For more than 40 years, Venable's healthcare attorneys have served every sector of this highly regulated industry. Positioned at the intersection of healthcare, law, and business, we help clients understand emerging policy, manage compliance, and anticipate trends, empowering them to advance their goals while mitigating risk.
With access to a significant network of industry experts, including in healthcare policy, operations, licensure, data forensics, and reimbursement consultants, our attorneys are equipped to address the unique needs of a diverse range of clients.
Litigation, Investigations, and Audits
We represent payors, providers, suppliers, and pharmaceutical and medical device supply chain stakeholders in civil and criminal U.S. Department of Justice (DOJ) and state attorney general litigations and investigations, and in whistleblower qui tam actions, reimbursement disputes, and federal and state audits.
To provide timely and impactful guidance for compliance process redesign, business operations, regulatory enforcement, and overall risk management, our healthcare team stays ahead of regulatory developments from newly enacted or pending legislation, caselaw developments, final and proposed rules, and regulatory guidance.
Our healthcare transactional work spans mergers and acquisitions, private equity fund investments in healthcare portfolio companies, restructuring and reorganizations, financings, joint venture transactions, strategic alliances, and structuring outsourcing and vendor arrangements. We offer regulatory, licensing, real estate, and zoning counsel to clients embarking on healthcare transactions and assist clients with issues that arise in the course of business transactions, including provider, supplier, managed care, and commercial contracting; due diligence; negotiations; and executive and workforce employment issues. Our attorneys review mergers through antitrust enforcement authorities, manage risk assessment and succession concerns, and provide risk and insurance analysis.
Combined with Venable's Legislative and Government Affairs practice and nationwide regulatory, litigation, and transactions capabilities, our healthcare team delivers full-service counsel that turns our clients’ business aspirations into achievements.
Our counseling includes all major areas of healthcare regulation and litigation, such as:
- Medicare Parts A–D, Medicare Advantage, state Medicare programs, Medicaid, ACA, Inflation Reduction Act (IRA), pharmacy benefit manager (PBM) legislation, and health plan reimbursement
- Risk adjustment and diagnosis coding in Medicare Advantage, Medicaid, and ACA commercial exchange plans
- Medicare and Medicaid certification, compliance with conditions and requirements for participation; state and local provider and professional licensure, certificate of need, certification, and accreditation
- Compliance with federal and state civil and criminal fraud and abuse laws as well as representation in investigations, litigation, and enforcement (False Claims Act, Anti-Kickback Statute, Stark Law)
- Administrative proceedings before the Centers for Medicare & Medicaid Services (CMS), the Office of Inspector General for the Department of Health and Human Services (HHS-OIG), the Food and Drug Administration (FDA), and the Federal Trade Commission (FTC)
- Compliance program development, implementation, and effectiveness; compliance redesign and Corporate Integrity Agreement (CIA) analysis and advice
- Investigating and defending whistleblower allegations
- Third-party payer disputes
- Corporate practice of medicine and fee splitting
- Data privacy, data security, and Health Insurance Portability and Accountability Act (HIPAA)
- Not-for-profit and tax-exempt organizations
Our healthcare lawyers guide clients through sophisticated transactions and related due diligence matters, such as:
- Acquisition and divestiture transactions and structuring
- Debt and equity financing transactions
- Regulatory due diligence and risk assessment
- Structuring development and commercialization deals for complex health-related technology
- Bankruptcy and reorganizations
Our clients consist of healthcare insurers, providers, and suppliers, including local, regional, and national for-profit entities and tax-exempt nonprofits across healthcare subsectors. We also work with private equity, family office, and venture capital investors, lenders, and other industry stakeholders, including:
- Ambulatory surgery centers
- Behavioral health, substance abuse, and disability services
- Clinical laboratory services
- Commercial lenders and direct debt and equity providers
- Digital health companies
- Durable medical equipment suppliers and distributors
- Health insurance plans
- Home care and hospice
- Hospitals and health systems
- Investors, private equity funds, family offices, and venture capital
- Long-term and post-acute care
- Outpatient clinics and providers
- Pharmaceutical and medical device companies
- Physician and healthcare professional groups
- Professional practice management companies
- Radiology and radiation services providers
- Rehabilitation services
- Retail, specialty, and institutional pharmacy
- Senior housing and services