Stephen A. Warnke
Stephen Warnke represents a wide range of health care clients on state and federal regulatory, enforcement and compliance matters. Most recently, he is helping clients navigate a myriad of legal and regulatory issues associated with the response to the COVID-19 pandemic. Stephen’s clients include not-for profit teaching hospitals and medical schools, managed care organizations, investor-owned health care and pharmaceutical companies, and community-based providers of health, mental health and social services.
Stephen advises clients on Medicare, Medicaid and other government funding programs; state and federal fraud and abuse authorities, including the Stark physician self-referral and anti-kickback statutes; the repayment and disclosure obligations that arise from overpayments and improper relationships with referral source physicians; the design and implementation of corporate compliance programs; and the increasingly aggressive use of the state and federal civil false claims statutes by prosecutors and the “qui tam” bar.
Stephen is the principal author of “Health Care Fraud and Abuse,” in White Collar Crime: Business and Regulatory Offenses (Law Journal Press, 2008), a treatise for practitioners co-edited by Otto Obermaier and Robert Morvillo.
A former policy advisor in New York City government, Stephen also counsels clients on New York’s unique regulatory, reimbursement and enforcement landscape and has extensive experience before the New York State Department of Health and other New York regulators. In 2009, at the request of Andrew Cuomo, then New York Attorney General, Stephen became the founding chair of FAIR Health, Inc., a New York charity that publishes the benchmark data used by health insurers to set “usual and customary rates” (or “UCRs”) for out-of-network physician reimbursement. FAIR Health issues independent UCR data for commercial, consumer and academic research purposes and is a major contributor to the health reform debate.
- Civil Resolution of Investigations: On behalf of health systems, managed care organizations, home health agencies, pharmacies and other direct care providers, Stephen has negotiated the civil resolution of multiple high-profile fraud investigations conducted by the New York State Attorney General, the United States Attorneys for the Eastern, Northern and Southern Districts of New York, and state and federal regulatory authorities, including the Office of Inspector General for the United States Department of Health & Human Services (“HHS-OIG”).
- Compliance Program Development and Advice: Dating back to the late 1990s, Stephen has represented a number of health providers and health plans in the development, implementation and refinement of corporate compliance programs designed to meet both the HHS-OIG’s evolving guidance for such programs and Corporate Integrity Agreement (“CIA”) obligations. More recently, Stephen has negotiated two of the first CIAs ever to be reached with the New York State Office of the Medicaid Inspector General, which were based on the HHS-OIG’s CIA models and subject to the HHS-OIG’s consent.
- Pharmaceutical Compliance: Stephen has advised a number of pharmaceutical clients on Medicaid drug reporting obligations, state supplemental rebate programs, Medicare Part D compliance, and application of state and federal anti-kickback laws to drug promotional activity, including interactions with health care professionals.
- Specific clients that Stephen represents include:
- IASIS Healthcare
- Visiting Nurse Service of New York
- Northwell Health
- ElderServe Health
- Village Care of New York
- Maimonides Medical Center
- United Cerebral Palsy of New York
- Yale University
- CenterLight Health System
- Amida Care
- Union Health Center
- United Shockwave Therapies
- Presenter, “The Civil Frauds Enforcement Landscape: Recent Developments and Trends,” New York City Bar Association (March 2012)
- Presenter, “Litigating New York False Claims Act Cases,” New York State Bar Association (December 2012)
- JD, Yale Law School, 1985
- BA, magna cum laude, Harvard University, 1981