Morgan Lewis combines its demonstrated litigation and healthcare regulatory experience to resolve and defend its healthcare industry clients’ most difficult litigation, regulatory, and government enforcement matters. Ranked the largest US healthcare law firm by Modern Healthcare (2016–2018), our team includes some of the nation’s most respected healthcare law practitioners, with experience spanning government, industry, and academia. We understand the complexity of our clients’ legal and operational challenges in this rapidly evolving industry, and have pioneered a number of cost-effective delivery systems for our legal services to maximize quality and value.
Morgan Lewis has litigated healthcare matters for more than a quarter century, offering the trial experience, industry knowledge, and legal prowess required to resolve lawsuits and government investigations to our clients’ greatest possible advantage.
We represent the full range of healthcare providers and suppliers, including:
Morgan Lewis provides compliance guidance, fraud and abuse counseling, and corporate and individual defense to the full range of healthcare providers and suppliers. Many of our lawyers represent healthcare industry clients in compliance and enforcement matters every day. Those who previously served as government lawyers and officials—including at the US Department of Justice and the Office of Inspector General of the US Department of Health and Human Services—bring added value to clients confronting compliance program assessments, corporate integrity agreements, and oversight by independent or government monitors. We also regularly provide government self-disclosure advice involving Medicare and Medicaid; the False Claims Act, Anti-Kickback Statute, and Stark Law; and excluded persons, as well as audit response and appeal assistance related to Medicare and Medicaid program audits.
Our experience with regulations and subregulatory guidance from the Centers for Medicare and Medicaid Services, including local coverage decisions and national coverage determinations, gives our clients a critical advantage in coverage and payment matters arising under Medicare, Medicaid, and other federal healthcare programs. We also advise and defend clients in audits and investigations—by Medicare, Medicaid, and their growing number of regional contractors—related to alleged fraud and abuse in billing and coding practices.
On Medicare reimbursement appeals, we represent clients at the redetermination and reconsideration stages before administrative law judges, the Medicare Appeals Council, and in US federal courts. We also represent Part A providers before the Provider Reimbursement Review Board and assist with respect to appeals at the US state level on a variety of Medicaid reimbursement issues.
Our lawyers advise healthcare clients across all areas of US Food and Drug Administration (FDA), US Drug Enforcement Agency (DEA), and state regulation impacting providers and practitioners, including regulatory requirements for blood and blood products, human cell and tissue products, clinical trials, hospital developed technologies, digital health, laboratory developed tests, medical device reporting, drug distribution and dispensing, pharmacy compounding and outsourcing facilities, and e-prescribing, as well as controlled substance purchasing, handling, security, and dispensing. We also advise clients in responding to inspections and other inquiries by the DEA, FDA, and state regulators, including state boards of pharmacy.
The Morgan Lewis healthcare team assists clients in the public policy sphere to interpret, monitor, and influence 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 allows us to offer clients astute analysis of rapidly evolving developments and timely guidance on matters critical to their businesses.
Our healthcare litigators have the trial experience, healthcare sector knowledge, and legal acumen required to resolve lawsuits and government investigations with the best possible outcomes for our clients, which include providers, suppliers, payors, and manufacturers. Our experience includes representing clients in payment disputes and actions related to the development, production, sale, and distribution of medical services, pharmaceutical products, and biologics.
Our lawyers handle litigation for clients operating across all facets of the healthcare delivery system—including managed care companies and insurers, hospitals and health systems, long-term and post–acute care facilities, and other healthcare providers, as well as specialty and retail pharmacies and pharmaceutical and medical device manufacturers. We assist at every stage of investigations and litigation—from responding to grand jury subpoenas through advocating for clients at trials and appeals. We routinely manage government investigations and parallel civil and criminal proceedings, including False Claims Act actions and negotiation and implementation of corporate integrity agreements. Our capabilities in US False Claims Act (including qui tam matters) and Anti-Kickback Statute and Stark Law investigations and litigation have been recognized by Chambers USA, and our team includes former criminal and civil fraud prosecutors as well as former senior lawyers from the Office of Inspector General of the US Department of Health and Human Services and the Centers for Medicare and Medicaid Services.
Morgan Lewis lawyers advise clients across virtually all healthcare sectors on privacy and security compliance matters, including those related to the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health (HITECH) Act, the Gramm-Leach-Bliley Act, state security breach notification laws, US Federal Trade Commission privacy and security standards, state medical privacy laws, and the Red Flags Rule, as well as international privacy rules.
In addition, we advise on developing privacy and data security policies and procedures, structuring healthcare information technology ventures, responding to security breaches, and handling data transmissions to state and federal healthcare agencies. We negotiate, and when called for, litigate data breach civil penalties imposed by the US Department of Health and Human Service’s Office of Civil Rights. We also help train employees on the disclosure of information and ongoing compliance monitoring.
We assist clients with interpreting, monitoring, and influencing privacy and data security rules and regulations, congressional legislation, and other policies issued by the executive branch. Clients benefit from the government healthcare agency background of a number of our lawyers, which translates into insightful analysis and opportune guidance on matters critical to our clients’ businesses.