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Results: 1-10 of 708

Gone in 60-days? Not so fast - federal court emphasizes corrective action in 60-day overpayments case
  • Hogan Lovells
  • USA
  • August 19 2015

A federal court recently issued a decision in the first case addressing a pivotal area of interest for healthcare providers following enactment of the


FTC issues principles for “unfair methods of competition”
  • Hogan Lovells
  • USA
  • August 14 2015

On 13 August, the Federal Trade Commission (FTC or Commission) issued its first set of principles governing enforcement of "unfair methods of


And then there were five: CMS approves Wolters Kluwer Lexi-Drugs as the fifth recognized authoritative compendium
  • Hogan Lovells
  • USA
  • August 14 2015

Patients, providers, and manufacturers seeking Medicare coverage of cancer drugs now have a new source to consult. The Centers for Medicare & Medicaid


OIG clears a path for limited ‘quick start’ program in new Advisory Opinion
  • Hogan Lovells
  • USA
  • August 13 2015

Recently, an increasing number of pharmaceutical manufacturers have sought to provide limited free supplies of their drugs to patients initiating


May the truth set you free: Amarin prevails in its First Amendment case against FDA
  • Hogan Lovells
  • USA
  • August 12 2015

On August 7, 2015, the U.S. District Court for the Southern District of New York ruled in favor of Amarin Pharma, Inc. (Amarin) in its suit against


Mobile Health in the EU (part 1): introduction to mHealth and privacy laws
  • Hogan Lovells
  • USA
  • July 24 2015

The mobile Health (mHealth) sector is rapidly developing and revolutionising the healthcare market. More and more consumers share information such as


Fourth Circuit’s application of Stark Law and the False Claims Act in Tuomey II may invigorate calls for reform
  • Hogan Lovells
  • USA
  • July 24 2015

In its second opinion in United States ex rel. Drakeford v. Tuomey Healthcare System, Inc., the Fourth Circuit Court of Appeals affirmed a judgment


Latest version of 21st Century Cures would create new civil monetary penalties for fraud in HHS grants and contracts
  • Hogan Lovells
  • USA
  • July 9 2015

On 2 July, the House Energy and Commerce Committee released a "manager's amendment" to H.R. 6, the so-called 21st Century Cures legislation. Among


FDA releases new guidance on UDI direct marking requirements
  • Hogan Lovells
  • USA
  • June 30 2015

On June 26, 2015, FDA released a draft guidance document providing further clarification on the direct marking requirements associated with the


Supreme Court upholds federal health insurance subsidies
  • Hogan Lovells
  • USA
  • June 25 2015

Today, in a 6-3 ruling, the Supreme Court upheld the federal regulation that makes subsidies available to eligible individuals who purchase health