While some targets of state and federal government investigations and audits have made mistakes, many have not. We help health care providers and pharmacies defend themselves and resolve fraud, waste, and abuse complaints in both sets of circumstances. We also counsel our clients to look beyond obvious potential outcomes and explore alternative legal and business solutions that they can use to move forward.
Representation for Health Care Providers and Pharmacies in Government Investigations, Audits, and Related Matters
Our attorneys represent health care providers and pharmacies in investigations and audits conducted by government authorities, including the U.S. Department of Justice (DOJ), the U.S. Drug Enforcement Administration (DEA), the U.S. Department of Health and Human Services Office of Inspector General (DHHS OIG), Medicaid Fraud Control Units (MFCUs), and the Virginia Department of Medical Assistance Services (DMAS). During these investigations and audits, we directly engage with agents and prosecutors to understand the allegations against our clients and begin working toward favorable outcomes.
Health care investigations and audits commonly involve allegations of:
- Anti-Kickback Statute and Stark Law (“self-referral”) violations
- Controlled Substances Act (CSA) violations
- False Claims Act violations
- Federal health care program (FHP) fraud
- Health Insurance Portability and Accountability Act (HIPAA) violations
- Licensing and other regulatory violations
- Medicare and Medicaid fraud
The ideal approach to an investigation or audit depends on the factual and legal issues involved, and we understand that not all of our clients have the same goals. Further, it is often advantageous to pursue competing goals. For example, while it might be a good strategy to vigorously dispute an agency’s allegations in one case, it might make sense to focus on getting back into the agency’s good graces at the same time.
Often, health care providers and pharmacies facing investigations and audits do not have time to waste. Unnecessary delays can lead to unnecessary consequences. On-site inspections can become detrimental if not handled carefully, and responding to subpoenas and other requests for information is a time- and resource-intensive process.
When we have the chance to do so, we work with our clients on-site to help them prepare. We also conduct compliance audits and mock inspections.
From developing updated compliance programs to drafting purchase and sale agreements, we help our clients move on from government inquiries. We provide our clients with a clear understanding of their options and responsibilities, and we give them the insight they need to make informed and strategic business decisions.