Database Upgrades

January 2015

As part of its ongoing commitment to 340B program integrity, HRSA has placed a top priority on data transparency and accountability.  Stakeholders from across the 340B community use the 340B registration database to perform critical functions, including accessing information about covered entities and manufacturers; downloading Medicaid Exclusion Files to prevent duplicate discounts; and recertifying and updating information on individual entities as well as their contracted pharmacy partners. Each of these functions must work smoothly, effectively and accurately in order to ensure that all stakeholders remain in full compliance.

Late last month, HRSA launched a new version of the 340B database to help augment these processes. The database has a completely new look and feel, featuring a simpler interface that modernizes the user experience.  The database front page more clearly guides the user to appropriate choices, based on the most common uses of the database itself, and HRSA continues to streamline on-screen instructions based on feedback from the user community.

The registration process for both covered entities and contract pharmacies leverages technology to streamline critical program integrity checks, including pre-populating hospital, health center and pharmacy eligibility data with feeds from the Centers for Medicare and Medicaid Services, HRSA’s Electronic Handbooks (EHB) and the Drug Enforcement Administration. The requirement for hospitals to submit hardcopy cost report worksheets has been dramatically reduced (and completely eliminated in many cases), and several other entity types are expected to benefit from the integration of additional external data sources in 2015.

HRSA has also improved the process of updating registrations for covered entities that have already been accepted to the program; we recently enhanced the online change request process to accommodate authorizing official changes when the prior official is no longer available to validate the request (e.g., when the prior official has retired and their e-mail account is no longer accessible). Hardcopy change requests forms are now only required in exceptionally limited circumstances; the most common is when authorizing officials need to be changed after the start of recertification but we anticipate being able to accommodate those updates during 2015 as well.

Recertification of several major entity types will begin shortly; numerous front- and back-end changes will streamline the issuance of login credentials as well as ensure that the database will more efficiently process entity updates and attestations of past and future compliance. Entities that request termination or that are identified as no longer being eligible will be efficiently and transparently removed from the program.

HRSA also continues to enhance the Medicaid Exclusion File, which is its primary tool for preventing duplicate discounts. Fixed quarterly files were reintroduced in 2014, providing stakeholders with authoritative information on which entities were using 340B drugs for their Medicaid patients for a given time period, and we are responding to stakeholder feedback by adding additional fields and releasing archived files to the start of 2011.

On the back end, the registration and change request review processes has been enhanced so that HRSA staff can conduct significantly more efficient reviews. We have also invested heavily in the database’s underlying hardware and software; these changes have already yielded significantly improved performance/reliability and we anticipate further improvements as modernization of the 340B infrastructure continues.

We welcome feedback on the database and ways to continue to improve the experience for all stakeholders. Please contact ApexusAnswers, a service of the 340B Prime Vendor Program, at apexusanswers@340Bpvp.com or 888-340-2787.