Deregulating CPAP Equipment
By Andrew Senske, President CPAP-Supply.com
Last Updated 9/15/2009 1:33:00 PM


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
www.cpap-supply.com

CPAP-Supply.com is a leading online retailer of CPAP equipment. Located in Spokane, WA CPAP-Supply.com has been serving thousands of customers around the world since 2001. Founded on a belief that patients are their own best primary care providers, CPAP-Supply.com understands the importance of educating patients and customers on both the effects of and treatment for obstructive sleep apnea. For more information visit CPAP-Supply.com or call toll free 1-888-955-2727.