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

Hosted by Robert Michel

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

Hosted by Robert Michel
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From Regulations to Innovations: Annual Executive War College Convenes in New Orleans

29th Conference Features Information on What Clinical Lab Leaders Need to Know About a ‘Perfect Storm’ of New Compliance Challenges

There are signs that the US Food and Drug Administration (FDA) is poised to release the final rule on laboratory developed tests (LDTs)—perhaps even during the 29th annual Executive War College on Diagnostic, Clinical Laboratory, and Pathology Management, which kicks off in New Orleans this week.

The Office of Management and Budget (OMB) concluded its review of the final rule on April 22. Former FDA commissioner Scott Gottlieb, MD, and other regulatory experts expect the White House to send the final rule to Congress as early as late April and no later than May 22.

Either way, Tim Stenzel, MD, PhD, former director of the FDA’s Office of In Vitro Diagnostics, and other regulatory experts will be on hand at Executive War College (EWC) to walk attendees through what promises to be a “perfect storm of clinical lab and pathology practice regulatory changes.” Stenzel is scheduled to speak about the LDT rule during three sessions with fellow panelists on Day 1.

On Tuesday morning, Lâle White, executive chair and CEO of San Diego’s XiFin, Inc., will present a keynote on new regulations and diagnostics players that are “poised to reshape lab testing.” Her presentation is followed by a general session on Clinical Laboratory Improvement Amendments (CLIA) regulations featuring Salerno Reynolds, PhD., acting director at the U.S. Centers for Disease Control and Prevention (CDC) Center for Laboratory Systems and Response.

Robert Michel, Editor-in-Chief of The Dark Report will wrap day one with a general session on the regulatory trifecta coming soon to all labs, from LDT to CLIA to private payers’ policies for genetic claims.

Innovation in the spotlight

“It’s a rich mix of expert speakers, lab leaders who are doing innovative things in their own organizations, along with the consultants and the lab vendors who are pushing the front edge of laboratory management, operations, and clinical service delivery,” says Michel, who each year creates the agenda for EWC.

Several sessions, master classes, and speakers will look to the future with discussions about how healthcare data drives innovations in diagnostics and patient care, digital pathology adoption around the world, and hot topics such as artificial intelligence (AI), big data and precision medicine.

Panels offer a variety of viewpoints

“One valuable benefit of participating at the Executive War College is the various panel discussions,” Michel says. “Each panel brings together national experts in a specific area of the laboratory profession. As an example, our lab legal panel this year brings together four prominent and experienced attorneys who share opinions, insights, and commentary about relevant issues in compliance, regulations, and contractual issues with health plans and others.”

This allows attendees to experience a breadth of opinions from multiple respected experts in this area, he adds.

For example, a digital pathology panel will bring together representatives from labs, service providers, and the consultants that are helping labs implement digital pathology. The session will be especially helpful to labs that are deciding when to acquire digital pathology tools and how to deploy them effectively to improve diagnostic accuracy, Michel says.

And a managed care panel will feature executives from some of the nation’s biggest health plans—the ones that sit on the other side of the table from labs—to provide insights and guidance on how labs can work more effectively with them.

Networking opportunities abound

The event is about much more than politics and policy, however. There’s also a distinct social aspect.

“This is a friendly tribe,” Vicki DiFrancesco, a US HealthTek advisory board member who first attended EWC more than two decades ago, wrote in a recent post.

“Everyone is welcome, and everyone appreciates the camaraderie, so don’t be shy about going up and introducing yourself to someone. The quality of the crowd is top-notch, yet I’ve always experienced a willingness for those of us who have been to this rodeo to always be welcoming,” she notes.

Michel agrees. “One of the special benefits of participation at the EWC is the superb networking interactions and collaboration that takes place,” he says.

 “From the first moments that attendees walk into our opening reception on Monday night until the close of the optional workshops on Thursday, one can see a rich exchange happening amongst circles of attendees. Introductions are being made. Connections are developing into business opportunities. The sum of an attendee’s experience at the Executive War College is to gain as much knowledge from the networking and collaboration as they do from the sessions.”

–Gienna Shaw

Implications of Academia’s Early Adoption of Whole Slide Scanning and Digital Pathology Systems

Understanding requirements of digital pathology workflow matters as regulatory and reimbursement elements align toward wider adoption beyond 2023. Upcoming Dark Daily webinar May 10 to cover infrastructure requirements

Nearly all pathology residents and fellows, as well as many histologists and other medical students, have been trained using digital images and, therefore, digital pathology tools. This resounds as a major and important development now working in tandem with recent coding decisions and regulatory recommendations that may combine to advance digital pathology to a significant tipping point.

As Dark Daily’s sister publication, The Dark Report, has described in great detail over the past several years, the trend toward digital pathology implementation started in the mid-2000s. Much has been learned through trial and error that may make the practical path forward clearer for those still on the sidelines.

Digital pathology infrastructure and information technology (IT) requirements are better known after years of research at academic centers throughout the United States—but only for those closest to the action. Two examples are University of Southern California (USC) on the West Coast and Memorial Sloan Kettering Cancer Center (MSKCC) on the East Coast.

During a free 60-minute educational webinar on May 10, W. Dean Wallace, MD, (far left) of University of Southern California (USC) and Orly Ardon, PhD, MBA, (immediate left) of Memorial Sloan Kettering Cancer Center (MSKCC) will explain digital pathology infrastructure, IT, and lessons learned through firsthand experiences. The webinar is sponsored by Hamamatsu, and continuing education credit is available for listening. (Photo copyrights: USC and MSKCC.)

Seven Advantages of Early Adoption of Whole Slide Imaging and Digital Pathology

Many pathologists know that academic centers throughout the U.S. have been the first to adopt and use digital pathology scanners and systems. Early work in what have become custom digital pathology ecosystems has enabled academic pathology groups to:

  • Learn how to implement, validate, and design workflows that include digital pathology systems and computational pathology.
  • Determine how physical environments need to change for slide scanners, achieving quality images, maximizing scanner utility, and expanding scanning capabilities in medium- and high-throughput laboratories.
  • Contract with pharmaceutical companies and drug developers to read digital images in support of drug research and clinical trials.
  • Understand how digital pathology applies for various use cases, including primary diagnosis, frozen section diagnosis, consultations, second opinions, and telepathology.
  • Successfully spread pathologist technical and professional support across multiple laboratory locations and remote customers.
  • Learn best practices for conducting tumor boards and peer reviews of pathology cases.
  • Validate and verify new hematoxylin and eosin (H&E) stains.

Hospital and Lab Leaders Have Questions About Digital Pathology Requirements

As a result of early adopter projects, digital pathology infrastructure and IT requirements are better understood and documented for a variety of use cases, according to W. Dean Wallace, MD, Professor of Pathology at the Keck School of Medicine of USC. Wallace specializes in pulmonary and renal pathology with a strong interest in informatics, as well as radiology and pathology correlation, and he warns of the danger of implementing an “incomplete digital pathology system.”

Wallace will join Dark Daily for a 60-minute webinar, “Digital Pathology Implementation Strategies,” on Wednesday, May 10, at 1 p.m. Eastern. Registration is free.

This webinar is for hospital and health system leaders, as well as independent pathology groups and reference lab executives, who want to know:

  • Key workflow aspects of the components needed in a digital pathology service.
  • Common limitations of commercial digital pathology products.
  • How to structure a digital pathology implementation team.
  • A goal-based approach to developing a business case for digital pathology implementation.

Wallace and Orly Ardon, PhD, MBA, Director of Digital Pathology Operations at MSKCC, will lead the call and take questions during the webinar’s live Q&A segment.

Questions About Digital Pathology Implementation

At MSKCC, teams have scanned and archived more than six million histology slides and are prospectively scanning all in-house H&E slides.

“There is a lot of interest out there for digital pathology implementation,” Ardon told Dark Daily, “not only the AI-machine learning opportunities that are enabled with digital slides, but how do we even start a basic digital pathology journey. Institutions and labs don’t realize how many factors they have to think about before they start scanning the first slide.”

“People have limited understanding of the complexities of the business case,” Wallace added. “Do you want to go with a full 100% deployment or a targeted deployment? Do you want to get digital pathology to support tumor boards? By introducing scanners into the tumor board workflow, you can actually cause more problems than you are solving if you are not careful.

“The other aspect of it is the actual technical deployments. You need to begin with careful analysis of functions or services to support,” Wallace said, adding the soft costs of digital pathology can take lab and pathology administrators by surprise.

Ardon and Wallace will present their insights and experiences during the webinar, which has been sponsored by Hamamatsu. Those interested can learn more and register at Dark Daily here. P.A.C.E. credit is available for this program through the American Society for Clinical Laboratory Science (ASCLS).

On the Horizon: Incentives and Further Alignment Toward Digital Pathology Adoption

Dark Daily’s new webinar is timely. Earlier this year, the Centers for Medicare and Medicaid Services (CMS) entered what has been called a “tryout” period to gather data about the use of new, digital-pathology-related Current Procedural Terminology (CPT) codes in clinical laboratories and anatomic pathology groups. (See coverage in The Dark Report.)

Some believe the efforts of CMS, clinical labs, and pathology groups will result in new reimbursable codes, reimbursement values, and other incentives for using digital pathology (starting sometime in 2024)—if analysis shows use of digital pathology is as widespread as numerous publications would seem to indicate.

The CPT coding development coincides with recent discussions within the federal Clinical Laboratory Improvement Advisory Committee (CLIAC) about sweeping recommendations to allow continued remote work once the COVID-19 Public Health Emergency ends on May 11 and recognize digital data as a vital component of diagnostic specimens. (See coverage in The Dark Report.)

CLIAC’s recommendations may translate into a running start for modernizing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CLIA as it is written currently is dated and needs to account for new and emerging technologies, such as digital pathology, medical laboratory industry sources have said for years. (See a recent Dark ReportDark Daily webinar.)

These developments, as they further align with actions by the U.S. Food and Drug Administration (FDA), could unleash swells of interest in onboarding whole slide scanners and digital pathology tools. Remote workflows became a priority during the COVID-19 pandemic, and it appears they will continue for a period as the Public Health Emergency unwinds, according to the FDA.

Watch Digital Pathology Implementation Strategies

Most executives at hospitals and health systems, private pathology practices, and independent reference labs are on the sidelines watching how digital pathology in research and clinical practice is unfolding.

However, as the pathology field integrates data science and computational pathology, forward-looking hospital and lab leaders can expect greater momentum toward advanced technologies, such as digital pathology tools.

Register here to participate in the upcoming webinar, “Digital Pathology Implementation Strategies.”

—Liz Carey

This content was developed through independent research and interviews by The Dark Intelligence Group, with support from Hamamatsu Photonics K.K., a provider of whole slide imaging systems and related technology such as optical sensors, light sources, and complex instrument systems that use them. Hamamatsu did not participate in the article’s development. Learn more about Hamamatsu at

Related Information

Dark Daily Webinar: Digital Pathology Implementation Strategies

Three Clinical Laboratory Trends Not to Misjudge

Shortage of Pathologists a Factor in Adoption of Digital Pathology

CLIA on Path to Recognize Lab Data as a Specimen

Use Histology Data to Illustrate Specimen “Life Cycle

New CPT Codes Debut for Digital Pathology Services

Proven Approaches to Clinical Laboratory Cost-Cutting and Effective Staff Recruitment/Retention to Be Shared at New Workshops in Chicago and Miami

Answers and effective solutions to the lab profession’s most urgent challenges will be front and center at the innovative ‘Lab Management Essentials Workshop’

Three powerful forces are slamming clinical laboratories today. One is the urgent need to cut costs. Second is the struggle to achieve and maintain full lab staffing. Third is the pressure to increase revenue and expand market share.

All of this is happening even as hospitals and health systems must deal with almost identical issues. Cost-cutting, recruiting more staff, and finding ways to increase revenue dominate the thoughts and actions of senior health administrators.

Most Hospitals and Health Systems Report Substantial Financial Losses

News reports about the financial losses at hospitals and health systems tell the story. For example, one report in Becker’s Healthcare described the financial damage at three major, multi-state health systems:

  • AdventHealth, a 48-hospital health system, reported a $417.7 million net loss in the first quarter of 2022. It reported that, because of inflation, costs had increased by 15% over prior year.
  • Kaiser Permanente, with 12.6 million members in seven regions of the United States, reported a net loss of $961 million in the first quarter of 2022. One major factor in these losses was the increase in expenses, which was 9.5%. For second quarter 2022, Kaiser Permanente showed a loss of $1.3 billion, most of that from a decline in the value of its investment portfolio.
  • Ascension Health, with 143 hospitals in 19 states, reported a net loss of $884.7 million in first quarter of 2022. It said its costs increased by 10.6% over the same period last year.

Most hospital-based clinical laboratory managers and pathologist are aware of these staggering financial losses. They also are watching how the shortage of nurses and other skilled personnel has hospitals scrambling to close that gap by paying more overtime, using temporary nurses who are paid at much higher rates, and increasing nurse salaries to prevent existing staff nurses from taking more lucrative offers from other hospitals in the community.

Clinical Laboratories Under Pressure to Cut Costs and Maintain Adequate Staff Levels

Hospital-based laboratories are on the frontline of these hurricane forces. Facing operating losses, hospitals ask their laboratories and other clinical service lines to cut costs below authorized budgets. Meanwhile, the labs themselves must deal with their own shortage of medical technologists (MTs) and clinical laboratory scientists (CLSs)—along with other skilled positions—that are required to provide the full menu of lab testing services.

This “perfect storm” of pressures to cut costs, keep staffing at authorized levels, and generate more revenue (that can offset rising costs of lab supplies and the higher salaries being paid to MTs and CLSs) is without precedent in the past four decades. To provide lab managers with the knowledge to resolve these challenges swiftly and confidently in their own laboratories, the team behind the Executive War College assembled experts to conduct a one-and-a-half-day interactive workshop.

The workshop is titled, Lab Management Essentials Workshop to Effectively Cut Costs, Improve Staff Hiring and Retention, and Generate More New Revenue. The first of these workshops will occur in Chicago on Oct. 20-21. The same instruction will be provided in a workshop in Miami on Nov. 10-11. By design, lab managers will learn in small settings that ensure personal interaction with the experts in lab cost cutting; staff recruiting, hiring, and retention; and generating more lab revenue.

Using Lab Case Studies to Teach Proven Solutions for Reducing Expenses

Each of the three important topics will be addressed in half-day learning modules. Following case study presentations on best practices, attendees at Lab Management Essentials will break out into smaller roundtable groups facilitated by lab industry experts. The groups will brainstorm how to apply these proven methods to cut costs, retain employees, and create revenue. They will then describe their findings to all participants.

Lab Management Essentials Workshop facilitators (clockwise from top left): Tafney Gunderson, Carlton Burgess, Dorothy Martin, Rick VanNess, Jane Hermansen, and Kim Zunker.

On the morning of day one, leaders of the lab cost-cutting module will be:

  • Carlton Burgess, Vice President of Laboratory Services at Prime Healthcare in Ontario, Calif.
  • Tafney Gunderson, Quality Systems Supervisor at Avera McKennan Laboratory in Sioux Falls, S.D.

On the afternoon of day one, leaders of the lab staff recruiting, hiring, and retention module will be:

  • Dorothy Martin, Regional Laboratory Manager at Dartmouth-Hitchcock Health in Lebanon, N.H.
  • Kim Zunker, MBA, MLS(ASCP), CAPM, Consulting Manager at Accumen in Scottsdale, Ariz.

On the morning of day two, leaders of the lab staff recruiting, hiring, and retention module will be:

  • Jane Hermansen, MBA, MT(ASCP), Manager of Outreach and Network Development at Mayo Clinic in Rochester, Minn.
  • Rick VanNess, Director of Product Management at Rhodes Group and TriCore Reference Laboratories in Albuquerque, N.M.

Delivering Essential Knowledge to Up-and-Coming Laboratory Managers

This Lab Management Essentials workshop is a first for the clinical laboratory profession. It brings together experienced, effective lab leaders to teach, guide, and coach your lab’s smartest up-and-coming lab managers. It accomplishes this in just one-and-a-half days, to minimize the time they are away from your lab.

To gain maximum benefits from this well-designed program, it is recommended that you send three or four of your front-line lab managers. Together, they will hear and learn at the same time, while working during the intimate sessions to identify the techniques and methods that will work best for your lab. This is important because, upon their return, they will have both enthusiasm and the knowledge to light the right fires under your lab staff and energize them into quickly deploying ways to slash expenses, attract top candidates to fill open positions, and even to tap new sources of revenue—all of which they learned during Lab Management Essentials.

Because the number of attendees to each workshop is limited, you are encouraged to click here to register yourself and your designated lab managers today.

—Robert Michel

Related Information:

Lab Workshop Solutions to Staffing, Cost Cutting, and Revenue Problems

Efficient Data Structure Can Bring in More Reimbursement Dollars and Allow Clinical Laboratories to Sell Aggregated Information

Post-Pandemic Strategies for Labs Include OIG Audit Prep and Repurposed Instruments

Some lab experts advise that clinical laboratories and pathology practices should also plan on delayed payments for COVID-19 testing for uninsured patients

Regardless of whether infection rates for SARS-CoV-2 continue to wane or perhaps surge again, business changes are coming for staff at clinical laboratories and anatomic pathology groups. Forward-thinking lab administrators will want to evaluate post-pandemic strategies for labs to stay ahead of potential legal issues and keep their organizations financially healthy.

The public health emergency stemming from COVID-19 is set to expire April 16. That deadline could be extended. However, the U.S. Department of Health and Human Services (HHS) is under pressure from some circles to end the public health emergency, which would affect some health insurance provisions and potentially rein in relaxed rules for telemedicine.

“If you’re a laboratory, now is the time you need to start buttoning up [the above] concerns. You don’t want to be at the mercy of a quick cutoff,” said Jon Harol, president of Lighthouse Lab Services in Charlotte, N.C. The company hosted a webinar last week called “Preparing Your Clinical Lab or Pathology Practice for Post-COVID Success.”

Pathologists and clinical laboratory leaders should consider post-pandemic strategies for labs in the following areas:

  • COVID-19 testing for uninsured patients;
  • Preparations for government audits of SARS-CoV-2 tests performed during the pandemic; and,
  • Repurposing PCR equipment used for COVID-19 testing into other areas of clinical diagnostics.

These strategies will be explored further during the Executive War College Conference on Laboratory and Pathology Management, which takes place April 27-29 in New Orleans. Leaders of innovative clinical laboratories will share how their lab teams are helping to improve patient outcomes while encouraging health insurers to pay them for this value.

COVID-19 Testing for Uninsured Patients

On March 22, the U.S. Health Resources and Services Administration (HRSA) announced that its COVID-19 Uninsured Program stopped accepting claims for testing and treatment due to lack of sufficient funds. This development affects 8.6% of the nation’s population that doesn’t have medical insurance, according to the U.S. Census Bureau.

For clinical laboratories, the announcement could lead to delayed payments for COVID-19 tests performed on uninsured patients, said Mick Raich, President of Revenue Cycle Management Consulting at Lighthouse Lab Services, who also spoke during the webinar. Medical laboratories and pathology groups should anticipate reimbursement gaps and how that might affect revenues collected from payers.

Jon Harol, president, Lighthouse Lab Services
“The patient relationship is going to be the most important thing. That puts labs at the head of the table,” says Jon Harol, president at Lighthouse Lab Services.

“Labs are going to do the testing and are going to bill for it, and there will probably be some retroactive payment,” Raich explained.

With midterm elections happening this year, don’t be surprised to see HRSA funding reinstated for COVID-19 testing for uninsured people, commented Robert Michel, Editor-in-Chief of The Dark Report and Founder of the Executive War College.

“We’ll have to wait and see. After all, it is an election year, so the representatives and senators in Congress would like to be re-elected,” added Michel, who also presented during the webinar.

“It is reasonable to assume that members of Congress don’t want to disappoint the clinical laboratories that stepped up to the table in the earliest days of the pandemic and have done huge volumes of COVID-19 testing.”

Preparations for Government Audits of Pandemic Testing

Another post-pandemic strategy for labs: Prepare for audits of COVID-19 test claims from the HHS Office of Inspector General (OIG).

The OIG has already stated it will begin to review HRSA claims for testing of uninsured patients to verify that, in fact, those people were not covered by Medicare or a private payer.

Ahead of any OIG action, labs should consider performing self-audits to determine whether they complied with HRSA requirements. “The best thing you can do is go back and look at the first two months of your billing. Do an audit to ask: Did we bill anybody with insurance by accident?” Raich suggested. “Take a hundred of those claims and audit them.”

If a medical lab finds problems with uninsured COVID-19 billing, it may be prudent to self-report those discrepancies to the government rather than ignore them. “That looks a lot better to the OIG than tucking the stuff in a desk drawer and waiting for someone to knock on your door,” Raich noted.

Harol predicted the OIG will also review another aspect of how COVID-19 test claims were coded. Auditors will want to see if PCR test claims coded for higher reimbursement if the results were reported within 48 hours actually met that requirement.

“I expect that we’ll see auditing of the coding that was used. Under COVID, you got paid more if you were running tests on a high-throughput platform. It was almost an honor system there. I don’t know that I’ve seen much outside verification of that,” Harol explained. “I’m curious to see if there will be OIG pushback and more documentation required to prove the code was correct.”

Repurposing PCR Equipment Used for COVID-19 Testing

When the pandemic finally winds down, there will be less demand for COVID-19 testing, which could leave PCR equipment collecting dust unless labs make plans now on how to repurpose those systems.

“If you have a PCR instrument that can be revalidated, you want to start thinking about putting in a panel that tests for UTIs, sexually transmitted diseases, respiratory diseases, or women’s health,” Harol explained. “Those types of tests can be done on the equipment that a lot of COVID testing was being performed on, and it can be performed by the same scientists with that same skillset. That’s the low-hanging fruit.”

The next step is more complicated: Moving into the future, clinical laboratories need to determine what menu of tests will meet the needs of patients who previously submitted COVID-19 specimens for testing.

“The patient relationship is going to be the most important thing. That puts labs at the head of the table,” Harol continued. “How can you market your laboratory services directly to patients who might be interested?”

Watch for Developments in Telemedicine

Any post-pandemic strategies for labs will be influenced by how state governments and federal health officials regulate telemedicine in the future.

Telemedicine rules affect pathologists who work on digital pathology systems given those platforms enable slides to be reviewed from any location.

Pathologists and clinical laboratory directors should keep their eyes on whether telemedicine rules revert to more onerous requirements once the public health emergency lifts. Before the pandemic, rules for physicians licensed in one state generally limited when they could practice over state lines through telemedicine.

“In response to the pandemic, both the federal government and the states relaxed many prohibitions on the practice of medicine across state lines. This is significant for pathologists,” Michel said. “There is speculation that once government officials let this genie out of the bottle regulatory-wise, they won’t be able to put it back in. Thus, there are many predictions that officials at the state and federal level will be under pressure to retain the newer telemedicine rules after the pandemic has ended.”

Telemedicine proved to be a big benefit for Medicare patients during the pandemic. A report from HHS in December indicated telehealth visits in 2020 for Medicare beneficiaries increased 63 times, from approximately 840,000 in 2019 to 52.7 million. That fact should catch the attention of clinical lab managers and pathologists who want to keep their labs at the front edge of clinical services. For Medicare beneficiaries who see their physicians virtually, labs need the capability to access that patient so as to collect the samples needed to perform those tests ordered by the physician during the telehealth consultation.

—Scott Wallask

Related Information:

On-Demand Webinar: Preparing Your Clinical Lab or Pathology Practice for Post-COVID Success

Executive War College Conference on Laboratory and Pathology Management

HRSA updates about Provider Relief Fund

Audit of Health Resources and Services Administration’s COVID-19 Uninsured Program

Telemedicine Gaining Momentum in US as Large Employers Look for Ways to Decrease Costs; Trend Has Implications for Pathology Groups and Medical Laboratories

EKRA Now Used to Combat Fraudulent COVID-19 Testing, Too

The Department of Justice steps beyond the law’s original focus on opioid-related lab testing fraud

An interesting aspect with enforcement of the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) is the government’s willingness to go after charges tied to fraudulent COVID-19 testing. 

The case U.S. vs. Malena Badon Lepetich provides a good example of this approach. A grand jury indicted Lepetich on various healthcare fraud charges last year, including that she allegedly offered to pay kickbacks for referrals of specimens for COVID-19 testing.

“The government had really only used EKRA in the context of addiction treatment space,” attorney Alexander Porter, a Partner at law firm Davis Wright Tremaine in Los Angeles, said in the latest issue of The Dark Report. “The Lepetich case shows that the government’s going to use EKRA beyond that context and go into other areas where they think that it can be useful—in particular, in the area of COVID-19 testing.” 

Clinical laboratories and pathology groups should take note of this development.

Attorney Alexander Porter said EKRA enforcement now goes after fraudulent COVID-19 testing. (Photo: Davis Wright Tremaine)

Defendant Allegedly Filed $10 Million in Fraudulent Lab Claims

Lepetich was the owner of MedLogic, a clinical laboratory in Baton Rouge, La.

In addition to the fraudulent COVID-19 testing charges, she allegedly solicited and received kickbacks in exchange for referrals of urine specimens for medically unnecessary tests, according to the U.S. Department of Justice (DOJ). 

The DOJ said Lepetich filed more than $10 million in laboratory test claims to Medicare, Medicaid, and Blue Cross Blue Shield of Louisiana for panels of expensive respiratory tests that were medically unnecessary. 

EKRA Provisions Rose from the Opioid Crisis in the U.S.

EKRA is a criminal law that falls under the Communities and Patients Act, which lifted restrictions on medications for opioid treatment and sought to limit overprescribing of opioid painkillers. Originally, EKRA targeted fraudulent practices at sober homes and substance abuse treatment centers. However, the final draft of the bill added clinical laboratories to the list of providers under potential scrutiny.

At the time Congress passed EKRA, the law was primarily aimed at fraudulent activity in opioid treatment centers, including related lab testing.

Thus, the government’s use of EKRA in the COVID-19 charges against Lepetich case is newsworthy and establishes a precedent, noted Porter. He’ll speak about EKRA at the 2022 Executive War College on Laboratory and Pathology Management. The event takes place April 27-28 in New Orleans.

A contentious part of EKRA for clinical laboratories and pathology groups is that certain conduct protected under the federal Anti-Kickback Statute is treated as a criminal offense under EKRA. Some common lab practices come under that confusing designation, such as paying lab sales reps on a commission-based formula based on testing volumes they generate. 

—Scott Wallask

Related Information:

Labs Should Be Cautious About “Surprising” EKRA Ruling

DOJ Announces Coordinated Law Enforcement Action to Combat Healthcare Fraud Related to COVID-19

Executive War College on Laboratory and Pathology Management

6 Impacts of EKRA on Laboratories, Clinics, and Other Treatment Facilities

Attention All Surgical Pathologists: Algorithms for Automated Primary Diagnosis of Digital Pathology Images Likely to Gain Regulatory Clearance in Near Future

Hello primary diagnosis of digital pathology images via artificial intelligence! Goodbye light microscopes!

Digital pathology is poised to take a great leap forward. Within as few as 12 months, image analysis algorithms may gain regulatory clearance in the United States for use in primary diagnosis of whole-slide images (WSIs) for certain types of cancer. Such a development will be a true revolution in surgical pathology and would signal the beginning of the end of the light microscope era.

A harbinger of this new age of digital pathology and automated image analysis is a press release issued last week by Ibex Medical Analytics of Tel Aviv, Israel. The company announced that its Galen artificial intelligence (AI)-powered platform for use in the primary diagnosis of specific cancers will undergo an accelerated review by the Food and Drug Administration (FDA).

FDA’s ‘Breakthrough Device Designation’ for Pathology AI Platform

Ibex stated that “The FDA’s Breakthrough Device Designation is granted to technologies that have the potential to provide more effective treatment or diagnosis of life-threatening diseases, such as cancer. The designation enables close collaboration with, and expedited review by, the FDA, and provides formal acknowledgement of the Galen platform’s utility and potential benefit as well as the robustness of Ibex’s clinical program.”

“All surgical pathologists should recognize that, once the FDA begins to review and clear algorithms capable of using digital pathology images to make an accurate primary diagnosis of cancer, their daily work routines will be forever changed,” stated Robert L. Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report. “Essentially, as FDA clearance is for use in clinical care, pathology image analysis algorithms powered by AI will put anatomic pathology on the road to total automation.

“Clinical laboratories have seen the same dynamic, with CBCs (complete blood counts) being a prime example. Through the 1970s, clinical laboratories employed substantial numbers of hematechnologists [hematechs],” he continued. “Hematechs used a light microscope to look at a smear of whole blood that was on a glass slide with a grid. The hematechs would manually count and record the number of red and white blood cells.

“That changed when in vitro diagnostics (IVD) manufacturers used the Coulter Principle and the Coulter Counter to automate counting the red and white blood cells in a sample, along with automatically calculating the differentials,” Michel explained. “Today, only clinical lab old-timers remember hematechs. Yet, the automation of CBCs eventually created more employment for medical technologists (MTs). That’s because the automated instruments needed to be operated by someone trained to understand the science and medicine involved in performing the assay.”

Primary Diagnosis of Cancer with an AI-Powered Algorithm

Surgical pathology is poised to go down a similar path. Use of a light microscope to conduct a manual review of glass slides will be supplanted by use of digital pathology images and the coming next generation of image analysis algorithms. Whether these algorithms are called machine learning, computational pathology, or artificial intelligence, the outcome is the same—eventually these algorithms will make an accurate primary diagnosis from a digital image, with comparable quality to a trained anatomic pathologist.

How much of a threat is automated analysis of digital pathology images? Computer scientist/engineer Ajit Singh, PhD, a partner at Artiman Ventures and an authority on digital pathology, believes that artificial intelligence is at the stage where it can be used for primary diagnosis for two types of common cancer: One is prostate cancer, and the other is dermatology.

Ajit Singh, PhD speaking at the Executive War College

On June 17, Ajit Singh, PhD (above), Partner at Artiman Ventures, will lead a special webinar and roundtable discussion for all surgical pathologists and their practice administrators on the coming arrival of artificial intelligence-powered algorithms to aid in the primary diagnosis of certain cancers. Regulatory approval for such solutions may happen by the end of this year. Such a development would accelerate the transition from light microscopes to a fully digital pathology workflow. Singh is shown above addressing the 2018 Executive War College. (Photo copyright: The Dark Report.)

“This is particularly true of prostate cancer, which has far fewer variables compared to breast cancer,” stated Singh in an interview published by The Dark Report in April. (See TDR, “Is Artificial Intelligence Ready for First Use in Anatomic Pathology?” April 12, 2021.)

“It is now possible to do a secondary read, and even a first read, in prostate cancer with an AI system alone. In cases where there may be uncertainty, a pathologist can review the images. Now, this is specifically for prostate cancer, and I think this is a tremendous positive development for diagnostic pathways,” he added.

Use of Digital Pathology with AI-Algorithms Changes Diagnostics

Pathologists who are wedded to their light microscopes will want to pay attention to the impending arrival of a fully digital pathology system, where glass slides are converted to whole-slide images and then digitized. From that point, the surgical pathologist becomes the coach and quarterback of an individual patient’s case. The pathologist guides the AI-powered image analysis algorithms. Based on the results, the pathologist then orders supplementary tests appropriate to developing a robust diagnosis and guiding therapeutic decisions for that patient’s cancer.

In his interview with The Dark Report, Singh explained that the first effective AI-powered algorithms in digital pathology will be developed for prostate cancer and skin cancer. Both types of cancer are much less complex than, say, breast cancer. Moreover, the AI developers have decades of prostate cancer and melanoma cases where the biopsies, diagnoses, and downstream patient outcomes create a rich data base from which the algorithms can be trained and tuned.

To help surgical pathologists, pathologist-business leaders, and pathology group practice administrators understand the rapid developments in AI-powered digital pathology analysis, Dark Daily is conducting “Clinical-Grade Artificial Intelligence (AI) for Your Pathology Lab: What’s Ready Now, What’s Coming Soon, and How Pathologists Can Profit from Its Use,” on Thursday, June 17, 2021, from 1:00 PM to 2:30 PM EDT.

This webinar is organized as a roundtable discussion so participants can interact with the expert panelists. The Chair and Moderator is Ajit Singh, PhD, Adjunct Professor at the Stanford School of Medicine and Partner at Artiman Ventures.

Panelists for June 17 webinar, Clinical-Grade Artificial Intelligence (AI) for Your Pathology Lab: What’s Ready Now, What’s Coming Soon, and How Pathologists Can Profit from Its Use

The panelists (above) represent academic pathology, community hospital pathology, and the commercial sector. They are:

Because the arrival of automated analysis of digital pathology images will transform the daily routine of every surgical pathologist, it would be beneficial for all pathology groups to have one or more of their pathologists register and participate in this critical webinar.

The roundtable discussion will help them understand how quickly AI-powered image analysis is expected be cleared for use by the FDA in such diseases as prostate cancer and melanomas. Both types of cancers generate high volumes of case referrals to the nation’s pathologists, so potential for disruption to long-standing client relationships, and the possible loss of revenue for pathology groups that delay their adoption of digital pathology, can be significant.

On the flip side, community pathology groups that jump on the digital pathology bandwagon early and with the right preparation will be positioned to build stronger client relationships, increase subspecialty case referrals, and generate additional streams of revenue that boost partner compensation within their group.

Act now to guarantee your place at this important webinar. Click HERE to register, or copy and paste the URL into your browser.

Also, because so many pathologists are working remotely, Dark Daily has arranged special group rates for pathology practices that would like their surgical pathologists to participate in this important webinar and roundtable discussion on AI-powered primary diagnosis of pathology images. Inquire at or call 512-264-7103.

—Michael McBride

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