Modifier TB

20.6.17 - Modifier TB (Rev. 11937; Issued: 03-31-23; Effective: 04-01-23; Implementation: 04-03-23) TB: Drug or biological acquired with 340b drug pricing program discount, reported for informational purposes for select entities A. General On January 1, 2018, CMS established HCPCS Level II modifier TB to facilitate the collection and tracking of 340B claims data for OPPS providers that are excepted from the 340B payment adjustment in CY 2018. Beginning January 1, 2019, modifier TB shall be reported by both select hospitals paid under the OPPS and by nonexcepted off-campus PBDs of a hospital paid under the PFS if a drug or biological was acquired under the 340B Program. The phrase “acquired under the 340B Program” is inclusive of all drugs and biologicals acquired under the 340B Program or PVP, regardless of the level of discount applied to the drug. Effective January 1, 2023, the TB modifier will be used by rural sole community hospitals, children’s hospitals, and PPS-exempt cancer hospitals to identify 340B drugs for informational purposes. Additionally, all pass-through drugs (reported with the status indicator “G”) purchased through the 340B drug discount program will report with the modifier TB by all OPPS providers. B. Effect on Payment From CY 2018 through CY 2022, rural SCHs, children’s hospitals, and PPS-exempt cancer hospitals providers that were exempt from the 340B drug payment adjustment reported the informational modifier TB to identify OPPS separately payable drugs (reported with status indicator “K”) purchased through the 340B discount program. The use of modifier TB did not trigger a payment adjustment, and these providers received and will continue to receive ASP plus 6 percent (or equivalent payment rate derived from the ASP methodology) for separately payable drugs furnished by these select providers. Furthermore, between CY 2019 and CY 2022, nonexcepted off-campus PBDs paid under the PFS (departments that bill the modifier PN on their claim lines) that furnished 340B- acquired drugs and biologicals and were exempt from the 340B payment adjustment (because their hospital is a rural SCH or children’s hospital) were required to bill under the PFS using the institutional claim form and report the informational modifier TB for 340B-acquired drugs and biologicals, which did not trigger a payment adjustment, and these providers received ASP+6 percent for separately payable drugs furnished in CY 2019, even if such drugs were acquired under the 340B Program. For CY 2023, the presence of modifier TB on a claim to indicate a drug is acquired under the 340B program will continue to not trigger a payment reduction and be used only for informational purposes. Claims for 340B drugs and biologicals identified with a TB modifier will be paid at the same statutory default rate as non-340B drugs and biologicals. Additionally, the requirement of the TB modifier to identify drugs acquired through the 340B Program complies with certain requirements of the Inflation Reduction Act because these modifiers are an established mechanism that have been in use by hospitals paid under the OPPS. The Inflation Reduction Act establishes a Part B inflation rebate by manufacturers for certain single source drugs and biologicals with prices increasing faster than the rate of inflation. However, it also specifically excludes units of drugs for which the manufacturer provides a discount under the 340B program from the units of drugs for which a manufacturer otherwise may have a Part B inflation rebate liability. A document explaining the use of this modifier is available via the Internet on the CMS Web site at https://www.cms.gov/files/document/part-b-inflation-rebate-guidance340b- modifierfinal.pdf.