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.

Although it’s unclear when HRSA will ultimately release a copy of the 340B Omnibus Guidance, if recent experience is any indication, the document could be released in a matter of weeks.  For example, HRSA issued a civil monetary penalty proposed rule (80 Fed. Reg. 34583) twelve (12) days after OMB had concluded its review. However, the scope of the 340B Omnibus Guidance may be much broader than the civil monetary penalty proposed rule, and given HRSA’s sensitivity regarding limits on its rulemaking authority, it would not come as a surprise if HRSA takes additional time to release the 340B Omnibus Guidance. 

Additional Information

Polsinelli will continue to monitor this important development and provide updates as they become available.