February 2017— In response to an Executive Order titled “Executive Order Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal”, HRSA has withdrawn its Mega-Guidance from White House review.
White House review is normally the last step before publication of regulations or guidance. However, due to this regulatory freeze, a final version of the Mega-Guidance can not be sent to the OFR until review and approval by the new administration.
According to Maureen Testoni, Senior Vice President and General Counsel at 340B Health, it is common for incoming administrations to freeze new rulemaking. She sites that the incoming Obama and Bush administrations issued similar memos when they took office.
Red Chip is monitoring the Mega-Guidance process closely and in the meantime, you can feel confident that we continue to utilize procedures that are compliant under the current 340B guidance from HRSA and OPA.
If you have questions or concerns, please feel free to call Mary Ann Barth or Holly Frye at (949)223-9828.