Hello Guest, Welcome to Apnea Board !
As a guest, you are limited to certain areas of the board and there are some features you can't use.
To post a message, you must create a free account using a valid email address.

or Create an Account


New Posts   Today's Posts

CPAP prescription/DME regulation
#1
ADMIN NOTE: These posts have been split-off into their own thread. The original thread is here.

(10-14-2016, 09:33 PM)PaulaO2 Wrote: Purchasing a CPAP machine without a prescription is illegal here in the US. We can help another member in figuring out the quality of a used CPAP. We can help another member learn where to find used CPAP machines. But we cannot hold their hand and guide them through the purchase of it.

If you wish to purchase a used CPAP machine, that is up to you. We can help you with questions regarding quality and what may be best for you. But that is it.

(yes, it is a thin line we dance, but, ah, we have shiny dancing shoes for it)

I have not read the law, but I would bet it uses the term "dispense" which would mean a new, factory refurbished, or used from a licensed DME. Before the sale between two private individuals can be decided, we would need to see if there is any actions by US FDA or case law. If there are no actions, then one would have to read the exact language of the code/statute/regulation to determine the legality.
Post Reply Post Reply
#2
If I get caught with a prescription drug which I purchased on the black market without a prescription then I will very likely be charged with a crime. If it's illegal to sell something without a prescription then it's illegal to possess it without a prescription unless you are someone licensed to prescribe or dispense prescriptions.
Ed Seedhouse
VA7SDH

Your brain is not the boss.

Post Reply Post Reply
#3
(10-17-2016, 07:38 PM)eseedhouse Wrote: If I get caught with a prescription drug which I purchased on the black market without a prescription then I will very likely be charged with a crime. If it's illegal to sell something without a prescription then it's illegal to possess it without a prescription unless you are someone licensed to prescribe or dispense prescriptions.

I respect what you post and your thoughts on sleep apnea, but do your really think you will be charged with a crime for possession of a CPAP? Controlled substances, particularly narcotics are not the same thing in the context of law. I just don't see the application of the analogy here, and how do you assume the O.P. does not have a prescription for CPAP?
Post Reply Post Reply


#4
(10-17-2016, 07:38 PM)eseedhouse Wrote: If I get caught with a prescription drug which I purchased on the black market without a prescription then I will very likely be charged with a crime. If it's illegal to sell something without a prescription then it's illegal to possess it without a prescription unless you are someone licensed to prescribe or dispense prescriptions.

I have a prescription. Where did you get the idea I didn't in the first place?

Post Reply Post Reply
#5
(10-17-2016, 11:18 PM)Lanco Wrote:
(10-17-2016, 07:38 PM)eseedhouse Wrote: f it's illegal to sell something without a prescription then it's illegal to possess it without a prescription unless you are someone licensed to prescribe or dispense prescriptions.

I have a prescription. Where did you get the idea I didn't in the first place?

I didn't have that idea at all. What makes you think I did?

I was replying to a claim by someone who said that the possession of a prescription item without having a prescription for it was not illegal. A drug doesn't have to be a narcotic for possession without a prescription to be illegal. For example, athletes sometimes use black market diuretics to enhance performance or meet weight goals. If they are found in possession of them without a prescription they are breaking a law.

I neither said nor implied that you were in such a position.

Ed Seedhouse
VA7SDH

Your brain is not the boss.

Post Reply Post Reply
#6
(10-17-2016, 08:00 PM)Sleeprider Wrote:
(10-17-2016, 07:38 PM)eseedhouse Wrote: If I get caught with a prescription drug which I purchased on the black market without a prescription then I will very likely be charged with a crime. If it's illegal to sell something without a prescription then it's illegal to possess it without a prescription unless you are someone licensed to prescribe or dispense prescriptions.

I respect what you post and your thoughts on sleep apnea, but do your really think you will be charged with a crime for possession of a CPAP?

Charging or not charging is at the discretion of the authorities. The fact that you weren't charged doesn't mean you weren't doing something illegal. I was stopped for speeding once but the cop didn't give me a ticket. That doesn't mean that I wasn't breaking the law, I was. Another time I was stopped and ticketed, quite properly. If I had been ticketed both times I would have no grounds for complaint.

Quote:how do you assume the O.P. does not have a prescription for CPAP?

I made no such assumption. Nor was it implied by what I said, which was in reply to a claim about a purely hypothetical situation.


Ed Seedhouse
VA7SDH

Your brain is not the boss.

Post Reply Post Reply


#7
Ed, go start a thread on prescriptions and enforcement and let this thread get back to the O.P.'s topic.
Post Reply Post Reply
#8
I split these posts into their own new thread so the discussion of CPAP prescriptions/DME regulations can be discussed separately from the OP's questions regarding purchasing CPAPs via PayPal on craigslist.

The original thread is here, and I've copied my info below:

SuperSleeper Wrote:Just for clarification, for a CPAP sale to be considered "illegal" in the U.S., one of the following criteria must be present:

1. The seller is not a licensed DME.
or...
2. The buyer does not hold a valid prescription for CPAP.

Either event will technically make it an "illegal" sale. But I'm pretty sure the law (FDA regs) holds the seller responsible for 1) meeting the DME licensing requirement and 2) ensuring the buyer has a valid prescription. I don't think there are any penalties to the buyer in any case, even though the regulations state that the buyer must hold a valid prescription.

The burden of abiding by the FDA regulations for the above 2 criteria lies with the seller, not the buyer, in other words. Sellers of Class II medical devices are the ones who are regulated, not the end-users of those devices.
SuperSleeper
Apnea Board Administrator
www.ApneaBoard.com


INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.



Post Reply Post Reply
#9
In Canada, it seems some of the brick-and-mortar (with an online presence) stores like to skirt this with a "Don't Ask/Don't Tell" policy. They assume you must have a valid prescription because you're buying the product. Someone selling their used machine on Craigslist can likely claim the same.

Would be interesting to see how they've arrived at this conclusion.

There is, of course, the risk of stolen goods or defective / repackaged goods, too.
Post Reply Post Reply


#10
The reality is that used and even new machines come up on gray market channels all the time. Online sites like Amazon and Craigslist pay lip service to compliance to regulations, and they do not police third party sellers that sell this equipment. I have purchased two units from private sellers, and would not personally hesitate to buy any CPAP, BiPAP or ASV device that was offered at a good price if I had the full burden of paying, as many people do today.

The legitimate DME channel has created a secret pricing policy that keeps insured people from knowing what they paid. They invoice hundreds of dollars over the MSRP and will let any uninsured patient pay that price if they are uninsured. On the other side of the coin, people who get machines under insurance, commit fraud by reselling those machines when they fail to tolerate them. This results in restrictive policies by insurance companies, including rental, requirements to demonstrate compliance, and overall higher prices for everyone buying legitimately through insurance. There is far too much incestuous behavior between certain sleep clinics and DMEs that involve referral commissions and dispensing of the cheapest equipment the meets a prescription standard. All of this relying on n uniformed consumer.

The bottom line is, many individuals with a health-need for equipment will behave within their knowledge constraints and risk tolerance to avoid over-paying for a commodity prescription product; generally without fear or regard for the FDA and federal laws, which only target manufacturer device approvals and licensed DME sellers. This has created a demand side to the gray market. The supply side is used machines from users that failed CPAP and new machines that "fall off the truck", and are sold as open-box or new, but outside the restrictive regulatory system. Even the discount channel that requires prescriptions to buy devices, relies on gray market purchases of new and used equipment to meet their demand. They clean them up, test and resell at a profit. Even thought they require rescriptions, it's not squeaky clean either. If Supplier #2 can buy used machines, why can't I? The direct used, and discount supply channels will only close when visible federal enforcement is initiated that prosecutes the sale or purchase of these machines. So far, not a problem, and this business is conducted virtually in the open. I don't see any effort at all to change that.
Post Reply Post Reply


Possibly Related Threads...
Thread Author Replies Views Last Post
  Prescription without supplier christian4870 11 447 09-09-2017, 05:25 AM
Last Post: holden4th
  750p PCA board swap - issues with writing my prescription mraroid 4 185 08-19-2017, 08:52 AM
Last Post: mraroid
  [Diagnosis] Long Time to Get Prescription for Machine Vesimir 39 1,433 07-19-2017, 04:16 PM
Last Post: Vesimir
  when is a prescription not a prescription? xxyzx 13 716 05-02-2017, 09:37 PM
Last Post: Sleeprider
  Wording of prescription PaulaO2 27 925 04-27-2017, 01:40 PM
Last Post: Sleeprider
  [Equipment] Where to buy cpap without prescription. BathTubSleep 13 1,548 04-21-2017, 01:30 AM
Last Post: Hydrangea
  [CPAP] International Prescription tonylkc1668 5 369 04-06-2017, 09:01 PM
Last Post: trish6hundred

Forum Jump:

New Posts   Today's Posts




About Apnea Board

Apnea Board is an educational web site designed to empower Sleep Apnea patients.

For any more information, please use our contact form.