The use of 340B modifiers was initially published on December 20, 2022 for all 340B Drug Pricing Program covered entities. The revised guidance provides that modifiers should be used to report drugs acquired under the 340B Program to align with the policies finalized in the calendar year (CY) 2024 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule. The guidance from CMS does not revise the overall requirement for all 340B covered entities to report a 340B modifier on claim lines for separately payable Part B drugs and biologicals. CMS has added revised information for 340B covered entities around which modifiers should be used in CY 2024 and starting on January 1, 2025.
- These changes will affect 340B Medicare providers and suppliers that participate in the 340B Drug Pricing Program who bill separately for Part B drugs and biologicals.
- CMS previously stated that as of January 1, 2024, it is requiring all 340B covered entities, including hospital-based and non-hospital entities, that submit separately payable Part B drugs and biologicals to report modifier “JG” or “TB” on claims for drugs acquired through the 340B Drug Pricing Program.
- The revision to this policy by CMS will start January 1, 2025. If you are a 340B covered entity, you must report the “TB” modifier on claims, even if you are currently using the “JG” modifier.
- For current 340B covered entities in CY 2024, they can continue to use their current modifier, or they may transition early to the “TB” modifier.
All 340B covered entities must transition to the “TB” modifier by January 1, 2025, which includes covered entities such as Ryan White clinics and hemophilia clinics. Providers and suppliers affiliated with 340B covered entities also are required to submit the appropriate modifier on separately payable claim lines for drugs. It is recommended that the “TB” modifier is implemented in advance of the effective date.
If you have any questions regarding 340B modifiers, please contact a professional at Forvis Mazars today.