Healthcare industry participants, including pharmaceutical and medical device manufacturers, biotechnology companies, and healthcare providers, often face government inquiries concerning their marketing, pricing, and manufacturing practices. Bates White’s industry experts, empiricists, and experienced economists provide analysis and strategic guidance to advise these companies in responding to confidential government and internal investigations in criminal, civil, and regulatory enforcement matters often stemming from alleged Anti-Kickback Statute or False Claims Act (FCA) violations.
Our professionals perform empirical analyses and offer industry knowledge that helps arm clients with the information they need to navigate and resolve investigations brought by federal and state enforcement agencies. We often leverage our extensive experience working with large, complex data sets, including Medicare and Medicaid claims data, pharmaceutical sales data, and marketing data, to perform economic and empirical analyses that shed light on potential liability, causation, and damages. Representative matters include:
- Served as lead consulting expert for a major drug manufacturer throughout a multiyear government investigation spanning several products and qui tam allegations. Provided consulting expertise on liability, causation, and damages. Allegations included off-label promotion, violations of the Anti-Kickback Statute, and violations of federal and state FCA laws. Analyzed hundreds of millions of claim records submitted to Medicare and state Medicaid programs. Also analyzed the manufacturer’s pricing patterns and medical providers’ prescription and drug administration patterns. Worked closely with counsel for several years throughout various phases of government investigations and litigation. Participated in settlement discussions with the government.
- Serving as lead consulting expert for a medical device manufacturer facing a government investigation regarding allegations of FCA violations for several products. Providing consulting expertise on liability, causation, and damages. Utilizing several large data sets pertaining to the products at issue and their clinical use to perform statistical and empirical analyses of the allegations. Assisting counsel in discussions with the government.
- Serving as lead consulting expert for a medical device manufacturer facing a government investigation regarding allegations of alleged kickbacks and medically unnecessary services. Analyzing several large data sets relating to the sales and pricing of certain products as well as the frequency of certain services.
- Serving as lead consulting expert for a pharmaceutical company facing an investigation relating to alleged off-label promotion. Evaluating causation and damages using several large data sets pertaining to the sales and reimbursement of products at issue.
- Serving as lead consulting expert for a large provider of in-home healthcare services. Analyzing several large internal compliance-related data sets to gather insights on issues relating to potential FCA violations.