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Re: Death By Medical Bureaucracy

Posted: Tue Jul 14, 2009 1:36 pm
by El Pap
raylo wrote: I can't think of too many other situations this policy could legitimately be meant to address, without going to the type of situations alnhwrd described in that very funny post.

Is there big trade in illicit machines? Unless you have a black market machine, why else would you by a mask without a prescribed machine?

I can understand a prescription for a machine, which "should " require accurate, detailed, and timely explanation of use from a medical professional such as a doctor. Once you have the machine, is there any real threat to having an alternate mask?
If you have a prescription for a machine, you can use that prescription to buy as many masks, machines and humidifiers as you can afford. Not to beat a dead horse, but I believe the intent is simply to ensure that patients suspected of having sleep apnea are diagnosed and treated by licensed medical professionals. This is no different than their stance on the diagnosis and treatment of other serious chronic conditions like hypertension, diabetes, heart disease, etc.
Anyway, how many people actually recieved accurate, detailed, and timely explanation of use from a medical professional such as a doctor before their first night on CPAP? How many got something closer to slap it on, don't change anything, and don't ask any questions? How many actually saw a doctor or prescription before they recieved a machine?
My primary care doctor referred me to the pulmonologist that read the results of my sleep study. He either didn't notice (or didn't care) that I didn't have any REM or deep sleep during the titration phase of my split night study and prescribed a pressure that was much too low (based on the small amount of predominantly stage II sleep I had during titration). He also failed to order a humidifier. The folks on alt.support.sleep-disorder encouraged me to ask for a second (titration) study, a heated humidifier and a better mask. I did, was titrated correctly, and finally started getting benefit from my treatment. The pulmonologist deferred to the DME to show me how to use the equipment, and I felt the RT from Apria did a great job showing me how to use and clean the equipment. I should also mention that the PSG tech that did my second study was himself an OSA patient, and gave me loads of useful tips and advice.

Now that I've shared my story, I come back to the same place: I don't think the knowledge that some doctors are providing less than stellar care is going to convince the medical board at the FDA that people should be treating this condition on their own.

Re: Changes To CPAP.com Prescription Policy

Posted: Tue Jul 14, 2009 1:47 pm
by ricochetv1
I, personally, feel that people would gain the best benefit by using an APAP to titrate themselves, using the readings from various nights of experimentation to find the sweet spot in their air pressures, and using the doctor as a check-n-balance

Re: Death By Medical Bureaucracy

Posted: Tue Jul 14, 2009 2:12 pm
by raylo
El Pap wrote:
raylo wrote: I can't think of too many other situations this policy could legitimately be meant to address, without going to the type of situations alnhwrd described in that very funny post.

Is there big trade in illicit machines? Unless you have a black market machine, why else would you by a mask without a prescribed machine?

I can understand a prescription for a machine, which "should " require accurate, detailed, and timely explanation of use from a medical professional such as a doctor. Once you have the machine, is there any real threat to having an alternate mask?
If you have a prescription for a machine, you can use that prescription to buy as many masks, machines and humidifiers as you can afford. Not to beat a dead horse, but I believe the intent is simply to ensure that patients suspected of having sleep apnea are diagnosed and treated by licensed medical professionals. This is no different than their stance on the diagnosis and treatment of other serious chronic conditions like hypertension, diabetes, heart disease, etc.
Anyway, how many people actually recieved accurate, detailed, and timely explanation of use from a medical professional such as a doctor before their first night on CPAP? How many got something closer to slap it on, don't change anything, and don't ask any questions? How many actually saw a doctor or prescription before they recieved a machine?
My primary care doctor referred me to the pulmonologist that read the results of my sleep study. He either didn't notice (or didn't care) that I didn't have any REM or deep sleep during the titration phase of my split night study and prescribed a pressure that was much too low (based on the small amount of predominantly stage II sleep I had during titration). He also failed to order a humidifier. The folks on alt.support.sleep-disorder encouraged me to ask for a second (titration) study, a heated humidifier and a better mask. I did, was titrated correctly, and finally started getting benefit from my treatment. The pulmonologist deferred to the DME to show me how to use the equipment, and I felt the RT from Apria did a great job showing me how to use and clean the equipment. I should also mention that the PSG tech that did my second study was himself an OSA patient, and gave me loads of useful tips and advice.

Now that I've shared my story, I come back to the same place: I don't think the knowledge that some doctors are providing less than stellar care is going to convince the medical board at the FDA that people should be treating this condition on their own.
I agree that people should not be treating it on their own either. I guess one of the things I was trying to say was that their must be a pretty small percentage of people engaged in illicit CPAP use, small enough that regulating mask or maks part sales by asking for prescriptions seems unnecessary. I found it just very cumbersome that a local DME, when I was searching for a particular nasal pillow (not the mask, but the cushion part) told me I would need my prescription. Difficult if a piece breaks on travel and one needs to find a DME. Out of luck unless you carry the prescription everywhere.

My other point in my rant, is that through all of this red tape, many of us, unfortunately aren't getting much more from the medical professionals than we would get on our own, except the machine and the original setting. I never talked to a doctor from my primaray's referral until I had been using the machine for 6 weeks. I did learn how to put a mask on and turn the machine on. I didn't get to talk over options for therapy or machines. I didn't get to ask many relevant questions that the people I did see could answer. I got more information from here.

Let me see if I can clarify my point this way, I don't think that requiring people to show that they have a prescription at some point in order to buy a maks is going to do much to increase the patient/doctor treatment collaboration for CPAP therapy (which is an admirable goal, I'm lucky to have a doc that when I do see him he and I discuss my treatment). It probably just means more harried phone calls from patients to doctor offices begging for a copy of their prescription, that is in a file somewhere.

I'd be much happier if there was a rule that you had to have a real session with a doctor (timely) after titration and before prescription and a real, effective counseling session with a knowledgeble CPAP vet. Then let us buy masks.

Then the feds can swoop down on the illegal machine trade and put all the buyers into our new effective and cheap national healthcare plan where xPAPS are plentiful and cheap. (Some parts of this post were written in my own little dream world )

Re: Changes To CPAP.com Prescription Policy

Posted: Tue Jul 14, 2009 2:44 pm
by BlackSpinner
Probably the biggest reason americans do self titration is to avoid loosing their insurance, because if they are officially diagnosed with OSA they might never get insurance again.

http://www.docudharma.com/diary/14728/t ... ps-growing

Re: Changes To CPAP.com Prescription Policy

Posted: Tue Jul 14, 2009 2:53 pm
by ricochetv1
There is one big misconception in American insurance I'd like to clear up, at least when it comes to the health insurance you get through employer group plans...
Pre-existing conditions are generally not covered if, and only if, you have not received (billable) care for it in the past X# of months, usually 6.

Re: Changes To CPAP.com Prescription Policy

Posted: Tue Jul 14, 2009 5:08 pm
by 6PtStar
El Pap wrote:
ricochetv1 wrote:To be honest, I'm afraid I'd be scared to get one of those implantable defribulators. I'm scared it'd go off every time I go through a toll booth.
My boss had an ICD prior to his heart transplant. After it went off the first time, he walked around scared ****less it would go off again. Apparently it's a VERY unpleasant sensation. Then again, it beats the alternative of dieing from an arrhythmia in your sleep or while waiting for medical help to arrive.
I got one of those infernal devices planted in my chest last September but mine has the built in clock also. Yes, I have been scared of setting it off. The folks that I have talked to that have set them off (not when needed) tell me it feels like someone hit you in the chest with a baseball bat. I did not know so many things could effect it. As I was leaving the hospital they gave me a book of all the things that can mess with it. I also went to the Metronics web site and read about it. Not supposed to get closer to an electric motor than 12", can't carry my cell phone in my shirt pocket, don't loop your ear buds from your Ipod over your shoulders, don't put your head under the hood of your car with the motor running, don't use a chain saw or gas weed wacker, don't weld with an arc welder, don't stop between the security panals at the department store, I could go on and on. So far I have not set mine off YET!! Don't know if the toll booth will set it off, going to have to research that one!!

Jerry

Re: Changes To CPAP.com Prescription Policy

Posted: Tue Jul 14, 2009 7:04 pm
by Ardy
So how does Amazon do it?You can order masks and machines without a script.I did it last week.Just hasn't caught up with them yet?

Re: Changes To CPAP.com Prescription Policy

Posted: Tue Jul 14, 2009 7:23 pm
by 6PtStar
Ardy wrote:So how does Amazon do it?You can order masks and machines without a script.I did it last week.Just hasn't caught up with them yet?
More than likely it has not caught up with them YET because they are not a major machine supplier!!!

Jerry

Re: Changes To CPAP.com Prescription Policy

Posted: Wed Jul 15, 2009 6:20 am
by El Pap
ricochetv1 wrote:I, personally, feel that people would gain the best benefit by using an APAP to titrate themselves, using the readings from various nights of experimentation to find the sweet spot in their air pressures, and using the doctor as a check-n-balance
With the possible exception of indigent patients without insurance, I feel the process should start with a full in-lab PSG diagnosis and titration. It's the only way your doctor can get a full picture of what is happening at night; OSA might be accompanied by restless legs syndrome, REM behavior disorder, or some other sleep-related comorbidity. Initial titration is also best done in a lab. The PSG can show whether centrals are occurring and under what conditions, whether pressure changes are causing arousals, and a plethora of other things that can be observed directly in the lab but only guessed at with an APAP titration.

Of course once the patient has the equipment in home and has acclimated to therapy, using an APAP or efficacy data from a CPAP to refine the lab titrated pressure is a fine idea.

Oh, and one more thing before I step off my soapbox. I strongly believe the FDA should ban the sale of CPAP machines that don't track efficacy data. The cost of this technology has dropped to the point where the small bump in price is easily justified by the higher standard of care these machines provide.

Re: Changes To CPAP.com Prescription Policy

Posted: Wed Jul 15, 2009 7:25 am
by ricochetv1
Don't know if the toll booth will set it off, going to have to research that one!!
Well, they use those RFID cards here for people to use the express lanes. You're going through a strong EM field that powers the transmitter on the card... passing right through it.... same kind of field an eletric motor gives off, thus the instructions not to get within 12" of one...

Re: Changes To CPAP.com Prescription Policy

Posted: Wed Jul 15, 2009 1:20 pm
by roster
El Pap wrote: ........ I feel the process should start with a full in-lab PSG diagnosis and titration. It's the only way your doctor can get a full picture of what is happening at night; OSA might be accompanied by restless legs syndrome, REM behavior disorder, or some other sleep-related comorbidity. Initial titration is also best done in a lab. The PSG can show whether centrals are occurring and under what conditions, whether pressure changes are causing arousals, and a plethora of other things that can be observed directly in the lab but only guessed at with an APAP titration.

...........
El Pap,

That's no soap box, that is Fantasy Island if you think we can build the resources to do an in-lab PSG for every one who needs one. Because,
the traditional model of care -- involving specialist physicians and overnight polysomnography on at least two occasions -- is leading to a shortage of resources.
And so far only the "tip of the iceberg" has been referred to sleep labs. Wait until the medical profession figures out more than half of the population has SDB. The system will be totally overwhelmed.

Nurse-led care will come on strong and even simpler methods will come behind that.
Nurse-Led Care for Sleep Apnea Passes Muster
By Michael Smith, North American Correspondent, MedPage Today
Published: March 06, 2009
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.


ADELAIDE, March 6 -- A simplified model of care for obstructive sleep apnea led by nurses is as effective as the traditional physician-guided model, researchers here said. Action Points
--------------------------------------------------------------------------------

Explain to interested patients that obstructive sleep apnea is usually diagnosed and treated by specialist physicians using the resources of a sleep lab -- a model of care that is expensive and time-consuming.


Note that this study evaluated a simplified model of care, led by nurses, and found results equivalent to the traditional model.
In a randomized noninferiority trial, the two models had nearly equivalent results in terms of improvement on the Epworth Sleepiness Scale, according to Nick Antic, M.B.B.S., Ph.D., of the Adelaide Institute for Sleep Health, and colleagues.


The nurse-led model also cost $722 less per patient, Dr. Antic and colleagues reported in the March 15 issue of the American Journal of Respiratory and Critical Care Medicine.


"While we were not surprised at this finding," Dr. Antic said, "we were very pleased, as it indicates a robust new avenue for providing better access to sleep services for those with moderate-to-severe (obstructive sleep apnea) in a timely yet cost-effective fashion without sacrificing patient outcomes."


Dr. Antic and colleagues said they undertook the study because the prevalence of moderate-to-severe sleep apnea is likely to rise in lockstep with the epidemic of obesity.


At the same time, the traditional model of care -- involving specialist physicians and overnight polysomnography on at least two occasions -- is leading to a shortage of resources.


In this study, they compared the traditional model with a system in which patients referred to the sleep center were supervised by a specialist nurse.


Home autotitrating positive airway pressure machines were used for four nights to find the appropriate fixed pressure for continuous positive airway pressure (CPAP).


During the trial, the nurse dealt with CPAP complications and referred patients to a specialist physician as needed.


Patients were recruited for the trial from a group referred to three Australian sleep centers for possible obstructive sleep apnea. Those eligible had overnight home oximetry and were randomized if they had a greater than 2% dip in blood oxygen readings more than 27 times an hour.


All told, 195 patients were assigned to one of the two treatment arms and followed for three months. The primary outcome was change on the Epworth Sleepiness Scale, but researchers measured other outcomes, including general health, neurocognitive function, and patient satisfaction.


After three months, the researchers found, patients in the nurse-led arm had an average improvement of 4.02 on the sleepiness scale, compared with 4.15 in the physician-led arm.


The mean difference of -0.13 was within the preset margin of noninferiority, the researchers said.


There was also no significant difference in:


Average sleep latency as measured by the Maintenance of Wakefulness Test
Any of the quality of life indices
Adherence to CPAP
Executive neurocognitive function

In neurocognitive maze completion tests, the two groups exhibited no difference in the change from baseline.


At the end of the trial, the number of mazes completed in eight minutes fell by 2.1 and 1.2 in the nurse- and physician-led models, respectively. But the decline was accompanied, the researchers found, by a "marked reduction" in the number of errors -- 33% and 27%, respectively.


They wrote that "we believed it important for the specialist nurse to be able to cross-consult under circumstances in which they were uncertain about the management of the patient. Twelve of 100 patients had a sleep physician review as a result of unsatisfactory progress in model A. Nine of these reviews were a once-only consultation."


Once informed consent was provided, only 22% of patients met the inclusion/exclusion criteria. Dr. Antic and colleagues noted that the study drew from patients already thought to be at risk for sleep apnea, so that the diagnostic criteria might have to be adjusted to suit other settings.


They added that the benefits of nurse-led care may not generalize to a less severely-affected patient population.


They also noted that "it is possible that the favorable findings of the current study may have depended on the specific combination of diagnostic and therapeutic equipment used, and may not be replicated if different technologies are used."



The study was supported by the National Health and Medical Research Council of Australia. Oximeters were donated by Masimo, of Irvine, Calif., and CPAP equipment was loaned by ResMed, of Sydney, Australia. Dr. Antic reported financial links with Respironics, ResMed, and Masimo.



Primary source: American Journal of Respiratory and Critical Care Medicine
Source reference:
Antic NA, et al "A randomized controlled trial of nurse-led care for symptomatic moderate-severe obstructive sleep apnea" Am J Respir Crit Care Med 2009; 179: 501-508.

http://www.medpagetoday.com/Pulmonary/S ... ders/13156
I like your other ideas, but you need to rethink this one.

Regards,

Re: Changes To CPAP.com Prescription Policy

Posted: Wed Jul 15, 2009 3:22 pm
by El Pap
rooster wrote: That's no soap box, that is Fantasy Island if you think we can build the resources to do an in-lab PSG for every one who needs one. Because,
the traditional model of care -- involving specialist physicians and overnight polysomnography on at least two occasions -- is leading to a shortage of resources.
It's the traditional model because it has been proven effective in diagnosing and treating many thousands of patients over the years. The model in the article will save money, but will it compromise outcomes? The study in the article didn't find a difference -- but it's a small study (195 patients) with carefully selected participants. I'm sure there will be more studies and I'll be anxious to see if they replicate the results of this one.
And so far only the "tip of the iceberg" has been referred to sleep labs. Wait until the medical profession figures out more than half of the population has SDB. The system will be totally overwhelmed.
More than half the population? Do you have a source for that? I don't doubt that the number we frequently see cited in articles (e.g. 4% of women and 9% of men) is a gross underestimate, but I've never seen anyone make the claim that it's higher than 50% in the general population.

Re: Changes To CPAP.com Prescription Policy

Posted: Wed Jul 15, 2009 3:42 pm
by roster
El Pap wrote: ........
It's the traditional model because it has been proven effective in diagnosing and treating many thousands of patients over the years. ............
It has not proven effective. People in droves stay away from sleep labs and avoid diagnosis and people in droves fail miserably at CPAP.
El Pap wrote: ........
More than half the population? Do you have a source for that? I don't doubt that the number we frequently see cited in articles (e.g. 4% of women and 9% of men) is a gross underestimate, but I've never seen anyone make the claim that it's higher than 50% in the general population.
Stay tuned. Science requires scientific proof. It may take another five to ten years for scientists to figure this out.

A few doctors have figured it out already. viewtopic/t43482/viewtopic.php?f=1&t=43 ... 42#p385542

Re: Changes To CPAP.com Prescription Policy

Posted: Wed Jul 15, 2009 5:44 pm
by El Pap
rooster wrote: It has not proven effective. People in droves stay away from sleep labs and avoid diagnosis and people in droves fail miserably at CPAP.
It's effective in that it accurately identifies all of their sleep disorders -- not just OSA, but CSA, complex/mixed apnea, RLS, PLM, etc., and gives visibility to problems (e.g. pressure related centrals) that can only be guessed at when attempting to titrate with an APAP. And it's essential in diagnosing many cases of UARS, where arousals can occur with mild flow limitations not severe enough for an APAP to notice.

You can't blame the protocol because people stay away in droves; people avoid colonoscopies like the plague, but doctors use it because it's more effective than less invasive measures at identifying colon cancer and its precursors. (And I'd undergo a month of nightly sleep studies to avoid a single colonscopy! )

People fail at CPAP for many reasons, the only one that can even remotely be blamed on the PSG protocol is an incorrectly titrated pressure. But as I said earlier, I think it's crazy that the FDA hasn't mandated that all CPAP machines track efficacy data, since I consider follow-up to ensure that the treatment is actually working (and fine tuning the titrated pressure if it isn't) an essential part of treating this condition.
rooster wrote:
El Pap wrote: ........
More than half the population? Do you have a source for that? I don't doubt that the number we frequently see cited in articles (e.g. 4% of women and 9% of men) is a gross underestimate, but I've never seen anyone make the claim that it's higher than 50% in the general population.
Stay tuned. Science requires scientific proof. It may take another five to ten years for scientists to figure this out.

A few doctors have figured it out already. viewtopic/t43482/viewtopic.php?f=1&t=43 ... 42#p385542
Hey, if that old lady and her country doctor say it, it must be true.

Re: Changes To CPAP.com Prescription Policy

Posted: Wed Jul 15, 2009 6:24 pm
by roster
El Pap,

I think we are mostly in agreement in the details, but as a country boy myself, looking at the big picture, I consider the diagnosis and treatment of SDB is a huge flop in the population in general. I hope we live long enough to see new, inexpensive and easy methods of diagnosis and treatment become universal.

Regards,