biomarker tests and billing

[CHL]

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Wonder if anyone can answer this one...

I'm trying to understand how company's like Oncotech or Response Genetics can get paid... that is, if hospital path labs are already doing some of the HER2, ER/PR, KRAS, P53, etc. tests in house, then how are these external labs (company's) able to get Medicare or Private pay?
Are these tests part of the DRG?
If the patient is already discharged and the test is ordered, after that, who can bill?
The point is, I'm trying to figure out what the motivation is, or why hospitals let the Oncotech's take on these tests instead of doing in-house...
Can the pathologist bill separately for these tests, and under what circumstances?
Same question for these external company's?

Sorry for the string of questions, I'm just trying to understand how this works, and what the impacts to both sides are.
Thanks to anyone who knows some of this!
C

 

[CHL]

anybody?
much appreciated.

 

[Gene_]

If I understand your question correctly, it's a pretty simple answer. The typical scenario for sending tests out is that a physician wants a test performed, but having the test in-house will cost you more than sending it out. Low-volume tests are usually send-outs.

The outside institutions get paid by the "ordering" hospital, not by Medicare directly.

 

[SaltySqueegee]

I assume for some of these biomarkers that licensing is involved for use of technology? Hence the outside companies provide the license and technical support for the analysis.

It is a huge headache to setup a CLIA certified lab to run one or a few biomarkers with low volume. The push these days is to license them to regional labs that are already established.

Someone with more experience want to reign in on this?

 

[CHL]

Thanks for the answers guys...

Just to clarify, I'm not referring to any proprietary tests... just ones like ER/PR, Her2, kras, p53, etc. Your typical oncology profile tests (usually just IHC runs... some mutation analysis).

These are gaining momentum, so I don't think they would fall under the 'low-volume' tag either really.

My understanding is that for inpatient status, the PC falls into Part B, and the TC falls into Part A (DRG). that makes me think that if the hospital sends out for the test, that they are only losing a little money (TC & PC are about equal, and the TC has a small margin... so it's about a wash, I think). As for outpatient orders, the TC & PC fall into Part B, so it's a separately billable event (for either the hospital or an outside lab).

Does this make sense/ring a bell with anybody?

I'm basically also looking to get a sense for whether there would be any real push-back from hospitals against outside labs for these sorts of tests...

thanks again to all who can help!!