3 Takeaways from the 340B Coalition Conference
Visante attended the 2024 340B Coalition Summer Conference from July 8-10. The event was packed with information and we learned a lot through chatting with other members of the 340B community. These are our top three takeaways:
Three Things We Learned About the Ever-Changing World of 340B
1. Contract Pharmacy Restrictions
Over the past four years, 37 manufacturers have initiated price restrictions on 340B pricing for covered entities’ contract pharmacy arrangements. Originally, this targeted hospitals only, but it has since evolved to include all covered entity types. The complexities of these restrictions are burdensome on the covered entity, not only from an operational perspective but financially as well. We must not lose sight of the impact on the patients that these covered entities serve.
Covered entities serve the most vulnerable patients, many of which have limited financial resources. The ongoing manufacturer restrictions impact many covered entities’ ability to provide free or reduced access to medications. Not only are there multiple manufacturers requiring data submission of claims, but the policy of the manufacturers also changes frequently and is operationally burdensome to manage. These restrictions continue to undergo litigation as to whether the manufacturers can, by statute, restrict access to 340B pricing.
2. States’ Response to Contract Pharmacy Restriction
Arkansas and Louisiana were the first two states to pass legislation that deemed the manufacturer restrictions illegal.
Eight states have passed laws banning manufacturer restrictions on 340B pricing at contract pharmacies. Bills in several other states are making their way through the legislature. This is one avenue for states to battle against manufacturer restrictions, and we continue to remain hopeful that legislation will side in favor of covered entities to increase the likelihood that they continue to provide free and reduced-price medication access to all vulnerable patients, as intended.
3. Update to HRSA Audits
HRSA audits focus on preventing duplicate discounts, among other areas. A duplicate discount occurs when a covered entity purchases a drug at 340B pricing, and Medicaid receives a rebate for the same drug from the manufacturer. Previously, HRSA audits focused solely on Fee-For-Service (FFS) Medicaid claims to identify duplicate discount violations. This included reviewing the UB-04 form to verify that the covered entity did, in fact, bill their state Medicaid plan with the required billing modifiers and the Medicaid exclusion file maintained by OPAIS.
In recent audits, HRSA has requested this documentation for Managed Medicaid Organizations claims (MCO) in addition to FFS claims. This change indicates a new focus on identifying duplicate discounts specifically related to MCO claims. HRSA has started to focus on ensuring the information contained in OPAIS, such as the covered entity’s DSH percentage, corresponds to the most recently filed Medicare Cost Report. This represents a shift from what HRSA focused on in previous audits. We recommend that all covered entities verify that no updates are needed after filing their Medicare cost report each year. If any changes are required, ensure a process is in place to update OPAIS as soon as possible after the Medicare cost report is filed.
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