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As you may know, I'm a staunch supporter of deregulating Sleep Apnea. So I was pleased to come across someone else who very eloquently makes the case for it, as I have done in the past.  Thought I'd share it with you:

Deregulating CPAP Equipment
By Andrew Senske, President CPAP-Supply.com 

Ever get a flu shot? If so, you didn't get a prescription for it. You didn't spend a night or two of being subjected to a $3,000 test to see how you might react to the flu shot. You just signed a waiver and got the shot. That's how I think it should be for CPAP equipment.
The argument for sleep studies and prescriptions from the clinical side seems to make a little sense on the surface. It goes something like this.

A sleep study must be conducted to determine the exact cause of daytime sleepiness. If the cause isn't obstructive sleep apnea and if the patient starts using a CPAP machine then the real underlying problem - perhaps central apnea - can be exacerbated. The end result of applying CPAP therapy to a patient with central apnea could be a worsening in the central apnea condition, which could lead to Cheyne-Stokes respiration and all the terrible things associated with that. In a nutshell, misapplied CPAP therapy could potentially kill someone.

Fair enough. But listen to my rebuttal before you buy in to the clinical perspective.

Risk is Common to Medical Procedures 

There are risks with just about every medical procedure in existence, and we all generally accept the risks when considering the potential benefit of the procedure. Take the flu vaccination as an example. Here's a quote from the CDC: "The risk of a flu shot causing serious harm, or death, is extremely small." The CDC continues by pointing out that "normally, about one person per 100,000 people per year will develop Guillain-Barré syndrome (GBS), an illness characterized by fever, nerve damage, and muscle weakness." That number doesn't include the number of people who will suffer or die from allergic reactions.

Even the CDC recognizes the potentially life-threatening effects of a flu vaccination, but they still highly recommend vaccinations. They recommend them without recommending any expensive studies to determine your potential reaction to the flu shot. They list factors to consider and leave the decision up to you. You and you alone get to determine whether you get a flu vaccination.

Let's call that... precedent. There's precedent in the healthcare community for allowing you to take control of your own healthcare. And that's good.

Is There a Downside?
 
You've gone to the doctor complaining about feeling tired all the time. You've mentioned to him that you sometimes doze off for a second or two while driving your car, which makes you nervous. You've said that you can't remember the last time you got a good night's rest. You may have even mentioned that your spouse sleeps in another bedroom because you're so loud and obnoxious when you're sleeping. You've begged him to figure out what's going on so you can live life normally again.

The doctor responds by saying, "You've probably got sleep apnea. You fit the profile, so I think you should try a CPAP machine. Set it at 10 and call me in the morning." (That's the new millennium take on "Take two aspirin and call me in the morning".)

So you get your hands on a CPAP machine and you give it a try for a few days, keeping in mind you basically have nothing to lose. If you don't do something to fix this problem you're going to drive your car into a tree or die of high blood pressure or heart disease. The potential benefit far exceeds the potential harm.

If after a few days nothing has changed and you still feel horrible and your spouse still won't move back into the bedroom, then the doctor might recommend a higher pressure. If after a few more days, you still don't feel like you're getting any positive results from CPAP therapy, you can continue the discussion with your doctor. If you fit the profile, though, chances are the CPAP therapy helped you and you'll continue on as a life-long CPAP user. Either way, you didn't have anything to lose and you had everything to gain.

Given a few minutes of education, the patient can run this experiment on his own without ever talking to a doctor. Sure, there's a small risk of harm. But there's a much higher risk of harm if the patient doesn't do anything at all.

Can Common Sense Ever Win?
 
Okay, so you're in the camp that thinks that no matter what anyone says a prescription should always be required for a CPAP machine. I call it "Respiratory Therapist Camp". Well then, what do you think about a CPAP mask, or a CPAP humidifier? No one would ever buy either of these items unless they already had a CPAP machine. It's just not the type of product that can be abused or misused. No one's going to be peddling CPAP masks on the corner outside your kid's school. Trust me. It'll never happen. So if a prescription is required for a CPAP machine, and only people who use CPAP machines need a CPAP mask or a CPAP humidifier, then it would be logical to conclude that whoever is buying a CPAP mask or a CPAP humidifier has - or at least had at one time - a prescription for a CPAP machine. If that's the case, why force CPAP users to supply a prescription every time they purchase a CPAP-related item. For many CPAP users, this would mean going to the doctor and paying for an office visit in order to obtain a copy of a prescription. If the doctor wants to cover his @## then he might even require one of those $3,000 sleep studies. It's all nonsense, primarily because the prescription is an unnecessary barrier that may prevent some people from getting the safe, effective CPAP therapy they need.

It might be argued that, indeed, a CPAP mask can be harmful. After all, the FDA classifies these devices as being potentially harmful. But I suggest that you could wear a nasal mask for twenty four hours a day for a year and absolutely no harm would come to you (provided you could eat and drink during that time period). What's next folks? A prescription for steak knives?

And why does the FDA classify CPAP masks as prescription devices that are potentially harmful to end users? They do it because the manufacturer checks the box that says "For Prescription Use" on the registration application. The manufacturer could check the other box that doesn't designate the equipment as requiring a prescription but they don't. I haven't figured that one out yet, but I imagine it has something to do with 1) liability, 2) Medicare and private insurance reimbursement vis-a-vis determining medical necessity, and 3) the effect of paradigms and close-minded thinking.

Healthcare Costs 

Forcing people to go to the doctor for medical devices that are not potentially harmful from a common-sense standpoint is wasteful and increases the cost of healthcare for everyone.

I spoke with a representative from the FDA on 8/18/09. I asked about prescription requirements and enforcement of FDA regulations like prescription policies. The response was "if it's not life-threatening like Class III then the FDA doesn't really focus on enforcement". The FDA representative said that the FDA is big and has to prioritize, which makes a lot of sense. CPAP equipment is Class II, which can be thought of as "medium risk". This is the very definition of bureaucracy. Even categorizing CPAP equipment as Class II is a stretch, but classifying at all if the regulations associated with the classification won't be enforced is nonsense. This bureaucracy drives up the cost of healthcare. If equipment manufacturers didn't have to spend as much time on registering harmless equipment, their costs could be reduced. If a patient doesn't have to go to the doctor for a $150 office visit, then insurance premiums go down.

And then there's Medicare...
Medicare makes beneficiaries rent a CPAP machine for 13 months - usually at around $200 or $300 per month - when the same machine could be purchased outright for $200 - $400. Medicare also requires an expensive sleep study to determine medical necessity. Medicare will not pay for CPAP equipment based on a prescription alone (I've seen it firsthand: denial by Medicare, followed by appeal and letter from the prescribing doctor, followed by another denial by Medicare). In every case the beneficiary actually has to go through a sleep study even if the beneficiary already has a prescription. The government is literally driving up healthcare costs unnecessarily.

So why not give power to the patient, just like with flu vaccinations? There's risk with every procedure, including CPAP therapy, but there's more risk in preventing people from receiving the healthcare they need. In one fell swoop we can reduce healthcare costs and make CPAP equipment readily available to everyone.

Please keep in mind we have no hidden agenda in proposing deregulation. In fact, deregulation would probably put us out of business because we can't compete with WalMart, Amazon, Walgreens and Costco - places in which over-the-counter CPAP equipment would potentially be sold. It's simply the right thing to do.

Andrew Senske

President

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Interesting line of thought. I wonder how many people there are who think they have sleep apnea and need treatment who would take advantage of deregulation. I know a lot of people sign on to the forum saying they think they have sleep apnea, or they do have sleep apnea and who are not getting treated.
Well Mike we were going to have to find some middle ground on this issue sooner or later. I agree with the poster on needing a prescription for accessories being a little much. When reading these post I am hearing more of a cost issue rather then a need issue.
i'm excited that you're willing to budge that much on this issue. i won't count on you burning the prescriptions of your patients just yet, though ;-)

Rock Hinkle said:
Well Mike we were going to have to find some middle ground on this issue sooner or later. I agree with the poster on needing a prescription for accessories being a little much. When reading these post I am hearing more of a cost issue rather then a need issue.
it is all to do with cost and liability
if they only made apap and discontinue cpap a lot of money would be make since you would still have cpap mode
secondly if these apap were set at 4-9 cm and sold as that and should the public alter the settings there could be no liabilty because the patient altered it themselves
I definitely agree with the whole argument over CPAP supplies/etc. I think that is pretty much a way for the suppliers to protect their (outrageously ridiculous) prices.

Getting on to the non-prescription CPAP...

This brings up another point though. How many xPAP users are there that have their machines set in this range (4-9). I suspect that it's not many, in fact, many of the numbers I remember reading on here are much higher. So, what is the "correct" range to use? I do not know.

So, maybe the non-prescription machines should just be APAP?

Can APAP replace all CPAP? In theory, it's a great idea. In actual practice, though, I think APAP machines are still "in development" - their algorithms don't necessarily track the patient well enough and they can't accurately determine when to kick in, how hard to kick in, etc. I know for a fact that some of the BiPAP w/ ASV machines really suck. The ASV tries to force a breathe and often incorrectly interprets what is going on.

Then, there's the whole issue of CPAP and centrals - where no centrals existed before... I don't think ANYONE really knows what's going on here (yet).

So, is CPAP as safe as Aspirin? Hmmmm - I bet a lot of people would say sure. I will simply say - I am NOT sure.

Interesting topic, though.

99 said:
if they only made apap and discontinue cpap a lot of money would be make since you would still have cpap mode
secondly if these apap were set at 4-9 cm and sold as that and should the public alter the settings there could be no liabilty because the patient altered it themselves
I think you have something here, 99. Unless I'm mistaken central apneas are more likely at pressures around and above 10. If the machines had safely limited pressures this might work.. Many OTC drugs are sold in smaller doses than prescription strength. If a pressure greater than 9 or ten was needed this would necessitate a doctors involvement, but perhaps this would be safest to prevent central apneas.

99 said:
if they only made apap and discontinue cpap a lot of money would be make since you would still have cpap mode
secondly if these apap were set at 4-9 cm and sold as that and should the public alter the settings there could be no liabilty because the patient altered it themselves
I'd like to see it deregulated, mostly because of the inept, uncaring, and neglectful way "sleep doctors" seem to treat their patients. These guys are falling down on the job -- you have to be your own doctor with them anyway.

Still, I can see the danger of folks grabbing a CPAP from Walmart, not even read the literature or know from straight up, and assume they are being helped, when they are not. Or assume it's not working.

The key is technology --we need an afforable way to monitor our oxygen overnight, and tell us about the AHIs. That's not quite here. Get an oxygen meter in the CPAP data recording machine, and we patients have powerful tools to help ourselves.
Mark Douglas said, "Still, I can see the danger of folks grabbing a CPAP from Walmart, not even read the literature or know from straight up, and assume they are being helped, when they are not. Or assume it's not working."

That certainly will happen. But is it any different than what happens today? If you read the sleep forums and talk to your friends who have sleep apnea, you know that problem exists in today's regulated market: most don't read the literature, most don't have data capability, most don't really know whether their settings are correct or not, whether they have large leaks or not, whether they are losing therapy through the mouth, etc. The regulations help the entrenched players and hurt the patients.

If we get rid of the regulatory morass and open up the market, I fully expect that public awareness and education will improve. Bring this condition and treatment out into the open. Let people see a CPAP display at WalMart. Let them look at the different models and compare prices and features. Much good will come out of that!!!

CPAP patients are victims of an oppressive government bureaucracy.
sent to me in private message from a retired RN:

Hi Mike,

They do it because they can. We need to keep the useless bureaucrats in high paying jobs. Same thing for blood glucose testing. Need a scrip. They should concentrate on fixing the system rather than concentrating on keeping their buddies in jobs.

As an aside, did you know that glucose monitoring meters can be off as much as 20%? I found that out the hard way.

Retired RN, MN

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