Oxygen Point & Counterpoint

• Mar 01, 2008

As respiratory therapists fight increasingly stringent reimbursement, meeting patients' clinical needs becomes even more important. New technologies built for the those demands also bring new controversies. We may be living in a renaissance of oxygen therapy choices, but how can we know we're making the right decisions for each patient?

Let Respiratory Management help you.

We've invited clinical experts Joe Lewarski, Bob McCoy and Ron Richard to square off on key clinical challenges involved in oxygen care. Read on to find out where these industry veterans stand on the merits of oxygen conservation, consumer-geared pulse oximetry, environmentally conscious oxygen care, oxygen needs at altitude and pulmonary rehab.

The Rules
To keep the focus on clinical issues, debaters were forbidden to mention specific products or manufacturers in their responses. Each response was limited to 300 words per issue.

The Debaters
Joe Lewarski
Joe Lewarski, BS, RRT, FAARC, has been actively working in health care for more than 23 years. He is a fellow of the American Association for Respiratory Care (AARC), a past recipient of the American Respiratory Care Foundation Award for Excellence in Home Respiratory Care (2001), and has served in numerous management and leadership roles in both the acute care and alternate health care settings, shifting to home care in 1991. He is a former partner and president/CEO of an independent HME/RT and pharmacy operation. Lewarski has served as a clinical and home care expert for numerous consensus conferences, advisory boards and industry programs. He is a regular speaker at regional and national pulmonary medicine, respiratory therapy and home care conferences. He has published more than 24 scientific and research papers in peer review, primarily in the areas of oxygen technology and home ventilation, as well as numerous articles, white papers and health care industry commentaries. Lewarski serves on the AAHomecare board of directors and as chair of the HME/RT Council. He is currently vice president of the Respiratory Products Group for Invacare.

Bob McCoy
Bob McCoy, BS, RRT, FAARC, is active in the American Association of Respiratory Care (AARC) and has been appointed to represent AARC to the American Society for Testing & Materials (ASTM). He is chairman of the AARC home care section. In addition, McCoy has published peer-review articles in professional journals, written for trade magazines, lectured at both state and national meetings, and participated in numerous LTOT consensus conferences. Currently, he is the managing director of Valley Inspired Products (VIP), a research and testing company in Apple Valley, Minn. He also manages ValleyAire Home Respiratory Services, an HME provider of respiratory products and services. McCoy has worked in all segments of oxygen therapy, starting as a staff respiratory therapist in a hospital and progressing to director of a large respiratory department.

Ron Richard
Ron Richard has more than 30 years of experience in the health care industry and has worked as a respiratory care clinician and in sales, product development and strategic planning. Richard sits on the board of directors for AAHomecare and is a published author in several peer-review journals. He actively supports patient advocacy groups to improve the outcomes and health benefits for patients suffering from chronic conditions, such as COPD, sleep apnea and degenerative neuromuscular disease. Richard has been active in several associations — including National Association for Medical Direction of Respiratory Care (NAMDRC), American College of Chest Physicians (ACCP), AARC and American Sleep Apnea Association (ASAA) — assisting with standards, health care finance issues, reimbursement and strategic planning. He is currently the senior vice president of sales and marketing at SeQual Technologies.

Clinical Challenge 1: To determine if oxygen conservation/pulse dosing is beneficial for a patient or if continuous flow is better

Pulse-dosing is beneficial, but the device must meet the patient's needs.
—Bob McCoy
Pulse dose is a volume delivery of oxygen. This can be very beneficial if the goal is not oxygen conservation. If a pulse-dose system senses a breath and gives enough oxygen, it is as good as, if not better than continuous flow. My bias is that intermittent flow makes more sense. We're all breathing intermittently. You breathe in, breathe out. Continuous flow is inherently wasteful because it's flowing all the time.

I've talked to physicians, and they say, "conserving devices don't work," and they don't seem to realize that conserving devices are used on almost every home care patient. Their perception is based on whenever they actually look at a patient that's on a conserving device and test them, they find out that they're not oxygenating. They draw the conclusion the conserver doesn't work, as opposed to the setting's wrong. If oxygenation is the end point, then if you can turn up the setting until the patient is oxygenated, then the device actually does work. The issue comes in that if you are turning the device up and you get to the top setting and the patient is not oxygenating, then it's not that the device doesn't work; it just doesn't have the oxygen production or dose capability necessarily for the patient to oxygenate.

We're finding that most patients that are exercising with oxygen are desaturating. They're not getting enough oxygen because of the limitations of their portable. The big fallacy is saying that's the disease when it's really the product that's causing the problem. I've found patients that are on the maximum setting on a lightweight system that think that they're at the end stage of their disease. I put them on a different system that has a high dose capability, and it's like they jumped into the fountain of youth.

Pulse-dosing is not right for all patients, during all activities.
—Ron Richard
General misinformation and lack of overall understanding related to the clinical capabilities of pulse or conserving systems have in some ways produced less than positive outcomes for patients. The end result in some patients is they experience symptoms associated with mild to severe hypoxemia and can't tolerate pulse systems. Some pulse systems can maintain adequate saturations in patients at rest and during mild exertion. In many ways, pulse systems were designed as a band aid in order to extend the operating time without regard to the ability of the system to deliver and maintain adequate saturations during the primary phases patients use their oxygen system, which are at rest, during ambulation or exercise, nocturnal or when sleeping, and at altitude — traveling in an airplane or at various elevations.

The controversy over pulse versus continuous flow systems will continue for the unforeseen future, but the work that is being done by the AARC and ACCP related to improving outcomes with patients using oxygen should unveil new approaches in the areas of titration and adjusting oxygen levels based on multiple approaches in order to maximize saturations and decrease hypoxic events. Continuous flow is likely to provide a greater degree of comfort and flexibility for patients at all phases of their care. Pulse systems are not tolerated well by all patients due to a number of side effects related to jetting, synchronization, functionality while speaking, and inability to be used with CPAP or ventilation systems. A greater understanding of how pulse systems actually work is needed so as to better educate the physicians and patients on the benefits as well as shortcomings.

Pulse-dose is the standard of practice.
—Joe Lewarski
The fact that there was a lot of misunderstanding about the actual use and titration associated with the devices led some people to believe there were efficacy issues. Some of those were real and some of those were perceived. We've learned, particularly over the last 10 years, a lot more about conserving. Generally speaking, today, for stable, low-flow oxygen patients in the home, pulse-dose or conserving technology is the standard of practice.

There are clearly patients that don't do well with pulse dosing. Most people will tell you that it's typically less than 5 percent. These are typically patients with very high flow needs or high minute-volume demands — like with pulmonary fibrosis who have higher flow needs typically greater than 3 lpm — but that's a relatively small subset. The vast majority of patients on home oxygen in the United States are on 3 lpm or less, and they're typically COPD patients as opposed to pulmonary fibrosis or other more challenging pulmonary disorders.

Is continuous flow better? That's a relative statement. There's scientific data out there that shows that a lot of patients who have continuous flow aren't being well-oxygenated, and it's not because the continuous flow doesn't work. It's because they haven't been prescribed the right dose for their activity level. Continuous flow clearly offers many more options clinically for patients with other needs for higher flow devices, for bleeding into ventilators, for bleeding into CPAP machines and many other things, but for stable ambulatory patients using nasal cannulas, arguably, I think you'll find that clinically there's no difference for most patients.

I think what it really comes down to is whether it's continuous flow or whether it's pulse-dose, the dose of oxygen should be appropriately prescribed and titrated for that patient's needs.

Clinical Challenge 2: To figure out what role pulse oximetry plays in helping patients manage their health

With proper use, pulse oximeters can play a role. Otherwise, the devices could be a liability.
—Joe Lewarski
Right now, there are two schools of thoughts. One is huge proponents for patients to have access to pulse oximetry to do self-monitoring and self-treatment. And there are schools that are not sure that's the right direction and that pulse oximetry is a diagnostic tool and needs to be taken into consideration with other clinical evaluations — pulse, respiratory rate and clinical condition. The device itself can give you misinformation if it's not functioning properly or if there's not good circulation on the finger. The short answer is that properly used, pulse oximetry plays a major role in helping identify patients at risk and in ensuring patients are being treated properly with oxygen therapy. I think the key phrase is that it's used properly. Patients may be relying on this information without taking other clinical variables into consideration. It can give a false sense of security and it can also give the opposite. It could make someone think that they're having a major problem when they're not, and it's simply a bad reading, a bad device, poorly positioned or poor circulation on the digit that it was positioned on.

Pulse oximetry has been around for a long time. There's plenty of good research that shows that when properly used, the devices provide relatively accurate information about blood oxygen levels. When properly done, pulse oximetry with certain patients can be a valuable tool. I think, not properly employed, it could be more of a liability.

Pulse oximeters are valuable tools.
—Bob McCoy
Oximeters are a very valuable tool for monitoring patient oxygenation. With proper education, a patient can use an oximeter effectively. The oximeters are not rocket science, and the information is used as a tool just like taking your temperature at home. Yes, oximeters can give false readings, and yes, patients can use them incorrectly. Yet what are the options? Oxygenation is a very dynamic process and clinicians are not available to monitor and adjust oxygen systems every time the patient moves. These are valuable products and should be available to properly trained oxygen therapy patients.

New oximeters are entering the market, and there is no way of testing or calibrating the units. Oximeter manufacturers and a standards agency should come up with a system to ensure proper operation of oximeters used in the home.

Pulse oximeters can encourage patient compliance.
—Ron Richard
The growth in sales of pulse oximeters has been noted by the increase in the number of Web sites selling these types of products. Even in outdoor sporting supply stores, you are seeing pulse oximeters being offered for use by active mountain climbers, hikers and anyone needing to check their Sp02 levels to ensure appropriate oxygenation is taking place.

Patients that take an active interest in managing their conditions are often more informed and more compliant. With oxygen therapy, one might think compliance is mandatory and quite high compared to other chronic conditions. But to the contrary, compliance is a problem for LTOT patients just as it is with other diseases. A simple device such as a pulse oximeter can provide decent feedback to the patient, much like a weight scale or a glucometer. A patient taking an active role in measuring and monitoring important vital signs, such as Sp02, can play a role in improving outcomes and providing patients with a better overall view of how they are feeling and if their oxygen delivery system is indeed functioning to meet the demands of their daily lives.

The caveat to this is that in the world of "consumer medical devices" one needs to be aware that certain pulse oximeters made off-shore may lack in quality and accuracy, thus providing poor data. The age-old adage "garbage in, garbage out" holds true with pulse oximeters, and the market in the USA has seen a number of very cheap, poorly made oximeters sold that are not FDA approved and could provide less than accurate information to the patient. Education on this topic is needed to ensure patients are getting quality health care supplies and equipment to best manage and monitor their conditions.

Clinical Challenge 3: To make more of an effort to develop and choose environmentally-friendly oxygen devices

Patients will start demanding more energy-efficient devices.
—Ron Richard
The big buzz for the upcoming years is going to focus on the environment in large part due to the efforts of Al Gore and many other activists who continue to pour their efforts into global warming and reducing carbon emissions. One area where little attention has been paid is health care. For some reason, not much concern for energy efficient or "green" type products have been designed. Is this due to concerns over impacting the clinical capability of a medical device? The answers are not apparent, but patients on a fixed income who are dealing with a chronic condition will be demanding more eco-friendly solutions. Baby boomers will lead this effort as they are more educated on the subject and will focus on energy efficient systems that produce clinically sound results. Electricity costs are going up across the United States, while the costs of gasoline and other energy sources are seeing similar price hikes. The push to design energy efficient medical devices should be a focus of manufacturers in the future as we all do our part in conserving resources.

Stationary concentrators are very inefficient and run at full power even when producing low levels of oxygen, thus consuming about 400-500 watts of power. In California where the average retail cost for electricity is $0.1282 per KWHr, the annual cost of operating a typical 5 lpm stationary concentrator is $498.44. Note that California has a high retail electricity cost relative to most other states. Home-filling devices or liquefiers can consume upwards of 600 KWHr at peak loads, thus doubling the cost per month in some cases. [The average retail cost of electricity broken down by state is available from the Department of Energy at www.eia.doe.gov/fuelelectric.html.]

Oxygen concentrators are consuming less energy than in years past.
—Joe Lewarski
The energy comments are most frequently associated with oxygen concentrators. If you look at modern oxygen concentrators, they've come a long way. While they still operate off electricity, you're looking at power consumptions that are under 300 watts today, which is substantially lower than early units which were 500-600 watt draws or greater. In measuring the trade of value of energy consumption vs. what this product delivers, the oxygen concentrator provides a 24/7 oxygen delivery system for what amounts to a few dollars a week in energy consumption today. If you look at other systems, liquid oxygen (for example), it had to be made somewhere. It starts out in an air liquification plant, which consumes an abundance of electricity. Then it has to be hauled from that plant to another plant, usually a distribution center in a giant tractor-trailer, and then it has to be transfilled to smaller systems, typically more trucks, and then delivered to the patient's home. Ultimately, while the liquid doesn't consume electricity in the patient's home, from a "go-green" standpoint, there's still a lot of energy consumption around it. And the same applies to cylinders.

The portable concentrators and newer concentrator systems are clearly going in the right direction. While they still consume energy, their energy consumption is substantially lower than years past and continues to improve with each version. The non-delivery solutions, like transfilling concentrators and portable concentrators, those clearly are consuming less total energy resources and (are having an) impact on a reduction in delivery and all of the other associated fuel costs that go into making oxygen outside of the concentrator mechanism.

Stationary oxygen concentrators need to run more efficiently, like portable systems.
—Bob McCoy
Oxygen conservers do not use that much oxygen, yet concentrators do. Portable oxygen concentrators have sophisticated management of the power source, which allows for longer battery life. If that same system managed home oxygen concentrators, less oxygen would be used when a lower flow setting was selected. At rest, patients typically require less oxygen, so lowering the setting would save power. New home portable filling systems use more power to fill the oxygen portables, yet if they are not used all the time, it may be more energy efficient than home delivery of portable oxygen systems.

I think what we have to do is use the oxygen more efficiently. That's where the stationary oxygen could probably be run at a lower flow, which would be lower oxygen or lower electricity. If we titrated appropriately, we probably would use less power. The efficient management of the disease and the equipment can address environmental issues. Environmentally friendly would be if we could clean up our atmosphere. That would be eliminate the pollutions, which include cigarettes and car exhaust. We're all sort of sitting in the same swimming pool, breathing the same gas. It may not be the smokers that's the problem; it's going to be just breathing polluted air that's going to be the problem in the future. We'll all have a breathing device.

That's why I think the world is starting to think green because we're blowing our resources and the consequences are you can't take a pill to fix it. We're going to have to change our evil ways.

Clinical Challenge 4: To make oxygen users safe in flight by giving them enough oxygen at high altitudes

Difficulty titrating POCs for in-flight use may cause patients to receive inadequate oxygen on planes.
—Bob McCoy
Portable oxygen concentrators have been a fantastic addition to the options for patients that travel. These devices are lightweight, provide for battery operation and have been approved by most airlines. The issue is that each device gives a different amount of oxygen at similar settings, and they have a maximum minute production of oxygen. Patient demands are different at attitude as the cabin pressure in most airplanes is around 8,000 feet. The consensus of most clinicians is to titrate the oxygen delivery system to the appropriate setting to maintain proper patient oxygenation. It is difficult to simulate the environment of a plane, so it is not possible to titrate the patient for the setting or device. If the patient had their own oximeter, they could titrate their system while in flight to maintain proper oxygenation.

The remaining issue is the limitations of different POCs. If the patient selected a POC that they liked, yet while in flight discovered that the unit they have could not be set to meet their oxygenation needs, there would be no recourse. It has been suggested that the setting a patient would use with a POC at exercise would be the appropriate setting for in flight. This is a reasonable suggestion, yet again, cannot be a guarantee as other factors may come into play.

Airlines might want to consider providing a higher dosing POC as an option to have on every flight as a backup to the compressed gas system they have for emergencies. The airlines need to reconsider their oxygen systems for both LTOT patients and their typical travelers.

Altitude may cause oxygen patients to desaturate.
—Ron Richard
Patients traveling at altitude should be aware that at higher elevations and inside a pressurized airplane cabin they may desaturate due to a number of influences. There are, first and foremost, less oxygen molecules at higher elevations. Hypoxia is the effects of an insufficient supply of oxygen to the body. Every person can have different symptoms when suffering from hypoxia. Some of the common symptoms are a lightheaded sensation, dizziness, reduced vision and euphoria. The early signs of hypoxia generally begin at 10,000 feet. (NOTE: The cabin altitude of an airliner and other transport aircraft by design will climb no higher than 8,000 feet.) Without supplemental oxygen, your blood has about 90 percent of its normal oxygen level at 10,000 feet.

Now take a person who has a lung disease that impairs normal gas exchange and it's not hard to see how they will respond to hypoxia at an accelerated rate compared to a healthy individual. POCs that may already be working at optimal values at sea level and not have the capacity to compensate for changes in altitude will result in a patient experiencing the same symptoms described above. There are reports that indicate that not all POCs set at 2 produce the same amount of oxygen. A patient should take a pulse oximeter on the airplane and adjust the settings on the system in order to manually compensate for changes in altitude and the needs they have for more oxygen in order to reduce or decrease hypoxic events.

Stable oxygen patients using the right equipment tolerate air-travel without problems.
—Joe Lewarkski
Bob makes a good point, and that's where matching the right product to the patient is important — and then ensuring that the product is appropriately titrated for that individual patient. I think what Mr. McCoy is getting at is that because you have a device set on 2 and because they get on an airplane with that device, if their needs at altitude increase and they have to turn it up, if your device is on the end of the spectrum where 2 is a very small number and you have to go to 4, and 4 is still a relatively small number — for that patient that device might not work at altitude. It might not put out enough oxygen to get their blood level where it needs to be. However, for other patients, it might do just fine. The issue is how much oxygen does that individual patient need at altitude to maintain the levels that the doctor wants them to be at? And is the device you're using going to achieve that? You've got to be smarter than the equipment you're working with.

If you read the science on traveling with oxygen at altitude, there isn't any data that suggests that COPD patients do any worse at altitude than healthy people do. We all have the same response to altitude. That in itself for a patient who is well managed at sea level may be enough to keep them oxygenated on the plane without changing their setting. For other patients, they're going to have to change the setting.

Patients really need to be cleared for flight. If you have a chronic illness and you've had a history of instability and you haven't traveled in a while, you definitely want to make sure that your doctor thinks it's safe.

Clinical Challenge 5: To determine home care's role in pulmonary rehab

Pulmonary rehab is beneficial and poised to gain support in 2008.
—Ron Richard
Home care providers should support any programs that are proactively trying to better manage patients suffering from chronic conditions such as COPD. It is promising to finally see some positive steps being taken to ensure payment and reimbursement be put in place to assist patients in pulmonary rehab programs. The ACCP and AARC have been active in these efforts, and we should see some changes in 2008, which should increase utilization as well as improve outcomes in this area.

The key milestone for 2008 in terms of pulmonary rehab is to gain support from private as well as government payors to reimburse for the services rendered to COPD patients. To only cover oxygen without support programs, which focus on education, is only providing the patients with a part of the equation. Although conflicting data has confused the benefits of pulmonary rehab, one only has to visit a handful of well-run programs to see the benefits firsthand. There is little doubt that with proper credentialing and management, these programs can reduce long-term costs and lower rates of recidivism.

Home care providers have a place in pulmonary rehab, though lack of reimbursement may prevent efforts.
—Joe Lewarski
I'm a huge proponent of pulmonary rehabilitation. It's another area that doesn't have an abundance of research but definitely has data supporting that patients who enroll in these programs do better than patients who don't. I think that part of the problem is that access has been limited.

When I ran my company, even though we weren't getting paid for the therapists' time, we felt it was necessary to fill that gap that wasn't being filled in other areas of health care from a patient education standpoint, from a clinical assessment and technology assessment standpoint. It would be nice to see some of those dollars, if that legislation goes through, allocated to allow for the extension of the payment into the home. How realistic is that? I don't know, but I do think that home care companies and home respiratory personnel can definitely play a major role. There's a lot of patient education that is part of rehab.

It would be great to incorporate pulmonary rehab as part of the home respiratory program. I think that's probably, unfortunately, a bit idealistic. I do think that home care companies can find ways to work with the clinics. It's essential to have good lines of communication with those clinics. To suggest that all patients need to be in rehab is probably not a fair statement. Patients need to be assessed for their knowledge, for the clinical benefit of going.

A lot of the theme of what we've talked about is assessing what's best for that individual patient and then prescribing and treating and measuring accordingly. I think rehab is going to fit right into that. Whether or not home care will play a big role, unfortunately, will be determined by the reimbursement.

Pulmonary rehab is a valuable resource, but is not supported by payors.
—Bob McCoy
Pulmonary rehabilitation is a valuable resource for LTOT patients. As part of the overall pulmonary rehab program, education on all aspects of COPD is provided. This education provides a foundation on the cause of the disease and how to live productively with the disease.

Home care providers are being challenged to do more with less, and the educational services that were provided by some HMEs are not continuing. CMS pays for equipment; therefore, HME is being squeezed to just do that, equipment.

A home care provider can work with pulmonary rehab to ensure that the patient is titrated on the oxygen system during activity, that the patient understands the importance of compliance with the prescription, and to be able to identify issues that may impact the patient's oxygen therapy program and prevent exacerbations.

Pulmonary rehabilitation is facing the same issues that all medicine is facing: Preventative medicine is not understood or reimbursed. Once payors recognize the clinical and economical benefits of preventative medicine, all clinicians will be able to focus on services to improve outcomes and not just focus on equipment.

This article originally appeared in the Respiratory Management March 2008 issue of HME Business.