Exclusions Compliance

News & Analysis as of

OIG Proposes Updates to Exclusion and CMP Authority

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

NFA Provides Further Guidance on Bylaw 1101 Obligations of Members Who Do Business with CPOs/CTAs Relying on an Exemption or...

The National Futures Association (the “NFA”) issued Notice I-14-06 providing guidance to its members regarding their Bylaw 1101 obligation to determine the CFTC registration and NFA membership status of persons with whom they...more

Final Rule on 340B Orphan Drug Exclusion Imposes New Compliance Requirements on Covered Entities and Contract Pharmacies

The 340B program permits eligible hospitals and other “safety-net” providers (Covered Entities) to purchase covered outpatient drugs from pharmaceutical manufacturers at significant discounts. The Affordable Care Act and the...more

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

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

CMS Issues Final Physician Payment Sunshine Rule

In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more

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