In the last several months, we have witnessed an uptick in government investigations of laboratories and other providers (audits and Civil Investigative Demands alleging violation of the False Claims Act (“FCA”)) related to the billing of the HRSA Uninsured Program for COVID-19 testing, treatment and vaccine administration (the “Program”). In light of this trend, providers may consider, with the advice of legal counsel, internally auditing their records to verify compliance with the terms and conditions governing the Program and other applicable legal requirements. Audits should seek to determine whether a provider has received an overpayment under the Program and evaluate appropriate remedial measures to address audit findings, which may include refunding the overpayment directly to the Program, pursuant to applicable Program rules, or the Office of the Inspector General – Department of Health and Human Services (“OIG”) through the OIG Self-Disclosure Program. Providers should note that acceptance into the OIG Self-Disclosure Program does not avail the provider of a release of claims under the FCA, but if a Provider is able to secure a release from the Civil Monetary Penalties Law through self-disclosing, it has been our experience that the U.S. Department of Justice does not routinely threaten or file an FCA action against the self-disclosing provider arising from the self-disclosed conduct. As such, voluntarily refunding/self-disclosing the overpayment may be a way to mitigate a provider’s risk of governmental investigations/actions.
Mandelbaum Barrett PC’s healthcare compliance and governmental investigation and prosecution defense team includes former federal and state prosecutors, including a former Chief of the Health Care & Government Fraud Unit at the U.S. Attorney’s Office for the District of New Jersey (starting in March 2023), a former assistant United States Attorney and Special Counsel to the U.S. Attorney in the District of New Jersey, a former Bureau Chief of the New Jersey Medicaid Fraud Control Unit in the Office of the Insurance Fraud Prosecutor, New Jersey Office of the Attorney General, a former Deputy Attorney General of the New Jersey Office of Attorney General, Professional Boards Prosecutions section, as well as former counselling Deputies Attorney General of the New Jersey Office of Attorney General, healthcare regulatory counsels who specialize in healthcare fraud and abuse laws applicable to pharmacies, laboratories, medical/dental practices, and other healthcare providers/entities and healthcare litigation attorneys.