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District Court Applying Escobar Rejects DOJ’s Materiality Allegations Under Rule 9(b)
  • Sidley Austin LLP
  • USA
  • July 22 2016

In one of the first post-Escobar decisions applying the Supreme Court’s guidance on materiality under the False Claims Act, a federal district court


CMS Addresses Impact of Value Based Purchasing Arrangements on Medicaid Drug Rebate Program
  • Sidley Austin LLP
  • USA
  • July 19 2016

On July 14, 2016, the Centers for Medicare and Medicaid Services (CMS or the Agency) issued a Medicaid Drug Rebate Program Notice to Participating


CMS Issues FAQs on the Medicaid Drug Rebate Program Final Rule
  • Sidley Austin LLP
  • USA
  • July 12 2016

On July 6, 2016, the Centers for Medicare and Medicaid Services (CMS or the Agency) issued Frequently Asked Questions (FAQs) regarding the Covered


OCR Announces First HIPAA Settlement With a Business Associate
  • Sidley Austin LLP
  • USA
  • July 7 2016

On June 24, 2016, Catholic Health Care Services of the Archdiocese of Philadelphia (“CHCS”) entered into a resolution agreement with the Department


Hong Kong Introduces New Labeling Requirements for Follow-up Formula and Packaged Food for Infants and Young Children
  • Sidley Austin LLP
  • Hong Kong
  • July 7 2016

Hong Kong has amended its food and drugs (composition and labeling) regulations (the Regulations) to introduce mandatory requirements for nutrition


FCA Charges Dismissed Against Wal-Mart, Kmart, and Rite Aid Pharmacies for Relator’s Failure to Plead Specific Allegations
  • Sidley Austin LLP
  • USA
  • July 6 2016

The U.S. District Court for the District of Massachusetts recently dismissed a False Claims Act (“FCA”) lawsuit against Wal-Mart, Kmart, and Rite Aid


Securities class actions in the life sciences sector: key trends
  • Sidley Austin LLP
  • USA
  • June 29 2016

This update addresses developments in securities class actions brought against life sciences companies in 2015. It provides an overview and analysis


Medical Device Company Settles with OFAC on Iran Sanctions Charges
  • Sidley Austin LLP
  • Iran, USA
  • June 28 2016

After an uncharacteristic lull in the release of enforcement notices, the U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC


New Regulations Modernize Payment for Clinical Laboratory Tests in the United States
  • Sidley Austin LLP
  • USA
  • June 27 2016

On June 23, the Centers for Medicare & Medicaid Services (CMS) published its long-awaited final rule (Final Rule) creating a market-based


EU Institutions Agree on Overhaul of Medical Device and IVD Rules
  • Sidley Austin LLP
  • European Union
  • June 23 2016

On June 15, 2016, the European Council's Permanent Representatives Committee and the European Parliament's Environmental Committee, supported by the