Healthcare continues to be one of the most challenging areas of business due to increasing government regulation and enforcement. Our lawyers are particularly well qualified to assist clients in managing the risks of doing business in this environment.
Dechert lawyers regularly represent healthcare companies in a broad range of matters involving allegations of healthcare “fraud and abuse.” These matters include federal and state government investigations and inquiries, civil and administrative enforcement proceedings, such as actions under the Federal False Claims Acts and state counterparts and related consumer fraud, deceptive practices and class actions cases brought by state Attorneys General or private plaintiffs. Our clients include pharmaceutical companies, medical device and equipment companies, clinical laboratories, hospitals, nursing homes and long-term care facilities, as well as individual officers and employees of such companies. We represent them in matters that involve alleged violations of the Medicare/Medicaid anti-kickback statute, the Food, Drug, and Cosmetic Act, the federal False Claims Act and state counterparts, the Stark Law, good manufacturing practices regulations, laws and regulations governing federal and state price reporting and state consumer fraud and deceptive practices statutes. Among the issues we address in these matters are marketing, sales and promotional practices, including off-label promotion, physician remuneration, physician entertainment, research and educational grants, clinical research fraud and continuing medical education; government billing and price reporting under Medicare, Medicaid and other government healthcare programs, specifically including the Medicaid Drug Rebate Program and the Section 340B program under the Public Health Services Act; and compliance with good manufacturing practices regulations in the manufacture of FDA-regulated products.
Increasingly, healthcare companies under government investigation must deal simultaneously with a criminal grand jury investigation, a related civil investigation or ongoing civil litigation by the government, a congressional inquiry and private civil litigation. Such situations require careful management of these parallel proceedings to ensure the best outcome for the client. Our lawyers bring extensive experience in handling the sometimes competing and conflicting interests that arise in these matters and achieving favorable results for our clients. Our team includes several former federal prosecutors and government lawyers who have valuable experience and insights into the investigation and prosecution of these matters. We have successfully resolved criminal investigations with no criminal charges against our clients. We have also successfully litigated cases brought under the qui tam provisions of the False Claims Act.
Some of the most valuable services we provide to clients occur outside the litigation context where the Dechert team regularly advises healthcare clients on fraud and abuse and other regulatory issues, including risk assessments, in order to avoid situations that might lead to government investigations or other litigation. We have also designed compliance programs for healthcare clients and worked with them to implement and improve such programs. As part of our work in this area, we have negotiated Corporate Integrity Agreements with HHS-OIG and assisted clients with fulfilling their obligations under such agreements.