Understanding the New U.S. Sunshine Act and Its Impact on Health Care Providers and Industry
[On Demand - DL1029]
Duration: 90 minutes
Course Type: Audio / PowerPoint Presentation / Online Q&A
Course Registration Fee: Lex Mundi Member Fee: No Charge / Non-Member Fee: $150
This webinar discusses proposed regulations for physician payment and ownership transparency under the Patient Protection and Affordable Care Act (“PPACA”), also known as the “Sunshine Act,” that will change the way industry and U.S. health care providers interact. The U.S. Sunshine Act applies to U.S. pharmaceutical, biologic device manufacturers, medical supply manufacturers, and GPO’s (Group Purchasing Organizations), and will likely be extended to all physicians eventually.
Compliance with the proposed regulations is a key concern for executives within every department of a pharmaceutical or medical device company, particularly as new legislation is passed and health care becomes an increasingly global industry. Medical affairs and communications departments are no exception to this rule as pharmaceutical companies pursue transparency and compliance. The proposed regulations provide guidance on disclosure of data, and significantly expand the rulemaking authority of the Centers for Medicare and Medicaid Services (“CMS”).
Since the U.S. Sunshine Act applies to U.S. companies and other providers operating globally, it is important for lawyers to be knowledgeable about the provisions of the Act. Comments on the proposed regulations are due on February 17, 2012.
What You Will Learn:
- Key elements of the Sunshine Act and its proposed regulations;
- How the U.S. regulations interact with regulations in individual U.S. states and globally;
- Strategies for ensuring ethical compliance with the Act.
Colin Zick’s practice is focused on health care and compliance issues, and often involves the intersection of those two subjects in administrative proceedings or litigation. His work has had a particular emphasis on compliance issues related to pharmaceutical and medical device companies, hospitals, practitioners and provider organizations. This compliance work includes helping clients establish and maintain effective compliance programs. Colin also defends clients in disputes alleging kickbacks, overpayments, and billing and coding problems, and represents clients before various state health care licensing and regulatory entities.
Colin’s practice also includes work on health care transactional matters. These projects include the establishment of joint ventures, the creation of new entities, drafting and negotiation of service and employment contracts, creation of patient assistance programs and negotiating clinical trial agreements.
Pat Cerundolo’s highly diverse administrative law, litigation and regulatory practice involves representing both private and public sector clients in a variety of local, state and federal regulatory concerns. He has assisted business clients from the energy, biotechnology and transportation industries, and represents telecommunications clients in connection with the regulation of fiber optic and wireless networks, including regulatory compliance, open access issues, and permitting. His work for public entity clients encompasses zoning matters, eminent domain, land use and related litigation.
Bill McKenzie, DePuy
Bill McKenzie currently serves as a Director of Health Care Compliance (HCC) at DePuy, a Johnson & Johnson company. DePuy is a manufacturer and marketer of orthopedic implants with operating company divisions located in Raynham, MA, and Warsaw, IN.
Bill served as co-chair of Johnson & Johnson’s HCC Council from 2007-2008 and led its medical device sector’s initiative for public disclosure of education grants and charitable donations in early 2009. He currently represents J&J on AdvaMed’s Sunshine Act implementation group.
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