Healthcare Regulatory, Investigations, and Litigation Counsel
Healthcare is among the most heavily regulated and politically exposed sectors in the country. Clients navigate regulatory, legislative, litigation, and public-facing challenges simultaneously, engaging government stakeholders, the plaintiffs’ bar, the public, and the press.
Holtzman Vogel provides expert advice and representation across these matters. Our healthcare lawyers have advised governors and state health departments, counseled and defended leaders of state agencies with authority over Medicaid, hospital licensure, and health insurance regulation, prosecuted federal healthcare fraud cases, and litigated constitutional and preemption challenges to state healthcare laws. Our nationally recognized political practice groups complement this work and are leaders in their respective fields of government relations, lobbying, political activity, and campaign finance compliance. Together, our lawyers provide clients with a collaborative, firm-wide team handling compliance, litigation, and government relations needs.
Who We Represent
Holtzman Vogel represents hospitals and health systems, academic medical centers, nonprofit and faith-based healthcare providers, hospital boards and trustees, insurers and managed care organizations, pharmacy benefit managers and pharmacy services companies, medical device and life sciences companies, healthcare investors, and trade associations, and state health agencies and officials.
Our Healthcare Legal Services
- Government and Internal Investigations. State attorney general, congressional, and regulatory investigations, and privileged internal investigations for hospital boards and executive healthcare leadership.
- Healthcare Fraud and Abuse Defense. Federal and state healthcare fraud investigations and prosecutions involving allegations of improper billing, kickbacks, and grant and relief fund misappropriation.
- Regulatory Compliance and Enforcement. Medicaid participation, licensure, certificates of need, health facility regulation, insurance oversight, and medical or health professional disciplinary proceedings and data privacy/HIPAA compliance.
- 340B Program Compliance and Litigation. Eligibility, contract pharmacy arrangements, manufacturer restrictions, HRSA audits, duplicate discount and diversion issues, state 340B legislation, and related litigation and administrative proceedings.
- Government Payor and Managed Care Reimbursement. Medicaid and Medicare reimbursement disputes, managed care contracting, supplemental payment programs, provider taxes, state plan amendments, waivers, and challenges to governmental payment determinations.
- Constitutional and Preemption Litigation. Challenges to state healthcare regulation, including ERISA preemption, dormant Commerce Clause, due process, and Contracts Clause claims.
- Healthcare Transactions and Change-of-Control Reviews. Regulatory approvals and strategic counseling for acquisitions, mergers, joint ventures, affiliations, physician practice transactions, and healthcare consolidations, state establishment review and charities bureau review.
- Land Use and Facility Development. Zoning, permitting, environmental review, and local approvals for hospital expansions, medical campuses, and new facilities.
- Nonprofit and Faith-Based Providers. Tax exemption, community benefit, charitable fundraising, lobbying limits and 501(h) elections, conscience protections, and religious liberty defense.
- Political Law and Government Relations Compliance. Federal, state, and local lobbying registration and reporting, gift and ethics rules, pay-to-play restrictions, PAC formation and administration, corporate political spending, and grassroots advocacy.
- Corporate Governance and Compliance. Board structure, fiduciary duties, conflicts of interest, executive compensation, compliance programs, and internal policies for health systems and their affiliated entities and foundations.
Our Approach
- Proactive Risk Management. Identify exposure through compliance and policy review before an inquiry arrives.
- Integrated Regulatory and Litigation Counsel. Advise on how regulatory positions carry into litigation risk and how litigation strategy carries into operations.
- Government Experience. Draw on healthcare attorneys who built, enforced, and administered the rules our clients operate under.
- Political Acumen. Navigate the legislative, regulatory, and public dimensions of matters that do not stay confidential.
- Collaborative Counsel. Work alongside in-house legal, compliance, and communications teams.