Manufacturer claims data requirements tied to 340B purchases continue to expand. As discussed in our April update on manufacturer claims data requirements, this trend began with a smaller group of manufacturers but has continued to accelerate. As of June 2026, ten manufacturers have now implemented or announced claims-level data submission requirements.
Manufacturer Claims Data Timeline
Covered entities should also track when each manufacturer requirement becomes effective and when claims data submissions may be required.
Each manufacturer’s name below is linked to the applicable policy document for reference. Covered entities should review the full policy to confirm current requirements, submission timing, state exemptions, and impacted products.
| Manufacturer | Effective Date |
|---|---|
| Exelixis | Oct. 1, 2025 |
| Eli Lilly | Feb. 1, 2026 |
| Novo Nordisk | Apr. 1, 2026 |
| AstraZeneca | May 1, 2026 |
| Bristol Myers Squibb | May 1, 2026 |
| Biogen | June 1, 2026 |
| UCB | June 1, 2026 |
| Amgen | June 1, 2026 |
| Sanofi | June 15, 2026 |
| GSK | July 1, 2026 |
Why This Matters
For covered entities, these requirements create a growing operational and compliance burden. Submitting claims data often requires coordination across TPAs, contract pharmacies, in-house pharmacies, billing systems, wholesalers, and compliance teams.
This becomes especially complex when requirements extend beyond traditional contract pharmacy claims and into mixed-use, in-house, or medical benefit workflows. Covered entities may need to determine where each required data element lives, who is responsible for preparing the submission, and how the organization will document decisions around data sharing.
Covered entities should also continue to evaluate manufacturer requests carefully to ensure any data shared aligns with HIPAA, 340B requirements, state law, internal policies, and vendor agreements.
Policy Details Remain Manufacturer-Specific
Even though these policies are part of a larger trend, the details are not identical across manufacturers. Effective dates, required data fields, submission timelines, impacted products, and state exemptions may vary.
Covered entities should avoid applying one manufacturer’s requirements across the board. Each policy should be reviewed separately, especially when determining whether a requirement applies to a specific covered entity, contract pharmacy arrangement, in-house pharmacy, or medical benefit workflow.
What Covered Entities Should Do Now
Covered entities should maintain a current tracking process for manufacturer requirements, including:
- Effective dates
- Impacted products
- Required data fields
- First submission deadlines
- Ongoing submission cadence
- State exemptions
- Vendor responsibilities
- Internal documentation of data-sharing decisions
Covered entities should also confirm where each required data element comes from, who is responsible for preparing the submission, and how the organization will review requests before data is shared.
Moving Forward
The continued expansion of claims’ data requirements shows that this is becoming a broader manufacturer strategy, not a short-term exception. As more manufacturers adopt similar requirements, covered entities will need a reliable process for reviewing requests, validating data, coordinating with vendors, and documenting compliance decisions.
The best next step is to stay current, review each manufacturer’s requirements individually, and build a consistent internal workflow before these requests become even more difficult to manage.
For more 340B claims data requirements information and manufacturer policies (including contract pharmacy policies), click here.