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CMS proposes ACA Medicare claims data sharing rule
  • Reed Smith LLP
  • USA
  • June 14 2011

On June 8, 2011, CMS published a proposed rule that would implement an ACA requirement to make standardized extracts of Medicare Parts A, B, and D claims data available to "qualified entities."

CMS postpones hospital reporting of DFRR
  • Bricker & Eckler LLP
  • USA
  • June 23 2010

The Centers for Medicare and Medicaid Services (CMS) has concluded that the Disclosure of Financial Relations Report (DFRR) may duplicate new hospital reporting obligations required by Section 6001 of the Patient Protection and Affordable Care Act (PPACA), which was signed into law on March 23, 2010.

New Commission Regulation (EC) No 6682009 on certification of quality and non-clinical data relating to advanced therapy medicinal products
  • Bird & Bird
  • European Union
  • October 13 2009

Article 18 of Regulation (EC) No 13942007 on Advanced Therapy Medicinal Products (ATMP) provides that Small and Medium-sized Enterprises (SMEs) developing an ATMP may submit to the European Medicines Agency (EMEA) all relevant quality and, where available, non-clinical data required in accordance with modules 3 and 4 of Annex I to Directive 200183EC on the Community code relating to medicinal products for human use, for scientific evaluation and certification.

HIPAA security rule audits likely to increase
  • Dentons
  • USA
  • November 7 2008

Last week, the Department of Health and Human Services Office of Inspector General ("OIG") issued an audit report criticizing the Centers for Medicare and Medicaid Services ("CMS") for ineffective and incomplete enforcement of the HIPAA Security Rule.

Joseph V. Moreno
  • Cadwalader Wickersham & Taft LLP