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
Sign In

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 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

Walgreens Continues Expansion into Primary Care as VillageMD Acquires Starling Physicians Group with 30 Locations in Connecticut

Expect there to be more clinical laboratory testing at pharmacies as retail pharmacy chains expand their primary care offerings

Walgreens Boots Alliance (NASDAQ:WBA) of Deerfield, Illinois, continues to expand its primary care footprint with VillageMD’s latest acquisition of Starling Physicians, a multi-specialty physicians group with 30 locations in Connecticut, according to a VillageMD news release. Walgreens is the majority owner of VillageMD, which now has more than 700 medical centers, Healthcare Dive noted.

This deal continues the trend of corporations acquiring physician practices. Already, the majority of physicians are employees, not partners in a private practice physician group. Under corporate ownership, these physician groups often decide to change their clinical laboratory providers. For that reason, managers and pathologists at local medical laboratories will want to explore how they might provide daily lab testing services to the corporate owners of these primary care clinics.

The Hartford Business Journal called VillageMD’s acquisition of Starling Physicians—which is subject to a state investigation for possible certificate-of-need requirement—one of Connecticut’s “more high-profile healthcare merger and acquisition deals in Connecticut in recent years.”

Starling Physicians locations offer full primary care services, as well as specialties that include geriatrics, endocrinology, nephrology, ophthalmology, and cardiology.

The Starling Physicians group acquisition comes just a few months after  

VillageMD paid $8.9 billion for Summit Health-CityMD of Berkeley Heights, New Jersey, with primary care services in the Northeast and Oregon. Walgreens invested $3.5 billion in that transaction, a Summit Health news release noted.

These acquisitions by Walgreens/VillageMD provide opportunities for local clinical laboratories to serve the physicians in these practices, though the operations may have a different patient flow and work process than traditional family practice clinics located in medical offices around community hospitals.

Tim Barry

“Starling shares our vision of being a physician-led model and they provide care in a compassionate and exceptional way to all the patients they serve. By integrating primary care with specialty care, we are able to optimize access to high-quality care for our patients,” said Tim Barry (above), CEO and Chair of VillageMD in the news release. “This is a natural extension of our growth in the Northeast, including our recent acquisition of Summit Health-CityMD. Together, we are transforming the way healthcare is delivered in the United States.” Clinical laboratories in these areas will want to develop a strategy for serving the physicians practicing at these non-traditional locations. (Photo copyright: The Business Journals.)

Primary Care at Retail Locations a Growing Trend

Dark Daily and its sister publication The Dark Report have reported extensively on the growing trend by pharmacy chains and other retail superstores to add primary care services to their footprint.

In “By 2027, Walgreens Wants 1,000 Primary Care Clinics,” The Dark Report covered how Walgreens had disclosed that it would spend $5.2 billion to acquire a 63% interest to become the majority owner of VillageMD. Fierce Healthcare reported that “[Walgreens] planned to open at least 600 Village Medical at Walgreens primary-care practices across the country by 2025 and 1,000 by 2027.”

In “Retail Chain Pharmacies Add CLIA-Waived Point-of-Care Blood Testing and Other Preventive Health Services to Their In-store Offerings,” we reported how eTrueNorth, a pharmacy‐based clinical laboratory services network headquartered in Mansfield, Texas, had partnered with Walmart (NYSE:WMT), Winn-Dixie, Kroger (NYSE:KR), and other retailers to offer their employees CLIA-waived point-of-care testing, preventive health services, wellness screenings, and other medical laboratory testing services through its eLabNetwork chain of retail pharmacies.

And in “Walmart’s Health and Wellness Chief Discusses Retail Giant’s Move to Healthcare/Telehealth Provider, a Step with Implications for Clinical Laboratory Testing,” Dark Daily pointed out that clinical laboratories need strategies to serve customers accessing healthcare in non-traditional settings, particularly as Walmart and the national retail pharmacy chains continue to expand the clinical services offered in their retail stores.

VillageMD

VillageMD is a primary care provider with same-day appointments, telehealth virtual visits, in-home care, and clinical laboratory diagnostic testing such as blood tests and urinalysis. Many VillageMD practices are located in buildings next door to Walgreens sites throughout the United States. (Photo copyright: Walgreens.)

Other Retailers Investing in Primary Care

Other retailers have recently taken deeper dives into healthcare as well.

According to Forbes, “The acquisition comes amid a flurry of acquisitions across the US for doctor practices, which are being purchased at an unprecedented pace by large retailers like Walgreens Boots Alliance, CVS Health, Amazon, and Walmart. Meanwhile, medical care providers owned by health insurers like UnitedHealth Group’s Optum and Cigna’s Evernorth are also in the doctor practice bidding war.”

In “Walmart’s Health and Wellness Chief Discusses Retail Giant’s Move to Healthcare/Telehealth Provider, a Step with Implications for Clinical Laboratory Testing,” Dark Daily reported on Walmart Health’s acquisition of MeMD, which was subsequently renamed in May to Walmart Health Virtual Care.

And in February, CVS announced plans to acquire for $10.6 billion Oak Street Health, a Chicago-based primary care company with 169 medical centers across 21 states that plans to have more than 300 centers by 2026.

Do Clinical Laboratories Want Retail Customers?

The question of whether clinical laboratories should pursue retail customers is at this point academic. Consumer demand is driving the change and labs that don’t keep up may be left behind.

“The trend of putting full-service primary care clinics in retail pharmacies is a significant development for the clinical laboratory industry,” wrote Robert Michel, Editor-in-Chief of Dark Daily and The Dark Report. “These clinics will need clinical lab tests and can be expected to shift patients away from traditional medical clinic sites for two reasons—lower price and convenience—since this new generation of primary care clinics will be located around the corner from where people live and work.”

Thus, healthcare system laboratories or large reference labs may want to reach out to Walgreens, CVS, Amazon, and Walmart for test referrals. These and other large retailers are investing heavily in the belief that consumers will continue to seek convenience in their healthcare.   

—Donna Marie Pocius

Related Information:

VillageMD Acquires Starling Physicians and Broadens its Footprint in the Northeast

Regulator Opens Inquiry into VillageMD-Starling Physicians Deal

VillageMD Acquires Summit Health-CityMD, Creating One of the Largest Independent Provider Groups in the US

Clinical Laboratory Trends: By 2027 Walgreens Wants 1,000 Primary Care Clinics

Walgreens-backed VillageMD Acquires Connecticut Medical Group

Walmart’s Health and Wellness Chief Discusses Retail Giant’s Move to Healthcare

CVS Health to Acquire Oak Street Health

CVS Reports $2.3B Q4 Profit, Will Buy Oak Street Health

Recent Separate Business Transactions by Fujifilm and GE Healthcare Suggest Bullish Outlook for Faster Adoption of Digital Pathology

Fujifilm acquired Inspirata’s Dynamyx digital pathology technology and business while GE Healthcare announced a partnership with Tribun Health in Europe

Clinical pathology laboratories, especially in the US, have been slow to adopt digital imaging systems. But recent industry deals suggest that the market may soon heat up, at least in the eyes of vendors. These collaborators may hope that, by integrating diagnostic data, the accuracy and productivity of anatomic pathologists will improve while also shortening the time to diagnosis.

In a December press release, Tokyo-based Fujifilm announced it acquired the global digital pathology business of Inspirata, including its Dynamyx digital pathology system. Inspirata is a Tampa-based cancer informatics company.

In the press release, Fujifilm stated that 85% of US healthcare organizations use analog systems for pathology. That compares with 86% in Europe and 90% in Asia, the company stated.

“Acquiring Inspirata’s digital pathology business allows Fujifilm to be an even stronger healthcare partner—bridging a technological gap between pathology, radiology, and oncology to facilitate a more collaborative approach to care delivery across the enterprise,” said Fujifilm CEO and president Teiichi Goto in the press release.

The press release cited data from Signify Research, a healthcare technology marketing data firm that is predicting the global market for digital pathology systems would double from $320 million in 2021 to $640 million by 2025.

Fujifilm previously had a deal with Inspirata to sell the Dynamyx system exclusively in the UK, Italy, Spain, Portugal, Belgium, the Netherlands, and Luxembourg, an August press release noted.

Henry Izawa

“A $320 million global industry in 2021 projected to reach $640 million by 2025, the rising number of cancer cases and the demonstrated benefits of digital pathology are fueling significant demand and market growth in the hospital and pharmaceutical industries,” said Henry Izawa (above), president and CEO, Fujifilm Healthcare Americas Corporation, in a press release. “These evolving clinical needs fuel Fujifilm’s investment and innovation in the digital revolution, and we look forward to introducing Dynamyx and its host of unique features and benefits to our Synapse customers and prospects as we strive to enable more efficient medical diagnosis and high-quality care.” (Photo copyright: LinkedIn.)

GE Healthcare Partners with Tribun Health

The Fujifilm acquisition followed an October 18 announcement of a collaboration between GE Healthcare and digital pathology company Tribun Health in Europe to provide an interface between the latter’s digital pathology software and GE Healthcare’s Edison Datalogue image-management system.

In announcing their new collaboration, GE Healthcare and Tribun Health said the integration of their systems—Edison Datalogue and the Tribun Health suite—would foster collaboration between pathologists and clinicians by providing a consolidated location for imaging records. This capability is especially important in oncology, they said.

“The oncology care pathway is one of the most complex with multiple steps involving a variety of specialists, complex tools, frequent decisions, and large data sets,” said GE Healthcare CEO of Enterprise Digital Solutions Nalinikanth Gollagunta in a GE press release. “With this digital pathology collaboration, we continue our journey towards simplifying the oncology care pathway with improved data management, the digitization of pathology, and streamlined data access.”

Tribun Health, based in Paris, France, offers a digital pathology platform that incorporates a camera system, artificial intelligence (AI)-based analysis, remote collaboration, and storage management, plus integration with third-party automation apps.

GE Healthcare claims that Edison Datalogue has the largest share of the Vendor Neutral Archive (VNA) market. That term refers to image archiving systems that use standard formats and interfaces instead of proprietary formats. They are an alternative to the more widely used Picture Archiving and Communications Systems (PACS) used in medical imaging.

The collaboration between the companies “is probably a strategic move to position GE as an integrator of imaging data and digital pathology data in oncology,” said Robert Michel Editor-in-Chief of Dark Daily and its sister publication The Dark Report.

GE’s History with Dynamyx

This is not GE Healthcare’s first foray into digital pathology. In fact, the company had a major hand in launching the very Dynamyx system that Fujifilm recently acquired.

Dynamyx was originally developed by digital pathology technology company Omnyx, LLC, which was a joint venture formed in 2008 between GE Healthcare and the University of Pittsburgh Medical Center (UPMC).

In “GE Healthcare Sells Omnyx to Inspirata,” The Dark Report interviewed Inspirata CEO Satish Sanan who at that time said the acquisition would allow his company to offer “a fully integrated, end-to-end digital pathology solution” in Canada and Europe. But GE Healthcare chose to end the partnership in 2016, citing regulatory uncertainty and variable global demand. Two years later, GE sold Omnyx to Inspirata.

GE Healthcare’s new collaboration with Tribun Health shows that the company “still recognizes the value of the pathology data in cancer diagnosis and wants to be in a position to manage that digital pathology data,” Michel said.

Fujifilm’s Plans

Fujifilm said it will incorporate Dynamyx into its Synapse Enterprise Imaging suite, which includes VNA, Radiology PACS, and Cardiology PACS. “Future releases of Dynamyx will also create opportunities for Fujifilm to support pharmaceutical and contract research organizations with toxicity testing data management for drug development,” the company stated in the press release.

US-based subsidiary Fujifilm Healthcare Americas Corporation will handle future development of the Dynamyx system. In the US, the system is currently cleared for the US Food and Drug Administration (FDA) for use with Leica’s Aperio AT2 DX scanner and Philips’ Ultra Fast Scanner.

With its recent moves into digital pathology, Fujifilm will be taking on major competitors including Philips, Danaher, and Roche, MedTech Dive reported.

Stephen Beale

Related Information:

Fujifilm Announces Asset Purchase Agreement with Inspirata, Inc. to Acquire the Company’s Digital Pathology Business

Fujifilm Agrees to Buy Inspirata’s Dynamyx in Challenge to Philips for Digital Pathology Market

GE Healthcare Announces Collaboration to Advance Digital Transformation of Pathology

Leica, Philips Come Out on Top in Digital Pathology Systems Market, KLAS Finds

GE Healthcare Sells Omnyx to Inspirata

Federal EKRA Law Continues to Cause Uncertainty in Clinical Laboratory Sales Compliance

Healthcare attorneys advise medical laboratory leaders to ensure staff understand difference between EKRA and other federal fraud laws, such as the Anti-kickback Statute

More than four years have passed since Congress passed the law and yet the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) continues to cause anxiety and confusion. In particular are the differences in the safe harbors between the federal Anti-Kickback Statute (AKS) and Stark Law versus EKRA. This creates uncertainty among clinical laboratory leaders as they try to understand how these disparate federal laws affect business referrals for medical testing.

According to a news alert from Tampa Bay, Florida-based law firm, Holland and Knight, “EKRA was enacted as part of comprehensive legislation designed to address the opioid crisis and fraudulent practices occurring in the sober home industry.” However, “In the four years since EKRA’s enactment, US Department of Justice (DOJ) enforcement actions have broadened EKRA’s scope beyond reducing fraud in the addiction treatment industry to include all clinical laboratory activities, including COVID-19 testing.”

It is important that medical laboratory leaders understand this law. New cases are showing up and it would be wise for clinical laboratory managers to review their EKRA/AKS/Stark Law compliance with their legal counsels.

David Gee

“Keeping in mind that [EKRA is] a criminal statute, clinical laboratories need to take steps to demonstrate that they’re not intending to break the law,” said attorney David Gee, a partner at Davis Wright Tremaine, in an exclusive interview with The Dark Report. “[Lab leaders should] think about what they can do to make their sales compensation program avoid the things the government has had such a problem with, even if they’re not sure exactly how to compensate under the language of EKRA or how they’re supposed to develop a useful incentive compensation plan when they can’t pay commissions.” David Gee will be speaking about laboratory regulations and compliance at the upcoming Executive War College in New Orleans on April 25-26, 2023. (Photo copyright: Davis Wright Tremaine.)

How Does EKRA Affect Clinical Laboratories?

The federal EKRA statute—originally enacted to address healthcare fraud in addiction treatment facilities—was “expansively drafted to also apply to clinical laboratories,” according to New York-based law firm, Epstein Becker and Green. As such, EKRA “applies to improper referrals for any ‘service,’ regardless of the payor. … public as well as private insurance plans, and even self-pay patients, fall within the reach of the statute.”

In “Revised Stark Law, Anti-Kickback Statute Rules Are Good News for Labs,” Dark Daily’s sister publication The Dark Report noted that EKRA creates criminal penalties for any individual who solicits or receives any remuneration for referring a patient to a recovery home, clinical treatment facility, or clinical laboratory, or who pays or offers any remuneration to induce a referral.

According to Epstein Becker and Green, EKRA:

  • Applies to clinical laboratories, not just toxicology labs.
  • Has relevance to all payers: Medicare, Medicaid, private insurance plans, and self-pay.
  • Is a criminal statute with “extreme penalties” such as 10 years in prison and $200,000 fine per occurrence.
  • Exceptions are not concurrent with AKS.
  • Areas being scrutinized include COVID-19 testing, toxicology, allergy, cardiac, and genetic tests.

“For many clinical laboratories, a single enforcement action could have a disastrous effect on their business. And unlike other healthcare fraud and abuse statutes, such as the AKA, exceptions are very limited,” Epstein Becker and Green legal experts noted.

“Therefore, a lab could potentially find itself protected under an AKS safe harbor and still potentially be in violation of EKRA,” they continued. “The US Department of Health and Human Services (HHS) and the DOJ have not provided any clarity regarding this statute (EKRA). Without this much needed guidance clinical laboratories have been left wondering what they need to do to avoid liability.”

EKRA versus AKS and Stark Law

HHS compared AKS and the Stark Law (but not EKRA) by noting on its website prohibition, penalties, exceptions, and applicable federal healthcare programs for each federal law: 

  • AKS has criminal fines of up to $25,000 per violation and up to a five-year prison term, as well as civil penalties.
  • The Stark Law has civil penalties only.
  • AKS prohibits anyone from “offering, paying, soliciting, or receiving anything of value to induce or reward referrals or generate federal healthcare program business.”
  • The Stark Law addresses referrals from physicians and prohibits the doctors “from referring Medicare patients for designated health services to an entity with which the physician has a financial relationship.”

EKRA is more restrictive than AKS, as it prohibits some compensation that AKS allows, healthcare attorney Emily Johnson of McDonald Hopkins in Chicago told The Dark Report.

“Specifically, AKS includes a safe harbor for bona fide employees that gives an employer wide discretion in how employees are paid, including permitting percentage-based compensation,” Johnson wrote in a Dark Daily Coding, Billing, and Collections Special Report, titled, “Getting Paid for COVID-19 Test Claims: What Every Clinical Lab Needs to Know to Maximize Collected Dollars.”  

EKRA Cases May Inform Clinical Laboratory Leaders

Recent enforcement actions may help lab leaders better understand EKRA’s reach. According to Holland and Knight:

  • Malena Lepetich of Belle Isle, Louisiana, owner and CEO of MedLogic LLC in Baton Rouge, was indicted in a $15 million healthcare fraud scheme for “allegedly offering to pay kickbacks for COVID-19 specimens and respiratory pathogen testing.”
  • In S-G Labs Hawaii, LLC v. Graves, a federal court concluded the laboratory recruiter’s contract “did not violate EKRA because the recruiter was not referring individual patients but rather marketing to doctors. According to the court, EKRA only prohibits percentage-based compensation to marketers based on direct patient referrals.”
  • In another federal case, United States v. Mark Schena, the court’s rule on prohibition of direct and indirect referrals of patients to clinical labs sent a strong signal “that EKRA most likely prohibits clinical laboratories from paying their marketers percentage-based compensation, regardless of whether the marketer targets doctors or prospective patients.”

What can medical laboratory leaders do to ensure compliance with the EKRA law?

In EKRA Compliance, Law and Regulations for 2023, Dallas law firm Oberheiden P.C., advised clinical laboratories (as well as recovery homes and clinical treatment facilities) to have EKRA policies and procedure in place, and to reach out to staff (employed and contracted) to build awareness of statute prohibitions and risks of non-compliance.

One other useful resource for clinical laboratory executives and pathologists with management oversight of their labs’ marketing and sales programs is the upcoming Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management. The conference takes place on April 25-26, 2023, at the Hyatt Regency in New Orleans. A panel of attorneys with deep experience in lab law and compliance will discuss issues associated with EKRA, the Anti-Kickback Statutes, and the Stark self-referral law. 

Donna Marie Pocius

Related Information:

The State of EKRA

Four Years After EKRA: Reminders for Clinical Laboratories

Revised Stark Law and AKS Rules Are Good News for Labs

Comparison of the Anti-Kickback Statute and Stark Law

Getting Paid for COVID-19 Test Claims: What Every Clinical Lab Needs to Know to Maximize Collected Dollars

EKRA Compliance, Law and Regulations for 2023

;