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The pace of manufacturer policy changes in the 340B space shows no signs of slowing down. This spring, several major pharmaceutical manufacturers have released new or updated policies that directly impact how covered entities (CEs) access 340B pricing. From expanded claims data submission requirements to new platform registrations and tightened contract pharmacy rules.
Whether you are a grantee or a hospital covered entity, these changes require your attention. Missing a deadline or failing to act on a required designation can mean one thing: loss of 340B pricing.
Here's a comprehensive look at what's changed, what's coming, and what you should be doing right now.
Lilly was one of the first manufacturers this year to expand its claims data submission requirements. Beginning February 1st, Lilly now requires ESP claims data for all 340B utilization, not just contract pharmacy claims as was previously required.
What this includes:
However, a specific set of drugs carry a 60-day window: Alimta, Amyvid, Cyramza, Erbitux, Kisunla, Omvoh, Portrazza, and Tauvid.
What to do: If your in-house pharmacy or medical claims aren't already flowing into ESP for Lilly drugs, this needs to be addressed immediately. These requirements are already in effect.
Novo Nordisk's April updates represent some of the most impactful changes of the year. There are multiple policy shifts happening simultaneously, and each one has real consequences for how your program operates.
Novo Nordisk now requires ESP claims data for all 340B utilization, including all three claim types, within 45 days of dispense:
Contract pharmacy designation changes: Previously, Novo Nordisk allowed covered entities to designate two contract pharmacies. That number has now been reduced to one. Additionally, you can only designate a contract pharmacy if you do not have an in-house pharmacy, and you'll need to attest to this within ESP when making your designation.
This is a significant shift from their prior policy, which allowed contract pharmacy designations regardless of whether a CE operated an in-house pharmacy.
For grantees: Grantees were already allowed to use unlimited contract pharmacies under Novo Nordisk's prior policy, and were already required to submit claims data for all of them. That part has not changed.
What is new is the consequence for non-compliance: under the updated policy, failure to submit claims data for even one contract pharmacy can result in suspension of 340B pricing at all of your contract pharmacies. Previously, a data gap at one pharmacy would only put pricing at that specific location at risk.
What's already happening: Since April 1st, CEs with in-house pharmacies have lost pricing at contract pharmacies. If a CE previously had two designated pharmacies, they've already lost pricing at one of them.
What to do: Review your current designations immediately. If you have an in-house pharmacy, you may need to restructure your approach entirely. Grantees should ensure claims are flowing for every contract pharmacy without exception.
Beginning May 1st, AstraZeneca will expand its ESP claims submission requirements to mirror what several other manufacturers have already implemented.
What's changing: AstraZeneca will now require ESP claims data for all 340B utilization, including in-house pharmacy and medical claims, not just contract pharmacy claims as was previously required.
Submission window: All claims must be submitted within 45 days of dispense.
What to do: If your in-house and medical claims aren't set up to submit to ESP for AstraZeneca drugs, that workflow needs to be in place before May 1st.
BMS is implementing the same expanded ESP requirements as AstraZeneca on the same effective date.
What's changing: BMS will require ESP claims submission for all 340B utilization, including in-house pharmacy and medical claims in addition to contract pharmacy claims.
Submission window: All claims must be submitted within 45 days of dispense.
What to do: Ensure your data workflows are updated to capture and submit all claim types for BMS drugs ahead of the May 1st deadline.
Organon's update is different in nature — it's not just a policy change but a platform migration. Organon is moving from ESP to Truzo, effective May 1st.
What this means for your organization:
If you don't already have a Truzo account, you'll need to register one — and this must be completed by your Authorizing Official
You'll need to designate your contract pharmacy(ies) within Truzo
All pharmacy claims data must be submitted through Truzo (not ESP) going forward
Claims must be submitted within 45 days of dispense
It's also worth noting that earlier this year, three other manufacturers — Alkermes, Argenx, and Puma Biotechnologies — also joined the Truzo platform (note: Argenx and Puma were not previously on ESP or any other claims platform).
What to do: Don't wait on this one. Truzo account registration requires action from your Authorizing Official, and incomplete registration by May 1st could put your pricing at risk. Get this on your compliance calendar now.
Pfizer released a significant policy update earlier this year with an effective date of March 31, 2026. If your organization hadn't acted by March 20th, there may already be impacts to your designations.
Key changes:
Claims data submission for contract pharmacy claims is now required within 45 days of dispense. Pfizer did not previously require claims data submission.
Grantees are no longer exempt from Pfizer's policy. All grantees must now designate a single contract pharmacy and comply with submission requirements.
All covered entities were required to complete a new attestation confirming the entity does not have an in-house pharmacy capable of dispensing Pfizer's drugs, and redesignate a contract pharmacy. This had to be completed by March 20th to be effective March 31st.
Pfizer discontinued all previous designations. If your entity did not complete the redesignation process, your prior designation is no longer active.
What to do: If your organization hasn't completed the required attestation and redesignation, contact Pfizer's ESP program and your RxTrail team as soon as possible to understand your options.
These changes are part of a larger pattern, and it's not slowing down. They're part of a broader, ongoing push by pharmaceutical manufacturers to expand data collection requirements, tighten contract pharmacy access, and shift more administrative responsibility onto covered entities.
The pattern is clear: more manufacturers are moving toward requiring claims data across all utilization types: in-house pharmacy, medical, and contract pharmacy. The window for submission is consistently 45 days. And the consequences for non-compliance are increasingly severe, with some manufacturers now tying pricing access at all contract pharmacies to compliance at each individual one.
For covered entities, this means compliance infrastructure matters more than ever. The right data workflows, a reliable TPA, and proactive policy monitoring aren't just helpful, they're essential.
If you have questions about how any of these updates affect your specific program, we'd love to connect. Reach out to the RxTrail team or visit rxtrail.com to learn more.
This post is intended for informational purposes and reflects manufacturer policy information available as of April 2026. We recommend confirming all policy details directly with manufacturers and through your ESP or Truzo accounts.
