Healthcare Regulatory Compliance

Healthcare organizations understand all too well the substantial risk of non-compliance with state and federal laws relating to fraud and abuse. Failure to comply can impede the pursuit of business goals and threaten the existence of the enterprise itself. The importance of remaining in compliance with these laws has been reinforced by a recent court decision in which Tuomey Healthcare System was ordered to pay over $230 million in fines as a result of violations of the Stark Law and the False Claims Act.

To avoid violations of these and similar laws, including the Anti-Kickback Statute (AKS), relationships between providers, referral sources and other parties must be carefully structured to fit within available exceptions and safe harbors. At Troutman Sanders, we help clients analyze their business models and the complex requirements of relevant laws so that they may ultimately achieve their business objectives.

Our services include:

  • Helping clients assess whether a particular issue presents a problem under the fraud and abuse laws and, if so, assisting the client in developing an effective strategy for ensuring compliance;
  • Advising clients on mitigation of confirmed compliance matters, and determining whether a matter requires voluntary self disclosure;
  • Advising clients on the fraud and abuse implications of business relationships, activities and transactions;
  • Responding to allegations of fraud and abuse, and conducting internal investigations related to such allegations;
  • Defending fraud and abuse claims brought by the government or by whistleblowers under the qui tam provisions of the federal False Claims Act; and
  • Helping clients update their corporate compliance plans.

  • Advising a multi-specialty ambulatory surgery center on the structure of its syndication in compliance with the multi-specialty Stark exception and AKS safe harbor.
  • Designing an electronic health records (EHR) donation program for a multi-campus hospital system that complied with the EHR donation Stark exception and AKS safe harbor.
  • Advising an enterprise health information exchange on its ability to donate interfaces pursuant to the community-wide health information exchange Stark exception.
  • Serving as statewide counsel for large groups of hospitals that were part of a national enforcement action by the U.S. Department of Justice for clinical lab unbundling and diagnosis-related group (DRG) upcoding cases.
  • Representing a large multi-state Medicare supplier in a qui tam case alleging overbilling, provision of unnecessary supplies and fraudulent documentation.