The American Society of Health-System Pharmacists recently released their forecast predicting major changes that will impact the industry in 2026. One of the major focuses of the report are the possible changes to the 340B Drug Pricing Program. The program, which allows covered entities to receive medications at a better rate, may face a major change to its processes in coming months. The program has had critics who want to reduce the benefits and scale it back. It appears this push may gain some traction in 2026.
What are the proposed changes?
This past summer, the Health Resources Services Administration (HRSA) announced it is considering a shift in how covered entities get deals on pharmaceuticals. Instead of an upfront discount, the changes would make use of a post-sale rebate. The agency states the shift is in response to concerns voiced by both manufacturers and covered entities and is an attempt to increase transparency. Manufacturers have voiced frustration that some covered entities are receiving duplicate discounts. The change may help to mitigate this risk.
To determine if such a shift would be helpful, the agency announced the voluntary 340B Rebate Model Pilot Program. The program is meant to test the rebate model to see if it achieves the stated goals. The Model Pilot Program is expected to start January 1, 2026.
Not everyone is on board with the proposal. At least one lawsuit is currently moving forward stating the Department of Health and Human Services has violated administrative rules which guide implementation of such changes. Covered entities have stated that the change would result in significant administrative burdens and would disrupt cash flow models that have been in place for decades. If successful, the lawsuit could result in a suspension of the changes.
How can health care leaders prepare for these changes?
Proper billing is essential for the financial health of a pharmacy. With such potential changes on the horizon, pharmacists are wise to review their billing strategies to help better ensure compliance. Leaders in this industry are wise to watch for potential changes and conduct regular internal audits to check for any potential issues. A failure to make needed changes if the Program gains traction and continues to move forward could result in allegations of a failure to comply with applicable regulations.
Attorney John Rivas is responsible for this communication.