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Recent changes in prescription requirements from the Food and Drug Administration (FDA) classify CPAP/Bi-PAP masks and humidifiers as Class II Medical Devices.I seen this yesterday on a web site and was wondering if it means it will be more difficult to order online????

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What are they listed as now?
I am not sure now but I know most web sites for mask you do not need a script but the way this sounds when it takes affect we will all need to send in our script tp buy mask as well as the machines.
I don't know if it has to do w/the Class II Medical Devices classification or what CPAPs have been classified as up to now but I do know that some of the online DME suppliers, cpap.com being one, have notified customers and have posted at their website that prescriptions will now be required to purchase a mask. Once you have a prescription on file w/an online DME supplier I would imagine that they would keep it on file so you don't have to provide a script each time you buy mask or equipment. cpap.com has said that is what they will do.
Medical Device Classifications
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overv...

Under the current democratically controlled administration and legislative branch’s major push (or should I say force feed) to health care reform, they had not anticipated the public bash lash to which they have encountered.

As a result, they are using back room tactics and methods to which are not on the radar screen (aka Chicago style politics) to effect their desired changes.

They have initiated administrative changes to the structure of Medicare and other controllable medical programs to which do not require legislative votes (in the public's eye) to loot the programs and their effectiveness.

One such manner is thru the re-classification of medical devices, which will result in the taxation of the devices, the lowering or complete removal of coverage using current / standard health insurance standards. (see attacks on the “scooter store” and similar devices)

Once they achieve this process, they will then remove or disallow the medical coverage of the related treatments. This is but Step 1 in their process.

Hence, Sleep Apnea is no longer a covered condition.

Gotta Love the Change – O’crap !!!!!!!!
I wonder if it's a CYA move due to some threat of liability from a patient(s) who may be using equipment without proper medical diagnosis/prescription, etc., i.e., treating themselves without appropriate testing, etc. .............

Susan McCord

Judy said:
I don't know if it has to do w/the Class II Medical Devices classification or what CPAPs have been classified as up to now but I do know that some of the online DME suppliers, cpap.com being one, have notified customers and have posted at their website that prescriptions will now be required to purchase a mask. Once you have a prescription on file w/an online DME supplier I would imagine that they would keep it on file so you don't have to provide a script each time you buy mask or equipment. cpap.com has said that is what they will do.
"(see attacks on the “scooter store” and similar devices)"

"Hence, Sleep Apnea is no longer a covered condition."

Are you really comparing a scooter to a CPAP machine? I do not think that we need to worry about CPAP not being covered. Even now as we speak more and more insurance companies are expanding their coverage of sleep disorders. Case and point RERAs and UARS. Not only that, but most insurance companies have just made moves to allow for PAP-NAPS, and home studies. Insurance, medicare, and medicaid, are moving forward with SBD and other sleep disorders, not backwards. Do not believe the hype!
It isn't what I believe, you believe, are for that matter what anyone believes except those who are in the driver's seat.

The FDA, an executive branch government entity, has the keys and are driving the vehicle. The legislative branch, to whom control the purse strings, and are currently attempting to ram health care reform through, don't seem to care about much of anything by way of the majority public opinion.

In so far as comparing a scooter to a CPAP, it totally depends on where you are standing.

Do you really think health insurance companies will continue to cover CPAP, accessories, sleep testing, etc. if the FDA and the government re-classify the "medical device"? Always remember that insurance companies answer to their board of directors and the stockholders, not the patients. Every claim they pay, large or small, affects the bottom line and the only reason they exist is to make money.

Of course, the alternative to this is a governmental run health care system, which has failed in every country to which it has been implemented (based on comparison to US system). This might be why patients flock to the US for major life threatening treatments. Based on the current direction the legislative branch is going, they are attempting to pilfer Medicare coverage to justify their cause. The majority of the health insurance coverage in the US is based on Medicare coverage basics in so far as treatable conditions.

If they slowly and systematically take steps to change the Sleep Apnea standards, or any treatment for that matter, they can remove it’s coverage from all the coverage systems and there isn’t a thing you or I can do to stop them.

It isn’t the instant change, but a slow mythological shifting in the policy you have to watch out for, and this is but Step 1.
Insurance companies do have to adhere or answer to a board of directors and/or shareholders. As long as treating apnea is less expensive then treating the effects of the disorder insurance will continue to pay for PAP therapy. Think about it Dan. Which is cheaper? A PAP device or heart sugery? How about a heart replacement? These surgeries cost 10000s to 100s of thousands of dollars. Your logic is probably right. Buisinesses are run the way you say. CPAP is the cheaper alternative though. the shareholders are going to vote for the cheapest rout as you say. The sleep industry as it sits right now is safe for the next 25 years. We can only hope it will get better. My advice to you is to think of another solution. Write it down. Get it out. Not one politician whom opposes Obama's plan has offered any other solution. Bitching does not fix the current problem. We need health care reform.
Years ago I had faxed my script to two providers to buy xPAPs and I recently had to fax my script to another provider to get some masks. Although it was an inconvenience to have to fax a script, it is one-time per provider and it isn't a big thing.
new health care reform blog: http://www.healthinsurancefinders.com/blog
Has anyone seen the "fix" our government came up with for exhorbitant credit card fees?

A California bank has already taken advantage of it and is poised to offer a $250-$300 limited credit card to "help" those who need to establish credit or repair damaged credit. The interest rate on that credit card will be 79.9% LEGALLY thanks to the new government regulations "fix".

As I've said MANY TIMES before: every time "my" government does me a favor I get SCREWED!!!
shcworts and all

Judy said:
Has anyone seen the "fix" our government came up with for exhorbitant credit card fees?

A California bank has already taken advantage of it and is poised to offer a $250-$300 limited credit card to "help" those who need to establish credit or repair damaged credit. The interest rate on that credit card will be 79.9% LEGALLY thanks to the new government regulations "fix".

As I've said MANY TIMES before: every time "my" government does me a favor I get SCREWED!!!

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