Fraud & Abuse Matters
In recent years, all participants in the drug, device, and healthcare fields have been under intense federal and state scrutiny for possible fraud and abuse. Given current governmental budgetary and oversight pressures, the number of investigations and prosecutions for violations of fraud and abuse laws—including False Claims Act cases at both the federal and state level—will only continue to increase. Our experience in counseling companies on federal and state fraud and abuse laws extends back for decades, and we are a well-recognized leader in helping pharmaceutical, medical device, and healthcare companies respond to fraud and abuse investigations and False Claims Act matters. We have been involved in some of the most high-profile civil and criminal fraud and abuse and false claims cases, and our litigators are well schooled in the latest theories of claimants and prosecutors.
Our practice routinely advises drug, biotech, device, and healthcare companies on the full range of issues arising under the Medicare/Medicaid Anti-Kickback Act, the False Claims Act, and other federal and state fraud and abuse laws. We also assist our clients in formulating compliance strategies, performing self-evaluative audits, designing compliance and corrective action plans, and mitigating liability-where appropriate-through self-reporting. Every day, we help clients to structure commercial agreements to avoid violation of the Anti-Kickback Act and other fraud and abuse constraints, including with regard to the safe harbors for discounts, personal services, and group purchasing organizations, and we often develop written policies for clients in connection with sales, marketing, and pricing strategies. An integral part of our fraud and abuse work involves developing offensive and defensive strategies relating to the Centers for Medicare and Medicaid Services (CMS), the Department of Veterans Affairs (VA), the Department of Health and Human Services, and the VA Offices of the Inspector General (OIG). Several of our partners have held high-ranking positions in these agencies.
We provide assistance in following areas as follow:
- False Claims Act
- Federal and State self-referral laws, including the federal Stark law
- Federal and State Anti-Kickback laws
- Health Care Fraud