Mask Need a Script?

[pitrow]

Well then I guess you better call up the surgeon general and ask... since apparently nothing else is going to satisfy you, since it's all just a consipiracy.

[Otter]

You should see if you can file a complaint against that DME with whoever regulates them. I wouldn't be surprised if there are legal requirements that anyone allowed to fill a prescription is required to fill that prescription.

Imagine if a pharmacist said "I refuse to fill this insulin prescription because I think I know more than your doctor."

Sounds a lot like practicing medicine without a license, eh?

[LinkC]

Masks are Class II Medical Devices. They require a prescription.

If you really need to see the regulations/definitions, you can find them at http://www.fda.gov. (You'll need to bounce around a bit to see that masks are Class II, and that Class II requires a prescription. It not all on one page. Here's a good place to start: http://www.fda.gov/MedicalDevices/Devic ... efault.htm)

Or you can take the word of an online supplier:
http://1800cpap.com/cpap-machine-mask-p ... olicy.aspx

[Otter]

The FDA requires a script to purchase a mask.

Is that true, or is that another rumor like "it's illegal to adjust your own CPAP machine?"

I think it is a bit silly, but I believe it's true. If it were not true, there would be at least one online DME selling masks with "NO PRESCRIPTION REQUIRED!!!" plastered all over the site.

I think the FDA has CPAP classed with all the other oxygen therapies. A doctor friend of mine (not the one who wrote my script) once told me that she killed a terminally ill patient a few days early by allowing her to turn up her oxygen. I'm not sure if that would happen with CPAP or not, but I'm willing to consider that it actually could be fatal for someone who was already extremely ill. OTOH, so could many things. Acetaminophen is orders of magnitude more dangerous than CPAP, even for people in good health, and it's OTC.

[archangle]

Or you can take the word of an online supplier:
http://1800cpap.com/cpap-machine-mask-p ... olicy.aspx

Interesting, that site indicates it's a recent change on masks. More ammunition for the medical mafia protection racket. (sigh)

[Janknitz]

I suspect many insurance companies require a prescription as well. I'm wondering if the FDA requires it.

FDA or not, no insurance company is going to pay for a mask without a prescription because that's one of the hoops you must jump through to get an insurer to pay. If your doctor didn't prescribe it, it's not a covered item with most insurers. That way they can keep from having to pay for an insured to get a mask at insurance expense to use as part of his Halloween costume

[Wulfman]

Or you can take the word of an online supplier:
http://1800cpap.com/cpap-machine-mask-p ... olicy.aspx

Interesting, that site indicates it's a recent change on masks. More ammunition for the medical mafia protection racket. (sigh)

RIIIIIIGHT! Here's a link to a post/thread from Johnny Goodman as to when it happened.......July 8, 2009.

viewtopic.php?f=1&t=43295&p=383331&hili ... on#p383331

That's when all this crap hit the fan. I always had the impression that it was ResMed trying to gum up the works (again) by urging the Feds to enforce some policy they hadn't before.

OK.......everybody can quit arguing now!!!


Den

[archangle]

I suspect many insurance companies require a prescription as well. I'm wondering if the FDA requires it.

FDA or not, no insurance company is going to pay for a mask without a prescription because that's one of the hoops you must jump through to get an insurer to pay. If your doctor didn't prescribe it, it's not a covered item with most insurers. That way they can keep from having to pay for an insured to get a mask at insurance expense to use as part of his Halloween costume

It's cheaper for me to buy the mask without insurance than with insurance.

[LinkC]

Interesting, that site indicates it's a recent change on masks. More ammunition for the medical mafia protection racket. (sigh)

Well, yes, it was "recent" at the time the page was created. But how long ago was that?

How do you suppose the FDA figures into this vast conspiracy theory that keeps you awake at night? (That's rhetorical, no need for an answer, btw...)

All we can do is turn on the light...it's up to your to open your eyes.

[rested gal]

archangle, I think you were right to question if the FDA truly includes cpap masks as items that need a prescription in the U.S.
(Answer is "Yes." )

It's smart to ask, "Is that really so?" about a lot of things to do with cpap stuff.

[Slartybartfast]

Consider this: My kids' overstuffed tomcat developed crystals in his urine. Plugged him up full and proper. Almost lost him.
Vet bill came to $2900 to unplug him and get him back on his feet. Now he's on prescription cat food. You heard me: PRESCRIPTION CAT FOOD!

Now, if the veterinary analog of the AMA is OK with their members writing scripts for CAT FOOD, how come sleep docs can't do the same for CPAP masks?

I'm sure Will Rogers must have said something appropriate about the current state of affairs, but I don't have time to look it up just now.

[archangle]

How do you suppose the FDA figures into this vast conspiracy theory that keeps you awake at night? (That's rhetorical, no need for an answer, btw...)

I'll answer anyway. It's not a conspiracy in the sense that they have an official "Medical Conspiracy Commission" that meets in secret on a regular basis. It's a system where every group involved has their own agenda which includes their own interests in addition to the interests of the general public.

The government regulator bureaucrats and politicians have self interests to add additional levels of complexity because that increases the size of their agency, their budget, and their own political power.

The professional or industry group isn't evil, but they have their own self interests. They work with the bureaucrats to justify regulations that are favorable to them. In some cases, they actually encourage unnecessary regulations because it makes it more difficult for new and efficient competitors to get into the business. If it costs millions or billions of dollars to introduce a new drug, that helps prevent a new competitor from introducing a new low cost drug that takes profit away from the existing companies.

Even if the government bureaucrats are trying to do a good job, they do meet with and work with the industry representatives all the time. They go to fancy conferences, see presentations, etc. Often paid for by the industry they're regulating.

After they leave the government, they often go to work for the industry they used to represent. Even if there is no outright bribery, there are incentives to work together and their own self interests often work in favor of each other, not in favor of the general public. This doesn't even have to be any outright corruption, either. Who better than an ex-government agency bureaucrat to help you deal with that agency? As an industry group, are you going to hire the ex-bureaucrat who fought against you at every turn, or the one who was helpful to you when he worked for the agency?

After a while, it gets to be an old boy system. They know how the other side is going to react. There is negotiation or quid quo pro. "We'll let you do X if you let us do Y. If you do Z, we'll raise a royal stink and your agency (or industry) will get a lot more public and Congressional scrutiny." They know how to manipulate each other, how far they can push things, and how they can gain from each other.

There are reasons why the drug industry and other industries spend billions of dollars each year on lobbyists, political campaigning, and government agency relations.

There's nothing that special about the medical industry in this regard. Much of the same things can be said for the regulation of Wall Street, the legal system, banking, coal, petroleum, gas, etc.

Is anyone going to suggest that our government agencies and regulatory systems are well run? Or that they aren't "in bed with" the industries they regulate? How good a job was our financial regulatory system doing keeping track of the mortgage industry, banks, and Wall Street in 2008? How well was the government agency that regulated offshore drilling doing before the BP oil spill?

It's not even unique to the USA. Many other countries have similar problems.

Read up on the history of the FDA. It's a pretty sorry story. It would take an entire web site to document their failings and incompetence bordering on corruption. The US Congress also meddles in the decisions of the FDA, for instance, allowing quack homeopathic drugs to be sold along side real medicine without any warnings on the labels.

Yes, the FDA does a lot of good stuff. I'm glad it's there. If we didn't have it, there would be a lot more dangerous drugs and medical equipment. Unfortunately, it often works against the interests of the general public. We need to understand its shortcomings and try to improve or work around it.

[Slartybartfast]

[snip]

The US Congress also meddles in the decisions of the FDA, for instance, allowing quack homeopathic drugs to be sold along side real medicine without any warnings on the labels.

[snip]

Geez, don't get me started. I've worked in pharmaceuticals the last 25 years. We've got development projects sitting on the shelf that could help a lot of folks, but the cost to push them through the development and regulatory pipeline is so enormous, they just sit there gathering dust. Not enough patients needing the drug to justify the cost. Meanwhile charlatans and quacks can be heard on the radio advising people to take this extract or that extract and follow it up with a series of coffee enemas. And when someone with a horrible disease dies because they, in desperatioin, believed the puffed claims, there seems to be no accountability.

Don't get me started . . .