The purpose of this article is to give manufacturers some initial background on the topics and some tools that could be considered.The review methodology described has been proven to help manufacturers and has been the starting point for developing an on-going monitoring.
Over the last few years, the 340B Program has experienced rapid expansion as the result of participation by new covered entities under the Affordable Care Act (“ACA”) and from covered entities contracting with multiple contract pharmacies. As it has grown, the 340B Program has come under significant scrutiny from the Government Accountability Office (“GAO”), the U.S. Department of Health and Human Services (“HHS”), and Congress, primarily to address what is perceived as an inadequate level of oversight by the Health Resources and Services Administration (“HRSA”) as well as a lack of specificity around the program’s requirements. HRSA was attempting to issue final regulations around the program but even those were frozen earlier this year with the Trump adminstrations regulatory freeze.