Strategic Review of Pending Sunshine Regulations for the Pharmaceutical, Biotech, Medical Device and GPO Industry LIVE Webcast

Jennifer S. Geetter, Partner, 
McDermott Will & Emery

• Although GPOs and life sciences industry entities may already have robust fraud and abuse compliance programs, these programs may not be sufficient to comply with the Sunshine provisions in light of the specific requirements set forth in the Act and the proposed rule. Correspondingly, even entities with well-established fraud and abuse compliance programs will need to take significant steps to comply with the Final Rule. Smaller biotech companies and start-ups may not have established programs to serve as a foundation for compliance with the Sunshine Rules and may face a more significant uphill battle to comply.
• Given the agency’s May 3rd announcement that it expects release a Final Rule in 2012 with data collection beginning in January 2013, regulated entities may have a compressed timeframe in which to built compliance programs. Accordingly, regulated entities may want to begin the process of developing a draft compliance program based on the provisions in the Act with the proposed rule serving as a guidepost for where the agency may be heading.
• The Proposed Rule contains a number of ambiguities and uncertainties that could be important to regulated parties. Given the detail and breadth of the Proposed Rule, some of these finer details — which could have a big impact — might get lost.
• Complying with the Sunshine Provisions is not just a concern of industry and the GPO community. Institutional providers, physicians, and physician family members will all be affected. Institutional providers and physicians should be considering potential necessary updates to existing conflict of interest programs to position themselves to comply with the rule.

Jen Johnson, Partner, 
VMG Health

• It is now imperative for all life science company executives to understand the Fair Market Value (FMV) requirement and appropriate methodologies for determining payments to physicians.
• The analytical process and documentation to justify the payment is FMV will be essential in defending the compensation level
• The presentation will include tips for determining FMV, use of internal calculators and a compliance checklist for selecting and compensating physicians.