The number of people diagnosed with obstructive sleep apnea continues to rise, making this a lucrative, yet challenging, opportunity for the home medical equipment industry. Patients with OSA, however, are not most providers' classic customers. Namely, they are not typically Medicare beneficiaries, which means providers must rethink how they market to this population. Likewise, payer sources expect positive outcomes, which means patient compliance is integral to the success of an OSA program.
There are certain characteristics that describe the typical OSA patient, such as middle-aged, male and overweight, but research is demonstrating that additional factors also come into play. “Generally, the most affected population is middle-aged males, though postmenopausal women face similar increased incidence,” says Nicholas J. Macmillan, global sleep products manager for Sunrise Medical's Devilbiss division and principal of Outside the Box Consulting.
Ron Richard, ResMed's vice president of marketing for the Americas, adds that about 80 percent of OSA patients are younger than 65, making them ineligible for Medicare benefits.
Some sources say the number of the undiagnosed is extraordinarily high. The National Institutes of Health estimates that 10 million Americans have OSA but are not being treated. “There are still a vast number of individuals who are undiagnosed, particularly because of the lack of institutional beds for sleep studies,” says Bob Mogue, executive vice president of sales and marketing, CareFore Medical.
Home Diagnostics
Mogue's comment raises questions that are currently under debate in the industry. Are in-home sleep studies growing, and are they as effective as those performed in laboratory settings? The commercial side is supportive, say experts.
“There has been more interest in doing in-home diagnostics for sleep from a number of different fronts, specifically, private-pay insurance groups that are looking at this as an alternative or option to in-lab studies due to cost, convenience and access,” says Richard. “On the CMS (Centers for Medicare and Medicaid Services) side or the Medicare side, it looks like it's going in the opposite direction, and they are actually trying to drive patients more to in-lab facilities that are accredited by the American Academy of Sleep Medicine.”
Macmillan sees it this way: “The ‘standard’ in the health care arena does not support home studies, primarily due to inconsistent results and lack of accepted standards of practice. Because of this lack of clinical acceptance, many are reluctant to go against the grain of the medical community. With that said, physicians, sleep labs and home care providers are pushing the envelope and providing this service on a limited basis.”
One of the primary drivers of the in-home alternative is the payer community, which is looking for a cost-reducing, yet reliable, diagnostic alternative, according to Macmillan. “The payer motivation is due to a steep rise in sleep diagnostic claims,” he says.
To respond to the need for in-home diagnostics that are reliable, the industry has begun offering more sensitive and specific devices.
“Other manufacturers are offering very small, portable, lightweight and simple devices that have very high sensitivity and specificity to the results that they can achieve,” Richard explains. “The results they are getting are in the 90 percent range.”
“The technology has always been there to do home diagnostic studies. In fact, in the early 1990s, the technology was there to do those pretty effectively in the home,” says Joe Smith, Invacare's respiratory clinical manager. “The equipment's there and the technology's there, but the lack of reimbursement is a determining factor [in its not being utilized].”
Although the benefits of utilizing in-home testing are obvious — the comfort of a home test and an expedited diagnosis — there are limitations, says Macmillan. “Limitations include a lack of consistent testing standards and diagnostic testing equipment variability, and these limitations lead to the more significant limitation, which is lack of reimbursement,” he says.
The Need for Results
Following diagnosis, there is enormous pressure from health care providers and payers for patients to be compliant with the prescribed treatment.
“Adherence and compliance to therapy are the ultimate measurements of a sleep disorder treatment program, and these are often accomplished by communication with the patient followed by the use of the appropriate equipment,” says Steve Moore, director of marketing for home care at Fisher & Paykel Healthcare Inc. “When problems are addressed early on, self-management can then take over.”
Outcomes that are measured vary from community to community and lab to lab, and are driven by medical director involvement, hospital/lab management and sleep lab accreditation.
“In some rare cases, the payer becomes involved because of the effect of health care expenditures for the undiagnosed, untreated or non-compliant sufferer of sleep disordered breathing,” says Macmillan. Yet, there may be another emerging trend. Employer involvement is still uncommon; however, as laws are legislated regarding the safety of vehicle operators, this involvement will become a more common occurrence, he explains.
Smith says compliance is significant, but adds that he is making the assumption that when a patient is compliant with therapy, it is effective. “I don't think anyone is at the stage where they are able to actually look down the road and say, ‘If we treat this obstructive sleep apnea patient now, 10 years from now when they might have had congestive heart failure, we've prevented that,’” he says. “I don't think anyone is up to that speed yet. Most folks are just still looking at very simple compliance.”
And compliance is not an exact science. According to Richard, several papers have been published recently that loosely define compliance as a patient's using his device four to five nights a week, for about four to six hours per night.
Smith adds that as more people are treated, the incidence of strokes, congestive failure and other consequences of untreated OSA are decreasing.
“Clinical results are still probably the biggest measure of compliance,” says CareFore's Mogue. “If the symptoms are alleviated and they stay alleviated over a period of time, then I think that's certainly one factor; the other quantifiable way to measure compliance is how long the patient continues to use the CPAP device and the interface.”
A Push to the Public
Untreated OSA can mean significant health risks, including increased risk for high blood pressure, heart disease, heart attack and stroke, as well as fatigue-related auto and work accidents. Yet the majority of those with OSA remain unaware of their options.
HME providers can play a positive role in educating physicians and other referral sources — as well as consumers — about sleep disorders.
“There are several communities of interest that should be involved in the education of the public [that] include HME providers,” Macmillan points out. “Others include the physician community as well as hospitals and sleep labs. In fact, a quick perusal of the newspaper or local billboards demonstrates the efforts being made in this regard.”
Most manufacturers agree that public awareness efforts have increased by groups such as the American Sleep Apnea Association (ASAA) and the National Sleep Foundation (NSF), but much more needs to be done.
Cheryl Hanley, Invacare's product manager for sleep products, says consumer publications such as mainstream women's magazine Real Simple, are including articles about OSA. She adds that HME providers can become involved at the local level by hosting sleep awareness events.
In February, ResMed launched MyResMed.com, a conosumer Web site that is available to patients “24/7 if they have questions on fitting their mask or questions on the newest technologies,” says Judi Livengood, the company's director of marketing communications. Patients can input information on their provider, mask type and CPAP and receive reminders from the site when it is time to check their equipment or replace their mask filters.
The site will provide benefits not only for patients but also for providers, says Livengood. “It will help them decrease the non-reimbursed activities they do, so they can focus more on educating the patient at the beginning and selling more items.”
According to Fisher & Payel's Moore, HME providers who are successful in OSA programs should use that success as a marketing tool. “Home care companies are the integral link with CPAP patients,” he says. “Their standards of practice and success with compliant patients should be shared with physicians and patients to further enhance their business.”
Experts Interviewed:
Paul Chiesa, vice president and CFO, SleepNet Corp., Manchester, N.H.; Cheryl Hanley, product manager for sleep, and Joe Smith, respiratory clinical manager, Invacare Corp., Elyria, Ohio; Judi Livengood, director of marketing communications, and Ron Richard, vice president of marketing for the Americas, ResMed Corp., Poway, Calif.; Nicholas J. Macmillan, global sleep products manager, Sunrise/Devilbiss, Longmont, Colo., and principal of Outside the Box Consulting; Bob Mogue, executive vice president of sales and marketing, CareFore Medical, Olathe, Kan.; and Steve Moore, director of marketing - homecare, Fisher & Paykel Healthcare Inc., Laguna Hills, Calif. For more information on these companies, see HomeCare's annual Buyers' Guide, or access the Guide online at www.homecaremag.com.
Sleep Apnea Facts
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More than 18 million Americans suffer from sleep apnea
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Ten million Americans remain undiagnosed
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More than half of all cases of sleep apnea are diagnosed in people 40 years of age or older
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Sleep apnea is more prevalent in men than in women
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An estimated $15.9 billion is spent in health care each year on sleep disorders, sleep deprivation and sleepiness
Source: The National Institutes of Health National Center for Sleep Disorder Research
CPAP Therapy Can Improve Couple's Mental, Physical Health
Continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA) not only improves patients' lives, it can improve the lives of their bed partners, according to researchers from the Sleep Disorders Center at the Scottsdale, Ariz., location of the Mayo Clinic. The study found that when patients with OSA were treated with CPAP, the mental and physical health, and overall quality of life (QOL) of patients and their bed partners improved significantly.
“Snoring and sleep apnea interfere with the quality of sleep of both the patient and the bed partner. Many bed partners choose to sleep in separate rooms rather than endure continuous sleepless nights caused by sleep apnea,” says James M. Parish, MD, FCCP, the Center's director. “With CPAP therapy, patients and their partners can experience restful nights that can ultimately benefit them physically and mentally.”
The researchers examined the effects of OSA on QOL in 54 pairs of patients and their regular bed partners and the effects of CPAP therapy on QOL in both groups after six weeks of patient treatment. Patients and bed partners completed three pre- and post-treatment questionnaires on their likelihood to fall asleep in routine situations, their overall physical and mental QOL, and their QOL specifically related to their experience with OSA.
Prior to therapy, patients reported situational sleepiness more than the national norm, and overall QOL was significantly lower than national norms. Initial bed partner scores were similar to national norms, except in the category of bodily pain, which was below the expected norm.
After CPAP treatment, both patient and partner scores showed a decrease in situational sleepiness and an increase in the majority of physical and mental QOL categories, including vitality, social functioning, role limitations due to physical health and mental health. In addition, QOL scores specific to OSA improved in both patients and bed partners.
Childhood Sleep-Disordered Breathing
Although sleep-disordered breathing typically affects adults, about 2 percent of children show symptoms. To determine how a child's anatomy correlates with the severity of sleep-disordered breathing, researchers examined MRI images and other data gathered from a group of children 7 to12 years of age with sleep-related respiratory disturbances of varying severity.
The researchers found that children with a narrow “retropalatal air space,” defined as the ratio of the retropalatal airway cross-sectional area (CSA) to the CSA of the soft palate, had significantly more apneas and hypopneas (abnormally slow, shallow breathing) during sleep than did the children with relatively unobstructed airways.
The study, entitled “Sleep-Disordered Breathing, Pharyngeal Size, and Soft Tissue Anatomy in Children,” found the following:
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The severity of SDB correlates significantly with the oropharyngeal volume and the size of the tonsils and soft palate in children 7 to12 years of age
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The pharynx of children with high-OAHI (obstructive apnea-hypopnea index) values is significantly narrower where the adenoids, tonsils and soft palate overlap
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The OAHI is inversely and significantly related to the size of the retropalatal air space
