Centers for Medicare and Medicaid Services

[Strapparatus]

http://www.cms.hhs.gov/MLNMattersArticl ... MM6048.pdf

Lots of reasons for CMS to make this choice in allowing HST (home sleep testing). Just released this information today which is essentially going to set-back the clinics from charging hundreds of dollars per study! CMS must be reviewing the documentation and finding some data that shows no difference in diagnosis of OSA in clinic vs. home... This is really good news since we all have the burden of insurance costs.

<Link Removed Per Admin>
http://www.HandbookLive.com HandBookLive video presentation of Strapparatus head straps. Please check it out, it is an excellent "how it works" and is quality work. Thank you.

[Slinky]

The problem w/the in-home evaluations and titrations still remains they can only detect OSA. Whereas the in-lab evaluations and titrations can determine any other concurrent sleep disorders as well.

[StillAnotherGuest]

I think another good way to save money would be to simply use the headgear that comes with each particular interface. It has been specifically designed and tested to insure the best possible compatibility and performance. This is a far better idea than throwing $39.99 (plus shipping) down the toilet on something that somebody made in their garage.

SAG

[Strapparatus]

The problem w/the in-home evaluations and titrations still remains they can only detect OSA. Whereas the in-lab evaluations and titrations can determine any other concurrent sleep disorders as well.

There are false positives and false negatives in each. PAT devices (peripheral arterial tone) for example will not detect electroencephalograph (EEG), electrooculomotor, and submental and additional PSG parameters such as heart rate, oximetry, apneas, hypopneas,
delta index. You're right about the other disorders. Have you heard of the ASV (Auto-support ventilation) machine? 4 of these machines were
purchased for use in Central sleep apnea. This device operates on minimum exhaled minute ventilation and provides support to the patient
when the brain ceases to send the signal to breathe. Its essentially a very expensive machine that was purchased simply on the belief that mixed disorders were prevalent. Why buy into manufacturers' devices when this is not prevalent but actually uncommon in the patient population? We have not used the ASV but once or twice. Hundreds of patients are placed on the cpap,bilevel, and varying available interfaces with satisfactory results. Simplification of testing will rule out the requirement or necessity of a full PSG, and be cost effective and easier to provide than a formal multi-sensitive test.

Response to foe: To breathe or not to breathe that is the question.

[-SWS]

Thanks for the CMS update, Strapparatus.

This [ASV] device operates on minimum exhaled minute ventilation and provides support to the patient
when the brain ceases to send the signal to breathe.

Not to nit pick, but depending on manufacturer, the machine operates (albeit only in part) on averaged peak flow or minute ventilation.

Its essentially a very expensive machine that was purchased simply on the belief that mixed disorders were prevalent.

So I take it you're at odds with the world's leading CompSA/CSDB researchers at Mayo, Harvard, and elsewhere who believe prevalence to be 20% or higher.

Hundreds of patients are placed on the cpap,bilevel, and varying available interfaces with satisfactory results.

With a CompSA/CSDB non-prevalence rate of somewhere around 80%, I would fully expect satisfactory results to amount to hundreds or perhaps thousands of patients. But that 80% still ends up very miserably fitting end-result compliance rates, which are in the forty-some percent range. So if the treatment status quo is a miserable fit (and it undeniably is), then I think we can understand why the likes of Mayo, Harvard, manufacturers, et al are looking very hard for both explanations and alternatives to that broken status quo of treatment. Stick with it if it truly works. But is it truly working?

We have not used the ASV but once or twice.

So stick with the status quo. But quite frankly, when you use any brand new treatment option only once or twice, you probably haven't learned how to apply it properly, let alone fairly evaluate it.

with early data from my center and other centers with whom I collaborate, the success rate on ASV appears to top 80%, and among these successful cases we often here phrases like, "that was the easiest PAP machine I've ever used" or "that was the best night of sleep I've had with a PAP machine."

Those are very interesting results from several clinics having gone to the trouble to learn how to properly apply ASV more than once or twice.


Bless you for trying to help patients, Strapparatus...

[StillAnotherGuest]

PAT devices (peripheral arterial tone) for example will not detect electroencephalograph (EEG), electrooculomotor, and submental and additional PSG parameters such as heart rate, oximetry, apneas, hypopneas,
delta index.

Well, since that's the whole list of parameters that one would need to assess SDB, then exactly what is it that PAT measures? I mean, saving money is great, but what the heck good is it if you get no product?

SAG

[Strapparatus]

PAT devices (peripheral arterial tone) for example will not detect electroencephalograph (EEG), electrooculomotor, and submental and additional PSG parameters such as heart rate, oximetry, apneas, hypopneas,
delta index.

Well, since that's the whole list of parameters that one would need to assess SDB, then exactly what is it that PAT measures? I mean, saving money is great, but what the heck good is it if you get no product?

SAG

I found this in wikipedia, "Science typically looks at the SNS as an automatic regulation system, that is, one that operates without the intervention of conscious thought. Some evolutionary theorists suggest that the sympathetic nervous system operated in early organisms to maintain survival as the sympathetic nervous system is responsible for priming the body for action.[1] One example of this priming is in the moments before waking, in which sympathetic outflow spontaneously increases in preparation for action.
The PAT measures sympathetic activity through an actigraph ("motion graphics"). Quite an invention using physics to determine the motion in the peripheral flow / pressure/ volume and signalling these changes. Wow, impressive! Kind of like a sphygmomanometer (blood pressure cuff)?
theory... cool.

Over simplified explanation.
So if there happens to be a false negative ? Good question! Maybe then, you seek a full sleep study to determine other causes?

[rested gal]

So if there happens to be a false negative ? Good question! Maybe then, you seek a full sleep study to determine other causes?

Or more likely, the person heaves a sigh of relief and thinks, "Good... I don't have it, so I don't have to be hooked up to one of those 'breathing machines'. Whew!! "

End of story.

And maybe a premature end to an undiagnosed OSA'er's life.

[StillAnotherGuest]

So if there happens to be a false negative ? Good question! Maybe then, you seek a full sleep study to determine other causes?

Terrific! Except how do you know when a false negative occurs? And that's assuming the patient is going to be properly followed up and will come back.

Better yet, what happens to the false positives? Buy an xPAP machine of some sort, spend 12 weeks on it, then get PSG when there's no improvement?

This doesn't look like cost savings, this looks like it costs more.

This is really good news since we all have the burden of insurance costs.

No, this is an

Over simplified explanation.

Look around the sleep forums and count up how many people have a treated AHI < 5 (which, whether you agree or not, like it or not, that's considered normal) and are saying they aren't doing as well as they should, or in many cases don't any feel any better whatsoever. Now throw in a pile of patients with limited-channel data. No wait! Throw in the target group for HST, the Medicare population! Who all have sleep-comorbidities! This just gets better and better!!

Just released this information today which is essentially going to set-back the clinics from charging hundreds of dollars per study!

Actually, there, Rip Van Winkle, this is already years old news.

And while OSA factories may take somewhat of a hit, Sleep Centers (there's more to sleep other than AHI) will eventually get clobbered as they will have to deal with a huge new influx of inadequately treated and complex patients.

SAG

PS - Why'd you delete all your old posts? Trying to create a new image? Again?

PPS - BTW, nothing ever really gets deleted.

[StillAnotherGuest]

And if you want to talk about PAT, then let's talk about PAT. Don't bring it up and then try to figure out what the heck it means afterwards.

[-SWS]

There is the topic of screening and there is also the interrelated but separate topic of diagnostics.

Screening is going to occur in the doctor's office and conceivably at home. IMO Rested Gal points out just one problem with screening: false negatives, a.k.a. less-than-perfect measurement sensitivity. Rotten and potentially disastrous results can happen when false negatives occur---which happens not only in screening, but also in diagnostic results. Diagnostics fortunately entail more robust measurements and quantitative methods than screening, typically yielding better sensitivity and specificity than screening. Hallelujah for diagnostics. But rhetorically, can less-than-perfect screening be relinquished? I think the results across the patient population become more disastrous if screening were relinquished. The goal IMO is to forever improve both methods and technology to forever strive for better screening sensitivity and specificity.

But diagnostics are an altogether different issue IMO. Clearly the in-lab PSG is preferred with some exceptions. And those exceptions will boil down to the cases when in-lab PSG diagnostics are either not possible or are ineffective for an entire variety of reasons. First and foremost, at least in my mind, is that highly common scenario of patients simply being unable to sleep in a PSG environment. That lab environment may be well "controlled" but those controls are worthless if they impose enough artifact that the patient can't even sleep. You simply can't measure sleep if it doesn't occur or happens to present data in a grotesquely distorted manner---by the physically and psychologically imposed artifacts of the measurement process itself. In fact, those measurement controls are utterly non-existent at that point. Enter home-based studies. If they yield adequate albeit less-than-perfect measurement, that is far better than the previous scenario of either no measurement or grotesquely distorted measurement.

There are additional scenarios that favor home-based studies IMO, but my frozen pizza is finally ready... Gotta go!

[StillAnotherGuest]

First and foremost, at least in my mind, is that highly common scenario of patients simply being unable to sleep in a PSG environment. That lab environment may be well "controlled" but those controls are worthless if they impose enough artifact that the patient can't even sleep. You simply can't measure sleep if it doesn't occur or happens to present data in a grotesquely distorted manner---by the physically and psychologically imposed artifacts of the measurement process itself.

But the problem there is that the great majority of HST technology doesn't measure sleep, they're OSA screeners. Not a lot of people are going to use Level II devices for HST because of the expense involved and the high probability of insufficient data when all the Exx leads fall off and there's nobody to replace them (I would offer that if somebody can't sleep in the sleep laboratory, they're probably not doing all that well at home, jumping around all night, and you'll end up with zero data).

If you're sure you're an OSA patient, then HST has a purpose. If you're co-morbid, then there's going to be a problem.

How sure? In an earlier post

Right, if you use oximetry in your screener, the chances of getting useful data become better. The University of British Columbia Hospital Sleep Disorders Program in their article in AoIM Diagnosis and Initial Management of Obstructive Sleep Apnea without Polysomnography was picking out over 95% of the moderate to severe OSA. But they weren't "diagnosing sleep disorders", they were "picking out moderate to severe OSA". If your RDI is <15 or you have co-morbidity, there will be no short cut. And again, in that study, in order to find 81 subjects they had to look at 2216 patients referred to their sleep center (not 2216 people on the street, 2216 people referred to their center, which means they all had a sleep issue) of which 2135 were ineligible for a myriad of reasons.

Beverly is the perfect example of "titrating" with limited channel data. Are you fixing wake (comfort measures) or sleep (respiratory events)?

Good News, Bad News

Just released this information today which is essentially going to set-back the clinics from charging hundreds of dollars per study! CMS must be reviewing the documentation and finding some data that shows no difference in diagnosis of OSA in clinic vs. home... This is really good news since we all have the burden of insurance costs.

Good thinking there, SFB, but that's not what's going to happen.

For whatever good or bad, OSA Factories sprung up because of profitability. How many organizations are going to do HST if the reimbursement is ~$170? You think this is going to help? How? By picking up the HST at a Drive-Thru window? What were they trying to fix? Quality? That wasn't the way to do it, it's going to get much worse. Cost? Oh yeah, they sure did that. Accessibility? If nobody can make $$, nobody's gonna do HST, and there goes your accessibility. Those profit mongers are simply going to look for another source of revenue.

Like selling homemade jellies, jams, and mask headgear.

OK, I do know of some folk who are making $$ handing out a heap of HSTs every night and instantaneous results in the AM ("Do you want a donut with that? Drive ahead to the next window").

I'll be glad to tell you where they are.

On second thought, actually I wouldn't.

my frozen pizza is finally ready...

Wanna trade? I got tuna fish with oatmeal and peanut butter.

Again.

SAG

[-SWS]

First and foremost, at least in my mind, is that highly common scenario of patients simply being unable to sleep in a PSG environment. That lab environment may be well "controlled" but those controls are worthless if they impose enough artifact that the patient can't even sleep. You simply can't measure sleep if it doesn't occur or happens to present data in a grotesquely distorted manner---by the physically and psychologically imposed artifacts of the measurement process itself.

But the problem there is that the great majority of HST technology doesn't measure sleep, they're OSA screeners. Not a lot of people are going to use Level II devices for HST because of the expense involved and the high probability of insufficient data when all the Exx leads fall off and there's nobody to replace them (I would offer that if somebody can't sleep in the sleep laboratory, they're probably not doing all that well at home, jumping around all night, and you'll end up with zero data).

If you're sure you're an OSA patient, then HST has a purpose. If you're co-morbid, then there's going to be a problem.

Well, I absolutely agree with that assessment... with the possible exception of PSG non-sleepers being approximately as predisposed to being HST non-sleepers. That statement may very well be true, despite my very strong hunch telling me the opposite. I was very close to being a PSG non-sleeper during what should have been my first split-night study. I self imposed sleep deprivation to ensure adequate sleep during my followup PSG titration. They nailed my pressure perfectly.

But I subscribe to the venerable Dr. Dement's views about this topic. I happen to think the in-lab PSG is head-and-shoulders above all other diagnostic methods---and yet is far from being infallible for an entire variety of reasons. On that basis diagnostic alternatives are necessary. The inherent risk that you correctly point out IMO is that those diagnostic alternatives are all too quick-and-easy to administer----virtually guaranteeing too many instances of that reckless cash cow approach. That, in turn, is going to guarantee instances of medical disaster.

Force the PSG as the only diagnostic method, and many patients will lose out in a far less-than-ideal diagnostic process IMO. Allow for easy-to-exploit HST, and yet other patients will lose out in the diagnostic process for altogether different reasons. These are growth pains of sleep medicine IMHO, and both less-than-perfect options entail the classic makings of a dilemma. Currently there is no perfect diagnostic option IMHO---not even close. And for better or worse, even sleep medicine's general direction is guaranteed to operate on the laissez-faire principle, given no clear-cut best consensus solution: some key players will perpetuate one less-than-perfect action or policy while another group of key players will perpetuate the other less-than-perfect approach.

my frozen pizza is finally ready...

Wanna trade? I got tuna fish with oatmeal and peanut butter.

Again.

SAG

When my wife and I were first married she almost always chose where to eat out for breakfast---only because all the restaurant choices sounded so darn viable to me. Regardless, I always held it over my wife's dear head that I was simply holding out until I could finally locate a restaurant that served my choice of breakfast foods: fried chicken, cigars, and grape juice---that latter choice only because one can never be too health conscious these days. Never did find that restaurant... thank God! She probably would have gladly called my bluff.