CMS says Medicaid and CHIP will support access and data collection after label changes

The White House · September 22, 2025

Summary

A CMS official said state Medicaid programs, in partnership with CMS, will cover prescription leucovorin after FDA label changes and that CMS will convene states and research networks to collect real‑world data while preserving beneficiary privacy.

A senior CMS official (referred to in the transcript as the Administrator, transcript name 'Mehmedaz') told the event that because "over .5 of American children are covered by Medicaid and CHIP," a labeling change by the FDA would allow state Medicaid programs, in partnership with CMS, to fund prescription leucovorin for eligible children. "Therefore, because they're covered in Medicaid and CHIP, upon this label change by Marty, state Medicaid programs in partnership with CMS will cover prescription LucoVorn around the country," the official told the event.

The official said CMS will issue guidance to convene states and existing research networks to support NIH and FDA efforts to collect real‑world clinical data, emphasizing beneficiary privacy and program monitoring to ensure appropriate utilization. He also addressed budget questions raised by reporters, saying a referenced legislative bill projects a $200,000,000,000 increase in Medicaid spending over 10 years and that grants to distribute some resources are being allocated.

CMS officials framed these steps as practical mechanisms to expand access once regulatory processes are complete, while noting that states will be responsible for implementation within their Medicaid programs.

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