Frier Levitt partner Jesse Dresser is featured in Pharmacy Practice News discussing a critical and emerging compliance risk for covered entities and contract pharmacies: Submission Clarification Code 20 at the point of sale.
In the article, “A New Call for 340B Transparency, Reform,” Jesse addresses the intensifying scrutiny facing the 340B Drug Pricing Program in 2025, including escalating litigation, new state-level protections, aggressive pharmacy benefit manager (PBM) tactics, and early federal testing of rebate-based pricing models.
Drawing from his presentation at the ASHP Pharmacy Futures 2025 Meeting in Charlotte, North Carolina, Jesse highlighted growing controversy surrounding Submission Clarification Code 20, a data field used to signal that a drug was purchased at 340B pricing. While covered entities dispensing to their own patients can typically identify 340B claims at the time of billing, contract pharmacies often cannot reconcile 340B eligibility until after the claim has adjudicated.
This operational reality creates significant compliance challenges as commercial PBMs, including Express Scripts and Humana, increasingly demand real-time identification of 340B claims despite longstanding post-dispense reconciliation models. Jesse notes that these requirements introduce both financial exposure and regulatory risk, underscoring the importance of careful contract review and well-documented compliance rationales.
As scrutiny of the 340B program continues to escalate, the article reinforces the need for pharmacies and covered entities to proactively evaluate their point-of-sale practices and compliance strategies in an increasingly complex enforcement environment.
