Healthcare Law

The health care industry is one of the most heavily regulated industries in the United States.  Physicians and other health care providers are subjected to a pervasive, ever-changing regulatory scheme, overseen by a host of federal and state agencies.  Health care providers also are subject to the same laws and requirements governing businesses in other industries; as a result, many health care clients require the full spectrum of legal services.

Our health law attorneys focus their efforts on issues specific to the health care industry.  Consequently, they have developed expertise in virtually every aspect of health law.  They also have developed an understanding of the business of health care, which helps convert legal knowledge into sound business advice. Where appropriate, they also work closely with outside attorneys on the application of other types of law in the health care setting.  This approach combines the benefits of industry specialization with the benefits of legal specialization, resulting in the delivery of high-quality, cost-effective services to our clients.

The accelerating pace of development of new drugs and medical devices has created exciting new opportunities for health care providers, entrepreneurs, pharmaceutical companies and others.  Along with these new opportunities come new challenges, as the law struggles to keep pace with science.  In conjunction with the firm’s intellectual property practice and others, members of the health law department work with physicians, institutions, site management companies, research organizations, medical staffs and others to identify and resolve legal issues arising from the tide of medical research and biotechnology.

Our experience includes:

• Negotiating and drafting clinical trial agreements with sponsors, institutions, CROs and principal investigators;

• Representing physicians involved in post-graduate training programs and related research projects;

• Advising clients regarding compliance with institutional review boards (IRBs), the Food and Drug Administration (FDA) and the Office for Human Resource Protections (OHRP) requirements, including requirements relating to participant informed consent; adverse events; and conflicts of interest;

• Representing principal investigators in negotiations with sponsors and institutions;

• Advising medical staffs regarding the establishment of privileging criteria for new technology and new applications of existing technology;

• Assisting clients in the development of policies and procedures designed to minimize fraud and abuse liability in connection with billing practices in clinical trial;

• Representing providers accused of unprofessional conduct in connection with experimental treatment;

• Structuring research joint ventures between physicians and other health care providers;

• Educating and advising clients regarding HIPAA compliance in the research setting.

In recent years, medical staffs have recognized the importance of independent legal counsel to provide advice in an increasing number of areas in which their interests may not coincide with the interests of hospital administration.  Our attorneys have years of experience representing medical staffs on the full range of issues affecting the relationship with the hospital, and regularly represent them in connection with credentialing, peer review and corrective action processes.  Since we do not represent hospitals, we avoid the legal, business and political conflicts of interest that arise when one law firm represents parties on both sides of these issues.

Our experience includes:

• Drafting and revising medical staff bylaws; department rules and regulations; fair hearing plans; and credentialing manuals;
• Developing and drafting of policies and procedures relating to physician health/impaired physicians; disruptive behavior; peer review; quality management and utilization management; credentialing for new technology and new applications of existing technology; information sharing; and fraud and abuse compliance;
• Representing medical staffs in peer review investigations; summary suspensions; the fair hearing process; and other types of corrective action;
• Counseling medical staffs involved in negotiations and conflicts with hospital administration on issues including: economic credentialing and conflicts credentialing; emergency department call coverage and EMTALA; control over bank accounts; and autonomy;
• Advising leadership on compliance with JCAHO standards; Health Care Quality Improvement Act and National Practitioner Data Bank obligations; and state medical board reporting obligations.