CPAP supplies on Amazon

Slartybartfast wrote:I thought all CPAP supplies were prescription-only. Has something changed?

Slartybartfast wrote:Ok, I guess certain suppliers that we all know and love require an Rx for mask parts, etc. and was surprised to see them selling on Amazon without an Rx. I suppose manufacturers might have something to say about how their products are sold, as well, so maybe that's why the practice of requiring an Rx is so widespread.

johnnygoodman wrote:Howdy All,

Den asked me to chime in here. Your DME needs a prescription for mask parts, but not for the reason they gave you. Your DME needs a doctors order (aka prescription) in order to make the mask parts they provide you billable per common insurance policy of denying claims for all items not explicitly doctor ordered. emphasis added.

The prescription side is a little less firm but here's the deal. The FDA defines the class of medical devices and their prescription level. CPAP is Class II meaning you need a doctors order. The manufacturers are regulated by the FDA and have to mark items that are prescription required as prescription required on their labeling. For things with serial numbers, they do this carefully and properly most of the time. For things like mask clips, it is rare anyone bothers to label it as prescription required. Reasonably, it shouldn't be and technically, without the label no Rx is required. This is true of any product coming off the line from a mfg. As they label it, so it is, as we they are doing so in compliance with and at the direction of the FDA.

From the dealer side, be it CPAP.com or a DME, we are regulated by the states. We are to have Rxs on file for products requiring Rxs. The regulations don't explicitly state which products require a prescription - they only say we inherit the policy of the FDA. Usually the people conducting the inspections are former RTs and so the convention is machines, humidifiers and masks need Rxs though other inspectors will say "anything with Rx printed on the label is Rx". There have been situations where a given product had the rx printed on the label for a run, then changed to not be on the label, then changed back.

Most dealers don't get this far into the weeds or aren't even aware this is a thing.

For our part, we watch the products we buy and adjust what can or can not be kitted based on the direction we receive from manufacturers based on their labels. We adjust kits available accordingly. Other dealers do other things, often opting to work a little closer to the horns. The thing is, they are involving their customers in that behavior too, likely unwittingly. Reasonably you'd say "so what, we're talking about $5 of plastic here." The regulatory environment in our country is punitive and excessive. It seems unlikely that a regulator would involve customers is an issue discovered but after what I've seen and the experiences I've heard others in the industry endure, I'd rather not risk it for our customers or our business. So we go off the labels per batch and comply with the letter of the law as best we can in good faith.

Johnny