Need Input ASAP- Do I need a license for a lab if I DO NOT bill insurance??

[LADoc00]

? Do I need lab license and CLIA certificate for a pure cash testing lab?

I have a med lab trailer and can grab 4+ analyzers and near unlimited kits that I want to cash charge 300 per for.

My state's lab licensing offices are totally closed, obviously I cant get an inspection or CLIA cert either.

If I just popped up a mobile cash only COVID center, am I running afoul of any laws?

thanks

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[Med Director New England]

Looks like you state licensure requirements may be laxed a bit.

I think there will be cash only concierge Covid testing soon. A lot of companies would pay big for a rapid TAT to screen their work force and send home anyone positive. Worth the costs to keep folks healthy and operations running.

Trump administration will allow doctors to practice across state lines to address pandemic

The Department of Health and Human Services will permit all medical care providers to practice across state lines, regardless of their state license, to treat more coronavirus patients. Vice President Mike Pence announced the new regulation Wednesday “to meet the need of hospitals that may arise...

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[Granular]

You still need a CLIA. Researched this a couple years ago while contemplating an all cash concierge medicine type lab. Doesn't matter if you bill the government or insurance or go all cash. If you get a specimen from a human and run a test on it for a wide range of reasons, you need to have a CLIA. Here is an excerpt from the CDC website. I thought that there would be even more restrictions after Theranos. The FDA is certainly on a roll, but I am not sure CMS has expanded its authority yet.
Another option I did not fully explore was an off shore lab. Collect specimens in the US and helicopter them out to a floating lab in international waters and do the tests. Maybe use a mothballed floating oil platform. That might work for all cash and escape US regulations. No proficiency, qualifications for testing personnel, accreditation, etc. But I didn't have the capital to set that up at the time, so I dropped the idea. Might revisit it in a couple of years.

 

[deleted314957]

? Do I need lab license and CLIA certificate for a pure cash testing lab?

I have a med lab trailer and can grab 4+ analyzers and near unlimited kits that I want to cash charge 300 per for.

My state's lab licensing offices are totally closed, obviously I cant get an inspection or CLIA cert either.

If I just popped up a mobile cash only COVID center, am I running afoul of any laws?

thanks

Hell yes! ANYBODY could open their mobile “lab” and use some phenolphthalein and pH strips and absolutely “wow” the public. You seem shaken LA.


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[AZpath]

I will sell you mine for 1 million

 

[kchan99]

See https://www.cms.gov/Regulations-and.../CLIA/Downloads/Research-Testing-and-CLIA.pdf

 

[LADoc00]

Hell yes! ANYBODY could open their mobile “lab” and use some phenolphthalein and pH strips and absolutely “wow” the public. You seem shaken LA.


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Not shaken hahaha, trying to cap on some ideas. Lots and lots of free time with no elective procedures being done.

I think this crisis is very geographic dependent..In California in my exclusive nice neighborhood, they had an armed security guard and staff directing customers at the pharmacy to “safe alternatives to toliet paper”. My grocery store had signs on every aisle “1 milk,1 bread, 1 chicken, 1 dozen eggs,1 water” like I was now in the USSR in circa 1983.
My neighbor had their 2 kids stuffing AR mags when I got home.
I’m hardly worried for myself but even if the virus is gone tomorrow, the economic and psychological harm to the common folk where I am is almost inconceivable.