Until recently, most primary-care physicians had no idea that three simple words could change their approach to treating some of the nation's top killers: stroke, hypertension, heart disease and diabetes. But thanks in part to the nation's leading sleep-product manufacturers, physicians are beginning to understand the far-reaching implications of sleep-disordered breathing. The question, “Do you snore?” now is standard fare in examining rooms from Tampa to Topeka, as millions of Americans are waking up to the importance of uninterrupted sleep.
The tip of the sleep-market iceberg is protruding from the water, but to uncover the market's true depths, manufacturers must address three obstacles to growth: awareness, diagnosis and compliance.
By some estimates, there are as many as 10 million undiagnosed sleep apnea sufferers in the United States. Light sleepers who are chronically tired, many of these people dismiss their snoring as an annoyance. Their physicians, who spent little time studying sleep-disordered breathing in medical school, often do not connect these symptoms to the patients' other medical problems, and obstructive sleep apnea goes untreated. To avoid this scenario, companies like ResMed, Respironics, Sunrise and Fisher & Paykel are launching innovative programs to raise awareness among both clinicians and consumers.
However, teaching patients and clinicians about the dangers of OSA is only the beginning, the manufacturers say. The logical next question is, “How will the market diagnose all those who need to be tested?” With greater awareness comes greater demand, yet some diagnostic labs already are reporting month-long waiting lists of potential OSA sufferers who need a sleep test.
Additionally, despite data that suggests continuous positive airway pressure therapy is safe and effective, many patients give up on treatment within the first two weeks, citing discomfort and inconvenience.
Such are the challenges inherent in a young and promising market, sleep-product manufacturers say. To address these challenges, manufacturers must become teachers, consumer advocates, researchers and innovators. Ron Richard, ResMed's vice president of marketing for the Americas; Bill Post, president of Respironics' home care division; Nick Macmillan, global sleep products manager for Sunrise/Devilbiss; and Steve Moore, director of marketing at Fisher & Paykel; explain below why their companies are up to the task.
HomeCare: How is your company serving as an advocate and teacher in the sleep-products market?
Ron Richard: Our Sleep Foundation, a nonprofit organization with a separate board of directors, accepts, reviews and funds applications for research projects. This year, we have funded four studies, including two whose results the Sleep Foundation recently released: The National Football League study, [which found that even young, physically fit men can suffer from OSA], was trying to get some high-profile awareness among the guys who watch sports. These guys may be young, but many of them are overweight and hypertensive. Another study showed that, with effective CPAP therapy, you could lower your blood pressure by as much as 10 millimeters, and not just during the night. [The treatment] had a long-lasting effect on daytime blood pressure as well.
[ResMed] also is sponsoring chat rooms on the Internet. We host a 1-to 1.5-hour ask-the-expert-type forum. We typically have 200 to 300 patients sign up at a time. We're exploring [consumer] publications like Men's Health and Maxim — places where we potentially could place articles or ads.
Finally, we are getting more active with the American Sleep Apnea Association's AWAKE support groups — small, self-funded groups of patients with common problems. There are several hundred of these groups across the United States.
Bill Post: Advocacy is part and parcel of the nature of the market. Awareness is one of the key drivers. We work to keep the physician base and provider base well informed. At the same time, we collaborate with and support a variety of independent agencies and groups focused on the awareness issue: the National Sleep Foundation, the American Sleep Apnea Association and the American Academy of Sleep Physicians, to name a few. We support these agencies financially and take a great interest in their work and success.
We also focus on research and development, which is really all about enhancements to positive pressure modality. Those enhancements are what drive comfort, compliance and continued efficacy in therapy. [Respironics'] C-Flex technology is a perfect example. [With CPAP], you've got this forced air to keep the airway open. That is fine on inspiration, but it makes for some discomfort on expiration. C-Flex modulates the application of pressure, relaxing air pressure during expiration. It drives a whole new level of patient comfort.
Nick Macmillan: In raising awareness, our primary focus has been advocacy with the National Sleep Foundation and [the organization's] drowsy driving campaign. Sunrise Medical has made a financial and in-kind commitment to support public awareness of this issue.
Drowsy driving is not always connected to sleep apnea, but there obviously is a strong correlation there. It's estimated there are approximately 100,000 police-reported crashes involving drowsiness and fatigue per year. Fatalities are estimated at approximately 1,500 per year, or 4 percent of all crash fatalities. That's in addition to about 71,000 injured in fall-asleep crashes per year. This represents $12.5 billion in monetary losses each year — not only from the accident, but for the health care and missed work. What's interesting is that [the above statistics] represent only “reported” crashes. There probably are many more incidents that go unreported.
Most of our research revolves around e-compliance, which allows you to set up the CPAP in the home and attach it to a Smart Track that automatically downloads usage data. The HME provider, the sleep center and the physician can view this data twenty-four hours a day, seven days a week.
Steve Moore: Some of our current initiatives focus on heated humidification, and the role that [heated humidification] plays in all areas of respiratory support, including sleep-disordered breathing.
HC: What are some of the challenges that this market faces, and how is your company working to overcome these challenges?
RR: As diseases become more diagnosed, the big challenge is that [the products are] being driven into a commodity space. There is a lot more pricing pressure from payers.
To overcome this challenge, we've taken the high road in developing products, recognizing that sleep-disordered breathing is a chronic illness that requires disease management.
BP: The challenges of sleep apnea include: awareness, the clinical recognition of comorbidity, the diagnostic universe and compliance.
Medical literature is demonstrating there is link between OSA and conditions like heart failure, hypertension and diabetes. We're in the early stages of fostering clinical acceptance of that data.
However, the challenge to fulfill the demand for sleep testing grows in parallel with this raised awareness. The more we're equipped to diagnose, the more likely it is that [diagnosis] will fuel market growth. [Finally], the challenge of driving patient compliance continues to be evident, regardless of how efficacious the therapy has been proven to be. The solution is about adding degrees of comfort and utility that allow patients to comply.
NM: I think the three main challenges that this market faces are the continuing backlog at sleep centers, reimbursement for HME providers and compliance.
We deal with the second two [challenges] more than with the first. [E-compliance] improves a provider's efficiency — so the provider can use the Internet instead of making phone calls or visits — and become a more-efficient provider of care. If [providers] are not operating in the black, they won't be around, and everybody will lose.
The clinical research clearly supports the fact that CPAP compliance is determined early on — usually within the first two weeks. With e-compliance, providers are able to get timely information about compliance automatically.
SM: One of the bigger challenges is to ensure initial acceptance and long-term compliance with therapy. Our product development is focused in these areas.
HomeCare: What is the current reimbursement climate for sleep products? Are payers open to reimbursing new technologies?
RR: I just got back from the [Statistical Analysis Durable Medical Equipment Regional Carrier] office, and they are open to reimbursing for self-adjusting auto titration devices. These devices adjust pressure all during the night, depending on the patient's needs. This year, they put in place higher reimbursement for full face masks for the first time.
For existing, core products, reimbursement is pretty stable and has been for three years.
BP: I think reimbursement is broadly favorable. I do think [payers] are open-minded to reimbursing new technologies, provided that the cost-to-benefit relationship is clearly understood and defensible.
Down the road, reimbursement will have to begin to embrace the value inherent in [treating OSA]. If it's clearly understood that OSA is at the heart of a heart condition, the value of OSA treatment changes significantly.
NM: To a certain extent, the climate looks favorable for new technologies. CPAP and respiratory equipment has seen a decline in reimbursement, but when you look at processes, you can still keep [sleep products] profitable.
We have some payers interested in e-Compliance and willing to pay for it. Managed care companies appreciate the fact that, as compliance improves, health care costs and hospital stays decrease.
SM: Reimbursement is slowly improving, and payers are becoming aware of new technologies that improve patient outcomes. Medicare has recently taken great strides in this area.
Survey Points to Continued Growth in Sleep Market
Today in America, there could be as many people suffering from sleep problems as there are receiving Medicare benefits, according to surveys from the National Sleep Foundation. Yet more than 60 percent of adults say that a physician never has asked about the quality of their sleep.
While this statistic may sound daunting, manufacturers and providers see the challenges that face the sleep-product market as an opportunity for tremendous growth.
In mid-January, 247 of HomeCare's readers responded to an electronic survey about the sleep market. Their responses to a few of the survey's questions appear throughout.
Status | No. of Responses | % of Respondents |
---|---|---|
Increased | 152 | 71.4 |
Stayed the same | 52 | 24.4 |
Decreased | 6 | 2.8 |
No answer | 3 | 1.4 |
Total | 213 | 100 |
Business Focus | No. of Responses | % of Respondents |
---|---|---|
HME Provider | 98 | 39.7 |
Specialty HME | 15 | 6.1 |
HME with Home Health Agency | 9 | 3.6 |
HME with Respiratory Therapy | 95 | 38.5 |
Pharmacy with HME | 24 | 9.7 |
Other | 6 | 2.4 |
Total | 247 | 100 |
No. on Staff | No. of Responses | % of Respondents |
---|---|---|
None | 65 | 26.3 |
1 employee | 57 | 23.1 |
2 employees | 33 | 13.4 |
3 employees | 16 | 6.5 |
4 or 5 employees | 23 | 9.3 |
More than 5 employees | 26 | 10.5 |
No answer | 27 | 10.9 |
Total | 247 | 100 |
Status | No. of Responses | % of Respondents |
---|---|---|
Increase | 175 | 82.2 |
Stay the same | 30 | 14.0 |
No answer | 8 | 3.8 |
Total | 213 | 100 |
Rank | Sleep-Disorder Product | % of Respondents |
---|---|---|
1 | CPAP Units | 99.5 |
2 | CPAP Masks | 97.7 |
2 | CPAP Headgear | 97.7 |
3 | Humidifier Systems for Nasal CPAP | 97.2 |
4 | CPAP Filters | 96.7 |
5 | Bi-level PAP | 93.4 |
6 | CPAP Moisturizers/Gels | 57.7 |
*A total of 213 readers responded to this question. |
% of Annual Revenue | No. of Responses | % of Respondents |
---|---|---|
1 to 5 | 31 | 14.6 |
6 to 10 | 37 | 17.4 |
11 to 15 | 21 | 9.9 |
16 to 20 | 29 | 13.6 |
21 to 25 | 19 | 8.9 |
More than 25 | 36 | 16.8 |
No answer | 40 | 18.8 |
Total | 213 | 100 |
Referrals | No. of Responses | % of Respondents |
---|---|---|
Yes | 189 | 76.5 |
No | 52 | 21.1 |
No answer | 6 | 2.4 |
Total | 247 | 100 |
Referrals | No. of Responses | % of Respondents |
---|---|---|
Yes | 141 | 57.1 |
No | 98 | 39.7 |
No answer | 8 | 3.2 |
Total | 247 | 100 |
No. of Labs | No. of Responses | % of Respondents |
---|---|---|
0 | 2 | 0.8 |
1 | 6 | 2.4 |
2 | 30 | 12.1 |
3 | 35 | 14.2 |
4 | 38 | 15.4 |
5 | 17 | 6.9 |
6 | 15 | 6.1 |
7 | 1 | 0.4 |
8 | 10 | 4.0 |
10 | 5 | 2.1 |
More than 10 | 45 | 18.2 |
Don't know | 36 | 14.6 |
No answer | 7 | 2.8 |
Total | 247 | 100 |
Services | No. of Responses | % of Respondents |
---|---|---|
Yes | 20 | 8.1 |
No | 221 | 89.5 |
No answer | 6 | 2.4 |
Total | 247 | 100 |
The complete results of HomeCare's 2003 Sleep Survey are available for purchase online. Please visit our Web site at www.homecaremag.com.