HRSA Response to Manufacturer 340B Changes

In September, several drug manufacturers announced that they would no longer be providing 340B pricing to most contract pharmacies.  You can read about those actions in our Fall 2020 Newsletter.  In response to those manufacturer actions, Apexus, the 340B Prime Vendor Program, published a sample form for covered entities to report instances where covered outpatient drugs are not available at a 340B ceiling price and/or are charged at the incorrect 340B ceiling price.

The form specifically asks if the issue reported is limited to a contract pharmacy purchase.  This question could help Apexus target where availability or pricing issues are specifically related to the recent manufacturer changes.  The form also asks the reporting party to note if purchasing is affected by a shortage-related issue, relates to a specialty drug, or is subject to limited distribution.  These questions may identify availability or pricing issues unrelated to recent manufacturer 340B actions.

Perhaps most telling is the instruction to “contact the wholesaler and manufacturer directly to determine the reason for unavailability and/or to document incorrect pricing” prior to submitting the form.  Per the form, “HRSA investigates allegations of non-compliance brought to its attention and will follow-up with all parties once the issue is reviewed.”  The form also asks if the covered entity has verified that the product is a covered outpatient drug, as listed on the Medicaid Drug Rebate Program file.  While this step is not listed as “required,” it may help to further validate a covered entity claim.

Completed forms, along with manufacturer and/or wholesaler responses, are to be emailed to HRSA.  Based on the availability of this form and its uptake and use by covered entities, HRSA may begin to quantify the extent and impact of manufacturers’ refusal to provide 340B pricing to all contract pharmacies.  Stay tuned as this chess match continues.


Posted November 2020

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