4/21/2026 – AstraZeneca and BMS Jump on 340B Claims Data Submission Bandwagon For Entity-Owned Pharmacies

AstraZeneca and Bristol Myers Squibb (BMS) became the most recent manufacturers to require covered entities to submit data for all 340B claims, including entity-owned pharmacy claims, for designated drugs, regardless of an entity’s use of contract pharmacies. Like policies released in the last several months by Exelixis, Eli Lilly, and Novo Nordisk, AstraZeneca threatens to restrict access to 340B pricing if a covered entity does not submit entity-owned pharmacy 340B claims data, while it is unclear if BMS plans to do so. To date, HRSA has not publicly commented on, or taken enforcement action against, the manufacturers’ policies. None of the companies has yet to discontinue 340B pricing for covered entities that do not submit the demanded data, so it is possible that HRSA might take action if 340B pricing is cut off in the future.

AstraZeneca’s policy states that it applies to “in-house” pharmacies, which it defines as a pharmacy that is owned by the 340B covered entity and listed in OPAIS as a shipping address. The BMS policy applies to “entity-owned” pharmacies. The BMS policy defines an “entity-owned” pharmacy as one “that is 100% owned by the Covered Entity” and may be listed as a shipping address on OPAIS. BMS specifically states that pharmacies that do not meet this definition have to be a designated contract pharmacy in order to receive 340B drugs. These definitions by the manufacturers are not new, but they have increased significance with the adoption of the new 340B claims data submission requirements. The difference between the two definitions also highlights how manufacturers interpreting and applying the law independently forces covered entities to comply with different and potentially inconsistent standards. For ease of reference, we use the term “entity-owned” pharmacy in this alert.

Effective May 1, AstraZeneca and BMS will require covered entities to use the 340B ESP platform to submit 340B claims data from entity-owned pharmacies for specified drugs in the companies’ portfolios within 45 days of the dispense date or date of service. Both drugmakers’ policies list the impacted medications. AstraZeneca now has separate policies applicable to entity-owned pharmacies and contract pharmacies, which are largely the same, except that Arkansas covered entities remain exempt under the contract pharmacy policy. BMS’ policy announcement states that its policy for contract pharmacies is unchanged and its new policy for entity-owned pharmacy 340B claims data submission exempts covered entities in Maryland, North Dakota, South Dakota, and Tennessee.

Under AstraZeneca’s policy, “[f]ailure to provide complete, timely, and accurate claims data may result in suspension of access to 340B pricing for the applicable products, until the required data is received and validated.” While BMS’s policy states that a covered entity’s “fail[ure] to accurately and completely submit the required data elements will be considered non-compliant with conditions of this policy,” the company does not say whether entity will lose access to 340B pricing.

While many manufacturers condition the delivery of 340B drugs to contract pharmacies on the submission of 340B claims, Eli Lilly, Novo Nordisk, AstraZeneca and BMS are the only companies that have extended these conditions to delivery of 340B drugs to entity-owned pharmacies for all covered entities. Exelixis exempts grantees from its policy entirely, regardless of the type of pharmacy to which 340B drugs are delivered.

Covered entities should document and report to HRSA the administrative and financial burdens that the companies’ policies place on them. Covered entity opposition to the policies will likely intensify if and when the manufacturers suspend 340B pricing to covered entities that refuse to submit 340B claims data. Powers believes there are strong legal arguments that the policies violate the 340B statute. Covered entities can avail themselves of the 340B administrative dispute resolution process to pressure HRSA to take action against the manufacturers. Litigation is also being explored.

Please contact Powers’ drug pricing team, or your lead Powers attorney, if you have any questions.