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Urine Drug Screen Billing in the Laboratory Setting

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diagnostico:
Our doctor's offices are using CLIA waived cups with a 12 panel test strip. They are billing 80101QW for the POC testing in their offices.
They then send the samples to our clia waived laboratory. The docs only use Workmen's Compensation and PIP. 

Is it legal for us to do another screening test on each drug class eventhough they have already billed 80101QW?
can we bill 80101 x 12

and

Is it legal for us also to also bill  (doc's only treat WC and PIP patients)
83518 x 4 immunoassay
80299 x 3 (3 positives that need to be confirmed)

I just want make sure that we are doing the right...

Your help is appreciated.

RichardP:
This comment at the end of the linked article might put things in perspective for you:

I know this is a bit of a late reply, but it struck me reading this article that, clinically speaking, the vast majority of POC tools are only useful in ruling out cases, rather than providing a definitive diagnosis. For that, laboratory testing remains essential. An example is spirometry. Office spirometry is helpful, but only in identifying cases that need a full spirometric test and ruling out non-COPD cases, not in diagnosing cases.

From here:  http://www.pharmaphorum.com/2010/05/12/point-of-care-testing-in-clinical-trials/

It is possible your doctors are doing a quick rule out the obvious at the POC, and then are forwarding the sample(s) to the lab for a more thorough diagnostic effort.  Hopefully you can see that those are two distinctly different types of testing on the same sample.

diagnostico:
RichardP,
Thanks for your comment. You have offered great insight.
My only concern is that since the office is currently "screening" the urine, is it legal for the lab to also "screen" the urine using immunoassay? It seems a little redundant and possibly illegal to bill the same procedure twice.

RichardP:
For background, this link defines CLIA-waived tests as simple laboratory examinations and procedures that ... employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.

http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatoryassistance/ucm124202.htm

Then, for specifics, we turn to this link and read on Page 2:

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/howobtaincertificateofwaiver.pdf

Q:  I am a physician performing urine dip sticks and finger sticks for blood glucose in my office as part of the patient's visit.  Am I considered to have a laboratory and do I need a CLIA certificate?

A:  Yes, the testing you perform qualifies as waived laboratory testing and you need a CLIA Certificate of Waiver. This testing requires a CLIA certificate regardless of how many tests you perform and even if you do not charge the patient or bill Medicare or other insurances.


Per Medicare, there can be a Physician Owned Laboratory (POL), or a clinical laboratory.  One laboratory or the other may bill for a given test, but both cannot bill for the same test at the same time.  If the doctor has a POL, he must have a CLIA number for that laboratory.  The clinical laboratory must have it's own CLIA number.  When the doctor uses his POL, he must bill that lab testing under his own CLIA number for his POL.  Even if the doctor has a POL, he may send the labs out to a clinical laboratory instead of using his POL (note that the doctor must inform his patients that they can use a lab of their own choice; they cannot be compelled to use the doctor's POL).  If the doctor sends the labs to a clinical laboratory, the clinical laboratory must bill for the tests, using their own CLIA number. 

Under the Medicare rules, a doctor may not bill for a lab test(s) using his own CLIA number and then send the same specimen samples to an outside lab - where they run the exact tests the doctor ran, and bill for the testing using their own CLIA number.  Medicare edits will catch that two different CLIA numbers are billing for the same series of tests for the same patient for the same date of service.  However, the doctor can run a series of tests in his POL and then send the specimen samples to an outside lab for a different series of tests.  That situation will pass the Medicare edits because the two different CLIA numbers are billing for two different sets of tests.

Finally, a doctor may send the specimen samples to an outside lab - and the lab runs the tests / creates the slides and sends the results back to the doctor for the doctor to interpret (xray, nuclear testing, pathology - but not urine or blood).  In this instance, the clinical lab will bill the technical component (TC) using their CLIA number, and the doctor will bill the professional component (PC), no CLIA numer required.  (The regulations re. TC and PC are changing as we speak, but that is beyond the scope of your question.)

Those are the definitions and regulations for Medicare.  They apply to all instances where the doctor sees Medicare patients.  But some states (California for example) have their own regulations that impose the Medicare regulations on all Insurance Carriers.  So what you just read would apply to W/C or Blue Cross or HealthNet patients in California, as well as to Medicare patients.

If you are working in California, I can tell you that the Medicare regulations do apply to your doctors and your lab even though your doctors only see W/C and PiP patients.  That is because I know the California regulations .  But I don't know the state law for whatever state you actually work in.  That is why you need to speak with a Health Care Attorney about the laws for your state.  What you described in your original post may be a legitimate issue, or it may be nothing.  Only the appropriate legal counsel can tell you.

diagnostico:
WOW! RichardP for President.
You are THE MAN. That is great information.
I sincerely thank you...

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