340B Purchases for Clinic Dispensing

Pills and Coins on a white backdrop

Did you know all clinic administered drugs purchased at 340B pricing require the same tracking and oversight as drugs dispensed through a contract pharmacy arrangement?

To purchase drugs at a 340B price, a covered entity must be eligible and registered on the OPAIS database. For 340B eligibility purposes, it’s likely that 340B drugs purchased for in-house use are dispensed to the covered entity’s patient by an eligible prescriber. However, diversion is a risk if tracking purchases and matching those purchases to eligible dispenses is not part of the entity’s process.

Maintaining accumulation records is necessary to ensure proper oversight of clinic purchases.

A primary concern for clinic dispensing of 340B purchased drugs is the risk of duplicate discount. Billing contrary to the Medicaid Exclusion File (MEF), having inadequate control to prevent duplicate discounts, or incorrect billing information on the MEF were among the audit findings identified in HRSA audits completed in 2017. Additional detail on the finalized 2017 HRSA Audit results can be found here.

These findings can be a result of unmonitored clinic purchasing of 340B drugs. If a covered entity carves-out on the MEF, 340B purchased drugs should not be administered to Medicaid patients in order to prevent a duplicate discount to the drug manufacturer.

If a covered entity carves-in on the MEF, the correct indicator(s) and process outlined by the State Medicaid Department must be followed in order to prevent duplicate discounts to the manufacturer.

An entity utilizing 340B purchased drugs for clinic administration must consider the risk versus the reward. More purchases create more room for non-compliance and require additional time and resources to ensure compliance is maintained.

We’re happy to discuss clinic purchasing further at our upcoming 340B Forum in Lake Placid, NY.

This post is part of our staff contributor series and was written by Beth Ligon, ATRIA 340B Business Analyst


Call Today 855.835.3402

Get In Touch.

Submit some basic information about your organization, and we’ll be in touch to discuss your program options.

  • This field is for validation purposes and should be left unchanged.
Hudson Headwaters 340B Pharmacy Services