Adherence (Compliance) vs Use: A Conflict Causing Some to Lose Sleep Part II

When a patient is non-compliant, insurance carriers do not distinguish between minimal users and sub-threshold users. Instead, in the example of a Medicare patient, the individual must undergo two additional steps: 1) they must meet with the prescribing physician; and 2) they must undergo a repeat titration. Without these steps taken, the DME company would be forced to withdraw the device from the patient.  

Now, clearly, if someone is averaging only 4 hours of PAP use per week, it makes a lot of sense for him or her to return to the sleep center to meet with doctor and then proceed to a retitration study in the sleep lab to help overcome barriers to use. We have seen such patients, and they can be re-motivated through these steps and make additional progress. In fact, with our REPAP protocol in which we focus on the , we find that repeated trips to the lab can completely reverse PAP failure and turn the patient into a PAP compliant one .

Still, there are some patients that can never adapt to PAP, so there must be some limit on how many times a patient could be brought back to the lab to address non-compliance. As an aside, there are other reasons to return to the sleep lab that prove helpful in maintaining the use of PAP and in optimizing the response. For these encounters in the sleep lab, it remains unclear how often patients might need to return.

Turning our attention to the sub-threshold patients, let us explore the truly borderline compliant cases first. These may be individuals who instead of reaching 70% of nights only achieved 65% to 69% of nights used. Over the period of one month of data collection—the usual interval required for the insurance companies—the calculation comes up short anywhere from 0.5 to 1.5 days fewer than the requirement. Instead of the patient having reached 21 days in a month (70% of a 30 day month), these patients only reached 19.5 to 20.5 days. Does this patient need a doctor’s appointment or a night spent in the sleep lab to get past the 21 day mark? In truth, there are some patients who would benefit from these additional medical encounters, because they suffer through lingering obstacles that if not addressed may turn their next data download into 18 days or 16 days. It would be crucial then for them to be seen at the sleep center and lab. And, some of the more common fixes would include a change in a mask style or size to reduce leak, the addition of a chinstrap, or new instructions on placement and fitting of the mask to resolve skin abrasions, headaches, and other areas of soreness on the face, neck or head.

But, the immediate question that should arise here is why would the sleep doctor or sleep lab be needed to solve these problems when the DME company should be well positioned to identify and address such issues? Then again, some sleep centers may have a greater proficiency in dealing with more vulnerable and sensitive patients who might need repeated mask fittings or a longer period of clinic time, such as a PAP-NAP, to fully address the mask issues. All in all, though, why would the sleep lab be needed for such a patient to resolve these issues when the new mask, as the best example, might solve all the problems on the very next night of using it? Then, 30 days later the download might show in excess of 21 days of use, and the patient is fully adherent.

Yet, according to the Medicare rules, the above scenario is not an option. If the patient shows less than 21 days and the average on those nights is under 4 hours (even at 3.95 hours per night), then it requires a doctor’s appointment followed by a night in the sleep lab. As you can see, the number of hours may be minutes away from compliance, similar to being less than a day away for the nights used requirement, and still the patient is required to return to the clinic and the sleep lab. 

As you know from previous posts, I am a firm believer in the experiential model of care for PAP therapy patients, and I want my patients to return to the clinic and sleep lab as much as possible whenever they are struggling to use the device. But, there are so many individual scenarios when attempting to use PAP therapy, it does not appear to be a cost-effective approach to insist on the Medicare steps as described above.

A more patient-centric and doctor-unregulated model would appear to make the most sense, because the capacity is greater for these two most important people in the process to troubleshoot and problem solve together. If the sleep center finds a rapid solution to the problem, why would the insurer want to pay for a sleep lab retitration so soon afterwards? Perhaps a retitration would prove valuable, but it would make much more sense to conduct a study a few or several months later after the patient has had the chance to attempt to solve the problem at home with the new mask.

So, with sub-threshold cases, it is clear that the Medicare metrics are not patient-centric. Indeed, they may be wasteful, because the premise is a shotgun approach that insists on delivering both barrels (doctor visit and sleep lab) despite the patient being so close to adherent. A smarter system would provide the physician with discretion. A simple phone call between the doctor and the DME company might resolve the whole problem with a change of mask. Common sense should be used in this situation, but unfortunately government regulations often do not tap into what is best understood as “in the trenches” knowledge, all of which reminds me of a quote from Milton Friedman (a Nobel prize-winning economist) : “If you put the federal government in charge of the Sahara Desert, in five years there’d be shortage of sand.”

Nevertheless, for the very low compliance patients who do not even come close to sub-threshold levels, the Medicare system is very intelligent and cost-effective in that some proportion of these cases will climb back up on the saddle and starting riding again, because they need the additional coaching from the sleep physician and sleep technologist via their encounters in the clinic and sleep lab. More importantly, beyond the coaching aspect, there can be serious problems that have prevented the patient from making strong headway in their efforts. When intercurrent medical or psychiatric conditions interfere with attempts to use PAP therapy, the sleep physician will often be able to recommend new options or refer the patient to the proper specialist.

When seeing patients with very low use, the problems range from the very psychological to the very physiological and often comprise both components. Some of these patients suffer a low threshold for distress intolerance and need a fair amount of the “baby-steps” approach to gain small degrees of progress that motivate them to continue. A large number of these cases require multiple mask changes in as little as the first month of use; some require these changes in the first week or two. While this discomfort has a strong physical component, in actuality these patients are so sensitive and vulnerable to distress that they just cannot “get over it” in the early going. One of the most ironic experiences seen quite commonly at our center is the claustrophobia patient who insists on starting out with nasal pillows masks but who eventually realizes that the full face mask actually lessens claustrophobia, because it easily permits the person to open the mouth while awake to breathe in the pressurized air. A restrictive feeling about the mask itself is what claustrophobic patients often complain about at first, but usually in time they learn that suffocation or smothering feelings from pressurized air are really the larger problem. That’s when the switch to the full face mask can yield significant progress. On the purely physiological side, pressurized air settings often need adjustments in the early going if not a switch to a more comfortable delivery system such as ABPAP or ASV.

These adjustments are labor-intensive and complex and require much more input from the sleep center staff. The good news is that Medicare rules align well in helping these individuals. But, if you look at the approach taken by United Health Care, you see the flexibility that I mentioned above. With UHC, the physician must see the patient, but then the patient and physician are permitted to make the determination to go forward with or defer another retitration study.

On the other hand, UHC adds the additional step that requires a prior authorization for the retitrations, and at this point a number of snags arise in their system. UHC physicians who are involved in approving prior authorizations are usually not sleep physicians, thus when conversing with these doctors there are often new delays. The odd thing about these interactions is that the UHC physicians seem to only know how to read from a template and appear less clear about making clinically relevant decisions about their patients.

An example about UHC will show the flaw in their system. When UHC rejects a diagnostic study in lab, they usually do so because the patient does not have the proper co-morbid conditions to qualify for the full night polysomnogram. Instead, they are recommended for home sleep testing (HST). These discussions are somewhat straightforward when the sleep doc is talking with the UHC doc. The UHC doc rattles off the list of co-morbid conditions such as heart disease, cognitive impairment, or some other potentially disabling disorder that would prevent the patient from managing a home sleep test. In our experience, these criteria are way too restrictive and should include conditions such as insomnia and nightmares as well as various psychiatric conditions, but all that is another story that I have addressed previously.

The problem when requesting the retitration is that many of the UHC doctors start rattling off the list of comorbid conditions from the original diagnostic study formula without apparently realizing the test being requested is not a diagnostic but a retitration. When I have had conversations with the UHC physicians, I explain to them the reasons someone is needing a retitrations such as complex mask issues, unresolvable mask leak issues, poor outcomes, low compliance data, or continuous and problematic adaptation issues. After explaining these details, more than half of the UHC doctors again refer back to the diagnostic list and ask, “what are the co-morbidities?” Just this past two weeks, I have suffered through a handful of these nonsensical conversations, but recently one of the doctors finally admitted there was a problem and indicated a new list would be forthcoming to facilitate the discussion when dealing with retitrations requests.

Now, let’s integrate all this information. First and foremost the problem of adherence versus use is fundamentally an insurance or cost-driven problem that may or may not have any bearing on patient care. This makes the adherence versus use conflict mind-boggling because it leads doctors so far afield from attempting to help their OSA/UARS patients. To reiterate, imagine a psychiatrist sitting in a clinical encounter with a patient and discussing the problem as follows: “You know it would be great if you could double the dose of your antidepressant, because I am convinced you would feel better, but by the way, if you do not increase the dosage, your insurance will stop paying for the medication. Let me know how things are going in a month, which is your next deadline to prove you are using the correct dosage. If at that time, your dosage is too low, you will need to return the rest of your medication to the pharmacy unless you decide to pay for those drugs out of your own pocket.” Last, let’s add one final insult to this analogous scenario: “Oh, and if you stop taking the medication, I will need to contact your insurance company for a prior authorization to determine whether or not they will provide coverage when you restart your medication.” 

Sadly, the scenario above is perfectly in line with how the PAP adaptation process, according to insurance policies, is designed to unfold with OSA/UARS patients in their quest to use a device. While we all understand the insurance company’s dilemma of trying to not waste money on patients who do not use their devices, common sense indicates that placing more trust and control of the situation in the hands of the doctors and their patients is ultimately likely to save more money and yield greater use of PAP devices. Regrettably, in modern healthcare systems, apparently such an approach is too easy!


Barry Krakow MD

Author

Dr Krakow’s 27 years of sleep research have focused on the complex relationship between physiological and psychological sleep disorders. Dr Krakow currently operates private sleep medical center, Maimonides Sleep Arts & Sciences, Ltd., and serves as Classic SleepCare’s paid Medical Director.



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