Cooley LLP has a leading group of health care and life sciences regulatory attorneys who understand the myriad challenges facing the health care and life sciences industries. In an environment of increasing regulation, issues such as FDA clearance and approval, coverage and reimbursement, licensure, compliance, data privacy and security and fraud and abuse are creating real demands on companies, providers, manufacturers and suppliers. Our team of attorneys has the depth of experience and legal expertise necessary to navigate these challenges.
Cooley attorneys have deep experience providing health care and life sciences regulatory counseling and advise on complex transactions to:
- Life sciences companies, including pharmaceutical, medical device and biologics companies
- Long term care facilities, including nursing homes, skilled nursing facilities and assisted living facilities
- Durable medical equipment and other suppliers
- Financial investors, investment banks, institutional lenders, private equity firms, venture capital firms and others with focus on the health care and life sciences industries
- E-Health, health care IT and related health technology companies
- Health insurance companies
- Payors and health maintenance organizations
- Home health agencies
- Managed care providers
- Physician groups
- Health care and life sciences associations
- Leads data breach response and related government investigations.
- Advises on health care data privacy, including compliance with the Health Insurance Portability and Accountability Act and compliance with Federal and state fraud and abuse laws.
- Develops fraud and abuse compliance plans and conducts compliance audits, structures arrangements with physicians and other referral sources to comply and provide advice on marketing and promotional compliance.
- Analyzes and processes licensure approval and notification requirements and assists companies with corporate practice of medicine & fee splitting prohibitions.
- Assists life sciences companies with US Food and Drug Administration (FDA) product approval and regulatory compliance.
Rankings & Accolades
- The group's chair, Drew Gantt, was recently recognized as one of the top 10 outstanding health care IT lawyers by Nightingale's Healthcare News and was recommended as a Health Care and Life Sciences attorney by The Legal 500: United States 2011 Edition.