Morgan Lewis provides sophisticated, integrated, and cost-effective counsel to businesses and organizations across the full spectrum of the healthcare industry. Our healthcare provider clients include hospitals and health systems; long-term care, home health, and hospice providers; retail and specialty pharmacies; behavioral health providers; suppliers; distributors; physician practices; medical societies; and private equity and venture capital investors, as well as the vendors that support these providers.
Our work in privacy and information security—US Health Insurance Portability and Accountability Act (HIPAA)/US Health Information Technology for Economic and Clinical Health (HITECH) Act, and state privacy laws—is acclaimed. Our advisory services cover the range of legal needs sought by participants in the healthcare sector—corporate and commercial finance; joint ventures; real estate matters; corporate governance; federal, state, and local regulation; litigation and dispute resolution; Medicare/Medicaid and commercial insurance reimbursement; US Office of Inspector General (OIG) corporate integrity agreements (CIAs); program integrity administrative proceedings; and other fraud and abuse and compliance counseling. We regularly represent clients in payment disputes; litigation involving federal and state False Claims Act (including qui tam claims), Anti-Kickback Statute, and physician self-referral (Stark Law) matters; antitrust proceedings; intellectual property prosecution and litigation; public policy advocacy; and labor and employment issues.
Our team includes some of the most respected healthcare law practitioners in the United States and a number of former senior US government officials. Leveraging our lawyers’ intimate knowledge of the inner workings of the government’s executive branch, and the regulatory agencies most critical to healthcare businesses, we bring special insight and savvy to the complex challenges and opportunities that our healthcare industry clients confront in the post–healthcare reform era.
Our antitrust healthcare lawyers regularly represent healthcare-related companies and service providers in federal and state investigations, civil litigation, regulatory inquiries, and clearance and completion of mergers, acquisitions, joint ventures, and other alliances. We also counsel on a wide array of antitrust issues, helping our clients to mitigate the potential for litigation and government investigations and to develop compliant strategic plans.
Our clients include hospital systems, physician practices, health insurers, medical trade associations, and medical and equipment suppliers, among others. We represents clients before US federal and state law enforcers such as the Department of Justice’s (DOJ’s) Antitrust Division, the Federal Trade Commission (FTC), state attorneys general, and state insurance departments. Our work on behalf of clients in civil litigation includes defending against single-plaintiff actions brought by competitors and other commercial parties, as well as multidistrict class actions.
Morgan Lewis has served as antitrust counsel on numerous multimillion- and multibillion-dollar hospital mergers and acquisitions, all of which completed without government enforcement action. We also have served as antitrust counsel on many health insurer mergers and acquisitions, including obtaining clearance for a merger-to-monopoly in the sale of health plans on Affordable Care Act exchanges.
Beyond our lawyers’ specialized knowledge and legal acumen in the healthcare and antitrust arenas, clients benefit from the strategic insights of members of our team with prior high-ranking government experience. Our team includes former government prosecutors, including an assistant chief of the Antitrust Division’s Healthcare and Consumer Products Section who oversaw all civil healthcare antitrust work, as well as an FTC general counsel and deputy director at the FTC’s Bureau of Competition.
Morgan Lewis provides compliance guidance, fraud and abuse counseling, and corporate defense in government investigations and proceedings to the full range of healthcare providers and suppliers, including hospitals and health systems; academic medical centers; pharmacies; hospices; specialty, post-acute, and long-term care providers; behavioral health providers; pharmaceutical and medical device manufacturers; health plans; contract research organizations (CROs); medical societies; private equity funds; and physician practices.
Healthcare providers and suppliers with nuclear medicine programs also benefit from our counsel on NRC and Agreement State regulatory issues. We assist clients with licensing and license transfers; regulatory reporting and compliance; security, storage, transport, and waste disposal; nuclear antiretaliation laws and policies (including safety conscious work environment issues); and internal and government investigations and enforcement actions.
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 (DOJ) and OIG, bring added value to clients confronting compliance program assessments, CIAs, and government monitor oversight matters. 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 in addition to audit response and appeal assistance in relation to Medicare and Medicaid program audits.
Our lawyers regularly handle mergers and acquisitions (M&A) and other transactions in the healthcare space, ranging from several million to billions of dollars per transaction. 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. We also advise on a variety of healthcare joint venture transactions and service agreements between and among healthcare providers and payors with sophisticated consideration of applicable regulatory, fraud and abuse, and tax law implications.
Our transactional clients in this sector include a wide range of healthcare enterprises, private equity firms, investment banks, venture capital firms, institutional lenders, independent directors committees, and management groups.
Our experience with regulations and subregulatory guidance from the CMS, including local coverage decisions and national coverage determinations, provides our clients a critical advantage on coverage and payment issues under Medicare, Medicaid, and other federal healthcare programs. We also advise and defend clients on audits and investigations related to alleged fraud and abuse in billing and coding practices by Medicare and Medicaid and their growing number of regional contractors.
On Medicare reimbursement appeals, we represent clients at the redetermination and reconsideration stages before administrative law judges and the Medicare Appeals Council and in federal courts. We also represent Part A providers before the Provider Reimbursement Review Board and with appeals at the 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 the regulatory requirements related to 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, e-prescribing, and controlled substance purchasing, handling, security, and dispensing. We also advise clients in responding to inspections and other inquiries by the DEA, the FDA, and state regulators, including state boards of pharmacy.
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 has a long history of assisting healthcare industry clients in virtually every area of labor and employment law. Our labor relations lawyers assist with union campaigns, corporate campaigns, and representations before government agencies and multiemployer bargaining groups. We have successfully solved novel and difficult labor-management problems, and we advise companies on long-range planning to build strong and effective employee-management relationships.
Our working knowledge of US union organizations is a critical differentiator in our representations of healthcare providers. We counsel on and litigate all matters regarding US Department of Labor compliance, particularly wage and hour issues, leave laws, and Occupational Safety and Health Administration (OSHA) compliance, as well as Equal Employment Opportunity Commission (EEOC) charges and related discrimination matters. Our immigration practice offers I-9 compliance, executive transfer visa programs, global visas, and comprehensive immigration strategic planning.
Morgan Lewis also has played a leading role in shaping public policy regarding healthcare industry employment and labor issues. For example, we represented employer coalitions during rulemaking on healthcare reform laws enacted in 2010, and in amicus briefs in Specialty Healthcare & Rehabilitation Center of Mobile, we negotiated this important US National Labor Relations Board case dealing with bargaining units in non-acute care facilities. Additionally, our workforce change practice provides strategic advice and counseling on important structural issues such as layoffs, restructurings, spin-offs, and acquisitions.
Morgan Lewis healthcare litigators have the trial experience, intimate knowledge of the healthcare sector, and legal prowess required to resolve lawsuits and government investigations to the greatest possible advantage of our clients, both payors and providers. Our experience includes handling payment disputes and disputes relating to the development, production, sale, and distribution of medical services and products.
Our lawyers handle litigation for clients across all facets of the healthcare delivery system, including managed care companies and insurers, hospitals and health systems, long-term care and post–acute care facilities, pharmacies, and other healthcare providers. We assist our clients at every stage of investigations and litigation, from responding to grand jury subpoenas through handling trials and appeals. We routinely handle government investigations and parallel civil or administrative proceedings, including False Claims Act actions and negotiation and implementation of CIAs. Our capabilities in federal 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 US Department of Health and Human Services OIG and US Centers for Medicare and Medicaid Services (CMS).
Morgan Lewis lawyers advise clients across virtually all healthcare sectors on privacy and security compliance matters, including those related to HIPAA, HITECH, the Gramm-Leach-Bliley Act, state security breach notification laws, US Federal Trade Commission (FTC) privacy and security standards, state medical privacy laws, and the Red Flags Rule, as well as international privacy rules.
We also advise on the development of privacy and data security policies and procedures, the structuring of healthcare information technology ventures, responses to security breaches, and data transmissions to state and federal healthcare agencies. Additionally, we help train employees on the disclosure of information and ongoing compliance monitoring.
We assist clients with monitoring, influencing, and interpreting federal rules and regulations, congressional legislation, and other policies issued by the executive branch. Many of our lawyers have government backgrounds in healthcare oversight agencies, and this experience translates to astute analysis of rapidly evolving developments and timely guidance on matters critical to our clients’ businesses.
Our real estate lawyers regularly guide healthcare industry clients in the leasing, acquisition, development, sale, and financing of their real property, including patient care facilities, senior housing, medical office buildings, research and development facilities, clean rooms, and vivariums. We represent a variety of industry property owners, operators, and tenants, as well as real estate investment trusts (REITs), in sophisticated transactions across the United States, wherever their business needs may take them.
For healthcare clients, our securities lawyers apply their skills to complex transactions, corporate governance issues, and public issuer reporting. We represent healthcare companies on the full range of US and global public offerings of securities and stock exchange listings on all US and alternative markets. Our corporate and securities lawyers and our securities litigators advise and represent boards of directors, board committees, and company executives on a broad range of both extraordinary and routine situations arising from the current financial disclosure and regulatory environment.