Two Federal Agencies Take Steps to Enhance 340B Drug Pricing Program

PHOENIX, AZ - October 20, 2026 - Two federal agencies have taken separate steps to enhance the 340B drug pricing program, impacting covered entities across the healthcare sector. The Health Resources and Services Administration (HRSA) has approved rebate plans from 10 drug manufacturers for its revised 340B Rebate Model Pilot Program, which will take effect on January 1, 2027. This pilot program is part of a broader effort to improve the 340B program, which provides discounted drugs to safety-net providers.

According to HRSA, the first version of the rebate pilot, set to begin on January 1, 2026, was enjoined by the U.S. District Court for the District of Maine in December 2025. The court vacated the notices and manufacturer approvals on February 10, 2026. The revised pilot was published in the Federal Register on August 3, 2026, and a lawsuit filed in the same court on October 9, 2026, seeks to stop the program from taking effect.

Under the terms of the pilot, covered entities will keep ordering the selected drugs through their existing 340B wholesaler accounts at the wholesale acquisition cost (WAC). However, they will receive rebates for the difference between the WAC price and the 340B ceiling price. Covered entities are required to submit claims data within 45 calendar days of dispensing the drugs, and manufacturers must respond to rebate requests within 10 calendar days.

Ponaman Healthcare Consulting, a 340B consulting firm established in 2001, has commented on the implications of these changes.

The firm advises covered entities to consider several key issues before the pilot takes effect. These include which account the pilot drugs are ordered through, as HRSA states that only purchases made in the 340B wholesale account at the WAC price are subject to rebate requests. Additionally, the quarterly ceiling price files that manufacturers must provide will impact Medicaid billing and sliding fee calculations.

Ponaman Healthcare Consulting also notes that the Centers for Medicare & Medicaid Services (CMS) has opened its Medicare Part D Claims Data 340B Repository to voluntary submissions. This repository serves a different program, which requires covered entities to submit data for claims with dates of service on or after January 1, 2027. According to CMS, the repository is being used to test whether data submitted by covered entities can be used to identify 340B units for Medicare Part D inflation rebate calculations.

In a separate development, Ponaman Healthcare Consulting published updated operational guidance for covered entities tracking the 340B rebate model pilot and the data validation requirements attached to it. The guidance is aimed at pharmacy directors, 340B program managers, compliance officers, and finance leaders who are being asked to prepare for operational change while the pilot is underway.

HRSA's Office of Pharmacy Affairs has audited a record number of 340B covered entities in recent years, with the agency's own audit data showing hundreds of findings annually against hospitals, health centers, and other covered entities enrolled in the federal drug pricing program. With audit activity showing no signs of slowing, and covered entities sitting on compliance infrastructures that were never designed to own 340B accountability in full, Ponaman Healthcare Consulting advises entities to ensure they have the necessary documentation and processes in place to meet the new requirements.