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Weekly Washington healthcare update
  • McGuireWoods LLP
  • USA
  • December 3 2012

In the first week back from the Thanksgiving Recess, Congressional and White House negotiators seemed to have reached an impasse over how to deal with the pressing "fiscal cliff" approaching at year's end


FDA posts shorter 510(k) and PMA approval times
  • McGuireWoods LLP
  • USA
  • December 6 2012

December 6, 2012 The FDA released the “Results of CDRH’s Plan of Action for Premarket Review of Devices,” which announced that the FDA review times under the 510(k) process have improved


RX drug costs declined 2006-2009
  • McGuireWoods LLP
  • USA
  • October 29 2012

A recent study by Health Affairs showed that from 2006 to 2009, the proportion of people under 65 who spent more than 10 percent of their income on health stayed steady because of less spending on prescription drugs


HHS announces anti-fraud priorities for 2013
  • McGuireWoods LLP
  • USA
  • October 29 2012

In a webcast posted last week, HHS-OIG officials said billing issues tied to the broader adoption of electronic medical records will be a priority for its 2013 work to address fraud in the Medicare program


Administration touts "donut hole" savings
  • McGuireWoods LLP
  • USA
  • October 29 2012

According to an announcement last week by HHS Secretary Sebelius, 5.6 million seniors and people with disabilities have saved $4.8 billion on prescription drugs since the enactment of the Affordable Care Act (ACA


Medicaid block grants would reduce insured by 30 million
  • McGuireWoods LLP
  • USA
  • October 29 2012

According to a report prepared by the Urban Institute for the Kaiser Family Foundation's Commission on Medicaid and the Uninsured, the House Republican Medicaid block grant plan would cut $1.7 trillion from the program and jeopardize health coverage for more than 30 million people, 17 million because of the ACA repeal and more than 14 million from the lower spending on block grants, by 2022


FDA releases list of New England compounding pharmacy customers
  • McGuireWoods LLP
  • USA
  • October 29 2012

In the wake the recent fungal meningitis outbreak, FDA has published a list of health care providers that have purchased drugs from the New England Compounding Center (NECC) since May 21, when the first lot of steroid injections linked to the fungal meningitis outbreaks was produced


HIPAA Omnibus Final Rule implements tiered penalty structure for HIPAA violations
  • McGuireWoods LLP
  • USA
  • February 14 2013

On Jan. 17, 2013, the Department of Health and Human Services (HHS) released the Omnibus Final Rule (Final Rule), interpreting and implementing


Staff change at Center for Consumer Information and Insurance Oversight
  • McGuireWoods LLP
  • USA
  • October 29 2012

Tim Hill, deputy director of the Center for Consumer Information and Insurance Oversight (CCIIO), announced last week he is leaving the office after having served a year and a half


CMS announces comprehensive ESRD care initiative for up to 15 ESRD seamless care organizations (ESCOS)
  • McGuireWoods LLP
  • USA
  • February 6 2013

On Jan. 31, 2013, the Centers for Medicare & Medicaid Services (CMS) released a request for applications to participate in the testing of its