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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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COLA Clinical Laboratory Workforce Summit in Fort Worth, Texas, Engages Stakeholders in Effort to Train More Medical Laboratory Scientists

Representatives from almost 50 different clinical laboratories, professional associations, and societies came together this week to align efforts to expand the supply and retention of qualified laboratory scientists

FORT WORTH, TEXAS—Last week, representatives from a broad cross section of clinical laboratories, lab and pathology associations, public health laboratories, and lab regulatory bodies gathered specifically to identify ways to expand the number of skilled lab professionals.

COLA organized the “Workforce Action Alliance Summit,” a one-day gathering of key clinical laboratory stakeholders who share a common interest in developing initiatives that would directly increase the number of individuals choosing to pursue a career in laboratory medicine.

This is not a new problem, as the lack of trained laboratory scientists across all scientific disciplines has been acute for many years.

COLA Graphic
The logo above was developed by COLA to support the Workforce Action Alliance Summit. This year’s first work session took place last week in Fort Worth, Texas. Participants came from such organizations as the CDC Division of Laboratory Systems (DLS), American Society for Clinical Laboratory Science (ASCLS), American Society for Clinical Pathology (ASCP), Association of Public Health Laboratories (APHL), and American Association for Clinical Chemistry (AACC), along with a number of clinical laboratories. The goal of this initiative is to pull together wide-ranging interests within the profession of laboratory medicine and align specific efforts with projects that directly increase the recruitment, training, and retention of skilled laboratory scientists. (Graphic copyright: COLA.)

Call to Action

In a communication sent to invited participants, COLA’s CEO, Nancy Stratton, and COO, Kathy Nucifora, described the objective of the summit, writing:

“Clearly a call to collective action is required if we are to address the impending clinical laboratory workforce shortage. The past three years have demonstrated the significance of a resilient laboratory infrastructure, not only for the daily care of millions of Americans, but also during the global pandemic. The numerous efforts currently underway to resolve the shortage are unquestionably a component of the solution. Many, however, believe that these efforts are insufficient to close the gap between the projected number of new entrants into the profession, the rate at which those currently in the profession are departing, and the future demand for laboratory testing.”

Robert L. Michel, Editor-in-Chief of Dark Daily’s sister publication The Dark Report was a participant at COLA’S workforce summit. The Dark Report regularly profiles clinical laboratory organizations that have developed innovative and productive initiatives designed to increase the number of students choosing to train as medical technologists (MTs), clinical laboratory scientists (CLSs), medical laboratory technologists (MLTs) and other skilled lab positions.

In materials distributed at the summit, the ongoing gap between demand for skilled lab professionals and the supply was illustrated thusly:

“The US Department of Labor estimates 320,000 bachelors and associates degreed laboratory professionals are working in the United States. If each of those professionals worked a standard 40-year career, the natural annual attrition of 2.5% would require 8,000 new professionals to maintain their current numbers. This exceeds the current output of accredited educational programs by more than 1,000 annually.” 

Case Studies of Success

Over the course of the day, participants at the summit heard about the successes of certain laboratory organizations designed to get more students into training programs, supported by the educational courses required for them to become certified in their chosen area of laboratory medicine. These case studies centered around several themes:

  • Obtaining funding specifically to establish an MT/CLS training program to increase the number of candidates in a region. One example involved ARUP Laboratories and its success at working with a local Congressional representative to get a $3 million federal grant funded as part of a larger legislative package.
  • The medical laboratory scientist (MLS) program at Saint Louis University (SLU) worked with Quest Diagnostics to launch an accelerated bachelor’s degree program. The 16-month program combines online academic courses with intensive hands-on learning and clinical experiences in Quest’s Lenexa, Kansas, laboratory. The first students in this accelerated degree program began their studies in the spring semester of 2023.
  • By rethinking the structure of its existing didactic and experiential learning structure, NorthShore University HealthSystem’s MLS program, located at Evanston Hospital north of Chicago, doubled its enrollment capacity.

During the afternoon, working groups addressed ways that lab organizations can collaborate to increase recruitment and retention of laboratory scientists across all disciplines of lab medicine. This input was synthesized into action planning for the three priorities that can lead to expanding the lab workforce.

By day’s end, several working groups were organized with specific next steps. COLA is taking the lead in managing this initiative and giving it momentum. All clinical laboratory professionals and pathologists are welcome to participate in the Workforce Action Alliance (WAA). Anyone wishing to learn more can contact COLA by clicking here, calling 800-981-9883, or by visiting https://education.cola.org/contact-us-page.

Robert L. Michel

Related Information:

COLA Workforce Action Alliance Summit

Building the Capacity and Resiliency of the Laboratory Workforce

Industry Execs Will Convene to Address the Lab Workforce Shortage

Executives Convene to Address the Laboratory Workforce Shortage

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

Executives and pathologists from many of the nation’s most prominent clinical laboratories are on their way to the Crescent City today to share best practices, hear case studies from innovative labs, and network

NEW ORLEANS—This afternoon, more than 900 lab CEOs, administrators, and pathologists will convene for the 28th Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management conference. Three topics of great interest will center around adequate lab staffing, effective cost management, and developing new sources of lab testing revenue.

Important sessions will also address the explosion in next-generation sequencing and genetic testing, proposed FDA regulation of laboratory-developed tests (LDTs), and innovative ways that clinical laboratories and pathology groups can add value and be paid for that additional value.

All this is happening amidst important changes to healthcare and medicine in the United States. “Today, the US healthcare system is transforming itself at a steady pace,” explained Robert L. Michel, Editor-in-Chief of The Dark Report and Founder of the Executive War College. “Big multi-hospital health systems are merging with each other, and payers are slashing reimbursement for many medical lab tests, even as healthcare consumers want direct access to clinical laboratory tests and the full record of their lab test history.

“Each of these developments has major implications in how clinical laboratories serve their parent organizations, offer services directly to consumers, and negotiate with payers for fair reimbursement as in-network providers,” Michel added. “Attending the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management equips lab leaders with the tools they’ll need to make smart decisions during these challenging times.”

Executive War College

Now in its 28th year, the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management convenes April 25-26 in New Orleans. Executive War College extends to a third day with three full-day workshops: LEAN fundamentals for lab leaders, a genetic testing program track, and a digital pathology track. Learn more at www.ExecutiveWarCollege.com. (Photo copyright: The Dark Intelligence Group.)

Challenges and Opportunities for Clinical Laboratories

With major changes unfolding in the delivery and reimbursement of clinical services, clinical laboratory and pathology practice leaders need effective ways to respond to the evolving needs of physicians, patients, and payers. As The Dark Report has often covered, three overlapping areas are a source of tension and financial pressure for labs:

  • Day-to-day pressures to manage costs in the clinical laboratory or pathology practice.
  • The growing demand for genetic testing, accompanied by reimbursement challenges.
  • Evolving consumer expectations in how they receive medical care and interact with providers.

Addressing all three issues and much more, the 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management features more than 80 sessions with up to 125 lab managers, consultants, vendors, and in vitro diagnostic (IVD) experts as speakers and panelists.

Old-School Lab Rules Have Evolved into New-School Lab Rules

Tuesday’s keynote general sessions (to be reported exclusively in Wednesday’s Dark Daily ebriefing) will include four points of interest for clinical laboratory and pathology leaders who are managing change and pursuing new opportunities:

  • Positioning the lab to prosper by serving healthcare’s new consumers, new care models, new payment models, and more, with Michel at the podium.
  • How old-school lab rules have evolved into new-school lab rules and ways to transition the lab through today’s disrupters in healthcare and the clinical laboratory marketplace, with Stan Schofield, Managing Principal of the Compass Group.
  • The growing trend of clinical laboratory-pharmacy relationships with David Pope, PharmD, CDE, Chief Pharmacy Officer at OmniSYS, XIFIN Pharmacy Solutions.
  • Generating value by identifying risk signals in longitudinal lab data and opportunities in big data from payers, physicians, pharma, and bioresearch, with Brad Bostic, Chairman and CEO of hc1.

Wednesday’s keynote sessions (see exclusive insights in Friday’s Dark Daily ebriefing) explore:

Wednesday’s keynotes conclude with a panel discussion on delivering value to physicians, patients, and payers with lab testing services.

Clinical Labs, Payers, and Health Plans Swamped by Genetic Test Claims

Attendees of the 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management may notice a greater emphasis on whole genome sequencing and genetic testing this year.

As regular coverage and analysis in The Dark Report has pointed out, clinical laboratories, payers, and health plans face challenges with the explosion of genetic testing. Several Executive War College Master Classes will explore critical management issues of genetic and genomic testing, including laboratory benefit management programs, coverage decisions, payer relations, and best coding practices, as well as genetic test stewardship.

This year’s Executive War College also devotes a one-day intensive session on how community hospitals and local labs can set up and offer genetic tests and next-generation sequencing services. This third-day track features more than a dozen experts including:

During these sessions, attendees will be introduced to “dry labs” and “virtual CLIA labs.” These new terms differentiate the two organizations that process genetic data generated by “wet labs,” annotate it, and provide analysis and interpretation for referring physicians.

State of the Industry: Clinical Lab, Private Practice Pathology, Genetic Testing, IVD, and More

For lab consultants, executives, and directors interested in state-of-the-industry Q/A and discussions concerning commercial laboratories, private-practice pathology, and in vitro diagnostics companies, a range of breakout sessions, panels, and roundtables will cover:

  • Action steps to protect pathologists’ income and boost practice revenue.
  • Important developments in laboratory legal, regulatory, and compliance requirements.
  • New developments in clinical laboratory certification and accreditation, including the most common deficiencies and how to reach “assessment ready” status.
  • An update on the IVD industry and what’s working in today’s post-pandemic market for lab vendors and their customers.
  • Federal government updates on issues of concern to clinical laboratories, including PAMA, the VALID Act, and more.

Long-time attendees will notice the inclusion of “Diagnostics” into the Executive War College moniker. It’s an important addition, Michel explained for Dark Daily.

“In the recent past, ‘clinical laboratory’ and ‘anatomic pathology’ were terms that sufficiently described the profession of laboratory medicine,” he noted. “However, a subtle but significant change has occurred in recent years. The term ‘diagnostics’ has become a common description for medical testing, along with other diagnostic areas such as radiology and imaging.”

Key managers of medical laboratories, pathology groups, and in vitro diagnostics have much to gain from attending the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management, now in its 28th year. Look for continued coverage through social media channels, at Dark Daily, and in The Dark Report.

Clinical laboratories are invited to continue the 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 Agenda

Six Important Themes to Help Labs Succeed

Executive War College Press

The Dark Report

Dark Daily eBriefings

The Dark Report Discussion Group

Executive War College Discussion Group

Community Anatomic Pathology Groups Show Increased Interest in Adopting Digital Pathology and Whole-Slide Imaging, But Can They Do It on a Budget?

Acceptance of digital pathology and whole-slide imaging is now almost universal among academic health center pathology departments and the nation’s largest pathology companies

Across the United States, many private practice anatomic pathology groups now recognize that digital pathology is the path forward for the entire profession. During the past decade, most academic pathology departments and large pathology lab companies have incorporated digital pathology (DP) and whole-slide imaging (WSI) into many of their labs’ daily activities.

However, in community hospital-based anatomic pathology groups, there have been barriers to even the partial adoption of digital pathology. The two biggest barriers are well-known and discussed frequently at conferences and in the literature.

Some Pathologists Reluctant to Give Up Light Microscopes

One recognized barrier to wider adoption of DP is the reluctance of many long-serving pathologists to give up their familiar light microscopes and glass slides so they can make the transition to reading pathology images on a computer screen. These pathologists remain loyal to the tools and workflows that have served them well throughout their careers.

They generally oppose their group’s move to digital pathology when the subject is discussed in partner meetings and strategic retreats. Since many pathology groups require 100% of partners or shareholders to approve major business decisions, even one recalcitrant and stubborn pathologist-partner can block the motion to adopt digital pathology that is supported by most partners.

The second barrier is the fully-loaded cost to acquire, validate, implement, and use a digital pathology system with whole-slide imaging. A full-featured scanner can cost $250,000 or more and acquiring all the software, systems, and tools needed by a group to fully incorporate digital pathology into daily workflow can easily total $500,000 to $1,000,000.

This substantial commitment of a pathology group’s capital can trigger the same intense debates as the original question of whether the pathologists in the group should adopt DP and WSI. And, not surprisingly, in most pathology groups the same dynamics come into play when votes are tallied on the motion for the pathology group to commit the funds necessary to acquire a digital pathology system, the scanners, and associated tools.

Just one or two partner holdouts can block the decision to spend the money, despite that most of the pathologist partners are ready to make the commitment.

More Community Pathology Groups Considering Digital Pathology

Yet, the momentum in favor of adopting DP and WSI continues to build. “Those pathology labs that are early adopters report multiple clinical and financial benefits. These can include generating positive financial outcomes—including the ability to attract new clients, increasing case referrals, and generating new sources of revenue to the group. In turn, the increased revenue can allow the group to increase pathologist compensation,” said Robert L. Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.

Every day, more anatomic pathologists in the United States use a digital pathology system with a workstation (like above) to view whole-slide images and manage their daily caseload. Most academic center pathology departments use digital pathology, as do many of the nation’s largest pathology lab companies. (Photo copyright: WizardHealth.)

“We are in a time when health insurers are hammering away at the reimbursement paid to anatomic pathologists,” Michel continued. “Year after year, payers cut reimbursement for technical component and professional component services. They exclude many pathology groups from payer networks. That is why more community pathology groups are recognizing several important benefits with the use of DP and WSI that can increase a pathology group’s revenue and boost its pathologist compensation.

Community Pathology Groups Can Use Digital Pathology to Add Value

Equally important, there are specific ways that digital pathology and whole-slide imaging increase the value of the clinical services pathologists deliver to their client physicians. These dual benefits of DP are often overlooked—or not discussed—when community pathology groups conduct their annual retreats and debate the key points of when to adopt—and how to fund—a digital pathology system for their group. These benefits range from giving physicians a faster diagnostic answer on their cancer cases to helping the group’s subspecialist pathologists get more case referrals from physicians in other states.

“It’s important for all surgical pathologists to recognize several realities in today’s pathology marketplace,” Michel noted. “First, almost every sector in healthcare is digitizing itself. Reinforcing this trend is the federal government’s mandates for interoperability across EHRs, HISs, and LISs. Any private pathology group practice that lags in its adoption of digital capabilities and digital images will find itself falling farther and farther behind as physicians switch their case referrals to other pathology labs that have converted to digital pathology and whole-slide images.

“Second, pathology groups that adopt DP and WSI put themselves in a position to build market share in their service region, while at the same time increasing case referrals for their in-house subspecialist pathologists from throughout the United States,” Michel continued. “Also, when the histology is done locally, the local pathology group can deliver faster diagnostic answers and provide digital images as appropriate to referring physicians and hospitals in that region without the need to transport glass slides by couriers.

“Third—and this is an often-overlooked benefit of digital pathology—the local pathology group with DP and WSI can recruit today’s graduating pathology residents and fellows who have trained on DP and WSI. These new pathologists typically limit their job search to pathology groups that have gone digital,” Michel noted. “Millennial pathologists trained with digital images in their residency program. They are eager to work with the automated image analysis algorithms now coming to market.”

To help pathology groups better understand the opportunities and challenges associated with implementing digital pathology and whole-slide imaging, Dark Daily is presenting a special webinar, “Adopting Digital Pathology on a Budget: Getting Started, Knowing What’s Feasible, and Funding Your DP from Overlooked Sources,” on Thursday, May 27, from 1:00 PM to 2:30 EDT.

On Thursday, May 27, at 1:00 PM EDT, Keith Kaplan, MD, Chief Medical Officer of Corista (left), Andrew Evans, MD, Medical Director of Laboratory Medicine at Mackenzie Health (center left), William DeSalvo, President of Collaborative Advantage Consulting and Manager of Histology Operations at Sonora Quest Laboratories in Tempe, Ariz. (center right), and Lisa-Jean Clifford, COO and Chief Strategy Officer at Gestalt Diagnostics (right) will present “Adopting Digital Pathology on a Budget: Getting Started, Knowing What’s Feasible, and Funding Your DP from Overlooked Sources.” Anatomic pathologists, clinical laboratory directors, laboratory managers, clinical pathologists, and laboratory technicians will gain a critical understanding of which components a fully integrated digital pathology system requires, the differences between your lab’s existing LIS and a digital pathology system, budget-minded approaches to buying the components of a digital pathology system and implementing them in a stepwise fashion, and much more! (Photo copyright: Dark Daily.)

Recognizing the significant capital investment needed to acquire and deploy digital pathology and WSI, one goal of the webinar’s panel of experts is to identify ways that pathology groups can go digital on a budget. “We will do our best to identify different ways that pathology groups with limited financial resources can get into digital pathology,” said Keith Kaplan, MD, Chief Medical Officer at Corista in Concord, Mass., who will chair the upcoming webinar. “This may be the first public presentation where there is candid information about different financial strategies that your pathology group can utilize to acquire the scanners, the DP systems, and the associated tools needed for a full conversion to daily digital pathology.”

Don’t overlook how your participation in this webinar can be the foundation for helping your pathology group practice develop a timely, cost-effective path forward to introduce digital pathology and whole-slide imaging. Use of DP and WSI can become an important factor in helping your group offset payer prices cuts, develop new clients and sources of revenue, and increase pathologist compensation.

Click HERE to register today (or copy and paste this URL into your browser: https://www.darkdaily.com/webinar/adopting-digital-pathology-on-a-budget/). Make sure to have your pathology practice administrator and your histology manager join you for this important webinar.

—Michael McBride

Related Information:

Digital Pathology Launched in the ‘Era of COVID-19’: Memphis Lab Company Makes the Business Case for Scanning Slides to Cut Costs, Boost Productivity

Anatomic Pathology at the Tipping Point? The Economic Case for Adopting Digital Technology and AI Applications Now

Digital Pathology Systems Will Create Opportunities: Community Pathologists Discuss Benefits of Being Early Adopters of Digital Pathology

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

Twenty Years of Digital Pathology: An Overview of the Road Travelled, What Is on the Horizon, and the Emergence of Vendor-Neutral Archives

Next Generation Diagnostic Pathology: Use of Digital Pathology and Artificial Intelligence Tools to Augment a Pathological Diagnosis

Concert Genetics, XIFIN, Bruce Quinn, MD, PhD, and The Dark Report to Update Clinical Laboratory Professionals on the State of the Genetic Testing Marketplace

Physician use of genetic tests continues to grow at robust rates, even during the pandemic, but uncertainty about managed care reimbursement hangs over the market

It may surprise many pathologists and clinical laboratory managers to learn that the market for genetic testing is robust and growing swiftly, even in the midst of the COVID-19 pandemic. At the same time, the explosion in both the number of unique genetic tests available to physicians, and the willingness of doctors to order genetic tests for their patients, are creating major challenges for both government and private payers. 

Moreover, how payers are attempting to gain control over this boom in genetic testing is creating serious problems for genetic testing companies seeking reimbursement for their test claims. This is because health insurers are taking aggressive steps to control their spending on genetic tests. Some of those steps include:

  • Prior-authorization requirements for an ever-larger number of genetic tests.
  • Reducing the prices paid for high-cost genetic tests.
  • Tough audits that use sampling and extrapolation and produce sizeable recoupment demands.

Unexpected Developments in Genetic Test Marketplace

These are reasons why clinical laboratories need to fully understand the state of the genetic testing market. Physicians are receptive to ordering genetic tests that will improve the care they provide their patients. But health insurers want better control over the unplanned and substantial increases in the total amount of money they pay out for the surging number of genetic test claims.

Collectively, these developments confront genetic testing companies with a mix of good news and bad news. The good news is that more physicians are using genetic tests in their daily medical practice. The bad news is that many payers are erecting ever-more restrictive hurdles that labs must overcome when submitting genetic test claims and seeking adequate payment.

To help executives and molecular pathologists from genetic testing laboratories understand the forces now shaping genetic testing in the United States, Dark Daily is presenting a special webinar, titled, “State of the Genetic Testing Marketplace–Getting Paid for All Your Lab’s Genetic Test Claims: What’s Changing, What’s Not, and What’s Working Best.” This webinar—which includes a panel discussion and live Q/A session— will take place on Thursday, March 25, 2021, at 1:00 PM EDT.

Strategic Insights into What’s Changing with Genetic Testing

This webinar will be one of the most important strategic assessments of genetic testing presented to the clinical laboratory and diagnostics industries since the COVID-19 pandemic began last March. Your presenters are recognized thought-leaders in the genetic testing and laboratory medicine industries. Speaking in order are:

  • Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates LLC, Los Angeles: An expert in how Medicare and private payers establish coverage guidelines and prices for new genetic tests, Dr. Quinn will explain the key differences in how private payers are managing genetic test utilization and payment, compare to the federal Medicare program.
  • Heather Agostinelli, Asst. Vice President, Strategic Revenue Operations, XIFIN Inc., San Diego: Heather will provide a detailed perspective on the daily actions by payers as they process claims and issue payment for genetic tests. She will also present recommendations for how labs can optimize the number of clean genetic test claims, thus helping shorten payment times in ways that improve cash flow.
  • Rob Metcalf, CEO, Concert Genetics, Nashville, Tenn.: He will discuss the scope and scale of the explosion in the number of genetic test claims by sharing data, charts, and analyses usually only available to clients.

Your Chair and Moderator will be Robert L. Michel, Editor-in-Chief of The Dark Report.

Bruce Quinn, MD, PhD,  Heather Agostinelli, and Rob Metcalf headshots
On Thursday, March 25, at 1:00 PM EDT, Bruce Quinn, MD, PhD, (left), Heather Agostinelli (center), and Rob Metcalf (right) will present “State of the Genetic Testing Marketplace–Getting Paid for All Your Lab’s Genetic Test Claims: What’s Changing, What’s Not, and What’s Working Best.” Molecular pathologists, financial analysts, and managed care and clinical laboratory executives will gain a critical understanding of how COVID-19 is shaping the future of genetic testing and learn how to navigate federal regulations and payer claims processing. (Photo copyright, Dark Daily.)

The purpose of the upcoming webinar includes helping attendees with the following and more:

  • Learn why payers must now deal with more than 1,000 new genetic testing products launching every month and how that complicates claims processing.
  • Understand how the variation in CPT coding by different genetic testing labs complicates claims processing by payers.
  • Learn why “benefit investigation” is already a huge factor as consumers seek the lab with the cheapest genetic test price before they agree to be tested.
  • Master the art of working with prior authorization programs and know why having documents prior to authorization still does not necessarily mean the payer will reimburse for a genetic test claim.
  • Understand Medicare’s policy changes at the national level for genetic tests.
  • Know the core elements of the Medicare MolDx program that gov-erns genetic test claims across 28 states.
  • Be prepared to use the Operation Double Helix court documents as the road map to identify the genetic tests and CPT codes that federal prosecutors use to guide their enforcement of the federal Anti-Kickback Statute, Stark Law, and the Eliminating Kickbacks in Recovery Act (EKRA).

Valuable Information for Financial Analysis, Managed Care Executives

In addition to bringing clinical pathologists and directors/managers of clinical laboratories up to date on the genetic testing marketplace, this webinar will provide valuable insights into financial analysts’ tracking of genetic testing companies, managed care executives’ handling of genetic testing claims, genetic counselors, and others involved in managing clinical service lines that utilize genetic tests in patient care.

Click here for full details or to register for the March 25 webinar, “State of the Genetic Testing Marketplace–Getting Paid for All Your Lab’s Genetic Test Claims: What’s Changing, What’s Not, and What’s Working Best.” Or copy and paste this URL into your browser: https://www.darkdaily.com/webinar/state-of-the-genetic-testing-marketplace-getting-paid-for-all-your-labs-genetic-test-claims-whats-changing-whats-not-and-whats-working-best/.

—Michael McBride

Related Information:

State of the Genetic Testing Marketplace–Getting Paid for All Your Lab’s Genetic Test Claims: What’s Changing, What’s Not, and What’s Working Best

Stark Law and Anti-kickback Statute to Encourage Value-Based Care and Reduce Technical Trip Wires

Federal Anti-Kickback Statute Final Rule

Physician Self-Referral Stark Law Final Rule

S.3254 – Eliminating Kickbacks in Recovery Act of 2018

Federal Law Enforcement Action Involving Fraudulent Genetic Testing Results in Charges Against 35 Individuals Responsible for Over $2.1 Billion in Losses in One of the Largest Health Care Fraud Schemes Ever Charged

Federal Advisory Committee Seeks Public Comments on Revising CLIA Regulations, says Keynote Speaker at 13th Annual Lab Quality Confab in Atlanta

At The Dark Report’s annual Lab Quality Confab for clinical laboratory administrators, managers, and quality team members, experts outline how disruption in healthcare requires labs to improve processes and cut costs

ATLANTA, Oct. 15, 2019—Clinical laboratory professionals have a chance to advise the federal Centers for Disease Control and Prevention (CDC) on how the federal government could revise the regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). That’s according to one of the keynote speakers on Wednesday at The Dark Report’s 13th Annual Lab Quality Confab (LQC), which began here on Tuesday.

Reynolds M. Salerno, PhD, Director of the Division of Laboratory Systems (DLS) for the CDC in Atlanta, explained that the agency is collecting comments from the public and from its Clinical Laboratory Improvement Advisory Committee (CLIAC) on how to revise the CLIA regulations.

This is an opportunity for clinical laboratory directors, pathologists, and other lab professionals, to comment on the proposed revisions to CLIA before or during the upcoming CLIAC meeting on Nov. 6.

The agenda for the meeting is posted on the CDC’s website.

Public to be Heard on CLIA Regulations

“For the first time in its 26-year history, the council has called for three workgroups to address how to revise CLIA,” Salerno said. The workgroups will address these topics:

“It’s a dramatic step for the government to ask the laboratory community how to revise the CLIA regulations,” Salerno commented. Chartered in 1992, the advisory council meets twice a year, once in April and once in November.

CLIAC issued a summary report of its April 10-11 meeting. It also published an agenda for its upcoming meeting in Nov. 6.

In the coming weeks, Dark Daily will publish more information on how clinical laboratory professionals can comment on the important issue of CLIA revisions.

Digital slides from Salerno’s keynote address are posted on LQC’s presentations website.

Clinical Laboratory Testing is Increasing in Value, Keynote Speaker Says

As a service to clinical laboratories, Salerno outlined many of the services the CDC’s Division of Laboratory Systems provides for free to clinical labs, including information on such topics as:

During his remarks at the 13th Annual Lab Quality Confab in Atlanta, Salerno had good news for the clinical laboratory professionals in attendance. He said that lab testing was becoming a more valued commodity in healthcare because physicians and other providers were growing increasingly confident in lab test results. [Photo copyright: The Dark Report.]

Healthcare System Disruption Impacts Providers, Including Clinical Laboratories

Other keynote speakers addressed how disruption in the US healthcare systems affects provider organizations in significant ways. For clinical laboratories, such disruption has resulted in reduced payment and demands for quality improvement and shorter turnaround times.

For all these reasons, quality management systems may be every clinical laboratory’s best strategy to survive and thrive, the keynote speakers said.

The first keynoter was Robert L. Michel, Editor-in-Chief and Publisher of The Dark Report. Michel’s remarks focused on how price cuts from Medicare, Medicaid, private payers, and the drive for value-based payment, are requiring labs to do more with less. For this reason, quality management systems are necessary for all labs seeking to improve results, eliminate errors, and cut costs, he said.

“The people closest to the work know how to fix these problems,” he added. “That’s why labs know they must train their staff to identify problems and then report them up the chain so they can be fixed,” Michel commented. “Labs that are best at listening to their employees are getting very good at identifying problems by measuring results and monitoring and reporting on their own performance.”

Michel identified three principle factors that are disrupting healthcare:

  • The shift from reactive care in which the health system cares for sick patients to proactive care in which the health system aims to keep patients healthy and out of the hospital and other costly sites of care.
  • The transition away from fee-for-service payment that encourages providers to do more for patients, whether more care is needed or not, to value-based payment that aims to reward providers for keeping patients healthy.
  • The consolidation among hospitals, health systems, physicians, and other providers. A trend that requires clinical laboratories to find new partners and new ways to improve lab services and reduce costs.

Informatics Performance Data Help Clinical Laboratories Respond to Change

“The attributes of new and successful labs are that they will have faster workflow and shorter cycle times for clinical lab tests and anatomic pathology specimen results,” Michel explained. “That means that labs will attack non-value-added processes by implementing continuous improvement strategies [such as Lean and Six Sigma] and by the sophisticated use of informatics.”

Making use of performance data enables clinical laboratory directors to make changes in response to disruptions that affect healthcare. “If you have good informatics, then seven or eight of every 10 decisions you make will be good decisions, and with the other two and three decisions, you’ll have time to pull back and adjust,” Michel commented.

The second keynote speaker, Jeremy Schubert, MBA, MPH, Division Vice President of Abbott, reiterated what Michel said about how the health system is moving away from fee-for-service payment. Instead of focusing on caring for sick patients exclusively, he said, health insurers are paying all healthcare providers to keep patients healthy.

“Healthcare today is about the whole life course of the individual,” Schubert explained. “Patients no longer want healthcare only when they’re sick. Instead, they want to be healthy. And health creation is not just about a person’s physical health. It’s about their mental health, their emotional health, and their social wellbeing.

“In fact,” he continued, “you can learn more about a person’s health from their Zip code than from their genetic code.”

That is essentially what TriCore Reference Laboratories (TriCore) has been doing in New Mexico, Schubert added. During his presentation, Michel mentioned TriCore as being one of four clinical laboratories participating in Project Santa Fe, a non-profit organization that promotes the movement from Clinical Lab 1.0 to Clinical Lab 2.0. (See “TriCore Forges Ahead to Help Payers Manage Population Health,” The Dark Report, May 20, 2019.)

“If you want to be a quality engine in healthcare you have to be operating at Lab 2.0. Who is best qualified to interpret information? It’s the lab,” Schubert said. Then he challenged labs to begin pursuing the goal of achieving Lab 3.0, saying “Lab 3.0 is being able to interface with the patient to address each patient’s problems.”

The 13th Annual Lab Quality Confab (LQC) in Atlanta continues through the 17th with post-event workshops in Six Sigma and mastering quality management systems. In attendance are 300 clinical laboratory administrators, managers, and quality team members who are learning a complete array of professional training methods.

To register to attend, click here or enter https://www.labqualityconfab.com/register into your browser, or call 707-829-9485, or e-mail lqcreg@amcnetwork.com.

—Joseph Burns

Related Information:

Clinical Laboratory Improvement Advisory Committee Agenda for meeting Nov. 6

Clinical Laboratory Improvement Advisory Committee Summary Report

TriCore Forges Ahead to Help Payers Manage Population Health

Helping Medical Laboratories Add Value to Health Systems, Providers, and Payers by Moving from Clinical Lab 1.0 to Clinical Lab 2.0

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