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The Physician Payment Sunshine Act final rule: key change from proposed rule affecting foreign entities
  • Hodgson Russ LLP
  • USA
  • June 26 2013

We now have only 36 days to go until August 1, 2013, when the new data collection obligations imposed on "applicable manufacturers" and group


Medical devices offer fertile ground for future whistleblower activity
  • Hodgson Russ LLP
  • USA
  • May 29 2014

Recent gatherings of False Claims Act attorneys who represent whistleblowers, the government, and the defense revealed a consensus


HHS proposes substantial reinsurance fee
  • Hodgson Russ LLP
  • USA
  • February 28 2013

The Patient Protection and Affordable Care Act (PPACA) establishes, among other things, a transitional reinsurance program to provide payments to


Mobile apps: the FDA publishes its final guidance on regulating mobile medical apps
  • Hodgson Russ LLP
  • Canada, USA
  • October 4 2013

Canadian mobile medical app developers will be interested in the FDA's recent guidance on the regulation mobile medical apps in the United States. On


Mobile apps: the FDA is on its path of enforcement actions
  • Hodgson Russ LLP
  • USA
  • July 24 2013

Mobile health care is one of the most booming industries worldwide, with a strong potential for growth and an excellent financial prognosis. No


New proposed regulation relating to wellness programs
  • Hodgson Russ LLP
  • USA
  • December 28 2012

In late November, the Departments of Health and Human Services, Labor, and Treasury issued a proposed regulation that makes important changes in the HIPAA


The medical device excise tax is here to stay
  • Hodgson Russ LLP
  • USA
  • July 3 2013

Given its key role in financing U.S. health care reform to the tune of $10 billion over 10 years, it seems safe to assume that unless the government


IRS issues final regulations regarding Affordable Care Act’s premium tax credit
  • Hodgson Russ LLP
  • USA
  • July 31 2012

On May 18, 2012, the IRS issued final regulations relating to the health insurance premium tax credit enacted as part of the Affordable Care Act


Agencies issue new FAQs regarding summary of benefits and coverage
  • Hodgson Russ LLP
  • USA
  • July 31 2012

The U.S. Departments of Labor, Health and Human Services and the Treasury have issued a set of frequently asked questions (FAQs) regarding the implementation of the Patient Protection and Affordable Care Act


Utilizing the concurrent de novo review
  • Hodgson Russ LLP
  • USA
  • October 11 2011

The FDA's release of the de novo draft guidance last week is causing a stir, but does the newly created concurrent review really help save cost and time?