CMS Proposed Rule on 2026 Physician Fee Schedule – 10-16-2025

On September 12, RWC-340B submitted comments to CMS regarding its proposed methodology for excluding 340B drug prices from Medicare Part D inflation rebate calculations.

Our Position: RWC-340B strongly supports CMS’s objective of ensuring 340B drugs are appropriately excluded from the rebate calculation, but expressed serious concerns with the two approaches outlined:

Prescriber-Pharmacy Methodology – CMS proposes a new Prescriber-Pharmacy Methodology that would identify 340B claims by pairing prescriber National Provider Identifiers (NPIs) with contract pharmacy designations in the Office of Pharmacy Affairs Information System (OPAIS).

• CMS acknowledged that this matching process is unlikely to identify all 340B claims accurately.
• RWC has strong concerns that the proposed methodology risks misclassifying claims, placing administrative burdens on RWCs to correct, and unnecessarily taking providers away from patient care.

and

Voluntary Data Repository – While progress toward retrospective claim identification is being made, this option gives manufacturers access to 340B claims data and raises concerns about neutrality and consistency.

RWC-340B Recommendation: We urged CMS to implement a neutral third-party clearinghouse model, operated independently (e.g., by the Medicare Transaction Facilitator). The clearinghouse would ensure accuracy and neutrality, reduce administrative burden, and protect covered entities’ sensitive claims data.

Our comments emphasize that a neutral clearinghouse structure aligns with congressional intent, ensures program integrity, and protects safety-net providers from discrimination.