We last discussed chinstraps and the difficulties many patients may have in their attempts to consistently use them. Eventually, some of these patients must gain access to the sleep lab as they are unable to accurately manipulate the chinstrap into their mask system. As noted, even something as straightforward as wearing the chinstrap inside the mask (nontraditional) versus outside the mask frame (traditional fitting) may still require a trip to the sleep lab, if we can persuade certain insurance companies to grant the authorization for testing.
In the examples that follow, you may or may not be surprised to learn how finicky some insurers operate to block the process entirely or complicate things so much as to erase any further patient motivation to move forward. On the other hand, we continue to be impressed with Medicare’s stance that permits the sleep physician to make the final call on which patient may need a sleep study. While many complain about Medicare’s rigid and arbitrary approach to compliance definitions as well as its lack of coverage for UARS, it is crystal clear Medicare has chronic budgetary problems and simply cannot afford to pay for devices that patients do not use. There is no excuse for Medicare not covering UARS, but that’s another story. To its credit, though, Medicare is willing to go every last mile to help OSA patients become compliant by creating very easy access to the sleep lab.
In these examples, you will notice how the scenarios might play out based on an insurer who requires an authorization to return to the lab versus those requiring no authorizations.
One of the most obvious objective findings mandating a return to the sleep lab is the new or persistent finding of central sleep apnea events showing up on a patient’s data download. We’ve discussed the advantages previously for the use of ASV for central apneas, and we’ve mentioned our REPAP study where many patients failing CPAP eventually demonstrated sufficient central apneas to qualify for complex sleep apnea (the technical diagnosis for what is otherwise called “treatment-emergent CSA,” meaning the treatment of PAP triggered the central apnea problem). If you were to see this problem on a Medicare patient’s download at any point in follow-up, it would be reasonable to consider a return trip to the sleep lab to determine to what extent these central apneas are interfering with the patient’s response. To be clear, a patient on CPAP, APAP, BPAP or ABPAP manifesting central apneas, but who also reports fantastic improvements in outcomes, no leak issues or mouth breathing, and no previous findings or suggestions of leg jerks, would have no obvious rationale for returning to the sleep lab. Such patients in fact do not want to return to the lab; and, no persuasion is attempted to pursue such a step, because of the excellent response.
Notwithstanding our prior discussions of the ceiling effect where patients might be overestimating how well they are doing with PAP, the finding of central apneas do not always indicate a patient is suffering a poor PAP response. Indeed, the consensus of the conventional wisdom in sleep medicine (which I dispute) is that central apneas may appear and then dissipate in many first time PAP users. We dispute this consensus because of the thousands of CPAP patients we have retested in the sleep lab who were presenting with mixed results and yet still demonstrated central apneas many months or years after initiating treatment. In other words, their central apneas did not disappear and were likely still preventing them from achieving an optimal response to PAP. When their outcomes, most commonly reports of persisting awakenings, sleepiness, fatigue and nocturia manifested in ways where treatment gains were observed to be minimal, we know the patient is likely to fare better by returning to the sleep lab and exploring the potential for the diagnosis of complex sleep apnea.
Now, here’s where things get really interesting, almost amusing, and certainly frustrating for those patients who are signed up with one of the largest insurers in the country. If one of their patients shows central apneas on the download, the insurer then initially rejects the authorization if the patient has been using their CPAP or APAP devices with the expiratory pressure relief (EPR) setting in place.
If you don’t recall, EPR functions like a mini-bilevel device, that is, the person inhales at one pressure, but when the individual goes to exhale, then the EPR setting drops the pressure slightly in a range of approximately 1 to 2 cms. Although this change might vary based on the manufacturer’s design of the device, you can think of the settings as if it were a bilevel device with pressures of 10/9 or 10/8 or maybe 10/7. Now stop for a moment and ask why anyone would be using EPR? The answer is easy if you have kept up with these posts, because we frequently talk about expiratory pressure intolerance or EPI. In our experience, EPI is the real culprit involved in so many patients rejecting or failing CPAP. While central apneas often appear in these patients, the EPI is really the iceberg and the CSA is really the tip of the iceberg.
The problem of EPI is so vast, it actually explains why various manufacturers invented EPR technology. Moreover, these same manufacturers recognize that EPI is a more prevalent problem compared to CSA. Still, with some degree of irony, it can be noted that in years past bilevel was actually a treatment for CSA, and yet there has also been some data suggesting bilevel might increase ventilation, blowing off CO2, and eventually triggering central apneas. You can see how much confusion resides in discussing bilevel, because we just stated that it could treat CSA while then stating some believe it causes CSA. Go figure.
Meanwhile, back on the EPR device, the insurer in question looks at data downloads, but if the EPR setting is turned on, then the patient’s symptoms are declared null and void, based on the assumption the mini-bilevel might have caused the problem of CSA. So, what does the insurer demand? The patient must turn off the EPR component of the CPAP or APAP device and then return 2 weeks later to determine whether central apneas as originally seen on the first download are still present. Now, I am not suggesting this theory is completely unfounded, but I can report I have never seen a single case where the central apneas disappeared after someone turned off the EPR component. More tellingly, virtually every patient who goes through these steps reports the worsening of EPI as soon as the EPR is turned off and the worsening of sleep quality and daytime symptoms without the use of this advanced mini-bilevel mechanism.
In my opinion, the insurer is clearly not acting rationally, because they are subjecting the patient to worse conditions that lead to worse sleep, which could in fact cause the patient to drop out of care altogether. Moreover, they have not updated their literature searches to recognize that bilevel is more likely to help CSA patients than to aggravate a CSA problem. Finally, a rational actor would do their homework and recognize how common central apneas are in patients failing CPAP and react proactively by wanting these patients to return to the sleep lab to see whether the problem can be fixed whether with ASV or perhaps some simpler method, as simple as fixing previously undiagnosed or untreated mouth breathing masquerading as central apneas.
No such depth of thought goes into this process with insurers. Instead, it’s all about ASV being expensive, therefore insurers approve seemingly reasonable steps to make sure no one gets ASV. In contrast, more patients who go on ASV are likely to be more regular users of PAP, which should yield better outcomes and ultimately decreased healthcare costs. If insurers acted in this manner, they would also build up their public relations images and win a great deal of loyalty among their consumers.
One of the most idiotic of insurer rationales is the not infrequent rebuttal to our appeals, delivered as the following verbatim, “the patient just needs to try harder.” We are no longer surprised to hear this refrain when we are going through an authorization process in a patient who is noncompliant, that is, is not attaining the metric of 4 hours for 5 nights per week per Medicare rules. As you probably know, many insurers use this metric for adherence, despite its arbitrariness. By the way, in this example, we are of course not discussing Medicare, because they do not require authorization. As their goal is to see the patient become adherent, they admirably have placed no restrictions on scheduling sleep studies in noncompliant patients. Indeed, they rule the patient must return to the sleep lab.
We are talking about an insurer who declares the only possible reason to explain a patient not adhering to PAP could only be the absence of motivation in the patient to do so. Here’s an example of how this story unfolds. The patient completes testing for the diagnosis and treatment of OSA and is prescribed a PAP device, usually CPAP; and, in this instance, the patient has tried using the device for about a year at some other sleep center in town. When we see this individual for a 2nd opinion, we review the case, looking for obvious problems that might be fixed before sending the patient back to the sleep lab. The most common issues arising would be related to mask fit, mask comfort, mask leak, mouth breathing, and difficulty adapting to pressurized air.
As you can imagine, we as well as the patient’s DME company can tweak all these components of PAP. The patient can be fit for a more comfortable mask and even briefly test it to see if leak seems better. This exercise by the way often proves useless, because it does not account for all the positions and movements a patient experiences during sleep. The same goes for any attempt at mouth breathing.
The new mask might appear to solve the problem when coupled with a chinstrap, but in our example, the patient goes home, tries all these new components, but then returns with the same lack of adherence. Other steps would be to add REMZzzs mask liners and to adjust the pressure up or down depending on the residual AHI and the degree of persistent flow limitation (flattening index on many downloads). Again, the patient returns with a lack of adherence.
So, any and all of these steps could be and were attempted in our example, but the patient complains they just can’t keep the mask on for more than 2 to 3 hours per night. He either removes it intentionally or notices it was ripped off at night during the sleep period. The patient, mind you, is very motivated to use PAP but now becomes increasingly frustrated that the milestones set by the insurance company just cannot be achieved.
It is at this point, we explain all these steps to the insurer and then after a first request for an authorization is sent in and rejected, there is a follow-up phone call with a medical director at the insurance company, a medical director who is rarely a sleep doctor. We have a short discussion of the events that have transpired, and then the medical director plays his trump card, “we assume the patient must not be that motivated to use PAP and is going to have to try harder to become adherent.” In a virtual Catch-22 moment, we explain the patient is trying very hard and has attempted a series of new steps that haven’t worked, so he needs to return to the sleep lab. But, the medical director again responds, “we need to see the patient trying harder to gain adherence, before we would consider authorizing a return to the sleep lab.”
I cannot begin to describe how irrational these responses are from the medical director of a major insurer in the USA. The idiotic part is that this medical professional is expressing a complete lack of knowledge on how patients adapt to pressurized air, which in our case example is not just very slowly or gradually, but more important, our patient is actually adapting quite poorly. And, the reason for much, maybe all these problems, is the use of the fixed pressurized air of CPAP. We even explain to the patient that there are other systems available such as bilevel that will enhance adaptability, but we cannot move forward with the new device due to insurance restrictions. Adding to the Catch-22, most insurers never allow for a switch to a different device unless the patient returns to the sleep lab to demonstrate a problem with CPAP. The problem of course is the insurer does not authorize the patient to return to the sleep lab, because “the patient isn’t trying hard enough” to become adherent.
In this example, I want to be clear that the insurer never provided an authorization for the patient to return to the sleep lab, and the patient eventually dropped out of care. From that point forward, we simply stopped working with new patients who use this major insurance company, because we informed the patient we would not be able to provide satisfactory care due to the insurance restrictions. Interestingly, previously established patients already prescribed and using an advanced PAP device such as ABPAP or ASV had less difficulty receiving authorizations to return to the lab, if they suffered from poor outcomes, perhaps because previously they had achieved adherence.
In effect, we are dealing here with the larger issue of adaptability, which I trust you understand as something more important than adherence, because adaptability drives adherence, especially among those with adaptation difficulties. Adaptability takes the form of both psychological adaptation and physiological adaptation and often the two are intertwined.
Psychological adaptation is governed by all the emotional reactions the individual may have regarding using PAP, including embarrassment, shame, guilt, and fear. These emotional responses can be so strong they actually prevent a patient from ever trying PAP therapy. Or, they flare up during the early attempts at use and trigger strong negative attitudes about PAP that result in noncompliance.
Physiological adaptation is governed by the physical sensations a person experiences with PAP and may be as simple as mask comfort issues, nuisance leak from a poorly fitting mask and difficulty in managing placement of headgear and tubing as it relates to adjustments of pillows or location by the bedside. The largest physiological issue is the sensations of pressurized air, which frequently converge with the psychological issues of fear and anxiety when the flow of air does not feel “right.”
The air “not feeling right” is arguably the greatest of all issues in a person’s struggle to use PAP, which is why we moved away from CPAP devices and towards BPAP and other advanced technologies. Fixed pressurized air as described above often triggers expiratory pressure intolerance, which patients frequently report, and if a sleep lab understands how to monitor EPI, they can also see it on the airflow curve in the sleep lab.
Most insurance companies caught up in the authorization game all but ignore this concept of physiological adaptation to pressurized air. And, by ignoring it, they get to make irrational statements about the patient needing to try harder. What the insurance company refuses to understand is that any adaptation problem must be resolved for the patient to be able to use PAP. And, while it is certainly understandable that emotional reactivity to PAP is more dramatic and thus more apparent to all concerned, it is in the vast majority of cases, more probable that the physiological sensation of fixed pressurized air or for that matter any form of pressurized air is the determining factor in whether or not someone adapts to PAP therapy.
So, what does it mean to physically adapt to pressurized air? And, why does the period of adaptation vary so much from individual to individual?
The capacity to use PAP varies so much because the device and all its accessories deliver new, unusual, unnatural, cumbersome or obtrusive sensations to the human organism. Worse, it is not a take it or leave it circumstance. These sensations are frequently experienced as new, unusual, unnatural, cumbersome or obtrusive to almost all individuals because PAP is attached to you. One slightly wide of the mark analogy would be like trying to adapt to a pair of uncomfortable shoes, because your podiatrist prescribed them for plantar fasciitis. Eventually, you would expect to get used to the shoes and even benefit from their use, but like PAP you can only adapt by their being attached to your body for a prolonged period of the 24-hour daily cycle.
For individuals who generally have no difficulties getting over the hump in trying out new things, the issue of CPAP adaptation is straightforward. They can put their noses to the grindstone and make it work, and eventually it does work. These patients constitute perhaps one-third of all those who attempt PAP.
However, in contrast, there are as many as two-thirds of patients who struggle in the early going, because PAP is not like adapting to say, switching to whole wheat bread to replace white bread. If your doctor informed you that the increased fiber in your diet from whole wheat is a necessity, you certainly might give it a trial period. But the process isn’t based on you having to eat whole wheat bread every day or three times a day or anything like having to wear a PAP device all night long. You might take months or longer to transition over to the potentially healthier whole grain bread, but each step of your adaptation is usually not a big deal.
With PAP, for highly sensitive people, every step of adaptation can be a big deal. EVERY.SINGLE.STEP. And, because each of these steps could be associated with pain or discomfort, the hassle factor in using PAP almost never seems to end for these individuals, which is a primary reason so many of them give up. And, what makes matters so much worse is that we are asking these vulnerable patients to manage nearly all the steps at home on their own without any sort of immediate back up plan.
Herein lies the great opportunity provided by the sleep lab. All these steps can be addressed in real-time, including both time awake and time asleep. The patient is a given a chance to show us he or she can put the mask on correctly, and then we can ask them to repeat these steps several times during the sleep study, if we discover improper mask placement is an ongoing problem. We can spot mask leak the moment it’s happening along with mouth breathing the moment it is happening. The sleep technologist enters the bedroom and helps the patient to understand that leak and mouth breathing are occurring and need to be addressed with chinstraps, new mask, mask liners, mouth taping or sometimes a simple change in sleep position. All these items had been addressed in the pre-interview, because leak and mouth breathing are such common reasons the patient has returned to the sleep lab.
If you are a PAP user and you have struggled at home trying to manipulate the mask to resolve mask leak, then you are fully aware of the immense frustration that emerges when night after night the problem keeps returning. Sometimes the leak wakes you up; other times the leak leads to a worse night of sleep even though you thought you slept all through the night; and still other times the leak varies so much you are clueless as to how to proceed in attempts to solve the problems.
Insurers clearly do not understand most, maybe all of the various factors we have been discussing in this series of posts. And, if you don’t really understand the nuances, subtleties, and sophisticated solutions provided by sleep technologists in the sleep lab (directed by their sleep physicians), then in my opinion, insurers will continue to act or react irrationally in trying to manage OSA/UARS patients.