Medical Claims in 340B: What the New ESP Requirements Mean for Your Program

A breakdown of evolving requirements, operational considerations, and what covered entities should evaluate.

For many years, 340B covered entities submitted contract pharmacy claims through the ESP platform. The process became familiar over time, with established workflows and expectations across most programs.

Recently manufacturers, including Eli Lilly and Novo Nordisk, have introduced additional data submission requirements through ESP. These updates expand beyond contract pharmacy claims to include medical claims data, and in-house pharmacy data as well.

For covered entities, this represents a shift in both scope and operational complexity. As requirements evolve, it becomes increasingly important to understand what is being requested, how it differs from prior processes, and what it may mean for program administration moving forward.

‍

Pharmacy Claims vs. Medical Claims: Key Distinctions

To understand the scope of these changes, it is helpful to revisit the distinction between pharmacy and medical claims within a 340B program.

Pharmacy Claims

Pharmacy claims represent prescriptions dispensed through retail pharmacies, usually contract pharmacies. These claims are typically processed through a TPA and have historically been the primary data source for ESP submissions.

Medical Claims

Medical claims include drugs administered or dispensed in a clinical setting, such as infusions, injections, or medications provided during outpatient encounters. These claims are often managed through medical billing systems and have not traditionally been included in ESP submission workflows.

Evolving ESP Submission Requirements

Under updated ESP requirements from certain manufacturers, covered entities may now be expected to submit multiple categories of claims data. Depending on program structure, this may include:

• Contract pharmacy claims
• Medical claims
• In-house or entity-owned pharmacy claims

For entities using a TPA, this can mean submitting three separate reports instead of one. Each report type has different data fields and formatting requirements. Medical claims, in particular, require data that may not be readily available in your TPA’s standard reporting, meaning additional manual steps may be needed to complete your submission.

Mixed-use claims can introduce additional complexity, as missing data fields may require manual adjustments before they can be submitted properly.

Industry Context and Considerations

The expansion of ESP requirements is occurring alongside broader industry discussions around claims visibility and program oversight. While approaches vary by manufacturer, these requirements are generally intended to increase transparency into how 340B pricing is applied across different dispensing settings.

At the same time, there is ongoing industry dialogue regarding the operational and legal implications of these requirements. Covered entities may encounter differing interpretations and evolving expectations as policies continue to develop.

Operational Implications

As submission requirements expand, so does the complexity of managing them.

Even for organizations with established ESP workflows, incorporating additional datasets introduces new operational considerations, including:

• Data alignment across multiple systems and manufacturer requirements
• Increased reporting and validation requirements
• Greater potential for discrepancies between submitted claims and purchasing data
• Additional coordination across internal teams or external partners

These factors can impact both the time required to manage submissions and the processes needed to ensure accuracy and consistency.

Key Questions for Covered Entities

As requirements continue to evolve, covered entities may benefit from evaluating the following:

• Which manufacturers currently require expanded ESP submissions, and what specific data is expected?
• Are there gaps in data fields, particularly for mixed-use or clinic-administered drugs?
• How is the submission process currently managed, and does that approach scale with increased requirements?

Addressing these questions early can help organizations better understand their current position and identify areas for improvement.

What Should Covered Entities Be Doing as ESP Requirements Expand?

As ESP requirements continue to develop, covered entities are navigating a more data-intensive and operationally complex environment. Staying informed, assessing internal capabilities, and establishing clear processes will be key to maintaining program stability.

Support with ESP Submissions

Managing ESP submissions across multiple data sources can require significant coordination. RxTrail works with covered entities to support submission processes, monitor data alignment, and help maintain operational consistency. Your claim submissions handled from start to finish.

If you’re evaluating your current approach or looking to better understand your program’s readiness, we’re here to connect.

‍