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New OCR HIPAA Audit Protocol Can Assist Providers with Preparing for Phase 2 Audits
  • Arent Fox LLP
  • USA
  • May 17 2016

Notably absent from the launch of Phase 2 was the release of the updated audit protocol that would be used in conducting the Phase 2 audits. But OCR


FDA To Reevaluate "Healthy" Food Claims
  • Arent Fox LLP
  • USA
  • May 13 2016

FDA announced Tuesday that it will begin reevaluating how it regulates the use of the term "healthy" on food labeling. Currently, if a food company


CMS Proposes New Requirements for Stark Self-Disclosures
  • Arent Fox LLP
  • USA
  • May 12 2016

On May 6, 2016, CMS published in the Federal Register a request for comments on proposed revisions to the information to be collected pursuant to the


Office of Inspector General Evaluates the Enhanced Enrollment Screening of Medicare Providers
  • Arent Fox LLP
  • USA
  • May 11 2016

In March 2012, the Centers for Medicare & Medicaid Services (CMS) enhanced its Medicare enrollment screening for new and existing enrollees to the


Texas Adopts NADAC and Eliminates Some Manufacturer Reporting
  • Arent Fox LLP
  • USA
  • May 10 2016

Texas Health and Human Services Commission (HHSC) has finally issued final regulations transitioning to the use of the National Average Drug


FDA Publishes Final Restaurant Menu Labeling Guidance
  • Arent Fox LLP
  • USA
  • May 9 2016

FDA recently issued its final guidance on restaurant menu labeling. The guidance, which dovetails with FDA’s December 1, 2014 Final Rule on


DEA Approves Medical Marijuana Clinical Trial
  • Arent Fox LLP
  • USA
  • May 6 2016

The Drug Enforcement Agency recently approved a first-ever randomized, placebo-controlled clinical trial to study the use of botanical (“whole


Don’t Discount the Discounts: Pfizer and Wyeth Reach Settlement Over Medicaid Drug Pricing Allegations
  • Arent Fox LLP
  • USA
  • May 4 2016

The Department of Justice recently announced it has reached a more than $780 million settlement with Pfizer Inc. and its subsidiary Wyeth to resolve


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