TIE D SR PU TT W EO S & I N V E S T I G AT I O N S Tier Three

Managing Complex Risks in Life Sciences Organizations

Life Sciences Disputes, Compliance and Investigations

About Navigant, Inc. (NYSE: NCI) is a specialized,

global expert services firm dedicated to assisting clients in creating and protecting value in the face of critical business risks and opportunities. Through senior level engagement with clients, Navigant professionals combine technical expertise in Disputes and Investigations, Economics, Financial Advisory and Management Consulting, with business pragmatism in the highly regulated Construction, Energy, Financial Services and Healthcare industries to support clients in addressing their most critical business needs.

In the complex regulatory environment of todays Pharmaceutical, Biotech, Medical Device and Diagnostics industries, companies and their counsel face an increasing number of dispute, compliance and investigation issues that have the potential for significant financial, economic and reputational impact. Navigant is the firm of choice when companies and their counsel need a resource who can successfully and efficiently integrate the skills of complex data management and analysis with the synthesis of highly complex healthcare transactions, rules, regulations, data, documents and business practices to bring meaningful value to the co-development of a dispute, compliance or investigation strategy and execution.

critically tested expertise

THE CHALLENGE NAVIGATING COMPLEX DISPUTES RELATING TO CLINICAL DEVELOPMENT THE SOLUTION
A major pharmaceutical company and their outside counsel required expert guidance in a case involving marketing practices, clinical development and data integrity. Navigant was engaged to evaluate clinical trial activity and related data management and advise outside counsel on potential case strategies, potential areas for further investigation and areas of risk to the case. Reviewing marketing practices in the industry, and related use of clinical data, our team further supported the case strategy development and provided insights into industry standards.

THE CHALLENGE COMPLEX INDEPENDENT REVIEW ORGANIZATION REQUIREMENTS THE SOLUTION

A global pharmaceutical company had entered into a Corporate Integrity Agreement (CIA) that required an Independent Review Organization (IRO) be appointed for five years. The review included among other things, a system review of Government Pricing, medical information requests, fee-for-service arrangements with physicians, funding of third party educational activity, research agreements, sales force compensation, and a transaction review of payments to U.S. based physicians, sampling, call plans and off-label inquiries. Navigant served as IRO, secured approval for the work plan and delivered the annual report in accordance with CIA requirements, while providing advice on relevant improvements based on the reporting year review, and in anticipation of future growth.

THE CHALLENGE DEPARTMENT OF JUSTICE LAUNCHES ANTI-KICKBACK INVESTIGATION THE SOLUTION

A global medical device company received a subpoena related to their contractual arrangements with healthcare professionals. Outside counsel turned to Navigant to investigate the companys arrangements and determine risk, support settlement activity and recommend actions to address risks. The Navigant team established a statistically relevant sample, analyzed extensive data sets and quantified the potential risk and related exposure. Working with outside counsel, our recommendations provided a road map to ensuring healthcare professional arrangements were established with the appropriate controls to manage risks associated with the Anti-Kickback Statute.

Saul B. Helman, M.D. Market Segment Leader, Life Sciences Disputes, Compliance and Investigations 317.294.1228 saul.helman@navigant.com Kevin Cornish Practice Leader, Healthcare and Life Sciences Disputes, Compliance and Investigations 602.528.8090 kcornish@navigant.com

www.navigant.com

The Healthcare and Life Sciences Disputes, Compliance and Investigations practice assists three distinct industry segments: Life Sciences/Medical Device, Provider and Payer, each of which requires unique regulatory and industry knowledge and expertise. Within each market segment, we provide an array of dispute, compliance, investigative services and expert witness testimony to companies and their outside legal counsel.

Some areas of service provided within each market segment include:

DISPUTES
Damages analysis Contract dispute/analysis Intellectual property Claims accuracy and contract compliance Clinical data analysis Product liability Expert witness testimony Claims reimbursement analysis Healthcare advisory Investigation and litigation support Tax exempt status revocation Electronic discovery support

COMPLIANCE
Contract/vendor compliance Comprehensive compliance program assessment and support Government enforcement support: IROs, CIAs, DPAs and monitorships Board level compliance effectiveness certifications Discrete issue compliance assessment Technology solutions development Quality of care reviews Provider education Due diligence

INVESTIGATIONS
Fraud and other special investigation Government shadow investigation False claims/qui tam investigations Fraudulent billing investigations Off-label pharmaceutical practices Provider outlier, billing, coding and documentation RAC audits/investigations Sales and marketing practices Self-disclosure assistance Data breach investigation and response

2012 Navigant Consulting, Inc. All rights reserved. 11-01241A Navigant Consulting is not a certified public accounting firm and does not provide audit, attest, or public accounting services. See www.navigant.com/licensing for a complete listing of private investigator licenses.