Compliance, Investigations & White Collar
We can assist clients in responding to and defending against government investigations of all kinds, including inquiries by the U.S. Department of Justice, Department of Health and Human Services, Office of Inspector General, Centers for Medicare and Medicaid Services, Fiscal Intermediaries, Program Integrity Contractors, U.S. Food and Drug Administration, Medicaid Fraud Control Units, and State Attorney General Offices. These investigations may involve allegations of fraud, improper medical and/or insurance company billing, “off-label” marketing or other drug/device misbranding or adulteration, illegal kickbacks, violations of the Stark self-referral law, HIPAA privacy violations, wrongdoing during clinical research, violations of the Prescription Drug Marketing Act, or other misconduct. Such investigations frequently involve both civil and criminal components, might span multiple years and require the review and production of hundreds of thousands of documents, and can be a financial and reputational drain on a company. Where appropriate, we can assist clients in attempting to resolve these investigations early enough in the process to mitigate these harms, with the aim of achieving a favorable settlement, or even obtaining a finding of no liability. If an early resolution cannot be reached, our experienced attorneys stand ready to litigate.