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Exclusions Compliance Patient Protection and Affordable Care Act (PPACA)

Baker Donelson

OIG Proposes Updates to Exclusion and CMP Authority

Baker Donelson on

The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a pair of proposed regulations to update its exclusion and civil monetary penalty (CMP) authority. The proposed regulations...more

King & Spalding

HRSA Issues Final 340B Orphan Drug Exclusion Rule: Agency’s Narrow Interpretation of Statutory Prohibition Puts Compliance...

King & Spalding on

On July 23, 2013, the Health Resources and Services Administration (HRSA) issued a final rule clarifying the orphan drug exclusion for certain covered entities created by the Affordable Care Act (ACA) (“Final Rule”). The...more

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