7/22/2025 – State 340B Covered Entity Reporting Laws Roundup

The trend continues among state legislatures to introduce and enact state-level 340B reporting bills. Six states – Colorado, Idaho, Indiana, Ohio, Rhode Island, and Vermont – have enacted 340B reporting laws in 2025 so far. Eleven additional states have introduced, but not yet passed, similar legislation. Washington, Minnesota, and Maine were the first states to impose reporting requirements in their 2023 legislative sessions.

These laws vary with respect to the categories of covered entities subject to reporting requirements and the type of information that must be reported. Vermont and Colorado’s laws apply specifically to hospitals, while the laws in Indiana, Idaho, Ohio, and Rhode Island apply to all covered entity types. All six state laws require covered entities to report aggregate acquisition cost of 340B drugs and aggregate reimbursement received for such drugs. They also require that such information be made available on a public website and, for some states, the information must be reported by payer type. Additionally, most laws require covered entities to provide a description of their use of program savings and the aggregate payments made to contract pharmacies, third-party administrators, and other vendors. Vermont and Rhode Island require covered entities to describe their program oversight activities.

The new reporting requirements in Indiana and Ohio are, by far, the most onerous. These states require, in addition to the data specified above, detailed information about covered entities’ patient populations, operating costs, and financial assistance policies. Ohio’s law requires covered entities to provide an itemized list of operating costs related to particular uses of 340B savings, including when the cost of 340B drugs is passed through to patients or billed based on a sliding fee scale.

Typically, state covered entity reporting requirements are passed as part of broader legislation providing protections for covered entities’ contract pharmacy arrangements. State legislators include reporting requirements to placate manufacturers that inevitably oppose such protections. In some states, proponents of contract pharmacy access legislation have proactively advocated for reporting requirements in anticipation of such requirements being imposed by the legislatures and/or to increase control over the language of such requirements. The reporting requirements in Ohio and Indiana, on the other hand, were adopted without accompanying contract pharmacy protections. Covered entities in those states complain that the laws increase administrative burdens while failing to ensure the sustainability of the 340B program through contract pharmacy protections.

While drug manufacturers are seeking to advance covered entity reporting requirements in state legislatures, covered entities have responded by explaining how there is scarce evidence proving a need for these requirements and how they are already subject to robust transparency requirements under both federal and state law.  Further, with serious existing and pending burdens and challenges facing 340B safety net providers, increased transparency is not a benign proposition for them. Covered entities have long argued and documented how drug manufacturers and payers use the information reported by covered entities to undermine the 340B program.  New changes to the Medicaid program, they point out, will exacerbate these threats because the changes will harm them the most.

For continued updates on covered entity reporting laws, 340B Report maintains a map, available to subscribers, that tracks the introduction and progress of reporting laws by state.