If you’ve been watching the 340B landscape over the past few years and telling yourself things will stabilize before you have to make major changes, a headline from this week says it plainly: “When the safest move can feel like no move at all. Why ‘waiting’ is no longer a viable strategy.”
They’re right. The 340B program is in the middle of the most turbulent stretch of its 30+ year history, and the pace of change accelerated dramatically in early 2026. Here’s what covered entities need to know right now.
The Rebate Model Pilot Is Back — in a New Form
Last year, HRSA launched a 340B Rebate Model Pilot Program that would have shifted how covered entities receive drug discounts — from upfront point-of-sale pricing to a rebate model. The pilot was vacated by a federal court in early 2026 due to procedural violations of the Administrative Procedure Act. Manufacturers had to immediately revert to upfront discounts.
But HRSA hasn’t given up. In March, they issued a Request for Information (RFI) asking stakeholders whether they should try again, this time on solid legal footing. The comment deadline, originally March 19, was extended to April 20, 2026, after major hospital associations pushed back. HRSA has also floated expanding any future rebate model to all drugs covered under the IRA’s Medicare Drug Price Negotiation program through 2027.
If you haven’t submitted comments on HRSA’s RFI, the deadline is April 20. This is your chance to shape the future of how 340B pricing works.
Child Site Registration: A Major Win for Covered Entities
On March 3, 2026, a federal district court overturned HRSA’s child site registration requirement. Previously, off-site facilities had to appear on a hospital’s Medicare cost report AND be registered in OPAIS before purchasing 340B drugs. The ruling eliminates that two-step barrier and returns to pandemic-era flexibility for off-site locations.
For covered entities with multiple off-site locations, this is significant: it removes delays in providing 340B-priced medications at community-based sites, which is often where underserved patients receive care.
Indiana’s Medicaid Proposal: A New Threat to Watch
While federal courts have been active, state-level threats to 340B are emerging as well. In Indiana, a proposed change to Medicaid drug reimbursements could eliminate the ability of safety-net healthcare providers to claim 340B drug discounts — effectively making those discounts unavailable for many Medicaid patients. If it passes, Indiana would join a growing list of states creating friction between 340B programs and Medicaid reimbursement.
The Bigger Picture: Complexity Compounds Risk
The 340B landscape in 2026 involves an active rebate model RFI, an ongoing federal drug acquisition cost survey by CMS, state-level Medicaid conflicts, a DOJ backing pharmaceutical companies against state 340B protections, and continued litigation over past HRSA policy. For covered entities that haven’t updated their compliance infrastructure, the probability of unintentional violations — particularly around duplicate discounts — is growing with every new policy layer.
American Exchange helps covered entities pair their 340B savings with a Premium Insurance Assistance Program (PIAP). Rather than simply absorbing 340B revenue, a PIAP channels those savings into helping patients access private insurance coverage — generating additional revenue streams, improving patient retention, and creating a more stable financial model that doesn’t depend on any single 340B policy outcome.
When 340B savings are invested in PIAP, covered entities create a self-reinforcing cycle: better-insured patients generate commercial reimbursements, which fund more services, which serve more patients. It’s a sustainable model that buffers against exactly the kind of policy turbulence we’re seeing now.
Don’t wait for the next court ruling to start optimizing your 340B strategy. American Exchange works with covered entities to build PIAP programs that turn 340B savings into sustainable care — learn more at americanexchange.com.
Sources
HRSA Extends Deadline to April 20 for Comments on 340B Rebate Model RFI — AHA News
Medicaid Drug Reimbursements Could End for Health Care Providers Across Indiana — WFYI
340B Rebate Model Is Set to Proceed in 2026 with 9 Drugs — HFMA
