CPAP and prescription requirements.

[Jay Aitchsee]

From another thread:

Very good points made by Sonny and PR. I don't know if advising someone to take a controlled substance is illegal, but certainly giving someone a controlled substance, without proper authority, is. Further, it would seem that the giver could be held accountable not only for the act of giving (dispensing), but also for any harm that befell the recipient as a result.
http://en.wikipedia.org/wiki/Controlled_Substances_Act
(Ambien is a Class IV controlled substance)

Edit: I don't think a lay person can give "medical advice". I think advice about medical matters by a non-professional would be considered "personal advice".

How about advising someone to use/get a CPAP...that's a prescribed item. It's done all the time on this forum.

How about advising someone to use/get a CPAP...that's a prescribed item. It's done all the time on this forum.

Cpap is not a "controlled substance" and I think advising its use would fall under the guise of personal advice - if given by a non-professional. But, I'm not a lawyer - or a doctor

From Googling around:

It looks to me that this prescription thing as it refers to CPAP is largely due to licensing requirements of DME providers as regulated by the Centers for Medicare and Medicaid Services (CMS) under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and has to do primarily with coverage of supplies by Medicare, Medicaid, and other agencies. One of the requirements for dispensing of equipment (and insurance reimbursement) is a "Doctor's Order", or statement of medical necessity, which is often referred to, I think erroneously, as a prescription.
Further, these requirements only apply to businesses which provide DME and have nothing to do with individuals who would like to personally buy, sell or advise about the use of equipment.

Edit: See additional posts below for the role of the FDA in restricting certain Medical Devices to sale only on oral or written authorization by a licensed practitioner or under conditions specified by regulation - which would appear to be the basis of the CMS regulations cited above.

[Julie]

Figures!

[IreneN]

Well, the prescription thing is an FDA thing, which regulates the ability to sell these medical devices. CPAP machines and masks are designated as Class II devices and are cleared by the FDA for sale only with a prescription.

[Jay Aitchsee]

Thanks, Irene. Can you supply a link to that bit about sale by prescription? I kind of thought the FDA Medical Device Class designation had to do with regulations placed on manufacturers to demonstrate the the efficacy and safety of a device prior to bringing it to market. (Never mind, see the edit below)

Edit: So here's some bits from the FDA:

Most medical devices placed on the market are prescription devices.
What that means is they can only be sold to or on the order of a physician, and labeling must not be false or misleading. If it is, it's misbranding; and as I talked about earlier, that is a violation of the Federal Food, Drug and Cosmetic Act. The Quality System Regulation or current good manufacturing practices is a good quality assurance program that the manufacturers must follow when marketing that device. What that does is it gives FDA assurance that once FDA has cleared that device for market, that it's going to be manufactured consistently, according to the specifications for which FDA granted marketing clearance or approval. It's very similar to the International Standard 13485, and it's the standard for which we audit and spec medical device manufacturers against.

What does it mean for FDA to "classify" a medical device?
FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three categories—Class I, Class II, and Class III.

Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls. For example, dental floss is classified as Class I device.

Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. For example, condoms are classified as Class II devices.

Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are marketed. For example, replacement heart valves are classified as Class III devices.

Class II – Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 43% of medical devices fall under this category.

So, as Irene points out above, medical devices are regulated by the Food and Drug Administration (FDA) and are subject to premarketing and postmarketing regulatory controls. Apparently the FDA decides which equipment requires a prescription, though I have been unable to find the mechanism through which they do that. Obviously, since condoms, pregnancy test kits, and CPAP machines are Class II devices, it is not by class designation alone. The authority to require a prescription looks like it stems from the provisions referenced in the quote below, though it does seem it might be rather arbitrary given the wide range of devices mentioned (heart valves to hearing aids).

Restricted Devices
Under the provision of Section 520(e) of the Amendments, the FDA is authorized to restrict the sale, distribution, or use of a device if there cannot otherwise be reasonable assurance of its safety and effectiveness. A restricted device can only be sold on oral or written authorization by a licensed practitioner or under conditions specified by regulation. Devices such as cardiac pacemakers and heart valves, for example, require a practitioner's authorization. Hearing aids are restricted by a regulation which limits their sale to persons who have obtained a medical evaluation of their hearing loss by a physician within six months prior to the sale of the hearing aid. The labeling of hearing aids must provide information on their use and maintenance.

For a decent overview of the FDA regulation of medical devices see https://www.fas.org/sgp/crs/misc/R42130.pdf

Please note that Controlled Substance Classes differ from Medical Device Classes

[IreneN]

I'm pulling this info from memory, from the days when I did 510(k) submissions to the FDA to obtain clearance for our devices, which were in a slightly different category because they were diagnostic devices.

Class II device are really split into 2 classes, A and B. I don't remember which is which, but one of them does not even require oversight by FDA based on specific criteria. The other is controlled by FDA, which must provide pre-market clearance. The prescription bit is determined by how much risk the FDA feels the patient is exposed to, and takes into account how difficult the device is to use and the degree of training required to run it. Some of it feels pretty arbitrary. There are product classification codes (three letters) that enumerate in quite some detail what the criteria are, depending on the code and the associated statute. For example, the product code for CPAP machines is BZD.

https://www.accessdata.fda.gov/scripts/ ... cfm?ID=BZD

The statute for this code is very sketchy and short. I'm sure there's more, but, honestly, I don't really have time to pursue it further. Hope this helps.

[Julie]

What would happen in court if someone wanted to prosecute a lay person for advising or selling an e.g. Class 2 device to another lay person who ended up getting sick as a result? Who would be at fault - the seller who may or may not have given cautionary advice to the buyer, or the buyer, who should have made themselves aware of what they were buying? Would either be subject to laws written for doctors? Could either be sent to jail?

[IreneN]

Just for interest, I'm posting a link to the 510(k) clearance database. I pulled an old one for a full face mask by Respironics. It shows the summary section of the submission by Respironics, the letter granting clearance, and a short summary by the FDA. Note that at the very end there is a selection between Rx or OTC.

http://www.accessdata.fda.gov/scripts/c ... ID=K082866

[Jay Aitchsee]

The statute for this code is very sketchy and short. I'm sure there's more, but, honestly, I don't really have time to pursue it further. Hope this helps.

Thanks, Irene. People often ask, "why is a prescription required for CPAP?" The answer seems to be buried deep within the rules and regulations of the FDA as generally outlined above and probably those of some other agencies, but like you, I really don't want to spend anymore time on it. If anybody else does, they can start with the info above.

Thanks again for providing the direction to the appropriate agency.

[Jay Aitchsee]

What would happen in court if someone wanted to prosecute a lay person for advising or selling an e.g. Class 2 device to another lay person who ended up getting sick as a result? Who would be at fault - the seller who may or may not have given cautionary advice to the buyer, or the buyer, who should have made themselves aware of what they were buying? Would either be subject to laws written for doctors? Could either be sent to jail?

Julie, these rules and regulations seem to apply primarily to manufactures who want to bring these products to market. Licensing vendors for sale of these items would appear to granted by other agencies (Federal and State) as alluded to in my first post.

I have yet to find and agency or restriction regulating the sale of these items on a one off basis by an individual, unlike the case with the DEA and Controlled Substances. Of course, continued sale of multiple items might be construed as conducting an unlicensed business.

Anyway, that's my take on it.

[IreneN]

What would happen in court if someone wanted to prosecute a lay person for advising or selling an e.g. Class 2 device to another lay person who ended up getting sick as a result? Who would be at fault - the seller who may or may not have given cautionary advice to the buyer, or the buyer, who should have made themselves aware of what they were buying? Would either be subject to laws written for doctors? Could either be sent to jail?

Hmmm... IMO, it's buyer beware, both for the device and for the advice. Unless the advisor/seller is representing themselves as either a doctor ("practicing medicine without a license") or licensed distributor, I doubt much could be done against them legally. Maybe if they were selling repeatedly and with full knowledge and intent. Or malicious intent. I don't know... Interesting question.

[IreneN]

The statute for this code is very sketchy and short. I'm sure there's more, but, honestly, I don't really have time to pursue it further. Hope this helps.

Thanks, Irene. People often ask, "why is a prescription required for CPAP?" The answer seems to be buried deep within the rules and regulations of the FDA as generally outlined above and probably those of some other agencies, but like you, I really don't want to spend anymore time on it. If anybody else does, they can start with the info above.

Thanks again for providing the direction to the appropriate agency.

Well, in this case it's all FDA. And remember that the FDA is empowered and limited by legislation. All the numbers and parentheses you see when reading about the FDA refer to the Federal Register that records what goes on in Congress. So these are not "regulations" of the FDA but laws passed by Congess. (Which might explain some of the stupidity. )

[Jay Aitchsee]

So these are not "regulations" of the FDA but laws passed by Congess. (Which might explain some of the stupidity. )

Yes, of course. Pardon me for using the terms incorrectly. I would guess a great many begin with lobbyist which might, indeed, account for some of the perceived "stupidity", unless, of course, you happen to be one supporting the lobbyist