Health Care Law and Life Sciences Update: The Sun Shines Brightly on Industry-Provider Financial Relationships: Strategies for Responding to Demands for Increased Transparency and Accountability

Expired

Program Number

1923

Program Date

2009-03-12

CLE Credits

Financial relationships between industry and providers involved in biomedical research and innovation, education and clinical care are both complex and commonplace. Senator Grassley’s ongoing investigation into institutional and physician financial relationships with industry and the January 2009 announcement of two historic settlements with major pharmaceutical manufacturers for alleged off-label promotion activity are just two among the many recent developments that highlight the federal government’s aggressive interest in compliance reform in this area. Also in January 2009, the federal government re-introduced the Physician Payment Sunshine Act of 2009, which would establish a nationwide standard requiring drug, device and biologic manufacturers to report financial relationships with physicians and physician-owned entities. This follows on the heels of several states’ enactment of sunshine laws requiring industry to publicly disclose various types of financial relationships. These events portend a continuation in the coming year of the government’s relentless focus on the various compliance implications of providers’ financial relationships with industry. They also suggest a compelling need for industry and providers to expedite their internal compliance programs and for such programs to take an integrated approach to managing the various compliance risks that includes, but also goes well beyond, the need to publicly disclose financial relationships. Join Bernadette Broccolo and Kate Feola of McDermott Will & Emery LLP, as they review the multi-dimensional risks and challenges related to industry-provider financial relationships, including conflicts of interest in research and clinical care, off-label promotion, false claims and anti-kickback, CME accreditation requirements, and industry ethical codes. Our presenters also explore strategies both providers and industry should consider for coping with the challenge of achieving effective but workable compliance approaches under today's shifting and evolving standards.