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Posted on Jul 1, 2006 in News

New RAD Guidelines Mean Better Treatment for Complex, Central Apneas and Better Business for Providers

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By Elisha Bury –

In April, the Centers for Medicare & Medicaid Services (CMS) updated its guidelines for respiratory assistive devices (RADs) to lift the oxygen desaturation requirement for patients with central and complex sleep apnea. The decision, effective retroactively to Jan. 1, sent waves of relief through the HME industry, which has been inundated by continuous cuts in respiratory reimbursement.

“So, if you put a patient on a blood pressure monitor, you can see their blood pressure going over 200 once every minute. That’s a picture of somebody’s heart getting eaten for lunch. But under the old Medicare criteria, that patient could literally walk out of a sleep lab with a score of zero. And then we could say to them, ‘You’re cured. Congratulations. And then they could go away and die of heart failure.” —Robert Daly, chairman of Total Sleep Holdings Inc., Wesley, Mass.
While the new guidelines clear a path for patients to get proper treatment — and for providers to get proper reimbursement — the guidelines also spotlight the changing needs of sleep apnea patients. Forget everything you thought you knew about sleep apnea. Turns out, the world of sleep-disordered breathing just got a little bigger and a little more “complex.”

Updated RAD Guidelines

What Is a RAD Anyway?
The RAD guidelines for complex and central sleep apnea refer to respiratory assistive devices with and without a backup rate. Typically these RAD devices are non-invasive ventilators such as bi-level devices, or biPAPs. A device with a timed backup feature delivers air pressure whenever sufficient spontaneous inspiratory efforts fail to occur, according to CMS.

“Basic biPAP is simple,” explains Robert Daly, chairman of Total Sleep Holdings Inc., Wesley, Mass., which operates a large sleep laboratory and sleep therapeutic companies. “The machine knows when you’re breathing in and it knows when you’re breathing out. And you say, ‘I want to set a high pressure when I’m breathing in and a lower pressure when I’m breathing out.’ So the machine just simply goes from pressure A to pressure B depending on what you’re doing. … A biPAP machine with a backup rate is sort of the next step up. … What we’ll do is we’ll increase that kind of differential to provide what amounts to artificial respiration if you appear not to be breathing. So what you say to the machine is, ‘Look, if this person seems to be breathing less than X number of breaths per minute or their breathing falls below some total level, pump them. Just start actively pumping them.’ So what happens is the machine converts from what we would call a spontaneous mode where you’re making the decision when the pressure changes … to where the machine takes over and says, ‘No, we’ll make the decision because you don’t seem to be breathing.’ ”

Generally, a bi-level device with a backup rate is used to supply oxygen for those with central sleep apnea. Complex or mixed apneas could include CPAP, biPAP and surgical techniques. In addition to bi-level devices, other treatments for central sleep apnea may include drugs, such as acerazlamide, theoplhyllinr, protriptolyne and klonopin, and low doses of oxygen, says Sanjay Chandran, CEO, InnoMed Technologies Inc., Coconut Creek, Fla.

The Nuances of Sleep Apnea

Think of sleep apnea as a family tree. At the top of the tree is the large classification of sleep-disordered breathing. From sleep-disordered breathing, the sleep apnea family branches off into two types — obstructive, which is very common, and central, which is rare.

“The easiest way that I think about these are that in the case of obstructive sleep apnea, the patient can’t breathe,” says Dr. William Abraham, professor of internal medicine; director, Division of Cardiovascular Medicine; deputy director, Davis Heart & Lung Research Institute, The Ohio State University, Columbus; and council physician on the “Sleep Well, Be Healthy” public relations campaign to help raise awareness of sleep apnea. “(The person’s) thoracic and abdominal muscles, which are used for respirations, continue to try to breathe but the upper airway is collapsed. … Central sleep apnea is due to an alteration in the signals from the brain from the central nervous system that tell the body to breathe. So, essentially, those signals become abnormal and periodically, the patient does not receive a signal from (the) brain to breathe. So, I like to describe that as the patient won’t breathe.”

Daly describes these two forms of apnea as plumbing and electricity. “We are saddled with a little bit of a design defect as mammals,” he says. “And the design defect is that we breathe through the same tube that we eat through. And that requires that that tube be collapsible. … That also implies, and it is true, that there are complex muscles which actually actively hold that airway open and muscles (that) can close it. … That’s how come I say it involves both plumbing and electricity because if the electricity goes off the muscles (that) are holding it open will no longer hold it open. If the plumbing is a problem, meaning that the pipe is too small or something’s squishing it … that can be a problem, too.

“Plumbing’s pretty easy to understand,” continues Daly. “You’ve got this limited space that has to contain both this pipe and your tongue; you’re getting heavy, you’ve got a lot of testosterone because you’re a man; that tongue muscle is a very bulky thing, it’s about the size of your fist actually… As they say, there’s only enough room in this town for one of us. Right? So, unfortunately it can tend to be the tongue, especially when a patient is on their back and that big muscle sort of wants to flop down onto the tube. The muscles holding it open may not be strong enough to counteract that and it may collapse.

“All the way on the extreme side is a condition that is called central apnea. Central apnea as it is understood out there is viewed almost entirely an electrical problem. And … for reasons that are complex, every so often the power to the entire system gets shut off, meaning that the brain stops sending the entire lung plant signals to breathe. And your diaphragm is not attempting to move because it’s got no electricity; your chest wall is not attempting to move; and very importantly … the muscles which are supposed to hold your airway open also have the power to shut off. So the question is should we be calling a plumber or should we be calling an electrician?”

Branching off obstructive and central sleep apnea on the tree is another type of sleep apnea — complex, also known as mixed. This form, the child of obstructive and central, has characteristics of both.

“Up until not all that long ago … it was viewed that 98 percent of the problem was the plumbing problem and 2 percent was the electricity — and by electricity what I mean is nerve impulses,” says Daly. “What has emerged is that in fact all sleep-disordered breathing actually exists on a spectrum where it is probably unusual for somebody to be entirely plumbing and have no electric problems or for someone to be entirely electrical and have no plumbing problems.”

Another variable to complex sleep apnea is co-morbidities. “We see (mixed sleep apnea), for example, in many patients with stroke or with heart failure,” says Dr. Abraham. “The patient is obese; they have a tendency for their upper airway to collapse; they have obstructive sleep apnea. They have a stroke; they develop central sleep apnea, but they still have obstructive sleep apnea as well. … Some of their episodes are obstructive and some of their episodes are central. … A lot of our heart failure patients because they may be obese or because heart failure patients retain fluid and they may get some swelling or edema in their upper airway, they may have collapse of their upper airway as well and they have an obstructive component to their sleep apnea. But also heart failure is associated with a derangement in the central nervous system… So many heart failure patients will have episodes of central sleep apnea, too. And some have mostly central and some have mostly obstructive. And some have a combination of both or the mixed form.”

Daly estimates that about one in five people who come into a sleep lab for a sleep study actually have the complex form of sleep apnea.

Prior to the new guidelines, patients with central and complex sleep apnea were required to fulfill an oxygen desaturation requirement in a sleep study to qualify for Medicare reimbursement on RAD devices.

“The previous RAD guidelines included sleep oximetry that demonstrates oxygen saturation is greater than or equal to 88 percent for at least five consecutive minutes, done while breathing the patient’s usual FiO2,” explains Chandran.

Ron Richard, senior vice president of strategic marketing initiatives, ResMed, Poway, Calif., says that patients with central apneas or complex apneas don’t necessarily desaturate during a sleep study. Before the new guidelines, if desaturation did not occur, the patient did not qualify for a RAD device with a backup rate, which delayed treatment.

Daly says, “Medicare had really up until recently enshrined sleep apnea as a disease of oxygen primarily, meaning that if you really look at what was implied by the Medicare guidelines, it was that what’s bad about sleep apnea is oxygen depravation, so therefore they used a measure for severity which was fundamentally based on oxygen desaturation. And they said, ‘Look … you have an apnea, but if your oxygen doesn?t drop at least 4 percent, then it doesn’t really have any clinical significance so we won’t count it and we therefore won’t pay for therapy.’ … (But) what will kill you in sleep apnea is not necessarily the oxygen desaturation — what kills you is the arousal.”

In fact, says Daly, the state of arousal signals the brain to activate blood pressure, heart rate and adrenaline — all things that spell disaster for the heart.

“It turns out that there’s sort of a paradox here,” says Daly, “which is that if you have so many events happening so fast, you don’t have time for your blood oxygen to drop 4 percent. So you could start to get to a point where you’re so sick that your score goes to zero. … You’re having so many events now, you’re so intensely ill, you never have time to desaturate, but … you’re having these horrendous arousals once a minute. So, if you put a patient on a blood pressure monitor, you can see their blood pressure going over 200 once every minute. That’s a picture of somebody’s heart getting eaten for lunch. But under the old Medicare criteria, that patient could literally walk out of a sleep lab with a score of zero. And then we could say to them, ‘You’re cured. Congratulations. And then they could go away and die of heart failure.”

The new guidelines eliminate the oxygen desaturation requirement for clients with complex and central sleep apnea who require a RAD, enabling them to get treatment immediately. (The guideline still applies to those with restrictive thoracic disorders and severe COPD who require RADs.)

“Physicians have written physician papers and (have) done analysis of clinical data and they presented that to the DMERC medical directors and had a review of that literature,” says Richard. “The DMERC medical directors decided that they would change the component associated with the desaturation side of it to say that if the patient’s primary diagnosis was central apnea or complex breathing … the desaturation measurements were not needed any longer or not required. … That opens up access for physicians to write prescriptions for the respiratory assistive device with a backup rate for this population of patients and for the home care dealers in turn to fulfill that prescription and then be reimbursed.”

Good News for Dealers

The new requirements make it easier for patients to receive the equipment they need because the reimbursement requirements better reflect the nuances of the condition. And that means dealers experience less hassle getting bi-level devices reimbursed.

The new guidelines mean “less paperwork,” says Richard. “In the past if a doctor said, ‘Look, I really have a patient that I feel that this is the best technology for them. I’m going to write a prescription for it, and I want you to fulfill that prescription with this type of device,’ the home care dealer then would oftentimes have to … re-file the bill or argue or debate … with whatever coverage the patient has in order to get reimbursed. There’s a big differential between a bi-level device with a backup rate compared to a bi-level device without a backup rate.”

The reason for the fight was the significant price difference between a RAD with a backup rate vs. one without a backup rate. “It’s several hundred dollars a month,” says Richard. “And the upfront acquisition cost is considerably more expensive for the dealers. So (the dealer) would be put in a position to where they want to make sure the patient is getting what’s prescribed for them and help the doctor out and the patient, but, of course, they need to get reimbursed for their work, their effort, the service they provide and the equipment.”

Chandran agrees that the new guidelines mean good news for providers. “The updated RAD guidelines clearly support a solution that improves patient care and patient outcomes,” he says. “This is certainly good for HME providers since it will save money and improve productivity by providing the appropriate treatment the first time. The updated RAD guidelines provide the only good news to HME providers on reimbursement for the last several months.”

Trends in Diagnosis

As the medical world becomes more familiar with sleep apnea, new trends are starting to emerge. For example, the relationship between sleep apnea and heart disease has made more physicians include sleep as part of a total care package.

“What’s happened over the last few years is there’s more referrals coming from cardiology, from bariatrics and from specialists that now have discovered that one of the key issues related to their patient groups is sleep-disordered breathing,” says Richard. “These referral sources … are sending patients in for sleep studies (that) are a little sicker patient that have other co-morbidities associated with their sleep apnea. So, the sleep labs now have to gear up to that level of service in the marketplace that better addresses the issues of these more complex patients.”

The more physicians decode sleep apnea, the more technological advances will be made to improve patient care. Even now, new studies about complex sleep apnea have changed the way sleep labs are organizing. As a result of the influx of patients, sleep labs have begun to designate beds for complex and central sleep apneas.

Daly said a dedicated unit in Boston recently opened to deal primarily with complex sleep apnea patients. The four-bed sleep lab is called the complexity unit.

“Sleep-disordered breathing has classically been defined as obstructive or central sleep apnea. This oversimplified view of the nature of sleep apnea has limited our ability to diagnose and treat patients with complex sleep-disordered breathing,” says Chandran. “Sleep labs will most certainly make advances in polysomnographic recognition of complex sleep-disordered breathing and improve accuracy of scoring complex sleep apnea.”

Some cardiologists, like Dr. Abraham, are joining forces with sleep labs to better treat patients. “We have developed an integrated program of sleep medicine and cardiovascular diseases here at Ohio State University so that we have sleep medicine specialists and cardiologists, heart specialists, working in clinic together in order to co-manage these patients,” he says.

Because of the statistics associated with heart failure patients and sleep apnea, these types of programs are becoming more important for patient care. “It turns out that 50 percent of heart failure patients have sleep apnea,” says Dr. Abraham. “One out of every two heart failure patients has sleep apnea. But in the United States at the present time, only about 5 percent of heart failure patients are being tested for sleep apnea.”

According to the Mayo Clinic, about 15 percent of all apnea cases are complex, but the link between sleep apnea and cardiovascular disease means that more people are at risk of developing this form of sleep apnea, especially if they are not tested.

“If you look at some of the peer reviewed articles and literature (that have) been published recently, there is an identification now of what’s called the emergence of central apneas after you’ve normalized obstructive events,” says Richard. “So what you’re seeing in patients now is … (once) you’ve got basically their obstructive component under control … then you start seeing central apneas starting to present themselves post the obstructive events.”

As more people develop central or complex sleep apneas, treatment becomes even more important.

Daly says, “Complex sleep-disordered breathing in a heart failure patient is considered to be the single most dire predictor of death, and apart from the new emergence of some techniques to help, up until reasonably recently this was a disease without a treatment.”

Updated RAD Guidelines

Below are links to the updated RAD Guidelines for each DMERC region. Look for the section corresponding to Central Sleep Apnea for updated information.

Region A: Tricenturion
Region B: AdminaStar Federal (Chapter 17)
Region C: Palmetto GBA
Region D: CIGNA (Chapter 9 or click Respiratory Assist Devices on the left)


Sleep Apnea Puts Cardiovascular System in the Red

At least half of the 5 million U.S. heart failure patients have obstructive sleep apnea, says Ed Grandi, executive director, American Sleep Apnea Association, Washington, D.C.

To understand the connection between sleep apnea and cardiovascular disease, Home Health Products spoke to Dr. William Abraham, professor of internal medicine; director, Division of Cardiovascular Medicine; deputy director, Davis Heart & Lung Research Institute, The Ohio State University, Columbus; and council physician on the “Sleep Well, Be Healthy” public relations campaign to help raise awareness of sleep apnea.

“The relationship between cardiac and vascular disease and sleep apnea or sleep-disordered breathing is really bi-directional,” says Dr. Abraham. “And what I mean by that is that sleep apnea is a risk factor and has been shown to be an independent risk factor for the development of a variety of forms of cardiac and vascular disease, including coronary heart disease, congestive heart failure, hypertension and stroke. And at the same time, some forms of heart and vascular disease, most notably heart failure and stroke, can in turn cause sleep apnea. … In some patients, it really becomes almost a chicken and egg thing in trying to figure out which came first.”

Dr. Abraham says that episodes of apnea or hypopnea — periods when a person can’t breathe or breathes inadequately — can affect the body in a number of ways. “You get a decrease in oxygen levels in the blood, you get an increase in the carbon dioxide levels in the blood, you activate a variety of neural and hormonal systems, most notably the sympathetic nervous system,” he says. “The sympathetic nervous system is the system that releases adrenaline into the body and is necessary for the fight or flight response.

“So as you can imagine, when people are sleeping during that restful phase of the day when everything should be quiet, in fact their bodies are responding as if they are challenged with some major form of stimulation producing this fight or flight type of response,” continues Dr. Abraham. “That in turn can cause constriction of blood vessels, and constriction of blood vessels can cause high blood pressure and the adrenaline can also increase the heart rate. And the changes in pressure in the chest when you’re trying to breathe but you actually can’t get air through your upper airway … create a lot of negative pressure in the chest and that increases the stress across the wall of the heart.”

The effects of apnea or hypopnea contribute to heart and vascular disease. “Changes in flow in the blood vessels themselves as well as the high blood pressure can injure the blood vessels and can stimulate the process of atherosclerosis, hardening of the arteries, which ultimately can lead to heart attack or stroke,” says Dr. Abraham.

Fortunately, the treatment for obstructive sleep apnea — CPAPs — has proved to be very effective. “CPAP, as long as you use it, essentially cures sleep apnea,” says Dr. Abraham. “What it does is it reverses all of those bad things … It maintains the oxygen level at a normal range; it lowers sympathetic activation; it reduces the wall stress on the heart; it lowers blood pressure. It has been show in heart failure patients to actually result in strengthening of the heart. The weak, failing heart actually gets stronger over time with the use of CPAP.”

To learn more about the campaign, visit www.sleepapneainfo.com.

Sleep Apnea and Spinal Cord Injury: Is There a Connection?

In a 2001 article, author Stephen Burns, M.D., Department of Rehabilitation Medicine, University of Washington, Seattle, asserted that sleep apnea is significantly more common in people with spinal cord injury. Weak respiratory muscles, especially in those with paralysis in both the arms and legs, are to blame, he says.

Burns also cited several other factors, such as most spinal cord injuries occur in males (a risk factor for sleep apnea); most people with SCI sleep in the supine position, which tends to cause obstruction in the airway; and many rely on neck and upper chest muscles to help with breathing because the diaphragm may not have normal strength. During sleep, the neck and upper chest muscles become inactive, which could disrupt breathing. The article pointed out that nasal congestion is also common in SCI due to a disruption in the autonomic nervous system that further obstructs the airway.

“About 40 percent of tetraplegic (quadriplegic) patients have sleep apnea,” says Burns. “When I reviewed all the published studies, it looked like about 75 percent were typical obstructive sleep apnea and the rest were primarily central sleep apnea.”

Burns further hypothesized that many people with SCI may have had untreated sleep apnea before the injury, especially in those involving motor vehicle collisions.

A 2005 Australian study that focused on 30 recently injured patients with SCI showed that sleep-disordered breathing is highly prevalent within four weeks of acute tetraplegia, says Burns.

Elisha Bury is the managing editor of Home Health Products. She can be reached at (972) 687-6731 or ebury@hmemediagroup.com.