Authored by: Joella Roland, Counsel, and Fernando Montoya, Associate
Powers’ Drug Pricing and 340B Program Practice Group
Beginning November 15, 2026, Amgen will require covered entities that dispense or administer Amgen’s 340B drugs to “submit standard healthcare visit and service claims data for applicable 340B pharmacy and medical claims,” pursuant to its updated 340B Policy. Covered entities must submit the required data through the 340B ESPTM platform within 45 days of product dispense or 60 days of administration. The required data includes anonymized encounter-level data regarding interactions between providers and patients that result in the dispensing or administration of 340B-priced Amgen products.
Amgen is the first drug manufacturer to impose encounter-level data submission requirements as a condition of accessing 340B pricing. This policy raises questions about how these requirements will interact with HRSA’s 340B Rebate Model Pilot Program, which expressly prohibits manufacturers from requiring encounter-level data as part of the rebate process. Although HRSA has not taken any action to prevent Amgen from implementing its encounter-level data requirements, the agency did approve Amgen’s separate 340B Rebate Model plan as one of the initial 10 manufacturer plans. Notably, Amgen’s approved rebate model does not reference encounter-level data submission requirements.
Amgen’s requirements also raise patient privacy considerations. Although the data is described as anonymized, covered entities should evaluate whether it has been sufficiently stripped of identifying information to satisfy the Health Insurance Portability and Accountability Act’s (HIPAA) patient privacy protections. Covered entities should also consider whether submitting the data raises concerns under applicable state privacy laws.
Amgen’s stated purposes for collecting encounter-level data raise additional concerns about whether the manufacturer intends to use the information to assess covered entities’ compliance with HRSA’s patient definition. Manufacturers have historically justified claims data submission requirements as necessary to prevent duplicate discounts, but it is unclear how encounter-level data would serve that purpose. Instead, Amgen may be seeking to determine whether individuals receiving its products qualify as patients of the covered entity under the 340B Program.
Such use would be inappropriate and inconsistent with HRSA guidance. A more appropriate approach, consistent with the 340B Program’s statutory framework, would be for Amgen to conduct an audit and, if warranted, submit an Administrative Dispute Resolution petition to HRSA for a determination of whether diversion occurred, rather than independently assessing patient eligibility.
Amgen’s policy exempts the following states, which have all enacted 340B contract pharmacy protection laws: Arkansas, Hawaii, Louisiana, Maryland, Minnesota, Mississippi, Missouri, Nebraska, Oregon, South Dakota, Tennessee, and Vermont.
Additional details regarding required data fields, field descriptions, file format, templates, technical instructions, submission procedures, and platform instructions are available on the 340B ESPTM resources page.
Powers will continue to monitor developments regarding manufacturers’ claims data policies. Please contact Powers’ drug pricing team, or your lead Powers attorney, if you have any questions.
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