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Cardinal Health sponsors continuing medical educational events for healthcare professionals across the country. You can register for upcoming sessions here, or watch archived webinar recordings at any time, from anywhere. These Cardinal Health sponsored events are presented by esteemed professionals in the world of healthcare and research, and managed by Whitehat Communications to ensure a professional environment. Attend these basic level webinars at no cost - all offer one P.A.C.E.® Continuing Education contact hour for up to six months after the live event. Be sure to check back often for new event postings. For information on Cardinal Health laboratory products, please visit our website here.

Closing the Gap in Pre-analytical Specimen Quality
Live Event: Tuesday, February 27, 2018  1:00 - 2:00 PM EST
PACE® Credit available until August 27, 2018  |  Florida Lab Credit available
Assessment of laboratory quality is broken down into 4 phases; general, pre-analytical, analytical, and post-analytical. While the laboratory has control over the general (safety, policies, proficiency testing) and analytical portions, pre-analytical and post-analytical quality are often outside of their hands. Post-analytical quality refers to the processes that occur after the lab testing is completed including patient reports, communication and complaints. Pre-analytical specimen integrity is just as critical to the result reported by the laboratory. The laboratory must have processes in place to educate the customer on specimen collection, specimen storage and specimen transport. The laboratory must also have processes in place to identify when to reject specimens based on improper collection, storage and/or transport, and to communicate back to the customer in a manner which will provide education for improved specimen quality.

This webinar will: 
  • Explain the importance of proper collection, transport, and storage of specimens
  • Identify collection, transport and storage concerns in their own laboratory
  • Outline improvements needed to improve pre-analytical quality in their own laboratory
  • Assess and evaluate the impact of these improvements

Margaret Blaetz, CLC(AMT), CCCP(AAPOL)
CEO, East Coast Clinical Consultants
Margaret Blaetz Photo
Margaret Blaetz began her career as a Medical Laboratory Technician specializing in Microbiology and obtained her Bachelor of Science Degree at Glassboro State College (Rowan University). Her 30+ year career in laboratory science includes clinical laboratory management, sales and customer service for a national laboratory, and research and development of diagnostic test kits.
2018 Outlook for the Clinical Laboratory Industry
Live Event: Wednesday, January 31, 2018  1:00 - 2:00 PM EST
PACE® Credit available until July 31, 2018  |  Florida Lab Credit available
Recording Slides  
Following a year of sending mixed policy signals to the healthcare industry, including the clinical laboratory sector, Washington policymakers will be grappling with a host of healthcare issues in 2018. These issues will range from key decisions impacting the Affordable Care Act to potential budget cuts affecting the Medicare and Medicaid programs.

This presentation will examine the latest national policy developments and trends affecting clinical labs. This includes the outlook for a new Medicare market-based national fee schedule that would make major payment cuts for many lab tests, how Medicaid and commercial insurer reimbursement to labs will be influenced by the changeover to Medicare market-based rates, the status of laboratory developed test oversight by Congress and the Food and Drug Administration, and lastly, the leading Washington policy challenges for the lab industry in the year ahead.

This webinar will: 
  • Analyze the latest policy initiatives affecting the Affordable Care Act for the short and longer term.
  • Discuss the outlook for federal budget cuts to Medicare and Medicaid and the impact they would have on both beneficiaries and providers, including labs.
  • Review the status of a new Medicare market-based payment system for lab testing and how payment rates will change starting in 2018.
  • Identify top federal policy challenges for labs over the next year.
Dennis Weissman
President, Dennis Weissman & Associates, LLC
Dennis Weissman Photo
A nationally known, independent analyst, consultant and thought leader for the clinical laboratory and anatomic pathology sectors for over three decades, Dennis is President of Dennis Weissman & Associates, LLC, Falls Church, VA, a consultancy which provides market intelligence, M&A advisory services, business leadership and public policy advice to diagnostic and life science companies and organizations. Mr. Weissman has expertise in Medicare and health care reform policies and trends; clinical laboratory and pathology payment & compliance policies as well as business trends affecting the diagnostic sector.
The First Cut isn't the Deepest: Proposed Clinical Lab Fee Schedule
under PAMA
Live Event: Wednesday, December 13, 2017 1:00 - 2:00 PM EST
PACE® Credit available until June 13, 2018  |  Florida Lab Credit available
Recording Slides
On June 23, 2016, the Centers for Medicare & Medicaid Services (CMS) released a final rule implementing Section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA). This legislation creates a single, national fee schedule which is based upon private payor rates. Applicable laboratories performing clinical diagnostic laboratory tests had to report the amounts paid by private insurers for laboratory tests. Medicare then used the weighted median of private insurer rates to calculate Medicare payment rates for laboratory tests paid under the Clinical Laboratory Fee Schedule (CLFS) beginning January 1, 2018.

CMS initially estimated that using a market-based system stipulated under PAMA would save $390 million in the first year of 2018, and $3.93 billion over a decade1. In September 2017, CMS released the proposed new rates and the rate cuts are more significant than originally anticipated. The proposed rate structure would result in reductions of $670 million in Part B program payments for clinical lab fee schedule (CLFS) tests in 20182. The preliminary rate schedule introduces dramatic cuts. 58% of tests will have reductions phased in over multiple years as the preliminary rates exceed the maximum per year reduction3.

This new rate structure represents a dramatic shift in the way laboratory tests are reimbursed. This webinar will provide clinical laboratories with an update on the implementation of the new Clinical Lab Fee Schedule and the financial impact to clinical labs.

1PAMA Regulations, CMS, September 19, 2016
2CMS 2018 PAMA Pricing Cut for Lab Tests Deeper Than Prior Estimate; Advanced Dx Lab Tests Fare Well, GenomeWeb
3CY2018 – Preliminary Private Payor Rate-Based CLFS Payment Rates and Analytics, available at

This webinar will: 
  • Discuss the changes to payment rates for tests paid on the Clinical Lab Fee Schedule.
  • Identify the 2018 payment rates for CPT codes including which codes are increasing/decreasing.
  • Recognize which CPT codes will have phased in rate reductions due to per annum caps.
  • Identify the payment changes to panel based tests, molecular diagnostic tests, etc.
  • Illustrate the impact to your clinical laboratory based upon the 2018 rates.
Chandra Branham Photo Chandra Branham, J.D., VP

Chandra Branham, J.D., joined the Advanced Medical Technology Association (AdvaMed) as Vice President, Payment and Health Care Delivery Policy, in 2011.

Julie Khani Photo Julie Khani, President

Julie Khani became president of the American Clinical Laboratory Association (ACLA), the largest organization representing the public policy interests of laboratories, in 2017.

Data Hidden in Plain Sight: Using Unexpected Analytics for Quality and
Process Improvement in the Clinical Laboratory
Live Event: Thursday, November 16, 2017 1:00 - 2:00 PM EST
PACE® Credit available until May 16, 2018  |  Florida Lab Credit available
Recording Slides
Clinical laboratories are swimming in data. However, many opportunities for improvement in the laboratory may go unrecognized. Studies are performed and actions are taken on common metrics like turn-around time and test volume while other, potentially more revealing metrics receive little focus. Workflows and activities such as specimen flow, testing protocols and pre-authorizations linked to the EHR, and blood utilization tactics are examples of where opportunities exist to uncover operational efficiencies and cost savings.

The ability of the clinical laboratory to effectively utilize available data will become increasingly important as the laboratory faces challenges on staffing and reimbursement. Opportunities also exist for laboratorians to utilize the data generated in their laboratories to educate providers, care teams, and patients which positively impacts patient care. This webinar will describe three different projects that utilized unexpected data points to affect change to the laboratory workflow and clinical care.

This webinar will: 
  • Discuss sources of unexpected data in the laboratory and how they can be used for improvement efforts.
  • Identify the need for data to support improvement efforts or implementing change.
  • Describe a process whereby current data sources can be tweaked for use in specific improvement activities.
  • Define financial and operational benefits associated with utilizing unexpected sources of lab data.
Jordan Olson MD FCAP
Medical Director Clinical Pathology Informatics
Geisinger Medical Center
Jordan Olson Photo
Jordan Olson is the medical director for clinical pathology informatics in the Geisinger Medical Laboratory, the medical director of pre-analytics and phlebotomy, and the medical director for the Geisinger Bloomsburg Hospital laboratory. Dr. Olson completed his undergraduate and medical school at the University of Wisconsin-Madison School of Medicine and Public Health.
Survival of the Fittest: Transforming Your Lab from Cost to Value Center
Live Event: Wednesday, October 18, 2017 1:00 - 2:00 PM EDT
PACE® Credit available until April 18, 2018  |  Florida Lab Credit available
Recording Slides
The new era of healthcare reform is here. Not only is there no going back, but maintaining status quo in healthcare organizations that operate inefficiently is a costly and unsustainable business model. Now is the time to adopt a new way of thinking and behaving around cost containment. Healthcare systems that get it will survive. Those that don’t likely won't.

Laboratory testing plays a central role in healthcare delivery that impacts both costs and outcomes. Unfortunately in some organizations, the laboratory is viewed as little more than a cost center that runs tests and reports results. In order to change this perception, labs must demonstrate quantifiable value well beyond the delivery of test results. When labs actively engage with clinicians to educate, inform, and support optimal test utilization, the transition from cost to value center has begun.

Utilization management has come to the forefront as an effective way to optimize laboratory testing in ways that benefit patients first and foremost, while driving down the overall cost of care. This presentation will discuss the components of an effective utilization management program. The speaker will present a roadmap for improving utilization management, provide specific examples of successful approaches, and highlight opportunities for improvement.

This webinar will: 
  • Identify industry trends driving the transition from volume to value-based healthcare.
  • Discuss key metrics associated with inappropriate test utilization.
  • Describe five components of the utilization management roadmap.
  • Cite successful strategies, beyond laboratory formulary, to optimize test utilization.
  • Define ways in which laboratories operate as value centers.

Suzanne Carasso, MBA, MT(ASCP), Director, Business Solutions Consulting with ARUP Laboratories
Suzanne Carasso
Suzanne is currently Director, Business Solutions Consulting with ARUP Laboratories. ARUP is a leading national reference laboratory owned by the University of Utah. As spokesperson for ARUP Laboratories Consulting Division, Suzanne works with a variety of organizations across the United States including large academic medical centers, integrated delivery networks, multi-hospital health systems, community hospitals, children’s hospitals, independent laboratories and group purchasing organizations.
FDA’s New Reclassification of Rapid Influenza Diagnostic Tests: Are you Prepared?
Live Event: Wednesday, September 27, 2017  1:00 - 2:00 PM EDT
PACE® Credit available until March 27, 2018  |  Florida Lab Credit available
 Recording Slides
Earlier this year, the U.S. Food and Drug Administration (FDA) published a final rule that reclassifies antigen-based Rapid Influenza Diagnostic Tests (RIDTs) from Class I to Class II and requires that these diagnostic devices meet increased sensitivity, specificity and annual strain testing quality controls. This reclassification becomes effective on January 12, 2018, which will have implications for laboratories during this upcoming influenza season (2017/2018).

This device reclassification was driven by concerns from the Centers for Disease Control and Prevention (CDC) about test sensitivity of RIDTs during the 2009 pandemic flu season. The goal of the reclassification is to improve the overall performance of RIDTs by requiring additional regulatory controls. These new measures should reduce the incidence of false-negative results, improving antibiotic stewardship across the continuum of care.

This webinar will review the FDA reclassification of RIDTs, discuss the new sensitivity and specificity requirements for RIDTs, and provide an overview of the products on the market that meet the new requirements. Also covered in the webinar will be information on how long products not meeting the new requirements can be sold by distributors and manufacturers, as well the date up until which laboratories may use such diagnostic devices. This webinar is intended to help enable laboratories to prepare for the changes and minimize any impacts to established influenza protocols.

This webinar will:
  • Review FDA influenza reclassification requirements and assess impact to currently utilized RIDTs
  • Identify the different types of influenza tests available and if they are compliant with the new FDA guidelines
  • Understand the pros and cons of each type of influenza testing based on the needs of your laboratory
  • Explain the dates until which products not meeting the new guidelines can by sold, as well as how long they can be used for patient testing

Click here to learn more about Cardinal Health’s influenza testing platforms that ensure FDA compliance.

Click here to download questions and answers from this webinar.
Gregory J. Berry, Ph.D., D(ABMM)
Assist. Prof., Pathology and Lab. Medicine
Hofstra Northwell School of Medicine
Greg Berry photo
Gregory J. Berry Ph.D., D(ABMM) is an Assistant Professor of Pathology and Laboratory Medicine at Hofstra Northwell School of Medicine and an Assistant Director of Infectious Disease Diagnostics at Northwell Health Laboratories in New York. He is also a Diplomate of the American Board of Medical Microbiology.
Six Trends that will Change Health Care over the Next 5 Years
Live Event: Wednesday, August 30, 2017  1:00 - 2:00 PM EDT
PACE® Credit available until February 30, 2018  |  Florida Lab Credit available
Recording Slides  
The dynamics of the healthcare are that the industry will continue to be fluid, with evolution and change continuing for the next several years. Beyond healthcare policy, change will be driven by multiple factors. These factors range from value-based care to technology and data to the demographics of the people accessing care. The macro trends identified will impact the industry as whole, but have downstream implications and opportunities for the clinical laboratory. The role of the laboratory is evolving relative to patient care as well as how it supports the goals and initiatives of its hospital or healthcare system. This shifting role requires laboratories to think differently and quickly respond to the changes in their environment. Considerations for the laboratory include how to better utilize the data they generate, the expanding role of precision medicine, and addressing how millennials want to consume healthcare and diagnostic testing.

This webinar will outline the six trends that will change healthcare in the next 5 years. These trends were identified as a result of a multi-faceted study conducted by Huron Consulting Group and have several downstream implications to the clinical laboratory. By recognizing the opportunities that exist for the laboratory in response to these trends, the laboratory will be well positioned to create value within their system.

This webinar will:
  • Discuss the major trends impacting healthcare over the next 5 years and the impacts to the laboratory
  • Identify how the laboratory can adapt to these changes and create value for its stakeholders
  • Determine how risk and value-based care models impact the laboratory
  • Recognize the shifting requirements of patient populations 
 Ted Schwab photo Ted Schwab, Managing Director, Huron Healthcare Practice
Huron Consulting Group Inc

Ted is an industry leader in innovation through his work with clinicians, executives, and governing bodies around the country, helping them design the next generation of healthcare organizations.

K.R. Prabha photo  K. R. Prabha, Senior Director, Healthcare Strategy
Huron Healthcare Practice
Huron Consulting Group Inc  

Prabha brings over 15 years’ consulting experience focused on care delivery strategy, innovation, and measurable improvements in access, quality, cost, and patient experience.
What's Your Cost of Poor Quality? Calculating an ROI for Your Lab's Quality Program
Live Event: Wednesday, June 21, 2017  1:00 - 2:00 PM EDT
PACE® Credit available until December 21, 2017  |  Florida Lab Credit available
Recording Slides
Within the clinical laboratory, quality has multiple components. The most thought of component of quality relates to CAP (College of American Pathologists) inspections, accreditations, and standard regulatory compliance activities. Clinical laboratories often struggle to justify the resources to adequately support quality management and regulatory compliance programs. Many times this is due to lab quality efforts being viewed as a costly and necessary evil to achieving regulatory compliance. What often goes unrecognized are how quality management programs can be utilized to drive expense out of laboratory operations. For example, robust quality management programs can help reduce expenses associated with lost specimens, repeat testing and reagent management.

This session covers the concept of Cost of Quality, but focuses on the cost of poor quality (CoPQ). Methods for labs to calculate and capture CoPQ will be discussed. Armed with actual CoPQ data, laboratories can begin to speak the language of the "C Suite" by demonstrating improvement in financial performance. Labs can begin to portray their quality programs as mechanisms to achieve cost savings and cost avoidance, in addition to the quality, regulatory and patient safety benefits that are already well recognized.

This webinar will: 
  • Discuss the concept of Cost of Quality and its components.
  • Differentiate between hard and soft costs associated with quality management.
  • Review methodologies to capture and track Cost of Poor Quality (CoPQ).
  • Analyze how labs can use CoPQ data to demonstrate a return on investment for their quality efforts.
Jennifer Dawson photo
Jennifer Dawson is Senior Director, Quality for Human Longevity, Inc in San Diego, CA where she is responsible for building a best practice Quality Management System as well as for CLIA compliance and obtaining CAP and CAP 15189 accreditation. She formerly served as Vice-President Quality for Sonic Healthcare USA and was responsible for developing their quality management system.
Using Lab Information to Reduce Downstream Healthcare Costs: Case Studies
Live Event: Wednesday, May 17, 2017  1:00 - 2:00 PM EDT
PACE® Credit available until November 17, 2017  |  Florida Lab Credit available
Recording Slides
Laboratory testing provides more than just a snapshot of a patient’s medical condition at any point in time. Leveraging the power of the information provided by the laboratory can have significant impact on other downstream costs within the health care ecosystem and beyond to community health.

This webinar will provide case studies on how laboratory information is being used at a large integrated health care delivery system to lower cost and improve patient outcomes. Case studies will discuss how the data generated by the laboratory can help educate patient care teams, streamline/optimize test ordering, and provide visibility to patient adherence.

This webinar will: 
  • Analyze the “real” value of laboratory information
  • Identify sources of concrete examples of where laboratory information provides downstream value
  • Evaluate new financial models for laboratory reimbursement and/or cost containment
  • Discuss the most effective ways to become an advocate for laboratory testing
Ran Whitehead, CEO, PeaceHealth Laboratories
Ran Whitehead photo
Ran Whitehead is the Chief Executive Officer at PeaceHealth Laboratories. He has enhanced the company’s reputation for technical and clinical excellence, collaborative partnerships, and innovative programs. Ran has led initiatives such as a distance learning program that was later adopted by laboratories across the country.
Actions You Can Take to Have Your Lab Viewed as a Profit Center
Live Event: Wednesday, April 18, 2017  1:00 - 2:00 PM EDT
PACE® Credit available until October 18, 2017  |  Florida Lab Credit available
 Recording Slides
As clinical management and lab operators, your day may be consumed with daily operational or service issues. Some days, it’s about all you can do to get through one more day. It is hard to set aside time to think strategically or understand what your laboratory management executive is thinking. This webinar will reveal the 5 steps you can take to create value and change the perception of your laboratory and outreach programs by hospital and health system executives.

This webinar will: 
  • Demonstrate an understanding of today’s market and business trends and how they can be used to provide strategic and financial value to your clinical laboratory
  • Identify actions you can take that can help various medical and laboratory executive stakeholders think differently about your laboratory operations
  • Apply relevant strategies to position yourself and your lab proactively for change and growth based on changing healthcare dynamics.

Click here to download the article referenced by Dr. Murphy, Good News and Bad News in PAMA Final Rule for Repricing Lab Tests, shared with permission from Laboratory Economics.
Kathleen A. Murphy, PhD, Senior Growth Advisor Chi Solutions, Inc.

Kathleen Murphy photo
Kathleen A. Murphy, PhD, Senior Growth Advisor for Chi Solutions, Inc., an Accumen company, is a noted laboratory expert, speaker, and author. Over her 35 years in laboratory management and consulting, including her former role as the CEO of Chi, Dr. Murphy has gained broad industry experience in laboratory strategy, turnarounds, and outreach. She is the author of The Profit Machine in the Hospital Basement: Turning Your Lab into an Economic Engine (Ellsworth Press, 2016).
How Effective Test Utilization Can Support Patient Safety
Live Event: Wednesday, March 29, 2017  1:00 - 2:00 PM EDT
PACE® Credit available until September 29, 2017  |  Florida Lab Credit available
Recording Slides 
Utilization of laboratory services is of constant concern because of the cost to our health care system, the drain on laboratory resources, and the waste of valuable time in diagnosing, treating and managing patients. A recent article in the Journal of the American Medical Association (JAMA) suggests that there are also patient safety issues that must be considered.

This webinar will report on the progress of the CDC project known as the Clinical Laboratory Integration into Healthcare Collaborative (CLIHC). This project has been examining how physicians order laboratory tests, what they need to be able to order appropriately and what gaps need to be filled by laboratory professionals. These projects give us a better understanding on what clinicians know about laboratory science and medicine. This presentation will also examine several different approaches to controlling utilization and discuss how to implement utilization programs. The “how” is very dependent on many factors, several of which will be described, that exist in every healthcare setting.

This webinar will: 
  • Describe the Clinical Laboratory Integration into Healthcare Collaborative (CLIHC) project.
  • Discuss instances of miscommunication, poor utilization of laboratory services and patient consequences.
  • Analyze barriers and solutions currently being discussed in various institutions.
  • Evaluate implementation processes that might be useful in your setting.

Elissa Passiment, MT(ASCP), EDM
Senior Partner, EP Clinical Laboratory Consulting
Elissa Passiment photo
Elissa Passiment is a clinical laboratory scientist with over twenty years’ experience in clinical laboratories as staff, educator and manager and another twenty years in health care consulting, association management and health policy.
Ms. Passiment has served on the congressionally mandated Negotiated Rulemaking Committee convened to standardize and simplify reimbursement for laboratory services under Medicare Part B; presented testimony to Institute of Medicine studies, and represents ASCLS at meetings with the FDA, CMS, and CDC.
Laboratory Test Utilization: Improving Outcomes and Reducing Costs
Live Event: Tuesday, February 28, 2017  1:00 - 2:00 PM EST
PACE® Credit available until August 28, 2017  |  Florida Lab Credit available
Recording Slides
The nation’s healthcare system has been steadily shifting from fee-for-service to fee-for-value models and patient’s centered models. This transition has created opportunities for clinical diagnostic laboratories to partner within their healthcare systems on initiatives, such as improved patient outcomes, lowering readmission rates, and reducing the cost of patient care. This approach not only provides benefit to patients and the healthcare system but also enables laboratories to play a more integrated role in the care of patients.

With the rapid advancement of molecular diagnostic testing, there is an increasing need for the laboratory to provide education and decision algorithms to help mitigate unnecessary testing. Creating guidelines to help clinicians navigate the increasingly complex landscape of molecular diagnostics is another opportunity for the laboratory to support the transition to value based care.

Optimal utilization of laboratory testing and the implementation of clinician decision support tools have enabled numerous healthcare systems to lower their laboratory testing expenditures and improve patient care associated with high-risk infections and conditions. The mechanisms for achieving, and the benefits associated with, proper laboratory test utilization can be achieved in a variety of ways. Critical to the success of laboratory test utilization programs is partnering with providers in the development of test plans and protocols. Utilizing a collaborative approach across the organization will help ensure adoption and adherence to new protocols.

This presentation will provide information on the how clinical laboratories can utilize testing protocols to help their healthcare systems to reduce costs and achieve goals associated with CMS’ Core Measures and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores. The benefits of enhanced utilization of laboratory testing and the utilization of decision support tools to enable improved patient outcomes will be discussed. Considerations and best practices for effective implementation and adoption of laboratory test utilization programs will be reviewed.

This webinar will: 
  • Identify how the laboratory can partner with stakeholders across the healthcare system to reduce healthcare costs by properly utilizing laboratory tests.
  • Define how laboratory test utilization and decision support tools can enable clinicians to improve patient outcomes.
  • Demonstrate how the laboratory can be utilized to address the transition from fee-for-service to fee-for-value
To download the Quality Chasm Series: Health Care Quality Report, click here.
Eugenio Zabaleta, Ph.D.
Clinical Chemist, OhioHealth Mansfield Hospital
Eugenio Zabeleta pic
Eugenio H. Zabaleta, PhD, is a Clinical Chemist at OhioHealth Mansfield Hospital. He is also Part-time Lecturer at Cleveland State University Graduate Clinical Chemistry Program in Cleveland, OH. He graduated from the Catholic University of Cordoba (Argentina) with a degree in Biochemistry and received his PhD in Chemistry from the University of Akron. His training in Clinical Pathology was at the Hospital Provincial San Roque in Cordoba. In his native country he was the Laboratory Medical Director at the Clinica Del Sol, a clinic devoted to mother-and-child care with neonatology intensive care services. Dr. Zabaleta performed a fellowship at OhioHealth Mansfield Hospital Laboratory.
Compliance Considerations for Clinical Laboratories
Live Event: Wednesday, January 25, 2017  1:00 - 2:00 PM EST
PACE® Credit available until July 25, 2017  |  Florida Lab Credit available
Recording Slides
Clinical laboratories provide valuable testing services to their institutions, patients and communities but are operating in increasingly complex and competitive environments. Healthcare reform continues to evolve and with this comes a responsibility by both the laboratories and clinicians to understand the compliance requirements associated with providing testing services. Violation of the laws can put both the laboratory and clinician at risk for criminal and civil penalties. Understanding the state and federal statutes associated with marketing testing services to new and existing clients will enable clinical laboratories to identify risks associated with kick-backs and fraud and abuse. To ensure proper use of funds, Medicare and private payors are increasing the frequency and depth of the audits to clinical laboratories. These audits are being performed to ensure medical necessity, proper utilization of specific test codes and types, as well as proper collection of co-pays and co-insurance. By understanding the laws and guidelines, clinical laboratories can develop robust compliance programs to reduce risks and provide transparency to their healthcare system, clients and payor network.

This presentation will provide an overview to the key laws and statutes as well as address a variety of compliance requirements that clinical laboratories must adhere to mitigate legal and financial risks. Compliance requirements and common issues related to laboratory billing will be identified. Examples of non-compliance will be reviewed. Also addressed within the presentation will be the risks clinical testing laboratories commonly have associated with payor audits.

This webinar will: 

  • Interpret how the Stark Law framework, anti-kickback statute, and exception to limitations applies to laboratory testing
  • Discuss the developments in compliance requirements for client account billing for laboratory testing
  • Identify risks and issues commonly associated with payor audits
Elizabeth Sullivan, Esq.
McDonald Hopkins LLC
Liz Sullivan Photo
Elizabeth Sullivan is a member of the firm’s National Healthcare Practice. She began her legal career as an associate in the Healthcare Practice group and recently returned to McDonald Hopkins. For the past four years, Liz served as associate counsel for The Cleveland Clinic Foundation where she provided regulatory advice and transactional guidance to various service lines, including the clinical laboratory, professional pathology, imaging, transplant, and remote and distance health teams. During her career, Liz has assisted clinical laboratories, hospitals, physician specialty groups, telehealth providers, transplant centers, surgery centers, healthcare associations, pharmacies, and other healthcare providers on regulatory, licensing, compliance, reimbursement, contractual, and corporate matters.
Clinical Lab Payment Reform under PAMA: Reimbursement, Reporting and your New Responsibilities
Live Event: Wednesday, November 16, 2016  1:00 - 2:00 PM EST
PACE® Credit available until May 16, 2017  |  Florida Lab Credit available
Recording Slides

On June 23, 2016, the Centers for Medicare & Medicaid Services (CMS) released a Final Rule implementing Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA), requiring laboratories performing clinical diagnostic laboratory tests to report the amounts paid by private insurers for laboratory tests. Medicare will use these private insurer rates to calculate Medicare payment rates for laboratory tests paid under the Clinical Laboratory Fee Schedule (CLFS) beginning January 1, 2018.*

The Final Rule not only reforms reimbursement for clinical laboratory testing but also has numerous requirements and components that laboratories need to understand and comply with. Noncompliance with these new requirements can have financial impacts on the laboratory/institution. Defined within the legislation are elements such as:

  • Definition of applicable laboratories required to report to CMS
  • Reporting periods, applicable information to be reported, and designated reporting authorities
  • Definition of advanced diagnostic laboratory tests (ADLTs) and how they differ in reporting and rate setting

This presentation will address important provisions of the law, including the new data reporting responsibilities for applicable laboratories, details about and timeframes for reporting private payer information, and information on the annual rate reductions allowed under the legislation. The presentation will also help laboratories translate the Final Rule to identify required actions and potential impacts for their laboratories.

*PAMA Regulations, CMS, September 19, 2016


This webinar will: 

  • Interpret the provisions of the Final Rule of Section 216 of PAMA which reforms payment to laboratory tests paid under the Clinical Lab Fee Schedule.
  • Identify and apply the new reporting responsibilities for their laboratory and understand the reporting timeframes and the impact it will have on their laboratory.
  • Recognize the methodology and opportunities to engage with CMS on the proposed payment rates before they become final.
Chandra Branham, J.D., VP
Advanced Medical Technology Association
Chandra Branham Photo
Ms. Branham leads the AdvaMed’s policy work in a number of areas, including diagnostics payment, coverage issues, and comparative effectiveness. Ms. Branham has spent most of her career focusing on healthcare regulatory and legislative issues involving Medicare coverage, coding, reimbursement and quality for providers and suppliers of Medicare items and services, including serving as a senior legislative analyst in the Centers for Medicare & Medicaid Services (CMS) Office of Legislation.

Julie Khani, Executive VP
American Clinical Laboratory Association
Julie Khani photo
Julie Khani joined the American Clinical Laboratory Association, ACLA, in 2013 as Senior Vice President, and was named Executive Vice President in 2016. In her current role Ms. Khani oversees the advocacy, policy and communications functions at ACLA and leads association efforts on implementation of the Clinical Laboratory Fee Schedule (CLFS) provisions of the Protecting Access to Medicare Act.

Whitehat Communications is approved as a provider of continuing education programs in the
clinical laboratory sciences by the ASCLS P.A.C.E.
® Program.

These webinars are sponsored by
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