Sleep Therapy: Comfort is King

• Apr 15, 2008

Innovative sleep therapy products encourage OSA consumers to comfortably catch Z’s while providers count cash.

When it comes to the world of sleep therapy, most would argue that size really does matter, along with comfort, portability and affordability. Let’s face it, comfort is king and clients are turning to HME suppliers to provide products that will enhance coziness.

In the last five years or so, strides have been made to offer obstructive sleep apnea therapy devices that are quiet, smaller and foster patient compliance.

Sleep Trends
One global trend that manufacturers are noticing in the categories of CPAPS, mask and nasal pillows is a move toward smaller devices.

“If it’s going to fit on your bed side table on a night stand you want it to be something that sort of fits the décor of the room as opposed to something that screams out “Hey, this is a medical device,” says Bob Messenger, product manager of sleep products at Invacare in Elyria, Ohio. “That’s one of the chief things that I see as far as trends of all the new devices coming out.”

Take the ResMed S8 line of CPAP flow generators for example; it introduces smaller and more compact devices. Other advancements include adaptive technology in some of ResMed’s bi-level (VPAP) range of devices, which provide ventilatory support systems for the treatment of adult patients with respiratory insufficiency or respiratory failure. ResMed has also developed APAP systems with auto set technology, which automatically adjusts to suit a patient’s pressure needs as they vary through out the night and over time, says Michael Farrell, senior vice president, Sleep Strategic Business Unit, ResMed, Poway, Calif.

“Essentially, we have designed masks and flow generators for every type of sleeper and every type of sleep-related breathing disorder,” Farrell adds.

Dusty Muck, vice president of sales and marketing at Healthcare Dynamics Inc. in Stone Mountain, Ga., agrees that the physical unit of CPAPS have become smaller and much easier to transport.
Another trend that Muck has noticed is that CPAP referrals are coming with humidifiers. Therefore, manufacturers have responded by giving integrated heaters, it’s been the overall trend to make them smaller and to add separate heaters to the products themselves, he said.
“It’s pretty globally understood now that humidification is an essential component when it comes to making patients compliant,” Messenger says.

“I think we and other manufacturers work on the area of humidification because certainly some of the dry mouth factors can lead to congestion problems,” says Gretchen Jezerc, director of U.S. marketing, sleep disordered breathing, Respironics, Murrysville, Pa.

To remedy that problem, one of the solutions Respironic’s offers is the Sleep Easy, a basic CPAP that provides integrated heated humidification at an affordable price. Equally as innovative as the Sleep Easy, is the Comfort Fusion mask, which was designed to bring comfort, seal and mask stability to CPAP users. This mix of comfort and value features two different size cushions, small and medium, which was made to fit 90 percent of faces, according to Respironic’s data.

Respironics has found that many homecare providers contact their patients every six months about replacement parts such as tubing, filters, masks and cushions. As in the case of many payors including Medicare, replacements can be made on some of these items every three months. “So we have a configuration of the product that has the mask as well as two cushions so in one shipment they’re able to send out both cushions and get two to three month periods worth of reimbursements,” Jezerc says.

Another trend in the sleep business, noticed by Messenger is that there’s been a shift away from the fancy and a movement to the basic CPAP or what he refers to as a blower in a box. As a result of competitive bidding and shrinking reimbursement, manufacturers are stripping out some of the more costly bells and whistles to create a basic CPAP unit that is less expensive and still provides therapy to the patient.

“I’m convinced that the bells and whistles are really important for about the first two or three weeks and then after that things like ramping no longer get used and exhalation unloading often gets turned off after this point in time,” Messenger says. “All these things that really add to the cost of a device, they have a practical life for only a few weeks and then they kind of go away.”

Some homecare companies are starting to offer patient funded upgrades, where patients are shown items that they could possibly help pay for themselves, says Jezerc who believes it’s a smart idea to have consumers who want to upgrade to flashier, new technology pay the difference.

“That’s an approach that can help homecare companies be able to offer patient choice without it having a big negative impact on profitability.”

When designing these therapies compliance is always at the forefront of the manufacturers mind. Manufacturers have a continuous goal of eliminating discomfort.


Working out the Bumps and Bed Bugs
Sometimes discomfort issues such as claustrophobia, skin chaffing and rashes impede patients’ compliance, but some of the Auto CPAP products from Respironics optimize comfort which tends to drive compliance, Jezerc says.

“If we get right first time therapy for the patient that definitely is a benefit to the homecare company,” she says.
Another benefit of that particular device and a trend that people will begin to see more of as technologies develop is that the unit can run as an auto with no flex technology and no pressure release or it can run as an auto with C-flex and an auto with A-flex. “So depending on what the prescribed therapy is for the patient, the same unit can be used and that can have benefits for the homecare company in terms of inventory management,” she says.

When opting for comfort, consumers typically favor products that are less invasive. The Optilife is a good example of a nasal pillow and a mask that’s of minimal contact. It has nothing in the field of vision and is beneficial to the claustrophobic client. Jezerc says Respironics gets positive feedback from a comfort perspective on its gel technology.

“We’re trying to make sure that the comfort of having a nasal pillow mask in this case does not impede the effectiveness of the therapy from the pressure relief perspective,” Jezerc says.
Flex technology and other pressure relief technologies are important along with mask and nasal pillows that fit correctly, she says.

Respironics has conducted clinical studies on the flex technologies that show that on average patients who use it sleep for an hour and 42 minutes longer each night.

Jezerc is also seeing autoservo ventilation continuing to blossom in the market place.
“Patients are coming in the sleep labs and displaying complicated breathing patterns and complex sleep apnea, and we’re very pleased that we now have the BiPAP Auto SV to be able to treat those patients and additionally, we have been working more closely with sleep labs to make sure that we have the appropriate titration protocols outlined for the effective treatment for different kinds of patients within the group,” she says.

Invacare offers products such as the Polaris Ex that features softX technology and exhalation unloading features, which makes it easier to exhale. Messenger says CPAPS can be compared to doing 80 miles an hour down the highway and sticking your head out of the window. “It’s easy to take a breath in, but it’s hard to exhale when you have all that additional flow being blown into your face so exhalation unloading really does help. It’s like putting the brakes on and slowing down to 50 when you exhale.”

Some of the key questions to ask as it relates to comfort with an interface device are: how does the mask feel, does it leak into someone’s eyes or make the bridge of their nose sore?

“Comfort is king, and it is essential from an equipment perspective that’s why we’re seeing things like masks that have adjustable forehead support that can maximize comfort and still control the potential for air leaking into the eye and it also lends itself to people liking to use nasal pillows,” Messenger says. “Nasal pillows are a step in the right direction. The less stuff you have on your face, chances are the more comfortable you’re going to be.”

Mike Hostetler, director of marketing at Aeiomed Inc. in Minneapolis, Minn., understands the anxiety that people experience when wearing a mask all night and awaking to marks on their face. That is why his company offers a nasal pillow, designed without straps, to eliminate what’s otherwise known as mask face that often leads to chaffing, rashes and is just plain uncomfortable.

“It increases compliance when it’s more comfortable,” he says of sleep therapy products.
Across the board manufacturers have empathized with the plight of consumers awaking to marks on their face that oftentimes lasts more than half of the day, and have developed products to help solve this problem. ResMed has introduced a number of new sealing technologies to its masks, including the Mirage dual-wall cushion for its nasal and full-face masks, and Swift technology in nasal pillows. The technological design allows the masks to seal with less pressure and headgear strap tension, which helps to reduce marks on the face. The Mirage Swift/Swift II was introduced as a compact nasal pillow mask that has a clear field of vision and no forehead support, which allows patients to read, watch television or wear glasses while wearing the mask, says Allen Ehrlich, director of product management at ResMed. “Our nasal pillow systems are small lightweight and quiet, which helps to overcome the psychological barriers of going on CPAP therapy,” he adds.

The Mirage Quattro employs the latest in sealing technologies which enables mouth breathers to have a full face mask that is comfortable and easy to use. ResMed also created the Mirage Liberty, a combination oral mask, which is ideal for those who are most claustrophobic and don’t want forehead support. It introduces dual wall nasal pillows with a mouth cushion, Ehrlich touts.

Hard Cash and Sound Sleep
Clearly as reimbursement goes down it can be potentially detrimental if the provider continues to offer more expensive products. To offset the problem with price, some are offering low-end units with not as many features on them, says Muck. In some cases, the prices of the machines are being slashed in half.

“But you’re not comparing apples to apples because they don’t offer the same features and benefits as the ones that are out right now,”Much adds.

Hostetler agrees that some manufacturers are trying to make CPAPS cheaper. In doing so, he believes that quality is compromised. “At Aeiomed our concept is portability, mobility, and we’re trying to give the patient the flexibility so that they can take the CPAP anywhere with them without having to worry about it,” he says.

Hostetler believes that DMEs want CPAPS smaller and more portable with an integrated battery. He says consumers can run Aeiomed’s CPAP on an airplane because it quietly operates on battery power allowing the patient to sleep through the night awaking more refreshed in the morning. Consumers, he says, are willing to pay cash for his integrated battery system, which gives 11 hours of CPAP therapy. It also serves as a back up plan during power outages and hurricanes. Hostetler spoke of a customer who purchased six of the batteries as a trip to the woods would have him without power for a week.
“HME’s love it because it’s cash business and it benefits the patients too,” he says. “Increasing their product line is going to be critical for them to survive.”

However, when it comes to making profit in sleep, the greatest opportunity may not come right out of the gate, Messenger says, but rather with the ongoing replacements of masks and cushions and tubing that are allowed to be replaced on a regular basis throughout the year.

According to Medicare the useful life of a product is every five years, but the reality is that these items probably need to be replaced more frequently. Tubing, nasal mask cushions and filters can be replaced every month. Headgear can be replaced every six months, while the mask itself can be replaced every three months
“I can’t tell you the number of patients I’ve seen that are using the same cushion and masks for two or three years, and it’s horrible,” he added.

Invacare has priced replacement cushions in such a way that is designed to incentivize the provider to want to replace cushions. “There’s a reason for them to do it, the reason is they can make money.”
Respironics has launched a capability that helps support home care companies keep up with the rate of replacement of consumers’ masks, tubing and filters. Jezerc says they’re able to ship equipment directly to the patient’s home on behalf of the homecare company. If there are any replacements, the provider takes down the information, gives it to Respironics who then ships it to the consumer using the homecare company’s name and label. The invoice also has the company’s name on it.

Sometimes it takes more than Comfort
Education, even more than comfort, is the biggest issue that surrounds compliance, Messenger believes. It takes spending time and talking with the patient about what the long term consequences of sleep apnea are and being there to support them, he adds.

In addition to education, other elements that aren’t product related that help with compliance include follow-up from HME suppliers, referring doctors and technicians. Checking in with the patient the first few weeks is critical to success with therapy, Jezerc says. She believes motivational enhancement therapy also works. It simply involves a conversation with the patient that’s conducted so that the patient comes to the conclusion that he or she really needs to adhere to therapy.
Manufacturers have developed ways that HME providers and physicians can closely monitor a patient’s compliance through tracking devices.

A few months ago, Respironics came out with its Encore Anywhere technology that helps home care providers and physicians monitor compliance. This technology can be delivered through a phone in modem, which essentially means that the CPAP machine is on a night stand connected to the phone line and data will flow from the device outlining the patient’s history of compliance, Jezerc says. Both the physician and provider can access the patient’s data without having to fax information back and forth. The patient’s prescription or pressure setting can be changed remotely through that same phone line so that data can flow from the homecare company to the patient’s device, which can save the provider a trip out to the customer’s home just to reset a ramp. This new technology also arms providers with objective compliance data that’s being required by payors for reimbursement for CPAP therapy.

ResMed offers a similar service with the ResTraxx system — a web-based monitoring device compatible with most ResMed devices —it allows sleep clinicians to check on their patients with daily/weekly/monthly trends and quickly identify causes of noncompliance from the computer. It is attached to the patient’s flow generator and transmits compliance data to ResTraxx online, which is a web-based program that provides up-to-date reports on patients. This gives clinicians an opportunity to proactively focus on those patients who require attention, says Farrell.

“Devices that are easier to use and more effective are a huge benefit to the patients, and providers also reap the rewards,” he says. “If patients are healthy and compliant, this results in better cost and time efficiencies for the HME business, including fewer callbacks and a reduction in fitting/training time.”

Sleep Rules
Of course, CMS’s recent ruling that it will expand its coverage for CPAPs to include beneficiaries diagnosed with obstructive sleep apnea via home sleep testing devices types II, III and IV could potentially open up yet another door for HME suppliers to take advantage of cash sales. (Before that, diagnosis of OSA can only be conducted in sleep labs.) CMS has made the caveate that because some OSA patients do not continue with CPAP treatment or do not improve with that treatment, it is limiting CPAP treatment for OSA to 12 weeks to determine if beneficiaries will respond to the treatment. It added that long-term CPAP coverage would be provided for patients who respond to the treatment. To read more about the ruling and the industry’s reaction to CMS’s ruling, turn to our news section (page 3).

In terms of market potential, here’s been studies done that have shown that sleep tests conducted in the home offer some advantages, and clearly someone sleeping in their own bed would be more comfortable and would sleep more normally than they would in a lab, Messenger says.

“From a dealer’s point of view, I see big advantages,” he says. “The dealers can now become part of the process. There are opportunities for providers to be the middle man, maybe working with a local sleep lab or now the labs don’t even have to be local.”

Providers should tell physicians about the service they can offer patients, which will allow them to do sleep tests within a day or two of receiving the order as opposed to six to eight weeks to get into a sleep lab, which is often the case.
“To me we’re sending a mixed message,” he says. “You’re saying you have this life threatening condition, but we’re not going to treat it for three months where as if you have an aneurism they’d have you in the OR this afternoon. So what are we really telling the patient? If sleep studies can be done in the home, we’re going to be able to expedite this process, and the speed from which we’ll be able to perform these diagnostic tests will be more consistent with the messages we’re sending these patients and my guess is more patients will be compliant because we’re sending a more consistent message.”

Hostetler believes the rule will increase the awareness of sleep apnea. “I think what you’re going to find is there’s going to be two types of markets, one of those is going to be the sleep lab and the other is going to be home testing.”
“Anything that gets more patients tested and into therapy, in our view, can only be good for the industry and the home care companies,” Jezerc says. But there are still a number of questions that need to be addressed, she notes, such as determining who will be authorized to set up patients, or, once it is determined that a patient has OSA, finding out whether the patient needs Auto CPAP therapy, bi-level or servo ventilation.

“There are all kinds of question marks that need to be handled through the titration process: Will that still be done in the lab or will that be done through auto titrating devices in the home?” she says. “So there are a lot of open ended questions.”
For all of the uncertainties in sleep, there’s one thing Jezerc knows for sure: “These are very, very interesting times in the world of sleep.”

This article originally appeared in the April 2008 issue of HME Business.