making life easier for her clients.

She cuts into the business of her competitors by offering simplification where others offer reams of guidelines. Her simplified approach has been embraced by sleep labs across the country, but it’s still difficult to get the word out through a considerable fog.

Canally attempts to clear this fog by convincing sleep lab directors that operational efficiency must match clinical excellence. Her competitors may undervalue the former, but clients ultimately see the logic. From this rationale came the sleep center accreditation program, now in effect for 5 years under the familiar Exemplary Provider™ brand started more than a decade ago.

TCT officials know they have their work cut out for them, but Canally continues to burnish her credentials in the sleep world, building on a foundation already long established in the world of DME. Sleep Diagnosis and Therapy caught up with the high-energy Canally to talk about the state of sleep lab accreditation, and the ongoing process of breaking into a business dominated by an aggressive “big dog.”

You are Well Known in Other Areas of Medical Accreditation, but TCT Still has Work to Do in the Sleep World. What Makes this Arena so Challenging?

Sandra Canally, RN, president, The Compliance Team, Spring House, Pa: Take hospitals for instance, so many people only thought of JCAHO. It’s a similar thing that is going on in the sleep market, with everyone saying they are bound to the American Academy of Sleep Medicine (AASM).

Why Do People Feel this Way?

AASM is the big dog. They were the first accreditor among sleep labs, and AASM is still the lead dog.

Why Do the Sleep Labs Continue to Choose the AASM for Accreditation?

It’s the only thing they know. They’re wondering what to do with their small business, and who is best suited to deal with them. Who is going to give them the best service and value for the dollar?

They must think carefully, because they are going up against competition that might be hospital-based or larger. Ultimately, providers must choose who is able best to meet their business needs.

How Do you Help Meet those Needs?

We help them through it with our conference call series ahead of time, which nobody else does. We’re saving them money up front because they don’t need to hire a consultant. They can get through the process in terms of preparation just by talking with us with during our conference call series. When they’re ready, we do an onsite evaluation. It’s all about education and continuous quality improvement.

We’re there to verify and validate that they meet the standards, but where they don’t meet the standards, we’re going to tell them how to meet it. We help them improve better and quicker than the AASM. We will help them reach their business goals, as well as their patient care goals better and easier.

What is the Difference Between TCT and AASM?

If you get back to simplification, the biggest difference between us and them is the fact that we are looking at the entire business. With AASM, it’s all about the sleep study and the medical director. We are looking at those things, but we are looking at much more.

Why is it so Important to Look at the Business as a Whole?

It’s my belief that you can’t have clinical excellence without operational excellence. You must have people properly trained and educating consumers appropriately. That means maintaining equipment the way you need to and paying attention to infection control. If you don’t do this, you will not have good results.

What Do you Consider a Good Outcome?

The outcome is not just a successful sleep study that determines the presence (or lack) of sleep apnea. The outcome is that the patient was able to follow instructions and everything worked.

How can that Outcome be Attained?

Pay attention to what the patient is told in terms of pretest and pretest instruction. They should know how to dress and what to bring, because it’s all about the patient, and whether or not the patient is comfortable and is adhering to the instructions by the sleep center. They should know what they’re supposed to do ahead of time.

It’s about patient expectations. Has the patient been appropriately instructed prior to coming?

Does Accreditation Cover these Specifics?

Good accreditation leads to a facility that checks throughout the night with techs who know how to check the leads and properly apply the mask and the leads.

How Do you Make Sure this All Happens Correctly?

We go in during the evenings so we can observe what happens to the patient, as opposed to just looking at the administrative aspects. We also pull files and look at studies, but it’s better to be there.

How Important is Staff Training?

Staff members must be trained in case of an emergency such as chest pains, a heart attack, or a seizure. Have the staff trained appropriately to deal with the unexpected, not just the expected.

You are Relatively New to the Sleep Lab World, but What’s your Rank in the DME Accreditation Market?

In the DME market space, we hover around two or three. I think of us as a littler guy that does a lot. It’s not about the size of our staff, it’s what we’re able to do with the staff we have—but we are a small business.

How Does Being a Small Business Give you an Advantage?

We’re not a bureaucracy, nor do we want to be one even when we do expand. It’s true that we are in the hospitals, and our plans are to be in every health care sector as it relates to accreditation. The key is that we still remain able to turn on a dime, which many of our competitors are not able to do.

Why is Turning on a Dime So Important these Days?

If something happens with regulations, or something changes and the people in the field on the front lines need to know, we’re certainly more able to implement change easier than other folks tied to ‘we have to have a task force and three committees’ to get the same thing accomplished. For us, it’s all about innovation and improving.

What Problems Do you See with Modern Sleep Labs?

It becomes all about the sleep study, and they’re not looking at things that affect patient care and service.

One of the things easy to overlook is infection control. If you go to a hotel, you want to be assured that the sheets have been handled appropriately as it relates to cleaning.

People tend to not think about that. It’s all about the machines and the waves and the leads, and everything being placed correctly on the patient—and the study and if they go to sleep. But we’ve got to look at the whole picture.

Consider the size of the room. If there was an emergency, is there enough room to deal with it? Is it handicapped accessible? What about the bathroom? All of those environmental factors are important, because the patient isn’t coming in for an hour and having a test done.

Does Accreditation Help with Private Insurance?

Some of the private insurers are much like Medicare looking for accreditation. Accreditation is best business practices. It’s quality recognition branding. Not only are they able to differentiate themselves from the competition, but also when they go to private payers they can show that an outside agency has come in and evaluated them onsite. That definitely gives them the leg up.

How Do Sleep Labs use Accreditation for Marketing Purposes?

We give them a certificate and a door decal with the logo. We have the brand “exemplary provider.” We also have the trademark that the quality standards are related to safety, honesty, and caring. So as an exemplary provider they are telling the world that they excel in safety, honesty, and caring. If they excel in those three things, what else matters?

What are your Goals for the Future?

We want to be in every health care sector that exists as a provider related with helping all of the smaller providers across the country. That’s DME, home health, hospice, critical access hospitals, rural health clinics, sleep labs, pharmacies, long term care, infusion, specialty, and mental health. It’s about helping the little guy, and helping the smaller providers to stay in business, stay focused, and continue serving the patients the best way they can.

You have to have the little guy. We can’t just have all the giants. That’s what America is all about. Yes, there is hope. The little guy has to continue fighting, going forward, and expanding. We can help them do that.

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Midmark Advances SleepView with Addition of Sleep-Wake Time Analysis

June 1, 2012 SleepDT Leave a comment

VERSAILLES, OH – May, 2012 – Midmark Corporation, a trusted leader in digital diagnostic devices for ambulatory care, recently released an algorithm update to provide actigraphy based sleep-wake time analysis that enables computation of the apnea-hypopnea index (AHI) used in the diagnosis of obstructive sleep apnea (OSA). AHI, an index used to assess the severity of OSA, is calculated by dividing the total number of apneas and hypopneas by the total number of hours of sleep or sleep time.

Introduced in 2011, the Midmark SleepView® Monitor is the market’s smallest and lightest portable home sleep testing device and meets all American Academy of Sleep Medicine guidelines for a Type-III portable monitor. SleepView allows patients to be tested for OSA in the comfort, convenience and privacy of their own home.

“With up to 90 percent of OSA patients remaining undiagnosed today, improvements are urgently needed in identifying and formally diagnosing those at risk,” said Tom Treon, senior product manager for Midmark. “Home sleep testing with SleepView represents a powerful option towards improving patient care related to sleep apnea. Midmark remains committed to exploring opportunities that advance the viability, accuracy and affordability of home sleep testing.”

Testing utilizing SleepView can occur during one night of sleep after the prescribing physician provides the device to the patient. Once the patient has watched the short introductory video and administered the test in the comfort and convenience of the home setting, he or she returns the device to the prescribing physician. The physician then either reviews the raw sleep test data or chooses to upload the data into the secure, HIPAA compliant SleepView Portal where it is scored by registered polysomnographic technologists and interpreted by board-certified sleep physicians. The physician schedules a follow up visit with the patient to review test results, provide treatment recommendations and discusses long-term management to ensure treatment effectiveness.

For more information on Midmark’s SleepView, please visit www.midmark.com/sleepview

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Drowsy Driving and Factors Associated with Traffic Accidents: New Study

June 1, 2012 SleepDT Leave a comment

Getting behind the wheel to drive when you are not alert, awake or sober is never a good idea, but most of us have heard more about the affects of driving while intoxicated but little about driving while fatigued.

According to a new study in the journal Archives of Internal Medicine, on car accident factors in southwest France. The study showed there was little difference between driving sleepy or drunk. Both doubled the risk of causing a car accident. This information is largely significant for drivers and the public to be aware because it can save lives.

The study included 679 people who were hospitalized because of a car accident between 2007 and 2009 in France. According to the study, men and younger adults were more likely to drive while sleepy.

The researchers wrote: In conclusion, the main factors associated with being responsible for a crash resulting in serious injury were younger age and driving cars, but more important were alcohol ingestion and sleepiness at the wheel, which are synergic.

Even though the study was in France, driving drowsy isn’t unique to that European nation. CNN also reported on a AAA poll, the results of which came out last year, showing that one in three people said they drove while they were drowsy in the last 30-day period.

Abstract and Letter are available online from the Archives of Internal Medicine

SleepDT
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Midmark Further Advances SleepView with Addition of Sleep-Wake Time Analysis

June 1, 2012 SleepDT Leave a comment

VERSAILLES, OH – May, 2012 – Midmark Corporation, a trusted leader in digital diagnostic devices for ambulatory care, recently released an algorithm update to provide actigraphy based sleep-wake time analysis that enables computation of the apnea-hypopnea index (AHI) used in the diagnosis of obstructive sleep apnea (OSA). AHI, an index used to assess the severity of OSA, is calculated by dividing the total number of apneas and hypopneas by the total number of hours of sleep or sleep time.

Introduced in 2011, the Midmark SleepView® Monitor is the market’s smallest and lightest portable home sleep testing device and meets all American Academy of Sleep Medicine guidelines for a Type-III portable monitor. SleepView allows patients to be tested for OSA in the comfort, convenience and privacy of their own home.

“With up to 90 percent of OSA patients remaining undiagnosed today, improvements are urgently needed in identifying and formally diagnosing those at risk,” said Tom Treon, senior product manager for Midmark. “Home sleep testing with SleepView represents a powerful option towards improving patient care related to sleep apnea. Midmark remains committed to exploring opportunities that advance the viability, accuracy and affordability of home sleep testing.”

Testing utilizing SleepView can occur during one night of sleep after the prescribing physician provides the device to the patient. Once the patient has watched the short introductory video and administered the test in the comfort and convenience of the home setting, he or she returns the device to the prescribing physician. The physician then either reviews the raw sleep test data or chooses to upload the data into the secure, HIPAA compliant SleepView Portal where it is scored by registered polysomnographic technologists and interpreted by board-certified sleep physicians. The physician schedules a follow up visit with the patient to review test results, provide treatment recommendations and discusses long-term management to ensure treatment effectiveness.

For more information on Midmark’s SleepView, please visit www.midmark.com/sleepview.

SleepDT
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Sleep Scholar

Monthly Archives: June 2012

Patient Protection and Affordable Care Act upheld by US Supreme Court

SleepDT

Game Changer – Why Sleep Labs are Shifting the Way They Operate and Why Those that Aren’t, Should

SleepDT

Fisher and Paykel’s Long-Awaited Pilairo Set to Debut at SLEEP

SleepDT

Partners In Compliance Management

SleepDT

Web-Based Data Management and Monitoring System for Sleep Apnea Evaluation in the Home

SleepDT

Pondering the Paradigm

SleepDT

Small Company, Big Expertise

SleepDT

Midmark Advances SleepView with Addition of Sleep-Wake Time Analysis

SleepDT

Drowsy Driving and Factors Associated with Traffic Accidents: New Study

Getting behind the wheel to drive when you are not alert, awake or sober is never a good idea, but most of us have heard more about the affects of driving while intoxicated but little about driving while fatigued.

SleepDT

Midmark Further Advances SleepView with Addition of Sleep-Wake Time Analysis

SleepDT

Sleep Scholar for Sleep Medicine Professionals

Getting behind the wheel to drive when you are not alert, awake or sober is never a good idea, but most of us have heard more about the affects of driving while intoxicated but little about driving while fatigued.

Sleep Scholar for Sleep Medicine Professionals

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