DARK Daily: Compliance with New Federal EKRA Law Creates Uncertainties in How Clinical Laboratories Pay Commissions to Their Sales Teams

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Media Contact: Chris Garcia
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EKRA (The Eliminating Kickbacks in Recovery Act) was passed October 24, 2018 as part of the SUPPORT Act, a combination of more than 70 bills aimed at fighting the current opioid epidemic. EKRA is intended to address patient brokering—in exchange for kickbacks—of individuals with substance abuse disorders.

As written, however, EKRA is far more expansive—with its broad language enabling the federal government to monitor provider arrangements intended to generate business for any laboratory services, not just those related to individuals in treatment for substance abuse disorders, payable by a FHCP or commercial health insurer.

“For sales-driven laboratories who have evolved practices to comply with Anti-Kickback Statute requirements, what are now best practices might soon create major concerns regarding laboratory compliance with EKRA,” stated Marty Barrack, Senior Vice President and General Counsel at XIFIN.

With fines of up to $200,000, 10 years in jail, or both, the new EKRA/SUPPORT Act regulations apply separately from existing AKS regulations. Compliance violations can expose not only the laboratory to prosecution, but also pathologists and others as individuals.

Additionally, noted Barrack, “because this is a criminal statute, some laboratories overlook the fact that felony convictions mean zero payments. This is more than worrying about federal prosecution, it can have a lasting impact on a laboratory’s financials and its reputation. The provisions regarding invoicing will raise concerns with how clinical laboratories bill and write-off co-payments and deductibles in areas previously untouched by AKS requirements.”

Though EKRA’s unprecedented reach may at some point be modified, current consequences are that clinical laboratories—and their compensation to sales and marketing personnel—are being brought under scrutiny, making this webinar: “Are You Ready for EKRA? What You Need to Know Now About How this New Legislation Affects Your Lab,” a must-attend event. Taking place Wednesday, April 24, 2019, at 1 pm EDT, the program is tailored to laboratory owners and C-suite executives; laboratory administrators, directors, and compliance managers; laboratory legal representation, as well as sales and marketing leaders, and is designed to educate lab leaders and their staff on EKRA and other legislative changes, clarify and provide understanding into the laws’ complexities, and help ensure labs stay in compliance and avoid fines and punishment.

Expert presenters are Marty Barrack, Senior Vice President & General Counsel with XIFIN, and Charles C. Dunham IV, Business and Health Care Attorney with Epstein, Becker & Green.

During the 90-minute session, including an interactive Q&A session, webinar participants will:

  • The main provisions of EKRA and its potential impact to labs
  • Steps to take now to conform to best practices and stay compliant
  • Examples of the most common violations that can put labs at risk
  • Why it is important to evaluate compensation arrangements with all referral sources
  • How and why it’s crucial to monitor and audit invoicing and write-off practices
  • Ramifications of payer industry influence on EKRA legislation
  • What labs should know about monetary and non-monetary whistleblowers, and more

Vague language and last-minute additions to the federal SUPPORT Act of 2018 and included EKRA provisions make it imperative for laboratory leadership and staff to get the latest updates on EKRA, an understanding of EKRA as it relates to their compliance programs, and how to best examine lab policies and practices to determine if changes are necessary to adhere to the new law.  For more information about “Are You Ready for EKRA? What You Need to Know Now About How this New Legislation Affects Your Lab,” and to view webinar details, click here.

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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.

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