340B Program Rules to Remain Unclear


In Depth

As had been widely anticipated, late on January 30, 2017, the Department of Health and Human Services (HHS) withdrew the 340B Program “Mega-Guidance” that had been under review at the Office of Management and Budget (OMB) since September 2016. The final guidance would have implemented guidance governing many aspects of 340B Program compliance and it was expected that the final guidance would clarify expectations on the safety-net providers that receive discounts on outpatient drugs through the 340B Program. What was not known publicly, however, was whether the final guidance even addressed two of the most controversial aspects of the proposed guidance—the definitions of those patients eligible to receive the discounted drugs and the drugs subject to the discounts.

It is not yet clear what the next step may be in the years-long process to obtain clear rules governing the 340B Program. With the specter of larger discussions related to prescription drug pricing and the unclear role of the 340B Program in those discussions, it remains to be seen whether HHS will reissue another round of “Mega-Guidance,” address the compliance concerns through targeted, smaller guidance materials or wait to see if the 340B Program is restructured through a reopening of the 340B Statute.

Although the withdrawal of the “Mega-Guidance” results in business as usual for the time being, 340B Program stakeholders should be prepared for substantive changes to the program in the coming months, whether through future HHS guidance or a reopening of the 340B statute.