What Covered Entities Should Know Before April 1, 2026

On March 2, 2026, Novo Nordisk released a revised 340B Distribution Policy that will take effect April 1, 2026.

While Novo Nordisk has collected claims-level data (CLD) from certain covered entities in recent years, this update significantly expands those requirements. Beginning April 1, all covered entity (CE) types will be required to submit claims-level data for both pharmacy and medical 340B dispenses, including:

• In-house pharmacy dispenses
• Contract pharmacy dispenses
• Medical Claims

The updated policy ties continued access to 340B-priced distribution directly to timely and complete data submission.

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What Is Changing on April 1, 2026

Under the revised policy:

• All CEs must submit claims-level data for all 340B dispenses
• This includes both pharmacy and medical claims
• Claims must be submitted within 45 days of the date of dispense
• Data must be uploaded via the 340B ESP platform
• Failure to submit timely and complete data may result in suspension of 340B distribution access until compliance is restored

Novo Nordisk states that the purpose of expanded data collection is to support duplicate discount prevention (including Medicaid and Medicare Maximum Fair Price (MFP) requirements), audit oversight, and broader 340B program integrity.

Importantly, the policy does not eliminate 340B pricing access, but it conditions continued access on compliance with the new submission requirements.

In-House Pharmacies: A New Requirement

One of the most notable shifts is the expansion of claims-level data submission to in-house pharmacies.

Under Novo Nordisk’s prior policy, claims-level data submission was not required for in-house pharmacy dispenses. Beginning April 1, 2026, all CEs operating in-house pharmacies must submit pharmacy and medical claims data within the 45-day timeline.

If data associated with an in-house pharmacy dispense is not submitted in a timely, complete, and accurate manner, Novo Nordisk may suspend access to 340B pricing for that location until the issue is resolved.

For organizations that have not previously operationalized in-house CLD submissions, this will require workflow review and potentially system adjustments.

Contract Pharmacies: Data Submission Now Required for Distribution

Under the updated policy, Novo Nordisk will only facilitate bill-to/ship-to distribution for contract pharmacies where the CE submits claims-level data associated with all 340B dispenses by those pharmacies.

This means:

• Contract pharmacies must have CLD submitted within 45 days of dispense
• Distribution may be suspended if required data is not submitted
• Prior CP arrangements without data submission will no longer qualify

Hospital CEs with wholly owned contract pharmacies may continue facilitating bill-to/ship-to orders to an unlimited number of wholly owned CPs, provided claims-level data is submitted.

Grantee CEs may continue facilitating bill-to/ship-to orders to multiple CPs (wholly owned or not)  again, contingent on CLD submission.

Covered Entities Without an In-House Pharmacy

Covered entities that do not operate an in-house pharmacy must designate one contract pharmacy for bill-to/ship-to distribution.

Key details:

• The designated CP cannot be a central fill pharmacy
• The designation must be submitted through the ESP platform
• To be effective April 1, 2026, the designation must be made by March 20, 2026
• CP designations may be changed once every 12 months (with limited exceptions)

Failure to designate a CP by the deadline may delay distribution access until a designation is properly submitted and approved.

Claims-Level Data Submission Timeline

Beginning April 1, 2026:

• Claims-level data must be submitted within 45 days of dispense
• Submissions must occur through the ESP platform
• Both pharmacy and medical claims are required

Novo Nordisk indicates that it will monitor timing and completeness of submissions.

Suspension language throughout the policy makes clear that data compliance and distribution access are now directly connected.

What Covered Entities Should Review Now

With the April 1 effective date approaching, organizations should consider reviewing:

• Current in-house pharmacy data workflows
• Medical claims extraction and formatting processes‍
• Evaluate current contract pharmacy arrangements to identify the single pharmacy that will be designated
• ‍ESP platform registration and account setup
• Internal controls to ensure 45-day submission compliance

For many organizations, this will require coordination across pharmacy operations, billing, IT, and 340B oversight teams.

This update does not remove 340B pricing eligibility. However, it does make continued access dependent on timely and accurate claims-level data submission.

Each covered entity’s impact will depend on its program structure, particularly around in-house pharmacy operations, contract pharmacy arrangements, and medical claims workflows.

We recommend reviewing the policy in detail and evaluating internal readiness well in advance of April 1.

If you would like to discuss how this may affect your specific program setup, our team is happy to connect and walk through next steps.

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