APA WF # 25-15 340B Revisions

The proposed policy changes are being promulgated as Permanent Rules.

These rule revisions seek to remove certain high-cost drugs and therapies from the 340B Drug Pricing Program. The 340B program is a federal initiative that allows health care organizations to purchase certain drugs directly from pharmaceutical manufacturers at a discount. The revision creates a 340B Carve Out Drug list, consisting of cell and gene therapies, drugs currently under a value-based agreement, or Brand Preferred Drugs where the cost to the Medicaid program is $500,000 or higher, annually. Drugs on this list would be prohibited from being dispensed or administered to Oklahoma Medicaid Members if purchased at 340B prices.

Please view the draft regulatory text here and submit feedback via the comment box.

Pursuant to 75 O.S. §303(D), a rule impact statement will be posted here beginning December 30, 2025. Individuals may also request a copy using the comment box, and the statement will be provided on December 30, 2025.

Proposed Policy Timeline

Circulation Date: 12/15/2025

Medical Advisory Committee: 1/8/2026

Comment Due Date: 1/15/2026

Public Hearing: 1/15/2026

Board Meeting: 1/21/2026

After you submit your comment, you should be re-directed to a confirmation page. If you are not, please submit your comment through e-mail to federal.authorities@okhca.org.

Please note that all comments must be reviewed and approved prior to posting. Approved comments will be posted Monday through Friday between the hours of 7:30 a.m. – 4 p.m. Any comments received after 4 p.m. will be posted on the following business day.