Practice Areas & Industries: Greenberg Traurig, LLP

 





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Practice/Industry Group Overview

Health care is not only one of the world’s largest and fastest growing industries, but also one of the most highly regulated.  By 2021, health care is expected to comprise 19.6 percent of U.S. GDP.  This increased spending will open up greater possibilities for industry participants. Advances in technology and the increased use of integrated delivery systems are also creating new opportunities. All of these developments are leading to significant changes in the structure and organization of health care services for many providers and related businesses.

Greenberg Traurig’s Health Care Practice provides strategic legal counsel to many organizations along the health care supply chain, helping them respond proactively to the rapidly changing marketplace.  Our interdisciplinary team brings together experienced attorneys from across the firm, including several who have served as in-house counsel for health care companies. Our experience as members of organizations firmly planted within the health care network, coupled with the firm’s broad capabilities in related disciplines – including corporate, finance, tax, antitrust, ERISA, litigation, restructuring, intellectual property and biotechnology – make GT well positioned to advise our clients on virtually all facets of the industry.

We offer our clients the practical know-how that comes from firsthand experience working in their industries and in regulatory circles. Our Health & FDA Business Group co-chair served for 10 years as health policy director for the United States Senate Committee on Labor and Human Resources, drafting and interpreting many of the major health care laws enacted during the past 20 years, including the Patient Protection and Affordable Care Act (PPACA). Other members of our team have worked for the Department of Health and Human Services, as well as a variety of health care companies.


 

Services Available

Our Clients

  • Assisted Living Companies
     
  • Clinical Laboratories & Biotech Companies
     
  • Dietary Supplement, Food & Cosmetic Companies
     
  • Employer & Provider Trade Organizations
     
  • Financial Institutions
     
  • Health Maintenance Organizations
     
  • Hospitals & Nursing Homes
     
  • Long-Term & Sub-Acute Care Providers
     
  • Managed Care & Insurance Companies
     
  • Medical Device Manufacturers
     
  • Pharmaceutical Companies
     
  • Physicians & Physician Groups
     
  • Provider Networks
     
  • Tax-Exempt Institutions
     
  • Dentist & Dentist Groups
     
  • Sleep Labs
     
  • Home Health Care
     
  • Home Medical Equipment

Legislation and Policy

  • Assist with the development of viable policy and legislative approaches
     
  • Evaluate and report on the political and policy environment and help formulate the most successful approaches possible for complex issues
     
  • Provide advice on the positioning and strategies through the legislative and administrative process to ensure that objectives are carried out consistent with policy objectives
     
  • Work at the federal and state levels to carry out policy and legislative strategies and respond to pending issues
     
  • Draft legislation and regulations concerning issues affecting our clients
     
  • Interact with important congressional leaders, stakeholders, policymakers and key opinion leaders
     
  • Provide comments to governmental agencies concerning proposed regulations
     
  • Regularly meet with representatives of various governmental agencies and legislative bodies to obtain early insight into the rapidly changing health care regulatory and reimbursement climate
     
  • Advise clients on impact of legislation and regulation, including fraud and abuse, reimbursement and coverage requirements
     
  • Maintain a focus on the FDA, the Medicare Advantage program and the Part D prescription drug benefit and assist the entities and providers involved

Fraud and Abuse, Self-Referral, HIPAA Compliance and Regulatory Compliance

  • Counsel clients concerning operational aspects of their business in light of pertinent federal and state fraud and abuse and self-referral prohibitions and restrictions
     
  • Advise on development, implementation and maintenance of corporate compliance plans and corporate integrity agreements
     
  • Assist providers, suppliers and practitioners in modifying operations and systems to comply with the Health Insurance Portability and Accountability Act (HIPAA) rules and regulations concerning health information privacy protections, standard electronic data requirements and electronic security standards

Joint Ventures

  • Counsel clients on the planning, development, implementation and operation of joint ventures designed to accomplish market definition, product focus and operational and financial efficiency
     
  • Structure both taxable and non-taxable entities, ranging from whole hospital ventures and diagnostic and sub-acute services to clinical laboratories and back-office support services
     
  • Draw on our team's wide-ranging experience handling tax, corporate, antitrust, fraud and abuse and self-referral, and reimbursement issues

Mergers, Acquisitions, Sales and Reorganizations

  • Represent clients in mergers and acquisitions
     
  • Advise clients engaged in the process of right sizing their organizations through targeted acquisitions and spin-offs
     
  • Counsel clients on restructuring their relationships with physician organizations
     
  • Represent long-term care and other sub-acute organizations on various aspects of their business relationships
     
  • Advise newly-formed provider organizations on acquiring distressed hospitals, long-term care facilities and sub-acute providers

Licensing, Certificate of Need, Survey and Disciplinary Matters

  • Guide clients through the maze of applicable regulatory, licensure, certificate of need, certification and accreditation processes and requirements, at both the federal and state levels
     
  • Assist at the many stages of the process, from the preparation of applications and filings, to survey and disciplinary matters, to the analysis and response to enforcement actions, to representation of clients before the relevant agencies
     
  • Draw on our team's knowledge of the federal agencies, including the Centers for Medicare & Medicaid Services (CMS) and several state agencies, to help clients attain their objectives while avoiding the litigation or appeal process
     
  • Represent clients in the litigation and appeal process, as appropriate
     
  • Advise clients throughout the licensure and disciplinary process for individual health care providers
     
  • Represent clients in investigations and potential actions against providers' professional licenses

Hospitals

  • Provide a wide range of legal services to hospitals including, without limitation, medical staff issues, governance, contracting, regulatory compliance, employment, reimbursement issues and tax
     
  • Work closely with hospitals' in-house counsels

Long-Term and Sub-Acute Care

  • Represent a broad range of clients in the long-term care industry and sub-acute provider industry, including skilled nursing; home health; hospices; physical, occupational and speech-language therapy; and assisted living
     
  • Advise clients on transactional matters, licensing and certification, regulatory compliance, survey issues, disciplinary matters, reimbursement matters, administrative hearings and appeals, and legislative matters
     
  • Counsel clients on regulatory matters such as medical records, end-of-life issues, and patient discharge matters and hearings
     
  • Assist in implementing regulatory issues and practices related to prospective payment systems, consolidated billing arrangements, service caps and network participation and payor arrangements

Reimbursement and Program Compliance

  • Provide a wide range of services in connection with reimbursement from private payors, as well as from governmental payors, their related carriers and fiscal intermediaries
     
  • Assist with Medicare, Medicaid, CHAMPUS and private payor reimbursement issues and qualification at both the state and federal level

Managed Care and Insurance

  • Represent health maintenance organizations and health care insurers in merger and acquisition transactions, provider contracting matters, regulatory and legislative issues
     
  • Advise integrated delivery systems, multi-specialty and single-specialty carve-out networks on managed care contracting issues
     
  • Assist in the formation and operation of utilization management and third-party administrator companies

White Collar Criminal Defense

  • Advise clients in light of the increased federal and state focus on health care fraud and abuse
     
  • Work closely with the firm's litigation department in providing our clients, their officers, directors and key employees with representation in connection with investigations and trials involving fraud and abuse, false claims, program exclusion, money laundering, asset forfeiture, securities, environmental, antitrust, employee discrimination, obstruction of justice and RICO claims

Tax-Exempt Institutions

  • Work closely with GT's tax, trusts and estates department to provide tax advice to tax-exempt hospitals, tax-exempt clinics, homes for the aged and medical education institutions
     
  • Counsel clients on the tax issues affecting tax-exempt health care organizations, including unrelated trade or business income, private inurement, intermediate sanctions, joint ventures with for-profit entities, obtaining of exempt status, physician practice acquisitions and physician compensation
     
  • Assist clients in structuring ambulatory surgical center joint ventures, joint operating agreements between tax-exempt hospitals and whole hospital joint ventures
     
  • Represent exempt organizations in connection with tax-exempt financing transactions
     
  • Advise on the organization and governance of not-for-profit corporations and compliance with state charitable solicitation laws

Antitrust and Trade Regulation

  • Work closely with GT's antitrust and trade regulation practice on matters affecting the firm's health care clients
     
  • Provide antitrust advise and counseling to clients in such areas as mergers and acquisitions, pricing, exclusive and requirements contracts, exclusionary practices, networking and customer and territory limitations
     
  • Advise and defend companies regarding health care product or service promotional claims
     
  • Process Hart-Scott-Rodino analyses and filings
     
  • Defend potential mergers or acquisitions that are subject to federal or state governmental investigation

Business Reorganization & Financial Restructuring

  • Work closely with GT's business reorganization and financial restructuring practice to handle aspects of health care-related insolvencies and restructurings
     
  • Represent for-profit and non-profit hospitals, nursing home facilities, home health agencies, physician groups and other health care-related businesses in both Chapter 11 and out-of-court reorganizations
     
  • Represent creditors' committees, equity holders, landlords (including health care facility REITs) and other stakeholders in financially distressed health care businesses
     
  • Represent financing sources providing liquidity to health care providers
     
  • Assist clients in acquisitions and dispositions of financially troubled health care facilities and related assets
     
  • Draw on the experience of members of our business reorganization and financial restructuring practice who have been instrumental in enacting the healthcare insolvency portions of the U.S. Bankruptcy Code, assisting in the drafting of the original bill and testifying before Congress in support of its adoption

FDA-Regulated Products

  • Represent companies that manufacture and market products regulated by the FDA that include drug prescription companies, biotechnology, medical device and food companies as well as pharmacies
     
  • Shepherd clients' product registrations, approvals and clearances through the appropriate regulatory process
     
  • Provide advice on critical issues such as product label and labeling requirements
     
  • Help clients through the government approval processes and policies that impact their products, such as procurement requirements and trade agreements
     
  • Connect clients with potential partners to advance their common interests
     
  • Represent both public and private entities before administrative and regulatory agencies
     
  • Counsel clients on IP matters that affect their businesses

 
Group Presentations
  Medtrade 2013, October 9, 2013
Breakfast Briefing on Best Practices in Employment Policy: The Affordable Care Act and Social Media, June 19, 2013
Healthy Beverage Expo, June 7, 2013
SupplySide Marketplace: SupplySide Why, May 1, 2013
 
 
Articles Authored by Lawyers at this office:

FDA Guidance for Industry and FDA Staff: Mobile Medical Applications
Chad D. Ehrenkranz,Nancy E. Taylor, November 19, 2013
On September 25, 2013, the Food and Drug Administration (the "FDA") released final guidance on the regulatory requirements regarding the introduction of mobile medical applications into the marketplace (the "Final Guidance"). The purpose of the Final Guidance and its Appendices...