This is over a year old, but still very relevant.
".......Resmed Corp. to Pay the United States $37.5 Million for Allegedly Causing False Claims Related to the Sale of Equipment for Sleep Apnea and Other Sleep-Related Disorders ResMed Corp., a manufacturer of durable medical equipment (DME) based in San Diego, California, has agreed to pay more than $37.5 million to resolve alleged False Claims Act violations for paying kickbacks to DME suppliers, sleep labs and other health care providers, the Department of Justice announced today.
“Paying any type of illegal remuneration to induce patient referrals undermines the integrity of our nation’s health care system,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “When a patient receives a prescription for a device to treat a health care condition, the patient deserves to know that the device was selected based on quality of care considerations and not on unlawful payments from equipment manufacturers.”
The Anti-Kickback Statute prohibits the knowing and willful payment of any remuneration to induce the referral of services or items that are paid for by a federal healthcare program, such as Medicare, Medicaid or TRICARE. Claims submitted to these programs in violation of the Anti-Kickback Statute give rise to liability under the False Claims Act.
The settlement resolves allegations that ResMed (a) provided DME companies with free telephone call center services and other free patient outreach services that enabled these companies to order resupplies for their patients with sleep apnea, (b) provided sleep labs with free and below-cost positive airway pressure masks and diagnostic machines, as well as free installation of these machines, (c) arranged for, and fully guaranteed the payments due on, interest-free loans that DME supplies acquired from third-party financial institutions for the purchase of ResMed equipment, and (d) provided non-sleep specialist physicians free home sleep testing devices referred to as “ApneaLink............” .
There is something very fishy in the Canadian sleep clinic business at least in Alberta. Each province may be different. The standard practice here is for a clinic to offer a "free" sleep test, and if it indicates a need for a CPAP device they give you one on trial, again for free. But, when it comes time to get the machine, the cost is $2400 (prices from 3 years ago or so). However if you go to an on line supplier, the price for the same machine and mask etc is $800 with free shipping. So what does the full CPAP setup really cost? 500$? don't know, but it has to be around there. So this begs the question as to where the $1900 difference between the cost of the machine and the sleep clinic goes? Private insurance companies cover this $2400. What is even more puzzling is that my son had his insurance company agree to the $2400 for the sleep clinic package. Then when he found out from me that he could buy the ResMed AirSense 10 AutoSet machine full package for $800 plus $1200 for a second portable (Z1 Auto) machine, the insurance company agreed to pay for them both. That would suggest they are not getting a kickback from the sleep clinic or from ResMed. So perhaps it is really the Sleep Clinic that is making totally exorbitant profit of $1900 from each customer. And this is not just ResMed. I was offered a F&P SleepStyle machine (which I disliked) for the same $2400, and I know of others who got a DreamStation for the same $2400. Kind of puzzling...
What it makes me think is that the private insurance thing is a rip off. You are better just paying for your own machine and not paying for insurance at all. That is what my wife and I did. No coverage for CPAP so we bought our own for the $800 or so each price.
I am not sure how Sleep Apnea is covered in the province of Alberta, Canada but in Ontario where I have a great number of friends and family, CPAP machines are covered by Provincial government healthcare , so the sleep clinic gives youa prescription for a machine with certain capabilities (BiPAP, Auto Pap etc ) and you take the prescription to a DME of your choice and they offer you different choices of brands. You end up paying a co-pay of about 10% under Ontario plan and get a new machine every 5 years . High end machines like ASV and AVAPS or S/T and travel PAPS are not covered.
This is however pretty much standard all over North America, whether or not there is a government program available, with the exception that private insurance can pay for higher end machines like ASVs and AVAPS.
Of course if you pay out of pocket like I do, you can purchase anything you want and given your experience in Alberta, it appears that the DMEs make a lot of money there with prescriptions, presumably because when they accept a prescribed sale, they will also have to undertake a lot of warranty liability...or they just enjoy gouging people because they can.
This being said, in most USA jurisdictions the insurance company would want to see your therapy compliance every month in order to continue coverage where as in Ontario this is very sporadic and rather laxed when it comes to checking your compliance.
The lawsuit above pertains to Resmed paying kickbacks to DMEs who pushed Resmed brands over others to patients who came to them for a newly prescribed machine.
This is evidently against the law in United States:-)
Ps,
In United States it is against the law to sell a PAP machine to a US resident without a valid prescription, whereas orders from outside of US can be filled without a prescription. So if you reside in Canada, there is a huge selection for you to choose from, if you are paying out of pocket and if you can negotiate with your insurance company and they do not require a running compliance report, then even better.
I don't think we have anything like the DME in Alberta. These sleep clinics are privately owned, and do the sleep testing and then sell you a machine. You are free to go to any one of them if your doctor gives you a referral.
So in that case you are able to get a prescription for the "type" of machine you need and then shop for it online because Alberta government doesn't cover the cost but your own private insurance does. I hear there are a lot of DMEs in Ontario (Durable Medical Equipment suppliers), depending on where you live and how populated the area is. These outfits usually have a licenced specialist on site who helps you with the setup. These outfits also have to be registered with the Ontario government so they can claim the cost of the equipment on your behalf, but from what I know through friends in Ontario, their prices are much higher than what you can get online, except that the government coverage does not extend to personal online purchases. You have to buy from a registered DME, if you are going to use the government coverage. In the US it is pretty much the same if you are a on medicare or medicaid. If you have a private plan, depending on the type of plane you have, you get varying degrees of autonomy of on you choice of DMEs. Some people choose to pay out of pocket because they don't want to be bound by their insurance "compliance" rules. This way they just report to their own doctor by giving hi/her a copy of their memory card every month. I they decide to go with insurance coverage, then the insurance company gets access to their therapy data that the machine cellular modem uploads every day...I don't like this part personally,which is why I just buy my own machines and deactivate the modem.
Bear in mind that if you buy a machine in the US, then the cellular modem on it will only work with US cell providers, so it will not connect in Canada, which I presume you don't care, anyway.
My only experience with Ontario comes from helping people out there through the forum, and both my wife's and my machine came from on line companies in Ontario. From what I understand there are two slightly different types of stores there. Some are qualified to OHIP standards and some are not. You may have to be a bricks and mortar store to qualify as a supplier of the OHIP paid machines. OHIP sets the price they will pay, so that kind of puts a ceiling on the prices charged in Ontario, which is a good thing. Some stores provide follow up assistance with the machine. Where my son got his machine in Ontario which I think was the same place my wife got hers does provide some follow up. Or, at least they promise it. I have checked my son's machine and they have never changed anything on it. The only changes are the ones I have made for him. I bought my machine at a different place that was on line only and they do not do follow up. They may in fact have the same owners as the storefront operation qualified to OHIP. They will do an initial set up based on your sleep study report, but that is it. I asked for my machines to be left as configured in the factory.
My only experience with the US DMEs is in helping people on the forum. It really does not sound like a good system at all, although I guess like Ontario it does provide machines without cost. These DME outlets seem to force patients to follow their procedures for machines depending on their assessed needs. In the worst case it seems one would have to be prescribed a fixed CPAP first along with the mandatory in lab titration study to set the pressure, then if that does not work, an Auto version, and if that does not work, then a BiPAP, and when that does not work on central apnea finally an ASV. And this is done despite the fact that the last time I checked an APAP machine is only $80 more expensive than a basic CPAP. And, there is no data to support that a BiPAP is more effective in treating central or mixed apnea than an APAP. It may in most cases be worse. Seems like a horrible waste of time and money.
There are some that advocate using home sleep studies, and immediately prescribing an APAP with no in lab testing or titration. This eliminates a lot of the expense. This is the way the system is going in Alberta. I know many people that get an APAP, and none of them actually go the route of an in lab sleep test, and just use a home test kit, no titration test, and then use an APAP in Auto. There are still in lab test facilities but they are suffering big time, and are not impressed with all the home study private companies that have popped up in Alberta. They are almost as many of them here now as there are pot retail shops! Perhaps that is because they pocket the $1900 profit on each machine they can get customers or the insurance company to pay for.
And then if APAP does not work as well as it should then there is the option to switch it into fixed CPAP mode and set the pressure at the 90% pressure level based on the experience in Auto mode. Some even advocate that as the best final solution especially for those that have central or complex apnea. That is where I am.
There are also now on line stores for CPAP machines and supplies in Alberta. I get some of my supplies there now as the delivery can be better, and prices sometimes are lower. One is a company called Sleep Yeti. I may buy my wife's replacement machine there if they ever get some stock... Right now like others they have nothing.
Yes, so just to let you know there are no import duties to be paid to Government of Canada on CPAP/BiPAP , ASV etc, should you ever decide to purchase your equipment from a US supplier.
They all fall under "medical equipment" with distinct tariffs exemption codes which your US supplier must include in their Commercial Invoice so your equipment won't get held up at customs.
In regards to Central Apnea therapy, there is really no machine other than ASV machines which were specifically developed to treat Central Apnea.
Fact is that for a machine to be able to distinguish Central Apnea events from Obstructive events, it must be able to provide a breath when one is missing and to do that, the machine software needs to be able to monitor each breath, continually.
Regular APAPs and BiPAPS are simply not designed for treatment of Central apnea therefore they are not capable of recognizing a single missing breath and then act like a ventilator and provide a breath to compensate. Only ASV machines can do that.
Regular APAPS and BiPAPS are ONLY designed to treat Obstructive Apnea by providing EPAP pressure (this is the pressure you feel when you EXHALE). This way EPAP keeps the upper airway open.
Regular non-ASVachines cannot provide single Breaths to compensate for missing breaths that Central Apnea patients experience.
Now, there are only 2 companies that make ASV machines. One is Resmed (Resmed Aircurve 10 ASV) and Philips-Respironics (Dreamstation BiPAP Auto SV).
Problem is that philips recall has made it difficult to find Philips products online even though there are still some US suppliers who sell them at heavily discounted prices. This leaves Resmed for an entire ASV market and as I have argued in my other post, Reamed ASV algorithm does not work too well.
In the US, it is unlawful for the docs to sell the machines (I think it’s called the Starkey Act) si it falls to the DMEs.) That worked reasonably well until about 2013, when Medicare unfortunately drove the DMEs into an overly competitive bidding process, with the result that the DMEs replaced their respiratory therapists with least common denominator delivery personnel, who don’t do much more than dropping off the machines. So, all too often, the patients are left on their own.
My sleep lab, however, had an excellent manager who devoted several hours a day to helping patients set up and trouble-shoot their machines and pressures. but I’m afraid that situation is more the exception than the rule. I was lucky.
I see the use of CPAP, APAP, BiPAP, and ASV's a bit differently. Yes, the ASVs are the only ones that monitor each individual breath and provide pressure support on a breath by breath basis. There are some BiPAPs that detect absence of regular breaths, and provide longer term pressure support, and may do a timed backup pressure support mode (VAuto ResMed?). And not all CPAPS and APAPs can distinguish between central apnea events and take the appropriate action. CPAPs take no action on either type of event, and that is the correct action in the case of a central event. The ResMed and Phillips DreamStation APAPs can distinguish between CA and OA events and basically use the same method to do it. And, they both respond appropriately in most cases which is no pressure increase in response to a CA event. One issue with them is that they don't distinguish between central based hypopnea events and obstructive based hypopnea events. If one is having central based hypopnea and the machine responds with more pressure then the treatment induced type of central apnea is aggravated instead of corrected. BiPAP machines try to use more pressure support and that also can aggravate central apnea. For these reasons pressure induced central apnea may be best treated with a simple CPAP or APAP in fixed pressure CPAP mode.
There are some machines out there, and the F&P SleepStyle may still be one of them that do not have the capability to distinguish between the obstructive and central events. They are the worst machines of all to treat complex apnea with central apnea. They actually increase pressure in response to CA events and that is the worst possible thing to do. I dodged a bullet when I got my sleep study done. The clinic I used would only offer a SleepStyle and not a ResMed or DreamStation. That machine would not have worked for me in Auto mode, but it may have in CPAP mode. And to your original point of this post it makes you wonder why they would only offer one brand of machine. This same sleep clinic only offered my wife the ResMed S9 a couple of years earlier. What changed? More of a "kickback" on the F&P SleepStyle?
The article at this link gives a deep dive look at the technical differences between the popular machines. It is a bit dated but does include the ResMed A10 and For Her versions, so is not that old. The Respironics machine included is the System One Remstar Auto, which I believe now is the DreamStation Auto.
Treatment of sleep-disordered breathing with positive airway pressure devices: technology update
As a long time ASV user I can assure you that your basic assumptions are incorrect. ASVs are designed to "take action" on detection of a potential CA event (remember that CLEAR AIRWAY is what the ASV detects as it has no other way to detect a Central event). A clear airway event signals that even though the airway is open, there is no flow when there is supposed to have been a "spontaneous breath". The ASV then intervenes by issuing a machine breath and looks for flow If no flow is registered on issuance of a machine breath, it is registered as a CA event however the machine continues to issue breaths at an elevated pressure each time up to maximum IPAP, as long as flow remains open (ie. patient's own spontaneous breathing has not resumed). ASV machines act like mini Ventilators to this regard, whereas regular CPAPS, BiPAPS et al act as positive air pressure sources, only which makes them good enough for OAS therapy.
Mind you, ASV therapy also takes care of OAS events through the same algorithm except that instead of supplying breatchs to break up an OAS event, it elevates EPAP pressure instead, thus helping keep the upper airways open and it does this breath by breath, also.
So ASV machines DO take action in a CA event (otherwise what's the point?) however Non-ASV and BiPAPS don't. Just clarifying here.
ASV algo does all this while at the same time setting a target for minute ventilation and then self adjust to keep MV constant AVAPS do the same except they keep TIDAL VOLUME constant so patients with other issues like COPD can benefit from therapy.
Now, when it comes to machines ability to distinguish between different events, the algorithm has to be high resolution (be able to monitor the characteristics of each breath), however even ASV or AVAPS machines are limited with what they can correctly detect since they can only monitor flow rate and mask pressure. To monitor anything else they need external sensors that can be attached to patients, for better feedback but then we are talking clinical type ventilators, a different ball game altogether.
For apnea events however you really only need the machine to recognize :
1-Clear Airway (CA this could also be Central because Central is when airways are open without diaphragm action).
2-Periodic Breathing (PB)
3-Hypopnea (H)
4-Obstruted Airway. (OA)
ASV machines actually do a great job of recognizing the above, except that in my experience, having owned both machines, Philips does a much more admirable job than Resmed.
I think you are misunderstanding my point. I am not saying that ASV's don't work in treating central apnea and mixed apnea. Clearly they do. What I am saying is that with certain types of central apnea such as treatment emergent complex apnea, a simple CPAP can work well too, and an ASV is not necessary. And further if an APAP is not working well on treatment emergent complex apnea, then a move to a BiPAP may be a mistake. Anything that increases treatment pressure can make it worse. A change to fixed pressure CPAP mode may be more effective.
I hear you, but that's not true. The reason ASV's were developed was because conventional CPAP therapy does not work on CSA.
Can't agree. I had treatment emergent complex apnea with a very high ratio of CA to OA events. A ResMed AirSense 10 AutoSet in fixed pressure CPAP mode works just fine for me. My total AHI over the last 285 days is 0.83. The CA component is still dominant at 0.52, compared to the obstructive index at 0.27. This compares very favourably to the total AHI of 3 to 5 I was getting in APAP mode. Now it may not work for every type of central apnea and complex apnea, but it does work for me
This takes us back to my other posts here, regarding Resmed's algorithm reporting incorrect AHI numbers. Also the Resmed Airsense 10 Autoset does nothing for CA events so I am not sure how it provided any therapy. This is a quote directly by Resmed themselves:
"......*It can be challenging to treat patients with central SDB. Continuous positive airway pressure or automatic positive airway pressure (CPAP/APAP) therapy is often used as the treatment of first intention, but experience shows that CPAP/APAP does not consistently control apneas or improve symptoms*.........."
I run my APAP machine in fixed pressure CPAP mode. I don't want the machine to be chasing central hypopneas, or adjusting pressure at all. All I want is a fixed pressure high enough to treat most OA events. That is one of the secrets in treating complex apnea with a CPAP or APAP in CPAP mode.
Ok so your OAS is the dominant apnea, otherwise your strategy would not help. My central apnea is dominant and it is not even a complex apnea (I have very little to no Obstructive events) so regular CPAP therapy is useless for me.
Also there is a lot of talk about Treatment Emergent Central Apnea. But it is worth noting that only 8% of patients under therapy for OSA, develop Central apnea (complex apnea). The vast majority of patients with predominant Central apnea disorder, are either long term Opioid users (prescription or otherwise) or patients with certain heart diseases. This group's central apnea tends to improve over time with therapy and the cessation of underlying causes.
There's also a subgroup who are idiopathic centrals, whereby the root cause of their disorder is none of the above or undetermined. This group Central apnea does not improve over time and can only be "managed" with correct therapy.
Its noteworthy to mention that the ONLY FDA approved form of therapy for Central apnea is ASV therapy.
I know someone who was successfully treated with a fixed pressure CPAP for complex apnea by an expert on the subject at BWGH at Harvard. I was VERY surprised (actually shocked) because I fully expected that she would require a VPAP. It had something to do with managing CO2 levels and the ventilatory drive, but I can’t explain the details.
Yes, there has been some spotty work to get conventional CPAPS to work for CSA or complex situations. Most were done before ASV was developed (its a relatively new technology). Some of thoese studies actually helped the development of ASVs.
Most respiratory therapists tend to shy away from prescribing ASVs , mainly because to get a ASV machine you must undergo testing for LVEF % and be found to have a more than 45% flow pressure in your heart's left ventricle first because back in 2008 there was a study on ASVs when some patients with this heart issue, died and they are a bit wary of prescribing ASVs for everyone now. But essentially there is no highly effective PAP therapy for CSA/ Complex disorders, other than ASV therapy.
You are correct, and are probably referring to the work done by Robert Thomas, M.D., Associate Professor of Neurology, Harvard Medical School and Beth Israel Deaconess Medical Center. He has written an article in the blog section here.
A quote from the article:
"I also remember noting that bilevel positive airway pressure (BILEVEL) was often resulted in worse responses than continuous positive airway pressure (CPAP, including auto CPAP). In fact, in patients with NREM dominant sleep apnea, auto CPAPs seemed to “chase” changing breathing patterns with pressures that went up and down during sleep, resulting in even poorer results than use of fixed CPAP."
He also describes the experimental treatment which essentially reduces the mask ventilation to increase the CO2 levels.
Altitude can play a significant role in central and complex apnea. People living at higher elevations can have significant issues with central apnea. I worked with one poster here that had a permanent home at a lower elevation but vacationed at a high elevation lake in Mexico. His machine worked at home but not in Mexico with the same settings. My recollection is that he didn't want to keep changing his machine so he bought an AirCurve ASV.
I live at 2000 feet so not high altitude compared to places like Denver but I notice a significant lowering of AHI when I vacation for a couple of weeks at sea level. I am also convinced that my AHI also changes with weather here at home and suspect it is likely to be changes in atmospheric pressure.
One thing for sure. Complex apnea is complex!
Correct, Sierra! Robert Thomas was the Doctor involved. I’m no longer in touch with the patient, but this treatment occurred within the last four or five years, when VPAPs were already available. However, I wasn’t aware of any altitude issues in her treatment. However, a couple of years prior to my own diagnosis I went on a Safari to equatorial Africa at an altitude of 8500 feet and had a constant headache (and I almost never get headaches) and felt slightly ill the entire trip. I later discovered on a trip to Denver, that at even 6000 feet the air pressure is only about 80% of what it would be at sea level, which has a major impact on breathing ann SA. (I was thankful that on the Safari trip I had declined the side adventure to climb Mt. Kilimanjaro. I wouldn’t have fared well. It was a company awards trips and our CEO had to be helicoptered off the mountain. He was later found to have—you guessed it- SA.
Window got too narrow to read or type in!
First just to clarify my diagnosis and treatment, I was diagnosed with an AHI of 37.3. Of that 0.4 was central apnea, and 17.4 was obstructive apnea, with the remainder hypopnea. Clearly untreated I had dominant obstructive sleep apnea. However when I first started treatment with an APAP in auto mode this drastically changed. Unlike my wife who was diagnosed up around 80 for AHI and went immediately to <1.0 for AHI, my outcome was very poor. I can't go back to all the details because SleepyHead "ate" my early data, and all I have left are some random screenshots. I recall AHI's as high as 13 or so. My ratio of CA to OA events went to about 3 to 1. This is a classic case of treatment emergent complex apnea. This is not uncommon at all. I have seen estimates that 6.5% of people treated for obstructive sleep apnea get this treatment emergent complex apnea with high central apnea. That is a large number of people when you consider how many get diagnosed with sleep apnea. Fortunately in most this emergent condition goes away in 6-8 weeks. I was not one of the ones where it went away. I seriously considered at that time going back to my doctor to request a prescription for a VAuto BiPAP or full ASV. But with help from forums and my own research I persevered with changes to my ResMed APAP. If my SleepyHead stats are correct, I have used over 40 different setups searching for an answer. Now with the machine in fixed CPAP mode and a relatively low pressure of 11 cm, and 2 cm of EPR I am finally getting good results with average AHI <1. Still not quite as good as the results my wife is getting (still in Auto mode), but pretty close. My conclusion is that a simple CPAP, set up properly, can be very effective in addressing treatment emergent complex sleep apnea.
I notice that you keep saying an APAP cannot distinguish between central apnea events and obstructive events because it cannot supply missing breaths. That is kind of mixing apples and oranges. Distinguishing between central and obstructive events is done very well with a ResMed APAP. Providing assistance for missing breaths is not a feature of an APAP, and is a totally different issue. The AirCurve VAuto can do that on a very crude basis, and of course as you know the AirCurve ASV does it in a much more sophisticated way on a breath by breath basis. And there are certainly types of complex or pure central apnea that do require an ASV. So far I have not found it necessary in my treatment emergent type of apnea though. If someone requires a significantly higher pressure to control the obstructive portion of the apnea, this fixed pressure option may not be effective. A BiPAP is not likely to work either, and an ASV will be necessary.
This is what I have been trying to Convey here. You do not know how your therapy would improve, if you were able to somehow try ASV therapy. I hear you in that you have fiddled with your CPAP mode and kinda got your AHI under control, but as I have argued in my other posts, Resmed's reporting of AHI , even for its ASV machines, is kind of dubious and cannot be relied upon, which is why I have both Resmed and Philips machines in almost all their models, Airsense, APAP, ASV and VPAP and given my history of dominant Central Apnea (my Polysomnography scored >53 events per hour). In conclusion I'd like to suggest that if you ever get an opportunity to try a Philips Respironics BiPAP ASV, you will find the quality of your sleep improve surprisingly well, as it was the case for me moving from APAP/CPAP therapy to ASV.
Actually I have zero concern that my ResMed AirSense 10 AutoSet is not reporting AHI properly. And with AHI averaging under 1.0 I really have no room for improvement. I sleep just fine if I avoid naps during the day and don't try to sleep more than 8 hours at night. If I get to the point where I cannot maintain AHI under 5, with centrals being the dominant type, then I will consider an ASV. I am currently no where near to that point.
If you were diagnosed with a CA index of >53 then you are dealing with a very different situation. A sleep test is done with no treatment pressure, so treatment pressure is obviously not that cause of your central apnea. An ASV would be an obvious choice.
If I was to wish for a technical improvement to my ResMed APAP it would be the ability to distinguish between obstructive hypopnea and central hypopnea. Some in lab polysomnography tests can do this, but I am not aware of any APAPs that can do it. Currently the ResMed APAP responds to OA and hypopnea events with a pressure increase. CA events are correctly not responded to. The ideal auto treatment would be to only respond to OA and obstructive hypopnea with a pressure increase, while providing no pressure increase to CA and central hypopnea. I suspect that this is technically very hard to do, so they are not doing it. The flow pulsing technique they use is probably not suitable for a hypopnea situation and only works in a no flow situation.
