Six Ropes & Gray Attorneys to Present at 2024 Pharmaceutical and Medical Device Ethics and Compliance Congress

Six Ropes & Gray attorneys will present four sessions at the 25^th Annual Pharmaceutical and Medical Device Ethics and Compliance Congress in Washington, D.C. October 28—29.

The forum for compliance professionals, legal counsel, regulators and industry consultants covers pharmaceutical and medical device topics including key laws, regulations, guidance and policy developments, among others.

Attorneys participating in the Congress include:

Samantha Barrett Badlam, litigation & enforcement partner, will moderate a panel on “Patient Support Programs and Patient Access Programs—A Look at the Evolution, Risks and Enforcement Activity.” The discussion will examine laws and recent enforcement activity impacting patient support and patient assistance programs as well as risks to avoid with respect to the False Claims Act, Anti-Kickback Statute, HIPAA/Data Privacy and Federal Food, Drug and Cosmetics Act off-label prescribing.

Christine Moundas, health care partner, will speak on the panel titled “Responsible AI at the Cusp of Scale” that will examine  AI ethics, strategic risk frameworks, scaling governance and the implications of new regulations. Christine serves as co-lead of the firm’s digital health initiative that advises on key issues posed by the rapid convergence of technology, health care, medical devices and pharmaceuticals.

Health care partners Eve Brunts and Margaux Hall and health care counsel Alison Fethke will present on the panel titled “Exploring Risks and Enforcement Trends for Buy-and-Bill Drugs.” The session will discuss the supply, distribution, promotion and reimbursement of buy-and-bill drugs, including key risk areas such as pharmacy/medical benefit switches, coverage of service and administration fees and reimbursement support for providers including under the Anti-Kickback Statute and government price reporting laws.

Amy Kossak, litigation & enforcement partner and former Senior Trial Counsel at the U.S. Department of Justice, will moderate the panel titled “Perspectives from DOJ, HHS-OIG, and the Relators Bar on How Compliance Departments Can Effectively Prevent and Help Respond to Qui Tam Whistleblower Suits.” The panel will explore practical steps a compliance department can take to reduce the risk of a qui tam filing, the role of self-disclosure, cooperation and remediation in the context of False Claims Act enforcement, and compliance measures that can help a company demonstrate to the government that its compliance program is effective.