Morgan Lewis

CMS Finalizes 60 Day Overpayment Rule

The final rule relaxes the requirements on “identification” and look-back period. The Centers for Medicare & Medicaid Services (CMS) has released its long-awaited final rule related to the reporting and refunding of…more
| Health

Supreme Court Stays Implementation of Controversial Clean Power Plan

The 5-4 decision temporarily blocks further execution of the EPA’s new plan to cut carbon emissions from existing power plants. On February 9, the US Supreme Court handed a potentially significant defeat to the Obama…more
| Civil Procedure, Civil Remedies, Energy & Utilities, Environmental Law

FDA Issues Draft Guidance on ‘Emerging Signals’

New guidance could present liability concerns for device manufacturers. On December 31, 2015, the Food and Drug Administration (FDA or Agency) issued a Draft Guidance for Industry titled “Public Notification of Emerging…more
| Consumer Protection, Products Liability, Science, Computers, & Technology

Reminder: FCC Annual CPNI Compliance Certifications Due March 1, 2016

The deadline applies to all telecommunications carriers and interconnected VoIP providers. Annual customer proprietary network information (CPNI) certifications are due March 1, 2016, for the period covering January 1…more
| Communications & Media Law, Consumer Protection, Privacy, Science, Computers, & Technology

Congress Considers Landmark Trade Secret Reforms

If enacted, the legislation would represent the most significant trade secret reform in many years. Major federal trade secret legislation is receiving strong bipartisan support and consideration in the US Congress. The…more
| Business Organizations, Civil Procedure, Civil Remedies, Elections & Politics, Intellectual Property

USDA Announces New Standards to Reduce Salmonella and Campylobacter in Poultry

New standards promulgated by the Food Safety and Inspection Service pose new challenges to the poultry industry. On February 4, the US Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) released…more
| Agriculture, Consumer Protection, Science, Computers, & Technology

Judicial Redress Act Would Extend Privacy Act Remedies to Citizens of Designated Foreign Nations

The pending legislation would authorize the US Department of Justice to designate foreign countries to allow the citizens of such countries to bring civil actions against certain US agencies to access, amend, or redress unlawful…more
| Consumer Protection, Elections & Politics, International Law & Trade, Privacy, Science, Computers, & Technology

Japan FSA Finalizes Amendments to the Article 63 Exemption

Final text of the Regulations with respect to the Amendments promulgated has been released as well as the Response to the public comments…more
| Business Organizations, Finance & Banking, International Law & Trade, Securities Law

EU-US Privacy Shield to Replace Safe Harbor

A new personal data transfer agreement was announced on February 3, 2016 between EU and US authorities: the EU-US Privacy Shield will replace the invalidated Safe Harbor programme. Since the landmark decision of the…more
| Civil Procedure, Consumer Protection, International Law & Trade, Privacy, Science, Computers, & Technology

FDA Issues New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public…more
| Consumer Protection, Health, Privacy, Science, Computers, & Technology

The CMS Final Covered Outpatient Drug Rule Addresses Many Industry Concerns

The rule implementing the Medicaid Drug Rebate Program is less burdensome and costly than what was originally proposed. In 2010, the Affordable Care Act (ACA) directed the US Centers for Medicare and Medicaid Services (CMS)…more
| Health, Science, Computers, & Technology

EEOC Proposes Significant Expansion of EEO-1 Reporting Requirements

EEOC’s proposed reporting requirements would mandate that employers submit annual reports detailing compensation information by ethnicity, race, and sex. On February 1, the US Equal Employment Opportunity Commission (EEOC),…more
| Civil Rights, Government Contracting, Labor & Employment Law

European Life Sciences Review: Issue 1

Welcome to the first issue of our EU Life Sciences Review . It is produced by our life sciences lawyers in London, Brussels, Frankfurt, Moscow, and Paris and covers some of the most critical developments in the pharmaceutical…more
| Environmental Law, Intellectual Property, International Law & Trade, Privacy, Science, Computers, & Technology

DOL Sends Fiduciary Rule to OMB for Review

DOL has indicated that the final rule will be released in the first half of the year. The US Department of Labor (DOL) sent its final Conflict of Interest Rule—Investment Advice (with related exemptions and amendments to…more
| Finance & Banking, Labor & Employment Law, Securities Law

SEC Staff Issues Guidance on Mutual Fund Distribution Arrangements

Recently issued SEC staff guidance reminds mutual fund directors of their obligations to evaluate fund payments to financial intermediaries and emphasizes investment advisers’ and other service providers’ obligation to provide…more
| Business Organizations, Finance & Banking, Securities Law
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