Read any newspaper or listen to any talk show, and it is clear that changes in the health care industry affect the lives of every American. Health care expenditures in the United States are growing exponentially, and the health care industry has become one of the most highly regulated industries in the United States, subject to complex and intricate federal and state laws, regulations, and polices. Rapidly changing and evolving health care legislation, as well as increased attention to health care on a global basis, presents challenges to businesses in the health care industry. To navigate the maze of health care laws and regulations, businesses require the assistance of experienced, knowledgeable legal counsel.
With nearly 300 attorneys firmwide and a group of experienced health care attorneys, Jones Walker offers a broad range of legal services to health care industry clients, including transactional matters, litigation, investigations, and regulatory compliance. Our representative clients include health care systems, hospitals, academic medical centers, pharmaceutical companies, home health agencies, nursing facilities, teaching universities, health insurers, health professionals, practices and associations, veterinary hospitals and practices, and other health care entities. We serve as general or special counsel to health care providers. To keep our clients up-to-date on changing regulations and legislation, we host seminars, send urgent electronic updates through the firm's E*Lerts and E*Bulletins, and provide in-house training programs for clients, as requested.
Transactions
Jones Walker's attorneys bring a wealth of experience in advising health care clients on transactional and organizational matters. From the acquisition of hospitals and other providers to the formation of new entities for the delivery of health care services, we routinely provide clients with the transactional experience necessary to meet their wide-ranging needs. Our health care attorneys have guided clients on mergers, acquisitions, divestitures, joint ventures, tax structure, entity formation, and financing. We have also advised health care entities on organizational issues, such as corporate governance, board operations, and bylaw preparation and analysis.
Investigations & Litigation
Our firm has qualified, experienced litigators who have handled numerous civil and criminal government health care fraud investigations and qui tam litigation. Jones Walker has represented both health systems and individuals in matters involving government entities such as Medicaid Fraud Units, the United States Attorney's Office, and the United States Department of Justice (DOJ). In the course of those representations, we have negotiated numerous settlement agreements and corporate integrity agreements with government entities. Our attorneys are experienced with Stark and Anti-Kickback Laws, the False Claims Act (FCA), cost reporting requirements, and other relevant regulations. Our team of health care attorneys has also handled investigations involving quality-of-care issues, such as medically necessary procedures.
Many of our attorneys assist health care clients in both preparing for and responding to investigations, surveys, audits, and reviews from both federal, state, and local governmental agencies, such as the Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), and fiscal intermediaries. We have also represented health care entities in the context of bankruptcy proceedings, appellate proceedings, administrative proceedings, and other disputes. We also assist clients with antitrust matters, commercial contracts, denial-of-coverage matters, drug and pharmaceutical issues, medical product or device liability, medical malpractice and professional liability, medical staff bylaw disputes, and resident and hospital-based physician issues.
Regulatory, Compliance & Self-Audits
As one of the most highly regulated industries in the world, the health care industry presents businesses and individuals with an often perplexing and evolving array of laws and regulations. From providers to suppliers, and from payers to billers, these laws and regulations can affect even those primarily engaged in other industries, such as retailers with on-site health clinics or businesses with self-insured health benefits plans.
Given the scope and complexity of current health care regulations, businesses need attorneys who understand the dynamics of health care compliance. Jones Walker's attorneys have substantial experience in assuring that our clients meet their obligations under applicable health care laws.
Our experience includes:
- Physician self-referral laws (Stark laws)
- Civil monetary penalty laws regulating patient inducement and other matters
- Anti-kickback laws
- False Claims Act (FCA)
- Medicare Conditions of Participation, state licensure, and accreditation standards
- Billing and coding requirements, cost reporting and reimbursement requirements
- Requirements affecting patient care, including credentialing, utilization review, peer review, and medical staff requirements
- Health Insurance Portability and Accountability Act (HIPAA) laws regarding the privacy and security of personal health information
- Emergency Medical Treatment and Active Labor Act (EMTALA)
- Clinical research laws, such as informed consent, adverse event reporting and Review Board processes
- Electronic health records and related matters
- Telemedicine
- Bioethical issues
We have conducted health care-related due diligence and hundreds of internal investigations. Our attorneys have extensive experience in the development, implementation, and evaluation of compliance programs for various providers, such as hospitals, home health agencies, and nursing home facilities, including conducting comprehensive training and preparing and revising policies and procedures for clients. All-too-frequent headlines announcing recent instances of health care fraud have made corporate responsibility and accountability a major focus of health care entities. Our experience allows us to craft compliance programs that are designed to effectively meet the requirements set forth by the federal and state governments.
Operations
In representing our health care clients, we strive to understand the demands of their business and to make their goals our own. Our multidisciplinary legal skills allow us to provide clients with guidance involving the range of legal issues that confront businesses in the health care industry. These include many operational issues such as contract drafting and negotiation, labor and employment, immigration, tax, the Employee Retirement Income Security Act (ERISA) and employee benefits, insurance coverage, intellectual property protection, preparing and negotiating clinical trial agreements, assisting with the establishment of clinical trial processes and procedures, and other operational matters.
Our experience also covers emergency preparedness and response, advising clients on pandemics, mobilization during natural disasters, and disaster recovery.