Dreaming Big: The market for sleep therapy just keeps on growing.

If thoughts of entering the sleep arena keep you up at night, there is good reason: The market continues to grow, fueled by new research and a wave of media attention.

“In terms of the market size for sleep disordered breathing, there are 40 million Americans with some type of SDB, encompassing the most prevalent condition, obstructive sleep apnea, as well as the critically important area of central sleep apnea,” says Michael J. Farrell, senior vice president of Poway, Calif.-based ResMed’s sleep strategic business unit.

“Additionally, there are important niche SDB opportunities in nocturnal hypoventilation and obesity hypoventilation as well as overlap syndrome, where OSA is found with chronic obstructive pulmonary disease,” he says.

OSA is not only a problematic disease in itself, but its correlation with other diseases is starting to be unraveled.

“There continue to be increasing linkages as demonstrated by clinical studies of OSA’s impact on hypertension, cardiovascular disease and diabetes, and the more we delve into just exactly what is OSA and how it impacts the body, we are seeing that it impacts these other diseases and has very serious health consequences,” says Robert D. Hoover, Jr., MD, MPH, FACP, chief medical officer, DeVilbiss Healthcare, Somerset, Pa.

In addition to recognition of the harmful effects of OSA by the clinical community, sleep disorders are garnering attention in the mainstream media, from newspapers to morning television shows. The attention has raised public awareness of the problem — more people are asking doctors about their risk — as well as awareness in the health care community, with more primary care physicians asking their patients questions about sleep quality and making referrals for sleep studies.

These are all good things, both for patients and HME providers who are involved in the sleep market. But growing awareness and numbers are not all it takes. It is important to understand the model that will create a successful business.

“The growth in managed care beneficiaries who are being diagnosed as well as competitive bidding are making people reassess what they’re paying for in sleep,” says Bob Messenger, RRT, sleep product manager for Invacare, Elyria, Ohio.

In HME’s changing environment, providers need to determine ways to reduce costs while continuing to provide the equipment — and the service that goes along with it, Messenger says.

“Across the board, manufacturers are coming out with value propositions as far as their products are concerned. Prices are coming down, and we are seeing devices that have fewer bells and whistles,” he says.

OPPORTUNITIES ABOUND

The majority of those with SDB have moderate-to-severe obstructive sleep apnea, according to Don Spence, president of Murrysville, Pa.-based Respironics’ sleep and respiratory group. “This is the area that is probably most ripe today for the home care provider, although we think in time other markets for sleep may open up as well,” he says. “This is being driven by the aging society and the … increase in obesity in the United States.”

There is a wealth of opportunities for HME providers, says Tom Pontzius, president of Waterloo, Iowa-based VGM Group’s Nationwide Respiratory network. Pontzius says providers should ensure their programs offer education and follow-up service that go “beyond just the CPAP itself.”

Providers who are looking for ways to diversify should pay close attention to their ability to satisfy referral sources, which means having a focus on clinical care.

“Keep in mind that most of the referrals for SDB therapy are coming from physicians and clinicians in sleep labs, so there’s a clinical component as well as a patient management component that needs to be considered,” Pontzius explains.

“Whoever is managing that patient the best and providing the best clinical care is probably who is going to end up with that referral. The doctor doesn’t want to see them back in his or her office, and the sleep lab certainly doesn’t want them back.”

A COMMITMENT TO CARE

Promoting a positive relationship with existing and potential referral sources can go a long way toward increasing market share, the experts say. HME providers should focus on physicians, such as pulmonologists, that are currently referring oxygen patients, as well as primary care physicians and specialists including cardiologists, ENTs and bariatric surgeons.

A commitment to patient care is not only good for business; it demonstrates a commitment to patients’ long-term success and well-being. One facet of continuing care involves making sure patients have access to an appliance and supply replacement program.

“Re-supply programs are related to financial success, but they have a strong relationship to promoting positive patient outcomes,” says Kelly Riley, CRT, RCP, director, National Respiratory Network, The MED Group, Lubbock, Texas. “When you do appliance replacement, it is an opportunity for you to continue to educate, encourage and empower patients.”

Re-supply programs also have an effect on demonstrating compliance.

“As your business grows and you become better at it, you also have more patients you can show — not just on a percentage basis, but in pure quantity — that you’re keeping them compliant,” says Spence. “It is important to have good, timely patient data to demonstrate that, and it’s also important that you not only keep them compliant but continue to support them.

“It is just good business for HME providers to have good follow-up programs and re-supply programs. It demonstrates to their referral sources that they are staying in touch with these patients,” he continues.

“Clearly, if the patients are demanding more masks and filters and so on, there is a high likelihood they are also utilizing the therapy.”

PROMOTING YOUR PROGRAM

Compliance is the ultimate demonstrable method by which to market a sleep therapy program to referral sources, these experts say. Physicians want to see results and know their patients are being educated and cared for.

“HME providers need to follow a disease management program,” says Pontzius.

“Disease management protocol provides quality care for co-morbidities, and it will help providers create a compliant patient. Being cognizant of the technology and programs that are on the market to help them follow up with the patients to make sure they are compliant is also important.”

Reimbursement levels could lead providers to believe it is too expensive to incorporate education and disease management into their sleep therapy business, but Riley says that’s not necessarily so.

“There is often a lack of patient education and support because of the constraints providers face, but it does not have to be a real expensive process,” says Riley. “So much can be done over the phone after the initial relationship has been established.”

She adds that providers must demonstrate credibility to referring physicians and patients.

According to Hoover, an education and management program that extends through the first two or three weeks the patient is placed on CPAP therapy is a valid marketing tool.

“If providers can measure their outcomes associated with improvements and compliance as a result of their program, that’s a very powerful marketing tool to use with their referral sources,” he says.

EDUCATION IS A WIN-WIN

When HME providers take an active role in educating both patients and physicians about sleep therapy and its benefits, it is a winning proposition.

Laura Castricone, CRT, director of clinical services for Health Complex Medical in Waterbury, Conn., says she spends a great deal of time counseling internal medicine physicians and general practitioners.

“I work with them to explain what the results from the sleep study mean and how the prescribed therapy will benefit their patients,” she says.

Castricone also works with physician offices to inform them about screening tools and the newest products and technologies that are on the market. “We give them copies of the Berlin questionnaire and provide charts they can display in their waiting rooms that can help them do a better job of screening their patients,” she says.

Castricone and her staff also provide details on new equipment to physicians and sleep labs to keep them up-to-date on the variety of positive airway pressure products and masks. (See “Tackling Compliance from the Start” on page 14.)

“There needs to be consistent, regular education and follow-up,” says Riley. “It has been established that education is what promotes compliance, and when you promote compliance, you start to see positive outcomes.”

According to Invacare’s Messenger, “In the United States, large studies that utilize multiple providers reveal that at six months, only 50 percent of patients are compliant. However, when you look at individual programs that are education-intensive, those patients have a higher rate of compliance.”

But the process can be arduous.

“It takes many weeks, and sometimes many months, before we can get a patient acclimated and compliant,” says Castricone. “It takes patience and perseverance.”

It may also require an initial hit to revenue. For example, Health Complex Medical will take back a mask if the patient has an adverse reaction. Although the company knows it will lose money, it has found this practice to be worthwhile.

“Compliance has been driven by our ability to be able to be flexible with the patient,” says Castricone.

Flexibility also promotes long-term patient loyalty.

“It involves some intensive work on the front end as the patient is started on therapy, but once they’re on and they are adjusted, it really involves making yourself available for the normal follow-up that you would offer with any type of equipment,” notes Hoover of DeVilbiss.

“If providers not only take care of the referral source but offer a commitment to taking care of the patient and doing what needs to be done, it will pay off for those who have a customer-service mindset.”

Explains Respironics’ Spence, “It comes down to quality of service. One of the big challenges in this market is providing therapy in such a way that the patients become compliant to the therapy.

“The HME community can go a long way to realizing their primary role is not just setting that initial patient up, but it’s ensuring that that patient remains compliant. The best way for the HME providers to be successful is to ensure they can demonstrate in a very quantitative way that a high percentage of them remain compliant.”

Spence adds patients are becoming well-informed, and they’re going to be expecting a higher level of service. “They will be expecting products that give them the highest chance of tolerating a very important therapy that could in many ways change or save their lives,” he says.

Keeping a clinical and an operational focus is the key to success, says Invacare’s Messenger. “When you put the clinician hat on, the goal is to take care of patients. You also have to consider the cost of doing business.

“If providers can do both of these things, they can be very successful in this business.”

Using Technology to Create Success

From CPAP to bi-level to auto PAP, there is a plethora of positive airway pressure devices that can help patients be successful in their therapy. Likewise, there are a growing number of devices available that have the ability to measure compliance.

“As insurance companies increasingly focus on their costs and the importance of effective measurement of treatment options they pay for, the monitoring of CPAP, APAP and VPAP compliance will only increase from where it is today,” says ResMed’s Michael J. Farrell.

“In terms of compliance, insurance companies are starting to ask for data well beyond a simple phone call and subjective ‘yes’ from the patient; they want objective data from the device encompassing not only run-time hours but measured hours at therapeutic treatment pressure with a mask detection circuit.”

Farrell adds efficacy data, including both measurement of mask leak and apnea-hypopnea index, is being requested to ensure that the treatment payers are reimbursing is not only used but also effectively treating the patient.

ResMed offers both its ResScan and ResTraxx monitoring technologies.

“The simplest method is to use one of our ResScan removable media cards and request that the patient mail the card in or bring it to the HME office on their scheduled visit,” says Farrell. “The latter approach of the patient visiting the HME office allows the provider to ask the patient about their needs for new masks, tubing, filters or other accessories, a potential revenue-generating activity.”

ResTraxx is a more advanced technology that has been used by providers who are looking to differentiate themselves in the area of patient monitoring, according to Farrell. With this system, the information is automatically sent by the device and can be reviewed by the provider or the referring physician using a dedicated password-protected Internet site.

Respironics offers its Encore and EncoreAnywhere products. The Encore Pro SmartCard technology enables providers to monitor and respond to patients’ needs by recording the date, time and duration of each session. The EncoreAnywhere patient management system incorporates features from the Encore Pro database system and enables physicians, clinicians and other care providers to access patient information anywhere through its Web-based portal.

“With EncoreAnywhere, providers and clinicians will be able to pull down patient data in real time,” says Respironics’ Don Spence. “Keeping in communication, whether it’s through phone calls or emails, the use of EncoreAnywhere is an important part of that overall program. Ultimately, as more and more patients come into the therapy, it will not only be an important tool for new patient set-up but it will keep what will be a sizable population of patients well supplied in what is a chronic disease.”

Invacare’s Polaris EX utilizes what the company calls a “quick code.”

“The advantage of the quick code is that providers make a phone call and use the code to identify — very early in therapy, which is kind of critical — if a patient is using the therapy. There is no card that has to go back and forth,” says the company’s Bob Messenger. “So the advantage is that the provider can quickly identify through a phone call if he or she needs to initiate a follow-up with the patient.”

DeVilbiss also offers tracking and monitoring systems to aid in improving compliance. Its CPAP LT software program is a Windows-based package that provides direct download capabilities of stored performance and compliance information. It presents graphical and statistical analysis to allow physicians, clinicians and home care therapists to assess patient compliance, analyze CPAP therapy and manage CPAP device inventory.

Part of its eCompliance system, the company’s Smart Track modem, connected to a DeVilbiss PAP unit in a patient’s home, automatically dials into the DeVilbiss server each evening. The server analyzes the data and notifies providers of any patients with low PAP usage. Through its Internet Processing Software, physicians and clinicians can generate compliance reports to show CPAP usage and receive email alerts on potential patient non-compliance.

Home-Based Testing For SBD

At press time, several manufacturers who offer sleep therapy products were anxiously awaiting CMS’ proposed decision memo on coverage for home diagnostics, expected Dec. 14.

DeVilbiss Healthcare’s Robert D. Hoover, Jr., MD, MPH, FACP, was optimistic about the outcome. “I believe CMS probably will provide some level of coverage for home studies. The question is going to be how deep down in the technology it will go in terms of the type of study it will allow and what kind of hoops patients or physicians will have to jump through in order to qualify for a home study,” he said.

For example, Hoover sees CMS allowing a home-based study if the patient has five out of eight subjective and objective criteria, such as a large neck circumference, a high body mass index, confirmed snoring and daytime hypersomnolence.

“Home-based testing would not be used for screening the general population, but in patients that are more likely to have obstructive sleep apnea, these tests … are more likely to be approved,” he explained.

If approved, home-based testing could increase OSA diagnosis, according to Don Spence of Respironics.

“There is a large population of patients that has not been diagnosed and treated, and it’s likely that if home testing is approved, it will allow some of those patients that may feel uncomfortable coming into a lab setting to consider having testing in their home,” Spence said.

However, he does not see home testing as a replacement for sleep lab testing.

“I don’t think this in any way says that testing in a lab won’t continue,” Spence said. “There is probably going to be a place for home testing under the correct clinical supervision, but ultimately, it is up for clinicians to decide what is the best way to diagnose these patients.”

No matter how the decision turns out, Invacare’s Bob Messenger, RRT, advised HME providers to get ready — now.

“If I was a provider today, I would want to strengthen my personal relationships with referring labs and be prepared to offer a service they are not accustomed to — that of delivering service in the home,” he said.