Breaking Insulin Pen Boxes: Where Are We Now?

This month marks two years since the U.S. Food and Drug Administration (FDA) clarified their intentions behind revising insulin pen labeling, yet insulin pen boxes continue to present issues to pharmacies trying to establish best practices surrounding its dispensing and billing. Let’s review the historical context and recent NCPDP guidance that PAAS is starting to see Payors/PBMs implement.

For historical context, Walgreens settled with the Department of Justice (DOJ) in January 2019 for $209.2 million due to their pharmacies improperly billing insulin pen boxes. Patients’ insulin pen prescriptions were placed on automatic refill with inaccurate days’ supply, resulting in millions of dollars of waste. Six months later, the FDA contacted insulin pen manufacturers requesting the labeling found on insulin pen boxes and package inserts be updated. As a result, the new labeling “dispense in the original sealed carton” was approved and subsequently printed on insulin pen boxes. In February of 2020, the new label had made its way through the supply chain and PAAS had issued a member alert to stop breaking boxes due to PBM audit enforcement.  However, eight months later, in October 2020, the FDA released “clarification” on their guidance of breaking insulin pen boxes, stating they acknowledge scenarios where breaking insulin pen boxes may be appropriate. In November 2020, PAAS wrote a Newsline article, reiterating our guidance that “while the FDA may understand and permit dispensing of individual pens on an exception basis, payors and PBMs may not” and therefore best practice would be to refrain from breaking insulin pen boxes.

As these updates were occurring, PAAS was an active participant in NCPDP Task Force Group meetings. In May 2021, NCPDP added an example scenario in Section 6.19 of their Telecommunication Version D and Above Questions. When a pharmacy is submitting a full insulin pen package and the calculated days’ supply exceeds the plan’s days’ supply limit, NCPDP’s guidance clearly states, “days’ supply restrictions should not hinder the pharmacy’s ability to dispense a full package” and subsequently states if “[the payer system requires some type of override action by the pharmacy], the recommendation is to use a Submission Clarification Code value 10 = Meets Plan Limitations. The pharmacy certifies that the transaction is in compliance with the program’s policies and rules that are specific to the particular product being billed.”

Recently, pharmacies have begun receiving adjudication rejects requesting the pharmacy to consider the use of SCC 10 when the days’ supply exceeds the plan limit. This presents potential audit risk and should be used as an opportunity to remind pharmacy employees of the importance of adjudication messaging. Billing the accurate, and larger, days’ supply (with an SCC=10 override), could put the pharmacy into an “extended days’ supply” (EDS) network. As such, it is possible that lower reimbursement and/or multiple member copays will occur. Pharmacies that ignore the messaging and reduced the days’ supply to the plan limit could face audits where PBMs argue pharmacies forewent using SCC 10 to avoid decreased reimbursement and failure to collect the appropriate copay amounts, causing the Payor’s costs to increase.

So, what is PAAS’ guidance given this new wrinkle? While audit risk related to breaking insulin pen boxes remains largely theoretical, pharmacies know PBMs cannot be trusted. PBMs enforce many other unbreakable packages (e.g., see PAAS Newsline article HIV Medications Cause Large Recoupments) and PAAS is aware of only one Payor who has formally stated it was “okay” to break insulin pen boxes. PBMs love the deregulated, opaque world they operate in, and failure to provide further guidance to pharmacies allows them to be judge, jury and executioner should they decide to enforce the FDA labeling restrictions. The SCC adjudication guidance adds another challenge for pharmacies trying to bill claims accurately.

PAAS Tips:

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Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.

  • Access Services
    • Audit Documentation Submission Guidance
    • An online form to submit safe filling and billing questions
    • Your PAAS Membership Manual
  • Newsline
    • Monthly newsletter articles, written by our expert PAAS analyst team, provide safe filling and billing tips and relays relevant/current PBM trends to be help prevent audits
    • Search the Newsline Archive to get PAAS tips at the click of a button
    • Special Edition Newslines including: Top 10 articles of the prior year, DMEPOS Article Series and a Self-Audit Article Series
    • Ability to print monthly issues or individual articles
  • Proactive Tips
    • Audit flags – list of various claim attributes the PBMs use to select claims for audit
    • Billing insulin vials – flowchart to assist whether you should bill Medicare Part B vs Part D
    • DAW Codes Explained – use to understand when to effectively use DAW codes, their definitions and why claims may be flagged for audit if a DAW code is used incorrectly
    • Basic DMEPOS documentation guidance
    • Onsite Credentialing Checklist and expanded definitions of policies and procedures
    • Proof of refill request and affirmative response form for DMEPOS items
    • Steps on how to prepare for an onsite audit
    • And more!
  • Days’ Supply Charts
    • Utilize the days’ supply charts for inhalers, insulins, nasal sprays, eye drops and topicals to aid you in calculating the correct days’ supply
    • Guidance on overbilled quantities and incorrect days’ supply account for a sizable portion of audit chargebacks
    • Additional miscellaneous charts, which include: Dispense in Original Container and Return to Stock
  • Forms
    • Signature Logbook for print
    • Signature Trifold Mailer
    • Fax and Email Coversheet
    • Patient Attestation for over-the-counter COVID-19 test kits
  • On-Demand Webinars
    • Short webinars on hot topics in the PBM industry. Here are a few examples:
      • USP 800 Compliance
      • Cultural Competency Training
      • Dispensing Prescriptions Off-Label
      • Biologic Medications and Interchangeability
      • Continuous Glucose Monitor Requirements for Medicare Part B

PAAS Tips:

  • MORE AUDITS, MORE INSIGHT – PAAS National® is the industry-leading defender of community pharmacy dealings with Prescription Benefit Programs, including Caremark, Express Scripts, Humana, Medicaid, OptumRx, Prime Therapeutics., and more. PAAS assists on all third-party audits, including: desktop audits, onsite audits, invoice audits, OIG/Medicaid audits, Medicare B audits. The PAAS team is dedicated to helping you! We have five pharmacists and a complement of technician analysts with over 50 years of dedicated audit assistance experience. PAAS continuously updates their database with every audit received — in fact, we even keep a scorecard on individual auditors.
  • Get answers to your questions on days’ supply calculations, drug substitutions, billing practices, required documentation, prior authorization requirements, record retention, and internal audit procedures – just to name a few. As a trusted partner, we will provide tailored guidance to help you proactively prevent audits. Remember, the prescription claims you submit today are the audits of the future.
  • Keep your employees engaged and help lower audit risk by adding all employees to the portal and giving them permission to access these tools, resources and eNewsline. For more information review September 2019 Newsline article, What Are You Waiting For? Make Sure ALL of Your Employees are Added to the PAAS Portal!
  • Contact PAAS at (608) 873-1342, if you would like a tour of your PAAS Member Portal, so you can reap all the benefits of your PAAS Audit Assistance. We appreciate you being a member.
Meredith Thiede, PharmD
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