We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 370

Supreme Court Weighs FCA Implied Certification Theory
  • Arent Fox LLP
  • USA
  • April 27 2016

“We expect the Supreme Court’s decision in Universal Health to be pivotal for the health care industry, with it likely serving as a bellwether case


3 Reasons Why Supreme Court Should Grant Cert in Critical Biotech Case
  • Arent Fox LLP
  • USA
  • April 26 2016

In Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit, relying on Mayo Collaborative Servs. V. Prometheus Labs., Inc., held that


New VA Policy: All Covered Drugs, Regardless if Compliant with the Trade Agreements Act, Must Be Offered
  • Arent Fox LLP
  • USA
  • April 26 2016

The Department of Veterans Affairs (VA) recently announced a significant policy change that will now require drug manufacturers to make drugs that


Secure Yourself: NIST Releases Final Version of the Cryptographic Standards and Guidelines Development Process
  • Arent Fox LLP
  • USA
  • April 25 2016

Covered entities and business associates subject to HIPAA Security Rule are closer to getting a benchmark for encryption standards with the release


Guidance to Pharma from CMS: How to Calculate the New Inflation-Based Additional Rebate for Generic Drugs
  • Arent Fox LLP
  • USA
  • April 22 2016

On April 15, 2016, the Center for Medicaid and CHIP Services, a part of the Centers for Medicare & Medicaid Services (CMS), issued a Program Notice


Stricter European Privacy Rules: Think Twice Before Marketing Health Care Goods and Services Across the Atlantic
  • Arent Fox LLP
  • European Union, USA
  • April 21 2016

On April 14, 2016, the European Union formally adopted a new scheme - known as the EU General Data Protection Regulation (GDPR) - to protect the


Health on the Move: FTC and HHS Release Guidance for Mobile Health App Developers
  • Arent Fox LLP
  • USA
  • April 20 2016

On April 5, 2016, Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of a new web-based tool to assist developers


HHS Re-Opens Comment Period on 340B Program Pricing and Penalty Rule
  • Arent Fox LLP
  • USA
  • April 19 2016

Today, the Department of Health and Human Services (HHS) announced that they are re-opening the comment period on its June 17, 2015 proposed rule


DEA Considers Rescheduling Marijuana
  • Arent Fox LLP
  • USA
  • April 18 2016

The US Drug Enforcement Administration recently announced that it is evaluating whether to downgrade the classification of marijuana under the


The Move to Value-Based Payment Continues: CMS Announces Initiative to Transform Primary Care Delivery and Payment
  • Arent Fox LLP
  • USA
  • April 18 2016

On April 11, 2016, the Centers for Medicare and Medicaid Services (CMS) announced its Comprehensive Primary Care Plus (CPC) initiative. Part of CMS'