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GAO Encourages More CMS Collaboration with States on Medicaid Program Integrity Efforts
  • Reed Smith LLP
  • USA
  • May 12 2017

The Government Accounting Office (GAO) has had ongoing concerns about the integrity of the Medicaid program due to its size, diversity, and recent


OCR’s Latest Health Breach Investigations Yield Big Settlements
  • Reed Smith LLP
  • USA
  • March 2 2017

In a span of a few weeks in early January 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced two major


Midnight Madness The FDA Continues To Discount First Amendment Implications Of Restrictions On Off-Label Promotion
  • Reed Smith LLP
  • USA
  • January 27 2017

This guest post is from Liz Minerd, an associate at Reed Smith. She previously wrote the post on the FDA’s off-label promotion meeting last November


October 16 Deadlines Quickly Approaching for the ACA’s Nondiscrimination Requirements: Are You Ready?
  • Reed Smith LLP
  • USA
  • October 4 2016

By October 16, 2016, all health programs and activities receiving federal financial assistance from the Department of Health and Human Services (HHS


Off-Label Promotion And The First Amendment Updates
  • Reed Smith LLP
  • USA
  • September 22 2016

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and


CMS Finalizes Emergency Preparedness Requirements for MedicareMedicaid Providers
  • Reed Smith LLP
  • USA
  • September 12 2016

The Centers for Medicare & Medicaid Services (CMS) has released a long-awaited final rule establishing emergency preparedness requirements for


FDA to Host Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Medical Products
  • Reed Smith LLP
  • USA
  • September 8 2016

On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on “Manufacturer Communications Regarding Unapproved


ICO Responds to the ePrivacy Directive Consultation
  • Reed Smith LLP
  • European Union
  • August 12 2016

In April, we reported that the European Commission had opened a public consultation seeking the views of various stakeholders on the current wording


Off-Label Marketing - Industry Groups Step into the Breach
  • Reed Smith LLP
  • USA
  • August 8 2016

We have been waiting, literally for years, for the FDA to revise, clarify, update, or simply pay attention to, its off-label promotion regulatory


The Stored Communications Act’s Warrant Provisions Do Not Apply Extraterritorially
  • Reed Smith LLP
  • USA
  • July 20 2016

On July 14, the Second Circuit in Microsoft v. United States ruled that the Stored Communications Act (SCA) "does not authorize a U.S. court to issue