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