August 18, 2015
Safety-net providers, manufacturers, members of Congress, and other stakeholders have been tracking the status of the Health Resources and Services Administration’s (“HRSA”) draft 340B Omnibus Guidance closely as it promises to incorporate long-awaited and wide-ranging updates to the 340B Drug Pricing Program. Today, Polsinelli learned that the White House Office of Management and Budget (“OMB”) completed its review of the 340B Omnibus Guidance, meaning the document is one step closer to public release. The 340B Omnibus Guidance has been pending with the OMB since May 6, 2015. A link to the OMB status page can be found here.

HRSA previously indicated that stakeholders should expect the 340B Omnibus Guidance to address the patient definition, hospital eligibility, contract pharmacies, and other fundamental components of the 340B Program.

To view the full alert, click here.