Gina Kastel practices in the health and life sciences group and advises a wide range of health care companies, including hospitals, health systems, physician practices, medical device manufacturers, health care franchisors and consulting firms on regulatory matters and corporate transactions. She takes a pragmatic, business-focused approach to client counseling and advising. Gina's representative transactions include the following:
Health Information Privacy and Security
- Advise health care providers, medical device manufacturers, consulting organizations and software companies regarding health information privacy and security issues, including compliance with HIPAA's privacy and security regulations, state medical records laws and the federal substance abuse records act.
- Manage data security breaches and assist clients in remediating breaches and providing notice to affected individuals and government agencies.
- Defend covered entities and business associates in investigations by the Office of Civil Rights and the Minnesota Attorney General regarding alleged privacy and security violations.
Health Care Compliance
- Advise hospitals, physician practices and medical device manufacturers regarding compliance with the federal anti-kickback statute, the Stark law, the False Claims Act and similar state laws.
- Help device manufacturers structure relationships appropriately with physicians, manage relationships with sales staff and distributors, comply with the Physician Payments Sunshine Act and similar state laws, develop compliance plans, and adhere to industry ethics standards, including the AdvaMed Code.
- Represent clients in internal and government investigations by CMS, the Department of Justice and the Minnesota Attorney General.
- Help clients comply with facility and individual practitioner licensure requirements, including prohibitions on the corporate practice of medicine, fee splitting and referral restrictions.
- Assist national companies, including retail clinic operators and health care franchisors, in managing regulatory issues across state lines.
- Draft and negotiate agreements for professional and administrative services, and recruitment support.
- Assist clients in mergers, acquisitions, and forming and restructuring joint ventures, subsidiaries and other affiliates.
- Advise hospitals, physician practices, skilled nursing facilities and medical device manufacturers regarding billing and reimbursement issues, including compliance with Medicare and Medicaid requirements.
- Assist clients in taking advantage of alternate payment structures, including accountable care organizations and gainsharing.
Health Care Franchising
- Analyze health care regulatory obligations of health care franchise companies.
- Develop business structures that comply with applicable health care laws.
- Draft and review franchise disclosure documents.
In addition to her health care experience, Gina also has a deep background in the law of nonprofit and tax-exempt organizations. She counsels public charities, private foundations, trade associations and other exempt organizations on maintaining their tax-exempt status, complying with the private foundation excise tax rules, avoiding excess benefit transactions and complying with charitable solicitation laws. She assists with corporate transactions, including mergers, acquisitions and joint ventures. She also advises nonprofit boards of directors regarding corporate governance, fiduciary duties and managing conflicts of interest.
- Minnesota Rising Stars — Health Care, 2007
- International Association of Privacy Professionals
- American Health Lawyers Association
- IRS Tax-Exempt/Governmental Entities Council, Great Lakes Region
- Minnesota State Bar Association — Health Law Section, Governing Council
- Ten Thousand Things Theater Company — Board Chair
Gina is a frequent speaker on health care and nonprofit legal issues. Representation presentations include the following:
- HIPAA Privacy and Security: Surviving Heightened Enforcement
HIPAA Summit West, 2011
- Other Significant New Developments
Health Law Institute, Minnesota CLE, 2010
- Classes of Federal Tax Exemption
Minnesota CLE, 2011
- Legal Basics for Corporate Grantmakers
Minnesota Council on Foundations, 2011
- New Developments in HIPAA
Minnesota CLE, 2009
- HIPAA Privacy and Security Mandates—New Breach Notification Guidance
- HIPAA HITECH Guidance
Online Health Resources, 2009
- New Privacy and Security Changes to HIPAA
- New HIPAA Privacy and Security Mandates
- Minnesota Hospital Association Regulatory Update
Minnesota Hospital Association, 2009
- Health Law Regulatory Update
Faegre & Benson, 2008
- Integrated Delivery System Roundtable
Medical Group Management Association/Faegre & Benson, 2008, 2009
- Nonprofit Political Activity and Lobbying
Minnesota CLE, 2008
- Street Smarts on the Law: What Grantmakers Need to Know
Minnesota Council on Foundations, 2008
- Frequent Contributor to Beyond Health Care Reform
Faegre Baker Daniels Blog on Legal and Regulatory Impact of Health Care Reform