Check It Out and Check It Off: 2010 and 2011 Group Health Plan Checklist
Several new laws and regulations from 2010 require significant design changes to group health plans and impose new notice requirements on plan sponsors. For a checklist of the major changes which require implementation in 2010 or 2011 as well as a listing of enrollment and annual notices that group health plan sponsors should consider during open enrollment, please see the Client Alert published by the Employee Benefits & Executive Compensation Client Service Group on September 20, 2010.
New Medicare Enrollment Requirements Will Burden Providers and Suppliers
On September 22, 2010, the Centers for Medicare and Medicaid Services issued proposed rules that will dramatically change the enrollment process for Medicare providers and suppliers, including new enrollment following a change of ownership. For more information on the new requirements, please read the Client Alert published by the Life Sciences and Health Care Client Service Group on September 22, 2010.
CMS Issues Regulations Changing the DMEPOS Supplier Standards
On August 27, 2010, the Centers for Medicare and Medicaid Services published final regulations in the Federal Register that impose new standards on suppliers of durable medical equipment, prosthetics, orthotics and suppliers. Most of the requirements contained in the new regulations will take effect on September 27, 2010. For more information on the regulations, please read the Client Alert published by the Life Sciences and Health Care Client Service Group on September 16, 2010.
From Bow Ties to Standing — The Federal Circuit and False Patent Marking Claims
Following the Federal Circuit decision in Forest Group, Inc. v. Bon Tool Co. 590 F.3d 1295 (Fed. Cir. 2009), there have been many lawsuits filed and decisions rendered under the patent marking statute, 35 U.S.C. Section 292(a). Section 292(a) creates a qui tam cause of action against one who, for the purpose of deceiving the public, falsely markets unpatented products as patented. For more information on this and related cases, please read the Bulletin published by the Intellectual Property group on September 2, 2010.
FDA Panel Split Over Meridia Approval
The FDA advisory panel tasked with making a recommendation on whether the agency should allow for the continued use of Meridia and which warnings shoud accompany the drug, was split in its recent decision, with half the members of a sixteen member panel urging that the drug be withdrawn. For more information on this and related issues, please see the Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin published by the Food and Drug Administration Practice on September 22, 2010.
EPA Phases in Regulation of Greenhouse Gas Emissions Under the Prevent of Significant Deterioration Program of the Clean Air Act
The U.S. Environmental Protection Agency has been working overtime to create a regulatory structure for addressing the emission of Greenhouse Gases under the Prevention of Significant Deterioration provisions of the Clean Air Act. Anticipating the applicability of the requirements to emissions as a consequence of EPA regulations issued in the wake of the Supreme Court’s decision in Massachusetts v. EPA, 549 U.S. 497 (2007), the agency has issued a series of rulemakings to put into place a phased approach to the regulation of emission under the Program. For more information, please see the Client Bulletin published by the Environmental Client Service Group on September 17, 2010.
FDA Launches New Performance Management Systems to Further Transparency
On August 31, 2010, FDA launched an innovative performance management system designed to advance the President’s commitment to transparency, public participation, and collaboration in the work of government. The system, called FDA-TRACK, will monitor more than 100 FDA program offices through data from key performance measures established each year. For more information on this and related issues, please see the Food, Dietary Supplement and Cosmetic Regulatory and Policy Bulletin published by the Food and Drug Administration Practice on September 9, 2010.
The European Court of Justice Dismisses Appeal for Legal Professional Privilege for In-House Lawyers
On September 14, 2010, the Grand Chamber of the European Court of Justice definitively confirmed that written communications between a company’s employees and its in-house counsel are not protected by legal professional privilege in EU competition law matters by dismissing an appeal. For more information on the case, please see the Client Bulletin published by the Antitrust & Competitition Practice dated September 17, 2010.