The Health Resources and Services Administration has sent its final 340B program omnibus guidance to the White House Office of Management and Budget for review prior to publication in the Federal Register.
HRSA transmitted the final mega-guidance to OMB on Sept. 1, according to an entry on an OMB website. OMB reviews all federal agency rules prior to their publication in the Federal Register. These reviews should take no more than 90 days. There is no minimum period. OMB can extend the review on a one-time basis for no more than 30 days and HRSA can extend it indefinitely. When the review is complete, OMB can clear the mega-guidance for publication or send it back to HRSA for further consideration.
If OMB's review moves at its normal pace and if OMB doesn't ask HRSA to make major changes, the mega-guidance could be released around late November or early December. There's no guarantee events will unfold this way, however. The final mega-guidance could come out sooner. It could be delayed indefinitely.
It has also been rumored that HRSA may have decided to move forward with only parts of the mega-guidance, rather than all of the topics originally proposed. Many of the topics proposed were essentially restatements of current HRSA policies, such as rules around registration and audits, and did not receive significant attention by parties that submitted comments. HRSA is not bound to address all the topics included in the proposed mega-guidance. However, there is nothing in the OMB notice to indicate the scope of the final document that has been submitted for their approval.
For more information, visit www.340bhealth.org