Our attorneys have represented some of the largest publicly traded, private and not-for-profit health care systems and businesses. We advise hospitals, academic medical centers, health care systems and service providers, managed care organizations, pharmacies, pharmacy benefit managers, health plan and insurance providers, and skilled nursing and senior living facilities and related REITs. We have counseled these clients in responding to government investigations, FDA enforcement challenges, mergers and acquisitions, restructurings, antitrust matters, tax issues, and litigation and international arbitration, among other matters.
Litigation
Our attorneys — many of whom have held senior positions in government — represent health care companies in the full range of civil and criminal litigation. We have counseled in state and federal individual and class action cases, as well as related multidistrict litigation proceedings. Our team has represented clients in connection with civil and criminal allegations involving Medicaid and Medicare fraud, including alleged violations of the Anti-Kickback Statute, the Stark Law and federal and state False Claims Acts, including those brought by qui tam relators, as well as commercial insurance fraud. The team regularly helps clients navigate Foreign Corrupt Practices Act investigations conducted by the DOJ and the SEC; Federal Food, Drug and Cosmetic Act investigations; securities litigation; and mass tort litigation. We also represent health care companies in a full range of commercial disputes in litigation and arbitration in the U.S. and internationally, including disputes relating to substantial corporate and commercial transactions in the industry.
M&A
We represent clients throughout the health care industry in merger transactions and significant acquisitions, leveraging our understanding of regulatory and business trends. We also routinely advise in connection with takeover preparedness and shareholder activism. In addition, we represent financial sponsors with a focus on M&A and financings in this sector. We provide innovative solutions to industry participants in distressed situations, including in both in-court and out-of-court restructurings.
We have advised on some of the largest health insurance mergers, bringing to bear our insurance M&A and reinsurance expertise.
Our attorneys also represent health care-related REITs in numerous mergers, acquisitions, joint ventures and spin-offs of REITs and their subsidiaries, as well as in IPOs and offerings of debt, equity, hybrid and synthetic securities in both private and public transactions.
Health Care Regulatory Compliance
We counsel clients on FDA, Medicare, Medicaid and other federal health care program laws and regulations as well as state health law matters (e.g., corporate practice of medicine and pharmacy laws). Our attorneys frequently advise on the regulatory aspects of sales and marketing practices, premarket review and licensure of medical products, financial relationships with physicians and health care providers, post-market regulatory and reporting requirements, medical affairs and clinical research, research funding, and grants for investigative studies. Our team has considerable experience conducting internal compliance reviews and, where appropriate, counseling on voluntary disclosures to government regulators. We also provide regulatory due diligence on corporate transactions, including mergers and acquisitions, financings, restructurings and insurance-related matters. Skadden attorneys have worked with numerous companies on matters before the U.S. Food and Drug Administration (FDA); the Centers for Medicare and Medicaid Services; and the U.S. Department of Health and Human Services, Office of Inspector General (HHS OIG) on reporting obligations and voluntary disclosures.
Compliance Programs
We have extensive experience developing, implementing and assessing corporate compliance programs in line with the U.S. Sentencing Commission and HHS OIG guidelines and in negotiating corporate integrity agreements and settlements with federal and state authorities. We also advise management and boards of directors of health care companies on corporate governance practices and developments specific to the industry.
Congressional Investigations
Our team has intimate knowledge of congressional processes, as well as experience working with congressional staff to understand a committee’s focus and needs, and, where possible, to narrow the scope of an inquiry. We are experienced in parallel government enforcement inquiries and grand jury and civil proceedings. In response to a congressional investigation, we provide counseling and judgment beyond the scope of typical government relations advice. Skadden has represented numerous Fortune 500 companies, executives and public officials in high-profile congressional investigations, including inquiries conducted by the major investigatory committees of Congress.
HIPAA and Privacy
Our attorneys counsel and defend a wide range of clients on privacy-related matters, including compliance with the Privacy Rule and Security Rule of the Health Insurance Portability and Accountability Act (HIPAA). We also advise on HIPAA data breaches and violations and the attendant litigation risks.
