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Is the Discount Safe Harbor No Longer “Safe?”
  • Arent Fox LLP
  • USA
  • September 20 2016

In a ruling that could, if adopted by other courts, expose all pharmaceutical discount and rebate arrangements to anti-kickback liability, on August


FDA Enforcement Against Cosmetics Continues at Record Pace in 2016
  • Arent Fox LLP
  • USA
  • September 14 2016

FDA continues to maintain an aggressive enforcement stance against cosmeticspersonal care product companies and has already issued a record 19


Needing to Adjust: DOJ and HHS Announce Steep Increases to FCA, Stark Law, Anti-Kickback Statute, and EMTALA Penalties
  • Arent Fox LLP
  • USA
  • September 13 2016

Life science companies, health care providers, and government contractors will be at risk for significantly larger penalties due to substantial


Congress Considering Legislation Giving FDA Additional Regulatory Authority Over Cosmetics and Personal Care Products
  • Arent Fox LLP
  • USA
  • September 6 2016

It is unclear whether Congress and the President will come to agreement and move forward this year on cosmetics and personal care products


EEOC Issues Final Guidance on Retaliation
  • Arent Fox LLP
  • USA
  • August 31 2016

The Guidance replaces the EEOC’s 1998 Compliance Manual section on retaliation. It also addresses the separate "interference" provision under the


New Dispute Resolution Process Finally Proposed for 340B Program: Abundant Opportunity for Comment by Stakeholders
  • Arent Fox LLP
  • USA
  • August 22 2016

On August 12, 2016, the Health Resources and Services Administration published a proposed rule setting forth the requirements and procedures of the


DEA Denies Marijuana Rescheduling Petition, Eases Research Restrictions
  • Arent Fox LLP
  • USA
  • August 16 2016

Ending months of speculation, the Drug Enforcement Administration announced yesterday that it declined to down-classify marijuana from Schedule I of


Ensuring Compliance With CMS 60-Day Overpayment Rule
  • Arent Fox LLP
  • USA
  • August 16 2016

Everyone working in the health care industry today knows how often overpayments can occur. Some are isolated instances, while others may involve


FTC Flexes Security Muscles in ASUSTek Settlement & LabMD Reversal
  • Arent Fox LLP
  • USA
  • August 5 2016

The Federal Trade Commission asserted its data security authority in two recent back-to-back enforcement actions, only a day apart from each other


Another Record HIPAA Settlement, Another Reminder to Keep Electronic PHI Secure
  • Arent Fox LLP
  • USA
  • August 4 2016

Today, the US Department of Health & Human Services' Office for Civil Rights (OCR) announced that Advocate Health Care Network (Illinois' largest