Leech Tishman advises healthcare organizations nationwide on complex regulatory frameworks governing healthcare delivery, life sciences, digital health, and health-adjacent products and services. Our attorneys possess deep knowledge of healthcare policy, regulatory enforcement priorities, reimbursement systems, and the operational realities that determine how compliance issues arise in practice.

We counsel clients across the full spectrum of federal and state healthcare regulation, including Stark Law, the Anti-Kickback Statute, the False Claims Act, Medicare and Medicaid participation and reimbursement requirements, CMS Conditions of Participation and Conditions for Coverage, corporate practice of medicine, fee-splitting restrictions, state licensure rules, DEA requirements, HIPAA and state privacy laws, telehealth requirements, and emerging regulation of artificial intelligence and digital health technologies.

Healthcare regulatory issues are rarely isolated legal questions. They affect operations, reimbursement, transactions, growth strategy, investor confidence, licensure, patient relationships, and enterprise value. Leech Tishman helps clients evaluate regulatory risk in context, develop practical compliance strategies, and implement structures that are defensible, commercially workable, and tailored to the client’s business model.

Our attorneys assist clients with structuring new business models, evaluating regulatory risk, developing compliance programs, conducting internal reviews, preparing regulatory opinion letters and memoranda, and responding to audits, investigations, and enforcement exposure. We advise healthcare organizations with a practical understanding of how regulatory requirements are interpreted by regulators, payors, licensing boards, enforcement agencies, and private litigants.

We also counsel clients on matters regulated by the Food and Drug Administration, including pharmaceuticals, medical devices, diagnostics, dietary supplements, cosmetics, wellness products, stem cell products, and other health-related products. Our team advises across the full spectrum of FDA compliance, including product classification, product safety, labeling, advertising and promotion, quality systems, clinical research, and enforcement risk.

As technology continues to transform healthcare delivery, we advise clients on the regulatory implications of telehealth, artificial intelligence, remote patient monitoring, digital therapeutics, health information technology, consumer health tools, and technology-enabled care models. We help clients assess how these innovations intersect with privacy, reimbursement, licensing, standard-of-care, FDA, and fraud and abuse requirements.

When regulatory issues escalate, our litigators work seamlessly with our regulatory attorneys to protect client interests in audits, administrative proceedings, investigations, enforcement actions, and litigation. Our integrated approach allows us to help clients address compliance gaps, resolve disputes with state and federal agencies, and defend business models under regulatory scrutiny

Healthcare Regulatory Compliance Services

• Federal and state healthcare regulatory compliance
• Stark Law and Anti-Kickback Statute counseling
• False Claims Act risk assessment and mitigation
• Corporate practice of medicine and fee-splitting compliance
• Medicare and Medicaid participation, billing, and reimbursement guidance
• CMS Conditions of Participation and Conditions for Coverage
• HIPAA, HITECH, privacy, cybersecurity, and health data governance
• Telehealth, digital health, and remote patient monitoring compliance
• Artificial intelligence in healthcare governance and risk management
• DEA and controlled substances compliance
• FDA compliance for drugs, devices, diagnostics, cosmetics, supplements, and wellness products
• State licensure, certification, enrollment, and regulatory approvals
• Compliance program development, risk assessments, and internal audits
• Regulatory opinion letters and memoranda
• Response to audits, data requests, agency inquiries, and enforcement actions

Leech Tishman advises healthcare clients on corporate and transactional matters throughout the business lifecycle. We understand the consolidation trends, emerging care models, reimbursement pressures, private equity investment strategies, and regulatory constraints shaping healthcare transactions, and we bring that industry insight to every deal.

Our attorneys counsel clients on entity formation and structuring, mergers and acquisitions, joint ventures, divestitures, succession planning, strategic affiliations, management services organization structures, professional entity arrangements, and transactions involving healthcare providers, digital health companies, life sciences businesses, consumer health companies, wellness companies, and health-adjacent businesses.

Healthcare transactions require more than traditional corporate documentation. They require careful attention to regulatory diligence, licensure, Medicare and Medicaid enrollment, reimbursement risk, corporate practice of medicine, fee-splitting, Stark Law, Anti-Kickback Statute, HIPAA, FDA, DEA, state-specific healthcare requirements, and post-closing operational compliance. Leech Tishman helps clients structure transactions in a way that supports growth while managing the regulatory risks that can affect valuation, closing certainty, post-closing operations, and long-term enterprise value.

We regularly advise investors, operators, founders, management companies, provider organizations, professional entities, and healthcare platforms on purchase and sale agreements, management services agreements, professional services arrangements, joint ventures, restrictive covenant issues, earnouts, roll-up strategies, and post-closing regulatory integration.

Our attorneys are particularly experienced in structuring transactions involving management services organizations and professional entities, including PC-MSO models designed to comply with state corporate practice of medicine rules. We help clients align ownership, governance, management rights, clinical oversight, banking, fee arrangements, intellectual property licensing, and control mechanisms with applicable state law requirements.

Because our healthcare transactional work is integrated with our regulatory and litigation practices, we are able to identify issues that purely transactional counsel may miss. We advise not only on how to close a transaction, but how to structure healthcare business relationships so they can operate, grow, withstand scrutiny, and be defended if challenged.

Healthcare Corporate Transaction Services

• Healthcare mergers, acquisitions, divestitures, and strategic transactions
• Healthcare private equity and platform transactions
• Management services organization and professional corporation structuring
• Purchase and sale agreements
• Joint ventures and strategic affiliations
• Business entity formation and healthcare business structuring
• Regulatory due diligence
• Licensure, change-of-ownership, certification, and enrollment issues
• Medicare, Medicaid, and commercial payor diligence
• Stark Law, Anti-Kickback Statute, and fraud and abuse analysis
• Corporate practice of medicine and fee-splitting analysis
• Management services agreements and professional services agreements
• Telehealth, digital health, and healthcare technology transactions
• Life sciences, FDA-regulated, consumer health, and wellness business transactions
• Post-closing regulatory integration and compliance remediation

Leech Tishman represents healthcare organizations, healthcare businesses, investors, providers, and individuals in complex litigation arising from regulatory, operational, reimbursement, and commercial disputes. Our litigation strategy is informed by a deep understanding of the healthcare regulatory landscape and the practical realities of healthcare operations.

We litigate high-stakes matters that materially affect healthcare businesses, including reimbursement disputes, payor recoupment actions, regulatory enforcement matters, commercial disputes, corporate practice of medicine disputes, licensure and certification challenges, provider termination matters, managed care disputes, False Claims Act-related matters, and cases involving industry-defining regulatory issues.

Our experience includes litigation involving state and federal regulatory agencies, commercial payors, healthcare companies, investors, competitors, and private litigants, as well as matters raising administrative law, preemption, constitutional, and statutory interpretation issues unique to the healthcare sector.

Healthcare litigation often requires more than courtroom advocacy. It requires an understanding of how regulatory rules, reimbursement systems, licensure requirements, agency positions, and healthcare business operations interact. Our attorneys understand how state-specific requirements and federal regulatory frameworks—including Medicare, Medicaid, DEA, FDA, HIPAA, Stark Law, Anti-Kickback Statute, False Claims Act, and corporate practice of medicine doctrines—intersect with litigation risk.

That regulatory fluency allows us to defend healthcare organizations effectively, develop leverage, assess business consequences, and position matters for favorable resolution. Because our litigation team works closely with our healthcare regulatory attorneys, we are able to identify legal, operational, reimbursement, and enforcement implications early and integrate them into litigation strategy from the outset.

Leech Tishman represents clients in litigation and disputes involving regulators, payors, business partners, competitors, investors, professional entities, management companies, employees, patients, and other stakeholders. We focus on resolving disputes efficiently where possible and litigating aggressively where necessary to protect our clients’ business, regulatory, and reputational interests.

Healthcare Litigation Services

• Healthcare regulatory litigation
• Reimbursement disputes and payor litigation
• Medicare, Medicaid, and commercial payor recoupment matters
• Recovery audits and overpayment disputes
• Administrative appeals and agency proceedings
• Corporate practice of medicine and MSO-related disputes
• False Claims Act-related litigation and defense
• Licensure, certification, and provider enrollment disputes
• Provider termination and exclusion matters
• Managed care and payor contract disputes
• Commercial litigation involving healthcare businesses
• Shareholder, member, investor, and business ownership disputes in healthcare companies
• Emergency injunctions and crisis litigation
• Preemption, constitutional, and administrative law matters affecting healthcare operations
• Litigation involving healthcare technology, digital health, and telehealth business models

Leech Tishman represents healthcare organizations, executives, providers, investors, and individuals in government investigations and enforcement matters involving federal and state healthcare agencies. Our government investigations practice combines deep healthcare regulatory knowledge with experienced advocacy in matters that can affect licensure, reimbursement, operations, reputation, and enterprise value.

We advise clients facing audits, subpoenas, civil investigative demands, data requests, administrative inquiries, repayment demands, enforcement actions, licensing investigations, and parallel civil, criminal, administrative, and payor proceedings. Our attorneys guide clients through investigations with a focus on preserving privilege, minimizing disruption, protecting licensure and reimbursement, managing communications with regulators and payors, and positioning matters for favorable resolution.

Our attorneys represent clients in matters involving the Department of Justice, HHS Office of Inspector General, Centers for Medicare & Medicaid Services, Drug Enforcement Administration, Food and Drug Administration, Office for Civil Rights, state attorneys general, state licensing boards, Medicaid Fraud Control Units, Medicare Administrative Contractors, Unified Program Integrity Contractors, Recovery Audit Contractors, Medicaid agencies, and commercial payors.

We handle investigations and enforcement matters involving healthcare operations, reimbursement, billing, documentation, referral relationships, Stark Law, Anti-Kickback Statute, False Claims Act exposure, corporate practice of medicine, controlled substances, privacy, cybersecurity, telehealth, FDA-regulated products, patient safety, quality-of-care concerns, and regulatory compliance.

Our work includes conducting privileged internal investigations, assessing potential exposure, preparing witnesses, managing document productions, responding to subpoenas and civil investigative demands, evaluating repayment and overpayment obligations, advising on self-disclosure considerations, developing corrective action plans, negotiating with government agencies and payors, and challenging adverse agency action through administrative or judicial proceedings.

When investigations involve parallel exposure, such as civil enforcement, criminal risk, administrative sanctions, licensure consequences, payor termination, exclusion risk, or reputational harm, we coordinate defense strategy across proceedings to protect the client’s broader business and regulatory interests.

Because our investigations practice is integrated with our regulatory, reimbursement, transactional, privacy, FDA, and litigation teams, we are able to evaluate not only the immediate enforcement issue, but also the operational and enterprise consequences that follow. We help clients respond decisively while preserving the ability to operate, negotiate, remediate, and defend.

Government Investigations Services

• Federal and state healthcare investigations
• DOJ, HHS-OIG, CMS, DEA, FDA, OCR, and state agency matters
• Medicaid Fraud Control Unit investigations
• State licensing board investigations
• Medicare and Medicaid audits
• UPIC, MAC, RAC, and commercial payor audits
• Civil investigative demands and subpoenas
• False Claims Act investigations and defense
• Stark Law and Anti-Kickback Statute investigations
• Controlled substances and DEA investigations
• FDA enforcement and product-related investigations
• HIPAA, privacy, cybersecurity, and breach-related investigations
• Internal investigations and privileged compliance reviews
• Overpayment, repayment, and self-disclosure analysis
• Corrective action plans and compliance remediation
• Administrative appeals and challenges to agency action
• Crisis response and reputation-sensitive investigations

• Addiction and Recovery
• Addiction Treatment
• Aesthetic Medicine / Beauty / Medical Spas
• Alternative Medicine Providers
• Ambulance / Medical Transport
• Ambulatory Surgery Centers
• Assisted Living Facilities
• Behavioral Healthcare
• Biologics
• Cannabis Cultivators
• Cannabis Dispensaries
• Cannabis Investors
• Cannabis Licensing
• Cannabis Manufacturers
• Clinical Research
• Consumer Medicine
• COVID-19
• Dentistry
• Diagnostic Imaging / Testing
• Digital Health
• Direct to Consumer Health
• DNA Testing
• Durable Medical Equipment
• Federally Qualified Health Centers
• Genomics
• Group Homes
• Health Plans
• Healthcare Plans
• Health Information Technology
• Home Health Agencies
• Hospice Care
• Hospitals & Health Systems
• Independent Physician Associations
• Integrative and Alternative Medicine
• Laboratories
• Laboratory Testing
• Long-Term Care
• Managed Care Entities
• Management Services Organizations
• Medical Cannabis
• Medical Devices
• Medical Staff Representation
• Mental Health
• Mental Health Professionals
• Nurses and Allied Professionals
• Nutraceuticals and Dietary Supplements
• Pharmacies and Pharmaceutical Companies
• Physical Therapy
• Physician Practices
• Physician-Hospital Ventures
• Plastic Surgery
• Professional License Defense
• Psychedelics
• Senior Services
• Skilled Nursing
• Telemedicine
• Value-Based Care
• Youth and Family Services