Insights

Washington, D.C. – January 13, 2015: Crowell & Moring LLP is pleased to announce the publication of its third annual "Litigation Forecast: What Corporate Counsel Need to Know in the Coming Year," and the introduction of its first-ever "Regulatory Forecast 2015: What Corporate Counsel Need to Know in the Coming Year."

Washington, D.C. – January 12, 2015: Crowell & Moring LLP is pleased to announce the arrival of James G. Flood as a partner and W. Scott Douglas as a senior policy director to the firm's Government Affairs and Health Care groups. With strong government relations and legal experience, Flood is a former counsel to Senator Charles E. Schumer (D-NY) and will chair Crowell & Moring's Government Affairs Group, and Douglas is the former finance director for Senate Majority Leader Mitch McConnell (R-KY). The bi-partisan duo joins the firm from Omnicare, Inc., where Flood served as vice president, government affairs, and Douglas served as senior director, government affairs.

Promising that the Department of Justice (DOJ) will “follow evidence of health care fraud wherever it leads, including into corporate boardrooms and executive suites,” Assistant Attorney General Leslie Caldwell staked out DOJ’s heightened efforts to pursue “large-scale corporate health care fraud” through both criminal prosecutions and civil enforcement actions. In an April 18, 2016 speech to the Health Care Compliance Association’s 20th Annual Compliance Institute, AAG Caldwell also warned health care companies against compliance regimes that are mere “paper programs,” and signaled that when misconduct comes to light, the quality and effectiveness of a company’s compliance program will be an important factor that prosecutors will consider in determining whether to bring criminal charges.

This summary of key lawsuits affecting managed care is provided by the Health Care Group of Crowell & Moring. If you have questions or need assistance on managed care law matters, please contact Chris Flynn, Peter Roan, or any member of the Health Care Group.

Washington, D.C.-based partners, Terry Rea, of Crowell & Moring's Intellectual Property Group, and Keith J. Harrison, of the firm's Labor & Employment and Litigation groups, weigh in on two important cases in the life sciences arena. Harrison discusses Teva Pharmaceuticals USA, Inc.'s challenge of a California appellate decision that a generic-drug manufacturer can be held liable for failing to warn consumers of the side effects listed on the equivalent brand-name drug, which may potentially be taken up by the U.S. Supreme Court. "This is going to be a case that is going to further define the scope of federal preemption," Harrison said. Additionally, Rea talks about the Cuozzo Speed Technologies LLC suit, which argues that the Patent Trial and Appeal Board uses the incorrect standard during America Invents Act (AIA) proceedings, making it difficult for inventors to retain their patents. "Everybody is going to be very, very careful how they handle this [case]," Rea said of the suit, which may upend new IPR standards.

Washington, D.C.-based Health Care Group partner, Troy A. Barsky, speaks with Report On Medicare Compliance regarding Medicare accountable care organizations (ACOs) receiving another year of relief from fraud-and-abuse laws with the recent extension of waivers from the Centers for Medicare & Medicaid Services (CMS) and the Health & Human Services Office of Inspector General. Barsky, a former director of the CMS Division of Technical Payment Policy, stresses the importance of ACOs needing to comply with the anti-kickback statuses of these waivers. "If they use the waivers, it's an area of compliance they need to pay attention to," Barsky continues, "It can trip you up."

Troy Barsky, a partner in the firm's Health Care Group, is interviewed by Modern Healthcare to discuss how government investigators are likely to start wielding the False Claims Act even more aggressively than in the past. Barsky says, "the Justice Department's willingness to pursue huge False Claims cases on physician compensation against hospitals is new. In fact, it has created a great deal of uncertainty among providers who also recognize various financial incentives from the [Centers for Medicare & Medicaid Services] that favor doctor-integration." Barsky is the former director of the CMS Division of the Technical Payment Policy, Chronic Care Policy Group.