Medicare Physician Fee Schedule Proposed Rule Archives

340B Rebate Models and Medicare Part D 340B Claims: What 340B Covered Entities Need to Know for 2026

340B covered entities should carefully review the approved 340B rebate models and the 2026 Medicare Physician Fee Schedule (MPFS) Final Rule provisions on new CMS processes for identifying Medicare Part D claims for 340B drugs.

While the current scope may seem limited or not applicable to certain 340B covered entities, now is the most important time to evaluate the implications of these programs if expanded to all 340B drugs and all 340B covered entities in order to ensure that the concerns of 340B covered entities are appropriately addressed.

340B Rebate Models

As a reminder, although the only drugs currently subject to the 340B rebate models are those that will be subject to the Medicare Part D negotiated prices, the 340B rebate models extend to all 340B covered entity types, all payors and all locations of dispensing/administration of the selected drugs. While the current 340B rebate models are being implemented under a “pilot program,” it is highly likely that 340B rebate models will be expanded to many more drugs in the coming years (possibly even during 2026).

Since the announcement of the approved 340B rebate models, the software platform that will be used for all rebate models approved to-date, Beacon, has released additional information about the implementation of the rebate models and details about operational aspect of the rebate models. All covered entities should familiarize themselves with the Beacon platform and rebate model as soon as possible and should be paying close attention to the [...]

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CMS Sneaks 340B Billing Proposals into Medicare Physician Fee Schedule: What 340B Stakeholders Need to Know

On July 10, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Medicare Physician Fee Schedule (MPFS) proposed rule, which includes proposals related to identification of Medicare Part B and Part D claims for 340B drugs in order to exclude them from inflation-related Medicare drug rebates established under the Inflation Reduction Act. Because MPFS is not often on the radar for 340B stakeholders, we want to make sure that folks are aware of the 340B-related provisions in the proposed rule and the deadline for submitting comments. We have excerpted the relevant pages of the MPFS proposed rule for ease of reference (the entire proposed rule is well over 2,000 pages and available here. The proposed rules are generally consistent with guidance materials previously released by CMS.

As described in more detail below, the CMS proposals would eventually require claims-level information reporting to exclude Medicare Part D 340B claims and use claim modifiers to exclude Part B claims. ALL 340B-covered entities are now expected to report claim-line modifiers for separately payable Medicare Part B drugs under guidance that was effective January 1, 2024.

Comments are due on September 9, 2024. We note that in light of the recent US Supreme Court decision in the Loper Bright case and the end of the Chevron doctrine, 340B stakeholders should consider submitting comments (both in support of the proposals and with alternatives that CMS should implement). Legal challenges to whatever rules CMS ultimately implements should be expected, and the [...]

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