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Recent OIG audits of home health and hospice surveys may signal increased scrutiny on worker qualifications
  • Foley & Lardner LLP
  • USA
  • July 1 2015

Recent audits by the Department of Health and Human Services Office of Inspector General ("OIG") conclude that state survey agencies in a number of


The biggest obstacle to value-based care
  • Foley & Lardner LLP
  • USA
  • June 30 2015

In this video, Foley Partner Lawrence Vernaglia discusses the biggest obstacle to realizing a value-based system of health care, and what


Federal Circuit invalidates another diagnostic patent
  • Foley & Lardner LLP
  • USA
  • June 30 2015

In Ariosa Diagnostics, Inc. v. Sequenom, Inc., Slip Op. 2014-1139, 2014-114 (Fed. Cir. June 12, 2015), the U.S. Court of Appeals for the Federal


CMS releases CY 2016 ESRD PPS proposed rule
  • Reed Smith LLP
  • USA
  • June 30 2015

On June 26, 2015, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule to update the Medicare end-stage renal disease (ESRD


Congressional health policy hearings
  • Reed Smith LLP
  • USA
  • June 30 2015

A House Ways and Means Subcommittee on Oversight hearing recently reviewed the effects of the Affordable Care Act (ACA) on health insurance premiums


CMS proposed 2016 Medicare payment rules in the pipeline
  • Reed Smith LLP
  • USA
  • June 30 2015

CMS recently sent several major proposed Medicare CY 2016 payment rules to the White House Office of Management and Budget (OMB) for regulatory


FDA responds on claims regarding distribution of off-label information
  • Weil Gotshal & Manges LLP
  • USA
  • June 30 2015

Last month, I blogged on Amarin Pharma, Inc.’s complaint against the FDA challenging the agency’s regulations that prohibit the company from


No induced infringement where off-label use of a drug is not “inevitable”
  • McDermott Will & Emery
  • USA
  • June 30 2015

Finding that a drug label’s language did not rise to the level of “active encouragement” that would induce doctors to infringe, the U.S. Court of


Activities for sNDA and citizen’s petition protected by “safe harbor”
  • McDermott Will & Emery
  • USA
  • June 30 2015

In a case addressing the “safe harbor” provision of 35 U.S.C. 271(e)(1), the U.S. Court of Appeals for the Federal Circuit affirmed the district


New OIG reports peg billing trends and prescribing hotspots as harbingers of Part D fraud
  • McDermott Will & Emery
  • USA
  • June 30 2015

On Tuesday, June 23, the U.S. Department of Health & Human Services Office of Inspector General (OIG) released two reports that hone in on data