Off-Label Marketing of Drugs & Devices: Recent Enforcement Efforts, Hot Topics & More (1.21.11)
In the last several years the U.S. Department of Justice, the Food and Drug Administration (FDA), and other federal and state agencies have aggressively pursued both criminal and civil cases against drug and device manufacturers engaged in the promotion of their products for uses not approved by the FDA. Since 2007 alone, cases involving the off-label promotion of drugs and devices have resulted in criminal and civil settlements totaling more than $6 billion, and the cases have involved several of the largest pharmaceutical and device companies in the world. This program will provide an overview of recent developments relating to the government’s enforcement efforts against off-label promotion. A distinguished faculty from the government and the defense bar will discuss the types of off-label marketing that have been detected in recent government investigations, the defenses that may be available, the increased prospect of strict liability misdemeanor prosecutions of corporate executives, and the exclusion of executives from participation in federal health care programs. This program is intended for in-house counsel and outside counsel, members of the white collar criminal defense bar, and all other attorneys who need to learn more about the pursuit and defense of cases involving off-label promotion.
The Impact of Health Care Reform on Employers & Employees in 2011: A Guide for the Practitioner (1.12.11)
Understanding the implications of the Affordable Care Act of 2010 (the Act) can be challenging for both employers and employees. This program is designed to assist in-house counsel and representatives for employers and employees in answering questions concerning employer and employee health care rights and responsibilities in the wake of the Act. The program will review provisions of the Act, provide practical suggestions for complying with the law, answer common questions of employers and employees concerning health care reform, and address emerging and hot topics such as compliance with Section 105(h).
The New Healthcare Reform Law: Impact on Coverage & Reimbursement in New York (7.27.10)
At this seminar a panel of experts will discuss the ramifications of the new Patient Protection Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law) signed in to law this March. The program will cover the impact of the law on Medicaid and Medicare, as well as the impact on hospitals and physicians. In addition, the State’s role with respect to the implementation of the law and health insurance exchanges will also be addressed. The program will end with a panel discussion allowing for interactive questions and answers.
To Share or Not to Share? Legal Implications of Sharing Electronic Health Records in RHIO & Other Health Information Exchanges (6.16.10)
The adoption of electronic health records has been cited as a critical step toward improving quality of care and reimbursement, giving providers better access to patient information, and facilitating communication among unrelated providers regarding the same patient, while reducing administrative costs. The stimulus bill enacted in early 2009 included $19 billion in incentives for hospitals and physicians to replace manual patient record systems with electronic data systems.
Regional health information organizations (RHIOs) and other forms of health information exchanges are integral to the implementation of electronic health records, as they provide the means by which health records can be shared among providers. This CLE will present many legal issues that arise from the sharing of electronic health records from the patient privacy, regulatory, provider and RHIO perspectives, with particular focus on the issues of privacy and security of patient information. Expert panelists, including legal and health care professionals from the private and public sectors, will provide attendees with the latest information on advising clients to properly protect themselves when handling these situations.