Compliance Considerations for Clinical Laboratories

Cardinal Health Lab Briefings webinar series

This webinar is presented by Elizabeth Sullivan, Attorney at McDonald Hopkins LLC.


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.



Upon completion of this continuing education activity, the participant should be able to:

  • 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.


Intended audience

This continuing education credit is intended for use by clinical laboratory professionals who are interested in learning more about compliance requirements for clinical laboratories.  

P.A.C.E.® credits are widely recognized in the clinical laboratory profession and can be used to fulfill most continuing education requirements. 


Take the course and obtain CE credits

Attend this basic level webinars at no cost. This webinar is managed by Whitehat Communications and offer one P.A.C.E.® Continuing Education contact hour1 for up to six months after the live event.

One P.A.C.E® credit is available upon completion of the course: Compliance Considerations for Clinical Laboratories.

P.A.C.E.® credits are widely recognized in the clinical laboratory profession and can be used to fulfill most continuing education requirements.

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