This is the third (and last) in a series of posts on Laboratory Developed Tests (LDT).  In this installment, I discuss where to find comparative analysis reviews of LDTs and add a few thoughts on LDT policies for pathology departments, cancer centers, and healthcare systems.  The prior two posts covered the definition of LDTs, the current state of regulatory oversight, and the FDA’s decision to end enforcement discretion and regulate LDTs.

The number and complexity of esoteric molecular oncology tests is rapidly increasing, as are the other demands for patients’ tumor tissue for clinical trials and biorepositories.  If a pathologist or laboratory medical director were fortunate enough to be asked for input on which tests are well validated, where should he/she begin looking for data and evidence-based guidelines?  A PubMed search is always a good place to start, but there are other resources that specifically address some of these questions.

For comprehensive summaries of the available evidence, two of the best sources I have found are the Technology Assessment Reports from the Technology Assessment Program (TAP) at the Agency for Healthcare Research and Quality (AHRQ) and the BlueCross BlueShield Association (BCBSA) Technology Evaluation Center (TEC). 

The Coverage and Analysis Group at the Centers for Medicare & Medicaid Services (CMS) recently asked  TAP at AHRQ to collect the available scientific evidence on the quality and validation of laboratory-developed molecular tests. The report, issued in May of 2010,  summarizes the data and potential areas of concern involving analytical validation, proficiency testing, and lack of adequate control materials for the more sophisticated multi-gene assays.  However, it does not include guidelines or recommendations on the tests themselves. 

The BCBSA TEC is an evidence-based practice center (EPC) for the AHRQ dedicated to comprehensive comparative effectiveness reviews on cancer and infectious diseases. In TEC Assessments, five criteria are used to determine if a technology improves health outcomes: 1) The technology must have final approval from the appropriate governmental regulatory bodies, 2) The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, 3) The technology must improve the net health outcome, 4) The technology must be as beneficial as any established alternatives, and 5) The improvement must be attainable outside the investigational settings.

The TEC Assessments cover a variety of topics and are not limited to laboratory tests.  However, using breast cancer as an example, one can find TEC Assessments on molecular testing and Laboratory Developed Tests (LDTs) that are timely and relevant.  In 2007, the BCBSA TEC published an assessment of breast cancer gene expression profiling tests and concluded that Oncotype Dx (Genomic Health, Redwood City, CA) “provides significant recurrence risk information in addition to conventional criteria for individual patient risk classification” for patients with hormone receptor-positive, lymph node-negative tumors.  In 2010, the BCBS TEC published an assessment of gene expression profiling tests for adjuvant therapy selection for women with lymph node-positive breast cancer, and concluded that Oncotype Dx did not meet TEC criteria for that patient population.

At our institution, the pathology department was recently asked by the cancer center to draft a policy for evaluating the molecular oncology send-out tests with an emphasis LDTs.  By relying heavily on the BCBSA TEC criteria and including a few other issues of concern to us, we drafted the following policy:

1.     The scientific and medical data must permit conclusions about the effect of the test results on clinical management.

2.     The test must have final approval from the appropriate government regulating bodies.

3.     A disease-specific working group in the cancer center (e.g. program directors and regular attendees of breast, lung, sarcoma tumor boards, and others) will review scientific and medical data and regulatory approval status.

4.     The Department of Pathology (i.e. Medical Director of Surgical Pathology, Medical Director of Laboratories, Director of Molecular Diagnostics and appropriate sub-specialty pathologists) will review the scientific and medical data and regulatory approval status after review in #3.

5.     Physicians ordering send-out molecular oncology tests must comply with he conflict of interest policies of the healthcare system and its hospitals.

6.     Physicians ordering send-out molecular oncology tests will inform patients about cost and payment (or lack thereof) by third-party payers.

We presented this draft to the cancer committee for our cancer center, and now the real discussion begins.

What would a set of guidelines for your institution look like?  Are there better sources of information than the ones I mentioned above?  As a pathologist, how much do you want to be involved in advising your clinical colleagues about these tests?  How would a hospital or healthcare system document the compliance of the ordering physicians with conflict of interest policies?  Should patients be informed about cost, and, if so, by whom?

WHEN AND WHERE: April 15-17, 2011 at InterContinental Hotel, Rosemont, IL

Sponsored by CAP Foundation

http://www.cap.org/apps/docs/futurescape/index.html

They say “the best way to predict the future is to create it” and at Futurescape IV, academics, practicing pathologists, laboratory staff and medical technologists have the rare opportunity to do just that.  Futurescape IV is a networking conference focused on immediate trends and technologies as the impact the pathology practice today and tomorrow.

Through interactive sessions and technology discussions you have a unique opportunity to

• Explore the transfer of innovation in to improved clinical practice
• Learn how the latest technologies may define future treatment trends
• Meet, network with pioneering innovators in areas such as molecular pathology or digital, data and information management
• Exchange ideas during the pre-conference industry workshops with Aperio and Definiens

Register now through January 2011 to benefit from the early bird special rate of $325 for CAP members, $125 for residents and $525 for non-CAP members.

http://www.cap.org/apps/docs/futurescape/index.html

This is the second in a series of three posts on Laboratory Developed Tests (LDT).  In this installment, I summarize developments in the past few years as the FDA eventually announced its intention to more actively regulate all LDTs.  The first first post covered the definition of LDTs and the current state of regulatory oversight.  In the next (and last) post, I discuss where to find comparative analysis reviews of LDTs and add a few thoughts on LDT policies for pathology departments, cancer centers, and healthcare systems.  

The FDA recently decided to end its policy of enforcement discretion and more actively regulate LDTs.  The agency has said it plans adopt a phased-in risk-based regulatory framework, but the details have yet to be established.  A summary of key developments over the past few years is provided below:

• The FDA issued a revised draft guidance in 2007 stating that In Vitro Diagnostic Multivariate Index Assays (IVDMIA) do not fall in the category of LDTs for which the agency had exercised enforcement discretion.  This was a revision to a draft guidance issued in 2006.
• The FDA cleared the first IVDMIA, MammaPrint® (a breast cancer gene expression profiling test), in February of 2007. 
• The FDA later dropped its proposal to regulate IVDMIA as a subset of LDTs and announced plans to more actively regulate LDTs in general.
• In April of 2008, the (Health and Human Services) Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS), recommended that "FDA should address all laboratory tests in a manner that takes advantage of its current experience in evaluating laboratory tests". 
• In an effort to get more input from laboratory professionals, treating physicians, patients, and industry, the FDA and the Center for Devices and Radiological Health (CDRH) held a public meeting on the oversight of LDTs in July 2010.  The subsequent public comment period originally scheduled to end on August 15, 2010 was extended to September 25, 2010.
• In July 2010 the FDA and CMS signed a Memorandum of Understanding (MOU) stating that the agencies would work together to build the infrastructure and processes required to evaluate LDTs safety, efficacy, coverage, payment, etc.

The FDA expects to begin providing details of the new regulatory structure a few months after the July 2010 meeting.  At the time this post was written (December 30, 2010), few, if any, new details were available.

Several key questions remain:

What type of premarket evaluation will be required?  Will companies and laboratories go through existing premarket evaluation [i.e. 510(k) clearance or premarket approval (PMA)] or a modified (or new) version of these requirements designed for LDTs?

The language in the MOU between the FDA and CMS included the words “payment” and coverage.”  But, will the agencies indeed work together to match reimbursement to the increased cost of premarket evaluation by the FDA?

What will the risk-based framework for evaluation of LDTs look like?  The College of American Pathologists (CAP) proposed it own risk-based scheme for LDTs.  It consists of three categories: low, moderate, and high risk.  The risk stratification is based on the likelihood of an incorrect result leading to serious morbidity/mortality and whether the test methodology is well understood and/or independently verifiable.  Premarket review by the FDA would only be required for high risk LDTs.  Moderate risk LDTs would undergo prior review and approval by CMS-deemed accreditors. 

If you would like to follow developments in the regulation of  LDTs, I recommend the following sources:

GenomeWeb (take a look at Kirell Lakhman’s blog, The Sample, and Turna Ray’s articles in the Pharmacogenomics Reporter)

Myraqa (timely blog posts by Mya Thomae and others)

American Clinical Laboratory Association (the ACLA and its president, Alan Mertz, have followed the evolution of LDT regulation closely, click here for more from their web site)

College of American Pathologists (information on LDTs can be found under the Advocacy tab)

It has been awhile since I came across another pathologist blogger.  My friend Dr. Brian Moore over at Neuropathology Blog mentioned a new pathology blog that focuses on academic and forensic neuropathology entitled "Path Wonk".  Brian's post mentions:

"Jeremy Deisch, M.D., a  neuropathology fellow at the UT Southwestern Medical Center in Dallas,recently has begun a pathology blog which focuses on neuropathology and forensic pathology."  

Some really nice posts to date even for a non-neuropathologist.  Look forward to more interesting stories and cases and welcome to the blogosphere!

This video is a brief introduction to Pixcelldata's Collibio product (video only). The video demonstrates some of the functionality within the "My Images" section of the product, registering an image server in Collibio and adding image links from an image server into Collibio.

FREE Special Edition White Paper

As registration began early this month for providers to participate in HHS’s meaningful use electronic health record (EHR) program, CAP leaders began a dialogue with agency officials to not only clarify the impact of this final rule on pathologists, but also to ensure that members are not penalized for not meeting meaningful use requirements when the program is fully implemented in 2015.

Because meaningful use eligibility is such a concern, the CAP has formed an HIT Policy Workgroup comprised of members from the Council of Government and Professional Affairs (CGPA) and the Diagnostic Intelligence and Healthcare Information Technology (DIHIT) Committee. This Workgroup’s co-chairs—David Booker, MD, FCAP, and Richard Friedberg, MD, PhD, FCAP—met with HHS officials on Jan. 7 to launch a discussion about these concerns.

“The meeting clarified for CMS and ONC [Office of the National Coordinator for Health Information Technology] that pathologists cannot comply with the meaningful use rules,” said Dr. Booker. “However, the meeting also underscored that pathologists are supportive of interoperable electronic health care IT systems, have long been the leaders in clinical HIT, and must be involved in ensuring that lab and pathology data are correctly incorporated into the EHR.”

Formidable Compliance Challenges

Despite being at the forefront of HIT adoption, pathologists—regardless of their practice setting—will have difficulty qualifying for incentive payments authorized through the Health Information Technology for Economic and Clinical Health Act (HITECH) portion of the American Recovery and Reinvestment Act (ARRA). According to this law, a maximum of $44,000 in incentive payments is available for Medicare physicians who demonstrate “meaningful use” by meeting the definition of an eligible provider (EP) while using “certified” electronic health record software.

However, the CAP is concerned some details of the “meaningful use” regulation prevent pathologists from becoming fully compliant. Therefore, questions surround whether or not CAP members will be subjected to penalties starting in 2015. Beginning in 2015, CMS will reduce Medicare payments to EPs who do not meet the rule’s requirements. Penalties range from 1% of Medicare fees in 2015 and would grow to 5% beginning in 2017.

One example of the confusion: the meaningful use rule requires pathologists to maintain 80% of patient records in certified EHRs; however, pathologists typically use LIS or APIS systems rather than the full EHR. A whole host of additional “meaningful use” requirements are outside of pathologists scope of practice and usual interaction with patients.

In addition, CAP members are confused about how—and if—they fit into this rule’s definitions of eligible providers (EPs). Since the HITECH Act provides federal funding to both physicians and hospitals to help offset the cost of purchasing health information technology, the regulations are specifically written to prevent hospital-based physicians from “double dipping.” While a substantial portion of pathologists practice in hospital-based settings, the passage of the Continuing Education Act of 2010 designated most pathologists as non-hospital based EPs. Therefore, many CAP members who practice in hospital-based are uncertain about whether they need to comply with meaningful use rules.

CAP is closely monitoring this issue and remains committed to working with key Congressional stakeholders and federal agencies to address our concerns. Keep watching to Statline for continuing coverage of this issue.

I am interested in getting a sense from readers that are willing to do so to tell me how they read this blog (and others).  Specifically, do you follow content or does content follow you?  I try to use a reader to have content follow me. In doing so, I peruse the headline or title of the feed, post or news item and drill down into the content if it seems of interest to me.  For whatever reason there are also sites and blogs that I go to rather than having in a reader.  Just curious what your habits may be.  Increasingly, I also find myself, however I read what I want via use of small(er) screen technology either through my smartphone or iPad.  I think this is also a common trend that will continue negating the need for desktop computer viewing/reading. 

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In this series of posts on Laboratory Developed Tests (LDTs), I discuss the history of the regulation of LDTs and impending changes (posts #1 and #2).  I also discuss possible criteria that pathologists, treating physicians, and healthcare systems could use to determine which tests are well validated (post #3).

I think there are at least four reasons for pathologists to learn more about LDTs right now:  1) the number of LDTs, particularly in oncology, is rapidly increasing, 2) the demands for fresh and fixed tumor tissue for reserch and biorepositories are also rapidly increasing, 3) some of these assays are associated with significant costs (thousands of dollars per test in many instances), 4) the regulatory oversight of LDTs is undergoing a major change.

Laboratoty Developed Tets (LDTs) are tests that are developed, validated, and performed in only one laboratory.  Unlike most tests, LDTs are not sold or distributed to other commercial or hospital-based laboratories. Many of these tests are complex genetic assays, some of which involve analyzing the expression of multiple genes to generate a predictive or prognostic index for a type of cancer or to help determine the site of origin for a metastatic tumor.  The tests that analyze multiple genes or evaluate combinations of results were formerly referred to as In Vitro Diagnostic Multivariate Index Assays (IVDMIA) (more on this in the next post). A gene expression profiling test for breast cancer would be one example of an IVDMIA.

Food and Drug Administration (FDA) clearance or approval is not required for LDTs.  The laboratory that develops and performs the test is regulated by the Center for Medicare and Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA).  The labs obtain a CLIA license and perform all the tests in their own facility.  CLIA regulates the development and analytical performance of LDTs, requiring the tests to meet standards for accuracy, precision, total sensitivity, and total specificity.  Over the past few years, the disccusion about the regulation of analytical and clinical validation of LDTs and the role of the FDA has intensified.  The policy of the FDA, until recently, has been one of “enforcement discretion,” meaning that the FDA believes it has the legal authority to regulate LDTs but has chosen not to.  The FDA recently announced an end to its policy of enforcement discretion for LDTs, and a new regulatory framework for LDTs is being drafted (more on that in the next post).  This proposed change in the oversight of LDTs has become quite controversial, to say the least.

The explosion in the number of patients tested by LDTs, particularly patients with (or at risk for) breast cancer, has prompted several questions....

Some in the regulatory agencies and healthcare have asked: How are patient safety and the effectiveness of the tests for the intended uses established?  Do we want treatment decisions for tens of thousands of patients to be based on tests over which the FDA exercises no oversight?  What type of premarket evaluation by the FDA (if any) should be required?

Members of industry and healthcare providers have asked: How will an increased regulatory burden affect assay development?  How will analytical and clinical validity be balanced with patient safety and access to cutting-edge technology that may help guide treatment decisions?  Will reimbursement for the tests keep up with the anticipated increased costs of development and compliance?

What do you think? Is FDA oversight of LDTs is long overdue or a new and unnecessary barrier to innovation in complex diagnostic testing?

In the next installment, I will briefly discuss recent developments in regulation of LDTs through the end of 2010.  Ben Calhoun

Ben Calhoun is a practicing surgical pathologist in Charlotte, North Carolina with expertise in breast pathology.  He trained at Yale and Vanderbilt and went to medical school and graduate school at the Medical College of Georgia. He is the Medical Director of Surgical Pathology for Carolinas Laboratory Network and, in his spare time, is an MBA student in the McColl School of Business at Queens University in Charlotte (anticipated graduation in December 2011).

Ben's initial posts have focused on Accountable Care Organizations (ACOs) and Laboratory Developed Tests (LDTs).

Just days after the CMS opened registration for the Medicare and Medicaid electronic health-record incentive programs, the first provider payments have been issued.

The state of Kentucky processed a $2.86 million payment to the University of Kentucky Healthcare, amounting to one-third of total payments for the hospital's participation in the Medicaid EHR incentive program. And Oklahoma issued payments to two physicians at the Gastorf Family Clinic of Durant, Okla., for $21,250 each, for having adopted certified EHR systems, also under the Medicaid incentive program.

Funding for the incentive payments programs was made available through the Health Information Technology for Economic and Clinical Health Act provisions of the American Recovery and Reinvestment Act of 2009. Registration for the program opened Jan. 3. - Rebecca Vesely

The popular social networking site for professionals could make the initial stock offering in the first three months of this year. The size of the offering is expected to be small relative to the company's value.

By Jessica Guynn, Los Angeles Times

January 7, 2011

Reporting from San Francisco

No one knows for sure how pathologists will fit into ACOs, but it's worth thinking about before the structure of ACOs is finalized.  In this installment, I discuss a newly announced role for the College of American Pathologists (CAP) in the ACO discusion and the response of the American Society for Clinical Pathology (ASCP) to the request for information (RFI) from the Center for Medicare and Medicaid Services (CMS). In the prior post, I covered the definition of ACOs and discussed possibilities for the leadership of ACOs (hospitals versus physicians).

The College of American Pathologists (CAP) recently announced that it is joining the 2010-2011 Brookings-Dartmouth Accountable Care Organization (ACO) Learning Network. The announcement contains the following additional information about the Network:  “The Network is headed up by Dartmouth Institute for Health Policy and Clinical Practice’s Elliott Fisher, MD, and former CMS Administrator Mark McClellan, MD, PhD, who is now with the Brookings Institution’s Engelberg Center for Health Care Reform. Both Drs. Fisher and McClellan are leading experts on ACOs; Dr. Fisher is credited with launching the ACO concept.”  The web site for the Brookings-Dartmouth ACO Learning Network is being re-designed, but it already contains valuable information about the network as well as presentations by Drs. Fisher and McClellan at the National ACO Summit in June 2010. 

The stated goals for the CAP’s involvement in the Network are: 1) to maintain input into and awareness of the evolving structure of ACOs, and 2) to raise awareness of ACO issues that may disproportionately affect pathologists. The CAP also plans to launch an ACO Resource Center (it’s not ready yet; look for it on the Advocacy page of the CAP web site under CAP Issue Resource Centers).

The Center for Medicare and Medicaid Services (CMS) issued a Request for Information (RFI) on the development and structure of ACOs.  In response, The American Society for Clinical Pathology (ASCP) wrote a letter to Dr. Donald Berwick on Decmber 2, 2010, and the ASCP’s point of view was described in a recent e-policy news brief (excerpted below):

"…….ASCP outlined the contributions that pathologists can make to ACOs as part of their managing structure. The agency is developing regulations to establish, structure, and outline how ACOs will function in the provision of healthcare services now that the implementation of Affordable Care Act has begun.

In urging the inclusion of pathology, ASCP wrote, 'Given the considerable role that pathology and laboratory testing plays in patient care, ASCP believes that ACOs that include pathologists as part of their key physician specialties are better positioned to attain the important goals of reduced costs, increased quality, and improved patient experience.'

In addition to identifying pathologists among the physician specialties central to the ACO framework, ASCP urged that pathologists be able to participate in any gain-sharing arrangements available to other physician members of the ACO team. The CMS RFI comes in advance of the highly anticipated ACO rule, which should be published by the end of January."

What do you think?  Will the efforts of the CAP and ASCP manage to shape the debate on ACOs?  Will pathologists be part of the “managing structure” of ACOs?  Are the multiple professional societies for pathologists coordinating their efforts for maximum impact or diluting what little influence pathologists might have?

This concludes a two-part series on Accountable Care Organizations (ACOs).  In future poss we will turn our attention to changes in the regulation of Laboratory Developed Tests (LDTs).  Ben Calhoun

-- This post was written by Ben Calhoun, MD, PhD. Dr. Calhoun is a practicing surgical pathologist in Charlotte, North Carolina with expertise in breast pathology.  He trained at Yale and Vanderbilt and went to medical school and graduate school at the Medical College of Georgia. He is the Medical Director of Surgical Pathology for Carolinas Laboratory Network and, in his spare time, is an MBA student in the McColl School of Business at Queens University in Charlotte (anticipated graduation in December 2011).

Cambridge Research & Instrumentation, Inc. (CRi), a leader in multicolor imaging solutions for preclinical and clinical research, recently announced the newest addition to the award-winning Nuance™ multispectral imaging product family for multicolor tissue and cell-based imaging. The TRIO system is compact, multipurpose and affordable, offering a simplified interface and versatile design to fit any microscope with a camera-mount. This newest offering strengthens CRi’s objective to offer a comprehensive and intuitive solution that enables customers from basic research through pre-clinical drug discovery to reveal correlations between protein expression in intact tissue and clinical outcomes.

Multi-analyte detection from intact tissue and cells often poses a challenge since overlapping signals and the sample’s own background autofluorescence can mask critical information. TRIO’s multispectral imaging technology found in all of CRi’s multispectral systems effectively unmixes overlapping labels in fluorescence or brightfield samples. It has a new easy-to-use software interface designed to preclude the need to have expert-level knowledge of multispectral imaging, a common hurdle that faces many scientists who want to be able to image multiple markers from a single tissue sample. TRIO’s interface ensures that data can be obtained in a matter of minutes.

 “Detecting multiple markers in intact tissue sections and in individual tumor cells is an important component of targeted drug and molecular diagnostic development,” said Darren Lee, Vice President of Marketing at CRi.  “We understand the hurdles associated with doing multilabel imaging, including the complexities of interpreting multispectral data. We are very excited about TRIO because it makes multicolor imaging of tissue and cells much easier and more accessible to the mainstream researcher.” Lee added, “TRIO fits nicely within our core strategies, providing solutions that help address one of the biggest challenges facing scientists: trying to understand the mechanisms behind disease.”

The following post and subsequent posts to follow on ACOs and Laboratory Developed Tests (LDTs) have been written by Ben Calhoun, MD, PhD. Dr. Calhoun is a practicing surgical pathologist in Charlotte, North Carolina with expertise in breast pathology.  He trained at Yale and Vanderbilt and went to medical school and graduate school at the Medical College of Georgia. He is the Medical Director of Surgical Pathology for Carolinas Laboratory Network and, in his spare time, is an MBA student in the McColl School of Business at Queens University in Charlotte (anticipated graduation in December 2011).

- My personal thanks to Ben for his insight and thoughts.  Welcome to the blogosphere.

The short answer to the question "Where do pathologists fit into Accountable Care Organizations (ACOs)? is: no one knows for sure.  But, it is still probably worthwhile to know something about ACOs and some of the latest commentary of on how physicians and their practices may be integrated into ACOs. In this post, I’ll start with  the definition of ACOs, point you in the direction of some good general information, and discuss and possibilities for the leadership of ACOs (hospitals versus physicians).

The Centers for Medicare and Medicaid Services (CMS) defines an accountable care organization (ACO) as “an organization of health care providers that agrees to be accountable for the quality, cost, and overall care of Medicare beneficiaries who are enrolled in the traditional fee-for-service program who are assigned to [the organization].”  As mandated by the Patient Protection and Affordable Care Act of 2010 (PPACA), the Medicare shared savings program for ACOs will begin no later than January 2012.

A recent Health Policy Brief in Health Affairs contains a nice overview of the ACO mandate in PPACA, the possible structures of ACOs, and eligibility criteria for organizations that aspire to be ACOs and participate in the shared savings program.  For another good article in Health Affairs on how independent physicians in general may fit into ACOs, take a look at the January 2011 paper by Shields et al.

For a provocative discussion on where the physicians or hospitals will lead ACOs, read this perspective from Robert Kocher and Nikhil Sahni in the New England Journal of Medicine.  The authors discuss the scenarios of ACO leadership by either hospitals or physicians, and they correctly point out the hurdles to physician leadership of ACOs, including: 1) the requirement for an unprecedented level of clinical, administrative, and financial collaboration among physicians, 2) the difficulty in allocating shared payments among primary care physicians and specialists, some of whom do procedures, 3) the required investment in information technology solutions to document and enforce accountability, and 4) the likely need for increased professional management to coordinate all of these activities to qualify for bonus payments from the shared savings program.

Kocher and Sahni (correctly, I think) outline the zero-sum game that hospitals and physicians (who need to collaborate now more than ever) face: “If physicians come to dominate, hospitals’ census will decline, and their revenue will fall, with little compensatory growth in outpatient services, since physicians are likely to self-refer……Conversely, if hospitals come to dominate ACOs, they will accrue more of the savings from the new delivery system, and physicians’ incomes and status as independent professionals will decline. Once relegated to the position of employees and contractors, physicians will have difficulty regaining income, status, the ability to raise capital, and the influence necessary to control health care institutions.” (emphaisis added)

What do you think?  Will hospitals or physicians lead ACOs?  Are these two possibilities mutually exclusive?  Will there be regional variation with the outcome dependent on the relative market position of integrated delivery networks (IDN) and physician groups?  Can/will physicians independently align themselves and form viable physician-led ACOs?  Do physicians have the access to capital required to invest in ACOs?

If you are interested in following developments with ACOs, I recommend the following sources:

The New England Journal of Medicine Health Policy and Reform web site.

The Health Affairs blog.

The Center for Medicare and Medicaid Innovation (the Innovation Center) web site and blog.

In the next installment,  I’ll discuss a newly announced role for the College of American Pathologists (CAP) and response of the American Society for Clinical Pathology (ASCP) to the request for information (RFI) from the Center for Medicare and Medicaid Services (CMS).  Ben Calhoun

Digital Pathology Leader to Discuss Rapidly Emerging Healthcare IT/Diagnostics Market

VISTA, Calif., Dec 28, 2010 (BUSINESS WIRE) -- Aperio, the global leader in providing digital pathology solutions that improve patient care, today announced that Dirk G. Soenksen, chief executive officer, will speak at the J.P. Morgan 29th Annual Healthcare Conference on January 11, 2011, at the Westin St. Francis Hotel in San Francisco. The Aperio presentation is scheduled to begin at 1:30 pm Pacific Standard Time.

During his session, Mr. Soenksen will provide an overview of the multi-billion dollar digital pathology market and discuss the strategic value of digital pathology in personalized medicine and molecular diagnostics. He will also describe Aperio's success in increasing adoption in hospitals by enabling pathologists and other physicians to improve patient care.

Aperio is the recognized leader in digital pathology, with a rapidly growing global installed base of more than 750 systems in over 30 countries, including nearly 500 systems in hospitals and references labs, the 13 largest pharmaceutical companies and a multitude of biotechnology and government organizations.

About J.P. Morgan Healthcare Conference

The J.P. Morgan event is the premier conference of its kind, bringing together established industry leaders, emerging fast-growth companies, innovative technology creators and globally minded service providers. In 2011, the organizers expect more than 300 companies, both public and private, to deliver presentations to more than 4,000 investors.

About Aperio

Aperio is the leading provider of digital pathology solutions in hospitals, reference labs, and pharmaceutical and research institutions across the world. Today, our affordable and complete product portfolio improves patient care by enhancing quality assurance, delivering more efficient workflows, facilitating access to new and more targeted therapies, and improving pathologists' skills via lifelong education. Our comprehensive product line features our ScanScope(R) scanners, Spectrum(TM) image management (PACS) software, SecondSlide(R) slide sharing service for pathology, and image analysis tools and services. Aperio's products are FDA cleared for specific clinical applications, and are intended for research and education use for other applications. For clearance updates and more information please visit http://www.aperio.com.

SOURCE: Aperio

Legal disclaimer: This post has nothing to do with digital pathology. It is just a personal battle between a man, new technology, a steep driveway, and a lot of snow. It has nothing to do with digital pathology.

I live on a steep driveway in Flagstaff, Arizona. We get snow, about the same amount as Denver or New Jersey or Tibet on a normal year, but there are no more normal years. We bought the house for the beautiful view of the mountains. The realtor assured us the steep driveway was, “Not a problem at all, the current owners barely notice it.” He then added, "I couldn’t talk to the current owners because they only have the stamina to make the walk up to the house once a day." I should have done more homework before the purchase of a home worth the equivalent of a whole slide scanner (no, not the little one, the big one that can hold 3,814 slides and scan for two weeks without reloading).

Then the big snow of January 2010 hit Flagstaff. The same storm that has just now hit the East Coast in time to ruin Christmas for New York. I was faced with shoveling three feet of snow on a driveway slope that would have made a double-diamond image analysis problem look easy. The storms usually start with a freezing rain, to make sure the driveway turns to an inverted ice rink before the cornices are built up, Fortunately with this much snow, you don’t slip down the driveway, just leave an impression like a standing snow angel in the drift below that you haven’t yet shoveled. But there two additional difficulties:

A) We can't park in the street - the city snow plow must deposit 10 foot drifts across my driveway without my car being in their way and B) Sometimes we like to leave the house in a car.

I carefully evaluated three technology options to conquer this problem:

1) Install a heated driveway, and keep it on the blowtorch setting until the storm stops. Even in Arizona, we have heard of global warming, I couldn’t bring myself to add this much heat to the environment – have you seen how hot it is down south in Tucson in the summer?

2) Throw salt on the driveway at regular intervals. This would have been easier if I could have done this from the front door, but I couldn’t get the front door open because of the drifts so I had to throw the salt on the driveway from my second bedroom window (actually my four-year old son’s second bedroom window). This isn’t just good old table salt, the package says you should use gloves when handling it. “Adults should handle it only, and with gloves.” The package had no advice for children or carpet spills.

3) Use a snowblower. My neighbor across the street has a beautiful flat driveway (but no beautiful view like mine), and offered to let me use his snowblower as he watched me toiling with drifts over my head like some Warren Miller movie sans skis and avec snowshovel. I think actually he was afraid I would try just driving the car down the driveway without shoveling. He had just gotten his living room repaired from last year when the previous owners of my house tried this (another fact the realtor forgot to mention).

 It took two hours to drag the blower up to the top of the driveway, and two seconds for it to go flying down, crushing or blowing snow in its way. I would need a snowblower with an engine bigger than an autostainer to actually power it up the driveway. When I had shopped previously for snowblowers, the salesman had assured me I would “barely notice a difference” between the performance on his linoleum department store floor and my steep driveway.

None of these three options were going to work. I have now abandoned all technology, and am left with a battle between a man, snow and his steep driveway, just how God intended.

Without technology, my workflow choices are much simpler. I can either:

A) Let it all come down, stay in the house, hope we have enough Ramen noodles and eggnog to survive the winter, and then shovel for a few hours or days in the Spring.

B) Run out every 10 minutes, and quickly shovel an inch at a time, keeping up with the layers of slides snow that keep accumulating on my desk driveway.

C) Ignore the snow, and back down the driveway, but never plan to return to the house.  And pray the car turns at the bottom of the driveway so I don’t end up visiting my neighbor’s living room.

I chose the middle option, keep up with the constant new layers of snow that keeps arriving, shoveling steadily and methodically with no interruptions.

But then I get interrupted by the heated driveway salesman, who has a new improved model with a blowtorch setting 2.0 that is three times better than blowtorch setting 1.0. The snowblower dealer also calls, with the good news that he can throw in a free mechanized wrench for pulling the snowblower up the driveway if I agree to place an order now on their new radiology/pathology snowblower/lawnmower integrated unit coming out next summer.

Meanwhile the work keeps piling up. I guess there is a difference between flat and hilly driveways, maybe good histology matters.

Leave me alone, I’m shoveling slides.

Legal disclaimer: This post has nothing to do with digital pathology. If it did, it would include a discussion on whether federal standards for lawnmowers are applicable to snowblowers, the cost savings associated with using integrated lawnmower/snowblower equipment, and a debate over PMA or 510k clearance approaches for proving that a snowblower is equivalent to a snowshovel on not just flat but hilly driveways. 

Submitted by Steve Potts, Digital Pathology Services

2010, in a word, was about change.  Personally, my family and I moved from Mayo Clinic in cold and snowy Rochester, MN to private practice in slight less cold and snowy Charlotte, NC. So far the move and new opportunities have exceeded our personal and professional expectations.  My many thanks to the readers and sponsors for your continued support, ideas, comments and criticisms.

The anatomic pathology and digital pathology market also saw many changes, particularly within the last few months of this year, namely, Ventana's acquisition of BioImagene , GE's acquisition of Clarient, Sonic's acquisition of CBL Path and Philips, Omnyx and Leica having a greater presence in the digital pathology space.  About this time last year Danaher made an offer to acquire Genetix which earlier acquired SlidePath and is the parent company of Leica Microsystems.  That deal closed in March of this year.  Most recently CRI's acquisition by Caliper Life Sciences was announced in the world of optical imaging technologies.

The arrival of the large healthcare companies with digital pathology products (Philips and Omnyx) was expected and we have seen hints of their efforts for some time before nearing production mode for distribution.  Leica's offerings were also present but on a smaller scale as they have ramped up production as well going into 2011.  By all accounts, the introduction of the large healthcare technology and last of the traditional microscope companies into the the digital pathology space shows maturation of the technology and the value these companies see in the digital pathology market. 

The acquisition of Clarient is interesting on several fronts.  Does GE have intentions of becoming a pathology services provider and stepping out beyond providing technology?  Will it do the same with its greater presence and bigger market with radiology imaging than currently exists with molecular diagnostics and the hopes of personalized medicine?  And where does these leave Omnyx?  Arguably it will make it more difficult for them to sell to other large reference laboratories if they view Clarient, A GE Healthcare Company and Omnyx as a GE Company.  Clearly Omnyx and Philips both need and will have a place in large reference laboratories and large academic/university medical centers given their high volume, high throughput scanning and respective emphasis on workflow and PACS-enabled viewing. Does a company like Philips benefit from the GE-Clarient deal?  Will GE keep Clarient? For how long?

CBL Path's acquisition by Sonic Healthcare, the large international laboratory services company gives Sonic another US laboratory, a presence in New York state and molecular pathology. 

Perhaps most interesting to goings on in digital pathology is the sale of BioImagene to Ventana, a company Roche paid close to $4 billion about 3 years ago.  It was not a secret when Siemens invested in BioImagene and brought in Ajit Singh, PhD, that his job was to get BioImagene sold.  What does it mean for the industry now? Historically, BioImagene was very aggressive with their pricing models and placed numerous systems.  Despite that, it is unlikely they ever generated more than $10 million a year in revenue. 

Ventana now has an offering in digital pathology to sell with their suite of stainers and stains that their competitors do not have.  Ventana customers can now have a complete end-to-end solution from staining to scanning with image analysis algorithms optimized for their stains. 

Leica of course produces microscopes, routine stainers and coverslippers and could perhaps develop an end-to-end solution from H&E to coverslip to scanner with their own image management and analysis in conjunction with SlidePath as both companies are owned by the same parent company.  This may also offer Leica a competive advantage offer Philips and Omnyx who do not have a similar presence in anatomic pathology laboratories.

With talk of "lot of money on the sidelines", talk of billion dollar IPOs in the offering for 2011 according to the Wall Street Journal, signs of economic rebound, as well as changes in healthcare it will be interesting to see what the next year brings for digital pathology vendors and consumers.

Any predictions? 

Expression Pathology and Flagship Biosciences recently announced a services alliance in tissue-based proteomics, combining digital pathology with mass-spec FFPE tissue proteomics. While this collaboration is oriented towards research and companion diagnostics development, mass spec is making rapid inroads in all areas of clinical applications, including tissue. The ability to run protein expression in FFPE instead of fresh tissue is a major enhancement on the road to clinical adoption. Mass spec offers the ability to better characterize post-translational modifications of proteins and various isoforms, high levels of multiplexing, and the avoidance of dependence on a given target epitope or antibody for test results. It does require up to 30,000 cells for protein expression measurements, meaning approximately 2 mm x 4 mm of 10 micron thick tissue sample. Up until now, one of the most manual steps has been the selection of tissue for the microdissection, an obvious application where digital pathology and histology pattern recognition can have advantages. The Mayo Clinic licenses Expression Pathology's approach in the diagnosis and classification of amyloidosis in routine biopsy specimen. A number of large reference laboratories are systematically transitioning their small molecular analysis platforms from the traditional ELISAs that require antibodies to mass spec.