Obstructive sleep apnea patients gain benefits from positive airway pressure therapy use, even if deemed “subcompliant” based on the commonly used definition. Why then, a research team asks, is it the norm to take a device away from patients during this early adaptation period simply because they did not meet an arbitrary compliance metric?
In the study Adherence and Subthreshold Adherence in Sleep Apnea Subjects Receiving Positive Airway Pressure: A Retrospective Study Evaluating Differences in Adherence Versus Use published in Respiratory Care, researchers propose a new framework for PAP therapy that emphasizes use as opposed to adherence.
Data and Results
The study evaluated compliant and subthreshold compliant obstructive sleep apnea (OSA) patients to test whether regular but fewer hours of PAP use would demonstrate clinically meaningful improvements and correlate with outcomes. Compliant regular users were defined as those who met Centers of Medicare and Medicaid Services (CMS) compliance guidelines (mean PAP use greater than or equal to 4 hours a night on 70% of nights), and subcompliant regular users were defined as those who were not meeting CMS guidelines but who averaged regular nightly use greater than 3 hours per night. A chart review was conducted of 113 consecutive OSA subjects, all of whom were using advanced PAP devices such as ABPAP or ASV.
In the study, 21 subcompliant users showed improvements in insomnia, sleepiness, and nocturia. The researchers propose that a scientifically determined dose-response metric devised by sleep medicine experts may be a more promising approach to the management of OSA (and other upper airway resistance syndrome patients) than the current “use it or lose it” policy used by CMS and other payors.
“This study shows that subcompliant PAP patients gain improvements in subjective insomnia, sleepiness, and nocturia symptoms, which lend clear support for a PAP dose-response relationship,” the researchers write. “These findings also mirror the clinical concept of transitional adaptation in which patients use a drug therapy and incrementally increase the dosage over time while gradually gaining more benefits.” Overall, the concept of use may provide a more pragmatic clinical tool in patient management, and a use framework may possibly lead to greater compliance, they say.
A New Framework
Barry Krakow, MD, lead author of the study, says, “I think it helps create a better framework for the doctor/patient relationship where the discussion is focused much more on use. Why should the focus be on ‘compliance’ if we can just get you using more and you get more benefit? Eventually you will use so much you will be compliant.”
Enthusiastic coaching that encourages patients for using their device is typically powerful and effective, Krakow says. “Some people may respond to negative coaching like ‘Oh you’re going to lose your machine if you don’t use it more. But a lot more people, if they’re using and getting benefit, tend to say ‘So if I use it even more, I might get more benefit. I want to keep doing this treatment because I’m feeling better’”.
As symptoms improve, a patient will want to continue to use his/her PAP machine, which will increase the chances that a patient will later be fully compliant. In addition to improvement in patient health, these types of findings may also impact insurance coverage. “The insurance companies need to take a step back and look at what this kind of research shows. Anybody who is using PAP therapy and getting benefit is typically saving money for the insurance company,” says Krakow.
Implications for Sleep
The study results support a dose-response approach to PAP therapy and underscores a “use” framework for PAP devices as opposed to emphasizing “adherence “If a patient is using PAP 3.85 hours a night and getting benefit, why wouldn’t you want insurance to cover it? There are several papers that have been out over the last decade that have described this concept of subthreshold compliance,” Krakow explains. “This work is another one of the papers that hopefully will get people thinking that the word subthreshold compliance means value and benefit. Anything that we can do in the field to push the insurers to cover our patients using PAP devices is a positive thing.”
Overall, Krakow says he hopes the findings of this study empower doctors to fight for insurance coverage for patients who may not use their PAP device exactly per the payor’s guidelines. “I’m hoping one day that the 4 hour, 70% rule will be scrapped because it isn’t based on science and because it defeats the purpose of the way you traditionally think about helping patients. We want doctors to feel empowered to explain to insurance carriers that subthreshold use of PAP therapy has clinical benefit and should be covered. The expectation is eventually those patients will be using the device even more.”
How to Incorporate in Care
Any patient who may be struggling with PAP can benefit from a dose-response approach to PAP therapy, according to Krakow, and he believes sleep medicine providers can implement this viable approach. If a patient sees benefit even from some use, it may eventually improve adherence. “It’s a very different model than might be standard by the way a DME company or a sleep doctor might be communicating with a patient. It’s much more important to recognize that use is where you start,” explains Krakow. “You don’t start with compliance and adherence, you start with use.”
In addition, determining the initial number of hours a patient should use his/her PAP device should be a collaborative effort based on the person’s level of comfort. For example, if a person shows anxiety, a physician can suggest a patient begin using therapy 1 hour a night. By mandating the patient wear the mask the entire night, Krakow says it may add undue pressure and in turn cause insomnia.
“There are so many ways in which you can slowly and gradually have the patient increase that number of hours based on their comfort. I don’t think you set the number of hours; rather you collaborate with the patient and ask ‘What would you like to try first? Every other night? Five nights a week? Every night for 2 hours? What do you think is realistic?’” Krakow explains. “You ask the patient.”
Guidance for Future Research
The research team notes that additional research on a dose-response approach to PAP therapy may raise the standard of care in sleep medicine by supporting higher levels of evidence in clinical practice to treat patients in lieu of arbitrary insurance rules. Krakow suggests future research focus closely on subthreshold compliance patients in light of the new evidence showing improvement in insomnia and nocturia.
“Everybody has proven that subthreshold use improves sleepiness so there’s no reason to reject subthreshold compliance If more people show the importance of looking at use for other symptoms as well, maybe the field’s emphasis will change to target use in a collaborative approach with patients,” says Krakow. “Eventually it will have a carryover effect to the insurance companies to begin recognizing that they should pay attention to use and not just adherence.”
Overall, this new framework for addressing PAP therapy can benefit the patient as well as the other parties involved in patient care and treatment. “We believe that using a ‘use’ framework may ultimately lead to greater adherence. Talking in terms of ‘use’ may actually lead to the solution we all want, which is improved adherence,” says Krakow. “I think everybody benefits from focusing on use.”
Cassandra Perez is associate editor for Sleep Review. CONTACT firstname.lastname@example.org
CMS does not specifically say “Lose it” – they do say they will not pay a device for someone who – by CMS’s arbitrary criteria – is not using the device “adequately”. CMS does provide a pathway to continue therapy post failure. By retesting and sitting back down with the physician to review why the patient cannot be compliant a patient can continue “paid for” therapy. Also, the patient – at least at our company – has the option of purchasing the PAP device for the balance of what CMS would have paid – ie.. the total rental balance less the amount paid for the 3 month trial. Failure to comply is not necessarily loss of the therapy – it just can have some negative financial consequences. Then the question can become – “How much do you want to do to correct your Sleep Disordered Breathing problem?” Patients with strong interest stay on. Patients with little interest drop out.
This comment has validity and suggests that the center involved (DME, Sleep center) is clearly patient-centric, but it misses the main thrust of our research. As we described in the paper, if a diabetic were using less than an optimal dosage of medication yet still gaining benefit, would insurance coverage be denied for the drug? Of course not. So, why are sleep apnea patients who try to use a PAP device and gain benefit from it despite low hours of use being discriminated against? Understandably, CMS must attempt to save taxpayer money among those patients who do not use the device. But, it makes no sense to penalize people who are benefiting from PAP therapy. Sub-threshold compliance yields better outcomes and should more logically be understood as part of a transitional process, which should not require so many administrative hoops to jump through to maintain coverage of the device. Everyone understands the CMS adherence metrics are arbitrary, but hopefully as more research proves the dose-response relationship between PAP and various sleep outcomes, compliance metrics will be adjusted accordingly.
Thanks for this informative article. I am new to CPAP and have pondered these same questions as the 70 %/4hour rule seemed to set me up for failure right from the start which seems counterproductive from a patient centered approach rather than financial centerend. A slow titration in time worn is necessary for me owing to ongoing chronic insomnia which has several factors. CPAP addresses one. The thought that Medicaide could yank the CPAP if I dont meet their unrealistic criteria is anxiety provoking and forces me to try to use it longer which means Im sleeping less and more likely to aggravate existing depression/bipolar issues. Also how do they adapt to someone who cant sleep witha full face mask who has a cold and the nose is plugged which is me in my first week of therapy. YAY. The whole medicaide criteria seems to doom many to failure and what is the point of that? Can I get my physician to write out a schedule for titration that the insurance could accept?
It’s funny that nobody told me anything (way back in 1999) and I just assumed I had to use it 100% of time sleeping (including naps). Of course, I dutifully did that and never complained.
While it did feel a little weird, I just never thought about skipping a night or napping without it.
I’ve been to two sleep studies in nine months.I’m medi/ medi public insurance.After my study in July,I was told I had over 60[i think 70+]apnea wakes .They didn’t put the mask on me all night.I had the same think happen last night.I asked the respiration therapist what was up?She gave me a kind of arcane answer from Medicare.This new criteria would have denied me a CPAP machine in 2006.I don’t think it’s based on science.Compare it to European practice.It would not add up.The bean counters at work.Partnership,the managed care[ghastly]of Medical-California’s Medicaid is worse I was told.My neurologist is going to do a whatever.I need a titration [sp.]The supply companies are too powerful to buck[I saw the action against Lincare-cost of doing business]so Medicare Medical sets out bean counting rules that aren’t scientific.
I am in the 2nd week of my trial, and am struggling badly. I tried to tell the respiratory specialist that I have issues breathing through my nose as I suffer regularly with severe nasal congestion (to the point that I simply cannot breathe through my nose)- take a guess which mask she sent me home with? yep, the bloody nasal pillow mask! I couldn’t breathe, and had to keep opening my mouth to breathe as I kept feeling like I was being suffocated! This has totally messed with the first week & a half of my 4 week trial- (I hate that I have this glaring record of my so-called ‘non compliance’ on the machine!). I all but BEGGED the respiratory specialist for a full faced mask (after explaining that I suffered from severe nose congestion) but NO! apparently THE NASAL PILLOW MASK IS THE MODERN ‘LIGHT WEIGHT’ MASK OPTION, SUITABLE FOR ALL!- and just like that she dismissed what I had said, & told me that I should give it a go anyway!?!). I genuinely want to be compliant, but I keep getting suffocated! What the hell am I meant to do!? :'(