Gathering at Informa Connect's Conference Focused on Transparency and HCP Interaction
On Tuesday, August 12, Amanda Masselam Strachan will participate in a fireside chat as part of Informa Connect's Transparency & HCP Engagement Conference. The title of her session is "Enforcement Update - Examining Today's Regulatory Landscape and Emerging Trends."
During the chat, Ms. Strachan will discuss key issues related to the regulatory landscape and emerging trends in the life sciences industry with a focus on the heightened enforcement environment and evolving compliance challenges. Her conversation partner will be Lauren Kootman, Principal Assistant Deputy Chief of the DOJ's Corporate Enforcement & Compliance Unit, Fraud Section.
The discussion will cover various topics, including HCP engagement, compliance monitoring, data reporting and governance, and the latest guidance and expectations for effective compliance programs. The session will take place from 11:15am to 12:00pm.
One of the main topics to be addressed is the relaunch of the DOJ-HHS False Claims Act (FCA) Working Group, which signals a renewed and intensified focus on FCA enforcement in life sciences. The Working Group will concentrate on drug, device, and biologics pricing, kickbacks, and manipulation of electronic health records to inappropriately increase Medicare utilization.
The Working Group will prioritise enforcement areas such as Medicare Advantage, pricing arrangements (discounts, rebates, service fees), patient access barriers, kickbacks, defective medical devices, and data manipulation. This reflects a broad federal commitment to scrutinizing improper financial arrangements and fraud in federally funded healthcare programs.
The agencies aim to leverage enhanced data mining techniques and OIG reports to identify enforcement targets more effectively and consider implementation of payment suspensions under relevant regulations for credible fraud allegations.
Recent OIG advisory opinions illustrate increased scrutiny around manufacturer-customer financial arrangements, highlighting forbidden practices that risk improper steering and competitive advantage, while also clarifying allowable patient support programs and manufacturer-sponsored services.
The chat will also likely touch on strategic implications for life sciences companies, including the necessity of strengthening compliance programs, proactive risk assessments, and alignment with evolving regulatory expectations amidst ongoing DOJ-HHS collaboration and enforcement activity.
Broader regulatory trends include escalating FDA and HHS regulatory policies affecting manufacturing oversight and M&A due diligence, which also integrate antitrust considerations exemplified by recent legal rulings and major industry transactions.
The discussion underscores an intensified enforcement landscape driven by collaborative federal efforts and data analytics, necessitating vigilant compliance programs in life sciences organisations to address pricing, kickbacks, data integrity, and patient access within a complex regulatory framework.
The Informa Connect's Transparency & HCP Engagement Conference brings together Pharma and MedTech visionaries, making it an invaluable opportunity for industry professionals to gain insights into the current and future regulatory landscape.
- During the chat, the focus on emerging trends in the life sciences industry will extend to discussions about financial arrangements and compliance programs, particularly in the context of the renewed and intensified focus on False Claims Act (FCA) enforcement.
- The relaunch of the DOJ-HHS False Claims Act (FCA) Working Group will prioritize enforcement areas such as drug, device, and biologics pricing, kickbacks, and data manipulation, signaling a broader federal commitment to scrutinizing fraud in federally funded healthcare programs.
- Beyond FCA enforcement, broader regulatory trends in the life sciences industry will be addressed, including the escalating FDA and HHS regulatory policies affecting manufacturing oversight and M&A due diligence, which integrate antitrust considerations. These trends highlight the need for companies to align with evolving regulatory expectations and maintain vigilant compliance programs.
