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Results: 1-10 of 2,267

FDA holds webinar discussing final guidance on Custom Device Exemptions

  • King & Spalding LLP
  • -
  • USA
  • -
  • October 27 2014

On October 14, 2014, the U.S. Food and Drug Administration (FDA or "the Agency") held a webinar for industry to explain the guidance document

FDA issues cybersecurity guidelines manufacturers of medical devices encouraged to develop cybersecurity controls

  • King & Spalding LLP
  • -
  • USA
  • -
  • October 27 2014

The Food and Drug Administration (FDA) issued guidelines this month recommending that manufacturers develop a set of cybersecurity controls in the

Medical devices and cybersecurity risks DHS investigates at-risk devices

  • King & Spalding LLP
  • -
  • USA
  • -
  • October 27 2014

On October 2, 2014, the U.S. Food and Drug Administration (FDA) issued its final guidance on cybersecurity for medical device manufacturers, titled

Hospital settles provider-based compliance investigation for $3.3 million

  • King & Spalding LLP
  • -
  • USA
  • -
  • October 20 2014

A New York State hospital has agreed to pay the U.S. Department of Justice more than $3.3 million to resolve an investigation conducted by the

CMS urges hospitals to adopt CDC guidance to prepare for potential Ebola patients

  • King & Spalding LLP
  • -
  • USA
  • -
  • October 20 2014

In response to the ongoing Ebola crisis, the CMS Survey and Certification Group issued a memorandum urging all hospitals and Critical Access

Report shows CMP enforcement actions on the rise against Part C and Part D sponsors

  • King & Spalding LLP
  • -
  • USA
  • -
  • October 20 2014

A new report issued October 16, 2014 by the Medicare Parts C & D Oversight and Enforcement Group (MOEG) reveals that civil monetary penalty (CMP

CMS and OIG extend interim final rule regarding waivers of fraud and abuse laws for ACOs

  • King & Spalding LLP
  • -
  • USA
  • -
  • October 20 2014

On October 17, 2014, CMS and OIG jointly published a notice extending the effectiveness of a November 2011 interim final rule establishing waivers

CMS withdraws Medicare Secondary Payer proposed rule

  • King & Spalding LLP
  • -
  • USA
  • -
  • October 20 2014

The Office of Management and Budget (OMB) has withdrawn an Advanced Notice of Proposed Rulemaking (ANPRM) in which CMS planned to address how

CMS allocates additional support for ACOs

  • King & Spalding LLP
  • -
  • USA
  • -
  • October 20 2014

On October 15, 2014, CMS announced that it will allocate up to $114 million towards 75 ACOs in order to encourage development in areas lacking the

CMS provides for greater MAC involvement in ALJ hearings

  • King & Spalding LLP
  • -
  • USA
  • -
  • October 20 2014

CMS recently issued Transmittal 543, Change Request 8501 in which it instructs Medicare Administrative Contractors (MACs) to, among other things