A CAP Statline from yesterday I saw on another blog mentions that an independent study shows the first clear evidence of self-referral of anatomic pathology services leads to increased utilization as well as higher Medicare spending and lower rates of cancer detection.

For CAP members, there will be a special webinar on the topic end of this week (see below for details).

This is a topic that any pathologist who is aware of anatomic pathology services being insourced, or "brought in house" by clinicians, referred to as in-office labs (IOLs) or POD labs, has suspected for as long as the practice has been in place.  The idea that perhaps some, if not all, of urologist IOLs or POD labs, and let's for the sake of argument, just say that is a minority of labs doing so, perform more testing, bill Medicare more, but do not increase their yield of cancer detection beyond conventional means of doing so with fewer tests wil come as no surprise to practicing pathologists aware of some of these practices at least.

At first glance it does not appear that the study looked at excess immunohistochemical stains that may be performed without providing clinically relevant information.  It looks like without more complete reading of the study design and findings that the author looked at number of biopsies inasmuch as additonal ancillary studies.  Nonetheless, it is a form of overutilization whether you look at number of biopsies or cups or stains, particularly if doing more biopsies does not increase the yield of cancer detection.

This is however a sensitive issue as pathologists are also physicians who own and/or operate laboratories where additional testing may also provide some financial incentives without necessarily being in the bests interests of patient care.  And pathologists can also self-refer vis-a-vis immunohistochemical stains, special histochemistry stains or perhaps molecular tests that are not needed, indicated or non-contributory in terms of diagnosis, treatment and management.

Do we reallly need to perform Alcian blue stains on every esophageal biopsy to insure we do not miss intestinal metaplasia?  Are Giemsa stains terribly helpful on every stomach biopsy? Some will claim their clinicians request these for these types of specimens and so they do it.  It reminds me of taking a "shotgun" approach with immunohistochemistry illustrated in this video.  Make sure to order the vimentin stain.  A negative or positive result among the other 26 stains will help to cinch the diagnosis and by doing them at once, despite not using the H&E morphology as a guide, will surely lead the right diagnosis quicker and more accurately without any prejudice to perhaps just doing a few fewer stains which will provide the same result with the correct diagnosis. 

I was saw a case in referral of a liver biopsy from an elderly gentlemen with biopsy proven colon cancer processed at the same lab and read by the same pathologist who was interpreting the liver biopsy.  The H&E appearance on the liver biopsy was identical to the colon cancer from the biopsy of that a week prior.  This, however, not to be undone and believing no case is complete unless the requisite number of immunostains are done, ordered 18 immunohistochemical stains on the liver biopsy.  18.  For a routine, typical, colon cancer metastatic to liver, of course metastatic at the time of the initial biopsy a week prior. The patient was seen at our institution for treatment.  The H&E of the liver biopsy and the H&E of the colon biopsy were likely all that would have been needed.  The CK20 and CDX-2 stain were confirmatory and the other stains, including MUC antigens I did not know existed, help proved, in case there was any doubt, that this was not likely a brain, lung, kidney, liver, pancreas, testicular, prostate, bladder or gallbladder primary metastatic to the liver.

The point is the urologists with the labs, specifically those in this study to be clear and without knowing specifically who they are, are not the first physicians/lab directors to come up with this or take advantage of the ability to self-refer on lab specimens within their shop.  

As a pathologist, we should applaud CAP's efforts on this issue in providing sound data to illustrate the iappropriate clinical business practices but we should also as a specialty be mindful of what is appropriate as well in our own laboratories if we are going to claim these in-office labs are conducting themselves inappropriately.

Perhaps this could be the start of removing anatomic pathology services from the exception on the Stark Law but we must also set clear examples of appropriate use of ancillary tests.

April 9—Self-referring urologists billed Medicare for nearly 75% more anatomic pathology (AP) specimens compared to non self-referring physicians, according to a study published today in a leading health care policy journal. Furthermore, the study found no increase in cancer detection for the patients of self-referring physicians—in fact, the detection rate was 14% lower than that of non self-referring physicians.

These findings, from an independent study co-funded by the CAP, provide the first clear evidence that self-referral of anatomic pathology services leads to increased utilization, higher Medicare spending, and lower rates of cancer detection. The study, led by renowned Georgetown University health care economist Jean Mitchell, PhD, will appear in the April 2012 issue of Health Affairs and is now available on the journal’s website.

“The findings are irrefutable,” said CAP President Stanley J. Robboy MD, FCAP. “The Mitchell study raises a red flag on self-referral, giving evidence that it tends to increase utilization and cost with little or no patient benefit.”

This analysis also supports the College’s long-standing position that self-referral of anatomic pathology services needs to end by removing anatomic pathology from the exception in the Stark Law.

“We need to close a loophole in the law to prevent anatomic pathology from being referred to labs where referring physicians have a financial self interest,” said Dr. Robboy.

• Watch and listen to the study’s author, noted Georgetown economist Dr. Jean Mitchell in a special CAP members-only Webinar this Friday, April 13, 1:30pm-2:30pm EST. Register online.
• Read the full article on the Health Affairs website, and more details in this week’s Statline.
• Visit the new Self-Referral Resource Center on the Advocacy website for more on the study and CAP’s efforts to stop self-referral of anatomic pathology testing services.