Kirstin Scheffler Do represents healthcare and life sciences companies in high-stakes government investigations and litigation involving the False Claims Act (FCA), the Anti-Kickback Statute (AKS), and other allegations of fraudulent conduct.

Kirstin draws on deep regulatory knowledge to advise clients across the healthcare and life sciences (HCLS) industry. Her clients include:

  • Managed care organizations
  • Pharmaceutical companies
  • Medical device manufacturers
  • Hospital systems and other providers
  • Health information technology companies

Kirstin frequently handles FCA investigations brought by the Department of Justice (DOJ) and has represented HCLS industry clients in connection with all phases of government investigations and qui tam litigation involving the FCA.  

Complementing her commercial work, Kirstin maintains an active pro bono practice, particularly in the areas of immigration and wrongful conviction. 

Kirstin served as a judicial clerk to the Honorable Roger W. Titus of the United States District Court for the District of Maryland. 

Kirstin’s experience includes representing:

False Claims Act Defense

  • A healthcare organization in an FCA lawsuit brought by DOJ related to alleged over-coding; secured full dismissal of DOJ’s entire complaint
  • A healthcare organization in an FCA lawsuit challenging a health plan’s gift card health reward program as an alleged kickback; secured full dismissal of qui tam complaint
  • A healthcare organization in a high profile FCA suit brought by DOJ related to alleged improper risk adjustment payments
  • A medical device company in an FCA qui tam suit related to alleged kickbacks paid to physicians
  • A healthcare technology company in an FCA qui tam suit related to alleged kickbacks paid to hospitals 
  • A healthcare organization in multiple FCA investigations by DOJ related to alleged over-diagnosing and over-coding of health conditions
  • A large specialty pharmacy in a successful resolution of the first DOJ FCA suit based on drug adherence program
  • A rehabilitation management services company in negotiating a favorable settlement in an FCA case based on alleged kickbacks

Other Government and Internal Investigations

  • A leading pharmaceutical distributor in a criminal investigation brought by DOJ related to the distribution of controlled substances
  • A large healthcare system in connection with an internal investigation regarding post-acute care compliance issues
  • A nationwide hospital system and healthcare management company in connection with a series of internal investigations of individual and corporate compliance with policies and federal regulations
  • A medical device company in connection with an internal investigation into AKS compliance issues
  • A large healthcare system in connection with an internal investigation regarding compliance of its ambulatory surgery centers

Significant Pro Bono Experience

  • A pro bono client wrongfully convicted of first-degree murder at age fifteen; obtained a new trial
  • Asylum applicants facing political persecution in Rwanda; obtained asylum for both
  • A pro bono client from Guatemala; obtained lawful permanent residence under the Violence Against Women Act 

Bar Qualification

  • Illinois
  • California
  • District of Columbia

Education

  • JD, Harvard Law School, 2008
    cum laude
  • Bachelor of Business, University of Michigan, 2005