Avoid the Creon® Chargeback Catastrophe by Following THIS Billing Rule

Creon® is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions. Claims for these pancreatic enzymes find themselves on audits year after year, and the audit risk has just increased as …

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ALL strengths of Creon® are now required to be stored and dispensed in the original container. This change was published in the FDA product label, updated October 12, 2023. The previous package insert (effective June 2, 2022) only required the 3,000 USP units of lipase to be stored and dispensed in the original container.

With this change to the package labeling, pharmacies MUST be sure to bill and dispense all strengths of Creon® in quantities that correspond with a full bottle, or multiples of a full bottle. Claims billed for quantities not evenly divisible by the quantity in a full bottle are easy for a PBM’s algorithm to flag for audit. If audited, these claims will likely face a partial or full recoupment with very little chance of a successful appeal. One example of language explaining this discrepancy can be found in the Fourth Edition (Version 4.1) of the 2023 OptumRx® Provider Manual, which reads “OptumRx reserves the right to recover payment for claims dispensed outside the manufacturer’s FDA-approved storage and dispensing recommendations. Claims for products where the manufacturer’s original package is designed and intended to be dispensed to patients without repackaging due to stability and patient safety concerns, may be subject to review and recovery. Pharmacies are advised to follow FDA requirements.”

Claims billed for LTC patients or patients enrolled in a medication synchronization or medication packaging program are NOT EXEMPT from the FDA rules to store and dispense medications in their original containers. In other words, these medications should NOT be put in bubble packs, blister cards, BINGO cards, strip packaging, medication boxes, or other compliance packaging and must only be dispensed by the pharmacy in their original containers.

PAAS Tips:

  • Dispense ALL strengths of Creon® in their original container
  • Print and display an updated copy of the Dispense in Original Container Chart
  • Confirm the prescription has calculable directions, such as the number of meals AND number of snacks, OR the total number of capsules per day the patient can take and contact the prescriber for clarification if the prescription is received with insufficient directions
    • Remember to document the clarification with a clinical note including the date of the call, the name and title of whom you spoke with, the clarification, and your initials
    • Be sure clinical note is retrievable and visible to the reviewer during an audit
    • Ensure the patient’s label is updated with the more specific directions prior to dispensing
  • If a prescription is received for a quantity LESS THAN what is in a full bottle:
    • Contact the prescriber or their agent to update the written quantity on the prescription to 70, 100, or 250 capsules (as applicable) and document with a clinical note
    • Or increase the dispensed amount to a sufficient quantity by borrowing capsules from an authorized refill; this is only an option in states where pharmacists have the legal authority to consolidate refills
Sara Hathaway, PharmD