PRESS RELEASE: Fines, decreased reimbursements, and more frequent payer audits await those clinical labs and pathology groups not prepared for tougher legal and regulatory changes starting January 1, 2018



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Media Contact: Chris Garcia


AUSTIN, Texas (November 2, 2017)—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.

“Looking forward into 2018, Medicare Part B clinical laboratory price cuts are not the only big story. Other significant threats can upend a lab’s business,” said Robert L. Michel, Editor-In-Chief of The Dark Report. “Those threats include issues 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,” Michel continued. As the new year fast approaches, these are reasons why 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.”

To keep labs 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,” taking place Wednesday, November 8, 2017 at 1 PM EST.

On board for the webinar will be 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: Jeffery Sherrin, President and Partner with O’Connell & Aronowitz in Albany, NY; David Gee, Partner with Davis Wright Tremaine, LLP in Seattle, WA; and Richard Cooper, Chair of National Healthcare Practice Group at McDonald Hopkins in Cleveland, OH.

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

  • Why private payers are doing more surprise audits of how labs are billing patients and collecting balances owed
  • Why many labs continue to struggle with basic compliance and the consequences of poor due diligence with buyers, investors, and regulators
  • The legal and compliance risks in the use of third-party marketing and sales reps
  • Risks for improper or inappropriate compliance
  • Why CLIA officials continue to take tough enforcement action in cases of inadvertent proficiency testing referrals and how labs should respond in such cases
  • 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
  • Action steps that lab teams should take to ensure that list prices for tests are appropriate for successful balance-billing of patients
  • How federal and state lab regulators are issuing rules that increase the personal liability of CLIA lab medical directors and lab managers

At the end of the speakers’ presentations there will be a Q&A period, during which labs will be able to submit their own specific questions to the experts, a segment of the webinar that represents particularly high value for labs. For more information about “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,” and to view webinar details including presenter biographies and pricing, click here. You may also contact Chris Garcia at 512-264-7103.


Established in 1995, THE DARK REPORT is the leading source of exclusive business intelligence for laboratory CEOs, COOs, CFOs, Pathologists and Senior industry executives. It is widely read by leaders in laboratory medicine and diagnostics. The Dark Report produces the famous Executive War College on Laboratory and Pathology Management every spring, which showcases innovations by the nation’s and globe’s leading laboratory organizations. Dark Daily is an Internet-based e-briefing intelligence service, read worldwide by thought leaders in laboratory and pathology management. Other well-known conferences conducted by THE DARK REPORT are Lab Quality Confab (on the use of Lean and Six Sigma methods in labs and hospitals) and Molecular Summit (on the integration of in vivo and in vitro diagnostics). THE DARK REPORT co-produces Frontiers in Laboratory Medicine annually in the United Kingdom; Executive Edge bi-annually in Canada; and The Business of Pathology bi-annually in Australia.