News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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COVID-19 Pandemic Triggers Decline in Anatomic Pathology Testing and Shows How Digital Pathology, Remote Sign-Out Can Increase Pathology Services

Because of ‘shelter in place’ orders, many anatomic pathologists are reviewing digital images from home during the COVID-19 outbreak and demonstrating the value of whole slide imaging, digital pathology, and CMS’ recent amended remote sign-out policy

COVID-19 is already triggering many permanent changes in the way healthcare is organized and delivered in the United States. However, not until the SARS-CoV-2 pandemic eases will the full extent of these changes become visible. This will be particularly true for anatomic pathology and the profession’s expanded use of telepathology, digital pathology, and whole-slide imaging.

Since early March, specimen referrals and revenues have collapsed at anatomic pathology groups and laboratories across the nation. Dark Daily’s sister publication, The Dark Report (TDR), was first to quantify the magnitude of this collapse in tissue referrals to pathology groups. In an interview with The Dark Report, Kyle Fetter, Executive Vice President and General Manager of Diagnostic Services at XIFIN, Inc., explained that pathology clients using XIFIN’s revenue cycle management services were seeing an average 40% decrease in specimens. And, for certain pathology sub-specialties, the drop-off in specimen referrals was as much as 90%. (See TDR, “From Mid-March, Labs Saw Big Drop in Revenue,” April 20, 2020.)

The College of American Pathologists (CAP) appealed to the Centers for Medicare and Medicaid Services (CMS) to allow pathologists to work remotely. In response, CMS issued a memorandum which stated, “Due to the public health emergency posed by COVID-19 and the urgent need to expand laboratory capacity, CMS is exercising its enforcement discretion to adopt a temporary policy of relaxed enforcement in connection with laboratories located at temporary testing sites under the conditions outlined herein.”

Since then, many physicians, including pathologists, have quickly adapted to working remotely in some form.

Push for Remote Pathology Services Acknowledges Anatomic Pathologist Shortage

The CMS memorandum (QSO-20-21-CLIA), which the federal agency issued to laboratory surveyors on March 26, 2020, notes that CMS will exercise “enforcement discretion to ensure pathologists may review pathology slides remotely” if certain defined conditions are met.

CMS’ decision, which “is applicable only during the COVID-19 public health emergency,” is intended to increase capacity by allowing remote site review of clinical laboratory data, results, and pathology slides.

Ordinarily, CLIA regulations for cytology (a branch of study that focuses on the biological structure of cells) state that cytology slide preparations must be evaluated on the premises of a laboratory that is certified to conduct testing in the subspecialty of cytology. However, a fast-acting Congressional letter sent by 37 members of Congress to US Department of Health and Human Services (HHS) Secretary Alex Azar II, MD, states, “it is unwise and unnecessary to overburden the remaining pathologists with excess work due to staffing shortages, thereby increasing the risk of burnout, medical error, and further shortages in staffing due to exposure. The number of COVID-19 cases will increase and peak over the next two months and will stretch existing healthcare systems to their limits.”

In response to the CMS remote waiver, the CAP committee on Digital and Computational Pathology, and the Informatics committee, published additional guidance on the CAP website.

Decreasing Number of ‘Active Pathologists’ Drives Adoption of Telepathology, Digital Pathology, and Whole-slide Imaging

The current COVID-19 outbreak is just the latest factor in support of enabling remote review of anatomic pathology images and cases. The trend of using telepathology, whole-slide imaging (WSI), and digital pathology systems has been gathering momentum for several years. Powerful economic forces support this trend.

The Dark Report devoted its June 10, 2019, issue to a deep dive of the challenges currently facing the anatomic pathology profession. In particular, TDR noted a study published May 31, 2019, in the Journal of the American Medical Association (JAMA) Network Open, titled, “Trends in the US and Canadian Pathologist Workforces from 2007 to 2017.” The study’s authors—pathologists in the United States and Canada—reported that between 2007 and 2017 the number of active pathologists in the United States decreased from 15,568 to 12,839—a 17.53% decline.

TDR noted that these findings imply there are fewer pathologists in the United States today in active practice to handle the steady increase in the number of cases requiring diagnostic review. In turn, this situation could lead to delays in diagnoses detrimental to patient care.

In fact, the National Health Service (NHS) in the United Kingdom is dealing with exactly this situation. The Telegraph reported that one in four cancer patients in the UK have delays of as much as eight weeks in the diagnosis of their biopsy. It is generally recognized that the UK lacks the number of histopathologists it needs to substantially shorten time to diagnoses. To address this, the NHS is implementing a national digital pathology network featuring Amazon’s Alexa virtual assistant to deliver health advice to the UK’s citizens. (See Dark Daily, “UK’s NHS Will Use Amazon Alexa to Deliver Official Health Advice to Patients in the United Kingdom,” December 2, 2019.)

In the United States, the COVID-19 pandemic created an “immediate need for remote sign-outs, reviews, and consults,” said Mike Bonham, MD, PhD (above), Chief Medical Officer for Proscia, a digital pathology software developer, in an interview with Dark Daily. “In the context of highly relevant workflow and workforce challenges, it reinforces the opportunity for wider adoption of digital pathology.” Prior to the outbreak of COVID-19, several distinct forces were driving adoption and use of digital pathology in combination with traditional microscopy, he said. (Photo copyright: Proscia.)

Distinct Forces Beginning to Reshape Anatomic Pathology

In recent years, the anatomic pathology profession has faced growing financial pressure, a shrinking workforce, and a surge in the global demand for pathology—issues that come at a time when biopsies and cancer diagnostics require greater expertise.

As Dark Daily and The Dark Report previously reported, digital pathology gained momentum starting with the US Food and Drug Administration’s approval to market the Philips IntelliSite Pathology Solution (PIPS) whole-slide imaging (WSI) system in April 2017. The second WSI system cleared by the FDA was the Aperio AT2 DX System from Leica Biosystem Imaging.

When it comes to adopting a digital pathology system (DPS), it is important to realize that digital pathology testing has moved forward at a rapid pace outside the US, explains a new white paper from Dark Daily, titled, “Anatomic Pathology at the Tipping Point? The Economic Case for Adopting Digital Technology and AI Applications Now.”

Gaining knowledge and first-hand experience of digital pathology adoptions is vital to future business development in anatomic pathology services.

Emerging Cancer Diagnostics Using Digital Pathology and Computational Solutions

Digital pathology adoption can be seen in various specialties of cancer care—in particular skin, breast, and prostate. One example is the University of California San Francisco (UCSF) School of Medicine, which adopted digital pathology in February 2015.

The UCSF School of Medicine started with frozen slide sections and moved to the broader volume of pathology slides. Since 2015, UCSF’s School of Medicine has moved toward a fully digital pathology operation and has serialized the adoption by specialty, according to Zoltan Laszik, MD, PhD, attending physician at UCSF and Professor of Clinical Pathology in UCSF’s Departments of Pathology and Laboratory Medicine.

Laszik is among a handful of specialists and digital pathology early adopters who collaborated on the new Dark Daily white paper, which is available for free download.  

Through the adoption of digital pathology, glass slides are digitized using a whole-slide image scanner, then analyzed through image viewing software. Although the basic viewing functionality is not drastically different than that provided by a microscope, digitization does bring improvements in lab efficiency, diagnostic accuracy, image management, workflows, and revenue enhancements.

Additionally, artificial intelligence (AI)-based computational applications have emerged as an integral part of the digital pathology workflow in some settings, the white paper explains.

“These developments are important to anatomic pathologists because the traditional pathology business model continues to transform at a steady pace,” noted Robert L. Michel, Editor-in-Chief of The Dark Report.

Anthony Magliocco, MD, FRCPC, FCAP, President and CEO of Protean BioDiagnostics and former Professor and Chair of Pathology at Moffitt Cancer Center, is featured in the white paper as well. His new pathology service model provides routine pathology services, precision oncology, second opinions, liquid biopsies, genetics, and genomics to cancer centers from a Florida-based specialty laboratory.

In addition to the white paper, Magliocco will share his experience adopting digital pathology during a free webinar, titled, “Streamlined Operations, Increased Revenue, Higher Quality of Care: Conclusive Evidence on the Value of Adopting Digital Pathology in Your Lab.” The webinar takes place Wednesday, May 13, and is hosted by Dark Daily.

To register for this important learning opportunity, click here or place this URL in your web browser: https://www.darkdaily.com/webinar/streamlined-operations-increased-revenue-higher-quality-of-care-conclusive-evidence-on-the-value-of-adopting-digital-pathology-in-your-lab/.

These digital pathology technologies represent an innovative movement shaping the present and future of pathology services. Pathologists wanting to learn more are encouraged to sign up for the May 13 webinar, which will build on the body of evidence and commentary that is included in the new white paper, and which will be available for free on-demand download following the live broadcast.

—Liz Carey

Related Information

Free Download New White Paper: Anatomic Pathology at the Tipping Point? The Economic Case for Adopting Digital Technology and AI Applications Now

To Register for Free Webinar Taking Place on May 13, 1 pm Eastern

Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency

Trends in the US and Canadian Pathologist Workforces From 2007 to 2017

UK’s NHS Will Use Amazon Alexa to Deliver Official Health Advice to Patients in the United Kingdom

New Telemedicine Strategies Help Hospitals Address COVID-19

CMS Memorandum: QSO-20-21-CLIA, March 26, 2020

Rush, Carter Lead Successful Effort to Ensure Pathologists are Able to Address Critical Testing Needs During Pandemic

March 25, 2020, Congressional Letter to HHS Secretary Alex Azar II, MD

CAP Secures Remote Work Waiver for Pathologists

Recent Updates on COVID-19: Remote Sign-Out of Cases with Digital Pathology FAQs

Laboratory Staff Turnover: A College of American Pathologists Q-Probes Study of 23 Clinical Laboratories

Is the Profession of Anatomic Pathology Shrinking?

Expert Sees Pros, Cons in DP and WSI Systems

Live Event Update: Executive War College on Laboratory and Pathology Management

Even as Digital Pathology Is Poised to Be Disruptive in Primary Diagnosis, Most Anatomic Pathology Groups Are Unprepared for How Their Incomes Will Change

Pathologists and practice administrators should prepare a strategy and a timetable for their group’s acquisition and deployment of a digital pathology system and whole slide imaging

Anatomic pathology is a medical specialty at the brink of a major technological disruption. FDA clearance of the first digital pathology system and whole slide imaging (WSI) for primary diagnosis means that every surgical pathologist will soon need to decide when to adopt this technology to avoid declines in group revenue and pathologist compensation.

Not in decades have pathologists faced a comparable dual threat. One threat is the use of digital pathology and WSI for primary diagnosis in ways that deliver faster answers to referring physicians, while creating new business models for anatomic pathology groups. At greatest risk from this technology, however, may be sub-specialist pathologists who depend on specialty referrals and second-opinion consults.

Second Threat Is How Digital Pathology Can Erode Pathology Group’s Revenue

The second threat is how failure to adopt digital pathology and WSI at the right time in the market cycle will put a pathology group’s revenue at risk, while causing pathologist compensation to erode. Pathology groups that are quick to adopt digital pathology and whole slide imaging are expected to gain clinical advantage and additional case referrals, while pathology groups that defer adoption will probably lose market share—and the revenue associated with those lost case referrals.

How Fast Will Pathology Groups Act to Implement Digital Pathology?

It was last April when the FDA cleared the first digital pathology system and whole slide imaging for use in the primary diagnosis of biopsied tissue and resection cases. With clearance to market of the Philips IntelliSite Pathology Solution (PIPS), it is expected that other companies will submit their digital pathology systems for FDA review as well. As that happens, the market for digital pathology systems will expand and become more competitive.

“How fast pathologists in the United States adopt digital pathology for primary diagnosis is the big question,” observed Robert L. Michel, Editor-In-Chief of The Dark Report, Dark Daily’s sister publication. “We’ve interviewed pathologists at several community pathology group practices who currently use digital pathology and whole slide images for things like tumor boards, second opinion consults within and without their practice, and teaching purposes. They have strong opinions about how quickly they want their group to begin using a digital pathology system for primary diagnosis.

“For example, Advanced Pathology Associates (APA) in Rockville, Md., is a group with 15 pathologists who cover seven hospitals,” stated Michel. “APA was the community pathology group site for the study data Philips needed to submit with its FDA pre-market application. They had the system for the nine-month trial and used it to evaluate 500 cases and thousands of glass slides and WSIs. APA returned the system at the conclusion of the study, but pathologists at APA are already in the process of acquiring their own digital pathology system to use for primary diagnosis.”

Anatomic Pathology Group Went Hands-on with Digital Pathology System

In a story The Dark Report published about Advanced Pathology Associates, pathologist Nicolas Cacciabeve, MD, APA’s Managing Partner, commented, “Because we had the opportunity to be hands-on with this digital pathology system, we saw how it changes daily workflow, improves the ergonomics of reading cases, and contributes to increased productivity.”

Cacciabeve identified the immediate benefits APA will accrue after it acquires its own digital pathology system and begins to use it for primary diagnosis. “[Having a digital pathology system] … also opens new opportunities for our pathologists to add more value—whether it is handling more complex cases through real-time consultation, or through better data management and image retrieval, or freeing up pathologists to get out of the lab to collaborate with clinicians.”

Pathologist Clive Taylor, MD, Considers DP’s Clearance to Be ‘Huge’

The FDA’s clearance of the first digital pathology system was called “huge” by noted pathologist Clive Taylor, MD, PhD, a professor of pathology at the Keck School of Medicine at the University of Southern California (where he served as Chair of Pathology from 1984 to 2009) in an interview with The Dark Report published on July 17.

“The FDA’s clearance of this system for primary diagnosis is huge,” stated Taylor. “… I say that because digital slide scanners in many pathology departments around the country are used secondarily. For example, a pathologist will look at a glass biopsy slide today and think, ‘I should scan this to get a score, or an accurate count, or to send it to a colleague in Washington or London or some place.’ In that sense, pathology labs are using whole slide imaging for secondary purposes.

“The FDA clearance of whole slide imaging for primary diagnostics will foster changes in anatomic pathology departments that will improve the accuracy and speed of diagnosis and drastically reduce the time it takes to get second opinions and to reach a primary diagnosis,” Taylor predicted.

Pathologists, Practice Administrators Need a Strategy for Digital Pathology

Because of the potential for digital pathology systems and whole slide imaging to be disruptive to both the clinical practice of pathology and the revenue and income earned by pathologists, it is recommended that pathology practice administrators and pathologist business leaders of their respective groups understand this new technology and how early-adopter pathology labs are using it to add value to their diagnostic services while generating new streams of revenue.

The four expert speakers for this critical Dark Daily webinar are (clockwise from upper left): Keith Kaplan, MD, Chief Medical Officer, Corista, Concord, Mass.; Liron Pantanowitz, MD, Professor of Pathology and Biomedical Informatics at the University of Pittsburgh Medical Center, Pittsburgh; Isaac R. Grindeland, MD, Gastrointestinal Pathology, Incyte Diagnostics, Spokane Valley, Wash.; and Dan Angress, for ClearPath Derm of Dayton, Ohio, and President of Angress Consulting, LLC, Los Angeles, Calif. (Photo copyright: Dark Daily.)

To give practice administrators and interested pathologists this comprehensive knowledge of digital pathology and whole slide imaging, Dark Daily is presenting a special webinar, titled, “Primary Diagnosis with Digital Pathology Systems and Whole Slide Images: What Every Pathologist Needs to Know, Why It Will Be Disruptive, and How Innovative Pathology Groups Are Already Making Money with DP.”

This critical webinar takes place on Thursday, August 17, 2017 at 1:00 PM EDT.

Essential Knowledge about Digital Pathology Systems, Whole Slide Imaging

The webinar is organized to help all pathology groups, academic pathology departments, and pathology laboratories understand:

  • The current capabilities of the technology for digital pathology and WSI;
  • How these technologies are evolving in ways that add functionality and improve productivity; and—most importantly,
  • Two case studies of pathology groups already using digital pathology and WSI imaging to add clinical value and develop new sources of revenue.

Speaking during this webinar will be:

  • Keith Kaplan, MD, Chief Medical Officer, Corista, Concord, Mass.: For nearly a decade, Kaplan has been one of the leading commentators on the use of digital technologies and Web 2.0 capabilities in pathology. He will provide strategic context about why the FDA’s clearance of a digital pathology system for use in primary diagnosis is a trigger event for all pathology groups.
  • Liron Pantanowitz, MD, Professor of Pathology and Biomedical Informatics at the University of Pittsburgh Medical Center, Pittsburgh, Pa.: An internationally known expert on the use of digital pathology systems and whole slide imaging, Pantanowitz will give webinar participants a concise understanding of the technology’s current capabilities; how it is being used at UPMC; the lessons learned in the use of digital pathology to support UPMC’s international pathology collaborations; and what technology advances to expect in the near future.
  • Dan Angress, for ClearPath Derm of Dayton, Ohio, and President of Angress Consulting, LLC, Los Angeles, Calif.: This is a fascinating case study of how ClearPath Derm is using digital pathology capabilities to support added value services for its referring physicians that, most importantly, generate additional revenue for the pathology group.
  • Isaac R. Grindeland, MD, Gastrointestinal Pathology, Incyte Diagnostics, Spokane Valley, Wash.: This regional pathology super-group has 40 pathologists, four anchor locations, and contracts with multiple hospitals. Grindeland will explain how Incyte leverages its digital pathology capabilities to improve productivity and performance, while better meeting the needs of its hospital and physician clients.

Preparing Pathology Groups for Disruptive Potential of DB, WSI

Because of the potential for digital pathology systems and whole slide imaging to disrupt many long-established clinical practices, while at the same time creating new financial winners and losers among the nation’s pathology groups, it is imperative that pathologists and practice administrators gain the necessary knowledge to prepare their groups. Armed with these insights, they then can develop timely and appropriate strategies to ensure their group’s clinical excellence and financial sustainability moving forward.

For details about the August 17 webinar and to register, use this link (or copy this URL and paste it into your browser: https://ddaily.wpengine.com/webinar/primary-diagnosis-with-digital-pathology-systems-and-whole-slide-images-what-every-pathologist-needs-to-know-why-it-will-be-disruptive-and-how-innovative-pathology-groups-are-already-making-money-w).

—Michael McBride

Related Information:

Primary Diagnosis with Digital Pathology Systems and Whole Slide Images: What Every Pathologist Needs to Know, Why It Will Be Disruptive, and How Innovative Pathology Groups Are Already Making Money with DP

FDA Allows Marketing of First Whole Slide Imaging System for Digital Pathology

Whole Slide Imaging In Pathology: Advantages, Limitations, and Emerging Perspectives

Digital Images and the Future of Digital Pathology, Liron Pantanowitz, MD

Philips Awarded FDA Clearance for Digital Pathology Solution for Primary Diagnostic Use

What Does FDA Approval of a Digital Pathology System for Use in Primary Diagnosis Mean for the Pathology Industry? New Dark Daily Webinar to Provide Answers and Insights for Pathologists and Pathology Practice Administrators

Dark Daily Story on Pathology 2.0 and Digital Pathology Blog

 

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