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Forty Years in the Making FDA Issues Propose Rule Requiring Electronic Submission of Labeling and Package Inserts for Class II and Class III Home-Use Medical Devices
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • October 21 2016

This past summer, the Food and Drug Administration (FDA or Agency) celebrated the 40th anniversary of the enactment of the Medical Device Amendments


Never fear, PCOR is here
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • June 6 2013

Just like a hero from the latest Star Trek-themed training video, the IRS has released additional PCOR guidance just in time to save the world. As


EBSA wellness fact sheet
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • November 28 2012

You won’t find any hidden nuggets of information in here, but it’s a good and short fact sheet on the new wellness regulations from EBSA


IRS affirms HDHP preventive care benefits
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • September 9 2013

This morning the IRS issued Notice 2013-57 confirming the extent of preventive care benefits that can be offered under an HDHP with no deductible


OCR and HIPAA privacy update
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • May 9 2013

The Joint Committee on Employee Benefits met Tuesday with representatives of OCR regarding the HIPAA privacy and security rules. We certainly


Final HIPAA omnibus rules require attention
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • April 19 2013

The time has come to take out and refresh those business associate agreements, HIPAA privacy and security compliance manuals, and HIPAA privacy


90-day waiting period regulations
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • February 20 2014

Today, the agencies issued final regulations on the 90-day waiting period rule. The final regulations define a waiting period as the period that must


Pre-tax individual medical coverage dealt a significant blow
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • September 18 2013

On Friday last week, Treasury, DOL and HHS issued new guidance with respect to employers who sought to drop group coverage in exchange for individual


Updated wellness clarifications
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • January 10 2014

The new FAQs issued yesterday include a number of helpful clarifications with respect to wellness programs. FAQ 8 provides that if a participant is


Additional ACA FAQs
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • January 9 2014

Today, the Agencies issued additional FAQs on the Affordable Care Act, including how the out-of-pocket maximum operates, expatriate health plans