Caroline Conneely works on regulatory matters in the healthcare and life sciences industries, assisting clients and their counsel in evaluating and managing regulatory and compliance risks; responding to and investigating allegations of fraud and other potential regulatory violations; and identifying opportunities for procedural and operational improvements.
These engagements typically include the evaluation of existing and historical systems, processes and controls; the analysis and quantification of potential financial exposure; and the development of integrated data to monitor compliance. Her clients include hospital systems and post-acute healthcare providers; companies throughout the pharmaceutical supply chain including manufacturers, drug wholesalers, prescribers and retail pharmacies; and commercial insurance plans.
Ms. Conneely works with organizations to conduct legal and regulatory assessments, to evaluate compliance programs and activities, and to develop strategic improvements to mitigate identified risks. She has advised clients across in the provider, life sciences, and healthcare technology arenas on a variety of regulatory compliance issues, including matters related to billing and reimbursement issues, controlled substance compliance, sales and marketing activities, and general compliance program activities. Additionally, she has supported hospital companies and pharmaceutical manufacturers on regulatory compliance activities pursuant to Corporate Integrity Agreements (“CIAs”).
Ms. Conneely has also assisted clients through all phases of the investigation and litigation lifecycle across the pharmaceutical, retail pharmacy, drug distribution, health system and managed care arenas on issues ranging from allegations of improper pricing, billing and coding activities to submissions of false claims and failures to meet regulatory obligations. In these matters, she has extensive experience performing assessments of potential compliance risks and regulatory violations; designing and managing complex data models to estimate financial exposure, to evaluate potential damages scenarios and to develop various settlement constructs; and identifying recommendations for process and control improvements.
Ms. Conneely is Certified in Healthcare Compliance (CHC) by the Health Care Compliance Association (HCCA). Prior to joining FTI Consulting, she provided advisory services in the litigation support practices at KPMG and Arthur Andersen.