Dispense in Original Container – Know the Audit Risks

PAAS National® analysts want to remind pharmacies of the audit risks when medications are dispensed outside manufacturer storage/dispensing requirements. PBMs can easily identify claims billed for a quantity that does not match the package size for a particular NDC, making them an easy target for recoupment.

Manufacturers submit storage/dispensing requirements to the FDA, which in turn appears on the package and in the package insert. These requirements may be based on light or moisture sensitivity or simply that the product has not been tested outside the original container. Pharmacies can utilize the DailyMed website to find product labeling information; however, be aware that variations in labeling precautions exists. PAAS has spoken with the FDA about inconsistent verbiage for precautions, even amongst products from the same manufacturer. While standardization would provide clarity and be helpful for all dispensing pharmacists, the FDA defers this language choice to the manufacturers.

Another twist on quantity dispensed not divisible by package size is diabetic test strips – the NDC must match what you are dispensing. Claims billed for the 100-count box, but quantity billed is not divisible by 100 (e.g., 150) can result in a partial recoupment.

PAAS has created a chart for the most common medications targeted on audit for dispensing outside manufacturer requirements. Download the Dispense in Original Container Chart from the PAAS Member Portal and access many other Proactive Tips, Days’ Supply Charts, On-Demand Webinars and additional resources that further assist PAAS members and their staff.

While on the website, check out PAAS’ Upcoming Events for locations you can find us. Stop by our booth to say “hi” and pick up our new 5×7 inch, laminated Dispense in Original Container Chart and Considerations for Billing Insulin Vials magnet!

Dana Westberg, CPhT
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