Following the pause of proposed rebate-based models, several drug manufacturers have begun pursuing an alternative approach: requiring covered entities to submit claims-level data tied to 340B utilization. What began with Eli Lilly has expanded, with additional manufacturers implementing or announcing similar data submission requirements, including Novo Nordisk, AstraZeneca, and Bristol-Myers Squibb.
This shift marks more than a policy change. It introduces a new, manufacturer-driven reporting dynamic that covered entities are now being asked to operationalize.
What Data Is Actually Required?
While submission formats vary by manufacturer, most requests include a defined set of required fields, along with several conditional fields that depend on claim type and billing structure.
Required fields include:
- 340B ID
- Claim number and claim line number
- Date of service
- Health plan name and ID
- NDC-11
- Quantity dispensed/administered
- Service provider NPI
Conditionally required fields may include:
- HCPCS Code or Unit of Measure (UOM)
(one is typically required depending on billing methodology; both generally cannot be submitted together) - Rendering physician NPI
- HCPCS modifiers
- Wholesaler invoice number
Importantly, these requirements often mirror traditional contract pharmacy data submissions but are now being extended in some cases to in-house pharmacy and administered drug activity as manufacturers seek greater claims-level visibility across all 340B utilization.
The challenge isn’t just submitting the data, it’s ensuring field-level accuracy across multiple systems while navigating manufacturer-specific formatting rules and validation logic.
Why Are Manufacturers Doing This?
Manufacturers have consistently expressed concerns about program integrity, particularly around duplicate discounts and diversion. With rebate models facing significant legal and operational challenges, some have pivoted toward claims data collection as a mechanism to gain greater visibility into 340B utilization.
While these stated goals align with longstanding program requirements, the scope, format, and authority of these data requests remain areas of active debate. In many cases, manufacturers are requesting detailed claims-level information that may exceed what covered entities have historically been required to share.
Administrative Reality
For covered entities, this is not a simple reporting exercise.
Meeting these requirements often involves:
- Building or modifying data extraction and reporting workflows
- Coordinating across TPAs and contract pharmacies
- Conducting legal and compliance reviews
- Allocating internal staff time or external resources
Across the programs we support, there is already significant variation in manufacturer requirements, including differences in data definitions, submission formats, and timing expectations. What’s emerging isn’t just added workload, but a non-standardized, manufacturer-specific reporting infrastructure that entities are being asked to support in parallel.
What This Means for Your Organization
- Fragmentation is increasing. Requirements vary by manufacturer, creating a complex and evolving compliance landscape.
- Access may be conditional. Some manufacturers have tied 340B pricing access, particularly in contract pharmacy arrangements, to participation in these data submission processes.
- Operational risk is rising. Inconsistent data definitions and submission requirements introduce real risk. Not just administrative burden, but potential eligibility disputes, data discrepancies, and retroactive scrutiny.
- Compliance obligations still apply. CEs remain responsible for ensuring any data shared aligns with HIPAA, 340B statute, and internal policies. Not all requests are clearly addressed in current guidance, and careful review is warranted.
Moving Forward
This is no longer just a compliance exercise. It’s becoming a strategic decision point around data governance, vendor alignment, and contract pharmacy structure.
Covered entities should:
- Stay informed on manufacturer-specific requirements
- Evaluate each request on a case-by-case basis
- Document decision-making and compliance efforts
- Coordinate closely with internal teams and external partners
The 340B program has supported safety-net providers for decades. Navigating these changes thoughtfully will be key to maintaining both compliance and access.
To review the manufacturer letters, click here.