Do you need a perscription to purchase a CPAP device

General Discussion on any topic relating to CPAP and/or Sleep Apnea.
RJB

Do you need a perscription to purchase a CPAP device

Post by RJB » Thu May 11, 2006 3:25 pm

Years ago I was diagnosed with sleep apnea. But I never did anything about it. Can I purchase a CPAP machine without a DR prescription.


User avatar
Snoozin' Bluezzz
Posts: 596
Joined: Sat Mar 18, 2006 4:12 pm
Location: Northeast Illinois

Post by Snoozin' Bluezzz » Thu May 11, 2006 3:28 pm

From a reputable provider? - Nope.

From the guy on the street or at a Yahoo auction? - Yep.

Caveat Emptor

SB

User avatar
Linda3032
Posts: 2255
Joined: Tue Nov 29, 2005 6:50 pm
Location: Georgia

Post by Linda3032 » Thu May 11, 2006 3:54 pm

See the answer above...

What you are thinking of doing is very risky, but if you're determined to do it, be careful.

To further that, if you find one on Yahoo or Ebay, be sure you get an Auto cpap and software. Then you can set the auto wide open and watch the software to see what your ideal pressures are.

Sleep Apnea isn't something to be taken lightly.


_________________
Machine: DreamStation Auto CPAP Machine
Humidifier: DreamStation Heated Humidifier
Additional Comments: Compliant since April 2003. (De-cap-itated Aura).

User avatar
tomjax
Posts: 1093
Joined: Mon Feb 14, 2005 1:20 am
Contact:

rx cpap

Post by tomjax » Thu May 11, 2006 5:36 pm

This is a very uncertain topic. imho.

Prescriptions have a very specific definition as contrasted to an ORDER.

Look at your bottle of medicine from the drugstore- the mfg container. It says- Rx only or the :Caution: federal law prohibits-------------

.
Now look at your cpap box or any mask. It refers to an ORDER.
Drugs are prescribed, tests and DME are ordered.
DME are not licensed to dispense an RX. Pharmacies are.

Goto the FDA site and put in cpap:
http://www.accessdata.fda.gov/scripts/c ... cation.cfm

One other site refers to assisted breathing devices that is an anesthesiololgy device, not a cpap.

I contend, and this is my opinion, that no laws are violated for the sale of a cpap. DMEs cover themselves by requiring a RX, but I think this is an evolved POLICY, rather than established law.
I could be wrong, but I have never had anyone show me verse and chapter that prohibits such.
I have written to several mfg and they also cannot be specific.

It is POLICY to require a RX to set the pressure, and this protects the DME.

Even fda personnel will say it requires a RX, but the IRS gives incorrect advice about half the time.
SHOW ME THE LAW.


Guest

Have a friend on APAP?

Post by Guest » Thu May 11, 2006 5:57 pm

If you can find a family member or good friend who has valid prescription for CPAP or APAP I would bet that they would order you one from a reputable suplier. I don't believe that a prescription is only good for one machine.


Guest

Post by Guest » Thu May 11, 2006 7:06 pm

First of all, since it has been years since your sleep study, you should have another one. A lot could have changed. It would be good to know your AHI, what your oxygen desats are, if you experience PLMs, if you have obstructive or central apnea, your titrated pressure, etc.

Secondly, I agree with Linda:
Linda3032 wrote:What you are thinking of doing is very risky, but if you're determined to do it, be careful.
in that buying a machine via the auctions could be risky business because you don't know the quality or condition of the machine.

But as for initiating treatment on your own with use of an auto-titrating machine; I wouldn't consider that risky at all. During the Q & A session at the "Catching Our Breath: Reflections on Diagnosis and Treatment of Obstructive Sleep Apnea" lecture held in Washington DC last spring where the speaker was Dr. David M. Rapoport, founder and director of the New York University Sleep Disorders Center and Director of the NYU Sleep Medicine Program, the ResMed rep said:
Cpap is as dangerous as a bowl of cereal. The only way that it could hurt you is if someone picked the damn thing up and hit you over the head with it.
Amazing admission, isn't it? This, from the representative of a manufacturer of CPAP machines!

If you acquire an auto machine (and the accompanying software) and do this on your own, come back to this forum for help. There are plenty of people who can assist you in getting the best possible treatment from your machine.


User avatar
Snoozin' Bluezzz
Posts: 596
Joined: Sat Mar 18, 2006 4:12 pm
Location: Northeast Illinois

Post by Snoozin' Bluezzz » Thu May 11, 2006 8:06 pm

I wasn't addressing risk or pros and cons. Just how it works. As the business stands now a reputable provider will not sell you a CPAP without a prescription. Whether it is a matter of illegality or liability protection practice I can not say.

Not buying from a reputable provider earns the proviso Caveat Emptor.

Using someone elses prescription would enable you to buy from a reputable provider. I doubt I would give someone my prescription to do this but if you find someone that would - go for it.

If you do this get an auto with software and study up on how to self titrate and monitor your therapy.

Good Luck

SB


Guest

Re: Do you need a perscription to purchase a CPAP device

Post by Guest » Thu May 11, 2006 9:24 pm

RJB wrote:Years ago I was diagnosed with sleep apnea. But I never did anything about it. Can I purchase a CPAP machine without a DR prescription.
RJB- How many years ago were you diagnosed with sleep apnea? Do you have your sleep study report?


User avatar
Moogy
Posts: 434
Joined: Sat Mar 04, 2006 12:32 pm
Location: a ranch in west Texas

Post by Moogy » Thu May 11, 2006 9:29 pm

You need a prescription, but you don't NECESSARILY need another expensive sleep study. If you have a primary care doctor who is willing, he/she can write you a prescription for an automatic cpap. They might not be willing, but you can try.

Moogy

Moogy
started bipap therapy 3/8/2006
pre-treatment AHI 102.5;
Now on my third auto bipap machine, pressures 16-20.5

chdurie2
Posts: 642
Joined: Fri Mar 03, 2006 8:25 pm
Location: New Jersey
Contact:

Post by chdurie2 » Thu May 11, 2006 10:08 pm

tom:

actually, the link you show shows that it is law--it's Title 21 of the USC--that's federal law. a regulation, which is part of a title to the US Code, is a clarification/amendment/later specification, and it carries the force of law.

if you ever have to fight an IRS matter in court, since you brought up the IRS, just try telling the judge that your alleged infraction was only the subject of a regulation and not the law, and see how far you get. (nowhere.)

so yes, it is mandated by law. and if you get a friend or relative to use their prescription to get you a machine, and you should injure yourself with that machine somehow, you both could be liable for criminal negligence and other not-nice things. it probably wouldn't go that far, but you never know...

caroline


_________________
Mask
Additional Comments: Large mask collection
caroline

User avatar
tomjax
Posts: 1093
Joined: Mon Feb 14, 2005 1:20 am
Contact:

Post by tomjax » Thu May 11, 2006 10:13 pm

[quote="chdurie2"]tom:

actually, the link you show shows that it is law--it's Title 21 of the USC--that's federal law. a regulation, which is part of a title to the US Code, is a clarification/amendment/later specification, and it carries the force of law.

-- Please show me the part that says PAP requires a prescription


chdurie2
Posts: 642
Joined: Fri Mar 03, 2006 8:25 pm
Location: New Jersey
Contact:

Post by chdurie2 » Thu May 11, 2006 10:37 pm

tom:

the website says that a cpap is a class II medical device and...

In addition, classification is risk based, that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.


As indicated above all classes of devices as subject to General Controls. General Controls are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and III.


That's as much legal research as I'm willing to do for you tonite. I'm not willing to go through sections 800-890 of Title 21 to find it. If you want to try to argue to a judge that a cpap does not require a prescription when even a pair of crutches does, and that a prescription is different from an order, go for it.

Caroline


_________________
Mask
Additional Comments: Large mask collection
caroline

Guest

Post by Guest » Fri May 12, 2006 12:36 am

You got me curious. I looked high and low and couldn't find CPAP mentioned anywhere. The closest I can come is PEEP in the anesthesiology section. (Located under Subpart F-Therapeutic Devices. Code 868.5965)

Part 868/Anesthesiology Devices
§868.5965 Positive end expiratory pressure breathing attachment.
(a) Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.

(b) Classification. Class II (performance standards).

wabmorgan
Posts: 395
Joined: Sat Apr 29, 2006 10:46 pm
Location: Southfork Ranch, Braddock County, Texas ;-)
Contact:

Post by wabmorgan » Fri May 12, 2006 2:09 am

Currently you DO need an Rx.... however... the FDA has AutoCPAP under consideration for sale without an Rx.

reval
Posts: 46
Joined: Thu Mar 30, 2006 12:56 pm
Location: The Netherlands

Post by reval » Fri May 12, 2006 2:31 am

On my PB420e (and the box that contained it) is an inscription that reads Rx only.
(Of course, in country that completely irrelevant, different laws, but that's something else)