Overview
This half-day boot camp for in-house counsel will address a variety of critical and emerging issues facing life sciences companies. Join a cross-section of panelists from McDermott’s Healthcare and Life Sciences teams to hear the latest on everything from reimbursement, fraud and abuse, and Anti-Kickback Statute trends and antitrust compliance to developments in digital health and therapeutics.
FEATURED SESSIONS INCLUDE:
- Fraud & Abuse: Reimbursement Issues for Life Sciences Companies: Life sciences companies that expand into the healthcare provider/supplier space must navigate numerous foundational principles, including reimbursement issues related to fraud and abuse. This panel will provide insight on the important requirements for provider enrollment with third-party payors, types of reimbursement models and government reimbursement programs, and key fraud and abuse frameworks, including the Stark Law and the Civil Monetary Penalties Law. The session will also highlight important updates on the Inflation Reduction Act, the new Medicare Drug Price Negotiation Program and their potential implications for life sciences companies.
- Anti-Kickback Statute Trends: The vast majority of False Claims Act enforcement actions in healthcare—and for life sciences companies, in particular—concern federal Anti-Kickback Statute allegations. This panel will discuss current enforcement trends and government guidance, including manufacturer-sponsored speaking programs and other financial relationships with physicians, recent Advisory Opinions regarding relationships with customers and genetic testing labs, emerging issues with patient support programs and clinical decision tools, and practical actions companies can take to mitigate compliance risks.
- Developments in Digital Health and Therapeutics: Life sciences companies are increasingly developing and investing in digital health and therapeutics solutions to reach new participants and enhance services. This panel will provide key information on evolving privacy regulations, the regulatory framework for the provision of virtual care and other areas of concern. The panel will also discuss challenges, opportunities and the important role that life sciences companies play in digital health.
- M&A Compliance: Antitrust Developments Impacting Life Sciences Companies: This session will focus on recent developments in M&A compliance, including major proposed changes to the FTC / DOJ Merger Guidelines and the Hart-Scott-Rodino Act filing regime. The panel will also provide insights on evolving antitrust issues involving loyalty discounts, bundled discounts, aftermarket parts and service for medical devices, and other contracting and business conduct issues.
