Our Administrative and Compliance practice represents a comprehensive approach to regulatory law, combining deep healthcare industry expertise with broad federal administrative law capabilities. We serve as trusted advisors to healthcare organizations, government contractors, and businesses operating within heavily regulated sectors, providing both proactive compliance guidance and aggressive enforcement defense.
Healthcare Regulatory Excellence
Our healthcare regulatory practice forms the cornerstone of our administrative law capabilities. We maintain extensive experience advising healthcare providers, hospitals, physician groups, and healthcare organizations on the intricate web of federal and state regulations governing the industry. Our counsel encompasses Medicare and Medicaid compliance, including Part A, B, C, and D regulations, as well as complex reimbursement structures and evolving payment methodologies.
We provide sophisticated guidance on HIPAA privacy and security requirements, helping clients navigate breach notification obligations, business associate agreements, and the intersection of privacy laws with operational necessities. Our fraud and abuse law expertise spans the Anti-Kickback Statute, Stark Law, False Claims Act implications, and emerging compliance risks in value-based care arrangements and alternative payment models.
Our team regularly represents clients in high-stakes proceedings before the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), and state health departments. This includes strategic counsel on Medicare and Medicaid audits, overpayment determinations, prepayment reviews, provider enrollment and revalidation challenges, and exclusion proceedings. We also advise on licensure matters, certificate of need applications, and regulatory approvals for new service lines or facility developments.
Federal Administrative Law and National Security
Beyond healthcare, our practice encompasses the full spectrum of federal administrative law, with particular strength in national security and personnel clearance matters. We represent individuals and organizations in security clearance proceedings before the Defense Office of Hearings and Appeals (DOHA), addressing adverse determinations, revocation proceedings, and appeals involving classified information and national security considerations.
Our national security practice includes representation in matters involving the Defense Security Service, Central Intelligence Agency, and other intelligence community agencies. We counsel clients on compliance with the National Industrial Security Program Operating Manual (NISPOM), Foreign Ownership, Control, or Influence (FOCI) matters, and facility security clearance requirements for government contractors.
Multi-Agency Regulatory Advocacy
Our regulatory advocacy extends across numerous federal agencies and highly regulated industries. We maintain active practices before the Food and Drug Administration (FDA), advising pharmaceutical, biotechnology, medical device, and food companies on product approvals, facility inspections, recall procedures, and enforcement actions. Our FDA practice encompasses drug and device development, clinical trial oversight, manufacturing compliance, and post-market surveillance obligations.
We represent agricultural businesses and food producers in matters before the U.S. Department of Agriculture (USDA), including food safety compliance, organic certification, import/export regulations, and Animal and Plant Health Inspection Service (APHIS) proceedings. Our Treasury Department practice focuses on financial services regulation, anti-money laundering compliance, and sanctions enforcement for banks and financial institutions.
Additional agency experience includes representation before the Department of Transportation, Environmental Protection Agency, Federal Trade Commission, and Securities and Exchange Commission, providing clients with comprehensive regulatory counsel across diverse industry sectors.
Compliance Program Development and Risk Management
We assist clients in developing robust compliance programs tailored to their specific regulatory environment and operational risks. Our approach includes compliance risk assessments, policy and procedure development, training program design, and internal audit protocols. We help organizations establish effective monitoring systems, reporting mechanisms, and corrective action procedures that demonstrate good faith compliance efforts to regulators.
Our risk management counsel extends to merger and acquisition due diligence, helping clients identify and address regulatory liabilities in corporate transactions. We also provide ongoing compliance monitoring services, regulatory change management, and strategic advice on emerging regulatory trends and enforcement priorities.
Enforcement Defense and Crisis Management
When enforcement actions arise, our team provides aggressive defense representation while maintaining focus on business continuity and reputation protection. We handle government investigations, administrative proceedings, civil enforcement actions, and parallel criminal matters. Our approach emphasizes early case assessment, strategic negotiation, and, when necessary, vigorous litigation to protect client interests.
We maintain extensive experience with qui tam litigation under the False Claims Act, regulatory exclusion proceedings, license suspension or revocation matters, and civil monetary penalty assessments. Our crisis management capabilities include coordinating with internal and external stakeholders, managing regulatory communications, and developing comprehensive response strategies for high-profile enforcement matters.
Cross-Disciplinary Integration and Client Service
Our practice's strength lies in its cross-disciplinary approach, integrating regulatory expertise with broader legal capabilities including corporate law, litigation, employment law, and transactional services. This comprehensive perspective ensures that regulatory advice aligns with overall business objectives and considers the full range of legal and operational implications.
We prioritize practical, risk-informed guidance that enables clients to operate effectively within complex regulatory frameworks while minimizing compliance risks. Our team maintains current knowledge of evolving enforcement trends, regulatory guidance, and industry best practices, ensuring clients receive timely and relevant counsel in today's dynamic regulatory environment.