Why CPAP.com Requires Prescriptions

[johnnygoodman]

Greetings All,

I do not plan on replying to this thread, though I will be reading and learning from it.

CPAP.com's position on this issue is as necessarily inflexible as the system which has forced us to implement it. Many topics are discussed on this board in an open way, a rational conclusion reached and opinions or actions changed. If you continue reading this, please know that that this has little to do with reason and everything to do with law.

The accusation has been made on CPAPtalk.com that CPAP.com is collecting prescriptions which it is not required by law to collect. The inference is that we don't really care how hard it is on you, we're going to put our head in the sand and keep marching. That is super offensive to me. We've suffered and struggled to deal with this change. We deal with it hundreds of times a day. We work hard to strike a balance between ease of shopping and complying with the rules. We do better than anyone else who does it. We will request a prescription from your doctor on your behalf in a speedy and automated fashion. However, we can't make an offer better than a company who knowingly breaks the law for short term financial gain.

Here is the path I traveled to arrive at CPAP.com Prescription Policy, from Federal to State:

1. CPAP.com follows the law to the best of our ability. This means we comply with all applicable state and federal regulations. The amount and pace of law continues to accelerate. It is a real burden on businesses and their customers. I don't believe the law makers understand or care. None the less, we follow the law and as we learn of new ones, we comply with them.

2. Federal vs State Law. In the United States, Federal preemption refers to the displacement of state law by Federal law. This is in the Constitution. Here's more on Pre-Emption: http://en.wikipedia.org/wiki/Federal_preemption

3a. The FDA is empowered by Congress to enforce section 361 of the Public Health Service Act. There have been challenges to this status, but none have been successful to point. Here's more on the FDA: http://en.wikipedia.org/wiki/Food_and_D ... _States%29

3b. Interpretation By Book: FDA Regulatory Affairs

You must comply with all the laws on each level state and federal. The Constitution and the courts prevent conflicts between the two levels of government and each level has its own “turf” so to speak.

In the US, because of the Constitution and some early decisions by the US Supreme Court, the federal government is supreme – a state must enforce federal laws and a state may not pass laws that interfere with any federal law. The state law is “preempted” by federal law.

A perfect example of preemption is the enforcement of the FDCA Federal Food, Drug, and Cosmetic Act. The federal government, acting through the Congress, established criteria that a new medical device must meet before it can be cleared for marketing and sale. The FDA has developed and issued certain regulations and applications, notably the Pre-Market Approval Application and the regulations at 21 CFR Code of Federal Regulations Part 814 Pre-Marketing Approval of Medical Devices and other related regulations. These federal laws and regulations preempt the ability of a state, to develop its own state-level requirements to market and sell medical devices.

So, Texas could not require a medical device manufacturers to prove to the satisfaction of the Texas Secretary of Health that a product under the jurisdiction of the FDCA, say a stent, is safe to use and have a separate Texas license to sell the stent.

The federal law doesn’t do away with all state requirements. Texas can still require any person doing business in the state to register, pay tax and collect sales tax on the devices sold.

Here is more from this book: http://books.google.com/books?id=HcEoe3 ... t&resnum=4

4. The FDA sets down classes of devices, which are used to determine how much risk they pose to patients and if they should be prescription controlled.

Medical Device Law -- An Overview (Deborah M. Autor, Office of Consumer Litigation, May 1996). This overview itself is not law, but it cites the laws that pin this up: http://www.justice.gov/usao/eousa/foia_ ... v00110.htm

Class II Devices - For Class II devices, the general controls applicable to Class I devices are insufficient to provide a reasonable assurance of safety and effectiveness. Therefore, in addition to general controls, FDA can establish "special controls," such as performance standards and postmarket surveillance, for Class II devices. FDCA § 513(a)(1)(B), 21 U.S.C. § 360c(a)(1)(B); see also FDCA § 514, 21 U.S.C. § 360d (establishment of, and allowable provisions for, performance standards); FDCA § 501(e), 21 U.S.C. § 351(e) (failure to comply with an applicable performance standard renders a device adulterated); FDCA § 502(s), 21 U.S.C. § 352(s) (a device that does not bear the labeling required by a performance standard is misbranded). An example of a Class II device is a CAT scan system. See 21 C.F.R. § 892.1750.

Here is more from wiki on Class II devices: http://en.wikipedia.org/wiki/Medical_de ... l_Controls

5. The FDA sets down in 510k approvals what class a specific product is and if that product is prescription or not.

All CPAP Machines, Masks and Humidifiers I've seen in 510ks are listed as Class II, Prescription Required. Here are some googled examples:

http://www.accessdata.fda.gov/cdrh_docs ... 041309.pdf (Mask: Page 4 Class II, Page 6 Prescription Use Per 21 CFR 801 Subpart D)

http://www.accessdata.fda.gov/cdrh_docs ... 050359.pdf (Mask: Page 3 Class II, Page 5 Prescription Use Required)

http://www.accessdata.fda.gov/cdrh_docs ... 082605.pdf (Machine: Page 3 Class II, Page 5 Prescription Use Required)

http://www.accessdata.fda.gov/cdrh_docs ... 080797.pdf (Humidifier: Page 1 Class II, Page 5 Prescription Use Required)

6. To sell devices in Texas, one must have a medical distributors license, here are prescription requirements for license holders

Prescription Requirements For Texas Device Distributors

(k) Distribution of prescription devices.

(1) A prescription device in the possession of a device distributor or manufacturer licensed under these sections of this subchapter is exempt from Health and Safety Code, §431.112(f)(1), relating to labeling bearing adequate directions for use, providing it meets the requirements of 21 CFR, §801.109, titled “Prescription devices” and 801.110, titled “Retail exemption for prescription devices”.

(2) Each device distributor or manufacturer who distributes prescription devices shall maintain a record for every prescription device, showing the identity and quantity received or manufactured and the disposition of each device.

(3) Each device distributor or manufacturer who delivers a prescription device to the ultimate user shall maintain a record of any prescription or other order lawfully issued by a practitioner in connection with the device.

Texas Administrative Code, Title 25, Part 1, Chapter 229, Subchapter X, Rule 229.441, Minimum Standards For Licensure. Here's the link: http://info.sos.state.tx.us/pls/pub/rea ... 229&rl=441

7. Is A CPAP Mask A Prescription Device per Texas Law? Answer: Yes.

(13) “Device,” except when used in Sections 431.003, 431.021(l), 431.082(g), 431.112(c) and 431.142(c), means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is:

(A) recognized in the official United States Pharmacopoeia National Formulary or any supplement to it;

(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals; or

(C) intended to affect the structure or any function of the body of man or other animals and that does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and is not dependent on metabolization for the achievement of any of its principal intended purposes.

Texas Health and Safety Code, Title 6, Subtitle A, Chapter 431, Subchapter A, Sec. 431.002(13)(A-C) Definitions. Here's a link: http://tlo2.tlc.state.tx.us/statutes/do ... 00.htm#431

8. CPAP.com is a texas health care company with a medical distributors license that is bound by federal and state law to collect prescriptions on the Class II medical devices it sells.

Here is a full dump of the laws I've referenced in the above logic flow:

Laws TX Device Distributors Must Follow

The Texas Administrative Code, Title 25, Part 1, Chapter 229, Subchapter X, Rule 229.441 sets out Minimum Standards for Licensure for “all distributors…of devices engaged in…storage…and servicing of devices” saying that “they must comply with the minimum standards of this section in addition to the statutory requirements contained in…”

Texas Administrative Code

Title 25, Health Services
Chapter 229, Food and Drug
Texas Health and Safety Code

Texas Food, Drug, and Cosmetic Act, Chapter 431
FDA Compliance Policy Guides

Chapter 3, Devices
Code Of Federal Regulations (CFR)

Title 21, Part 807, Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices

Title 21, Part 801, Labeling

Texas Business and Commercial Code

Chapter 17, Deceptive Trade Practices
Federal Device Regulations and Guidance

Here are some FAQs I anticipate:

Q. Why not move to another state?

A. All states are obligated to follow and enforce federal law.

Q. Due to my reading/references/ridicule of law X, your logic has a hole in it. Why not fight there?

A. I have no doubt that a CPAPtalker will take my logic above and poke a huge and legit hole in it. However, in Texas, and in other states I've researched, you agree to another set of rules when you sign up for a medical distributors license. Included in those is the right of the Texas State Department Of Health Services to review your case via an internal panel. This panel can give fines or jail time. This panel sides with the state investigator greater than 95% of the time.

Bottom line: if you sign the form, you sign away your right to a fair hearing.

Q. So how can we change this rule?

A. You effectively can't unless you can get the federal government to change the law.

Johnny

[Gerryk]

I don't have a problem with being required to have a prescription for a mask or machine.

As You stated Johnny Lawmakers don't care, they only care when it comes time to vote for them or send money into their fundraisers. They mandate stuff on businesses and consumers daily. They also mandate things on smaller local governments yet do not fund it.
I missed out on a mask trial because I didn't have a copy of my prescription for my machine or mask. That was my fault no one elses. Would I have liked to participate? Yes, but I didn't have a copy of my prescription. That is one thing that was required so I couldn't participate and I accepted that.

I have since obtained a copy. I scanned it into a pdf and keep a copy on my desktop computer, on my Network storage, on my laptop, on my USB drive and in my sent email and home and work. I keep it so if anything ever happens, I am only a few minutes away from having my script and getting what I need.

I understand requiring a prescription for this.

Many people will not like this, but prescriptions are a way of protecting us from ourselves. Imagine where we would be today if we didn't require prescriptions for medicine or medical devices.


Gerry

[carbonman]

I don't understand why I can't buy a cpap when my Rx is for an apap.

If I can operate an apap, why can't I be trusted w/a cpap???

....it's not like transmissions.........

[flylow]

Pretty hard to argue CFRs. Do I think the rules are over the top? Hell yes. Interpretations of the law are why software is hard to get and why manufacturers try to hide the data from us. The only way to fight it is to get the laws changed. CPAPers unite!

[jnk]

I don't understand why I can't buy a cpap when my Rx is for an apap.

If I can operate an apap, why can't I be trusted w/a cpap???

....it's not like transmissions.........

Hey carbonman, I can relate. My Rx is for bilevel, so I can't be trusted with CPAP or APAP, even though my autobilevel will run as a CPAP! Actually, come to think of it, the doc wrote "BiPAP," so I guess I'm technically breaking the law by buying a ResMed, if someone wanted to get technical about it.

Johnny, I say do what ya gotta do to stay in business. We much prefer you outa jail as opposed to in one. I mean, there are good reasons for going to jail and all; this just isn't one of them.

Personally, I'm glad you'll sell to me at all. One company in California claimed they can't ship medical stuff to me, even if I have an Rx for it, because I live in NY State. I'm still not sure what that was all about. Uh, do me a favor, and don't look that up for me, OK.

jeff

[Gerryk]

I don't understand why I can't buy a cpap when my Rx is for an apap.

If I can operate an apap, why can't I be trusted w/a cpap???

....it's not like transmissions.........

Because your doctor has said you need an autoset machine. How could you use a machine that is to be set at a certain pressure if your doctor wants you on a machine that will detect and react within a range he or she has determined.

Gerry

[Wulfman]

I don't understand why I can't buy a cpap when my Rx is for an apap.

If I can operate an apap, why can't I be trusted w/a cpap???

....it's not like transmissions.........

Your APAP has a CPAP mode, silly.

However, that IS a problem for people who get their doctors to write a specific prescription for an APAP. It does potentially restrict getting another, less-expensive CPAP for backup or travel purposes.

For purchasing machines from online sellers, in most cases, "generic" (CPAP) prescriptions are usually better.


Den

[Muse-Inc]

Thanks Johnnie! Maybe this will stop some of the complaining. I do have some sympathy for our long-time CPAP therapy users as they may not have copies of scripts (written yrs ago) and who may not have a current doc who oversees their CPAP therapy...make it challenging for them.

[Patrick A]

Thanks Johnnie! Maybe this will stop some of the complaining. I do have some sympathy for our long-time CPAP therapy users as they may not have copies of scripts (written yrs ago) and who may not have a current doc who oversees their CPAP therapy...make it challenging for them.

I don't really like that I now have to get prescription to get a new mask, but if it helps CPAP.Com cover their back side then so be it. I went to a local DME and asked about getting a head gear for my mask they wanted a scrip. I went to one two blocks away and they sold it to me. Go
figure.

[carbonman]

Because your doctor has said you need an autoset machine. How could you use a machine that is to be set at a certain pressure if your doctor wants you on a machine that will detect and react within a range he or she has determined.

Gerry

Gerry, that may be all fine and good if your doc is involved in your therapy
and you buy into the "doctors are God" syndrome.
My doc, DME or sleep lab are not involved in my therapy and
since I got educated, I don't buy into that syndrome.
I have an autoset machine because in the beginning, I told him
I wanted an autoset machine.....because I would be in charge of my therapy.

Your APAP has a CPAP mode, silly.
Den

Yes, and because I had all those therapy options I was able
to titrate myself and find my "sweet spot".
I am using it as a cpap and receiving excellent therapy.

It does potentially restrict getting another, less-expensive CPAP for backup or travel purposes. Den

Bingo!

[secret agent girl]

.

[Gerryk]

Carbonman, I am in charge of my therapy. I however keep my doc and my dme in the loop. I download my data and send it off to my doc and dme at least monthly. Their have been times that I missed somethign because I was busy and didn't catch it that my dme either emailed me back or called me. Who would imagine they would send an email off to their dme with their data and get a phone call on their cell an hour later suggesting something?

If you don't like or trust your doc then find another, but at least keep them in the loop. By keeping mine in the loop, all I have to do is make a phone call or send an email off and I have what I want or need.

Gerry

[jnk]

"Hello, doctor's office? Yes. This is carbonman. I need to ask you a favor. Is there any chance you could have the doc make out a quick Rx for me for "CPAP, 10 cm" [or, whatever] and fax that to me today? I still have my Rx for APAP, of course, which is great, but my equipment provider won't let me purchase a plain CPAP for travel with that APAP prescription--you know how equipment people can be, right?! [chuckle, chuckle] Anyway, I don't mean to be a bother, but I need that today, if it all possible, so I can complete a purchase. I figured it was best if I got that Rx from him instead of getting another doc to do it. Thanks a lot. I appreciate it. Bye."

[carbonman]

If you don't like or trust your doc then find another, but at least keep them in the loop. By keeping mine in the loop, all I have to do is make a phone call or send an email off and I have what I want or need.
Gerry

Gerry, that's great that you have that kind of relationship...with both doc and DME.
I trust my doc totally. He has taken care of me for over 25yrs.
In that same relationship, he trusts me.
We go round and round about what he wants me to do
and what I want to do. We often agree to disagree.
He knows that if I am drawing him into the loop, there is a good reason.
He reacts in kind.

"Hello, doctor's office? Yes. This is carbonman. I need to ask you a favor. Is there any chance you could have the doc make out a quick Rx for me for "CPAP, 10 cm" [or, whatever] and fax that to me today? I still have my Rx for APAP, of course, which is great, but my equipment provider won't let me purchase a plain CPAP for travel with that APAP prescription--you know how equipment people can be, right?! [chuckle, chuckle] Anyway, I don't mean to be a bother, but I need that today, if it all possible, so I can complete a purchase. I figured it was best if I got that Rx from him instead of getting another doc to do it. Thanks a lot. I appreciate it. Bye."

You read me like a cheap paperback novel.
I would have written the letter, verbatim......
and the Rx would have been at the front desk w/in the hour.
I have made other arrangements and will have what I want in a few days.

[Tcamillemars]

I agree with carbonman. I have tried 4 doctors and they are all living in another world in my opinion. I prefer to be in charge of my therapy, not some "educated" person who looks at data from a sleep study showing 3 hours of actual sleep. Cpap.com got a copy of my Rx for me, all I had to do was give them the doctor's name. I didn't have to deal with the idiots in his office at all. The laws are really a pain in the backside for everybody but I don't see them changing anytime soon. Cpap.com has been a true blessing for me, and I will never deal with the Big A again. Thank you soooooooo much Johnny. I really appreciate what you do for us.