Why do we need a prescription for a face mask?

[LSAT]

In my 6 years on CPAP I have never had a prescription for a mask specifically. My first prescription was after my titration and it specified a machine and pressure. I used this prescription for 5 years until I wanted a new machine. The new prescription only specified an autoset and a pressure setting...nothing about a mask. My DME has never mentioned a mask prescription. I think if you are going outside of your normal DME any new DME will want a copy of a prescription for their file.

[cnaumann]

So DME's can bill you and your insurance. You shouldnt need an RX for anything but a machine in my opinion!

Insurance can cover non-prescription items. Why should you even need a prescription for a machine? They have a low potential for harm by misuse.

I can understand insurance requiring a doctor's blessing before covering the cost of a machine. Also, I think it is a really good idea to talk to a doctor before putting yourself on xPAP therapy. This is also true of most OTC meds out there. I think it is fine to buy them without a prescription, but you really should talk to a doctor at some point before taking many OTC meds long-term.

[bwexler]

You MUST have a prescription for a PAP machine and mask, because the Manufacturers of the equipment and the doctors that prescribe it have a much more effective lobby then us stupid Patients.

[Sleeprider]

The whole regulatory aspect of our CPAP therapy is baffling, but it exists as part of patient protection against dangerous machine and mask defects that could cause anything from asphyxia with injury or death, to simply ineffective therapy. As a result, the equipment is classified as a Type 2 Medical Device along with hospital ventilators, anesthesia masks and respiratory support and medical respiratory tract humidifiers. Link to FDA Product Classification http://www.accessdata.fda.gov/scripts/c ... .cfm?ID=67

Regulated medical equipment is dispensed under a prescription to prevent unapproved equipment that might be unsafe from entering the market. It's a bit of an inconvenience to consumers, but in a wide open market, you can imagine what might be attempted to be sold. While we mostly consider ourselves competent in selecting and buying equipment, the choices we are making are of approved medical devices. In a wide open system, people would self-diagnose and treat without the supervision of a physician, and would be free to purchase whatever a manufacturer would put on the market. When you consider the dangerous ramifications of that kind of system, the inconvenience of a prescription might not seem so bad.

So the real issue is not to make it harder for you to get a mask, it is to prevent the market from being flooded by unregulated, untested equipment being used to treat patients that may or may not have a diagnosed medical condition or "need". It is certainly the only structure under which insurance will pay for "medically necessary" apnea treatment. Consider exercise equipment, or diets as a model of unregulated therapy.

[Pesser]

The whole regulatory aspect of our CPAP therapy is baffling, but it exists as part of patient protection against dangerous machine and mask defects that could cause anything from asphyxia with injury or death, to simply ineffective therapy. As a result, the equipment is classified as a Type 2 Medical Device along with hospital ventilators, anesthesia masks and respiratory support and medical respiratory tract humidifiers. Link to FDA Product Classification http://www.accessdata.fda.gov/scripts/c ... .cfm?ID=67

Regulated medical equipment is dispensed under a prescription to prevent unapproved equipment that might be unsafe from entering the market. It's a bit of an inconvenience to consumers, but in a wide open market, you can imagine what might be attempted to be sold. While we mostly consider ourselves competent in selecting and buying equipment, the choices we are making are of approved medical devices. In a wide open system, people would self-diagnose and treat without the supervision of a physician, and would be free to purchase whatever a manufacturer would put on the market. When you consider the dangerous ramifications of that kind of system, the inconvenience of a prescription might not seem so bad.

So the real issue is not to make it harder for you to get a mask, it is to prevent the market from being flooded by unregulated, untested equipment being used to treat patients that may or may not have a diagnosed medical condition or "need". It is certainly the only structure under which insurance will pay for "medically necessary" apnea treatment. Consider exercise equipment, or diets as a model of unregulated therapy.

Oh boy; in Canada we are really in trouble. I can buy a mask without a prescription. And if you think that we are safe because Americans are there with their prescription requirement and that protects us; then someone has to explain why my scuba equipment is so good and so safe….huh! It does seem that everyone dislikes the CPAP paperwork.

[Sir NoddinOff]

I am not a bleeding heart liberal; just a realist who hates seeing innocent, decent, hard working people gets screwed! You "CAN" get legal supplies; even legal "NEW" machines at a quarter of the insurance allowable amount!

Please post your questions, comments, concerns or if you would like to know where to get CPAP, Bi-PAP, VPAP Machines/Supplies legally.
Ciao,
Squallie

Show me

Yeah, me too. Emphasis mine.

[balor123]

I've gotten the same run around too. Different DMEs have different policies. Seems stupid to bother a doctor for a new prescription simply to change mask types. Fortunately, it doesn't apply to the specific mask model.

That being said, I think full face masks can be used to make meth so I can see how they'd want to limit it's usage just to the people who really need it. (kidding, of course!)

[Sleeprider]

I don't think you need a new prescription just to get a mask. I have used the same prescription I got in 2008 to repeatedly refill the mask prescription. It is worded very generally so the type, brand and other mask details are not specified. In fact my prescription is "Auto CPAP with auto titration humidifier and supplies". That's it, and it has worked as a scanned copy at every online source and DME since.

[cnaumann]

Sleepyrider, you explanation makes some sense, and I promise that I will read the link you provided when I get the chance.

However:

Regulated medical equipment is dispensed under a prescription to prevent unapproved equipment that might be unsafe from entering the market. It's a bit of an inconvenience to consumers, but in a wide open market, you can imagine what might be attempted to be sold.

This is bullshit. Lets compare the situation to OTC drugs.

Can I imagine "what might be attempted to be sold"? The answer is no, I cannot. Just because we have OTC drugs, and even generic ones at that, it does not mean I can just whip up a batch of PPIs or other drugs in my basement and put them on the shelf at my local market.

What is keeping CPAP-like machines off the non-prescription market right now?

You can still have good regulation and make sure that drugs and medical devices are safe and effective without the need for prescriptions.

Heck, compare the situation to most consumer goods. Take SUBA gear. It that stuff is even slightly defective, you are dead. Yet you can get it without a prescription. Take cars. Cars are legal. You can buy them without a prescription. They are capable of causing GREAT HARM to the driver and others if built incorrectly. But defective cars are not really a major issue. Why can't the same regulations work for most DME?

People worry about all sorts of crazy thing that might happen if any kind of regulation is eased. We really are adults. We really can make big important decisions all by ourselves.

[archangle]

Needing a prescription in the US:

Apparently, big brother has harassed some sellers about selling masks without a prescription, and claimed it does require a prescription. Enforcement is variable, but some people have sold masks without a prescription in the past. Whether the law really requires a mask is open for discussion. I don't know if anyone has suffered any serious legal repercussions for selling masks without a prescription.

The mask manufacturers claim it requires a prescription. I trust them about as far as I can throw them.

Insurance:

Many insurance companies do drop coverage for certain things if they're not prescription items. For instance many drugs are dropped when they become OTC. Whether this would happen with masks is a moot point.

[Janknitz]

Back to the OP, if you use an online supplier like our hosts, you can give them the contact info for your doctor and THEY will play telephone tag and message marathon with your doctor for you.

[chunkyfrog]

Same thing I did, but I gave the doc's office a heads-up in advance.

[jacobsbd]

Its all power, control and politics. I have seen distilled water labeled as prescription only in doctors offices and hospitals

[quetzal]

The prescription requirement is a RACKET, PURE AND SIMPLE.

SHAME on the FDA for doing this to us!

[purple]

UH, Seems to me that there is a fundamental miss-understanding as to how one carries on contact with Sleep Doctors. One should not need to speak with the doctor themselves, unless he is also your golf buddy and you want to arrange tee times with him. All the sleep doctors have staff to do such things as send copies of scripts around. While the initial phone answer person may not seem so knowledgeable, the docs office usually has an RT, who can get a copy of script, or have another written from doc when necessary. Leave a message for the doc, someone should screen the docs phone requests, give it to the RT, the RT will screen it, and for minor things, it is more likely get it done faster.

Let me say, Doctor Welby has retired. Now we have a interlocking group of helpers. Which is some better and some worse.

OTC, originally was a great idea to rid ourselves of the need for prescriptions for common items. Ibuprofen being one. Now, I spend a hundred dollars a month for OTC items while if they were prescriptions, I would spend 12 dollars or so. Much less. OTC has become code for, let the individual pay the full unregulated cost for themselves.

One of those key words being regulated costs, as in insurance negotiated prices. Those prices are not something we, as single individuals could ever have the leverage to negotiate a reasonable price for some things.

I was speaking to an old retired pharmacist. He sold the five pharmacies he owned on the east coast when regulation (in his opinion) made it to hard to compete with the mega-pharmacy chains. He told me that in the early days of the statins, he paid perhaps half a cent apiece for a statin drug, and he sold thirty pills for like 120 dollars a month. He felt the actual price of pills to pharmacies had not changed, so when Wal Mart sold them for five or ten dollars a prescription they were still making plenty of money. Mega-pharmacy chains made it more profitable for the company compared to what he had been doing.

YMMV.