Does anyone know how to reformat a ResScan data card?

[Velbor]

Pianomagoo:
I'm glad that you found my information useful, and I'm relieved that you are not uncomfortable with the erasure of your data. For other readers, particularly in the US, I would remind you of the posting provided on 21 July:
viewtopic.php?t=33300

Medicare is getting a little more specific with it's PAP policies, which I think is a good thing. One biggie for B&M DME's is this one (Documentation of adherence to PAP therapy shall be accomplished through direct download of usage data. This information does not have to be submitted with the claim but must be available upon request.) ....

If this is accurate, and if private insurers in the US follow Medicare's lead (which they usually do), then many of us will need to pay much more attention to maintaining the availability of summary compliance data. (Wonder what the impact of Respironics' reported loss of nights of data will be??)

Slinky:
Yes, these products (AutoScan, ResScan, EncorePro) do technically require prescription in the US. (Interestingly, I cannot find a similar statement on Encore Viewer!) This has always been the case. As I wrote, "FDA has always approved and regulated medical software in the USA". That's just the point. FDA says that with a prescription, they CAN be sold. But ResMed and Respironics now appear to be telling their sellers that these products CANNOT be sold to US patients, period. That excess is a business decision, not a regulatory mandate, as far as I can see.

ResMed does make a strong case. Their "Preferred Internet Provider" policy includes the requirement that sellers:
http://www.resmed.com/en-us/patients/in ... nu=dealers

Refrain from misbranding, altering the intended use of or promoting off-label uses for ResMed products.

which sounds eminently reasonable. And their FDA approval documentation includes the "labeling" that "The ResScan software is intended to be used by clinicianswith ResMed flow generators that have software incorporating ResMed's proprietary communication protocol." Thus, sale to patients would constitute off-label use.

However, by way of comparison, for pharmaceuticals, once a drug is approved by FDA for any use, a licensed physician may prescribe it for any purpose and in any manner, even if not included in the labeling. A pharmacist may sell the drug, with prescription, even if they know that it is for an unlabelled use. What ResMed and Respironics appear to have done is to go beyond regulatory requirements, based on business considerations. They talk a very good game to support this action in the name of patient safety, but it all appears to be business, not regulation.

Of course, there is more or less adherence to all of these restrictions. And even more or less adherence to FDA regulations. Technically, CPAP masks can be sold only with prescription; this is routinely ignored. (I'm looking at the user guide for the UMFF mask and find the familiar words: "In the USA, federal law restricts this device to sale by or on the order of, a physician"). But almost no online sellers require a Rx for masks. Violation of the law?? Putting patients in danger?? I'll pass on that one.

Bottom line: as I said in my first post in this topic, the CPAP manufacturers CLAIM to be restricting software sale for reasons of patient protection. You seem to indicate that you felt that they were responding to FDA regulatory pressure. I remain unconvinced of that, in the absence of specific evidence.

[pianomagoo]

Medicare is getting a little more specific with it's PAP policies, which I think is a good thing. One biggie for B&M DME's is this one (Documentation of adherence to PAP therapy shall be accomplished through direct download of usage data. This information does not have to be submitted with the claim but must be available upon request.) ....
Thanks, Valbor.

I have a question you may be able to help me with. First, I live in Canada so that may make a difference, for now. I don't know. the question is, after you are using the cpap machine for a month does the dme have anymore to do with you or are you on your own ...except for when you need supplies?

I was given a data card and I returned it at three weeks as I had to get someone to drive me out of town because I wanted my machine checked to see why I didn't seem to be getting air even though there was air going through to the mask and out the vent.

The machine was checked and ok so I asked for a higher pressure as I couldn't breathe with the mask on, especially with stuffed nose. I wear a full face mask as I normally breathe through mouth. They gave me doctor's number and I called from there. It took two more weeks to hear from doctor regarding pressure change. I stopped using machine while waiting for doctor to up pressure. I had been getting a cm below prescribed pressure on my machine. After waiting a week I increased pressure up one cm thinking I would get my prescribed pressure. I told the dme I increased pressure one cm and was now getting original prescribed pressure, but it still was not enough to breathe comfortably.

After another week dme called and said doctor said I could raise pressure one or two cm. They told me I could do that myself as I knew how to do it on my machine. This was to save me an out of town trip because I don't have a vehicle.

I do not know if I am supposed to let them know how my readings are. They are different from day to day even though I have been sticking with the same pressure for at least a month. Is it normal at three month time span on machine (with 100% compliance with exception of one week) to have AI that goes from 2 to 13 or AHI that goes from 5-34? This is from day to day readings! What about length of apneas 10 to over 50 sec.?
I don't know if readings are supposed to fluctuate so much on same pressure from day to day or if they are supposed to be more consistent from day to day according to pressure being used. I would think the latter.

I knew 0 when I first saw the doctor a month after sleep lab and still know little but am anxious to learn. If I had known more when I first saw the doctor I would have been able to understand what he was talking about.

I only found out about the apnea through a nurse who noticed I stopped breathing after a endoscopy procedure in the hospital. It explains all the morning headaches, struggling to stay awake after breakfast, thinking I have alzhmeirs because I am losing my memory and cannot multitask two things at once even at breakfast without burning toast.

Very happy it is not Alzhmeirs
Anne

[Velbor]

Dear Anne

after you are using the cpap machine for a month does the dme have anymore to do with you or are you on your own ...except for when you need supplies?

I have no knowledge of how insurance works in Canada. Here in the US, a typical scenario (though plans differ in details) is that a "recertification" is needed every three months to continue insurance payments for machine rental. In essence this means that the clinician or the DME has to certify to the insurer that a) the patient is USING their CPAP at least to certain standards of frequency, and that b) the patient is deriving benefit from the CPAP. A "legitimate" clinician or DME will want to see your data card (or other form of evidence for less sophisticated machines); this is where the "summary data" comes in. A competent sleep physician should want to see the patient at least that often, in the beginning, in any case. After 10 to 15 months, there is usually a final certification, resulting in purchase of the machine for the patient by the insurer. All very reasonable - a high percentage of CPAP patients "drop out" early on, and the insurer doesn't want to continue paying if the machine isn't being used.

Typically, the DME is the primary point of contact with the insurer, since the insurance payments are going to them, and they "own" the machine until after purchase. In my own case, I prefer to contact my sleep physician directly, provide her with my data, and have her send certification letters to my insurer (Blue Cross - Blue Shield).

Both before and after machine purchase, many insurers require that additional supplies (e.g. masks, filters, hoses) are certified as "medically necessary" before they will pay for them, and thus the DME has to obtain updated prescriptions from the sleep physician.

I do not know if I am supposed to let them know how my readings are. They are different from day to day even though I have been sticking with the same pressure for at least a month. Is it normal at three month time span on machine (with 100% compliance with exception of one week) to have AI that goes from 2 to 13 or AHI that goes from 5-34? This is from day to day readings! What about length of apneas 10 to over 50 sec.?

Many participants on this forum will tell you that this is not good, that AHI should be no more than 5 on therapy. I am uncomfortable with such dogmatic pronouncements. First let me say that in my own experience (though not everyone's), fairly wide day to day fluctuations are the norm. (That's another reason why being able to look at summary statistics over time can be both helpful and important.) In addition, it has often been stated (though not necessarily proven) that ResMed machines "sense" more apneas and hypopneas than do other brands. My own (very knowledgable and experienced) sleep physician has not been unhappy to have my AI, rather than my AHI, under 5, and she has little interest in my HI.

That being said, I would nevertheless opine that your AI is higher than one would hope for. Your profile says that you're using the Elite, so you have a fixed pressure each night. Your pressure may need to be higher. At the same time, it is critically important to control leaks: both leaks between mask and face, and leaks from the mouth (which shouldn't be an issue as you use a Quattro FF mask -- but ResMed FF masks can be tricky to reassemble after cleaning, and Quattro leaks at the elbow have been reported, so you might want to reassure that the mask itself is functioning properly). I would encourage you to be in more frequent communication directly with your physician (though some others on this board might disagree), and perhaps rely less, if possible, on the DME as an intermediary.

You are very welcome on this forum, and hopefully you will continue to ask questions, read replies, collect differing opinions and understand their reasons, make informed decisions, and be comfortable and confident in talking to and being a partner with your clinician regarding your health.

Blessings, Velbor

[pianomagoo]

pianomagoo wrote:
I do not know if I am supposed to let them know how my readings are. They are different from day to day even though I have been sticking with the same pressure for at least a month. Is it normal at three month time span on machine (with 100% compliance with exception of one week) to have AI that goes from 2 to 13 or AHI that goes from 5-34? This is from day to day readings! What about length of apneas 10 to over 50 sec.?

Many participants on this forum will tell you that this is not good, that AHI should be no more than 5 on therapy. I am uncomfortable with such dogmatic pronouncements. First let me say that in my own experience (though not everyone's), fairly wide day to day fluctuations are the norm.


Valbor,

Do you mean that, for say, you and me, although not everyone, day to day wide fluctuations are normal in the first few months... and then will begin to all come down every day in a matter of time?

If it doesn't change and become more stable with consistent lowering over time and day by day consistentsy why would we need to even do the therapy? I guess I need to see evidence of improvement over time and am still looking ahead to feeling refreshed instead of same struggling to stay awake. If all I am ever going to see is wide daily fluctuations up and down in my AI I will in all likelihood become very discouraged. I need to see progress, even if it is slow. Slow is better than stagnant.


My S8 Elite cpap machine (also has EPR which I don't use because it is too fast for my breath pattern) has one set pressure but the graphs show it fluctuating between set pressure, 9.6 and 9.8 and 10. It is a straight cpap.


My machine was purchased at end of month trial period. It isn't a rental so I don't think I need to worry about it being reposessed.

If it is purchased, even through the government, can they really reposess a cpap machine, and have you ever heard on the news that a person with sleep apnea had their therapy machine taken from them? Just curious, as I think that would make a fine news story.

Thank you for your responses,

Anne

[pianomagoo]

That being said, I would nevertheless opine that your AI is higher than one would hope for. Your profile says that you're using the Elite, so you have a fixed pressure each night. Your pressure may need to be higher. At the same time, it is critically important to control leaks: both leaks between mask and face, and leaks from the mouth (which shouldn't be an issue as you use a Quattro FF mask -- but ResMed FF masks can be tricky to reassemble after cleaning, and Quattro leaks at the elbow have been reported, so you might want to reassure that the mask itself is functioning properly). I would encourage you to be in more frequent communication directly with your physician (though some others on this board might disagree), and perhaps rely less, if possible, on the DME as an intermediary.

Thank you again Velbor,

In Canada we have a big shortage on doctors. I believe most of them went to the US when Brian Mulrony was PM. It is difficult and almost impossible for a lot of folk to even get a family doctor these days. As for specialists, it takes months to get to see one and one has to be referred by family doctor. although I believe our health ins may be better.

The case may be different with sleep doctors, I don't know. We are told we see the doctor once after sleep lab to get results and then don't need to see him for another year as a followup. I did call his office once to have my pressure raised as it was prescribed for 7cm and the machine was reading 5.8 -6.2 -6.6. I felt like I was suffocating. Had to stop wearing mask, so no cpap.. so I could breathe. It took two weeks for answer from doctor to raise pressure. After first week I already raised it one cm to 8 figuring it would give me my prescribed 7cm. the 8cm was not enough and I was told by doctor (through dme) that I could raise it as much as 2 cm more. Even at 9.6 it is comfortable but I don't feel very much air. If I am stuffed, it is not comfortable.

If my readings don't start leveling out more on a daily basis, I just may try to call the sleep doctor again. I'm not sure I am allowed to but will give it a shot. Thanks for the encouragement.

I am working on leaks. they aren't all the time but when they occur I try to fix them. The leaks don't read high on the graphs, in fact, I think 98 % of the time they are pretty good.

Again, thanks, Valbor

Anne

[Slinky]

I have COPD so I get quite a bit of fluctuation in my AHI data, mostly the HI, the AI is usually pretty good w/quite a few 0.0 AIs. But my leaks tend to be high or more likely all over the place. Not mask leaks, nor mouth breathing but due to "the lip flutters" where air just escapes gently between my lips. I've been aware of that on occasion whilst still awake.

I've forgotten which xPAP you are using but in regards to your pressure. EPR is going to lower your 95th percentile pressure reading. Hey, half the night you are inhaling and half the night you are exhaling so that is understandable. These devices are quite capable of handling leaks by increasing pressure and my Elite could actually raise my pressure a full 1 cm above my set pressure when I had a particularly bad leak.

[Velbor]

Do you mean that, for say, you and me, although not everyone, day to day wide fluctuations are normal in the first few months... and then will begin to all come down every day in a matter of time?

If it doesn't change and become more stable with consistent lowering over time and day by day consistentsy why would we need to even do the therapy? I guess I need to see evidence of improvement over time and am still looking ahead to feeling refreshed instead of same struggling to stay awake. If all I am ever going to see is wide daily fluctuations up and down in my AI I will in all likelihood become very discouraged. I need to see progress, even if it is slow. Slow is better than stagnant.

You raise reasonable, important and insightful questions. My responses may be inadequate, and may engender criticism. I can give no guarantees. But I hope I can encourage you.

I find that I must first give some details about my own experience, so that you can evaluate where I am coming from. On AutoPAP, with pressure set between 6 and 12 (which some will say is too wide a range), with a ResMed Activa nasal mask, mouth taped to eliminate leak, and with almost no leak at all, my AHI typically varies between 4 and 21, with a nightly average of 12.5. My AI typically varies between 0.5 and 6.0, with a nightly average of 2.8. Some on this forum would shudder at these numbers. I am delighted with them, as is my sleep specialist. Key question #1 is: what would I be like without CPAP? Goal #1 is: to be better on therapy than I would be off therapy. I am. I hope that you are.

I have been at this a long time. I can't assure you that your numbers will "stabilize" over any particular length of time. Mine haven't. But Key question #2 is: is my therapy doing all that it can be doing for me? And Goal #2 is: optimize your therapy. That means a) getting the right pressure, and b) assuring that leaks are controlled as well as possible - and that all equipment is in proper working order. It may also possibly mean c) getting the right sort of machine for YOUR needs - which may be CPAP, or may be APAP, or may be BiPAP - depending on your particular situation. That's why data is important, and why regular and meaningful interaction with a competent sleep clinician is important.

I must also disclose that CPAP is not the optimal therapy for me. Most of the time I use an oral appliance, a mandibular repositioning device, to treat my sleep apnea. I currently use CPAP only two nights weekly. My appliance, for whatever reason, provides better therapy for me (verified by sleep studies) than does CPAP. This is not usually the case. And appliances don't work for everyone, nor are they tolerated by everyone. I stress all of this to make the point that each of us is unique.

I would urge you to focus on the above two questions and goals. I would urge you remember the unacceptability of doing nothing, of giving up. I would urge you not to compare your experience to that of others, except so as to learn from them. I would urge you to think and learn, and to demand and partner in the best care possible from the medical community.

Blessings, Velbor

[pianomagoo]

I've forgotten which xPAP you are using but in regards to your pressure. EPR is going to lower your 95th percentile pressure reading. Hey, half the night you are inhaling and half the night you are exhaling so that is understandable. These devices are quite capable of handling leaks by increasing pressure and my Elite could actually raise my pressure a full 1 cm above my set pressure when I had a particularly bad leak.


Slinky,

My cpap unit is a ResMed S8 Elite. I do not use the EPR because it is too fast for my breathing pattern. I use the straight cpap. I am at set pressure of 9.6 but it changes to 9.8 and 10 cm during the night.

My leak rate is very low, except for the occasional time when I have to scratch my nose itch. I have gotten fluttering but deal with it right away by tightning the straps. I wear a full face mirage quattro and concentrate on keeping my mouth closed while sleeping. (as much as possible.)

On the graphs the big leak is when I know I have removed my mask for a few minutes before shutting off the machine. I don't think my AI daily fluctutations are caused by leaks, that I can see on the graphs. My leaks are mainly .02 or .04 L/S and occasionally a little more.

Maybe I am just expecting to see more progress faster and not so much fluctuations.

If it doesn't level out more on a daily basis I will probably take Valbors advice and call the doctor. In the meantime I will recheck every thing that has been suggested regarding this, from formum members.

Thank you for your imput. It is much appreciated.

Anne

[pianomagoo]

I would urge you to focus on the above two questions and goals. I would urge you remember the unacceptability of doing nothing, of giving up. I would urge you not to compare your experience to that of others, except so as to learn from them. I would urge you to think and learn, and to demand and partner in the best care possible from the medical community.

Valbor,

I want you to assure you that I will not give up on therapy but I will keep trying till I have success. I am listening to all advice and will check out anything and everything that could cause problems and if still no change will try a little more pressure change. If that doesn't change I will definetly call the doctor.

At this time, I don't feel it is doing what it should be doing and I am not feeling anymore less tired so I know that something has to change soon.

If I knew that it was common after 3 months with a lot of people it wouldn't concern me as much. I realize it is common with you but if it is only common with a few to have such wide daily fluctuations in AI's and it is uncommon with the majority, doesn't that say something isn't right? I believe that was a run on and on sentence.

I will take your advice but I cannot settle for long term wide fluctutations in my AI's because I know they are causing damage in one way or another.

I hope you, too, will not accept them as normal for a long term.

I say this very sincerely and warmly.

Anne