Trends from SLEEP 2016: Part III

Electrical Stimulation Treatments (RLS, PLMD, OSA, UARS) 

In this age of technology, it is no surprise that innovative therapeutic techniques are being investigated to treat the two most common physiological disorders, sleep-disordered breathing and restless legs and periodic limb movements. Dr. Winkelman gave a very lengthy talk on all the various attempts to use assorted techniques to stimulate and thus simulate a leg movement that might resolve the feelings of restless legs. The techniques are mostly predicated on the phenomenon that RLS resolves when the patient moves the legs or gets up and walks around. Thus, the question has been posed for some time on whether an electric trigger of some sort might simulate the sensation of movement and thus calm the legs. He must have gone through 20 case reports with many similar techniques of which none were conclusively shown to make much difference.

However, the theory of mechanical treatment of RLS/PLMD still draws attention as there were a few items discussed in the exhibit hall or in the poster sessions describing devices purported to reduce these vexing symptoms. Stay tuned for attempts at technological solutions in addition to the recently described pneumatic compression devices, the ones that prevent blood clots for inpatients at hospitals. 

In contrast to these mostly mediocre results for RLS/PLMD, more evidence is emerging to show that stimulation of the tongue muscle by way of the hypoglossal nerve (the nerve connected to the tongue in various points) does indeed decrease sleep breathing events. The most active company appears to be Inspire, and it is clear that despite the current high cost, there is considerable interest in pushing this technology as far and as fast as it can be pushed, because of the great interest among so many patients who want to sleep without the PAP machine.

Questions about ASV and Heart Failure 

The most salient point was that so many sleep researchers and clinicians seem to feel the recently published works about the dangers of ASV in some heart patients were overblown, not to mention confounded by flaws in the investigations. For an excellent discussion of these problems, I strongly recommend this commentary, which has the telling title: SERVE-HF: More Questions Than Answers.

Arbitrary Nature of Medicare Compliance Metrics

There was an excellent talk on the topic of how to define compliance, and like other work in this area, once again we find that virtually all sleep professionals are on board with the recognition that Medicare rules are arbitrary and not based on scientific evidence. One study in particular delved into the difficulties inner-city African Americans experience due to numerous barriers while adapting to PAP therapy, including an apparent unique fear at the outset of care when they report fears about going to a sleep center akin to when “people go to a hospital and do not return home due to the bad things that happen in hospitals.” There are also educational barriers requiring a lowering of the language level to communicate more effectively. In sum, the researcher explained how these patients routinely need more time to adapt to PAP therapy and how the Medicare rules adds additional stress to their efforts because they may require a longer window for adaptation.

As discussed in two posts on our recently published article in Respiratory Care on the distinctions between adherence and sub-threshold adherence (Part IPart II) we heard many attendees at this conference complaining about the lack of attention given to this issue by insurance companies. Once they fall in lockstep with Medicare rules, there is no room for discussion of clinical care on a case-by-case basis. In sum, too many institutions are following these Medicare policies and our patients are losing out because of this arbitrary approach to care. 

Telemedicine is a Wave of the Future

A huge emphasis was placed on the coming age of telemedicine and how it will integrate into the field of sleep medicine. The American Academy of Sleep Medicine has put considerable energy and work into the development of a model of care that appears to go beyond the basics and even seems to have some “bells and whistles.” In all the discussions about telemedicine, the most impressive point I heard was the acute recognition that reimbursement should not be deemed as instantly constrained by insurance carriers or government regulators. Many of the speakers or those in attendance offering opinions reported on the potential for cash-basis interactions with patients. So many healthcare professionals are ingrained with the belief that insurance must be involved to get paid, telemedicine will likely see a whole array of new billing codes forthcoming to “solve” this problem. But, in reality, telemedicine actually represents what I believe is the coming wave of non-insurance based healthcare. As there are so many aspects about telemedicine that can conveniently serve both patient and sleep professional, my expectation is that this expedient approach to care will drive many patients to demand telemedicine for which they will gladly pay out of pocket for what could prove to be high quality care, delivered in extremely timely fashion, and at affordable prices. 

PAP-NAP Research 

Three posters were presented on the PAP-NAP, and one involved using the procedure with children. I was able to speak with two researchers who had completed two of the posters, and both were very enthusiastic about their use of the PAP-NAP. They reported considerable success in the form of salvaging patients who otherwise were reluctant or suffered too much difficulty in their attempts at PAP therapy. The third study allegedly was a controlled design, but the sample was small, and it appeared to me that several confounds were evident in the protocol. This study purported to show no value in the PAP-NAP. Regardless, the good news is that sleep professionals are taking the PAP-NAP seriously and engaging in clinical research to test its utility and validity. Hopefully, much more research will clarify the role that can be played with the PAP-NAP procedure.

In related areas of billing and reimbursement for the PAP-NAP, as follow-up to the earlier post in 2014, we are seeing new trends where insurance carriers are attempting to dismiss use of the PAP-NAP in two different ways. First, due to so little research on the procedure, they can insert into their policies and procedures a statement declaring that the procedure is experimental and not proven to be of clinical value. Second, some insurers are going way out on a limb and declaring the PAP-NAP is not medical necessary. The reason this approach is so extreme is that it is not usually in the purview of the insurance company to decide what is medical necessary. The insurance company plays a role in the case by case decision-making of treatment steps but it would not typically a priori rule that some procedure is not relevant to their patients’ care.

As discussed in the earlier PAP-NAP post, take the case of a patient who tried CPAP one year ago in a sleep lab, who suffered a severe panic attack, ripped off the mask and vowed never to use PAP again. If this patient sees a worsening in sleep symptoms like daytime sleepiness, high blood pressure or cardiac arrhythmias, the primary care doctor will like urge the patient to return to the sleep center for reevaluation. At some point, the question will arise about re-attempting PAP therapy, but such patients often sneer in disbelief that someone would suggest revisiting the pressurized airflow treatment, masks and tubes and all!

What then would a sensible sleep doctor recommend? The answer is obvious when you have conducted as many PAP-NAPs as we have as well as for those centers who have also conducted many of these procedures. All sleep specialists put in this situation realize that no amount of education will assist the patient to try PAP again. Rather the patient has to be convinced to complete a prolonged desensitization with the mask and pressure, and there is no better and no cheaper way to move forward with this exposure protocol than to conduct a PAP-NAP.

In fact, most insurer’s medical directors understand this precise point, which is why some insurance companies that write rules and regulations that dismiss the PAP-NAP will actually authorize the procedure for such patients, and the insurer will reimburse the sleep center for the CPT 95807. Unfortunately, many people who might mention the PAP-NAP protocol in talks to other sleep professionals may not understand these fine points, perhaps because they do not have experience in working with insurance companies who, to reiterate, may authorize the procedure in these complex and difficult to manage patients.

Last, one point that seems to be coming up a lot is the wealth of data out there given the hundreds of sleep centers/labs already regularly using PAP-NAPs in their patient. It would be a magnificent attempt at crowd-sourcing to gather these experiences from so many different sleep professionals, and it would serve as a form of evidence on the PAP-NAP rescuing or preventing CPAP failure cases.

Persistent confusion about UARS

Last and never least, another matter related to Medicare entanglements described their recurring lack of recognition of UARS cases or those with AHI metrics that do not meet their stringent definition of a hypopnea. Two conflictual posters looked at this issue from decidedly opposing perspectives.

One was conducted by Dr. Jerry Simmons, who was a part of the original team at Stanford that discovered upper airway resistance syndrome. In his research team’s poster they pointed out the obvious problem of underscoring breathing events by using Medicare criteria, which rejects the diagnosis of the UARS condition and the meaning of RERAs and flow limitation events. The poster clearly demonstrated a proportion of patients in this low AHI/high UARS category would go untreated and thus continue to suffer the consequences of untreated sleep-disordered breathing. 

The other poster raised a related and opposite question about Medicare scoring rules, namely, are the rules too liberal?! By using a more stringent cut-off, that is, raising the bar to diagnosis by assuming an even more rigid set of rules to score hypopneas, a smaller proportion of patients would qualify for the diagnosis and treatment of OSA. The bottom line here is the bottom line, i.e. Medicare would potentially save a lot more money if fewer people suffered OSA. As you might imagine there were some testy discussions on the merits of both posters between the poster presenters.


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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