Managing Unused Aliquots in 340B: Or -- Horseshoes, Hand Grenades, and 340B
A question arose in a recent HRSA integrity audit involving how unused aliquots were managed. As it turned out, not well from a 340B perspective. As we polled various entities about this topic, we found a few other facilities with similar compliance concerns. This is an often-over-looked aspect of 340B, so take a few minutes to read on and then look at your own operation to ensure it is compliant in this area.
This blog will examine the use and documentation of unused aliquots in a 340B program. But before we begin, a nod to the long established but disreputable Curmudgeons of note: Yes, we will tie 340B together with hand grenades and horseshoes – read on!
One of our prior blog posts covered 340B Waste Management in this article: https://blog.cpspharm.com/340b-and-managing-waste. If you are would like more information click about waste management in 340B, click the link above, or click [here].
In our own external audits, we see many, if not most Covered Entities have a good to excellent understanding of how to compliantly manage unused aliquots. In all situations we’ve seen, the split billing software appropriately manages charged aliquots, accumulating the aliquot to the appropriate ‘bucket’, 340B, GPO or WAC, along with the dose administered/charged. However, while most Entities are compliant in billing for aliquots, we often see a disconnect in maintaining 340B compliance for unbilled aliquots that may be used for other purposes. To help clarify, we will use a specific example of Alteplase.
Patient specific doses of Alteplase frequently result in unused aliquots, with many Patients commonly receiving a partial dose of a vial. Entities typically do not charge for the unused aliquot if they can save it for use on other patients. Since frozen Alteplase may be stored and used later, many IV rooms take these unused aliquots, draw it up into 2 mg syringes, and use this as they would use commercially available Cathflo®. This common practice allows significant savings and avoids charging a patient for that unused portion of a vial they do not need.
So, what’s the problem?
The compliance issue ties back to the HRSA 340B requirement for an 11- digit NDC replenishment model. The text box (Figure 1) shows the Apexus FAQ on this topic. You can see the citation at this [LINK].
The key phrase noted in FAQ 1222 is, “9-digit NDC replenishment should not be part of standard operations”. The bolded sentence in the text box is our edit, not that of the Apexus team.
See the Visio flow chart for a graphic example: There can be two different NDCs, in addition to the manufacturer’s Cathflo NDC used for the dose of Alteplase 2mg given to a patient. However, the charge normally goes through using the Cathflo NDC. Replenishment credits then accumulate to the Cathflo NDC, but not back to the Alteplase 50mg/100mg NDCs. This may result in over-accumulation to the 2mg dose, and under-accumulation to the 50mg/100mg doses. While this error is unlikely to require any pay-back or penalty, it could result in a HRSA finding requiring a response. So, it deserves ‘fixing’.
The ‘good news’, so to speak, is that this can be compliantly maintained via documentation and manual adjustments to the accumulators. Use the steps shown in the flowchart (figure 3) to manage compliance. As the flowchart shows, each month manually track the doses of Alteplase 2mg that were compounded from either the 50mg or 100mg vial. Adjust your accumulators to reflect the individual vial size actual usage. Document these adjustments and retain the documentation for as long as your policy specifies for all 340B documentation.
One last crucial step: Update your Policy and Procedure to reflect your rationale and practice. Of course, reach out to your friendly neighborhood Comprehensive Pharmacy Services 340B team to assist if needed.
And now back to what some of our Curmudgeon readers consider the most important part: How someone can relate 340B to something so obviously unrelated: 340B, Hand Grenades and Horseshoes.
The idiom “Close Only Counts in Horseshoes and Hand Grenades” is endemic in our culture and does a great job of illustrating the importance of accuracy. Baseball Manager Frank Robinson is credited with an interview where he used the idiom back in 1977, but I recall hearing it far before then (1966), from as Asbestos Worker Local #22 Insulator named Shaky Gregory. While not eloquent by nature, Shaky was a master of idioms, and in fact had close personal knowledge of Hand Grenades (from the Korean Conflict) and Horseshoes (he played them regularly).
So, my Curmudgeon Colleagues (and you know who you are), since accuracy is critical to a sound 340B program, it is appropriate to link 340B to the idiom.
Thanks for reading, and as always, reach out to your Comprehensive Pharmacy Services 340B team for any assistance.