Question New to CLIA/80307 Billing - Please help!

THK

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Our office just recently began billing 80307. We have multiple locations from which urine samples are collected, but these samples are all sent to our main location for analysis, which is the location that has an active CLIA. When creating the claim, we're trying to decide if we should list the location as the place the sample was collected or the place the analysis actually happened. Most of these samples are being taken on the day our patients have an office visit, so we’re also trying to figure out if we should list the date as the day the sample was taken (the same day as the office visit) or the day the sample was analyzed (usually a day or so later after being transported). As I mentioned, we’re new to this so any thoughts or suggestions would be greatly appreciated!
 
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It has to be the location where the test is performed because it will be tied to your CLIA certificate. I recommend getting in touch with the lab's accrediting organization with these questions as they can tell you exactly what's required in your state.
 

THK

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Logan, UT
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It has to be the location where the test is performed because it will be tied to your CLIA certificate. I recommend getting in touch with the lab's accrediting organization with these questions as they can tell you exactly what's required in your state.
Thank you for your response! Just to clarify, when you say "the location where the test is performed" do you mean the location where the sample was collected, or do you mean the location where the sample was analyzed? Also, do you happen to know anything about whether we should use the date of the sample collection or the date of the sample analysis?
 
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Puyallup, WA
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Thank you for your response! Just to clarify, when you say "the location where the test is performed" do you mean the location where the sample was collected, or do you mean the location where the sample was analyzed? Also, do you happen to know anything about whether we should use the date of the sample collection or the date of the sample analysis?
I'm having a similar issue, have you had any luck answering the question of billing based on location taken or location analyzed?
 

karamac

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Glendale, Arizona
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This can be a complicated answer depending on how the practice is set up, especially if each location has a separate TIN. In addition as mentioned above the accrediting organization absolutely needs to be contacted to ensure compliance. The date of collection is always the date of service in lab testing, not the date that the sample is analyzed. Now there are some exceptions for molecular pathology, but for drug testing, it is always the date the patient is seen. So in this situation, if all of the check boxes are checked- TIN, and accrediting then you would bill POS 11 and one unit of 80307.

I would caution that there are multiple potential issues with the model that you are currently working under. First, a presumptive drug screening is meant to be used in the treatment of the patient (meaning while the patient is there in the office and the provider uses the results that day (I know, I know, it takes 52 minutes for the analyzer to run, don't kill the messenger payers are on this) then as a physician office lab, you would then base any definitive testing on the results of the presumptive. My experience is that the laboratory consultants who set these labs up don't tend to explain to the physician the issues that this can cause. Second, make sure that you do temperature transportation studies on your collection cups, or this could be a major CLIA violation, and ensure that the samples being transported are secure from a HIPAA perspective, you can't imagine how many cases I have dealt with where the MA in charge of transporting the samples left the samples in their car overnight, or the specimens didn't have two identifiers that matched the cup to the paperwork.

Hope this helps, I would highly recommend your practice get in touch with a healthcare attorney that has clinical laboratory experience before continuing to bill for these services.
 
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Thank you for your response! Just to clarify, when you say "the location where the test is performed" do you mean the location where the sample was collected, or do you mean the location where the sample was analyzed? Also, do you happen to know anything about whether we should use the date of the sample collection or the date of the sample analysis?
The test is performed in the lab. Collecting a sample isn't the test.

I'm going to echo myself and karamac and say please get in touch with your accrediting organization and echo the suggestion that you contact a consultant or attorney.

Urine drug screens have been a big headache for Medicare and private payers for years - it may be decades now - with over- and improper utilization being the key issues. At this point they will not be patient with practices that make mistakes. In addition, running an accredited lab comes with another raft of potential compliance issues. It may cost some extra money now, but it is worthwhile for a practice to make sure it has everything straight before it starts billing these codes. The alternative could be a recoupment, punitive fines or worse.
 
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