The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program. The guidance was proposed in the Fall of 2015, and would have updated all areas of 340B Program guidance. The guidance would have included significant changes to the definition of an eligible patient, and to 340B Program integrity provisions. By withdrawing the guidance, the Office of Management and Budget indicates that omnibus guidance will not be adopted as it was proposed. The new administration could issue new guidance that differs materially from the previous proposal. The withdrawal of the omnibus guidance coincides with a meeting between the President and the heads of major pharmaceutical companies.
As a result of court cases limiting the scope of the administration’s ability to issue regulations that have binding legal effect with regard to many aspects of the 340B Program, the new administration will need to evaluate the scope and intended effect of any forthcoming guidance. Until such time as guidance is finalized and adopted, 340B Program covered entities and drug manufacturers should continue to rely on the historical guidance.