CMS published revised guidance on December 14, 2023 to defer its decision to require 340B point-of-sale modifiers for Part D drugs beginning in 2026. RWC-340B submitted comments to CMS’s initial proposal and urged it not to adopt a 340B point-of-sale claims identifier requirement.

In issuing this revised guidance, CMS acknowledged the issues raised by RWC-340B and stated that it will continue to evaluate its options in finalizing the IRA Part D requirements. CMS said that it “continues to evaluate different options for identifying 340B units and will finalize a policy for excluding 340B units by plan year 2026 in accordance with the statute.”

RWC-340B’s comments, and meetings with CMS, highlighted the significant administrative and financial burdens the methodology would pose and expressed concern over the reliability of CMS’s proposed method.

RWC-340B urged CMS to implement a retrospective clearinghouse model like the one adopted in the state of Oregon. RWC-340B explained that this model would be more beneficial from both a legal and practical perspective, noting that it would improve the accuracy of claims identification and ease the burden on safety net providers. In the alternative, RWC-340B suggested that CMS adopt a hybrid arrangement, combining claims-level identification with a retroactive batched-claims approach.

Under the Inflation Reduction Act (IRA), CMS is required to “exclude from the total number of units for a Part D rebatable drug…those units for which a manufacturer provides a discount under the 340B Drug Pricing Program.” CMS had proposed a point-of-sale modifier to identify drug purchases under the 340B program.

While CMS has yet to make a final decision regarding Part D modifiers for 340B drugs, it is a positive sign that CMS noted RWC-340B’s comments among the other 53 comments to its initial memorandum and decided not to finalize its initial proposal to require a Part D point-of-sale modifier beginning in 2026.

If you have questions or would like more information, the Powers’ Team is available.