Novo Nordisk Announces Covered Entities Must Submit Claims Data for All of Its Products

3/6/2026 – Novo Nordisk Announces Covered Entities Must Submit Claims Data for All of Its Products

Pharmaceutical manufacturer Novo Nordisk (Novo) announced in a notice that, effective April 1, all covered entities must submit claims-level data for “all 340B dispenses,” regardless of whether an entity uses contract pharmacies. Novo warns that, if a covered entity fails to provide timely, complete, and accurate data, the company may no longer offer 340B pricing to the entity. In January, manufacturer Eli Lilly established a similarly broad 340B claims data submission requirement for covered entities. More than 40 manufacturers condition the delivery of 340B drugs to contract pharmacies on the submission of 340B claims. Lilly and Novo are the only companies that have extended such conditions to delivery of 340B drugs to all covered entity types’ in-house pharmacies. Manufacturer Exelixis has a similar policy that applies to hospitals but exempts grantees.

Novo directs covered entities that are not already submitting 340B claims data to access contract pharmacies to visit www.340BESP.com or to call Second Sight Solutions to register for the 340B ESP platform. Entities must submit the required claims data using the 340B ESP platform for all products manufactured by Novo within 45 days of the date of dispense. Novo encourages covered entities to submit 340B claims data on the 1^st and 16^th of each month. Unlike Eli Lilly’s policy, Novo’s notice does not provide exceptions for covered entities in certain states with laws protecting entities’ access to 340B drugs.

Novo’s Fiasp, Fiasp FlexTouch, Fiasp PenFill, NovoLog, NovoLog FlexPen, and NovoLog PenFill have been subject to Medicare maximum fair prices (MFP) under the Inflation Reduction Act since January 1, 2026. Novo states that 340B claims data allows the company to prevent MFP-340B duplicate discounts, as well as Medicaid rebate-340B duplicate discounts. Novo also states it will use the data to initiate 340B audits of covered entities.

To date, HRSA has not taken enforcement action against Lilly or publicly commented on the company’s new policy, despite provider associations and individual covered entities sharing their concerns about the policy with the agency. The day after Novo announced its policy, the American Hospital Association sent a letter to HRSA urging the agency to take immediate action to stop the policy from taking effect by April 1. In the letter, AHA noted that HRSA had not responded to the association’s prior letter asking the agency to take action regarding Lilly’s policy.

Lilly’s policy requires covered entities to submit within 45 days of product dispense 340B claim data for certain products dispensed on or after February 1. Therefore, covered entities must begin submitting 340B claims data for some of Lilly’s products by mid-March or risk potentially losing 340B pricing. HRSA’s lack of action regarding Lilly’s policy coupled with Novo’s announcement may encourage other manufacturers to issue similar policies.

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 start cutting off 340B pricing to covered entities that refuse to submit 340B claims data. Powers believes there are strong legal arguments for why 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 two companies. Litigation is also being explored.

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