As the story goes that I have heard a couple of versions of, somewhere in Florida in the early 1990s, a urologist or small group of urologists, taking advantage of exceptions in the Stark Law (actually there are multiple parts to this single law) and skirting anti-kickback regulations, started to perform anatomic pathology services and referring those specimens to their laboratories, or themselves.

Folks familiar with this recognize that Stark does allow self-referral of imaging or other diagnostic tests within the practice that is actually ordering or referring the patient for the test.  With passage of Obamacare, these groups are suppose to provide a letter to patients and inform them where else in the area these services may be available.  Kind of like a restaurant showing you a menu for 3 other restaurants after the restaurant manager referred you to his/her restaurant.  Not sure if this happens with any regularity.

Anyways, somewhere in Florida around 20 years ago, in-office pathology was born.

Throughout the 1990s, many urologists had supplemented their revenues through an arrangement with the maker of Lupron, a hormone drug for prostate cancer. Under the arrangement, Lupron producer TAPPharmaceutical Products Inc. sold urologists the drug at a steep discount, while the urologists in turn billed Medicare for the full price.

The arrangement ended in 2001 when several urologists were indicted and TAP Pharmaceutical paid more than $840 million to settle a Justice Department investigation. Deprived of the Lupron profits, some urologists' incomes declined by as much as one-half according to accounts by urologists at that time.  

It is thought that declining reimbursements from Lupron that eventually ended in 2001 led at least in part to urologists looking for other sources of revenue.

According to their website, In-Office Pathology was formed in 2004. The site mentions over 45 installations in eighteen states in urology, gastroenterology, dermatology and multispecialty practices. This company also claims "We do it better than anyone else". Laboratory Economics reviews this regularly and almost every issue contains new physician owned laboratories within urology, GI and dermatology

Recently, as I mentioned earlier this week in a post on over utilization within in-office pathology laboratories, in what may come to be called The Mitchell Report (OK, the Other Mitchell Report), a study published by Dr. Jean MItchell, a noted Geogetown economist confirmed with a multi-year study of such practices an increasing number of biopsies with actually fewer cases of prostate cancer detected by those practices. 

Besides from perhaps doing more rather than less and violating the principle of "first do no harm" fewer diagnosed cases of prostate cancer also hurts their referral rate to their specialized IMRT centers for treatment but that is for another post on another day...

Since the article on this topic was published that American Urologic Association wrote a letter to the editor in the journal the article appeared in referencing a "turf war" and claiming over the past decade the number of jars for best clinical practices increased from 6 to 12, with one biopsy in each jar.  This translates to 12 CPT codes (88305) for the referring physician who will capture the technical and professional component within his/her respective self-owned laboratory.

For more on this story and a copy of the AUA's response and response from In-Office Pathology check out The Pathology Blawg for continuing coverage of the story.

So, what does any of this have to do with digital pathology?  A lot.

I can't really say that I have a horse in this race or any "turf" worth getting into a war over in my practice per se.  This freight train left the station years ago and I do not begrudge IOL, the urology community or pathologists who are employees or part-owners of these laboratories for trying to make a buck, if done correctly and in accordance with best clinical practices.

One of the real problems here is that the technology to process tissue has become so good one can have a tabletop tissue processor, small stainer and coverslipper and IOP with 350 square feet of office space, some drywall and nails and create a full-service anatomic pathology laboratory. I bet it would be hard to find any of the laboratory information system companies geared toward the outreach/outpatient market who does not have at least one install in an operation such as this.  

This is a perfect market for digital pathology.  You could create the possibilty to have a team of prostate experts review cases remote from the provider, patient and histology lab and report those findings with web-based LIS systems.  For straight TC/PC relationships this would work fine where everyone gets paid for what they are doing.  Save the urology or GI group the cost of a pathologist plus additional coverage when that person is attending a prostate pathology meeting or on vacation.

Whole slide imaging could augment the laboratory or completely eliminate the need for pathologists to be onsite beyond some basic medical director functions. Of course the idea here is that some of these urologists and gastroenterologists would want the full global charge capability rather than outsourcing the professional component.  Perhaps if they hire the wrong pathologist they might re-think this model as well.

Here is an idea, I can do a one-year endoscopy fellowship for upper and lower GIs, set up an endoscopy center complete with the latest state of the art endoscopes, build a lab in the back of the practice, do my own biospies and read my own biopsies.  Would anyone have a problem with that? I saw the patient, I did the gross examination via endoscopy and can correlate it with the slides.  Perfect. It turns out that the CPT codes and reimbursements for upper or lower GI endoscopy with biopsy is higher than a UGI or LGI examination without biopsy. Even better. And because it is an invasive procedure, I should take more rather than fewer biopsies to diagnose disease. None of this of course would be driven by financial reasons.  It is all evidence-based and presumably my rates of disease detection would go up or I would consider doing fewer biopsies over the course of time (certainly within 3-5 years) if the yield is no greater (or lower) than a control group (self-referring vs. refer to AP lab).

Cirdan Imaging, a new name in digital pathology, is developing new low-cost digital pathology solutions to improve workflow within the laboratory.

We would like to build up a detailed picture of what digital pathology techniques have been implemented in the laboratory and to determine how far these have penetrated into day-to-day operations.

If you are working anywhere within the pathology laboratory environment or have an interest in new digital pathology techniques, we would appreciate your comments.

You can enter our survey at:

https://www.surveymonkey.com/s/cirdanimaging

The full results of the survey will be available and will be circulated to all respondents. The respondents will also have the opportunity to be entered into a draw for an new iPad.

The Proportionator principle is a significant advance for stereology as a discipline, which will allow scientists to implement stereological study designs also in high-throughput environments. 

Hoersholm, Denmark - April 11, 2012 - Visiopharm A/S, a global leader in Quantitative Digital Pathology, announced today that the European Patent Office has issued the European Patent No. EP 2102817, entitled: Proportionator. 

“With the new Proportionator principle, we have demonstrated a several fold increase in efficiency, when compared to traditional Systematic Uniform Random Sampling”, says Prof. Jens Randel Nyengaard. 

Stereology is a method that allows scientists to answer important research questions about the total amount of microstructure in a tissue volume, including at the organ level; and provide statistically unbiased answers with a known precision. Examples are number of cells, trabeculae, alveoli, and other objects. Also total volume, surface area and total length of structures in an organ are examples of what can reliably be quantified. Stereology is the only way to achieve accurate quantitative data about such tissue properties with a known precision. 

Scientific communities and regulators with a genuine concern about the validity of quantitative histomorphometric data are increasingly requesting stereological data, or at least evidence that such data is concordant with an appropriate stereological reference. Stereology is now becoming a critical component for a useful Quantitative Digital Pathology platform; and a technical discipline that research professionals with a need to study tissue properties can no longer afford to ignore. 

With classical stereological methods and tools, implemented on traditional microscope systems, it is time consuming, repetitive, and costly work to produce stereological data. Typically, service requirements for complex microscope systems are not trivial. Until recently, there were no good alternatives. 

Since 2004, when Visiopharm took over the highly respected CAST™ stereology technology developed by Prof. Gundersen, Visiopharm® has invested massively in the development of innovative and efficient stereological techniques and research tools, in close collaboration with the world-leading stereologists at the Stereological Research Laboratory in Aarhus, Denmark. The result is newCAST™ and a patented set of tools and techniques that efficiently overcome the bottlenecks of classical stereology. 

The Proportionator™ is the latest addition to this toolbox and a revolutionary stereological sampling principle that allows image analysis to guide the sampling of fields, while still providing statistically unbiased results, which is the hallmark of stereological methods. The Proportionator™ was co-developed with the Stereological Research Laboratory in Aarhus, Denmark, which remains the leading innovators and practitioners of stereology, and are the founders of modern design-based stereology. 

Says Prof. Jens Randel Nyengaard, “With the new Proportionator principle, we have demonstrated a several fold increase in efficiency when compared to traditional Systematic Uniform Random Sampling. This is a significant advance for stereology as a discipline, and will allow scientists to implement stereological study designs also in high-throughput environments”. 

Johan Doré, CTO at Visiopharm adds “We see this new patent as an important addition to our Automated Physical Disector patent, which has already made Whole Slide Stereology extremely efficient by automatically aligning serial tissue sections and sampling perfectly aligned disector pairs. Powering this technology with the Proportionator will further enhance the efficiency, saving users countless hours of repetitive work, and providing quality results with very high precision. We believe that the combination of Whole Slide Imaging with automation of stereology is the key to successful implementation of stereology in life-science research”. 

“In order to become successful with stereology, it is important to understand that a complete stereology solution is more than a few standard techniques implemented in a software program. It is critical to have a firm grasp of all steps from tissue sampling over Field Of View sampling to counting and reporting of results. Without access to competent application support, the transition can sometimes be a painful and expensive experience for adopters. For almost a decade, Visiopharm have invested significantly in innovation, development, practical work, and people with the right skill-set; and we are developing our technology in close collaboration with the world-leading stereologists from the Stereological Research Lab in Aarhus. This is giving our customers the certainty and comfort that we are able bring them safely all the way through an important and very rewarding transformation, which is in some ways quite radical”, says Michael Grunkin, CEO of Visiopharm. 

The latest example of how Whole Slide Stereology is applied, using AutodisectorTM and ProportionatorTM, is offered in our Webinar on: “The application of whole slide stereology for cost effective assessment of beta cell changes”, on April 12, 2012m by Jacob Jelsing, MSc, PhD, and CSO from Gubra ApS. 

About Visiopharm Over the past 10 years, Visiopharm image analysis and stereology software has become the preferred Quantitative Digital Pathology solution for leading biopharmaceutical companies, clinical researchers, and academic researchers all over the world. Visiopharm has more than 300 deployed systems worldwide and a large network of distribution and support partners, and is featured in over 400 scientific publications. 

Last month ASCP Press published a new book on pathology informatics, the first multi-authored textbook on the subject geared towards a comprehensive review of the field of pathology informatics.  

Drs. Pantanowitz (UPMC), Weinstein (U of Arizona) and myself have a chapter devoted to telepathology and whole slide imaging.  

A must read (at a great price) for resident or practicing pathologist alike as well as anyone with interests in the diverse nature of pathology informatics for practical management, operations, budgeting and project planning.

Editors:

Liron Pantanowitz, MD
J. Mark Tuthill, MD
Ulysses G.J. Balis, MD

Description:

Order#5831 | ISBN:9780891895831

Pathology Informatics: Theory & Practice is the first multi-authored, current and comprehensive compendium of the diverse and rapidly expanding field of pathology informatics.

It includes all of the critical and practical advice for management, operations, budgeting, and project planning and will serve as a comprehensive review of the field for students, pathologists, and laboratory professionals. This book deals with the role of computing hardware, software and databases involved in the efficient information management for pathology practice, as well as the fundamental science of informatics that is so deeply embedded in this subspecialty.

The text builds from basic principles of computer theory to more sophisticated informatics concepts.

• Databases and data mining; networks and workstations; system interfaces and interoperability. 

• Bioinformatics, imaging informatics, clinical informatics, and public health informatics. 

• Automation and middleware that facilitate complex workflows encountered in both anatomic and clinical pathology practice. 

• Molecular testing and point of care solutions. 

• Coding and nomenclature. 

• Standards in Laboratory Information Systems (LIS) and imaging systems. 

• Project management and business skills. 

• Pathology reporting. 

• Electronic medical records. 

• Specimen tracking and identification. 

• Error reduction and quality management. 

• Training and education in pathology informatics.

Hardbound • 336 pages • 112 figures • 368 tables

List Price: $135.00

Member Price: $105.00

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.

PathXL is working alongside The Royal College of Pathologists to coordinate a pilot project with the aim of exploring the benefits and usage requirements of Digital Pathology by College fellows.

Other objectives include investigating whether the College should create an archive of slides in support of e-learning.

PathXL, a global pioneer in the use of web-based solutions for digital pathology, is providing the image and content management software as well as secure cloud hosting for the pilot. With PathXL, slides can be accessed from any location, including within NHS firewalls. Slide management tasks can also be conducted from any location.

There are two digital scanners installed at the College – one fromNikon /Hamamatsu and the other from Laser 2000/3D Histech. The equipment is available for fellows to use and test, and is located in the Fellows room on the first floor of 2 Carlton House Terrace.

All fellows are welcome and encouraged to use the equipment to scan slides and to comment on the suitability of the equipment and the results generated. A short evaluation form has been designed to capture feedback from users and this important feedback will be used to write a report at the end of the pilot for consideration by Council.

The pilot will run until 6th May – to book a particular time slot please contact the front of house team on scanning@rcpath.org or telephone 020 7451 6707. All of the front of house staff have been trained to use the scanners and software and will be available to help out if required.

For more information please visit http://www.rcpath.org/