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A look ahead: the 2009 U.S. health legislative agenda

  • McDermott Will & Emery
  • -
  • USA
  • -
  • October 13 2008

While systemic health reform promises to be a top U.S. policy priority in any new administration, Congress's first health policy focus in 2009 will be on already identified and targeted health initiatives

Compliance to Red Flag Rule due November 1, 2008

  • McDermott Will & Emery
  • -
  • USA
  • -
  • October 10 2008

Health care providers likely will be subject to the Rule and should develop the required Program by the compliance deadline, unless formal relief is granted

Preventing parallel trade in the European Union

  • McDermott Will & Emery
  • -
  • European Union, Greece
  • -
  • October 31 2008

Lelos and Others v GSK C-46806 concerned a dispute between the Greek subsidiary of GlaxoSmithKline (GSK) and a number of Greek wholesalers

Diagnostic test anti-markup provisions

  • McDermott Will & Emery
  • -
  • USA
  • -
  • November 14 2008

The anti-markup rule in the final 2008 Medicare Physician Fee Schedule will require a number of physician office-based diagnostic testing arrangements to be restructured or unwound by January 1, 2009

Potential for delayed generic launch does not give rise to declaratory judgment jurisdiction for second ANDA filer

  • McDermott Will & Emery
  • -
  • USA
  • -
  • October 31 2008

For the second time in three months, the U.S. Court of Appeals for the Federal Circuit held that Apotex lacked declaratory judgment jurisdiction in the context of its Hatch-Waxman litigation for its Abbreviated New Drug Applications (ANDAs

Commission proposal on stronger animal protection in scientific experiments

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • November 7 2008

On 5 October 2008 the European Commission issued a proposal to amend Directive 86609EEC on the protection of animals used for experimental or other scientific purposes

Developments in Medicare payment for services in clinical trials

  • McDermott Will & Emery
  • -
  • USA
  • -
  • November 3 2008

Providers and research sponsors must consider two recent Medicare-related administrative issuances indicating CMS and OIG interpretations regarding provisions of clinical trial arrangements and Medicare payment for routine cost services in clinical trials

Ambulatory surgery center Conditions for Coverage and 2009 payment update finalized

  • McDermott Will & Emery
  • -
  • USA
  • -
  • November 5 2008

The latest final rule from CMS imposes new regulatory burdens on ASCs and revises the amount of Medicare payment ASCs will receive for furnishing services to program beneficiaries

Preliminary report on pharmaceutical sector inquiry

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • December 5 2008

On 28 November 2008, the European Commission issued its preliminary report on the competition inquiry into the pharmaceutical sector

Commission dawn-raids pharmaceutical companies on eve of sector report

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • November 28 2008

The European Commission has confirmed that on 24 November 2008, Commission officials started inspections at the premises of a number of pharmaceutical companies in several EU Member States