As more clinical and AP laboratories receive requests for records and demands for refunds based on audits conducted by government contracted companies, it becomes apparent that labs must become more sophisticated in their audit practices. In addition, new rules and regulations that affect these practices increase the potential for serious consequences at labs unwilling to change in response. This workshop assesses the current government audit climate, describes potential problem areas, and explains internal audit best practices.

Learning Objectives:

• Identify what the government considers an “error” for laboratory claims
• Respond to government audits and requests for records in a way that will deflect unnecessary questions and complications with the intended affect of resolving problems as early in the process as possible
• Learn how to conduct comprehensive internal audits of their laboratory services including billing audits and audits of compliance with Stark and Anti-kickback rules and regulations
• Analyze the potential effect of the 60-day rule for refunding and reporting overpayments

Each year, clinical laboratories and anatomic pathology practices face a slew of coding and reimbursement changes that require tweaking of chargemasters and billing systems. Next year is shaping up to be one of major changes, as Medicare establishes payment for more than 100 new molecular diagnostic codes, and lawmakers continue to ratchet down reimbursement for laboratory tests. In this practical in-depth workshop, learn about upcoming coding and payment modifications affecting labs and pathologists, and get insight into what system changes you may need to make.

Learning Objectives:

• Learn about coverage and payment changes associated with Medicare fee schedules for labs and pathologists
• Find out what CPT coding changes will take effect in 2013
• Get an update on coding and payment for molecular diagnostic tests
• Understand what other payment challenges labs and pathologists might face in the new year

Join your colleagues from around the industry in this interactive, no-holds barred pre-Institute forum which airs some of the hottest issues and developments shaping the laboratory market. Back by popular demand, the town hall format allows your voice be heard while sharing information, opinions, and perspectives with a cross-section of industry participants.

Learning Objectives:

• Identify key issues and trends shaping the lab market in differing geographic areas
• Share critical market developments with industry colleagues
• Compare your local market experience with a cross section of Institute attendees
• Voice your opinion about market forces most directly affecting the financial health of labs

As the former CEO of Philips Healthcare, Quest’s new President and CEO, Steve Rusckowski, has a strong track record of driving growth and emphasizing operational excellence that has produced consistently impressive results. In his inaugural address to lab industry stakeholders, Mr. Rusckowski examines the challenges and opportunities that lie ahead in a dynamic health care environment where diagnostics is increasingly taking center stage.

Learning Objectives:

• Assess key challenges and opportunities that lie ahead in a dynamic health care environment
• Assess how these broad-based trends may influence the lab and pathology sectors
• Evaluate the current and potential future roles of diagnostic testing in health care

"Disease is boundaryless. Unfortunately, clinical expertise is not as ubiquitious," says Pascale Witz, President and Chief Executive Officer of GE Healthcare's Medical Diagnostics business. "But there are opportunities to touch every corner of the world with innovation – we have to dedicate resources and do just that." At a time when genomics, proteomics, epigenomics, transcriptomics, and pharmacogenomics are driving both insight and complexity, the question remains: How do we bring together all of this information for clinical utility? This session offers a perspective on not only the complexity of personalized medicine but also its increasingly integrated, digital, and global nature. With an eye to the unique position of diagnostics and pathology as the core enablers of personalized medicine, GE Healthcare initiatives to combine in vivo and in vitro approaches for an integrated solution will also be discussed.

Learning Objectives:

• Outline the key challenges for personalized medicine with regard to healthcare economics and clinical utility
• Assess the potential risks and benefits of an integrated approach to diagnostics, from risk stratification through prediction and monitoring
• Describe the role of molecular diagnostics in understanding the pathways that drive cancer and in identifying the weak points for intervention

In one of the most toxic political environments in memory, the 2012 national campaign is being fought on many divisive fronts, but clearly economic and fiscal issues remain at the forefront in the battle for the presidency and Congress. Find out how President Obama and Mitt Romney are framing the Supreme Court ruling on the Affordable Care Act (ACA) and how the election outcome will affect the future of U.S. healthcare. Plus, get expert analysis and insight on all the election dynamics, as well as plus what to expect on November 6 from one of the nation’s most respected political reporters

Learning Objectives:

• Discuss how the highly polarized political climate is affecting the 2012 election
• Understand the major issues driving the White House and congressional races
• Find out how the Supreme court ruling on the Affordable Care Act will impact the election and how it shape policymakers’ decisions on healthcare in the future
• Forecast who will win the White House and which party will control the House and Senate in 2013

After the November elections, a lame-duck Congress will have a small window to diffuse a fiscal time bomb set to go off around the new year that would raise taxes and cut military and domestic programs, including up to a 2% reduction in Medicare provider payments, debt extension, and deep cuts in physician payments. This panel session covers what it all means to labs and pathologists in 2013.

Learning Objectives:

• Review the budgetary and fiscal issues at stake during the lame duck session of Congress this November
• Discuss the implications for Medicare providers including labs and patholgosts in the lame duck Congress
• Find out what strategies lab and pathology interests are using to advance their legislative priorities on Capitol Hill
• Forecast the potential financial impact that labs & pathologists will face under Medicare in 2013

The American Medical Association has created new CPT codes covering more than 90% of molecular diagnostic testing now performed, which are set to take effect for Medicare payment purposes in 2013. Meanwhile, Palmetto GBA’s new Molecular Diagnostic Services Program is using its own novel system of McKesson Z-Codes and Palmetto Test Indicators to identify and pre-establish coverage and reimbursement for molecular diagnostic tests — tests that were previously reported with CPT methodology-based “stacking codes”. This session takes a hard look at these initiatives and the crucial issues they raise.

Learning Objectives:

• Review recent updates on coding, coverage, reimbursement, and pricing of molecular tests and discover how you can prepare yourself to respond
• Discuss the major implications of these changes for lab finances and commercialization
• Gain insight into the effects the novel coding schemes may have on pricing of molecular tests and the significant impact this initiative poses for planning and modeling

With all eyes focused on the changing role labs and pathologists play in the health care system, our expert panel updates you on key legal and policy issues affecting your business, including the Supreme Court’s ruling on health care reform, oversight of lab-developed tests, the health care enforcement climate and outlook, and efforts to eliminate the in-office ancillary services exception to the Stark law.

Learning Objectives:

• Understand critical legal and policy issues affecting labs and pathologists
• Get insight into the Supreme Court’s ruling on health care reform and what it might mean for your business
• Find out what’s happening with FDA oversight of lab-developed tests and efforts to close a loophole in the Stark law allowing physicians to self-refer for certain services, including pathology
• Learn the latest about federal enforcement activities plus the outlook for the in-office ancillary exception under the Stark law

At a time when payors are scrutinizing utilization and organizations are setting new benchmarks for quality as well as cost, innovative health systems are taking matters into their own hands. The University of Rochester Medical Center looked to the model used by hospital pharmacies to develop the concept of a laboratory test formulary. Initially created to stem the rising costs of send-out testing, the published, tiered formulary is now managed by a special committee of clinicians and works to improve alignment between medical necessity and the tests themselves.

Learning Objectives:

• Define the concept of a lab formulary
• Outline the steps taken by the University of Rochester Medical Center to develop a lab formulary
• Describe the URMC's three-tiered system for all reference testing and how it is managed
• Compare and contrast lab test formularies with those developed by pharmacists for drugs

Negotiating contracts with hospitals can be tricky business, but savvy pathologists will ensure that they cover all the bases when working out arrangements with hospitals. Therefore, this session addresses key elements of contract negotiation, including compensation, restrictive covenants, and the role of the pathologist in risk-based arrangements. Plus, gain new insight into how to ensure that you are involved in the development of new business.

Learning Objectives:

• Learn how to ensure appropriate compensation for your services
• Find out which restrictive covenants you can live with and which ones you should avoid
• Understand what the pathologist’s role should be if the hospital joins an accountable care organization or enters into a risk-based arrangement
• Get insight into how to ensure you are involved in the development of new business

A new CLIA option for alternative quality control is aimed at matching both changing technology and the needs of individual labs. Published by the Clinical and Laboratory Standards Institute, the guideline (EP-23) is called the Individualized Quality Control Plan (IQCP), and is being implemented via interpretative guidelines by CMS. This session details the IQCP background, its current scientific validity, and why it is a choice made by the lab director.

Learning Objectives:

• Describe the background of the Individualized Quality Control Plan and why CMS is committed to this new approach
• Present details of the IQCP including why existing CLIA QC regulations and quality system concepts won’t change
• Explain why IQCP is a choice made by the lab director
• Respond to critics of the change that question its scientific validity

Perhaps the biggest challenge lab organizations face is providing a comprehensive test offering in a cost-effective manner. That means maintaining economies of scale and maximizing infrastructure and staff utilization at a time when physicians increasingly seek a diagnostic resource that can meet all of their testing needs. This session will detail key strategies for “right-sizing” an organization’s test offering, from consulting with medical leadership with an eye to clinical needs and optimized ordering to conducting in-depth analysis of send-out volumes.

Learning Objectives:

• Describe how a lab’s test menu can help to guide clinicians to select the correct test or panel of tests for a suspected condition
• Prepare to analyze your lab’s test mix, including volume, cost, and turnaround time
• Outline steps necessary to project test demand and costs to determine which tests to in-source

As automation assumes an increased role in clinical laboratory operations, labs of all sizes are grappling with difficult questions: What are the benefits of automation? What is the end goal? How does automation affect the life cycle of a laboratory? What’s the return on investment? Is now the right time to automate? This session provides an in-depth look at every phase of automating a laboratory—from developing project priorities and selecting a vendor, to optimizing implementation and achieving measurable results of automation.

Learning Objectives:

• Outline the changing role of automation in the clinical laboratory
• Review automation strategies, highlighting factors for success and recipes for failure
• Assess economic and operational efficiencies and measurable results of automation
• Weigh automation strategies relative to factors essential for laboratory growth, perhaps more essential than automation

Many factors today are working against small to mid-size hospital affiliated independent pathology groups—ranging from modest or no capabilities for specialization, to little or no access to capital for infrastructure development. Based on a survey of these groups, this session focuses on how independent pathology groups view options for their future structure and affiliations, plus which strategies they believe are best suited for their practices.

Learning Objectives:

• Learn the demographics and market segmentation of independent contractor
• Understand how hospital and health care system, and pathology groups leaders perceive the threats and opportunities facing small to mid-size independent contractor pathology groups
• Evaluate strategies to re-position independent contractor small to mid-size pathology groups in order to improve their long term viability

Major changes in the health insurance industry are being driven by transformation in the U.S. health care system, and will undoubtedly affect both clinical and AP labs alike. Discover what labs need to know to succeed in this emerging environment, changes required to the traditional lab business model, new services labs will be required to provide, and preparing your lab for the next stage of managed care.

Learning Objectives:

• Discuss the major alternations to the business practices of priave health plans
• Assess the necessary changes to the traditional lab business model
• Identify the new services that labs should plan to provide
• Describe the alternative models that will prepare labs for the next stage of managed care

No matter the size or services offered by your clinical or anatomic pathology laboratory, the quality of the company’s employees is the primary key to growing and maintaining a successful enterprise. Learn why proactively seeking and retaining the most talented people available provides a crucial competitive edge in today’s hypercompetitive lab market. Our speaker also highlights key factors driving the current lab job market and assesses what company attributes potential candidates find particularly appealing.

Learning Objectives:

• Highlight key factors driving the current lab job market
• Discuss the importance of attracting the most talented people to your lab
• Assess what company attributes potential candidates find particularly appealing
• Explain why hiring and retaining the best people for key lab positions pay big competitive dividends for your company

With hospitals and health systems continuing to buy physician practices, and coming together to form accountable care organizations, the traditional model of hospital labs will be challenged. Find out about market trends driving changes in the hospital lab market, how hospital labs may organize around bundled services and regional delivery systems, and how a value-driven market could well give a competitive advantage to hospital labs.

Learning Objectives:

• Discuss how emerging market trends are making the current hospital lab model obsolete
• Identify characteristics of a revamped hospital business model
• Describe how hospital labs will have to operate as health care moves to bundled services and regional delivery systems
• Assess the implications of a value-driven market and the competitive advantage it may afford of hospital labs

A recent study published in the journal Health Affairs found that urologists who referred patients to in-office pathology labs billed Medicare for more anatomic pathology specimens, but had lower cancer detection rates than physicians who did not benefit financially from ordering more tests. Lab interests say the findings support eliminating the exception in the Stark law that permits physicians to self-refer pathology services. However, key specialty groups strongly disagree. Our speaker, the researcher who conducted this study, discusses the findings and implications for health care costs.

Learning Objectives:

• Learn about the Georgetown pathology study and how it was conducted
• Understand what the study conclusions mean for the health care system and patient care
• Find out what impact this could have on the Stark in-office ancillary services exception

While most clinical laboratories have some sort of compliance program in place, the quality of programs can vary from one lab to another. An effective compliance program can help protect your organization from whistleblower lawsuits, billing errors that can result in fraud charges, and other state and federal enforcement actions. This session details specific ways to measure the effectiveness of your compliance program, how to establish effective compliance training programs, and how to handle internal reporting of employee concerns.

Learning Objectives:

• Understand elements of the Laboratory Compliance Guidance published by the Health and Human Service’s Office of Inspector General
• Learn how to establish effective compliance training programs for all staff
• Find out how to handle internal reporting of compliance concerns by employees
• Discuss ways to measure the effectiveness of your lab’s compliance program

As new esoteric tests challenge established engineering processes and traditional laboratory planning solutions, today’s lab managers must work closely with their architecture and engineering teams to leverage work practices, standard operating procedures, and personal protective equipment in conjunction with engineering controls to create a safe and effective work environment. This session will highlight five keys to smart lab design with a particular focus on opportunities to minimize energy consumption.

Learning Objectives:

• List five key aspects of planning a safe and effective clinical laboratory working environment
• Identify architectural or engineering strategies that minimize the risk of cross-contamination of samples and control hazardous chemical quantities
• Describe a six-step process for selecting the right exhaust device for your laboratory
• Explain the difference in energy consumption between the proper exhaust device and a conventional fume hood

Discrepant lab results are often identified by delta check alerts. A valuable tool for quality control, delta checks compare current lab results to previous results — if the difference between the two values exceeds predetermined biological limits (within a predetermined length of time), a technologist is alerted and the discrepancy can be investigated further. This session highlights current methods used to determine delta check limits, tips for implementing a systematic investigation of discrepancies, and clinical implications of reporting discrepant results.

Learning Objectives:

• Assess strategies for implementing a systemic investigation of discrepant lab results
• Define delta check
• Describe the advantages of delta checks over traditional QC methods and how they can help to "check" the reporting of erroneous lab results
• List current methods used to determine delta check limits

In-sourcing of pathology services as a revenue stream by nonpathology physician specialists continues to exert a significant impact in many areas nationwide. Through case studies, this session examines how much certain specialty physician groups are making from in-sourcing and explores how national pathology labs are coping with this trend. Specifically, find out how much urology, gastroenterology, and dermatology groups are making from in-office pathology labs as well.

Learning Objectives:

• Review key issues relating to the in-sourcing of pathology services
• Find out how much urology, gastroenterology and dermatology groups are making from in-office pathology labs
• Learn how national pathology labs are dealing with this trend
• Review case studies for specialty groups that have insourced pathology services

As the health care market transforms into one that is driven by value and outcomes, clinical laboratories need to adapt to thrive. Labs have indeed begun to explore a number of value-centered approaches that will give them a place at the table as health systems and physicians restructure for payment and delivery reform. This session explores various value-centered strategies, the importance of global payment and shared savings arrangements, and ways in which labs are participating in the health care transformation.

Learning Objectives:

• Understand the market forces driving labs toward value-centered models
• Get insight into new payment arrangements and the roles labs can play
• Hear about labs that are already involved in ACOs and learn how they are making a difference in the value equation

Following a banner 2011, when lab and pathology merger and acquisition transactions topped $3 billion, robust activity is expected to emerge again—particularly during the last half of 2012. This session reviews recent transactions, explains what’s driving the M&A market— including valuations and forecast—and what to expect in the future. The discussion continues with how the investment community views the lab and pathology sector.

Learning Objectives:

• Review current lab & pathology M&A activity
• Learn what factors are determining the valuation of labs
• Explain what market forces are driving M&A activity
• Discuss how the investment community views the lab & pathology sector

One of the leading advocates of personalized medicine discusses why the value of diagnostics to the health care system has never been greater. Whether identifying disease earlier, selecting the right therapy, or monitoring efficacy of treatments, the ability for the diagnostics sector to deliver benefits to society has finally come. In this keynote session, discover critical new insights into this transformation, including how multiple diagnostic tools can work together to enable precision medicine, which forces are driving the increasing value of diagnostics, and what key industry players can do to help shape the future of the health care system.

Learning Objectives:

• Learn how diagnostics is becoming more critical in the health care value chain
• Gain insights into what forces are driving the increasing value of diagnostics
• Advance your perspective on what the diagnostic industry can do to continue its momentum
• Discover how multiple diagnostic tools can work together to enable precision medicine in the future

“Most of the conditions that kill us, including cancer and heart disease, could be prevented or delayed by a new way of looking at and treating health,” says David B. Agus, M.D. As molecular diagnostics increasingly allows for customized treatment, the real shift to preventive medicine will also depend on data. Meanwhile, the next generation of revolutionary technologies in medicine will emerge as accessible, cost-efficient realities thanks in large part to consumer demand. This session examines how the advancement of these and other technologies make it progressively easier to monitor and maintain health.

Learning Objectives:

• List three barriers to realizing “the end of illness” in the current health care system
• Describe the role of protein-based testing, patient data collection, and consumer technology in fueling the shift to preventive medicine
• Assess the implications of personalized medicine on physicians’ responsibilities and ideal skill sets

Personalized medicine has the potential to change the way drugs are developed and medicine is prescribed. However, the regulatory and financial systems that will support it are not yet in place. In this session, Paul Landauer draws upon his experience working with a range of stakeholders, to discuss the opportunities and challenges of personalized medicine — from its promises of improved safety and reduced costs, to the hurdles of evidentiary requirements and ensuring fair market access.

Learning Objectives:

• Identify the stakeholders who can drive the advancement of personalized medicine as a viable solution to the challenges of efficacy, safety, and cost
• Describe the evolving reimbursement picture for novel methods of molecular analysis that may be used to better manage a patient’s disease or predisposition toward a disease
• Assess the potential roles of clinical labs, in vitro diagnostic manufacturers, and providers in supporting changes needed to further the public interest in personalized medicine

Which key market trends will directly impact both your organization and your own prospects for success in the near future? This briefing by a team of market analysts and editors from G2 Intelligence identifies the next big developments in the lab and pathology sector that you need to watch for over the next year. Don’t miss this fast-paced session—your chance to gain perspective on the potential risks and opportunities coming your way in 2013.

Learning Objectives:

• Identify the top five industry trends that will most likely affect your operations over the next year
• Review how these trends are liable to impact the lab and pathology sectors
• Assess how these major market developments may influence your company’s revenue and growth in 2013

A new market paradigm for laboratory and pathology organizations is on the horizon where patient care is integrated, ACOs and patient-centered medical homes start taking hold in various markets, and value is rewarded over volume as provider reimbursement moves from a fee-for-service to a bundled services system. In this dynamic session, leading industry executives discuss emerging lab organizational models, key challenges affecting today’s lab business climate, and what factors will shape the future competitive environment for the lab and pathology sectors.

Learning Objectives:

• Define the changing market paradigm for lab and pathology companies
• Describe how lab business models are likely to change in the future
• Learn about leading challenges affecting today’s lab business climate
• Discuss the factors shaping the future competitive environment for labs