Counting $heep

• By Lunzeta Brackens
• May 13, 2008

Will home sleep testing get new patients to flock to your door?

In March, CMS rendered a verdict on home sleep testing that has some HME providers sleeping more soundly these nights. The decision expanded the coverage of CPAPs for those diagnosed with obstructive sleep apnea through home sleep testing devices types II, III, and IV, which could open a window of opportunities for home care providers.

“This is a huge move forward in the sleep industry field and will open up the potential for more people being tested in the comfort of their homes,” says Marcia Nusgart, R. Ph., executive director of the Coalition of Respiratory Care Manufacturers. “Of the 20 to 40 million people with obstructive sleep apnea, there have only been approximately six million who have been tested after 20 years, and the goal is to get more people tested sooner and on treatment faster.”

Benefits of HST
For those on the fence about home sleep testing accurately diagnosing OSA, there are studies proving its efficacy. Ron Richard, vice president of sales and marketing at SeQual Technologies Inc., says that there has been peer reviewed evidence from several manufacturers that revealed the high degree of sensitivity and specificity home sleep testing devices have to determine whether a patient has obstructive sleep apnea.

In the National Coverage Determination, it was determined that levels II, III, and IV devices are ideal in affordable unattended home monitoring: the lower the level, the more channels and the higher the level, the fewer the channels. However, the fewest number of channels that could be accepted in level IV would be three channels, and that typically consists of some sort of airflow, oximetry and heart rate, Richard says.

There has been an ongoing debate for many years about what channels should be used and how accurate those channels are, Richard added. The biggest determinant of obstructive sleep apnea is lack of airflow and you want to make sure that the airflow channel is sensitive and specific to detecting small changes in airflow from the patient’s breathing. Then there’s pulse oximetry, which is also a critical part of a home study. Sampling rates and the ability for the device to detect subtle changes in oxygen blood saturation associated with hypopneas and apneas is essential when qualifying patients for treatment. Other respiratory physiological parameters that are important include chest excursion, respiratory effort and EEG. However, Richard believes that there are a lot of simple OSA patients out there that can be diagnosed very easily with few channels and less costly technologies.

Published validation studies in medical peer review journals have documented the accuracy of home sleep testing, says Mike Thomas, CEO and president of Sleep Solutions Inc., which manufacturers the NovaSom QSG. NovaSom QSG is a level III cardio respiratory device designed to evaluate OSA. The five-channel device measures snoring, airflow, breathing effort, oxygen desaturation and heart rate. Thomas says he’s contracted with many insurance companies and received favorable reimbursement for the product long before the CMS decision.

“We’re feeling pretty confident that in-home sleep studies are not only more cost effective and more convenient but also possibly more accurate than sleep lab studies,” he says. “When you’re in a sleep lab, you’re in a sterile environment and it’s been shown that there’s a high level of variability in terms of the manual analysis that occurs in sleep labs. It’s something that’s called the first night affect and all of these affect the accuracy of a sleep study and you don’t get a lot of that with the in-home.

Plus, you have the ability to tests for multiple nights, which is another benefit that you get from in home versus in lab.”
In fact, Thomas predicts that within the next five years or so that 80 to 85 percent of all sleep studies will be conducted in the home.

On the other hand, Nusgart believes that there’s no comparison when putting a polysomnography up against a home sleep test. PSG will look at sleep due to the EEG; whereas the home sleep testing equipment has three to four channels and doesn’t assess sleep, she stated.

Since there were already insurance companies, providers and manufacturers involved in home sleep testing before the CMS rule, their decision to jump aboard will only catapult home sleep testing into the mainstream more so than it already is, says Sarah Weimer, product manager, Division of Sleep Disorders at CleveMed.

CleveMed has had various home sleep testing devices on the market for years, before releasing its latest device in 2007, the SleepScout, a nine-channel type three monitor that comes along with an instructional video and sheet that can be sent home with the beneficiary. The machine saves all of the data to a SD memory card. The downloaded data is then scored and interpreted by a physician.

Weimer says CleveMed has seen favorable results with home sleep testing. Some of the earlier devices were used to test patients in nursing homes who were unwilling and are typically unable to get to labs along with those patients who suffer with chronic pain from fibromyalgia.

“By being able to test them at home, we’ve been able to get a better diagnosis based on a typical night’s sleep rather than an atypical night’s sleep,” she says.

For some patients, home sleep testing is the only way.
“A lot of us in the public don’t sleep anywhere but home,” Richard says. “People go to work, they come home at night, have dinner, watch television and sleep in their own bed, so I think in some cases if the device is being used, its simple to put on the patient and instruct them on how to attach the various sensor bells and electrodes or whatever connectors you’re using to collect the data, and you don’t have a lot of educational or instructional issues to go along with that.”

Home testing for any chronic disease has to be easy to implement and associated with a 95 percent return rate related to the data collected or you will spend more time doing repeat studies, he added.

Providers Seek Clarity, Compliance and Compensation
Before delving into the home sleep testing arena, some providers have decided to wait on the LCD (local coverage determination) to gain more clarity as to what’s expected. At press time, two local coverage determinations (LCDs) regarding home sleep testing have been released, though the LCDs that will impact respiratory providers aren’t expected until May or June, according to industry sources.

“The national coverage determination is a very broad based document and it has always been the place of the LCD to come in and provide specifics,” says Kelly Riley, director of The Med Group’s National Respiratory Network. Program contractors are required to review and appropriately revise affected LCDs within 90 days of the publication of the program instruction. “Everyone is in a data gathering mode right now,” Riley adds.

Since the coverage of CPAPs has been expanded to include some home sleep testing devices, the Centers for Medicare and Medicaid Services has limited the coverage of CPAP for OSA to 12-weeks to determine if the recipient is responding to treatment.

“In some ways I commend CMS for saying ‘we want to see patient improvement in 12 weeks,’” says Riley. “That puts the onus back on the provider to not just move product. They have to show that when you put a device on a patient that you did complete some type of formal follow up to see if it worked.”

Is 12 weeks enough time to determine if patients are responding to treatment?
“I’ve personally seen patients positively respond within three days,” Richard says.
Richard says he has had patients to tell him that their quality of sleep was like night versus day after treatment. He compared sleep therapy to the likes of being on an exercise program.

“You build up a certain amount of reservoir of sleep then you start to get more rested, then you hit the peak of now I’m just going to continue to maintain my routine of where it feels good,” he says. “If I’m going to weigh 180 pounds I can’t go out and eat two pizzas every night, I have to eat one pizza or a half of a pizza. It takes discipline, it takes education and a lot of effort on the behalf of the patient to work with their therapists, clinicians and doctors to maintain sleep habits.”

This is similar to asthma and diabetes support programs, he says. Clinicians that routinely work with patients make a tremendous impact on overall outcomes of patient therapy adherence.
“I continue to encourage HMEs and physicians to develop sleep centric educators in their practice,” Richard says. “Patients suffering from sleep disorders commonly are associated with a number of other co-morbidities thus requiring a clinician to be familiar with the treatment of these conditions in addition to sleep apnea.”

Although Richard says he believes 12-weeks is adequate enough time for treatment response, he adds that there are a few gray areas when dealing with compliance. Typically providers are paid to set up the equipment and then in some cases, depending on the insurance coverage, see to it that the patient is using the equipment. But there needs to be more compensation. Richard believes that insurance companies should pay accredited home care providers that have qualified clinicians just as diabetes and asthma educators are paid for ongoing in-office visits. Diabetes educators are paid depending on the program and states they are located in for a set number of visits once a patient has been diagnosed with diabetes.

“In some cases the amount is $75 for 10 subsequent visits or something like that that they can bill and get paid for a service call or a service fee,” he says. “It will help ensure compliance, and I think it’ll make a positive impact on long term adherence.”

Compliance isn’t the only place where there are shades of gray as it relates to home sleep testing. Some questions that have been left unanswered include:
•    Who needs to order the sleep study?
•    Who can perform the sleep study?
•    What would be the Medicare payment for the CPT code 95806? Nusgart asked.
“If you look at the CPT code right now that’s applicable to portable unattended monitoring that code has been paid by some private payor for years, and there’s varying amounts of money associated with it,” Richard says. He says he has always believed that people should provide at least four plus channels for an unattended monitoring study to get paid about $200 for a diagnosis. Some will look at that and believe that they can use a level II, III or IV and still get paid the same amount of money. This particular area of CMS recommendations needs clarification, he adds.
“I’m thinking you can’t buy simply a three-channel device and get paid the same amount of money as someone using a level two-device,” he says. “That’s where I think there should be some sort of separation in the payment amounts.”

Working Together
For references of how the home sleep testing model can work well, Richard says providers should look to those companies that have it down to a science such as Kaiser Permanente, whom he believes is a great example.“They’ve been doing home sleep testing on most of their sleep patients for many years, as well as in many countries,” he says.

In Europe, thousands of patients are being tested each year with a high degree of success.”
As long as home sleep testing is utilized in the context for which it was defined, there should be no problems. It was not meant to be used in the diagnosis of other sleep disordered breathing anomalies, says Riley. “And it’s certainly not directed towards patients who also have other co-morbidities.”

Patients who complain of snoring, who are middle-aged, and are overweight are typically good home sleep testing candidates, Weimer says. But this isn’t the case for the patient who has different types of sleep disorders such as insomnia or patients with known heart problems and even complex diabetes cases would probably do better going into a sleep lab to have a more comprehensive test with supervision, she explains.

Riley added that patients with cardiac disease, congestive heart failure and drug resistant hypertension should be sent to full sleep labs. Anytime a patient is outside of the narrow window of OSA, the HME provider and primary care physician should come to terms and work together, she says.

“Theoretically we could be sending a lot more patients to sleep labs just because we’re getting more patients through the door,” Riley says. “The sleep lab will get more complex patients where of course again in this area of medicine their expertise is highly regarded and respected and that should be the patients that without a doubt are going to sleep labs.”
Weimer agrees that sleep professionals at the labs and sleep physicians are key components in being able to interpret the data.

“Even with some of the autoscoring that’s available with some of the diagnostic systems out there, I think you really need a trained professional to be able to interpret those results,” she says. “It’s a great referral source for both the HME company and for the sleep lab to be able to refer patients to each other.”

The Possibilities
CMS decision to expand the coverage of CPAPs to include home sleep testing devices is a great opportunity for providers to establish themselves as a more trusted and integral part of the entire delivery system of management of patients with OSA with the opportunity now being for primary care physicians, family medicine physicians and general practitioners to be more actively engaged in this market, says Riley.

“Those physicians are going to be very eager for people who are going to be good partners and by that I mean HME providers can step up and they’re really in a position to promote public awareness campaigns and work with their day to day business operations,” Riley says. “They’re just a wealth of information, and they can use that information to really advance this area of medicine if they will step up and do that.”

Speaking from experience, Thomas said he has partnered with home health companies for the joint marketing of home testing services and therapy products, and believes that it may be a good path for others to take as well. For those providers who are looking to continue to grow their revenue and company, home sleep testing is a good avenue to look into, Thomas says. It is also a way that providers can help to mitigate some of the effects of competition.

“They may be able to replace revenue that’s coming in from the heightened competition, whether it’s competitive bidding or sleep labs pulling therapy in house,” he added.

Those providers who are already strong in respiratory or the oxygen business could benefit from including sleep therapy in their business model, as well as those providers that have good relationships with sleep labs and sleep doctors, Weimer says.
It’s not a bad idea to scout out those sleep centers who aren’t exactly interested in conducting home-based sleep studies themselves, Richard says. Find a self-insured or contracted type of environment or make a relationship with a provider that could do the studies, take the data and then have the sleep center physician score the information, Richard says.

“You’re not adding on more cost, and you’re doing something good for the patient,” he says. “ It’s similar to a one stop shop approach because you’re able to scale the technology and services to the needs of the payor as well as offer the patients an option. I do believe sleep specialist should be instrumental and highly engaged in home study programs so they can oversee the results and if questions arise they can make arrangements for more complex patients to be studied in the sleep center.”

With change there will certainly be conflict and those that doubt that a portable study can produce results leading to a diagnosis and treatment, Richard says. “Over time and with appropriate measures in place, portable studies will become the standards for most OSA testing,” he affirmed.

There is research ongoing right now that is looking at having a patient exhale air into an analyzer that detects certain bio markers which are closely aligned with sleep apnea. If this proves to work well, Richard says he envisions a number of patients being tested using this method and then being placed on AutoPAP systems as the natural evolution of the sleep market.

The home sleep testing revolution is not unlike what happened in the 1970s, when most, if not all pulmonary function studies from the basic simple pulmonary function on up to the most complex were performed in hospitals and in laboratories . But if a patient needed a pulmonary function study they were sent to a lab located in a hospital.

In the early 1980s, due to technological advances it was realized that a small pulmonary function device could be used outside of hospital settings. The technology continued to get smaller, less expensive and now a lot of pulmonary function studies with these types of devices are done in primary care physician’s offices, Richard says. More patients were tested, earlier diagnosis occurred and more patients were then placed on bronchodilators earlier in their disease stage. Mainly because more emphasis was placed on education at the primary care level to determine when pulmonary function studies should be done and that made a positive impact in getting patients treatment earlier, he says.

“I think the same thing will happen with this portable monitoring,“ Richard says. “If we can educate primary care physicians with simple tools that can be placed on a patient and get earlier diagnosis and detection of sleep apnea then you’re going to make a positive impact on health care dollars and potentially save people’s lives by getting them on treatment sooner than later.”

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