Morgan Lewis offers sophisticated, integrated, and cost-effective counsel to a wide spectrum of clients within the healthcare industry, including service providers, physician practices, medical equipment suppliers, health insurers, medical societies, and private equity firms. We advise clients on litigation and dispute resolution; business transactions and joint ventures; US federal, state, and local regulation; coverage and reimbursement; fraud and abuse; and compliance. We also represent healthcare clients in intellectual property, antitrust, real estate, and labor and employment matters, and we guide and advocate for our clients in the public policy arena.
Our team includes some of the most respected healthcare law practitioners in the United States, with experience working in the federal government (Centers for Medicare and Medicaid Service, Office of the Inspector General, and US Department of Justice), industry, and academia. Leveraging our lawyers’ knowledge of the inner workings of the government’s executive branch, as well as the regulatory agencies most critical to healthcare businesses, we bring insight and sophistication to the complex challenges and opportunities that our healthcare industry clients confront in a constantly evolving marketplace.
We also have pioneered a number of cost-effective delivery systems for our services by using, where appropriate, non-legal professionals and creative billing structures to maximize both quality and value for our clients.
After litigating matters for healthcare clients for more than a quarter century, Morgan Lewis offers the combination of trial experience, intimate knowledge of the US healthcare industry, and the legal prowess required to resolve lawsuits and government investigations to the greatest possible advantage of our clients. Our experience includes payment disputes; disputes relating to the development, production, sale, marketing, and distribution of pharmaceuticals, biopharmaceuticals, medical services, and products; and disputes arising from US healthcare reform legislation and its implementation at the federal and state levels.
Our lawyers have achieved success handling litigation and dispute resolution for clients in all facets of the healthcare delivery system, including managed care companies and insurers, hospitals and health systems, long-term care and post-acute care providers, pharmacies, and other healthcare providers. Our capabilities in False Claims Act (including qui tam matters), Anti-Kickback Statute, and physician self-referral (Stark Law) investigations and litigation are nationally recognized by Chambers USA. Our defense team includes former criminal and civil fraud prosecutors, as well as former senior attorneys for the Office of Inspector General (OIG) of the US Department of Health and Human Services (HHS).
We regularly handle million- to multimillion-dollar mergers, acquisitions, investments, and other transactions in the healthcare space. Our experience includes business acquisitions and divestitures, negotiated business combinations by public and private companies, tender offers (friendly and hostile), proxy contests, restructurings, leveraged buyouts, and going-private transactions.
Our healthcare sector transactional clients are healthcare enterprises, insurers, private equity firms, investment banks, venture capital firms, institutional lenders, independent directors committees, and management groups. We also advise on healthcare joint venture transactions and service agreements between and among healthcare providers. This includes a sophisticated consideration of the applicable US regulatory, fraud and abuse, and tax law implications.
Morgan Lewis lawyers possess a command of data privacy and security issues as they specifically apply to the US healthcare industry. We advise healthcare clients and employers on privacy and security compliance matters at the federal and state levels, including those related to the Health Insurance Portability and Accountability Act (HIPAA) and the Gramm-Leach-Bliley Act. We develop privacy and data security policies and procedures, structure healthcare information technology ventures, and respond to security breaches on behalf of our clients.
Our team counsels clients on operations such as recruitment, marketing, web and new media usage, and data transmissions to state and federal healthcare agencies. We help train employees on the disclosure of information and monitor ongoing compliance.
Our background and experience with privacy and security laws and regulations enable us to provide prompt, bottom line–driven solutions in this complex and fast-moving area of the law. Our lawyers understand the privacy and security laws affecting healthcare provider operations, from HIPAA and the Health Information Technology for Economic and Clinical Health (HITECH) Act to state security breach notification laws, Federal Trade Commission (FTC) privacy and security standards, state medical privacy laws, general state security obligations, and the Red Flags Rule, as well as international privacy rules.
The Morgan Lewis healthcare team assists clients as they monitor, influence, and interpret US congressional legislation, federal rules and regulations, and other policies issued by the executive branch. Many of our lawyers served in government healthcare oversight agencies, and this experience offers our clients astute analysis of rapidly evolving developments and timely guidance on matters critical to their businesses.
Morgan Lewis provides compliance guidance; fraud and abuse counseling, including corporate integrity agreement negotiation and implementation; and corporate defense in government investigations and proceedings for clients such as:
The lawyers and professionals on our compliance and fraud and abuse team—including lawyers formerly with HHS-OIG and compliance professionals—represent healthcare industry clients every day in compliance and enforcement matters. We also regularly provide government self-disclosure advice involving Medicare and Medicaid programs, the False Claims Act, the Anti-Kickback Statute, Stark Law, and excluded persons.
Our antitrust experience in the healthcare industry includes FTC investigations of Hatch-Waxman Act settlements, antitrust counterclaims arising from patent infringement suits, multidistrict class actions alleging horizontal conspiracies, Robinson-Patman Act price discrimination claims, and antitrust challenges to intellectual property licenses and standard-setting activities. We defend mergers and acquisitions before antitrust authorities that include the US Department of Justice (DOJ), the FTC, the European Commission, and other non-US competition authority agencies.