340B Price Unavailability - How to Report to HRSA

December 2015

Manufacturers who participate in Medicaid are required under the 340B statute to enter into an agreement with the Secretary under which the manufacturer must agree to charge a price (“the 340B ceiling price”) that will not exceed the amount determined under a statutory formula when selling covered outpatient drugs to particular covered entities listed in the statute. However, there may be occasions when a 340B covered entity is unable to obtain a drug at the 340B ceiling price for various reasons. Some of these reasons include:

drug product is in short supply;
drug is on back-order;
drug product is only available through a limited distribution network established by the manufacturer; or
covered entity does not have a contract with the manufacturer or wholesaler for purchasing the drug product.

If a covered entity is unable to purchase a covered outpatient drug at the 340B price, the entity should first contact the wholesaler and/or manufacturer to determine the underlying issue as to why the product is unavailable at the 340B price. Then, if the issue is not resolved by taking such action, covered entities are encouraged to bring these occurrences to the attention of HRSA

The 340B Prime Vendor has created a template form (PDF - 291 KB) that can be used to report the information to HRSA and they can provide any needed assistance to covered entities when notifying HRSA of 340B price unavailability.

HRSA thoroughly reviews each notification and communicates back to the covered entity and the manufacturer, if necessary, in an effort to address the issue of the unavailable 340B ceiling price. This recently revised form (PDF - 291 KB) requests important details regarding the situation that will help HRSA to respond as efficiently as possible.

The notification form requests:

a description of the communications between the covered entity and the manufacturer or wholesaler regarding the reason for the unavailability of the 340B ceiling price;
the individual submitting the notification and/or to be contacted by HRSA and the manufacturer, if necessary;
the drug product for which the 340B price is unavailable; and
the alternative method used by the covered entity to obtain the drug.

It is important to note that HRSA reviews each and every allegation of non-compliance brought to our attention and takes program integrity very seriously – for manufacturers and covered entities. The information provided to HRSA regarding 340B price unavailability assists us in taking the appropriate steps to ensure manufacturers are in compliance with program requirements.

If you have any questions, or need further information, the team at ApexusAnswers; a service of the 340B contracted Prime Vendor Program-stands ready to assist by email (ApexusAnswers@340bpvp.com) or by phone (888-340-2787).