For more than 25 years, Laura Laemmle-Weidenfeld has successfully defended a broad spectrum of health care providers, digital health entities, distributors, and pharmaceutical and medical device manufacturers against health care fraud enforcement actions brought by the U.S. Department of Justice (DOJ), U.S. Attorney’s Offices, private whistleblowers, the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), and state attorneys general. Earlier in her career, she led health care False Claims Act (FCA) investigations and litigation, including those brought under the FCA’s qui tam (whistleblower) provisions, at the DOJ’s Civil Division.
Laura also draws on her enforcement experience to provide clients with practical regulatory advice regarding compliance with federal and state health care fraud and abuse law, particularly under the federal Physician Self-Referral Law (Stark Law), Anti-Kickback Statute (AKS), and FCA, and their state analogs. In addition, Laura helps clients conduct internal investigations, prepare and negotiate self-disclosures to regulators including HHS-OIG and the Centers for Medicare and Medicaid Services (CMS), and obtain advisory opinions from HHS-OIG. She also helps clients negotiate corporate integrity agreements (CIAs) with HHS-OIG and counsels clients on creating and maintaining effective compliance programs.
