The Office of Management and Budget (OMB) posted that they concluded their review of the 340B Program Omnibus Guidelines (Mega-Guidance) on August 17, 2015. If you remember, the Health Resources and Services Administration (HRSA) sent the 340B Mega-Guidance to the OMB on May 6, 2015 and on August 4, 2015, the OMB posted that the review of the Mega-Guidance was extended.
Here is the link to the OMB website where you can view the Regulatory Review summary: http://www.reginfo.gov/public/do/eoDetails?rrid=125135
While there is no legal deadline or specified publication date according to the OMB dashboard, we anticipate that the Mega-Guidance could be published in the Federal Register for notice and comment at any time. According to the OMB website, "This proposed guidance would address key policy issues raised by stakeholders for which HHS does not have statutory rulemaking authority." Will the guidance include clarification on 340B patient definition, address 340B external audits or covered entity 340B compliance? Only time will tell. SCA will be closely monitoring the Federal Register website and alert our subscribers as soon as the proposed Mega-Guidance is posted. SCA will also issue a blog series analyzing the specifics of the posted Guidance and the affects to the program and covered entities.
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