Understanding ESP Data Requirements & Submission Policies: What You Need to Know

If your organization participates in the 340B program, you’ve likely encountered challenges with ESP data submission. From changing manufacturer policies to confusing timelines, keeping up with the requirements can feel overwhelming. But understanding what’s expected—and why it matters—is essential to maintaining compliance, avoiding delays, and protecting your 340B savings.

In this post, we break down the key ESP data requirements, common submission policies, and tips to help your organization stay ahead.

‍

What is ESP and Why Does It Matter?

ESP, or 340B ESP™, is a platform used by drug manufacturers to collect claims data from covered entities. Its purpose? To prevent duplicate discounts—ensuring that manufacturers aren’t providing a 340B discount and a Medicaid rebate on the same drug.

But what started as a tool to support compliance has become a major pressure point for 340B entities.

‍

Core Data Requirements: What Manufacturers Expect

While each manufacturer sets its own policies, there are common data elements typically required:

• NPI & TIN information
• Date of service / Fill date
• NDC number (11-digit)
• 340B indicator
• Payer and plan info
• Patient-level claims data

Note: The lack of standardization across manufacturers can make this process difficult. Some require submission only if a specific NDC was purchased; others want ongoing reports whether or not a 340B claim exists.

Submission Timelines & Frequency

Most manufacturers require submissions every 14 days. Missing a deadline—even once—can result in:

• Loss of access to 340B pricing for that manufacturer
• Flags in your audit trail
• Revenue disruption until access is restored

Challenges with ESP Submissions

1. Data Quality – Mismatched NDCs, missing payer info, or incomplete records can lead to rejections.
2. Privacy Concerns – ESP asks for sensitive patient-level data, raising HIPAA questions.
3. Time Burden – Smaller clinics often lack the capacity to manage complex submissions monthly.

Tips to Stay Ahead

• Standardize Your Internal Data Collection: Make sure your EHR or pharmacy software captures all necessary fields.
• Stay Up to Date on Manufacturer Policies: Policies change frequently—set a recurring calendar reminder to review updates.
• Use a TPA or 340B Consultant: A good partner can help automate submissions and flag data issues before they’re a problem.
• Document Everything: Keep detailed records of submission dates, confirmations, and any manufacturer correspondence.

What Happens If You Don’t Submit?

Non-submission can lead to blocked pricing—meaning your 340B accounts may have to pay WAC pricing until compliance is restored. And even if you correct the issue later, some manufacturers will not retroactively honor 340B pricing.

Take Control of Your ESP Strategy

Understanding ESP data requirements isn’t just about compliance—it’s about protecting the integrity of your 340B program. By getting proactive with data management, staying informed on manufacturer expectations, and leaning on trusted partners, you can keep your savings flowing and reduce the risk of pricing interruptions.

Have questions about ESP or need support building your submission workflow? Reach out to the RxTrail team—we’re here to help.

‍