The Future of 340B in 2016

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

Considering that policies and procedures are ever-changing within our industry, it is crucial that experts like those at PBIRx have staff dedicated to industry changes bringing opportunities to their clients on a continuum. Continuing to place our focus on the 340B Drug Pricing Program, the latest news and updates suggest that 2016 is going to be quite a year, with changes and new initiatives on the way. Below, we want to share a few key points that we have compiled through our research on predictions about 340B for this year:

1. In September of 2016, it is expected that HRSA will publish their final 340B Program “mega-guidance.” For those of you who are unaware, their first “mega-guidance” was published in August of 2015, however, concerns and a federal court decision led to the need for a second edition.
2. New rules regarding monetary penalties for drug manufacturers that overcharge covered entities under the 340B program, such as hospitals, will be put into place. These rules are expected to be brought into the public eye in May of 2016.
3. Also in May of 2016, we can expect to see HRSA propose a new rule surrounding the 340B Program’s administrative dispute resolution process. It is said that this proposal will apply to both the drug manufacturers and covered entities.

In addition to the above, our research also states that the HHS Office of Inspector General (OIG) also has plans for this year that involve the 340B Program. One plan of action is to take a look at Medicaid managed care organizations that pay for drugs purchased through the program and determine the risk of duplicate discounts for them. An explanation on the efforts that will be taken to prevent this is also said to be on the horizon.

To learn more about the expected future for 340B in 2016, check out the full article from Health Care Law Today here. 

At PBIRx, we are heavily involved with the 340B Program and offer our own independent compliance audits along with ongoing management, which include monthly compliance audits and updates to Policies and Procedures documents.    These services ensure that our clients will maintain their 340B status. For more information about this service, as well as our participation with the program, please visit www.pbirx.com or call (888) 797-2479.