The Growing Inevitability of New 340B Reporting Requirements

Just before the end of most state legislative sessions for 2023, two states enacted the first ever 340B-specific reporting requirements for covered entities. As my colleague Will Newton reported in 340B Report, Minnesota was the first to enact a reporting law. It is a broad in scope and impacts all covered entities in the state. The new law, which was introduced and passed by a narrow margin on the last day of the state’s legislative session in late May, contains eight new reporting requirements, including the total acquisition cost for 340B drugs, the total payment received for these drugs, and the total payment made to contract pharmacies to dispense 340B drugs. These annual requirements, which must be submitted to the state’s health commissioner each April, apply to all 340B covered entities. Hospitals must additionally report acquisition costs and payments at the national drug code level for their most frequently used drugs.

The 340B provisions were just one page of a 909-page health care bill and there was no debate or discussion about the 340B elements according to our reporting. 340B stakeholders in the state were blindsided by the legislation and are now convening a working group to better understand the new law and figure out how to comply with rules. One community health center representative told 340B Report that the law contains around 10 provisions, including the 340B requirements, that will have a “profound impact” on Minnesota’s health centers. Hospitals, which have complex health care arrangements consisting of a vast array of clinics, health care services, and departments, will need to invest significant time and resources into complying with the new rules. Read more >