Ponaman Healthcare Consulting Comments on HRSA’s Rebate Pilot Approvals and the New CMS 340B Claims Repository
PHOENIX, AZ – October 20, 2026 – Two federal agencies took separate steps on October 1 that ask 340B covered entities for claim-level data. The Health Resources and Services Administration approved rebate plans from 10 drug manufacturers for its revised 340B Rebate Model Pilot Program, which takes effect January 1, 2027, and the Centers for Medicare & Medicaid Services opened its Medicare Part D Claims Data 340B Repository to voluntary submissions. Ponaman Healthcare Consulting, which has provided 340B consulting to hospitals and health centers since 2001, commented on what the two programs ask of the covered entities they reach.
Rebates Paid After the Claim
The pilot is limited to drugs selected for the 2026 and 2027 price applicability years of the Medicare Drug Price Negotiation Program whose manufacturers hold an approved plan. Covered entities keep ordering those drugs through their existing 340B wholesaler accounts, but at the wholesale acquisition cost (WAC), and receive the difference between that price and the 340B ceiling price as a rebate. Under the terms HRSA lists on its pilot page, covered entities submit claims data within 45 calendar days of dispense, and manufacturers must pay or deny each rebate within 10 calendar days of a completed submission. Covered outpatient drugs without an approved plan stay at the upfront 340B price.
The same page states that HRSA will incorporate rebate-model compliance into its audits of covered entities and manufacturers, and that covered entities are expected to maintain auditable records of purchases and rebate requests.
This is HRSA’s second rebate pilot. According to HRSA, the first version, set to begin January 1, 2026, was enjoined by the U.S. District Court for the District of Maine in December 2025, and its notices and manufacturer approvals were vacated on February 10, 2026. HRSA’s notice for the revised pilot was published in the Federal Register on August 3, 2026. A lawsuit filed in the same court on October 9, 2026 asks it to stop the revised pilot before it takes effect.
A Separate Request From CMS
The CMS repository serves a different program. CMS is required by statute to remove 340B units from its Medicare Part D inflation rebate calculations, and according to its fact sheet it built the repository to test whether data submitted by covered entities can be used to identify those units. During the testing period, covered entities may submit Part D 340B claims with 2026 dates of service, and CMS has said it will not use that data to remove units from rebate calculations. In its Calendar Year 2027 Physician Fee Schedule proposed rule, CMS proposed requiring covered entities that are Medicare providers and suppliers to submit data for claims with dates of service on or after January 1, 2027. That proposal has not been finalized.
“Both programs ask a covered entity to identify its 340B drugs claim by claim, after they are dispensed,” said Scott Ponaman, President of Ponaman Healthcare Consulting. “For the pilot drugs, the claims file becomes how the entity receives the 340B price. For the entities we work with, that is a larger change than the timing of the rebate.”
Ponaman Healthcare Consulting said the questions it expects covered entities to raise before January include which account the pilot drugs are ordered through, since HRSA states that only purchases made in the 340B wholesale account at the WAC price are subject to rebate requests, and how the quarterly ceiling price files that manufacturers must provide will feed Medicaid billing and sliding fee calculations. HRSA has said it will publish interim summaries of pilot findings and a first-year evaluation by April 30, 2028.
About Ponaman Healthcare Consulting
Ponaman Healthcare Consulting is a 340B consulting firm established in 2001 and led by Scott Ponaman, MSHA, ACE, its President. Its clients include children’s hospitals, disproportionate share hospitals, critical access hospitals, community health centers and Ryan White programs, and its services include HRSA 340B audit support, program integrity audits, independent external audits, compliance monitoring and program implementation support. The firm’s team of 340B consultants, auditors and analysts is supported by medical and legal specialists. Service detail is on its 340B services page.
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