Healthcare Regulatory Compliance

From day-to-day operational issues to long-term strategic matters, the experienced attorneys on Holland & Knight's Healthcare Regulatory Compliance Team work to understand our clients' objectives and then develop effective strategies for achieving those goals. The depth and breadth of our regulatory experience is central to our mission. The confidence our clients place in us is based on our more than 50 years of experience with healthcare regulatory law and the fact that many of the solutions we have developed are now models used throughout the healthcare industry.

Federal Regulations

Healthcare clients rely on the counsel of Holland & Knight's regulatory compliance lawyers for assistance with a variety of federal regulations, including:

• Stark Law
• Anti-Kickback Statute
• Medicare enrollment and reimbursement
• Emergency Medical Treatment and Active Labor Act (EMTALA)
• Health Insurance Portability and Accountability Act (HIPAA)

State Licensure, Certification and Compliance

Holland & Knight's Healthcare Regulatory and Compliance Team has comprehensive experience regarding state licensure and certification issues, state anti-kickback regulations, state corporate practice of medicine laws and all manner of complicated regulatory problems. Additionally, we represent healthcare clients in matters involving Certificate of Need applications and opposition.

Comprehensive Industry Experience

Our healthcare attorneys advise investor-owned and tax-exempt healthcare providers from virtually every segment of the healthcare industry, including hospitals and health systems, behavioral health, ambulatory surgery centers and outpatient services, post-acute and long-term care providers, and dental practices and dental support organizations. Our experience with physician practices and practice management companies spans a wide range of specialties, including:

• anesthesiology
• chiropractic and physical therapy
• dermatology
• gastroenterology
• oncology
• ophthalmology, optometry and optical
• women's health

Transactional Matters

Our Healthcare Regulatory and Compliance Team advises clients on the regulatory aspects of healthcare mergers, acquisitions, syndications, joint ventures, divestitures and restructuring. Providers rely on our vast experience in structuring mergers and acquisitions (M&A) and joint ventures to ensure compliance with federal and state regulations. Private equity and venture capital firms and healthcare specialty lenders leverage our deep understanding of the healthcare regulatory environment in investments and commercial finance transactions.

Holland & Knight healthcare attorneys advise clients with respect to innovative models for hospitals and physicians to work together, including through clinical co-management agreements and foundation models, within physician-hospital organizations and accountable care organizations, and through clinically integrated networks. We also assist clients with the use of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) Self-Disclosure Protocol and the Centers for Medicare & Medicaid Services (CMS) Voluntary Self-Referral Disclosure Protocol for acquisition targets when undisclosed compliance issues can slow or derail a strategic deal.

Data Security and Patient Privacy

Holland & Knight routinely advises healthcare providers and business associates on compliance matters involving protected health information and other patient data, including:

• HIPAA patient privacy and security regulations
• electronic storage and transfer of medical records
• electronic payment systems
• security programs under the HITECH Act
• data breaches
• HIPAA enforcement matters with the HHS Office for Civil Rights

Regulatory Investigations and Audits

Clients rely on our experience when confronted with government investigations, claims of overpayment or allegations of False Claims Act violations. We counsel clients in investigations and enforcement actions brought by the U.S. Department of Justice, HHS-OIG and Medicaid Fraud Control Unit. Holland & Knight attorneys conduct regulatory investigations, audits and appeals involving Medicare reimbursement, and we have successfully challenged overpayment allegations involving Unified Program Integrity Contractors (UPIC), Zone Program Integrity Contracts (ZPIC), Recovery Audit Contractors (RACs), Medicare Administrative Contractors (MACs), OIG audits and Medicare payment suspensions.