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Surviving Disruption: Rethinking Business Models,
Technologies, and Competitive Strategies in a
Changing Lab Market

October 24-26, 2018
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Prepare Your Lab to Do Business in the Most Challenging and
speakerCompetitive Market for Diagnostic Lab Services Ever!Make no mistake: in the coming few short years, the way your diagnostic lab or pathology practice does business is going to change far more rapidly and dramatically that ever before — and it’s going to be a very bumpy ride!.crowdFor starters, the massive new Medicare Part B reimbursement cuts just slashed an estimated $400 Billion annually off testing revenue to diagnostic labs — putting extreme financial pressure on many existing lab business models and long-held competitive strategies.

And that’s just the tip of the iceberg!

Rising co-pays are forcing more patients to postpone or even decline testing — cutting even more deeply into lab revenue. At the same time, labs are under growing pressure to spend more to adopt the new tests and new testing technologies they need compete in a changing market.

How will these changes affect your lab? What steps can you take NOW to position your lab to compete more effectively in the new market?

Join us at Lab Institute 2018: Surviving Disruption: Rethinking Business Models, Technologies, and Competitive Strategies in a Changing Lab Market, and get the practical, plain-language help you need to understand the rapid change in today’s market for diagnostic lab services and position your lab to grow and profit in the coming years.

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Keynote: Transforming Health Care in the Information Age
Presenter: Jack Cochran, MD, Strategic Advisor, Clarify Health Solutions, Inc.

“We can’t treat our way out of the health care crisis. We must learn our way out of it.”
For most of history, health care was centered on the doctor’s office or hospital. Today, health care is much more complex. The proliferation of information available to physicians and to their patients has fundamentally shifted the focus of information and power to patients. In the information age, the evolution of learning and application of big data, analytics, and artificial intelligence will be a central reality in the diagnostic laboratory practice. Lab professionals will be a major contributor to the growth of meaningful data and information and will add to the volumes of existing data. This information must be available to patients, physicians, and care teams, along with the technology and tools to understand and use the data. In this keynote, Dr. Cochran will explore how health care must transform in order to meet the challenges of the information age and to address the crisis of affordability and value in health care.

Keynote Presentation: Transitioning from Lab 1.0 to Lab 2.0: What It Means for You; What It Means for Your Stakeholders
Presenter: James M Crawford, MD, PhD

“This is your call to be part of the Lab 2.0 Movement”
The concept of “Clinical Lab 2.0” was introduced in 2017 by Project Santa Fe, with the goal of establishing the evidence base for valuation of the clinical laboratory in the next era of American health care. In this session, lessons learned from ongoing demonstration projects will be shared, with the goal of equipping attendees to transform their own work effort from transactional 1.0 involvement in health care delivery, to a leadership position in driving 2.0 Health Care. This is also your call to be part of the 2.0 movement, and to help us collectively drive the future success of clinical laboratories. Learning objectives are:

  • To understand the substantial asset that the clinical laboratory constitutes for integrated health systems
  • To identify the tools and skill sets needed to transform from delivery of 1.0 to delivery of 2.0 laboratory services
  • To gain insight into the evidence base that will favorably influence the decision-making of health system leaders, payers, and consumers about what laboratory should be their provider

Keynote Presentation: Elevating the Clinical Laboratory’s Role in Healthcare
Presenter: David Humphreys, Head of Health Policy & Clinical Evidence Practice, Economist Intelligence Unit

The movement towards value-based healthcare has provided a platform for a better future for all involved in the health ecosystem. Driven by converging forces—growing population health needs, limited resources, advances in science and data analytics—the focus on how to adapt established systems to drive better patient outcomes and improved cost efficiencies has become paramount.
However, among the multitude of value initiatives, the clinical laboratory has largely been left to play a secondary role. Despite its core value principles of data, timely and efficient diagnosis, and patient centricity, the lab has been relegated to near commodity status. This is also indicative of a broader problem: a fragmented value chain that underexploits sources in decision-making at a time when the health world’s stated focus is on outcomes.
Still, as a more welcoming environment for new ideas has emerged, there is clear recognition among all stakeholders that the lab can be part of the long-term solution. Executives, physicians, payers and patients recognize the lab can be a pivotal building block of an improved system. To put this key element in health at the forefront of care does require overcoming well-entrenched processes and culture, hurdles that have held back true transformation over the past decade.
This session will present the key results from the Economist Intelligence Unit’s (EIU) study aimed at identifying an actionable, achievable path for the lab to play an elevated role in healthcare.
The learning objectives will include an understanding of:

  • the reality of the clinical laboratory today across different countries,
  • the influence of stakeholder perception and actions on current dynamics, and
  • the specific initiatives that could increase the lab’s impact in the overall patient care pathway.

NGS Oncology Panel Reimbursement:
What Does the Future Hold Now that CMS Has Issued an NCD?

Presenter: Chance Scott, Associate Director, Life Sciences | Navigant

In March 2018, the Centers for Medicare & Medicaid Services (CMS) issued a final National Coverage Determination (NCD) for patients who receive next generation sequencing (NGS) testing with an assay that meets coverage criteria for solid tumor patients with Stage III and Stage IV, metastatic, recurrent, relapsed, or refractory cancers.

This is a major milestone in payer acceptance for NGS oncology panels.

But what will be the effect on other payers? Will others follow suit? Will they have more or less restrictive coverage indications? And how fast will they act?

This presentation will examine the various positions that different payers have taken on NGS oncology panels in 2018, and highlight the rationale behind their existing polices.

We will also review case studies examining historical patterns of coverage for other high profile, clinically impactful technologies that have gone through the CMS NCD process.

What can history tell us about the future?

After this session, attendees able to:

  • translate key implications of the recent CMS NCD for Next Generation Sequencing
  • apply historical benchmarks to under the likely impact on commercial payers
  • distinguish nuances across payer segments when evaluating new technologies

Laboratory Compliance 2.0
Presenter: Barb Senters, CCEP, Chief Compliance & Ethics Officer
for Sonic Healthcare USA

This session will provide an overview of how to strengthen the effectiveness of your compliance program to prevent whistleblowers, protect your culture, and utilize compliance as a strategic advantage.

It will utilize the speaker’s experience of being a panel member for the OIG’s Resource Guide “Measuring Compliance Program Effectiveness” and her experience of meeting with the former Ameritox whistleblower after closing out their Corporate Integrity Agreement.

Learning Objectives:

  • Review tools to ensure appropriate laboratory risks are being addressed
  • Learn how to demonstrate compliance effectiveness to prevent a federal investigation and/or Corporate Integrity Agreement
  • Hear how to use culture to execute the mission of the company, while strengthening the compliance program

Laboratory Operational and Clinical Analytics: Use and Benefits
Presenter: Dennis Winsten, MS, FHIMSS, FCLMA, President, Dennis Winsten
& Associates, Inc. Healthcare Systems Consultants

Medical laboratories and pathology groups face enormous levels of change in their clinical, regulatory and financial environments. With reduced reimbursement, laboratories are under increasing pressure to optimize business practices, improve utilization and cut costs while improving patient care. To meet this challenge, pathologists and lab managers know they must get better at using metrics to support the many operational decisions required to boost productivity while simultaneously reducing overall costs throughout their labs. Timely access to accurate performance metrics is the single biggest requirement for labs wanting to improve both operational and financial performance while concurrently contributing to enhanced patient care.

This presentation will describe the latest achievements and best practices for both operational and clinical analytics and describe how pathologists can evaluate, select and use analytical software for:

  • Retrospective and prospective performance measures
  • Utilization measurement and monitoring
  • Quality improvement
  • service level benchmarking

Auditing Your Lab Revenue, Finding Out What You Are Missing
Presenter: Mick Raich, President/CEO Vachette Pathology and Stark
Medical Auditing

The billing for lab services is amazing complex and nuanced, there are thousands of variables which go into the process to get paid for services. It is imperative in these times of financial crisis that labs work to audit their billing process. Mick Raich will discuss how this process is handled and teach the attendees the tenets of this process.

  • Charge capture, are you billing everything you do?
  • Claim review, HFCA versus service performed, are you missing anything?
  • Denial management, a primer on how to use denials to increase your revenue.
  • Getting paid correctly, comparing your EOB to the actual paid amount. Finding those lost dollars.

This speech will teach those in the lab revenue cycle world how to begin the audit process and where to look for lost revenue.

Out-of-Network: Frequently Asked Questions
Presenter: Richa Singh, Executive Vice President, CollectRX

Out-of-network reimbursements remain a viable option for labs, but many struggle because they are unfamiliar with some of the intricacies required to successfully run an operation with this payment model. In fact, there are many unanswered questions that could greatly affect being aptly compensated for services they are rightfully delivering.

Learning objectives:

After attending this session, attendees will be able to:

  • Negotiate and appeal out-of-network bills more successfully
  • Navigate against varying out-of-network policies
  • Recognize pitfalls in third-party network agreements

Health System Laboratory Evolution: Achieving Patient Integration
Presenter: Jane Hermansen, Manager Outreach and Network Development, Mayo Clinic

With the formation of larger health systems and integrated delivery networks across the US, the role of the laboratory and integrated laboratory data remains of critical importance. What is the best way to achieve balance in local delivery of care and optimization of testing across multiple laboratories? What is most important? Delivering high quality and excellent service? Eliminating redundancy and realizing economies of scale? Can these philosophies co-exist? Patient-centered testing must remain our industry’s top priority. Further, laboratory data integrated with the patient medical record will be critical to the laboratory’s future success in alternate payment models. In this session, attendees will learn of the importance of achieving patient integration across a health system, and how to most effectively accomplish that integration.

Learning objectives:

  • Describe national trends of health system integration and identify the key role of the laboratory in achieving this integration
  • Define a laboratory integration strategy, to include internalization of testing, provider use of the health system laboratory and the power and value of integrated patient data
  • Develop a plan for integration of laboratory services across a health system which includes a strong outreach program

How to Secure Coverage and Reimbursement for New Technologies
Presenter: Greg Richard, Chief Commercial Officer, Interpace Diagnostics

The bar for providing evidence to secure coverage and reimbursement for new technologies is routinely being raised. As an example, laboratories can meet the evidence requirements of Evidence Street and still not meet those of Anthem BCBS, another BCBS Association member. The varying definitions of clinical utility among health plans and third party technology assessment providers require lab companies to conduct numerous studies and publish data in multiple peer reviewed publications with little to no assurance that they will successfully secure coverage. Further, this lack of coverage often results in challenges with physician adoption due to the financial burden placed on patients in the absence of coverage for high cost, molecular testing and the continuing increase in patients’ responsibilities associated with benefit plan design. This talk will provide suggestions to address these challenges for participating laboratory providers.

  • Learner will be able to negotiate with Medicare and/or Commercial payers for coverage of molecular products/testing services
  • Learner will be able to develop a dossier and effective submission to third party technology assessment organizations
  • Learner will be able to respond to RFP’s or other requests for information required to secure coverage

Accelerating Diagnosis and Treatment of Cancer Using Digital Pathology
Presenter: Lisa Jean Clifford, COO & Chief Strategy Officer, Gestalt Diagnostics

This presentation will discuss accelerating the diagnosis and treatment of cancer using digital pathology to improve efficiencies in workflow secondary consults, tumor boards, research, training, and much more.

After attending this session, participants will:

  • have a clear understanding of how digital pathology speeds the diagnosis and treatment process for patients
  • be able to determine if digital pathology is a good technology for their lab to consider
  • know the key areas that digital pathology can help in advancing the pathology workflow process

Medicare Access and CHIP Reauthorization Act (2015) MACRA: What Is It and Why Is It Important?
Presenter: Patricia Goede, Vice President, Clinical Informatics, XIFIN, Inc.

MACRA impacts pathologists’ reimbursement under Part B Medicare reimbursement. The 2018 updates to the legislation introduces changes to the existing mandate that will further impact reporting and financial adjustments. Pathologists need to understand what MACRA is and how it affects their institutions.

This session will be presented in the following parts:

  • Historical overview
  • MACRA as the mandate
  • Reporting
  • Financial implications; and
  • Solutions

Learning objectives include:

  • Introduction to MACRA
    2018 MACRA – Quality Payment Program (QPP)
    2018 MACRA – Eligibility, Reporting, and Timelines
  • Why does MACRA matter to diagnostic providers and how to diagnostic companies benefit from MACRA?
  • Data and system requirements for diagnostic companies to increase thir value to providers under MACRA
  • Provider Education and Outreach

The Impact of Mindset on the Improvement of the Patient Care Experience
Presenter: Joseph G. Keary, MS, MBA, CEO, JGK Leadership Consulting and Director, Clinical Laboratory Management Association

The essential role of the laboratory profession in providing quality patient care has traditionally been absent from the perspective of our patients and, oftentimes, the medical and nursing staff. The traditional “profile” of the laboratory professional is of an introvert who likes to work away from the limelight and frequently only leaves the bench or office for lunch and to go home. This lack of visibility and lack of clarity on the critical nature of our profession in patient care leads to reduced morale and staff engagement, a lack of respect for our efforts, an increase in the commoditization of lab services ad reduced interest in the profession. We need to break out of our self-imposed cocoon and follow the examples of pharmacists, dieticians, etc., and be active participants in the patient care experience. We also need to become ore engaged in organizational governance and demonstrate the personal and professional value we provide.

After attending this session, attendees will be able to:

  • Identify the key differences between outward and inward mindset
  • Assess the impact of adopting an outward mindset on a relationship between the Laboratory and the Emergency Department
  • Operationalize the tools of the outward mindset in improving both interdepartmental relationships and the patient care experience at their institution

Manage Costs and Eliminate Unnecessary Expenses Using Precise Cost-per-Test Studies
Presenter: Stephen Stone, BBA, Managing Director, Argent Global Services

Learn how laboratory workflow experts execute precise cost-per-test studies as a necessary step in managing costs and eliminating unnecessary expenses. This presentation will explore the correct approach to identifying relevant cost parameters, along with proven ways to analyze the resulting data to intelligently guide cost-cutting efforts.

Attending this session, participants will:

  • gain insight on how workflow experts evaluate laboratory costs
  • learn the correct approach to identifying relevant cost parameters
  • learn how cost-per-test analysis can guide lab improvement efforts

Toxicology and Genetic Testing Audits and Defenses
Presenter: Andrew Wachler, Owner/Principal, Wachler & Associates, PC

This presentation will address regulatory, reimbursement, and other legal challenges that confront laboratories that engage in genetic and toxicology testing.

We will also look at audit strategies that address issues of medical necessity and coverage determinations raised by payor such as Medicare, and review new appellate reforms, including Settlement Conference Facilitation and the Statistical Sampling Initiative.

Learning Objectives:

After attending this session, the attendees will be able to:

  • Identify and defend against highly targeted audit issues affecting laboratories, including genetic, pharmacogenomic, and toxicology testing;
  • Utilize the most current settlement initiatives for the Medicare program. Specifically, the presentation will discuss the settlement initiatives released by the Office of Medicare Hearings and Appeals, including the recently implemented expanded Settlement Conference Facilitation program and the Statistical Sampling Program, which are intended to offer providers an alternative route to reach a financial determination for claims pending at the Administrative Law Judge hearing level without enduring the 2-3 year delay for a hearing; and
  • Develop compliance strategies to reduce audit risk.

Billing, Coding and Payment Update for 2019
Presenter: Diana W. Voorhees, M.A., CLS, MT, SH, CLCP, Principal/CEO, DV & Associates, Inc.

In this session Diana Voorhees, nationally recognized coding and billing compliance expert, will provide a close look at how to comply with the perennial lab challenges, including documenting medical necessity, test order documentation, coding changes for 2019, coverage issues and more. Plus, you’ll explore how the rules are evolving and being applied to novel billing, coding and reimbursement issues, and review critical billing and coding changes upcoming for 2019.

Learning Objectives:

  • Discuss procedural coding changes for 2019
  • Describe proposed changes in government reimbursement
  • Discuss pertinent policies and issues affecting coverage
  • Determine anticipated impact of CMS editing systems
  • As time allows, delve into additional topics of interest or concern

Breaking Down Barriers: What We Can Learn from England’s National Program for Pathology Benchmarking, Consolidation, and Service Improvement
Presenter: Laura Comilla, Commercial Director Americas, LTS Health

In this presentation, Ms. Comilla will discuss the approach LTS Health used to lead the UK NHS consolidation plan, which is transferable to USA health systems. The approach was initially applied to pathology labs and has now been extended to imaging, which has started Phase 1.
This consolidation plan had three phases:

Phase 1: Workforce efficiency benchmarking
Defining, collecting, and reporting the system operational metrics for 110 pathology service providers (laboratory systems). LTS Health also worked with each of the 110 providers to reduce the variances seen amongst the groups, yielding $40MM per year savings.

Phase 2: Consolidation
Through the creation of a national dataset, consolidation planning reduced 110 pathology service providers to only 29. LTS Health worked across health systems to identify the optimal locations to remain as full-service providers. This yielded additional yearly savings of $300MM.

Phase 3: Business process optimization
By working closely with each provider, LTS Health optimizes its processes based on individual requirements and challenges. This includes, but is not limited to, managing population cost variation, new reimbursement opportunities and the reduction of wasteful tests.

Learning Objectives
At the end of this session, attendees will be able to:

  • Identify the requirements for data collection and benchmarking.
  • Outline best practices for publishing health data.
  • Conceptualize the consolidation model and considerations to achieve national consolidation.

Behind the Manager’s Closed Door: Lessons in Management Leadership
Presenter: Lee Hubert, MBA, SPHR-SCP, Principal, Manager Success LLC, Affiliate, Voltage Leadership

This session is a primer based on Lee’s new e-book by the same name. It is great help for leaders who are good at the technical part of their jobs, but who may struggle at times with the people part of their jobs. It explores what’s happening out there, what really matters and why, and what to take behind closed doors? We’ll equip leaders with practical tools on how to help people unlock their God-given talents and abilities, including how to apply the success equation, build the trust bridge, erase drama, push people appropriately, coach people up, grow people, and resolve conflict.

After this session attendees will be able to:

  • Describe why work-teams exists and how to focus them on what really matters
  • Develop a plan to identify and address some counter-productive workplace behaviors
  • Apply some tips and tools to help build trust in leadership and reduce drama

Impact of Declining Reimbursement on Lab Operations and Test Utilization Management
Presenter: Linda L. Smith, Vice President Laboratory Services, SSM Health

How will hospital laboratories be able to provide quality laboratory service in a healthcare environment that is increasingly subject to disruptive change? With laboratory reimbursement declining to unprecedentedy low levels, how will hospital labs adapt to survive and potentially thrive? How can laboratories manage test utilization to ensure best practice care and operational efficiency? What roles do physician engagement and employee engagement play in developing utilization algorithms to effectively manage expensive genetic/esoteric tests? How can laboratories partner with physicians, hospital executives, and revenue integrity to minimize denials for lab tests and optimize strategies for reimbursement?

Participants will learn about and discuss how recent changes in lab reimbursement can be counteracted through lab productivity optimization, innovation, evidence-based test utilization management; and focused integration of laboratory services into hospital operations.

Case studies, change management techniques, and cost analysis tools will be shared.

Key learning objectives:

  • Describe recent and future changes in laboratory and pathology reimbursement and the potential impacts for hospitals and laboratories.
  • Identify major lab test utilization management opportunities that can lower total cost, improve lab quality, service, and productivity so that the laboratory adequately supports hospital performance and growth.
  • Learn successful techniques for engaging physicians, hospital executives, nursing, and laboratory staff in working together to develop exceptional, evidenced-based test utilization management that leads to improved outcomes.

Managed Care Marketplace or Labs: Impacts and Opportunities
Presenter: Steven Stonecypher, Partner, Shipwright Healthcare Group

Laboratory technology is growing rapidly, and with the expansion of genetic and molecular-based testing, insurance companies have fallen behind in the explosive growth. The cost of the technology is increasing more rapidly than the ability to understand and manage; as a result, health plans have reacted by cutting reimbursement, adding medical policy limitations, contracting with benefit managers, and narrowing and closing their networks to any new providers. We will discuss how these trends may impact your laboratory, and potential workable solutions to these and other network contracting problems.

Key Learning Objectives:

  • Define the current trends in healthcare today
  • Learn the potential impact benefit managers have on your labs ability to perform and to receive reimbursement.
  • Understand how distinguishing your lab, creating opportunities to show your value.

Questions to Ask Before Retaining or Outsourcing Hospital Laboratory Services
Presenter: Sherri Flax, Vice-Chair of Clinical Affairs & Outreach, University of Florida

Should a hospital outsource or sell part or all of outreach services? Does partnership or joint venture with a commercial lab make economic sense? How will PAMA affect hospital outreach laboratories? What is the true value of a hospital outreach lab? There are many correct answers, but they usually begin with “it depends”. This presentation will detail the history of financial growth in hospital laboratory outreach, the timeline for regulatory oversight, and the new changes and incentives that MACRA and PAMA present. This presentation makes the case for making for an informed decision before retaining or outsourcing hospital laboratory services.

Key learning objectives:

  • Understand the major changes in reimbursement that affect hospital versus reference laboratories
  • Be able to identify the pros and cons of retaining versus selling a hospital outreach laboratory
  • Identify the role of “laboratory identity” in terms of market share and client relationships

Building an Effective Hospital Laboratory Joint Venture: A Case Study with 3 Perspectives: The Hospital, The Commercial Laboratory, and The Lawyer
Presenters: Noel K. Maring, Vice President, Hospital Affiliations, Sonic Healthcare; Paul N. Fiedler, M.D., Chair, Department of Pathology & Laboratory Medicine, Connecticut Health Network; and David Gee, Health Care Attorney

In this session, the presenters will offer perspectives about why hospitals and commercial laboratories pursue strategic partnerships; how to align business objectives and patient care needs; and key legal and compliance considerations hospitals and commercial laboratories must address in implementing strategic partnerships.

Three learning objectives:

  • Learn about strategic and patient care considerations that are important to hospitals in a strategic partnership with a commercial laboratory
  • Learn what strategic and business considerations are important to commercial laboratories in a strategic partnership with a hospital or health system
  • Learn about how hospitals and commercial laboratories can address fundamental legal and compliance considerations when implementing strategic partnerships

Master Your Fate: Perspectives on the Advantages and Disadvantages Confronting Laboratories in a Post- PAMAgeddon World
Presenters: Lâle White, Executive Chairman & CEO, XIFIN, Inc.

As the industry presses toward value based care and with ongoing reimbursement compression still at play, laboratories are struggling to control their destinies. They to need to take steps to mitigate lost revenue, and to develop strategies that exploit their unique advantages. Hospital vs. independent, clinical vs specialty are just two of the schisms evident in healthcare diagnostics today that are setting laboratories on divergent paths.

This session will discuss specific steps to:

  • Identify areas of competitive differentiation
  • Mitigate revenue losses due to reimbursement compression, higher copays and cost structure challenges
  • Exploit or develop advantages specific to your lab’s unique attributes and environment
  • Harness the insights residing in data, including aggregated PAMA data and information locked within the laboratory

Uncovering Valid Insurance Coverage: How to Increase Lab Reimbursement & Reduce Staffing Expenses
Presenters: Kyle Fetter, Executive Vice President & General Manager of Diagnostic Services, XIFIN, Inc.

As a result of the new clinical laboratory fee schedule that was derived from the PAMA exercise, labs are facing major reimbursement pressures and fee cuts. This, coupled with a rise in the number of patients with high-deductible health plans and inaccurate data, put revenue at risk for many laboratories. This session will discuss challenges around insurance coverage for self-pay patients, the resulting denials and ways to improve reimbursement rates and reduce operating costs.


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