Ariane M. Horn | People | Arnold & Porter

Ariane Horn focuses her practice on fraud and abuse compliance and FDA regulation of pharmaceuticals and biological products. Ms. Horn regularly advises pharmaceutical, biotechnology, and medical products companies on a wide variety of complex arrangements with commercial customers, healthcare professionals, and patients. Her counseling in this area includes questions related to the federal Anti-Kickback Statute, the False Claims Act, and the Civil Monetary Penalties & Exclusion laws, as well as various government price reporting laws. In addition, Ms. Horn regularly counsels clients on a broad range of advertising and promotion compliance issues including professional and consumer-directed messaging and advertising, speaker programs, sales representative activities, call and sampling plans, unsolicited requests, scientific exchange, press releases, medical field personnel, consultants, research grants, medical education grants, and publications.

Prior to joining the firm, Ms. Horn was a legal director of US commercial operations for a major pharmaceutical company, where she advised senior management on issues related to advertising and promotion, commercial agreements, and compliance with anti-kickback, government price reporting, and antitrust laws.

Ms. Horn also served previously as Associate General Counsel at Celanese International Corp./Ticona Polymers, Inc.

Focus Areas

Life Sciences & Healthcare Regulatory

Experience

Lead counsel in connection with requests for advisory opinions from the Office of Inspector General of the US Department of Health and Human Services.
Conducted various comprehensive internal business reviews assessing compliance with federal laws relating to healthcare fraud and abuse, including the Anti-Kickback Act.
Negotiation and development of numerous complex commercial contracts with pharmacy benefit managers, insurance companies, wholesalers, pharmacies, hospitals, and many other commercial customers.
Counseling a variety of clients on structuring and implementing a variety of patient support programs, including co-pay assistance programs, free product programs for financially needy patients, coverage/reimbursement support, and patient educational programs.
Served on company promotional and non-promotional material review committees for multiple pharmaceutical manufacturers, including in support of new product launches.

Developed and helped implement compliance policies and procedures.
Conducted numerous in-house trainings for small and large groups (legal and non-legal personnel) concerning fraud and abuse compliance, FDA regulation of promotion, and enforcement trends.