I just got word from Matt Carmel, inventor of the Palm Pistol:
I thought you might be interested to learn that the FDA has completed its “Device/Not a Device” determination and concluded the Palm Pistol will be listed as a Class I Medical Device, exempt from 510(k) Pre-Market Notification in accordance with 21 CFR 890.5050 “Daily Activity Assist Device.”
I have now submitted an application to the CMS contractor Noridian for a DME (Durable Medical Equipment) Coding Verification in order to be assigned an HCPCS code. Once assigned , physicians will be able to prescribe the Palm Pistol for qualified patients who may seek reimbursement through Medicare or private health insurance companies.
Matt seems pretty confident that he’ll be able to get medicare to reemurse patients for the Palm Pistol:
All the “experts” said the Palm Pistol would be AOW and I proved them wrong.Â All the “experts” said the Palm Pistol would never be classified as a medical device by FDA and I proved them wrong. Now all the experts are saying there is no way this will be reimbursable under Medicare. Well, we shall see about that!
Go Matt!Â I love troublemakers, especially ones that create headaches for federal bureaucrats.Â The progressives created this system, and now we have hijacked it to help people buy guns!Â Matt has hoisted them on their own petard.Â This is the kind of creative thinking our movement needs.
18 thoughts on “Hoisted on their Own Petard”
I had always thought the Heller scenario would have originated from a lawsuit by an amputee with only one arm, claiming a handgun ban violates both his 2A rights and ADA compliance laws.
All I can say is … HOLY COW!
The right, and the practicality, of self-defense is going main-stream!!
Wonder if my HMO will pay for it, seeing my hands hurt from all of this blogging…mmmm.
Good for Matt.
Now the question is since its been declared a medical device – do you have to fill out a form 4473 and pass a background check to get it?
I admit it . . . I didn’t make any public comments about this pistol, but I’m shocked that the FDA classified it as a medical device. I would have bet against that in a heartbeat.
Happy to be wrong.
RKM, I think it will probably be exempted the same way that black powder firearms are.
I want one.
You would still have to fill out all the same federal forms to get the firearm.
As a physician, I’m looking forward to prescribing these.
(Unfortunately, I doubt Medicare will pick up the tab. I have a hard enough time getting them to cover wheelchairs.)
Interesting question: If the FDA ruling forces the BATF to grant the Palm Pistol an exemption from AOW status under an implementation of the ADA (enough abbreviations yet?), would the exemption be granted on a case-by-case basis of “medical need” — or for the device regardless of who owns it?
If the device is exempted from AOW status, what sort of doors will be opened for the reclassification of other palm pistols or “knuckle dusters” with unusual trigger mechanisms and shapes?
If not, what happens to the exempt status if the owner dies? Does it become an AOW? Does the owner’s surviving spouse or estate then become liable for the transfer tax and paperwork?
The Palm Pistol is already declared a standard handgun under ATF rules. My understanding of the rule is, that if it’s declared a “medical device” by FDA rules, if a doctor is willing to prescribe it, then medicare will have to pay for it.
But regardless of that. ATF has already declared it a pistol, so you can get it through normal means as a firearm. The question now is whether a doctor can prescribe it, and medicare pay for it.
As a Freelance Writer, I was contacted by Matt Carmel after an article I had done on the problems experienced by the disabled in shooting traditional firearms was published in Concealed Carry Magazine. I’ve been following his battle with the government trying to get his product licensed as a medical device. I love people who march to the beat of a different drummer. firstname.lastname@example.org
The sticking point, I think, is whether a Palm Pistol can meet Medicare’s vague and nebulous standards of “medical necessity” to qualify for reimbursement. My writing a prescription and stating that the patient requires something as a matter of necessity typically isn’t enough.
They have their own rules which are Byzantine, on a good day. I had a dying patient who required Marinol (a prescription form of THC) to suppress her nausea and improve her appetite. Medicare flatly rejected paying for my prescription, despite the widespread use of Marinol in hospice patients with similar problems. She died without receiving it.
(I was offered a choice of rewriting my prescription for another medication that was wholly inappropriate, but cheaper. I refused.)
Just a foretaste of what’s to come…
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