Litigation and Health Care Teams Examine DOJ’s Enforcement of Anti-Kickback Statute

In an article for Law 360, litigation & enforcement partners Doug Hallward-Driemeier and Laura Hoey, and health care counsel Alison Fethke examined how the federal government’s False Claims Act settlement involving California-based biotech Ultragenyx may punish and deter conduct that benefits patients and poses little risk of fraud and abuse.

“The settlement agreement illustrates a trend in AKS enforcement in which the government seeks to have it both ways by insisting that advisory opinions issued by the U.S. Department of Health and Human Services Office of Inspector General apply only to the parties and facts at issue, while later using that same advisory opinion as a cudgel to impose civil or even criminal liability if an industry participant is out of step with its limited, often ambiguous, guidance,” said the team.  “Rather than embarking on a campaign of regulation through enforcement actions and settlement agreements, the government — namely, the DOJ and HHS OIG — should educate industry participants on practical, reasonable steps they may take to ensure sponsored testing programs can be maintained in a form that continues to benefit patients, providers and sponsors while remaining compliant with fraud and abuse laws.”

Ropes & Gray is ranked Band 1 in the Chambers USA – Nationwide “False Claims Act” table.