Tag Archives: HRSA

340B Guidance: Eight Key Points Covered Entities Should Consider

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush, Dena Kessler, Nita Garg and Lindsay Holmes on Posted in Uncategorized
On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to as “proposed” guidance by HRSA, the Guidance is intended to clarify a multitude of issues for the thousands of registered covered … Continue Reading

Proposed 340B Rule Would Impose Penalties for Overcharging, Plus Other Charges

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
A recently-released proposed rule would impose civil monetary penalties on drug manufacturers that intentionally overcharge healthcare providers for medications purchased under the 340B Discount Drug Program. The proposed rule, if adopted, could open the door to significant financial penalties for manufacturers, even if it is the manufacturer’s wholesaler or other business partner that overcharges the … Continue Reading
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