It's no surprise that home medical equipment providers continue to increase their involvement with the growing sleep disorders market. There are 12 million Americans affected by obstructive sleep apnea (OSA), and research continues to demonstrate that, untreated, the condition results in serious health consequences. One recent report projects that sales of OSA products will increase from $364.6 million in 2003 to more than $636 million in 2007, a growth rate of nearly 15 percent.
“The opportunity is very rich,” says Nancy Nicoll, Respironics' marketing programs manager. “The number of undiagnosed and untreated patients is still very large, and because of the cardiovascular implications, the market is going to continue to grow.”
But with a growing market comes growing competition. Today, experts say, building a successful sleep program requires both a concentration on patient care and education as well as effective marketing. Sleep management programs must be beneficial for the patient, efficient and profitable for the HME provider — and valuable to referral sources and payers.
Getting in on the Ground Floor
Getting into the sleep business makes good sense, according to Nick Macmillan, Longmont, Colo.-based Sunrise Medical's global sleep products director.
“As a business, it is important to diversify, and sleep can be a growing component of your portfolio,” he advises. “It is an industry that is growing at [a high rate] and, for that reason, I think you don't want to be on the outside looking in.” Macmillan also emphasizes that providing sleep therapy products to the OSA population is an advantageous way to establish a relationship with potential users of additional services.
When a patient is prescribed CPAP (continuous positive airway pressure) therapy, he needs a flow generator and mask. Many patients also need a humidifier. Where they get these products, though, has become anyone's game. Because of the revenue potential, HME providers now must compete with sleep labs and even pulmonologists who are beginning to provide the equipment for their patients.
Tammie Williams, CRT, director of respiratory for Mediserve Medical Equipment in Gray, Tenn., says sleep labs and pulmonologists are taking an active role in the market, specifying products and even using their own staffs for training and set-up. So, Williams continues, Mediserve markets its services by focusing on its staff's years of experience.
It is clear the sleep therapy market has not truly matured, says Macmillan. “The potential models out there are yet to be defined, so it's up to the entrepreneurs of the world — and who are known as entrepreneurs but HME providers — to go out there and create a model that works,” he says. “That means securing the screening, diagnostic, therapeutic and ongoing follow-up opportunities, bundling those up, educating the employer or the payer and then building a revenue model around it.”
Who exactly will be able to flourish with such a model is up for grabs. “The first one out on the street with a program in their community is the one who wins,” Macmillan states.
Ron Richard, vice president of marketing for the Americas for ResMed, Poway, Calif., says a model that melds many types of providers into in a single process is part of the evolution in health care. “However, you can't easily replace the vast network of home care providers and what they do for the community and for the health care industry,” he says, adding that “there is an infrastructure there that's been in place for a number of years that involves delivery, education, billing and teaching.”
Jeff Maglin, product manager for sleep therapy for Respironics, Murrysville, Pa., believes a key component of success in the field comes down to patient care. “If providers want to be strong, smart leaders in the sleep field in their own community, it comes back to [making sure] that they're giving the best care possible,” he says. “A lot of business they receive is from direct and indirect referrals, so how well they do their jobs will affect how many people they have coming into their system.”
Creating a Successful Program
Vernon Pertelle, MBA, RRT, CCM, corporate director of respiratory/HME services for Lake Forest, Calif.-based Apria Healthcare, says the goals of any sleep management program should be to educate the patient, encourage adherence to treatment and to facilitate improved well-being and functional status. “Treatment response is assessed from changes between baseline and follow-up measures of mood, energy/fatigue and functional status/general health,” he explains. “Treatment goals are to eliminate snoring, stop the breathing pauses and allow more refreshing sleep.”
According to Pertelle, the role HME providers should pursue to ensure goals are met includes facilitating comprehensive patient education; assuring optimization of interface comfort; identifying “early” and communicating to the patient's physician the need for heated humidification; and timely intervention to address issues that inhibit adherence to therapy.
Respironics' Nicoll advises that providers ensure the patient is effectively treated. “The patient needs to accept the therapy, tolerate it and respond to it,” she says. “It's not just compliance that's important, but patients need to understand that they have a chronic illness and how to manage their disease process.”
Focusing on Education
Education, a critical component of any sleep management program, must occur with patients, referral sources and payers, Nicoll continues.
“Home care companies need to play an active part in the education,” agrees Williams of Mediserve. “We have the experience that will benefit the patients.”
Patient education should include a description of OSA, the importance of treatment and hands-on instruction for the equipment and mask.
John Basile, RRT, manager of Swedish Sleep Therapy Supply in Seattle, says his company optimizes face-to-face patient time with a consult room that features a twin bed and a bedside table. “We try to duplicate what's going to happen tonight — the first night they use the equipment,” he explains. “We have the patient show us how they're going to use the equipment, and then they sign off on an educational check sheet what they have learned.”
The next step that occurs is critical, Basile says. The respiratory therapist has the patient agree to a day, time, location and phone number where he can be reached for follow-up questions and support. This is the point at which the therapist can determine what problems the patient has encountered and what intervention needs to be made.
Such understanding is important because research has shown that education alone is not enough, according to Terri E. Weaver, PhD, RN, CS, FAAN, associate professor, School of Nursing and School of Medicine, Division of Sleep Medicine, University of Pennsylvania. Weaver has studied the effect of first-week contact with CPAP users, and her research reveals that skipping CPAP for two or more nights during the first week of treatment signals potential non-adherence and emphasizes the need for close follow-up.
Basile agrees, and notes that providers must take the time to understand why the patient is not adhering to the therapy in order to offer support and/or options. He sends patients home with two trial masks. Because patients will typically try both masks, and then try one of them again, the provider has essentially bought three nights of compliance.
“The patient is increasing his acclimation time, his comfort level with the machine and has actually had the first good night's sleep in many years,” explains Basile. “These patients wake up and they have energy during the day, they feel better, their brain works better and they say they will do it again.”
According to Pertelle, Apria's CPAP Center uses group instruction at a branch location with “a presentation on OSA and the importance of treatment with CPAP followed by a short video describing the life in a day of a CPAP user, and ultimately offers hands-on instruction along with a mask-fitting workshop.” During this visit, the patient's CPAP pressure is set, and the patient performs a return demonstration on interface self-adjustment and operation of the CPAP.
Measuring Compliance
Like all medical treatments, CPAP therapy benefits patients when it is used as prescribed, so compliance is another critical element of sleep management programs. But there is no universally accepted definition of compliance, says Pertelle. “A few studies have determined that a compliant patient is one who uses CPAP four hours a night for more than 70 percent of nights,” he explains.
Measuring a patient's compliance, say professionals, can be subjective or objective. Many providers conduct phone surveys to determine how often and how long CPAP is used. Yet often, the response is over-exaggerated.
To measure compliance objectively, some manufacturers offer compliance systems that report overall CPAP use and pressure setting. “We now have the ability to monitor what's happening on a night-by-night and, actually, breath-by-breath basis,” explains David Pendarvis, ResMed's global general counsel.
ResMed's Richard concurs that the definition of compliance is vague but says there are other ways to determine whether the treatment is effective. “A lot of times the physician will ask the patient how he feels — is he more awake, and have symptoms such as falling asleep at work, being tired or being depressed been alleviated?”
How the patient feels will certainly affect compliance. Sleep authorities say providers should investigate the patient's primary complaints and then determine the best solution.
“The first step is gaining an understanding of the patient's complaint and then taking the steps needed to address the side effects of positive airway pressure therapy,” Nicoll explains. “What's important in building an effective sleep management program is that [providers] follow a case management-type protocol in which you do the simplest, least expensive first, and then you move down the line to more complex and more costly equipment.”
Respironics' Maglin says the three typical obstacles to compliance are humidification, the ability to tolerate the positive airway pressure and mask fit.
Concerning mask fit, he says, everyone has different physical features and different likes and dislikes regarding how the device fits on their face. “They may be claustrophobic, they may be concerned with their hair or they may not want anything touching certain parts of their face or head. But there have been a variety of new technologies created to give these patients different options,” he says.
Pertelle says evidence shows there are three factors that significantly improve patient acceptance and compliance, including patient education in a group setting, optimization of mask comfort and heated humidification. Therefore, providers should pay close attention to their patients' view of each of these factors.
Measuring compliance may also impact the provider's bottom line. “If compliance is an issue in a provider's specific referral community, it is important to find a way to more efficiently get the compliance data and then make certain that data is objective,” says Macmillan of Sunrise. “Some payers are even paying for this kind of service.”
Making Marketing Effective
To make a sleep management program effective, providers must market it effectively. The bottom line, says Macmillan, is that providers must validate that their program is better than that of their competitors through patient satisfaction, compliance and proving the benefits of that compliance.
The physician must see value, agrees Nicoll. “For every referral that the physician sends them, that physician saw at least 10 other patients that week who have undiagnosed OSA,” she says. “The only way he is going to continue to see and identify these patients who have potential problems is if he sees value in getting that one patient that he has diagnosed treated.”
Nicoll continues that providers must realize the importance of communication. “It is extremely important to communicate with the physician, to follow up with the physician, update them on the status of their patient and address any problems the patient has had,” she says. “That will really position [providers] well in the marketplace.”
Swedish Sleep Therapy's Basile says the best way to market a sleep program to physicians is to make their patients a priority. Too often, HME providers send a “mixed message” to patients when they take several days to fill an order, he points out. Providers should show a sense of urgency and commitment to having patients fitted and educated about their condition and the prescribed treatment.
“Somewhere between 4 to 15 percent of the population has sleep apnea, and 80 to 90 percent of them don't know they have it. I ask my DME colleagues if they want these millions of Americans to do business with someone else or if they would like a piece of that pie,” says Basile.
Demonstrating the value of a sleep program to payers is optimal. “Payers are looking for a return on their investment, which they get when a person who suffers from sleep apnea uses his equipment,” says Macmillan.
Payers also hope to see that the ongoing treatment may eliminate future problems, including cardiac disease, congestive heart failure, diabetes, ongoing growing obesity and the other conditions that OSA negatively impacts.
“People who have sleep apnea that are treated are healthier people — they utilize [fewer] health care dollars, and that's better for the payer,” Macmillan concludes.
Growing Patient Population
The American Sleep Apnea Association states that of the 12 million Americans with OSA, the majority remains undiagnosed. Without treatment, these people — most male and middle-aged — are at risk to develop high blood pressure and other cardiovascular diseases, memory problems, weight gain, impotency and headaches. Another potential risk is the increased possibility of traffic accidents due to excessive sleepiness.
Treatment of OSA aims to restore regular nighttime breathing and relieve symptoms such as very loud snoring and daytime sleepiness, according to the National Institutes of Health's National Heart, Lung and Blood Institute. The first step for those with mild sleep apnea involves making lifestyle changes, such as avoiding alcohol or medications that cause drowsiness, losing weight and changing sleeping positions. But for those with moderate or severe OSA, additional treatment is necessary.
The primary treatment choice for moderate or severe OSA is CPAP therapy, which works by keeping the patient's throat open during sleep. Some patients need bilevel therapy, and other treatment choices also include the use of oral appliances or surgeries.
Recently, two additional treatment options have emerged — a soft palate implant and the use of etanercept, a TNF-alpha antagonist. The implant procedure, called the Pillar Procedure, involves placing three small woven-polyester inserts into the soft palate at the back of the roof of the mouth. The inserts stiffen the palate to prevent the tissues from collapsing during sleep and blocking airflow.
The use of etanercept, which is typically prescribed for rheumatoid arthritis, showed a decrease in sleepiness and a reduction in apnea episodes in a small study conducted by the Pennsylvania State University College of Medicine.
Although research may produce even more treatment choices for those with OSA, CPAP remains the standard — and the therapy that allows HME providers to create a successful sleep management program.
Medicare Considers In-Home Sleep Testing
At a Sept. 28 meeting, members of the Medicare Coverage Advisory Committee (MCAC) gave moderate, but not overwhelming, support for Medicare coverage of in-home sleep testing.
The meeting was part of CMS' review of national coverage of OSA requiring CPAP therapy. Current policy requires a sleep test, or polysomnography, to be performed in a facility-based sleep-study laboratory, but CMS is considering changes to accept the use of portable multi-channel home sleep test devices.
At the meeting, MCAC members voted on whether they felt facility-based polysomnography and in-home sleep testing devices represented similar technologies.
“[The committee] voted that they were moderately confident that the two technologies were identical,” said Dr. Terence Davidson of the University of California San Diego, who wrote a letter to CMS in April requesting the policy change. He explained that the committee, which consists of medical experts from universities and elsewhere across the country, heard arguments for and against in-home sleep testing. In-the-home tests, he said, “have fewer wires hanging off you, and you get to sleep in any position … at a fraction of the price of [polysomnography]. And this comes at a time when access to polysomnography is limited. People may have to wait three to six months [to schedule a test].”
Those opposed to in-home sleep testing have argued that in-lab polysomnography remains the best way to obtain information about how an individual sleeps, Davidson said.
CMS has said it intends to make a final coverage decision early next year.
