Leech Tishman advises healthcare organizations nationwide on complex regulatory compliance matters affecting the delivery of healthcare services and the operation of healthcare businesses. Our attorneys counsel hospitals, ambulatory surgery centers, clinics, physicians, digital health platforms, and other healthcare providers and stakeholders on regulatory issues that directly impact operations, growth, reimbursement, and enterprise risk.

In today’s healthcare environment, regulatory issues are inseparable from business strategy. Our attorneys advise clients with a clear understanding of how regulatory frameworks shape real-world operations, transactions, and reimbursement outcomes. We help clients navigate not only what the law requires, but how those requirements are interpreted and enforced by regulators, payors, and enforcement agencies in practice.

Healthcare regulation continues to expand in both complexity and enforcement intensity. Federal and state agencies, as well as commercial payors, increasingly rely on sophisticated data analytics, utilization trends, and comparative billing patterns to identify potential compliance issues. At the same time, emerging technologies, including artificial intelligence, telehealth, remote monitoring, and technology-enabled care models, are creating new categories of regulatory exposure. Our attorneys help clients evaluate and respond to these developments with a combination of deep regulatory knowledge and practical, operational judgment.

Our firm has substantial experience navigating the full spectrum of federal and state healthcare regulatory frameworks, including those enforced by the Centers for Medicare & Medicaid Services (CMS), the U.S. Department of Health and Human Services (HHS), the Office of Inspector General (OIG), the Drug Enforcement Administration (DEA), and the Food and Drug Administration (FDA). We regularly advise on compliance with core statutory and regulatory regimes, including:

• The Stark Law and physician self-referral restrictions
• The Anti-Kickback Statute (AKS) and related safe harbors
• The False Claims Act (FCA) and civil enforcement exposure
• Medicare and Medicaid reimbursement rules, including coverage, coding, and billing requirements
• Conditions of Participation and Conditions for Coverage
• Controlled substance prescribing and diversion enforcement
• Telehealth and digital health regulatory frameworks
• State-specific licensing, scope-of-practice, and corporate practice of medicine requirements

We provide strategic, forward-looking guidance on policies, procedures, and enterprise-wide compliance programs designed to support defensible and scalable operations. Our work includes designing and implementing compliance programs, conducting internal audits and risk assessments, evaluating billing and documentation practices, and preparing clients for regulatory scrutiny.

Leech Tishman advises clients across the full lifecycle of regulatory compliance, from structuring new business models and transactions to responding to audits, civil investigative demands, subpoenas, and government inquiries. We routinely assist clients in preparing responses to audits, data requests, and enforcement actions initiated by CMS contractors (including UPICs and MACs), OIG, DOJ, and state agencies.

Our practice is distinguished by the combination of proactive regulatory structuring and real-world enforcement defense. We do not simply advise on compliance in theory, but also regularly defend healthcare organizations in investigations, repayment disputes, overpayment determinations, and allegations of fraud, waste, and abuse. This dual perspective allows us to help clients identify risk early, structure defensible positions, and respond effectively when issues arise.

Clients rely on our attorneys for strategic guidance on both emerging and established regulatory issues, as well as effective representation when compliance matters escalate into investigations, disputes, or enforcement proceedings. Our national platform and deep industry focus enable us to provide consistent, high-level counsel across jurisdictions while remaining closely attuned to evolving regulatory trends and enforcement priorities.

Services

• Artificial Intelligence in Healthcare
• Corporate Practice of Medicine
• Data Privacy & Cybersecurity
• FDA Compliance and Defense
• Governance
• Medicaid
• Medicare
• Regulatory Opinion Letters & Memoranda
• Revenue Cycle, Billing & Documentation Risk
• State Regulatory Compliance, Licensure, and Scope of Practice
• Telemedicine