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Sidley Austin LLP global pricing newsletter - volume three 2014

  • Sidley Austin LLP
  • -
  • Brazil, Canada, China, European Union, France, Germany, India, United Kingdom, USA
  • -
  • April 15 2014

On October 21, 2013, Brazil’s National Agency of Supplemental Health enacted Normative Resolution 388, which mandated that all private healthcare

Whistleblowers’ lawyers begin digging into provider-specific Medicare data to support FCA claims

  • Sidley Austin LLP
  • -
  • USA
  • -
  • April 14 2014

An April 14 article on Reuters.com titled "Lawyers start mining the Medicare data for clues to fraud" explains how plaintiffs' lawyers are eagerly

Physician payment law revamps clinical laboratory payment again

  • Sidley Austin LLP
  • -
  • USA
  • -
  • April 8 2014

On April 1, 2014, President Barack Obama signed the "Protecting Access to Medicare Act of 2014" (H.R. 4302) revamping the diagnostic clinical

China amends its cornerstone Regulation on Medical Devices

  • Sidley Austin LLP
  • -
  • China
  • -
  • April 7 2014

On March 31, 2014, China's State Council published the amended Administrative Regulation on Medical Devices, which will become effective on June 1

2013 health care fraud and abuse report highlights significant recoveries under the FCA

  • Sidley Austin LLP
  • -
  • USA
  • -
  • April 1 2014

On February 26, 2014, the Departments of Justice and Health and Human services released the annual Health Care Fraud and Abuse Control Program report

European Commission offers further guidance on antitrust assessment of patent settlement agreements

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • March 27 2014

On March 21, 2014, the European Commission adopted a revised version of its guidelines on the antitrust assessment of technology transfer agreements

China issues implementation rules for its new pharmaceutical and medical device blacklist system

  • Sidley Austin LLP
  • -
  • China
  • -
  • March 19 2014

On December 27, 2013, China's National Health and Family Planning Commission (NHFPC) published an agency rule to update the "blacklist system" for

Sunshine Act data submission delayed

  • Sidley Austin LLP
  • -
  • USA
  • -
  • March 12 2014

The Centres for Medicare and Medicaid Services announced that Physician Payments Sunshine Act registration and data submission for applicable manufacturers and group purchasing organisations will be executed in two phases

New FDA off-label guidance responds to industry petitions, raises significant issues

  • Sidley Austin LLP
  • -
  • USA
  • -
  • March 11 2014

On March 3, 2014, FDA issued a new draft guidance allowing manufacturers to distribute journal Articles, textbooks, and clinical practice guidelines

Greater patient access to laboratory test reports

  • Sidley Austin LLP
  • -
  • USA
  • -
  • March 5 2014

The US Department of Health and Human Services has released a final rule that amends the Clinical Laboratory Improvement Amendments of 1988