HME Today: What is your opinion of the recent CMS decision on home testing?

Todd Eiken, RPSGT, technical director for Mays & Associates Inc, Nashville, Tenn, responds: CMS painted with a rather broad stroke, leaving many unanswered questions and important decisions to be made by the local Medicare administrations. As a result, I think it's too soon to know how it will all play out until we see what the local coverage determinations will consist of.

There is a specific, limited patient population that, if properly evaluated and followed, could benefit from some type of in-home monitoring. I think it's unfortunate that portable monitoring has finally come to the surface, but it was in such a haphazard manner, in my opinion. I do have some concern that at least early on some poor quality testing might occur.

Diana Guth, RRT, owner of Los Angeles-based Home Respiratory Care, responds: I'm very concerned about it. I worry that there doesn't appear to be any regulation in place on the actual testing, and I worry about the quality of the tests and who is going to be performing them.

Having had a lot of one on one with CPAP patients, I know that some of them are very mechanically challenged. Even if they come in and are told to attach different leads and press this button to start, a lot is going to go wrong. I've had patients who have put CPAP masks on upside down and they are completely unaware.

My concerns also have to do with the freestanding labs that are doing excellent studies. It is doubtful that the home studies that are unattended can even begin to compare to the excellent attended studies being done in the good labs.

Aaron Morse, MD, board member of Physician's Medical Group of Santa Cruz County, Santa Cruz, Calif, responds: Portable monitoring has been a significant part of our process here for more than 20 years, but I am of mixed opinion about CMS' decision. I think that portable, ambulatory monitoring has its place when used properly in the setting of a sleep center that can provide comprehensive management. You will notice that I refer to a sleep center, not sleep laboratory. The key to making portable monitoring work is to provide the same level of care to patients irrespective of what type of study they are having.

My concern about the CMS decision is that they went from one extreme to another. They seem to have made any kind of monitoring available to anyone who wants to do it. I do not think that is going to get the results that they anticipate. Portable monitoring definitely has an acceptable role in the management of these often complex patients, but it has to be taken in the context of understanding the limitations of the studies, and within the context of comprehensive management of the patient.

CMS used to pay for portable monitoring; 7 or 8 years ago, maybe a little longer, they stopped. The stated reason at that time was that the technology had not been adequately evaluated. I think an additional reason is that the number of portable monitoring studies being done was skyrocketing, because everyone with a few thousand dollars and a flat spot in the road could start doing them.

HME Today: What role will HME providers have in home testing?

Todd Eiken

Eiken: I think it is logical to assume that an HME provider who is properly trained in the application of a particular home testing device's sensors could enter the patient's home, apply sensors, and provide the patient with instructions on the use of the device. I think that's kind of a given. And also, obviously, providing patients with conventional CPAP equipment and setup services can continue as they currently are. I don't think that would change within a home testing scenario.

Guth: Some may partner with some sleep labs to do this. There is a risk of endangering your referral source if you do this without talking to them first, or even talking with them might be a big risk, depending on the neighborhood you're in and the relationship you have with the sleep labs. I'm not sure how it is going to shake out.

Morse: I don't think they should be doing testing. Period. There is so much more to the diagnosis and treatment of sleep apnea than reading a test and supplying equipment. I don't think home care companies do the job they're supposed to be doing, and to add testing to that is really the wild west. I think home companies should focus on improving their abilities in managing the difficulties patients experience with CPAP, doing patient follow-up, and providing feedback to sleep centers.

Their role needs to be better defined. Are they just going to be like drugstores selling equipment? Or are they going to manage patients once they're on CPAP? They have to decide whether they are going to be retail companies or are going to provide a medical service. Right now, that's not at all clear.

HME Today: Where does the role of the sleep professional end and the role of the HME provider begin?

Eiken: I think it's important, if both sides feel as though there are some benefits in getting involved with this, that there needs to be some sort of collaborative effort put forward—and some dialogue to answer some of these questions. And they need to do it quickly. There are still so many gray areas as we wait for the local coverage determinations to come out ... I don't think you can make that distinction at this point.

Guth: Different levels of service are provided by different companies. I can only speak for myself. My vision is: I'm a respiratory therapist, and the equipment is the tools of our trade. We do a tremendous amount of patient care and follow-up. You're talking to someone who really values patient care, and I put the resources into it. There are other companies that do not do the same.

Morse: My own bias is that sleep labs should be able to do their own CPAPs on everybody because everything is in one place. Personally, I don't think home care companies are likely to be in a position where they can adequately manage patients. There is too much variability between companies and their policies as well as personnel turnover.

They should focus more on providing the best equipment in a timely fashion, and the sleep centers should have a way to pay for personnel to manage patients. Either that or the sleep labs should provide equipment and pay for the personnel to manage patients out of the income they derive from the equipment.

HME Today: How will home testing impact HME providers financially?

Diana Guth

Guth: It could be an advantage, I don't know. If more people are tested and qualified, we might get more business. It could be quite positive if the companies that are doing the testing also provide the DME equipment, then there will be more competition.

HME Today: How will home testing impact sleep labs financially?

Eiken: I think it is too soon to know at this point. If HME providers and sleep labs work together to define this method of testing, I believe both sleep labs and HME providers can actually experience a favorable financial impact—particularly in the area of in-lab CPAP titration studies for patients who were initially tested in the home. I feel quality patient testing and therapy compliance will surely require in-lab titration, which will favorably impact sleep lab revenues.

On the other side of the fence, when considering the general age range of the Medicare patient population, as well as the percentage of patients within a particular referral area who have all the cardinal symptoms of OSA without any other coexisting medical problems that would interfere with the results of an in-home study, the resulting number of candidates eligible for in-home testing is pretty limited. In this light, I don't currently foresee the inclusion of in-home monitoring into the landscape dramatically reducing testing volumes at existing sleep labs.

Aaron Morse

Morse: I don't know. It depends—with the current situation, it is going to vary a lot from community to community. I don't think that, just because Medicare approves it, primary care physicians are going to go out and buy their own equipment … unless the testing equipment manufacturers start banging on their doors promising extra income. As I stated before, proper patient management is much more involved than testing.

It may make sleep labs busier because the level of awareness of sleep disorders is going to be raised. There is still going to be a very significant need for polysomnograms, and many patients are going to want the "gold standard" for diagnosis as well as care. Medicare is not telling anyone that they have to do home testing.

HME Today: How can HME providers and sleep professionals work together to help achieve better compliance with CPAP?

Eiken: The first thing that needs to be done is CPAP compliance needs to be defined. Within the recent national coverage decision, CMS kind of left this task up to the local Medicare administrators. It is more logical for those in the sleep medicine community and the HME industry who have been attempting to work with patients in this area for years to tackle the answer to this question.

Morse: The literature on CPAP compliance says that the more patients are followed, the better they do. Again, DME providers, as a group, need to decide what their role is going to be and then coordinate with the sleep professionals to be part of a continuum of care. Availability, responsiveness, and close follow-up are what needs to come out of this, and decisions need to be made as to how this is going to be accomplished, including what role the DME companies really want to play.

HME Today: What is the biggest misconception that HME providers have about sleep professionals?

Eiken: Donuts, candy, and monogrammed pens do not have any impact on the decisions made by sleep labs regarding relationships with local HME providers.

Morse: I think they see a lot of sleep labs as mills, where they grind out tests and just send them off to the DME provider without much information. And I'm not sure how much that is a misconception in many cases. There are certainly a lot of entrepreneurs out there whose only goal is to grind out as many sleep studies as they can.

HME Today: What is the biggest misconception that sleep clinicians have about HME providers?

Guth: The misconception is that we have an endless pot of gold. They don't understand the economics. Their expectations for us to provide top-of-the-line equipment when prices are fixed (and going down) make it very difficult for us. They don't want patients to have out of pocket [costs]. These are conscientious clinicians who are really very clueless about what it takes to run this kind of business.

HME Today: What is the most important thing HME providers should know about home testing?

Eiken: If HME providers are interested in providing high-quality sleep diagnostic services using the in-home monitoring methods, then they should collaborate with an established sleep center, or employ trained sleep professionals to oversee and work within the program. A proper clinical evaluation is the key to identifying the appropriate patients to test with in-home monitoring. And additionally, it should be considered that fewer channels of recorded data require more experienced people to look at and evaluate the data.

Guth: I would have to acquire that information myself should I venture out in that. I've never done any testing myself, other than oximetry. I would say that if you are going to do this, you should investigate it carefully, and try to determine the consequences, both pros and cons.

Morse: There are significant limitations, especially if mild sleep apnea or upper airway resistance syndrome is present. Because sleep itself is not measured, the severity of the respiratory sleep disorder may be underestimated if the patient is awake at all during the study. More importantly, the limitations are not so much the technology, as who is doing the test, interpreting the test, and managing the patient. When they get a report that says "sleep apnea" or "no sleep apnea," they have to be aware that this statement may not be entirely accurate,

The raw data needs to be reviewed by a clinician to assess the adequacy of the study. There is often a tendency to tell patients that they are "normal" if the study is negative, and this is frequently not the case. In particular, the patient's symptoms need to be explained, as sleep apnea is not the sole cause of daytime sleepiness. It is also common for patients to have multiple sleep disorders, and this is one of the reasons why evaluation by a sleep specialist is so important.

HME Today: HME providers often say that they are far better equipped to fit masks and follow up with patients. Why do you think they say this?

For more information and articles on CPAP/Sleep, click on the free online archives section. Relevant articles include: April 2008 CMS Approves In-Home CPAP Qualification By Mickey Letson. March 2008 New Era, New Opportunities by Tor Valenza.

Eiken: If that is the case, then I can only assume they say this because they are currently involved in contacting the patients after therapy has begun. But I think one needs to remember that there is a financial incentive for them doing this, and that's called convert to purchase, and it's also called mask and accessory replacement. That is not to say that there are not people in the HME industry who actually do care about compliance, following up with the patient, and effectively addressing barriers to compliance. But we also know that there are HME providers who simply make a couple of phone calls to get the convert to purchase done.

Morse: That's nonsense. We employ a full-time respiratory therapist who does nothing but mask fitting all day long. We discuss patients' needs frequently throughout the day because she is on site here with me. There was an editorial last year titled "It's Time to Start Treating Obstructive Sleep Apnea Like a Chronic Disease" in the journal Chest Physician, published by the American College of Chest Physicians. That article discussed the marginal job that DME providers often do in managing patients. This is a common impression of sleep physicians who are really taking care of patients. DME providers are right, they may be equipped to do mask fitting, etc, but they often don't do a very good job of it, especially with follow-up. They need to put their money where their mouth is, because so far that hasn't been demonstrated.

Katie Griffith is news editor for HME Today.