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

November workshop to teach Clinical Lab 2.0 to forward-thinkers among clinical laboratories, IVD manufacturers, and lab IT vendors offered many examples where clinical laboratory diagnostics can add value and improve patient outcomes

DATELINE: ALBUQUERQUE, New Mexico—Here in this mile-high city, a special Project Santa Fe Workshop devoted to teaching the principles of Clinical Lab 2.0 attracted an impressive roster of innovators and forward-thinkers in clinical laboratory medicine. In attendance were leaders from a select number of the nation’s first-rank health systems and hospitals, along with executives from In Vitro diagnostics (IVD) manufacturers, lab IT companies, other lab service companies, attendees from the Centers for Disease Control and Prevention, and from institutions in Canada, Germany, Israel, India, and the UK.

Their common goal was to learn more about the emerging clinical and business model for medical laboratories known as “Clinical Lab 2.0.” A key objective of the workshop was to help those lab leaders in attendance develop strategic action plans for their own lab organizations, so as to take advantage of the insights coming from the vast information streams generated by their clinical laboratories. These services would be in support the evolving needs of health systems, hospitals physicians, and health insurers to more effectively provide integrated patient-centered clinical care.

Medical Laboratories Can Use Clinical Lab 2.0 as a Path to Adding Value

Clinical Lab 2.0 is the clinical and business model of the future for medical laboratories, assert the developers of this concept. “Clinical Lab 2.0 describes the attributes needed by all medical laboratories that want to succeed in a healthcare system organized to provide precision medicine, keep people out of hospitals, and where providers—including labs—are reimbursed based on the value they provide,” stated Khosrow Shotorbani, CEO of TriCore Reference Laboratories, one of the organizers of the Project Santa Fe Clinical Lab 2.0 Workshop.

“Clinical Lab 2.0 is the path medical labs will need to follow if they are to continue providing relevant lab testing services and generate the reimbursement necessary for them to maintain a high level of clinical excellence and financial stability going forward,” he added. “This is the next generation of medical laboratory organization and operation.”

Lab 1.0 Was Lab Clinical/Business Model for 50 Years

For more than 50 years, Clinical Lab 1.0 was the model for labs,” noted James Crawford, MD, PhD, Executive Director and Senior Vice President of Laboratory Services at Northwell Health Laboratories and an organizer of the Project Santa Fe Clinical Lab 2.0 Workshop. “Lab 1.0 is transactional, focusing on generating high quality analytical data on specimens received, but without assembling these data into integrative clinical care programs. In the simplest sense, Clinical Lab 1.0 focused on generating ever-greater numbers of specimens to drive down average cost-per-test, while maximizing revenue in a fee-for-service system.

This chart shows the attributes of Clinical Lab 1.0 and compares those to the attributes of Clinical Lab 2.0. Lab 1.0 is transactional and based on increasing test volume to lower costs and maximize fee-for-service revenue. Clinical Lab 2.0 is integrative in ways that add value to lab testing services. (Graphic copyright Project Santa Fe.)

“But fee-for-service payment is going away,” he said. “Increasingly, clinical laboratories will be paid based on the value they provide. This payment can be in the form of bundled reimbursement, as a per-member-per-month payment, or as a share of the budgeted payment made to a health system, an accountable care organization (ACO), or a multispecialty provider network. As these alternative forms of provider payment become dominant, to earn a fair share of reimbursement, all medical laboratories will need a clinical strategy to deliver lab testing services that measurably contribute to improved patient outcomes while reducing the overall cost of care. This requires looking at medical laboratories’ contribution to effective delivery of the full dollar of the healthcare spend, not just the three-cents-on-the-dollar representing laboratory testing.”

Innovators in Clinical Laboratory Industry Identify New Ways to Add Value

There are already a handful of innovative clinical laboratory organizations that have clinical experience in moving past the Lab 1.0 paradigm of reporting an accurate test result within the accepted turnaround time. Leaders within these labs are collaborating with physicians and frontline care givers specifically to help them better utilize lab tests in ways that directly improve the speed and accuracy of the overall diagnostic sequence, as well as achieving therapeutic optimization as rapidly as possible. These collaborations are tracking the improvement in patient outcomes while demonstrating how better use of lab tests can lower the total cost per episode of care.

During the Clinical Lab 2.0 workshop, case studies were presented demonstrating how clinical laboratory leaders are taking the first steps to practice Clinical Lab 2.0 so as to achieve added value with medical laboratory tests. The case studies included:

·       A project to improve diagnosis and treatment of sepsis at Geisinger Health System.

·       A project at Henry Ford Health to collaborate with physicians to more appropriately utilize lab tests and build consensus in support of a new lab test formulary.

·       A multi-hospital initiative at Northwell Health to collaborate with physicians and nurses in the use of creating testing to make earlier, more accurate diagnoses of acute kidney injury during inpatient admissions, and better guide decisions to treat.

·       A partnership involving TriCore Reference Laboratory and certain health insurers in New Mexico where the laboratory—using lab test data (some generated by emergency room testing) and other clinical data—alerts the insurers to women who are pregnant, thus allowing the insurers to provide timely guidance to the women’s care teams with the goal of improving prenatal care.

The Project Santa Fe Clinical Lab 2.0 Workshop convened on November 13-14 in Albuquerque, N.M. A broad spectrum of innovative professionals from the five Project Santa Fe member laboratories (above) were there to teach the lessons learned from their first successful efforts to collaborate with physicians and create added value from medical laboratory diagnostics. Other attendees included progressive lab leaders from several of the nation’s most prominent health systems, along with thought leaders from the IVD, lab software, and lab association sectors. (Photo copyright Project Santa Fe.)

Project Santa Fe Workshop: A Well-Attended Lab ‘Think Tank’

Participants attending the Clinical Lab 2.0 workshop included hospital lab administrators, pathologists, and clinical laboratory industry executives. The importance of this workshop is reflected in the educational grants and financial support provided by leading in vitro diagnostics manufacturers, lab IT companies, and other lab industry vendors. The lab industry vendors included:

·       Abbott Laboratories

·       ARUP Laboratories

·       Beckman Coulter

·       DiaSorin

·       MedSpeed

·       Roche Diagnostics

·       Siemens Healthineers

·       Sysmex

Also providing educational grants and similar support were:

·       American Clinical Laboratory Association

·       CAP Today

·       Centers for Disease Control and Prevention

·       Mayo Medical Laboratories

·       The Dark Report

Project Santa Fe was launched in 2016 by clinical lab leaders from five of the nation’s most respected integrated health systems:

·       TriCore Reference Laboratories;

·       Henry Ford Health;

·       Geisinger Health;

·       Kaiser Permanente Northern California; and,

·       Northwell Health.

Described as a think-tank venture, the organizers are committed to implementing projects that demonstrate how lab tests can be used in ways that add value, and then publish the resulting projects, along with data about improved patient outcomes and reductions in healthcare costs, in peer-reviewed journals. Multi-institutional studies will be required to validate the findings and outcomes from the added-value clinical collaborations initiated at the different medical laboratory organizations participating in Project Santa Fe.

Another primary goal is to share the lessons learned from these innovative projects with other like-minded pathologists, lab administrators, and lab managers. In May, Project Santa Fe organizers led a one-day workshop to teach Clinical Lab 2.0 at the Executive War College on Laboratory and Pathology Management. The workshop in Albuquerque on November 13-14 was the second learning opportunity available to medical laboratory professionals. A November 2018 workshop is planned.

—Robert L. Michel

Related Information:

Project Santa Fe Workshop

Improving American Healthcare through “Clinical Lab 2.0”: A Project Santa Fe Report

Laboratory 2.0: Changing the Conversation

CEO Describes Characteristics of the Clinical Lab 2.0 Model: Five Health System Labs Using Project Santa Fe To Demonstrate Value

Moving to Clinical Lab 2.0: Deliver More Value! Get Paid More Dollars!

Lab Innovators Advocate Need for Clinical Lab 2.0: Lab 1.0 Is the Low-Paid Commodity Lab, While Lab 2.0 Gets Paid More for the Value It Contributes

Using the Laboratory Value Pyramid and Clinical Lab 2.0 to Position Your Lab to Add Value in the Era of Population Health, Precision Medicine, and Value-Based Payment

Clinical Laboratories and Pharmacies Scramble to Be Ready for the Era of Hospital Antimicrobial Stewardship Programs That Starts on January 1, 2017

All hospital laboratories will be part of these programs, and it is an opportunity for medical laboratory professionals to deliver considerable value, as hospitals take steps to improve the utilization of antibiotics

Clinical laboratories and pharmacies in the nation’s hospitals and health systems have a huge opportunity to deliver substantial value in patient care. That’s because, at the start of 2017, hospitals must put effective antimicrobial stewardship programs (ASPs) in place to meet the new accreditation requirements of Medicare and The Joint Commission.

Overuse and inappropriate use of antibiotics is now considered one of the biggest problems in medicine. “Antibiotics are lifesaving drugs, and if we continue down the road of inappropriate use we’ll lose the most powerful tool we have to fight life-threatening infections,” stated Tom Frieden, MD, MPH, Director, Centers for Disease Control and Prevention (CDC) and Administrator, Agency for Toxic Substances and Disease Registry (ATSDR), in a press release issued by the CDC last May. “Losing these antibiotics would undermine our ability to treat patients [who have] deadly infections, cancer, provide organ transplants, and save victims of burns and trauma.”

Much publicity is devoted to the rise of the increase of antibiotic-resistant organisms. In recognition of this problem, the Centers for Medicare and Medicaid Services (CMS), and The Joint Commission (TJC), took steps to add antimicrobial stewardship program requirements to their respective hospital accreditation programs. (more…)

Two Lab Leaders Present Different Ways to Help Physicians Get Greater Value from Clinical Pathology Laboratory Testing

In response to healthcare’s transformation, a pathologist and a lab CEO describe two powerful ways that medical laboratories can collaborate with physicians, patients, health systems, and health insurers to deliver more value

DATELINE: Phoenix, Arizona—It may be appropriate that, with the pace of change heating up in both healthcare and the clinical laboratory industry, it was here in the hot Sonoran Desert that more than 500 medical laboratory professionals gathered last week for the annual Sunquest User Group Conference (SUG) hosted by Sunquest Information Systems. (more…)

Speakers from UCLA, Alverno Clinical Laboratories, and TriCore Reference Labs Discuss the Creation of Value-Added Lab Services at 20th Annual Executive War College

Primary themes were healthcare’s transition away from fee-for-service and how innovative medical laboratories are delivering more value with lab testing services

NEW ORLEANS, LA.—Two clear themes for clinical labs and pathology groups emerged from yesterday’s opening presentations at the 20th annual gathering of the Executive War College on Laboratory and Pathology Management.

Transitioning from Fee-For-Service to Value-based Reimbursement Programs

Theme one is that the pace of transformation within the U.S. healthcare system is accelerating. In his opening remarks, Executive War College Founder Robert L. Michel warned medical laboratory professionals that they must not allow their lab organizations to be unprepared or unresponsive to the changes now unfolding across the nation’s healthcare system.

In particular, Michel reminded the more than 850 lab executives and pathologists in the audience that fee-for-service payment for clinical laboratory tests and anatomic pathology services will not remain the dominant form of reimbursement for much longer. “This market trend is aptly described as ‘volume to value,’” noted Michel. “For decades, labs maximized revenue and operating profits by maximizing the volume of specimens that they tested. Those days are coming to an end. Healthcare will increasingly want lab testing services to be high value. These lab services will be paid as part of a bundle, or included in the different forms of global payments and budgeted payments that are made to integrated care delivery organizations, such as ACOs and patient-centered medical homes.” (more…)

Facing the Looming End of Fee-for-Service, Clinical Laboratories and Anatomic Pathology Groups Look for New Business Models

Failing finances at technical pathology laboratories may be the most immediate concern for many pathology group practices

Many clinical laboratories and anatomic pathology groups now recognize the new reality of the American healthcare system: less reimbursement for laboratory testing. On one hand, the fee-for-service prices for lab tests paid by government and private payers have been aggressively slashed.

On the other hand, all payers have become stubbornly resistant to issuing coverage guidelines and setting adequate prices for the flood of new molecular assays and gene tests coming to market.

These trends have already brought a handful of medical laboratories and pathology practices to the point of bankruptcy, sale, or closure. This is definitely true for the technical laboratories owned by many local pathology groups, which have become unprofitable due to fee cuts. (See below.) (more…)

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