Risk, Regulatory & Quality

We help clients respond to and resolve litigation, disputes, and investigations across the entire healthcare and life sciences continuum.

We have played a significant role in many well-known, high-stakes healthcare litigation and investigation matters, including post-acquisition disputes; False Claims Act cases; Fair Market Value, Stark Law and Anti-Kickback Statute investigations; class actions, antitrust and business disputes; and other issues.

We deliver proven solutions at each stage of an investigation’s life cycle, from structured data collection, production, and analysis, to privileged consulting support, to expert witness services. We are comfortable working in the “gray area” of an issue, regulation or allegation, and we excel at developing thoughtful solutions to unique challenges.

Clients engage us to help conduct internal investigations related to government healthcare programs, including Medicare and Medicaid fraud and abuse issues. As part of these investigations, we regularly assist clients and their counsel in discussions with the DOJ, OIG, state Medicaid and regulatory agencies, and the SEC.

Clients engage us to develop and assess the effectiveness of their compliance programs. This involves identifying and implementing opportunities to strengthen internal monitoring and auditing processes; advising on policies, procedures, and standards of conduct; building effective training programs and lines of communication; and performing detailed reviews of healthcare claims using statistical samples, benchmarking of client and industry data, and sophisticated electronic models.

Our multidisciplinary team includes nurses, clinicians, physicians, coders, and other experienced healthcare professionals. Clients rely on our clinical experience in matters involving medical necessity of care; analysis of billing, coding, and reimbursement issues; and other federal and state healthcare program coverage and healthcare compliance issues.

We have performed independent review and monitoring activities for a wide variety of healthcare clients, including serving as Independent Review Organization (IRO) and Compliance Expert as part of Corporate Integrity Agreements. Government agencies also regularly engage us to help them develop analytical methodologies and reporting formats.

Compliance due diligence is playing an increasingly important role in evaluating and delivering on business combinations. We work with clients to provide tailored solutions for assessing compliance risks and developing post-acquisition process improvement plans. Our work includes evaluating the people, processes, and technologies making up a target’s compliance program; conducting coding and billing reviews; reviewing medical records; evaluating medical necessity; and conducting data-based company- and market-specific risk profiling. We also regularly assist in the post-deal integration of Risk and Compliance Program functions.

Our Technology Quality, Risk and Compliance team implements compliant solutions and integrated controls for the life sciences and healthcare industries. Our industry portfolio of solutions covers Privacy Program Effectiveness Reviews, HIPAA Privacy and Security Rule Risk Assessments, Privacy Incident Support, Enterprise Privacy Program Design and Implementation, Computer System Validation, Enterprise Risk Management, Medical Device Safety and Security, Data Integrity, Automation and Quality Transformation solutions.

Regulatory Solutions help our clients navigate the complex, global regulatory environment to reduce risk and achieve regulatory objectives. FTI helps healthcare and life sciences companies improve compliance and address requirements of the many health, safety, environmental and financial agencies that impact the sector, in the United States, in the European Union, and globally.

Our regulatory team provides a full range of leading practice solutions, including facilitating development of regulatory strategy, operating model enhancement, developing regulatory intelligence solutions, submission and lifecycle process optimization, and implementation of Regulatory Information Management (RIM) and intelligent automation technologies. The team is active in RAPS and the DIA, including leading development of the RIM Reference Model and RIM Whitepaper 3.0.

Quality solutions span the continuum from simple quality control and quality assurance activities to establishing a robust, globally compliant Quality Management System. Quality embodies concepts of compliance, accuracy, reliability, and availability among others, and is a fundamental requirement across the healthcare ecosystem.

Our Quality team provides a full range of quality solutions including Quality Management System (QMS) development and optimization, continuous improvement, quality and risk analytics, culture of quality / change management, SOP development, lifecycle management, data integrity and product quality strategy. Our team works closely with the FDA and Medical Device Innovation Consortium leading workstreams including Advanced Manufacturing, Leadership Engagement and Quality Metrics.