Few areas are changing as rapidly as the 340B program. In our previous blog, we provided a foundational overview of the program’s background, growth drivers, and the strategies manufacturers have deployed to date. This update builds on that foundation, drawing from our recent 340B webinar to highlight the most critical developments across four key areas: the rebate model, contract pharmacy policies, duplicate discounts, and the broader regulatory landscape. With regulatory, legal, and operational dynamics shifting quickly often manufacturers cannot afford to stand still.

The 340B Rebate Model: Accelerated Activity, Limited Resolution

The rebate model concept has moved from a theoretical alternative to a dynamic flashpoint, with significant legal, regulatory, and operational events that have occurred. The timeline has accelerated dramatically:

• In late 2024, manufacturers began announcing intentions to implement rebate models, seeking a comprehensive solution to 340B growth and abuse, but those announcements were quickly met with threats from HRSA.
• Those manufacturers filed lawsuits against HRSA. Federal judges acknowledged that the 340B statute contemplates rebates and that requiring claims data from covered entities is permissible.
• In mid-2025, HRSA announced a formal 340B Rebate Model Pilot Program. Eight manufacturers were approved for January 1, 2026, effective date; one was set for April 2026.
• In December 2025, the American Hospital Association (AHA) and covered entities sued HRSA, leading the Judge of to put the pilot program on hold.
• In early 2026, HRSA dropped its appeal and formally withdrew the rebate model pilot program, but then promptly issued a new Rebate Model Request for Information (RFI), with comments due on April 20, 2026.
• To-dates, there have been numerous comments submitted to HRSA but most of them have come from Covered Entity stakeholders.

Based on this, manufacturers must now ask critical questions: does the rebate model, as constructed in the pilot program, actually solve the 340B problem? does HRSA understand the key areas in the rebate mode, such as claim collection, that are critical?

The short answer is only partially. The 340B rebate model pilot program primarily addressed MFP-specific duplicate discount risk by limiting manufacturers to denying rebates only for MFP or duplicate claims. This left significant gaps; duplicate discount risks in Medicaid, commercial, TRICARE, and other emerging government rebate areas remained unaddressed, and operational barriers limited the use of 340B claims data across these other contexts. Compounding this, participation in the pilot program was limited, meaning not all manufacturers could take part. While the rebate model represents a promising vehicle, in its current form it falls well short of a silver bullet for the full range of 340B growth and abuse challenges that manufacturers face today.  Manufacturers should use the RFI as an opportunity to explain this to HRSA, including focusing on how 340B claim collection can be used to solve the duplicate discount problem.

Contract Pharmacies: Diminishing Returns and a Shifting Landscape

Contract pharmacy policies remain one of the most widely deployed manufacturer strategies, with 37 manufacturers currently operating some form of a contract pharmacy policy. These policies fall into three categories:

• 9 manufacturers with voluntary or don’t require 340B claims submission
• 25 manufacturers with mandatory contract pharmacy claims submission
• 3 manufacturers that have expanded beyond contract pharmacy to collect in-house 340B claims as well

Despite these policies, the financial impact for many manufacturers is diminishing for two reasons but even that is evolving:

State-Level Legislation

Over 20 states have now enacted 340B legislation effectively reopening contract pharmacy access, directly nullifying manufacturer restrictions. States with particularly large contract pharmacy footprints, most notably California and New York, amplify this exposure considerably. To manage legal risk, manufacturers have been forced to exempt these states from their policies, which directly erode the financial benefit of those restrictions.

The map below illustrates the current state-level legislative landscape. A notable recent development to all this is the Department of Justice and HHS have begun to file an amicus brief siding with manufacturers in specific state contract pharmacy access cases. This is worth monitoring closely, as it may signal a growing federal government willingness to push back on state law in this area.

340B State Legislative Landscape 1*

https://340breport.com/legislative-map/contract-pharmacy-protection-bill/

Contract Pharmacy Workarounds

Even in states where manufacturer policies are not excepted, covered entities, PBMs, wholesalers, and third-party administrators (TPAs) have developed and accelerated workarounds such as alternative distribution models, virtual credit replenishment (VCR) models, and optimization of the single contract pharmacy exceptions. Manufacturers who initially saw significant 340B chargeback volume reductions have continued to see a meaningful bounce-back as these workarounds mature, a trend that has only accelerated following recent rebate model announcements.

Duplicate Discounts: The $20B Problem That Is Expanding

While much of the industry's attention is focused on the rebate model and contract pharmacy debates, the duplicate discount problem is now becoming an immediately actionable area.

A 340B duplicate discount occurs when a commercial or government payer submits a rebate request to a manufacturer for a product that was dispensed using a drug acquired at the 340B price. Because 340B identifiers are frequently absent from payer claims data and rebate invoices, manufacturers bear a significant burden in identifying and disputing these claims. Industry estimates place the total annual cost of 340B duplicate discounts at over $20 billion across Medicaid, commercial, Medicare — including IRA/MFP rebates and Part B and Part D inflation rebates — and TRICARE.

The problem is compounding. Duplicate discounts are most prevalent in Medicaid and commercial channels but are growing rapidly in newer areas, particularly in Medicare with MFP. Manufacturers relying on today's fragmented, point-solution approaches face a range of operational challenges:

• Inconsistent algorithms and methodologies across Medicaid, commercial, and Medicare create gaps in identification and missed recovery opportunities.
• 340B claims data gathered through contract pharmacy policies is frequently underutilized or not even used for duplicate discount scrubbing, particularly in Medicaid.
• That same claims data is rarely shared with manufacturers or leveraged for broader 340B program insights.
• Point-solution vendors operate in silos, integrating poorly with the net-revenue management platforms where government and commercial rebate validations and the processing of those rebates occur.
• Visibility into disputes across rebate types remains limited, making tracking and resolution difficult.

The solution lies in consolidating and operationalizing all 340B claims data within a unified, modernized framework that integrates 340B claim validation directly into a manufacturer's net-revenue platform and rebate processing workflows, rather than treating it as a separate function. This ensures that duplicate discount identification occurs within the government and commercial rebate cycle, not outside of it. The result is stronger gross-to-net predictability, reduced dispute management burden, lower third-party fees, and richer insight into claims activity overall.

Industry View: Manufacturers at a Crossroads

Taken together, the current landscape reflects an industry standing at an inflection point. The rebate model offers a limited but evolving path. Contract pharmacy policies are producing diminishing returns but there may be legal hope. The regulatory and legal environment continues to shift with little predictability. And the financial stakes have never been higher.

Manufacturers who continue to rely on non-dedicated 340B teams and/or individual “point solutions” for each 340B strategy will find themselves perpetually reactive. The new reality requires a more integrated, platform-based and modernized approach that starts with all 340B claims collection but more importantly allows for the 340B claims to be used in duplicate discount identification processes.

This is not just an operational improvement; it is a financial imperative.

What’s Next: Strategy Evaluation for 340B and Duplicate Discounts

The pace of change in 340B, legally, legislatively, and operationally, demands that manufacturers act now rather than wait for a definitive resolution that may never come. Based on the current landscape, here is how we suggest manufacturers frame their near-term strategy:

On the Rebate Model

Monitor the new HRSA Rebate Model RFI and the comments closely including submitting comments on 340B claims collection and duplicate discount practices.  Comments are due April 20, 2026, but this is an opportunity for manufacturers to further support their position including what data is needed, who can participate, and how the data should be used.

On Contract Pharmacy

For those that have contracting pharmacy policies, assess the true financial impact and status of your existing policy given state legislative exemptions and workaround activity. Understand which workarounds are affecting your volume and what options are available to cut off those workarounds. Track the DOJ/HHS amicus brief development closely to see if this offers further opportunities.

On Duplicate Discounts

This is the most actionable area today. Manufacturers should review their current duplicate discount identification and dispute process across all rebate types; Medicaid, commercial, Medicare (including MFP, Part B, and Part D), and TRICARE, and determine how well there are working and whether their current approach could leverage 340B claims data. The opportunity to modernize by integrating 340B claim validation directly into net-revenue platforms is significant and available now, regardless of what happens with the rebate model or contract pharmacy policies.

The manufacturers who will be best positioned in the next 12 to 24 months are those who invest now in a 340B strategy and build the operational and data infrastructure to manage 340B holistically, not as a collection of isolated strategies, but as an integrated dimension of their overall net-revenue platform.

IntegriChain offers a full suite of 340B solutions and advisory services designed to help pharma manufacturers navigate the complexities of the 340B program. Reach out to our 340B experts to discuss where you stand today and what your next move should be.

To learn more or request access to the full webinar and supporting materials, please contact cwillis@integrichain.com.