How do you deal with outside mol reports??

[LADoc00]

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I have a quick ? for the attendings/senior fellows etc.

How do you deal with outside molecular reports, crap like OncotypeDx where the reports are huge 21-primer data sets with broad sweeping conclusions (one example, there are others...)?

Do you review them and have them typed into the EMR and actually sign them out? Or do you treat them like esoteric clinical lab test and simply input the data into the EMR and fax the report to the clinicians without a staff pathologist having to sign them??

Im very nervous about signing this crap out when I have many doubts about its scientific validity to begin with.

 

[KeratinPearls]

Welcome back LA. We missed your input on this board.

 

[LADoc00]

Welcome back LA. We missed your input on this board.

well...thanks? I need input though, Im about to stun gun some of my staff BART police style (I kid I kid..)

 

[SLUsagar]

I have a quick ? for the attendings/senior fellows etc.

How do you deal with outside molecular reports, crap like OncotypeDx where the reports are huge 21-primer data sets with broad sweeping conclusions (one example, there are others...)?

Do you review them and have them typed into the EMR and actually sign them out? Or do you treat them like esoteric clinical lab test and simply input the data into the EMR and fax the report to the clinicians without a staff pathologist having to sign them??

Im very nervous about signing this crap out when I have many doubts about its scientific validity to begin with.

I do the latter. Not knowing the details of these tests, I don't think there's a need to formally sign them out. Clinicians are requested them, not me. I will signout/incorporate consults I requested, bout it.

 

[pathstudent]

If you didn't order it and it isn't directly related to the diagnosis, I wouldn't add it as an addendum. I would just fax the result to the oncologist. Hopefully the result would just go to him anyway and bypass you completely.

 

[LADoc00]

thank you, as I suspected....I need more inputs though..

 

[2121115]

Here they go straight to the oncologist.

 

[pathstudent]

Didn't oncotype go under? Awhile back the lab told me they recieved a fax from them saying "don't send us anything after today."

We just are asked to pick tumor in a case and then the block goes away. I have never seen a report from any of these tests.

The worst I have been told by the AP lab manager is sometimes they try to bill the lab for the test even though they state on their form that the lab won't be billed.

 

[pathdoc68]

We fax the original report to the referring oncologist and then we scan it into a PDF which is attached as an addendum to the surg path report. Works quite well - thus it is entirely available in our EMR.

 

[lipomas]

Issue an addendum with the important info, put a note also that says "a copy has been faxed to the clinician" and then fax it to the clinician. Then have the secretary scan it so it is saved for when the clinician loses the fax or the patient sees another physician who has no idea what's going on and comes whining to you for help. We don't yet have the capability to scan it in and upload it to the EMR but that is probably the best idea.

If it's not associated with a surgical or cyto or heme case then give it to whoever runs your lab and have them figure out a way to put it in as "other."

 

[LADoc00]

Didn't oncotype go under? Awhile back the lab told me they recieved a fax from them saying "don't send us anything after today."

We just are asked to pick tumor in a case and then the block goes away. I have never seen a report from any of these tests.

The worst I have been told by the AP lab manager is sometimes they try to bill the lab for the test even though they state on their form that the lab won't be billed.

Yes we had a $50000+ bill from Oncotype for tests Pathology didnt order that were sneakily sent to the accounting branch of a hospital. Then when they reach my supervisor, the company claimed they were DRG tests they couldnt directly bill for..which they werent.

The whole thing is very very shady.

Has anyone heard from academics on this Oncotype proprietary poo genotyping crap. They are doing RT-PCR from whole sections? Doing microdissection? Or what? The whole thing reeks of a speakeasy.

Are academic pathologists actually buying this test has validity??

The more dive into this company, the more its looking like some surreal corporate conspiracy starring Clive Owen....not approved by the FDA....No one in the government knows how they are validating these studies...since its a proprietary formula, no outside reference..nada.WTF...

 

[DrBloodmoney]

If it was done on my tissue, I document in an addendum what test was performed and where to find the result (ie. what lab, their accession/test number, etc). If I don't interpret it, the results typically don't make it into my report. The only real exception is for inside or outside flow reports where I include it super-hedge-style like this: 'flow cytometry performed on material from this specimen is reportedly clonal/not clonal etc'.

Bottom line: If I don't interpret it, I don't report it.

 

[pathstudent]

I have seen it ordered in academics too. The oncologists want it.

Remember if a patient is medicare, wait 14 days after the procedure to send the test, otherwise the DRG applies. After 14 days, medicare pays the company directly.

 

[2121115]

Oncologists are ordering it at our institution, not the pathologists. Our program is a high profile academic center and the attending pathologists pretty much roundly agree that Oncotype does not give any more information than a Nottingham grade and a Ki67 immunostain. However, Oncotype has a pretty report and issues a specific number (I think they call it a "recurrence score" or something along those lines). The oncologists like it because they can go to the patient and say "Your recurrence score is 42. That means you have _% chance of recurrent disease over the next 10 years". The kicker is that you can easily look up data showing that a Nottingham grade of _ and a Ki67 proliferation index of _ gives the patient a _% chance of recurrent disease over the next 10 years. Its just that pathologists don't bother to do that, even if it could be easily built into a macro that automatically populates the recurrence % based on data entered.

The Oncotype Dx is only an array that looks at basically the same genes that determine Nottingham grade and proliferation index by Ki67.

 

[deleted314957]

Oncologists are ordering it at our institution, not the pathologists. Our program is a high profile academic center and the attending pathologists pretty much roundly agree that Oncotype does not give any more information than a Nottingham grade and a Ki67 immunostain. However, Oncotype has a pretty report and issues a specific number (I think they call it a "recurrence score" or something along those lines). The oncologists like it because they can go to the patient and say "Your recurrence score is 42. That means you have _% chance of recurrent disease over the next 10 years". The kicker is that you can easily look up data showing that a Nottingham grade of _ and a Ki67 proliferation index of _ gives the patient a _% chance of recurrent disease over the next 10 years. Its just that pathologists don't bother to do that, even if it could be easily built into a macro that automatically populates the recurrence % based on data entered.

The Oncotype Dx is only an array that looks at basically the same genes that determine Nottingham grade and proliferation index by Ki67.

The oncologists order it and get their copy, my lab generally gets a "courtesy" copy which goes in my circular file. neither I or my lab have/had any involvement in that interaction. I see this coming to some kind of end soon due to the expense and questionable "medical necessity" and value. This stuff is also pissing off a large # of patients and some reasonable oncologists due to the MASSIVE bills their patients are getting for out-of-the pocket expense. we have profited from this area of rip off from what my mol/esoteric people tell me

 

[GeoLeoX]

To answer both this question and to address LADoc's comment in the thread about molecular genetic pathology - this is exactly why we need MGP training. If I had my way it would be required for every resident (to a greater extent than it already is). Otherwise we are stuck looking like idiots as clinicians drive diagnostic modalities. I think it's safe to say that this trend will continue - clinicians ordering useless tests like Oncotype, tests not developed with clear input from pathology, and then requesting that we either foot the bill or interpret the results. Pharmacogenomics, whole genome sequencing, molecular profiling of circulating tumor cells, etc.

I am MGP-trained and I don't interpret Oncotype DX results. If we want a dog in the fight we pathologists should be developing these kinds of tests rather than letting them rain down on us, hoping that they stop.

 

[KCShaw]

Or, to look at it differently, find ways to have pathology (the real-world clinical version, not just the basic science pathophysiology background material) actually taught in medical school. I come back to this because I think there's a lot of accuracy in the statement that clinicians are driving diagnostic modalities, and there are enough PhD's or companies out there who can and will develop something to be profitable without really having the understanding, responsibility, or interest in being practical, efficient, or useful compared to other methodologies. But frankly the average clinician is bred to look at such things with blinders on.

In time some of the snake-oil sales will fall away on their own, but we're left with the problem that clinicians largely see pathology as their tool to be used as they like, and don't have the same understanding or perspective as someone with even a modicum of pathology training and willingness to look beyond mindless marketing.

 

[LADoc00]

To answer both this question and to address LADoc's comment in the thread about molecular genetic pathology - this is exactly why we need MGP training. If I had my way it would be required for every resident (to a greater extent than it already is). Otherwise we are stuck looking like idiots as clinicians drive diagnostic modalities. I think it's safe to say that this trend will continue - clinicians ordering useless tests like Oncotype, tests not developed with clear input from pathology, and then requesting that we either foot the bill or interpret the results. Pharmacogenomics, whole genome sequencing, molecular profiling of circulating tumor cells, etc.

I am MGP-trained and I don't interpret Oncotype DX results. If we want a dog in the fight we pathologists should be developing these kinds of tests rather than letting them rain down on us, hoping that they stop.

Here is what I want: I want ALL molecular diagnostic tests personally reviewed by a Pathology with appropriate training.
I want this to have an appropriate CPT code and be appropriately assigned a CMS reimbursement rate.
I want this CPT code to be cut right from the technical amount, meaning Oncotype would have to surrender 20% of every test as a pro fee for pathologists to sign off on this and handle the tissue etc.

I just dont see this happening. Government is WAY too dysfunctional for any other the current wild west crap that is prevailing in the molecular realm.

If you are a mol-trained, do you know anything about Genomic Health/Oncotype?
Can you give a quick expert opinion on it??

 

[GeoLeoX]

Here is what I want: I want ALL molecular diagnostic tests personally reviewed by a Pathology with appropriate training.
I want this to have an appropriate CPT code and be appropriately assigned a CMS reimbursement rate.
I want this CPT code to be cut right from the technical amount, meaning Oncotype would have to surrender 20% of every test as a pro fee for pathologists to sign off on this and handle the tissue etc.

I just dont see this happening. Government is WAY too dysfunctional for any other the current wild west crap that is prevailing in the molecular realm.

If you are a mol-trained, do you know anything about Genomic Health/Oncotype?
Can you give a quick expert opinion on it??

I think Mike Sheree's response above details my experience as well ("aaaaand here's your bill for $3500 for a test for which we don't know what the result means!"). Beyond all the technical/scientific validity arguments that have been made against Oncotype (too small a study group, the same population used to develop the pertinent genes to test was also used to "validate" the assay, etc. etc.) there really isn't any data to support that Oncotype testing either improves outcomes or ends up decreasing cost (in "wasted" SERM therapy). Starting with such a tenuous basis and then embarking on a huge clinical trial (TAILORx) is not the science that I learned about in school. The deck is already stacked in favor of Oncotype. Now there's a colon cancer Oncotype and they are working on other tumors as well (prostate, lung, melanoma)...

I can't speak on the "health" of Genomic Health. I just don't know.

 

[Pathwrath]

I have the secretaries enter the data into the EMR without my having to do anything with it. I don't interpret that garbage and it goes out without my signature. Even doing that much bothers me, but the oncologists want it to access the results.

 

[LADoc00]

I think Mike Sheree's response above details my experience as well ("aaaaand here's your bill for $3500 for a test for which we don't know what the result means!"). Beyond all the technical/scientific validity arguments that have been made against Oncotype (too small a study group, the same population used to develop the pertinent genes to test was also used to "validate" the assay, etc. etc.) there really isn't any data to support that Oncotype testing either improves outcomes or ends up decreasing cost (in "wasted" SERM therapy). Starting with such a tenuous basis and then embarking on a huge clinical trial (TAILORx) is not the science that I learned about in school. The deck is already stacked in favor of Oncotype. Now there's a colon cancer Oncotype and they are working on other tumors as well (prostate, lung, melanoma)...

I can't speak on the "health" of Genomic Health. I just don't know.

Wow...so Oncotype might really be a total scam. Who else is looking into this? Do you have references I can look all this up at?

This is fairly Orwellian.

Thanks for the post!

 

[GeoLeoX]

Wow...so Oncotype might really be a total scam. Who else is looking into this? Do you have references I can look all this up at?

This is fairly Orwellian.

Thanks for the post!

Sorry, beyond the initial NEJM (2004) and the JCO paper in 2006 (I don't recall the reference) and subsequent publications by the same group there isn't much beyond the speculation (mine included). If you want to read for yourself the initial NEJM paper where they publish their methodology it can be found here:

http://www.nejm.org/doi/full/10.105...un&search_tab=authors&andorexacttitleabs=and&


My post is just hearsay (heresy?) and based on my own interpretation of the paper. If you (or anyone else) finds something enlightening, please post.

 

[KeratinPearls]

Yes we had a $50000+ bill from Oncotype for tests Pathology didnt order that were sneakily sent to the accounting branch of a hospital. Then when they reach my supervisor, the company claimed they were DRG tests they couldnt directly bill for..which they werent.

The whole thing is very very shady.

Has anyone heard from academics on this Oncotype proprietary poo genotyping crap. They are doing RT-PCR from whole sections? Doing microdissection? Or what? The whole thing reeks of a speakeasy.

Are academic pathologists actually buying this test has validity??

The more dive into this company, the more its looking like some surreal corporate conspiracy starring Clive Owen....not approved by the FDA....No one in the government knows how they are validating these studies...since its a proprietary formula, no outside reference..nada.WTF...

Holy cow! $50,000 bill? Genomic Health, who I think owns the patent, must be balling. What about Dr. Paik?

 

[pathstudent]

It is true about onologists marginalizing pathologists. There has been a movement recently about histologic subtyping mattering in dx of nsclc. I just heard a talk by a ultra premier academic oncologist saying histology doesn't matter and that a panel of eight or so molecular studies dictate chemotherapy. Personally I think oncs would like to take us completely out of the picture and just have the biopsies done in their cancer care centers and hit them with a microarray. And from what I can tell is ocologists are more knowledgeable about gene studies, psthopfysilogy and therapy than pathologists. The salesmen for the reference labs have done a good job

To answer both this question and to address LADoc's comment in the thread about molecular genetic pathology - this is exactly why we need MGP training. If I had my way it would be required for every resident (to a greater extent than it already is). Otherwise we are stuck looking like idiots as clinicians drive diagnostic modalities. I think it's safe to say that this trend will continue - clinicians ordering useless tests like Oncotype, tests not developed with clear input from pathology, and then requesting that we either foot the bill or interpret the results. Pharmacogenomics, whole genome sequencing, molecular profiling of circulating tumor cells, etc.

I am MGP-trained and I don't interpret Oncotype DX results. If we want a dog in the fight we pathologists should be developing these kinds of tests rather than letting them rain down on us, hoping that they stop.

 

[GeoLeoX]

Wow...so Oncotype might really be a total scam. Who else is looking into this? Do you have references I can look all this up at?

So, as usual, this forum got me thinking and I decided to do some digging into the inter-tubes to see if I could find some more data. Unfortunately, nothing really concrete. However, I did turn up a few interesting bits:

http://www.genomeweb.com/dxpgx/wall...c-healths-colon-cancer-dx-survey-shows-some-d

That's frightening, huh?

This guy has written a few posts about Oncotype and applied some critical thinking:

http://www.mindsay.com/tags/oncotype

 

[Ziehl-Neelsen]

My favorite paper on the subject:

http://www.ncbi.nlm.nih.gov/pubmed/18360352

We went over the paper in Journal Club (GeoLeo and Dr. Bloodmoney may remember), and I subsequently gave it to my wife (a staff internist who will be starting Heme/Onc fellowship when she returns from Iraq) to distribute amongst the Heme/Onc staff.

The amount of blowback she received from her staff was unbelievable, and this isn't even one of the papers that attempts to discredit the test. It merely points out that in a majority of cases, oncotype provides no additional information outside the nottingham score. Furthermore, while oncotype examines genotypic factors, it is the phenotypic factors that determine the natural history of the tumor.

My wife plans on being far more circumspect with the test than her colleagues, but patients drive a large amount of the testing. It's, in the words of Will Smith, the "new hotness" and must be ordered. As we all know the goal is to have insurance cover it, because if patient's had to foot the bill, suddenly that Nottingham score might look better to the patient.

 

[Substance]

I looked into this sham test last year, while the clinical trials were going on. Around the same time, company insiders(CEO etc) sold off a ton of their shares. I guess they knew that the results of the study were not going to be promising(blinded study? yeah right)

This test holds no value for determining chemotherapeutic response in intermediate-grade tumors. The reason it still exists is that the public wants to have a cancer test, effective or not; they just want something to be done.

Notice that recently, the big fund that owns the majority stake in Genomic Health repurchased shares. My guess is that they are riding the hype train until it arrives at reality station.

Give it a few years: insurance won't cover this useless test, or something better will come out. Genomic Health will go under.

 

[Substance]

My favorite paper on the subject:

http://www.ncbi.nlm.nih.gov/pubmed/18360352

We went over the paper in Journal Club (GeoLeo and Dr. Bloodmoney may remember), and I subsequently gave it to my wife (a staff internist who will be starting Heme/Onc fellowship when she returns from Iraq) to distribute amongst the Heme/Onc staff.

The amount of blowback she received from her staff was unbelievable, and this isn't even one of the papers that attempts to discredit the test. It merely points out that in a majority of cases, oncotype provides no additional information outside the nottingham score. Furthermore, while oncotype examines genotypic factors, it is the phenotypic factors that determine the natural history of the tumor.

My wife plans on being far more circumspect with the test than her colleagues, but patients drive a large amount of the testing. It's, in the words of Will Smith, the "new hotness" and must be ordered. As we all know the goal is to have insurance cover it, because if patient's had to foot the bill, suddenly that Nottingham score might look better to the patient.

As mentioned above, some suspect oncologists will resist any badmouthing of a potential goldmine genetic test. More money in their pockets.

 

[zao275]

The reason it still exists is that the public wants to have a cancer test, effective or not; they just want something to be done.

I think this hits the nail on the head. Which brings up the question of marketing tests and drugs and what a company should and should not be able to say, as it changes the perception of the public.

 

[APCPPathologist]

Give it a few years: insurance won't cover this useless test, or something better will come out. Genomic Health will go under.

Genomic Health is an interesting company --it went to $100 million in annual revenue in less than 5 years (took Myriad almost 15 years to do that). It is a multiple gene Quantitative RT-PCR test run in only the california lab facility. They are CAP accredited and were approved by the california medicare administrator early in the process (like a couple of years ago). The reimbursement varies from private insurer. They have refused to particpate in the FDA's IVDMIA guidance document and now that FDA is restructuring the entire LDT (laboratory developed test) process they (Genomic Health) will likely play how ever they want for the near future.

The breast test as previously mentioned really 'impressed' some clinicians before ANY prospective data became available -- actually no prospective data is available - ZIP. As mentioned TAILORx will be the first prospective trial - but don't hold your breath for it.

At last year's CAP meeting some ***** oncologist (actually a very prominent one that did the clinical validation for a lot of the current breast markers) scoffed at the pathologist's ability to interpret er/pr her2---and said we needed more consistent tests like oncotypedx - Ridiculous, he has no clue what is going on at genomic health - nobody does.

Basically, Genomic Health has some great marketing and regulatory folks and has threaded the needle better than just about any laboratory developed test company. And they've done this with minimal to no propsective clinical data!

Their colon test was a FAIL --but they started marketing it this year.

I don't blame the clinicians - they don't understand testing - they just want numbers. This is across the board of tests - not just molecular genetics but also serologic tests like the Prometheus IBD panels. Clinicians don't have a clue how it works, but since it's offered commercially in a clia certified lab they assume it is legit.

For all my complaining - I send out all these tests ASAP and without a question since that is what my clinician and lab director overlords dictate.

 

[BU Pathology]

The Government Accounting Office has done an investigation of direct to consumer genetic tests and prepared a rather scathing report. There is also an audio of phone calls where consumers are speaking with company representatives.

http://www.gao.gov/products/GAO-10-847T

 

[Substance]

I don't blame the clinicians - they don't understand testing - they just want numbers. .

I blame them. They should not be ordering and depending on tests they do not understand.

 

[KCShaw]

There's probably blame enough to go around. But in principle I tend to agree -- clinicians, like all practitioners, need to know their limits and not practice outside of them. Most clinicians are pretty good about asking a cardiologist, endocrinologist, or orthopedic surgeon for consultation or advice.. but not so much when it comes to laboratory testing. Be that as it may, how many pathologists are ahead of the curve when it comes to knowing about and proactively discussing with clinicians the pros & cons of "new" laboratory tests? Especially tests lumped as CP-only? It's hard to be taken seriously when as a group we put ourselves behind the 8-ball and are largely reactionary rather than proactive.