Avoid Common Investigation-Related Compliance Mistakes

In our discussions with health care lawyers Gina L. Simms and Robert E. Mazer for their Perspectives on the government’s fraud enforcement initiatives (see pages 5-8), they revealed some compliance do’s and don’ts that laboratory compliance officers should heed.

To be proactive and avoid becoming the subject of a government investigation of any size, Mazer recommends that laboratory compliance officers should be asking: “Do the arrangements that [the laboratory] currently has with clients, e.g., physician practice groups, comply with Stark and the Anti-Kickback Statute? How recently have these arrangements been scrutinized by counsel?” Mazer explains, “I have found that, over time, sometimes these arrangements start out compliant, but out in the field, get ‘morphed’ so that they no longer reflect the business arrangements that were carefully put together to satisfy applicable legal and regulatory requirements.” “Compliance is an ongoing activity,” he advises.

If the government does target your laboratory for investigation, make sure you respond appropriately. We asked Simms, a former federal prosecutor, what mistakes providers commonly make when faced with an investigation. Simms indicated common missteps include “not responding quickly enough to a subpoena or government inquiry,” and “failing to view the government’s subpoena as a possible red flag that further internal investigation into certain practices might be warranted.” She also notes that providers sometimes “fail to preserve all relevant and responsive documents.” Furthermore, she says that she has seen, on some occasions, that “after a government subpoena is issued, a company’s employees start communicating openly in emails about the conduct under investigation by the government, sometimes with the view of trying to make sure that everyone ‘gets their stories straight’ on what exactly happened.” This is problematic for many reasons, one of which is that colluding or conspiring to create a version of what happened is what prosecutors call lying or obstructing an investigation.