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Areas of Experience
Morgan Lewis offers healthcare providers and suppliers of all types sophisticated, integrated, and cost-effective counsel covering all of their unique needs—in business and finance (including transactions and joint ventures); federal, state, and local regulation; coverage and reimbursement; fraud and abuse and compliance counseling; intellectual property; antitrust; litigation; public policy advocacy; real estate; and labor and employment issues.
Our team includes some of the most respected healthcare law practitioners in the country and a number of former senior government officials. Leveraging our attorneys' intimate knowledge of the inner workings of the government's executive branch, as well as 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.
Scope of Practice
Healthcare Industry Clients
- Hospitals, health systems, and academic medical centers
- Healthcare specialty providers and suppliers
- Pharmaceuticals and biologics
- Medical devices and radiological manufacturers
- Diagnostic companies
- Health information technology suppliers
- Home health agencies
- Investment companies
- Pharmacies (retail and specialty)
- Physician practices
- Post–acute care providers
Healthcare Industry Transactions
We regularly handle mergers, acquisitions, and other transactions in the healthcare space, from million- to multimillion-dollar deals. 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.
Clients we represent in transactions in the healthcare sector include a wide range of healthcare enterprises, private equity firms, investment banks, venture capital firms, institutional lenders, independent directors committees, and management groups. We also advise on a variety of healthcare joint venture transactions and service agreements between and among healthcare providers, with sophisticated consideration of applicable regulatory, fraud and abuse, and tax law implications.
Healthcare Industry Litigation
Morgan Lewis has litigated matters for healthcare industry clients for more than a quarter century, offering the combination of trial experience, intimate knowledge of the healthcare industry, and legal prowess required to resolve lawsuits and government investigations to the greatest possible advantage of our clients, among them both payors and providers. Our experience includes payment disputes; disputes relating to the development, production, sale, and distribution of medical services and products; and impending litigation as a result of healthcare reform legislation.
Our attorneys also have achieved widespread success handling litigation 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 facilities, pharmacies, and other healthcare providers. Our capabilities in False Claims Act (including qui tam matters) and Anti-Kickback and Physician-Self Referral (Stark) Law investigations and litigation is nationally recognized by Chambers USA, and our defense team includes former criminal and civil fraud prosecutors, as well as former Health and Human Services, Office of Inspector General senior attorneys.
Healthcare Industry Coverage and Reimbursement
Our in-depth experience with the regulations and sub-regulatory guidance issued by the Centers for Medicare & Medicaid Services lends our clients a critical advantage in matters relating to coverage and payment under Medicare, Medicaid, and other federal healthcare programs. Often our representations include advising on local coverage decisions (LCDs) and national coverage determinations (NCDs). We also advise on legal and regulatory issues related to coding and billing, and in compliance and fraud and abuse matters we provide both defense of government and commercial payor audits and investigations of such billing and coding practices.
On reimbursement appeals, we represent providers in the Medicare appeals process 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. Finally, as Medicare and Medicaid increasingly rely on contractors—program safeguard contractors, zone program integrity contractors, and recovery audit contractors—and we have represented providers in responding to and defending against related audits.
Healthcare Industry Privacy and Data Security
Morgan Lewis attorneys possess a command of data privacy and security issues as they specifically apply to the healthcare industry. We 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) and the Gramm-Leach-Bliley Act. We often develop privacy and data security policies and procedures, structure of healthcare information technology ventures, and respond to security breaches on behalf of our clients. We offer clients guidance on a range of operations—recruitment, marketing, web and new media usage, and data transmissions to state and federal healthcare agencies. We also 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 speedy, bottom-line-driven solutions in this complex and fast-moving area of the law. Morgan Lewis attorneys are familiar with the entire range of 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.
Healthcare Industry Public Policy and Advocacy
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 attorneys have government backgrounds at healthcare oversight agencies and this experience translates into astute analysis of rapidly evolving developments and timely guidance on matters critical to our clients' businesses.
Healthcare Industry Compliance and Fraud and Abuse
Morgan Lewis provides compliance guidance, fraud and abuse counseling, and corporate defense in government investigations and proceedings to the following sectors:
- Manufacturers and suppliers
- Hospitals and health systems
- Academic medical centers
- Specialty and long-term care providers
- Health plans
- Clinical research organizations
- Medical societies
- Private equity funds
- Physician practices
Most of the attorneys and professionals on our compliance and fraud and abuse teams represent healthcare industry clients every day in compliance and enforcement matters. Those who previously served as government lawyers and officials bring added value to clients confronting compliance program assessments, corporate integrity agreements (CIAs), and government monitor oversight matters. We also regularly provide government self-disclosure advice involving Medicare and Medicaid programs, the False Claims Act, Anti-Kickback and Stark Law, and excluded persons.
Healthcare Industry Labor, Employment, and Workforce Issues
We have a long history of assisting healthcare industry clients in virtually every area of labor and employment law. Our labor relations attorneys serve healthcare industry clients with a broad spectrum of needs, including union campaigns and union avoidance programs, corporate campaigns, and representations before government agencies and multiemployer bargaining groups. We have successfully solved novel and difficult labor-management problems, and advised companies on long-range planning to build strong and effective employee-management relationships.
Our working knowledge of national union organizations is significant and a critical differentiator in our representations with healthcare providers. We counsel on and litigate all matters of 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. We have also played a leading role 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 brief filings in Specialty Healthcare, we negotiated the important National Labor Relations Board case dealing with bargaining units in non-acute care facilities. Our Workforce Change Practice provides strategic advice and counseling on important structural issues such as layoffs, restructurings, spin-offs, and acquisitions.
Healthcare Industry Antitrust
Our antitrust experience in the healthcare industry includes FTC investigations of Hatch-Waxman 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 have successfully defended M&A transactions before a wide range of antitrust authorities, including the Department of Justice, the FTC, the European Commission, and other foreign competition authority agencies.
Healthcare Industry Real Estate
Our Real Estate attorneys regularly guide healthcare industry clients in the leasing, acquisition, development, sale, and financing of their real estate property, including patient care facilities, senior housing, vivariums, and medical office buildings. We represent a variety of healthcare industry property owners, operators, and tenants, as well as real estate investment trusts (REITs), in sophisticated transactions on both coasts and across the country, wherever their business needs may take them.