Carrie Valiant has been safeguarding health care and life sciences organizations from fraud and abuse and government payment program enforcement challenges since civil and criminal investigations in health care became a government priority over 30 years ago. She leverages her many years of experience in these matters to defend clients undergoing civil and criminal investigation for health care fraud by the Department of Justice (DOJ), the Department of Health and Human Services Office of the Inspector General (OIG), and other state and federal governmental authorities and to recommend compliance strategies to manage risk and preserve business value. Clients seek Carrie’s strategic, yet practical, advice and tenacious advocacy, focused on front-end prevention and back-end assertive defenses, to lead the resolution of complex fraud and abuse matters.
Carrie’s clients come from all segments of the health care industry, including hospitals and academic medical centers, managed care organizations, home health care companies, physician group practices, clinical laboratories, specialty pharmacies, pharmaceutical and device manufacturers, and distributors and group purchasing organizations. She advises them on managing government health care program compliance risks, including designing and implementing corporate compliance programs for health care organizations, preparing OIG advisory opinion requests, and conducting internal investigations and, where necessary, voluntary self-disclosures. Clients also seek Carrie’s advice on complying with the Stark Law, the Anti-Kickback Statute, beneficiary inducement prohibitions, and other regulatory initiatives in the fraud and abuse area, and responding to identified deficiencies.
Among her accomplishments, Carrie has obtained DOJ declinations to intervene in False Claims Act qui tam cases and subsequent dismissal/summary judgment of qui tam relator cases. Where the government has elected to pursue these matters, Carrie uses her deep regulatory knowledge of government payment programs to mitigate government demands, often settling matters at substantially reduced amounts. Her work in these matters also includes negotiating corporate integrity agreements and advocating to avoid them or minimize their scope where possible. Clients frequently turn to Carrie when business exigencies dictate the need to close False Claims Act matters that have been languishing at DOJ without resolution. Her approach is one of relentless, but respectful, advocacy, bringing the parties to the table with creative solutions that result in a satisfactory resolution for everyone.
Carrie recognizes that not every issue is a problem and that many identified problems can be solved creatively without harm to an organization’s financial position or reputation. When potential problems are identified, Carrie leads thorough, yet efficient, internal investigations, and, where necessary, effectively manages the self-disclosure and/or refund process, always sensitive to controlling the scope of the disclosure and the potential for business disruption from these activities. She has negotiated and settled various OIG voluntary disclosures at substantially reduced amounts and without imposition of a corporate integrity agreement.
Clients look to Carrie to handle a variety of Medicare/Medicaid and other government health care program payment and certification matters. She advocates persistently on behalf of clients to reduce substantial CMS overpayment assessments, and to manage EMTALA and other CMS survey and certification matters involving both providers and managed care organizations, including preparing Corrective Action Plans and other strategic agency outreach to avoid federal Medicare program termination.
Carrie understands that health care organizations are challenged to move forward in an environment of limited safe harbor protection for their business activities. Carrie works closely with clients to structure their activities appropriately to mitigate risk yet move forward productively. Her balanced approach and strategic analysis help clients navigate the risks while satisfying stakeholders and accomplishing their business goals.
Long involved in health care fraud and abuse policy work, Carrie has represented clients who are seeking safe harbor or similar protection for their business activities and advocated for a more rational approach to fraud and abuse interpretation and enforcement. Through the preparation of comments to regulations and related activities, she has advocated on behalf of clients to OIG for expanded Anti-Kickback Statute safe harbor protection and to CMS for expanded Stark Law exceptions. A number of Stark Law statutory and regulatory exceptions and Anti-Kickback Statute Safe Harbors can be traced to Carrie’s advocacy. Most recently, she has advocated on behalf of clients across the health care industry in connection with the new value-based safe harbors and Stark law exceptions.
Notably, Carrie was one of the first women attorneys to gain a national reputation in health care fraud and abuse as it emerged as a recognized area of law practice. Her thought leadership includes being the founding author of Legal Issues in Health Care Fraud and Abuse: Navigating the Uncertainties, 4th ed., published by the American Health Lawyers Association. She continues to write and speak frequently on health care fraud and related topics.
Carrie founded and is President of the Health Care Industry Access Initiative, a nonprofit, tax-exempt organization dedicated to promoting collaborative action across the health care industry to improve access to health care coverage and services in the United States. She chairs Epstein Becker Green’s Diversity and Professional Development Committee, a Board-level committee that includes the firm’s Pro Bono Program and Hiring Committee, and speaks frequently on diversity and inclusion in the legal profession. She is Vice Chair of the Board of Directors of Street Law, an international nonprofit organization dedicated to civics education and the rule of law, and also serves on the Board of Directors of WBL, a nonprofit dedicated to promoting senior executive leadership and board service for women in health care.