Health Law and Life Sciences

The health care industry is facing unprecedented challenges as competition increases to deliver quality health care to a growing and aging population in a cost-efficient manner. At the same time, the regulatory environment is becoming more complex and the penalties for noncompliance more severe, as government agencies increase enforcement efforts. Out of necessity, health care entities will need to seek innovative collaborations and business relationships to thrive in this challenging environment. Shutts & Bowen is committed to serving the health care industry in Florida and has assembled a talented and experienced Health Law and Life Sciences Group to meet the varied needs of its diverse health care clients.

Attorneys

We are committed to providing exemplary legal services to all sectors of the health care industry. Several of our attorneys are Florida Bar Board Certified in Health Law, recognized by Chambers USA as leading health care lawyers, Martindale-Hubbell AV-rated, and Florida Super Lawyers. Our attorneys speak and write on health law matters and strive to remain in the forefront on issues related to this industry.  Our attorneys are active in the American Health Lawyers Association, the Health Law Sections of the Florida and Texas Bar, and the New York Bar.

Representative Clients/Areas of Law

We have experience with a variety of health care clients, including hospitals and multi-hospital systems, surgery centers, home health agencies, pharmaceutical and medical device companies, medical equipment suppliers, nursing homes and adult living facilities, pharmacies, physicians and physician groups and other health care providers and suppliers. We:

• Provide legal advice on corporate development, from formation through exit strategies, including mergers, acquisitions, divestiture, management of internal structure and growth and capital formation.
• Counsel on regulatory and legislative activity relating to health care entities.
• Provide advice on fraud and abuse, self-referral, HIPAA compliance and regulatory compliance.
• Represent hospitals and physician groups in controversies before administrative agencies and courts.
• Provide strategic tax planning advice and expertise particularly in controversial areas.
• Provide legal counsel on operational issues.
• Serve as recognized bond counsel working with counties and municipalities on  tax exempt and conventional financings.
• Serve as counsel to underwriters of both tax exempt and taxable securities, as well as special counsel to various banks, other financial institutions and financial consultants.
• Serve as counsel on credentialing, contracting, peer review, medical staff privileges and discipline, bylaws, PHOs, professional office and clinical facilities.
• Represent clients in insurance claims work, antitrust, disciplinary procedures, medical staff disputes and a variety of employment matters.
• Represent clients in labor contract negotiations and arbitration, and counsel on strategy in employee relations including EEOC, Title VII, OSHA, ADA, unemployment compensation, and wage and hour matters.
• Provide advice on patient care issues, including risk management, and claims defense, policies for treating patients with AIDS and other diseases and conditions requiring sensitive and unique care and treatment.

Fraud and Abuse

We represent and advise clients regarding state and federal fraud and abuse and self-referral prohibitions and restrictions. Our attorneys are well-versed in the laws affecting hospitals, physicians, physician groups, home health agencies, surgery centers and other health care providers. We assist clients in planning and structuring transactions to minimize unwanted governmental scrutiny. We handle complex issues arising from hospital-physician joint marketing agreements, upcoding, global billing, fraud, billing for services provided by physician assistants and nurse practitioners, amongst other situations. We have experience dealing with the Federal Bureau of Investigation, Department of Justice, Office of the Inspector General and other state and federal agencies.  Our attorneys develop corporate compliance plans and counsel  health care providers to assess and react to violations of federal and state law.  We:

• Review and analyze contracts, joint ventures and other agreements.
• Provide advice to properly document services to preclude billing issues with state and federal health care payors.
• Conduct internal investigations  and employee compliance training.
• Provide counsel on restructuring non-compliant relationships to avoid potential civil and criminal penalties.

Health Care Entity Operations

We guide health care providers through the myriad of legal issues which arise from day-to-day operations. We have experience with licensure, clinical trials and human research, peer review, internal and external audits, compliance planning and training, HIPAA, patient consent, medical records, general contracting and other areas.  We work to become valued members of each client’s team to serve their day-to-day needs.  We:

• Assist clients with medical staff and governance issues.
• Counsel clients on internal and outside audits.
• Develop programs for clinical trials to protect human research subjects.
• Counsel on general contracting matters.
• Counsel clients on licensure, state and federal regulatory compliance and end of life issues.
• Provide advice on executive employee compensation and tax implications.
• Serve as outside general counsel to in-house counsel.

Life Sciences

We provide a wide range of services to health care clients engaged in medical product development and medical research and discovery.  Our focus is on pharmaceutical and medical device companies, hospitals, physicians, physician groups, and health systems that participate in all types of clinical research.  We counsel our on  regulatory compliance to assure their interests are protected so they can concentrate on the advancement of medical knowledge.  We negotiate and draft:

• Confidential Disclosure Agreements
• Clinical Trial Agreements and Budgets
• Strategic Alliance and Joint Venture Agreements
• Contract Research Organization Agreements
• Sponsored Research Agreements
• Research Consortia Agreements
• Material Transfer Agreements

We advise and counsel clients about:

• Medicare reimbursement for clinical trials
• Fraud and abuse issues in research programs
• Research issues and tax-exempt status
• Protection of human and animal subjects in research
• HIPAA privacy and research
• FDA regulation and compliance

And we assist with obtaining intellectual property protection, including:

• Preparing and prosecuting patent and trademark applications
• Licensing of patents, trademarks and technology
• Performing patent, trademark and copyright infringement analyses
• Conducting intellectual property audits and due diligence reviews

HIPAA

We have a wide range of experience in HIPAA compliance and operational concerns.  We have prepared policies, forms, and communications for virtually all health care entities.  We have educated and counseled governing boards, management and medical staffs of hospitals, multi-state health care providers, long term care facilities, and physician practices on HIPAA requirements. We have significant experience in advising and defending our clients in the broader areas of health information management and patient confidentiality, and work regularly with clients who are implementing electronic health record systems.