3 ms·

The regulations don't just disappear to allow for such imports as in your example ...?

JumpCrisscross 3y ago
> regulations don't just disappear to allow for such imports as in your example My point is the regulations are leading to the duopoly, which is the source of the problem. The last private-equity owner seems to have been fine. And the market was competitive before the CMS rules in 2005. I’m not suggesting scrapping the rules. But the rules are clearly well past safety.
- MichaelZuo 3y ago
  Perhaps you've confused which comment I was replying to with one further up, from what I can see you were trying to answer the question, and nothing else is visible: > how would it fix things then if it wasn't private equity dominating that market? The visible answer is clearly contingent on some future regulatory landscape coming into existence, otherwise it makes no sense, so I was wondering how does it answer the original question?
cogman10 3y ago
Well, that's the interesting thing. You likely can import and use these wheelchairs, but they can't be sold as medical devices and, subsequently, won't be covered by your insurance. The dumb thing is these super cheap wheelchairs would likely cost the end users more money than the expensive ones as they will buy them out of pocket vs having their insurance/medicare cover most/all of the cost. The reason these companies don't sell these wheelchairs in the US is likely because the marketing would run afowl of regulations about selling medical devices. You probably could sell these as bicycles and hobby chairs though.
- charrondev 3y ago
  I mean they could market similar to Not a Wheelchair I guess? https://notawheelchair.com/products/the-rig https://notawheelchair.com/products/the-rig
- Spivak 3y ago
  > they can't be sold as medical devices and, subsequently, won't be covered by your insurance. This is something I've never really understood. Wouldn't the insurance company be ever grateful to you if you accepted a non-medical wheelchair because it's 1/10th the cost. Hell, have 5! Is there any reason insurance can't pay for them?
  - kazinator 3y ago
    Not if it's owned by the same private equity firm as the wheelchair guys; then it's just another face of the same racket. Also, medical insurance is supposed to cover bona fide medical treatments and supplies. So this likely bumps up against regulation again. If something goes wrong with the out-of-regulation device that insurance paid of as if it were a medical wheelchair (e.g. safety incident leading to injury), they could be liable. It's the same as why dental insurance won't pay for your next door neighbor handyman to pull out your tooth with a pair of pliers.
yumraj 3y ago
The price difference seems to be enough for a person to fly to India and bring one with them. Can the FDA stop a person from using one by coming to their home and confiscating it?
- Spivak 3y ago
  No and you needn't bother with the medical tourism. You're allowed to use whatever assistive device you'd like, it's only when you wade into getting insurance or the govt to pay for it that the regulations start to matter.

> regulations don't just disappear to allow for such imports as in your example My point is the regulations are leading to the duopoly, which is the source of the problem. The last private-equity owner seems to have been fine. And the market was competitive before the CMS rules in 2005. I’m not suggesting scrapping the rules. But the rules are clearly well past safety.

MichaelZuo 3y ago
Perhaps you've confused which comment I was replying to with one further up, from what I can see you were trying to answer the question, and nothing else is visible: > how would it fix things then if it wasn't private equity dominating that market? The visible answer is clearly contingent on some future regulatory landscape coming into existence, otherwise it makes no sense, so I was wondering how does it answer the original question?

cogman10 3y ago

Well, that's the interesting thing. You likely can import and use these wheelchairs, but they can't be sold as medical devices and, subsequently, won't be covered by your insurance. The dumb thing is these super cheap wheelchairs would likely cost the end users more money than the expensive ones as they will buy them out of pocket vs having their insurance/medicare cover most/all of the cost. The reason these companies don't sell these wheelchairs in the US is likely because the marketing would run afowl of regulations about selling medical devices. You probably could sell these as bicycles and hobby chairs though.

charrondev 3y ago
I mean they could market similar to Not a Wheelchair I guess? https://notawheelchair.com/products/the-rig https://notawheelchair.com/products/the-rig
Spivak 3y ago
> they can't be sold as medical devices and, subsequently, won't be covered by your insurance. This is something I've never really understood. Wouldn't the insurance company be ever grateful to you if you accepted a non-medical wheelchair because it's 1/10th the cost. Hell, have 5! Is there any reason insurance can't pay for them?
- kazinator 3y ago
  Not if it's owned by the same private equity firm as the wheelchair guys; then it's just another face of the same racket. Also, medical insurance is supposed to cover bona fide medical treatments and supplies. So this likely bumps up against regulation again. If something goes wrong with the out-of-regulation device that insurance paid of as if it were a medical wheelchair (e.g. safety incident leading to injury), they could be liable. It's the same as why dental insurance won't pay for your next door neighbor handyman to pull out your tooth with a pair of pliers.

yumraj 3y ago

The price difference seems to be enough for a person to fly to India and bring one with them. Can the FDA stop a person from using one by coming to their home and confiscating it?

Spivak 3y ago
No and you needn't bother with the medical tourism. You're allowed to use whatever assistive device you'd like, it's only when you wade into getting insurance or the govt to pay for it that the regulations start to matter.