News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Tougher Lab Regulations and New Legal Issues in 2018: More Frequent Payer Audits, Problems with Contract Sales Reps, Increased Liability for CLIA Lab Directors, Proficiency Testing Violations, and More

An all-new webinar!
Recorded November 8, 2017

Attention clinical laboratory and pathology group execs: learn the steps you and your management team need to take NOW to mitigate risk and keep your lab organization financially strong!

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Looking forward into 2018, Medicare Part B clinical laboratory price cuts are not the only big story. Other significant threats can upend your laboratory, such as tougher payer audits with higher recovery demands or new federal and state regulatory rules that increase the personal liability of CLIA lab directors and lab executives.

And that’s not all! The list of regulatory, compliance, and managed care threats that must be addressed by clinical labs and pathology group practices in 2018 is lengthy. Each comes with the potential of government sanctions, exclusion from provider networks, large recoupment demands, and greater risk for individual liability of lab directors and lab managers that can include jail time, sizeable fines, and exclusion from federal health programs.

As the new year fast approaches, these are reasons why savvy clinical lab executives, pathologists serving as medical directors of CLIA-licensed labs, and their financial and legal advisors need to come up to speed on the most serious regulatory, compliance, and managed care contracting issues confronting all labs today.

To keep your lab ahead of these powerful developments, is presenting a timely new webinar, “Tougher Lab Regulations and New Legal Issues in 2018: More Frequent Payer Audits, Problems with Contract Sales Reps, Increased Liability for CLIA Lab Directors, Proficiency Testing Violations, and More” which took place Wednesday, November 8, 2017, featuring three of the nation’s leading attorneys with extensive experience in issues unique to clinical labs, pathology groups, hospital labs, toxicology/pharmacogenomic labs, and molecular/genetic testing labs.

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You’ll hear first from Jeffrey Sherrin, President and Partner with O’Connell & Aronowitz in Albany, NY. Sherrin will cover with you new lab referral and billing arrangements on the rise, the ways they can violate Federal and State Laws, and affect provider agreements with health insurers. In addition, you’ll learn more about tougher commercial payer audits, particularly in toxicology and pharmacogenomics, and about the emerging “pricing dilemma” for labs—complications in establishing list prices, then balance-billing patients to comply with payer agreements.

Second to share essential knowledge is David Gee, Partner with Davis Wright Tremaine, LLP in Seattle, WA. Gee will discuss why even basic compliance is still a struggle for many labs and how poor due diligence creates a variety of problems with regulators, lab buyers, and investors. This topic is of great importance to you because a solid compliance program underpins a successful lab operation.

Gee will also help you better understand today’s third-party marketing agreements between labs and sales firms, including why sales companies control physicians, what compliance issues must be addressed, and how labs are exposed during Medicare and private payer audits. These are great insights and perspectives on why the use of contract marketers is now a trend that will not go away soon.

Finally, of particular relevance to pathologists who are medical directors of CLIA labs and executives at tox/pharmacogenomics/specialty genetic lab companies, Gee will share insights about big changes for CLIA lab directors and lab executives regarding the new ways that regulators are increasing individual liability.

Moderating the webinar and next to speak is Richard Cooper, Chair of National Healthcare Practice Group at McDonald Hopkins in Cleveland, OH. Cooper will share his expertise about why Private Payer Audits are now more frequent, tougher, and result in larger monetary demands of labs, which payers are the most aggressive, and best ways for labs to document claims and be ready for surprise audits.

Cooper will discuss how inadvertent proficiency test referrals continue to be an issue with CMS—why CLIA offices still pursue these cases, how to deal with this problem in your lab when it happens, and what you can learn from recent case studies of inadvertent PT referrals.

In anticipation of the Medicare Part B lab test fee cuts coming in 2018, you’ll learn the specific steps that your lab should be taking now with your private payer contracts, as well as other key measures to take to protect your lab’s financial stability.

Finally, adding an invaluable perspective to information earlier shared by Sherrin and Gee, Cooper will provide additional nuances and insights on the topic of piggyback arrangements by toxicology and pharmacogenomics labs that violate federal and state laws.

Many labs find themselves confronted with the dilemma of how to set list prices for tests and balance-bill patients without violating their provider agreements with health insurers. All three attorneys are dealing with aspects of how labs bill patients, and therefore can enlighten you with their indispensable insights and recommendations.

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Listen and learn from the shared wisdom of our expert faculty
as they address key issues in these areas, and more:

  • Understand why private payers are doing more surprise audits of how labs are billing patients and collecting balances owed
  • Discover why many labs continue to struggle with basic compliance and why poor due diligence has consequences with buyers, investors, and regulators
  • Identify the legal and compliance risks in the use of third-party marketing and sales reps
  • Know your risks for improper or inappropriate compliance
  • Learn why CLIA officials continue to take tough enforcement action in cases of inadvertent proficiency testing referrals and how your lab should respond in such cases
  • Hear about the risks and legal exposure triggered by new lab referral and billing arrangements that often include a hospital as the in-network provider that bills payers for outreach lab tests
  • Relate the action steps your lab team should take to ensure that your lab’s list prices for tests are appropriate for successful balance-billing of patients
  • Learn how federal and state lab regulators are issuing rules that increase the personal liability of CLIA lab medical directors and lab managers, plus much more!


Jeffrey J. Sherrin, President and Partner, O’Connell & Aronowitz, Albany, NY.

Sherrin is the President of O’Connell & Aronowitz, in Albany, New York. In his national health law practice, he has represented clinical laboratories throughout the country for approximately 35 years. His representation includes litigation and administrative proceedings against the federal and state governments and commercial payors on behalf of laboratories and other providers, handling fraud and abuse, false claims and overpayment claims, investigations and audits. He actively represents providers in all types of regulatory compliance matters, particularly with federal Antikickback Statute and Stark law, and their state law counterparts. Jeffrey also guides clients through the labyrinth of laws affecting their business transactions.

He practices in all federal and state courts, and has successfully represented health care clients in two appeals before the U.S. Supreme Court and serves as general counsel to many providers and their trade associations.

Sherrin obtained a $15.4 million jury verdict for an individual plaintiff in a sexual harassment trial. He also recovered $18 million and $5 million from the State of New York for excessive license fees, in two separate lawsuits representing groups of clinical laboratories, and over $8 million for an individual clinical laboratory from a major health insurance company for wrongful denial of claims. He has also defended laboratories in federal qui tam actions.

David W. Gee, Partner, Davis Wright Tremaine, LLP, Seattle, WA.

Gee has 25 years of experience advising clinical and molecular diagnostic laboratories nationwide, including 12 years of experience as in-house counsel for three of the nation’s largest clinical labs. Gee’s responsibilities include counseling labs and other healthcare clients on a wide range of matters, including compliance with fraud and abuse laws, Medicare and Medicaid reimbursement, HIPAA compliance and preparedness, CLIA certification and compliance, business operations and transactions, corporate governance, managed care contracting, patient rights, and quality assurance.

Graduating magna cum laude from Brigham Young University, J. Reuben Clark Law School, where he was articles editor of the Law review and a member of the Order of the Coif, Gee formerly served as a law clerk for Associate Chief Justice I. Daniel Stewart of the Utah Supreme Court. He is a member of the Washington and California Bar Associations. He regularly speaks and writes on legal and regulatory issues facing the clinical laboratory industry.

Gee has advised many laboratory clients concerning the FDA’s evolving stance on regulation of Laboratory Developed Tests (LDTs), including the FDA’s most recent Draft Guidance and Framework for Regulatory Oversight, and how these proposed new requirements will likely affect their laboratory operations.

Richard S. Cooper, Chair, National Healthcare Practice Group, McDonald Hopkins, LLC, Cleveland, OH.

Cooper is the Manager of McDonald Hopkins’ National Healthcare Practice Group and is co-chair of its Healthcare Restructuring Practice Group. Cooper served on the firm’s Board of Directors from 1992-2012. He focuses his national practice in healthcare law, representing clients in transactional, restructuring, corporate compliance, regulatory, licensure, reimbursement, contractual, strategic planning, and venture matters. Practice group clients include private practice and academic physician groups, physician networks, laboratories, healthcare associations and societies, multi-specialty clinics, medical staffs, imaging centers, surgery centers, outpatient medical facilities, home health providers, hospitals and health systems (including tax-exempt and investor owned hospitals, critical access to large systems and academic medical centers), mental health/substance abuse facilities, occupational medicine companies, healthcare technology companies, healthcare billing and management companies, and healthcare funds.

Cooper has a national practice in the representation of laboratories and pathology groups. McDonald Hopkins represents in excess of 500 pathology groups and several hundred laboratories, including anatomic, clinical, molecular/genetic, toxicology, and specialty laboratories. He’s a frequent speaker on laboratory and pathology issues at state and national conferences and is a frequent contributor to laboratory and pathology publications. Cooper has been listed in The Best Lawyers in America for Health Law for 23 consecutive years and was named as one of the Top 100 Lawyers in Ohio in 2015. He has been selected for inclusion in Ohio Super Lawyers from 2005–2014.