340B Mega Guidance:  When will the new rules come to roost?  Or will they ever?

December 52016340B Mega Guidance: When will the new rules come to roost? Or will they ever?


In case your head was in the sand—and who can blame you with an unyielding budget season, negative-zero arctic blasts (be glad you aren’t in North Dakota!), and that ever-looming Christmas presents list you haven’t even thought about—Alinea has confirmed with several policy experts that the mega-guidance, scheduled to be released in December of 2016, will now be delayed.

Further substantiated by Chris Hatwig, President of Apexus, at the ASHP 2016 Mid-Year Conference, the 340B mega-guidance, currently at the Office of Management and Budget (OMB), will likely push several months or longer into 2017 as a result of the transition from the Obama administration to the Trump administration.

While it is unclear whether the Trump administration will move forward with its own mega-guidance, the delay forces covered entities to continue operating in the “grey” on several key regulatory statutes that are unclear. In addition to continuing in a “wait and see” mode, to jog your memory, significant concerns over several proposed prohibitions on access to 340B pricing including discharge medications, infusions, independent audit requirements, physician relationships, and speculation around certain covered outpatient drugs will continue to loom in the meantime. It was reported that a record number of letters were submitted to the OMB by hospitals voicing their opposition to proposed 340B changes within the mega-guidance.

Stemming from a scathing OIG report and strong lobbying from government officials and pharma calling for a total 340B program overhaul due to mismanagement and abuse, HRSA has allocated significant dollars and resources to ensure proper oversight and integrity of the 340B program. Since 2012, HRSA has conducted 100’s of audits while also providing improved media and communication to inform covered entities on the right way to administer the 340B program. 340B mega-guidance legislation, proposed by a key committee last year, contained many provisions that would have made it much more difficult, if not impossible, for many hospitals to continue participating in the 340B program. While speculation is that a modified mega-guidance will be released sometime early to mid-2017, no timeframe has been outlined regarding the release of this important regulatory guidance.