Department of Health & Human Services (HHS)

Within the rapidly evolving regulatory landscape, leading life science and healthcare companies face a complex landscape of intricate regulations and government agencies (including the Department of Health & Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), the Food & Drug Administration (FDA), and Department of Justice (DOJ)) regarding the development, delivery, and marketing of products and services. Latham’s Healthcare Regulatory Practice draws on experience within both the public and private sectors to provide comprehensive litigation, regulatory, investigational, and transactional counsel, including how to:

• Obtain, in the most efficient and effective way, regulatory approval to market new pharmaceutical products, biotechnology, and medical devices
• Develop a reimbursement pathway to obtain timely and sufficient coverage, coding, and payment for new products and technology
• Build out an effective compliance program to ensure a company’s commercial strategy is consistent with the complex fraud and abuse landscape
• Respond to an investigation involving the False Claims Act, off-label promotion, or government healthcare program policies
• Litigate against the government
• Ensure compliance with healthcare-related data privacy requirements and how to successfully manage all the ramifications of a data breach

When it comes to advising on bet-the-company regulatory strategies for healthcare providers and life sciences companies at every stage of development, Latham’s Healthcare & Life Sciences Practice is well positioned to navigate the agencies and processes that lead to a successful outcome. The group is co-led by a former General Counsel to the HHS and draws on the experience of former senior counsel to the CMS, HHS Office of Inspector General (OIG), and the US House of Representatives Committee on Energy and Commerce. 

Complementing this regulatory experience, Latham lawyers play important roles in the healthcare and life sciences industry, serving, for example, as long-standing outside counsel for the Advanced Medical Technology Association and as outside FDA counsel to the Medical Device Manufacturers Association. The Latham team also includes former senior DOJ officials and experienced jury trial litigators to handle clients’ most complex matters. The team provides you with creative counsel and pragmatic solutions needed to compete in the healthcare and life sciences marketplace, and to defend clients aggressively when disputes with the government arise.