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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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 https://nanozoomer.hamamatsu.com/us/en.html.

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

Great Resignation Hits Retail Pharmacies, Causing Shorter Hours, Closures

As with clinical laboratories, worker shortage is affecting large retail pharmacy chains and independent pharmacies alike

Staffing shortages in clinical laboratories and anatomic pathology groups caused by the Great Resignation is having a similar impact on retail pharmacy chains. Consequently, pharmacy chains are reducing store hours and even closing sites, according to USA Today.

As Dark Daily covered in “Clinical Laboratories Suffer During the ‘Great Resignation,” the US Bureau of Labor Statistics reported that from August 2021 through December 2021, the healthcare and social assistance workforce saw nearly 2.8 million workers quit—an average of 551,000 people during each of those months. By comparison, in December 2020, 419,000 healthcare workers left their jobs.

Pharmacies now report similar shortages in qualified workers, partly due to the sharp decrease in revenue from COVID-19 vaccinations, but also due to worker burnout. Both developments have counterparts in clinical laboratories as well.

B. Douglas Hoey, PharmD

“I’m concerned that without the help from the COVID-19 vaccinations that everyone needed, these pharmacies that were able to tough it out for another year or two might not be able to continue,” B. Douglas Hoey, PharmD, CEO of the National Community Pharmacists Association (NCPA), told USA Today. Clinical laboratories that processed large numbers of SARS-CoV-2 diagnostics have experienced the same sudden drop in revenue causing similar difficulties maintaining staffing levels. (Photo copyright: Cardinal Health.)

Staffing Shortages Leading to Safety Concerns

According to the Washington Post’s coverage of a study conducted in 2021 of 6,400 pharmacists in various retail and hospital environments, a majority did not feel they could conduct their jobs efficiently or safely.

  • “75% of the pharmacists in [the] survey disagreed with the statement ‘Sufficient time is allocated for me to safely perform patient care/clinical duties.’”
  • “71% said there were not enough pharmacists working to ‘meet patient care/clinical duties.’”
  • “65% said ‘payment for pharmacy services’ did not support their ‘ability to meet clinical and non-clinical duties.’”

“Workplace conditions have pushed many pharmacists and pharmacy teams to the brink of despair,” said the board of trustees of the American Pharmacists Association (APhA) in a press release, the Washington Post reported. “Pharmacy burnout is a significant patient safety issue. It is impacting patients today with delayed prescription fulfillment, unacceptable waits for vaccines and testing, and potential errors due to high volume, long hours, and pressure to meet performance metrics.”

This is a sentiment that has been repeated across every facet of healthcare—including in clinical laboratories—where staff shortages are being felt.

Shortage of Pharmacists or Lack of Morale?

In “Drugstores Make Slow Headway on Staffing Problems,” the Associated Press outlined from where it believes the staffing problems originate. “There isn’t a shortage of pharmacists. There’s just a shortage of pharmacists who want to work in those high-stress environments that aren’t adequately resourced,” Richard Dang, PharmD, Assistant Professor of Clinical Pharmacy at the University of Southern California (USC), told the Associated Press.

This statement is reminiscent of the views expressed by Susanna Bator, a former clinical laboratory technician, in her personal essay published in The Daily Nurse titled, “The Hidden Healthcare Heroes: A Lab Techs Journey Through the Pandemic.” She previously worked at the Cleveland Clinic and with MetroHealth System in Cleveland, Ohio.

Dark Daily covered Bator’s journey as a clinical laboratory technician working in the trenches during the COVID-19 pandemic in “Clinical Laboratory Technician Shares Personal Journey and Experience with Burnout During the COVID-19 Pandemic.”

“The pressure never let up. No matter how mind-numbing and repetitive the work could get, we had to work with constant vigilance, as there was absolutely no room for error,” Bator wrote.

“We techs were left unsupported and unmentored throughout the pandemic,” she continued. “No one cared if we were learning or growing in our job, and there was little encouragement for us to enter training or residency programs. We were just expendable foot soldiers: this is not a policy that leads to long-term job retention.”

Healthcare workers feeling burnt out and under-appreciated during the pandemic led to mass resignations that produced staffing shortages throughout the industry. It appears this trend has caught up to pharmacies as well.

Workforce Wasn’t Ready

Local and chain pharmacies played an important role in the COVID-19 pandemic. Pharmacists distributed COVID-19 tests and treatment to their communities. But for many it was a struggle to keep up.

Stefanie Ferreri, PharmD, Distinguished Professor in Pharmacy Practice and Chair of the Division of Practice Advancement and Clinical Education at University of North Carolina’s Eshelman School of Pharmacy, told the Associated Press that she felt the expanding role of pharmacies in public health was “awesome” but stated that “the workforce wasn’t quite ready” for what took place during the pandemic.

Much like Bator recounted in her essay, pharmacy workers suddenly had new responsibilities, longer working hours, and little room for error.

“There are multiple stories about pharmacists just getting overwhelmed. The stress level and burnout is high,” Dima M. Qato, PharmD, PhD, told USA Today. Qato is Hygeia Centennial Chair and Associate Professor (with tenure) in the Titus Family Department of Clinical Pharmacy at the University of Southern California. “So, pharmacists leave, and stores have to shorten” their hours, she added.

Scheduling and Patience Can Help

What can be done to soften some of the issues staff shortages are causing? Ferreri suggests that pharmacies set appointment times for regular customers so that a pharmacist’s workload can be more predictable. An appointment system can ease stress for both the pharmacist and patient. Ferreri advises customers to be patient when it comes to their prescriptions. She suggests patients give pharmacies more than a day’s notice for refills.

“I think on both sides of the counter, we need to all have grace and realize this is a very challenging and stressful time for everyone,” said Brigid Groves, PharmD, Vice President, Pharmacy Practice at the American Pharmacists Association.

With burnout, staff shortages, and stress affecting nearly every aspect of the healthcare industry, having patience with each other will go a long way to helping clinical laboratories, pharmacies, and patients navigate the road ahead.

Ashley Croce

Related Information:

Pharmacies Are Cutting Hours and Closing Stores. What It Means for Customers.

Pharmacists Are Burning Out. Patients Are Feeling the Effects.

Drugstores Make Slow Headway on Staffing Problems

The Hidden Healthcare Heroes: A Lab Techs Journey Through the Pandemic

US Hospitals Continue to Be Squeezed by Shortage of Nurses, Rising Salaries

Clinical Laboratories Suffer During the ‘Great Resignation’

Clinical Laboratory Technician Shares Personal Journey and Experience with Burnout During the COVID-19 Pandemic

Bob McGonnagle, Publisher of CAP Today, Honored with Lifetime Achievement Award at 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management

McGonnagle’s involvement with medical laboratory medicine spans five decades and 38 years of support for the nation’s anatomic pathologists and clinical laboratory professionals

NEW ORLEANS—It was a standing ovation last week at the Executive War College on Diagnostic, Laboratory, and Pathology Management when Bob McGonnagle—first and only Publisher of CAP Today magazine—received a Lifetime Achievement Award.

The presentation was made in front of 950 attendees. During the presentation, several of McGonnagle’s peers described the multiple ways that he regularly supports the profession of clinical laboratory medicine.

In 1986, McGonnagle was engaged by the College of American Pathologists (CAP) to develop the concept of a new, tabloid-sized, color magazine to be called CAP Today. It was January 1987 when monthly publication of CAP Today formally commenced.

McGonnagle was again tapped by CAP to oversee production of another publication that was created in 1996. Since its inception, he has also been publisher of the Archives of Pathology and Laboratory Medicine.

Al Lui, MD, Robert Michel, Bob McGonnagle, Stan Schofield

During last week’s Executive War College on Diagnostic, Laboratory, and Pathology Management in New Orleans, Bob McGonnagle (center right) was honored with a Lifetime Achievement Award for his 38 years as Publisher of CAP Today, along with his innumerable contributions to advancing the clinical laboratory and anatomic pathology professions. McGonnagle is joined by Robert Michel, founder of the Executive War College on his right; Al Lui, MD, of Innovative Pathology Medical Group on his far right; and Stan Schofield of Compass Group on his left. (Photo copyright: The Dark Report.)

38 Years as Publisher of CAP Today Magazine

But McGonnagle’s duties as publisher are just the starting point of the contributions McGonnagle has made to the House of Laboratory Medicine in the past 38 years. He is regularly seen at pathology and lab meetings, conferences, and workshops throughout the United States and overseas. As a speaker and moderator, he is much in demand. He is often asked to sit in during strategic retreats and think tanks organized by laboratory associations, lab organizations, and lab vendors.

During the presentation ceremony, three of McGonnagle’s peers offered insights and examples of his unstinting support of pathologists, lab managers, and companies serving medical laboratories. First to speak was Stan Schofield, Managing Principal at Compass Group and past CEO of NorDx Laboratories in Scarborough, Maine.

“Bob McGonnagle is excellent as a moderator for conferences, meetings, and conventions and will always say ‘yes’ when asked to serve,” Schofield observed. “He is quick to recognize and adapt to emerging issues. He processes information from various parts of the lab industry, then generates insights and information all can understand and use to the benefit of their respective labs and pathology groups.”

Next to speak was pathologist Al Lui, MD, President and Medical Director, at Innovative Pathology Medical Group in Torrance, California. Lui has been active on committees and initiatives of CAP for decades. “Recognition of Bob McGonnagle’s past and continuing contributions to the profession of pathology and laboratory medicine is long overdue,” he said.

McGonnagle as Farmer, Fan of Classical Music, and Oenophile

Lui then presented slides that showed the range of McGonnagle’s activities outside of his publishing responsibilities. For example, Bob is remote manager of two inherited family farms in Iowa that produce corn, soybeans, and cattle. His wife competes in equestrian events. They are wine aficionados and close personal friends with one of Napa Valley’s most respected vintners.

One key figure in McGonnagle’s publishing activities is the Editor of CAP Today Sherrie Rice. She has served in this role since 1987 and thus has collaborated with Bob for the 38 years of CAP Today’s publication. “His leadership of the periodicals department at the CAP has been brilliant and working alongside him for more than three decades has been the gift of a lifetime,” Rice noted.

Rice also described an underappreciated aspect of McGonnagle’s efforts as Publisher. “Bob constantly works to connect the IVD manufacturers and lab vendors with labs that need and benefit from these solutions,” she noted. “He is quick to recognize emerging technologies and help explain them with in-depth stories in CAP Today that help pathologists and lab managers better understand when such innovations are ready to be implemented.”

A Career That Spans Five Decades

As McGonnagle was handed his Lifetime Achievement Award, Robert Michel, Founder of the Executive War College and Editor-in-Chief of Dark Daily and its sister publication The Dark Report, made several observations. “Bob McGonnagle has all the hallmarks of a loyal friend. He is always willing to help and never asks for anything in return,” Michel noted. “He is discreet and trustworthy, with keen powers of observation and analysis. Our profession is blessed that his career and contributions have spanned five decades.”

All of Bob McGonnagle’s colleagues, friends, and associates are encouraged to use social media to send him congratulations and notes of appreciation for his 38 years of service as Publisher of CAP Today, and for his many contributions to the clinical laboratory and pathology professions.   

Here are social media links where it would be appropriate to post comments about Bob McGonnagle, with best wishes, congratulations, and examples of his selfless support:

On Twitter: https://twitter.com/Dark_Daily

On Twitter: https://twitter.com/thedarkreport

On LinkedIn: https://www.linkedin.com/company/the-dark-intelligence-group/

—Robert L. Michel

Related Information:

Executive War College on Diagnostic, Laboratory, and Pathology Management

College of American Pathologists

Archives of Pathology and Laboratory Medicine

Executive War College Headliners Connect Genetic Testing, Wearable Technology, Precision Medicine, and Struggle Over Claim Reimbursement between Clinical Labs and Payers

Keynote speakers advise clinical laboratory leaders to leverage diagnostic data that feeds precision therapies

At this week’s Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management in New Orleans, keynote presenters dissected ways that clinical laboratory leaders and anatomic pathologists can contribute to innovative treatment approaches, including wearable technology and precision medicine.

The speakers also noted that labs must learn to work collaboratively with payers—perhaps through health information technology (HIT)—to establish best practices that improve reimbursements on claims for novel genetic tests.

Harnessing the ever-increasing volume of diagnostic data that genetic testing produces should be a high priority for labs, said William Morice II, MD, PhD, CEO and President of Mayo Clinic Laboratories.

“There will be an increased focus on getting information within the laboratory … for areas such as genomics and proteomics,” Morice told the keynote audience at the Executive War College on Wednesday.

William Morice II, MD, PhD

“Wearable technology data is analyzed using machine learning. Clinical laboratories must participate in analyzing that spectrum of diagnostics,” said William Morice II, MD, PhD (above), CEO and President of Mayo Clinic Laboratories. Morice spoke during this week’s Executive War College.

Precision Medicine Efforts Include Genetic Testing and Wearable Devices

For laboratories new to genetic testing that want to move it in-house, Morice outlined effective first steps to take, including the following:

  • Determine and then analyze the volume of genetic testing that a lab is sending out.
  • Research and evaluate genetic sequencing platforms that are on the market, with an eye towards affordable cloud-based options.
  • Build a business case to conduct genetic tests in-house that focuses on the long-term value to patients and how that could also improve revenue.

Morice suggested that neuroimmunology is a reasonable place to start with genetic testing. Mayo Clinic Laboratories found early success with tests in this area because autoimmune disorders are rising among patients.

A related area for clinical laboratories and pathology practices to explore is their role in how clinicians treat patients using wearable technology.

For example, according to Morice, Mayo Clinic has monitored 20,000 cardiac patients with wearable devices. The data from the wearable devices—which includes diagnostic information—is analyzed using machine learning, a subset of artificial intelligence.

In one study published in Scientific Reports, scientists from Mayo’s Departments of Neurology and Biomedical Engineering found “clear evidence that direct seizure forecasts are possible using wearable devices in the ambulatory setting for many patients with epilepsy.”

Clinical laboratories fit into this picture, Morice explained. For example, depending on what data it provides, a wearable device on a patient with worsening neurological symptoms could trigger a lab test for Alzheimer’s disease or other neurological disorders.

“This will change how labs think about access to care,” he noted.

For Payers, Navigating Genetic Testing Claims is Difficult

While there is promise in genetic testing and precision medicine, from an administrative viewpoint, these activities can be challenging for payers when it comes to verifying reimbursement claims.

“One of the biggest challenges we face is determining what test is being ordered. From the perspective of the reimbursement process, it’s not always clear,” said Cristi Radford, MS, CGC, Product Director at healthcare services provider Optum, a subsidiary of UnitedHealth Group, located in Eden Prairie, Minnesota. Radford also presented a keynote at this year’s Executive War College.

Approximately 400 Current Procedural Terminology (CPT) codes are in place to represent the estimated 175,000 genetic tests on the market, Radford noted. That creates a dilemma for labs and payers in assigning codes to novel genetic tests.

During her keynote address, Radford showed the audience of laboratory executives a slide that charted how four labs submitted claims for the same high-risk breast cancer panel. CPT code choices varied greatly.

“Does the payer have any idea which test was ordered? No,” she said. “It was a genetic panel, but the information doesn’t give us the specificity payers need.”

In such situations, payers resort to prior authorization to halt these types of claims on the front end so that more diagnostic information can be provided.

“Plans don’t like prior authorization, but it’s a necessary evil,” said Jason Bush, PhD, Executive Vice President of Product at Avalon Healthcare Solutions in Tampa, Florida. Bush co-presented with Radford.

[Editor’s note: Dark Daily offers a free webinar, “Learning from Payer Behavior to Increase Appeal Success,” that teaches labs how to better understand payer behavior. The webinar features recent trends in denials and appeals by payers that will help diagnostic organizations maximize their appeal success. Click here to stream this important webinar.]

Payers Struggle with ‘Explosion’ of Genetic Tests

In “UnitedHealth’s Optum to Offer Lab Test Management,” Dark Daily’s sister publication The Dark Report, covered Optum’s announcement that it had launched “a comprehensive laboratory benefit management solution designed to help health plans reduce unnecessary lab testing and ensure their members receive appropriate, high-quality tests.”

Optum sells this laboratory benefit management program to other health plans and self-insured employers. Genetic test management capabilities are part of that offering.

As part of its lab management benefit program, Optum is collaborating with Avalon on a new platform for genetic testing that will launch soon and focus on identifying test quality, streamlining prior authorization, and providing test payment accuracy in advance.

“Payers are struggling with the explosion in genetic testing,” Bush told Executive War College attendees. “They are truly not trying to hinder innovation.”

For clinical laboratory leaders reading this ebriefing, the takeaway is twofold: Genetic testing and resulting precision medicine efforts provide hope in more effectively treating patients. At the same time, the genetic test juggernaut has grown so large so quickly payers are finding it difficult to manage. Thus, it has become a source of continuous challenge for labs seeking reimbursements.

Heath information technology may help ease the situation. But, ultimately, stronger communication between labs and payers—including acknowledgement of what each side needs from a business perspective—is paramount. 

Scott Wallask

Related Information:

Executive War College Keynote Speakers Highlight How Clinical Laboratories Can Capitalize on Multiple Growth Opportunities

What Key Laboratory Leaders Will Learn at This Week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management

Ambulatory Seizure Forecasting with a Wrist-Worn Device Using Long-Short Term Memory Deep Learning

UnitedHealth’s Optum to Offer Lab Test Management

Learning from Payer Behavior to Increase Appeal Success

Executive War College Keynote Speakers Highlight How Clinical Laboratories Can Capitalize on Multiple Growth Opportunities

From ‘new-school’ rules of running a clinical laboratory to pharmacy partnerships to leveraging lab data for diagnostics, key industry executives discussed the new era of clinical laboratory and pathology operations

Opening keynotes at the 28th Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management taking place in New Orleans this week covered three main forces that healthcare and medical laboratory administrators should be preparing to address: new consumer preferences, new care models, and new payment models.

COVID-19 didn’t change a whole lot of things in one sense, but it accelerated a lot of trends that were already happening in healthcare,” said Robert L. Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report, and Founder of the Executive War College, during his opening keynote address to a packed ballroom of conference attendees. “Healthcare is transforming, and the transformation is far more pervasive than most consumers appreciate.

Disintermediation, for example, is taking traditional service providers and disrupting them in substantial ways, and if you think about the end of fee-for-service, be looking forward because your labs can be paid for the value you originate that makes a difference in patient care,” Michel added.

Another opportunity for clinical laboratories, according to Michel, is serving Medicare Advantage plans which have soared in enrollment. “Lab leaders should be studying Medicare Advantage for how to integrate Medicare Advantage incentives into their lab strategies,” he said, highlighting the new influence of risk adjustment models which use diagnostic data to predict health condition expenditures.

Robert L. Michel

Opening sessions at this week’s annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management, presented by Robert L. Michel (above), Editor-in-Chief of Dark Daily and its sister publication The Dark Report, discussed demand for delivering healthcare services—including medical laboratory testing—as consumer preferences evolve, new care models are designed, and as payers seek value over volume. While these three forces may be challenging at the outset, they also create opportunities for clinical laboratories and pathology groups—a focal point of the Executive War College each year. (Photo copyright: The Dark Intelligence Group.)

Medical Laboratories Must Adapt to ‘New-School’ Rules

During his keynote address, Stan Schofield, Vice President and Managing Principal at The Compass Group, noted that while the basic “old-school” rules of successfully running a clinical laboratory have not changed—e.g., adding clients, keeping clients, creating revenue opportunities, getting paid, and reducing expenses—the interpretation of each rule has changed. The Compass Group is a trade federation based in South Carolina that serves not-for-profit healthcare integrated delivery networks (IDNs), including 32 health systems and 600 hospitals.

Schofield advised that when it comes to adding new clients under the “new-school” rules of lab management, clinical laboratory directors must be aware of and adapt to hospital integrations of core labs, clinical integrations across health systems, seamless services, direct contracting with employers in insurance relationships, and direct-to-consumer testing. Keeping clients, Schofield said, involves five elements:

  • Strong customer service.
  • A tailored metrics program for quality services based on what is important to a lab’s clients.
  • Balanced scorecards that look at the business opportunity and value proposition with each client.
  • Monitoring patients’ experiences and continuous improvement.
  • Participation in all payer agreements.

As to the problem of commoditization of laboratory goods and services, Schofield said, “Right now, we’re facing the monetization of the laboratory. We’re going to swiftly move from commoditization to monetization to commercialization.”

Pharmacies Enter the Clinical Laboratory Market

In another forward looking keynote address, David Pope, PharmD, CDE, Chief Pharmacy Officer at OmniSYS, XiFin Pharmacy Solutions, discussed the “test to treat” trend which could bring clinical laboratories and pharmacies together in new partnerships.

Diagnostics and pharmacy now intersect, according to Pope. “Pharmacists are on the move, and they are true contender as a new provider for you,” he said. “An area of pharmacy that is dependent upon labs is specialty medications.”

Specialty medicines now account for 55% of prescription spending, up from 28% in 2011, driven by growth in auto-immune and oncology, Pope noted. Other examples include companion diagnostics required for targeted treatments pertaining to all major cancers, and new areas like thalassemia (inherited blood disorders), obesity, next-generation sequencing, and pharmacogenomics, in addition to routine testing such as liver function and complete blood count (CBC).

Federal legislation may soon recognize pharmacists as healthcare providers who will be trained to perform specific clinical services, Pope said. Some states already recognize pharmacists as providers, he noted, explaining that pharmacies need lab data for three primary reasons:

  • Service—Pharmacies can act as a referral source to clinical laboratories. When referring, pharmacies may need to communicate lab test results to patients or providers to coordinate care.
  • Value-based care—Pharmacies would draw on data to counsel, prescribe, and coordinate care for chronic disease management, among other services.
  • Diagnostics and pharmacogenetics—Specialty medication workflows require documented test results within a specific timeframe prior to dispensing.

Another point Pope made: Large pharmacies are seeking lab partners. Labs that can provide rapid turnaround time and good pricing on complex tests provide pharmacies with partnership opportunities.

Using AI to Create Patients’ ‘Digital Twins’ That Help Identify Disease and Improve Care

High-tech healthcare technology underlies many opportunities in the clinical laboratory and pathology market, as evidenced throughout the Executive War College’s 2023 curriculum. An ongoing challenge for labs, however, is how to produce the valuable datasets that all labs have the potential to generate.

“It feels like we’ve come so far,” explained Brad Bostic, CEO of hc1 during his keynote address. “We’ve got the internet. We’ve got the cloud. All of this is amazing, but in reality, we have this massive proliferation of data everywhere and it’s very difficult to know how to actually put that into use. And nobody’s generating more data than clinical laboratories.

“Every single interaction with a patient that generates data gives you this opportunity to create the idea of a ‘digital twin.’ That means that labs are creating a mathematical description of what a person’s state is and using that information to look at how providers can optimally diagnose and treat that person. Ultimately, it is bigger than just one person. It’s hundreds of millions of people that are generating all this data, and many of these people fall into similar cohorts.”

This digital twin opportunity is heavily fueled by medical laboratory testing, Bostic said, adding that labs need to be able to leverage artificial intelligence (AI) to:

  • Improve lab operations.
  • Identify disease earlier.
  • Personalize treatment.
  • Run predictive analytics.

“I recommend lab leaders sit down with their teams and any outside partners they trust and identify what are their lab’s goals,” Bostic stated. “Think about how this technology can advance a lab’s mission. Look at strategy holistically—everything from internal operations to how patient care is affected.”

Lab and pathology leaders are invited to continue these and other conversations by joining the Executive War College Discussion Group and The Dark Report Discussion Group on LinkedIn.

Liz Carey

Related Information:

Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management

Report to Congress: Risk Adjustment in Medicare Advantage

Executive War College Press

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