The False Claims Act and Medical Necessity: Recent Cases Involving Clinical Labs and Drug Testing

The federal government continues to pursue physician offices and independent clinical laboratories (and the individuals associated with them) for troublesome patterns of medically unnecessary drug testing. The federal government—which has the option of filing cases it originates or which originate through “whistleblowers”—often bases false claim allegations on patterns of conduct showing deliberate ignorance or reckless disregard of applicable licensing board rules and professional standards for, and departures from, payer coverage and reimbursement policies governing drug testing. False Claims Act (FCA) cases may also involve allegations of inappropriate physician compensation schemes and other forms of inducement/kickbacks to gain test volume. Documentation of testing protocols, decisions, and use of test results is central to proving these cases. This course will examine common allegations and theories the government uses in FCA litigation. Attendees will learn the difference between an FCA and an overpayment matter and will be able to identify problematic conduct typically exposed in FCA cases. The overall goal of the course is to provide attendees with a framework by which they can evaluate their own testing patterns and processes in light of the lessons learned from a closer look at these false claims cases.

Learning Objectives

  • Examine the basic legal framework of a False Claims Act Case, including Whistleblower (Qui Tam) Case
  • Examine the difference between an FCA and an overpayment matter
  • Identify problematic conduct typically exposed in FCA cases and the theories used by the Government when it brings or intervenes in these cases
  • Use course information to facilitate the evaluation of physician and qualified healthcare practitioner business arrangements with clinical laboratories, including POLs, and drug testing patterns and processes; Evaluate the importance of proper test orders, documentation of testing rationale, and use of test reports

Additional Information

AttachmentSize
PDF icon Slides and Disclosures12.52 MB
Course summary
Available credit: 
  • 1.00 AAFP
  • 1.00 AANP
  • 1.00 ACCME (All Other)
  • 1.00 ACCME (MD/DO Only)
  • 1.00 ACPE Pharmacy
  • 1.00 ANCC
  • 1.00 APA
Course opens: 
06/01/2021
Course expires: 
06/01/2022
Rating: 
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Jen Bolen, JD

Founder
Legal Side of Pain
Knoxville

Available Credit

  • 1.00 AAFP
  • 1.00 AANP
  • 1.00 ACCME (All Other)
  • 1.00 ACCME (MD/DO Only)
  • 1.00 ACPE Pharmacy
  • 1.00 ANCC
  • 1.00 APA
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Required Hardware/software

A computer with an internet connection
Internet Browser: Internet Explorer 7.x or higher, Firefox 4.x or higher, Safari 2.x or higher, or any other W3C standards compliant browser
Other additional software may be required such as PowerPoint or Adobe Acrobat Reader.