John Gould

Medicaid Rebates: CMS Releases The Long-Anticipated Proposed AMP Rule
Jonathan Connell,John Gould,Jeffrey L. Handwerker,Kristin Hicks,Rosemary Maxwell, January 31, 2012
The Patient Protection and Affordable Care Act, as amended (PPACA), made major changes in the methodology for determining Medicaid rebates that pose operational challenges and compliance risks for manufacturers. Effective October 1, 2010, PPACA changed the definition of the Average Manufacturer...

HRSA Issues Proposed Rule on Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program
Jonathan D. Connell,John Gould,Jeffrey L. Handwerker,Kristin Hicks,Rosemary Maxwell, May 24, 2011
On May 20, 2011, the Health Resources and Services Administration (HRSA) published a proposed rule regarding the exclusion of orphan drugs for certain covered entities under the 340B program. According to HRSA, the proposed rule is the first in a series of regulations that will outline certain...