Solutions · HRSA 340B Rebates

January 1, 2027 is coming fast. Be ready.

The HRSA 340B Rebate Model Pilot is changing how - and when - 340B savings are realized.

The Pilot was originally scheduled for implementation in 2026 but was stayed following legal challenges. HRSA has since revised the Pilot, and the new model is now on track for implementation beginning January 1, 2027. For covered entities, this is more than a new data-submission requirement. It represents a fundamental change in how - and when - 340B savings are realized.

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IMPLEMENTATION

Jan 1, 2027 - the revised Pilot begins

INITIAL DRUG LIST

Pending final list not yet announced

THE WORKFLOW

6 stages from purchase to realized savings

The model

From an upfront discount to a post-purchase rebate.

Under the traditional 340B model, covered entities purchase eligible drugs at the discounted 340B price. The financial benefit is realized immediately at the time of purchase.

Under the HRSA Rebate Model Pilot, that timing changes for affected drugs. Covered entities will purchase applicable drugs without receiving the traditional 340B discount upfront. Required claim-level data must then be submitted to support the rebate process, and the 340B savings are not realized until the rebate is processed and payment is received.

That lag matters.

Every eligible claim awaiting submission or payment represents 340B savings the covered entity has not yet realized. For organizations with significant utilization of affected drugs, those outstanding amounts can accumulate quickly - creating a new category of 340B receivable that pharmacy and finance teams will need to actively monitor and reconcile.

Vitalyze is ready

Built for the rebate workflow, end to end.

Vitalyze has prepared the infrastructure and operational structure to help our clients manage this transition. EngineRx brings together the data, automation and reconciliation processes necessary to manage the HRSA rebate workflow from eligible utilization through payment.

01 · IDENTIFY

Affected drug utilization

Identify affected drug utilization across the enterprise.

02 · VALIDATE

Claim-level data

Validate the required claim-level data before it goes out.

03 · SUBMIT

Eligible claims, on time

Submit eligible claims in a timely manner.

04 · TRACK

Claims & outstanding rebates

Track claims and outstanding rebates as they move.

05 · RECONCILE

Expected vs received

Reconcile expected rebates against payments received.

06 · RESOLVE

Every shortfall pursued

Resolve missing, delayed, denied or disputed rebates.

The goal isn't simply to submit data. It's to manage the entire process - from the initial drug purchase through the point at which the 340B savings are actually received and realized.

The initial scope

The affected drug list is being finalized.

The HRSA Pilot will initially apply to a defined group of drugs from manufacturers approved to participate in the rebate model. The specific drugs and NDCs subject to the rebate model depend on manufacturer participation and HRSA approval - and the final list has not yet been announced.

Built to scale as the drug list grows.

January 1, 2027 is only the beginning. The number of drugs potentially affected by the HRSA rebate model is expected to grow over time. As additional products are added, covered entities could face an increasing volume of eligible claims, data submissions, outstanding rebates and payment reconciliation. A process that appears manageable with an initial group of drugs can quickly become a significant administrative and financial undertaking as that volume grows.

Vitalyze has built EngineRx with that growth in mind. Rather than creating a new manual process each time the scope expands, our infrastructure is designed to incorporate additional affected drugs into the same workflow:

IDENTIFYVALIDATESUBMITTRACKRECONCILERESOLVE

This provides our clients with a scalable structure for managing the HRSA rebate process on January 1, 2027 and as the program evolves.

Visibility

Visibility into outstanding 340B dollars.

Moving from an upfront discount to a rebate also creates a new visibility challenge. With the traditional model, the financial benefit is reflected in the acquisition cost. Under the rebate model, organizations need to know not only what they purchased, but also which claims are eligible, which have been submitted, which have been paid and which dollars remain outstanding.

EngineRx provides visibility into:

Eligible claims awaiting submission
Submitted claims awaiting rebate
Expected rebate amounts
Rebates received
Payment timing
Missing or delayed rebates
Denied or disputed claims
Outstanding 340B dollars

This gives pharmacy and finance teams a clearer picture of where their 340B savings are in the process - from purchase to payment.

Automation

Don't let data submission become another manual process.

The HRSA Pilot introduces new data requirements at the same time covered entities are adjusting to a very different financial model. Manual processes, spreadsheets and disconnected data sources can make it difficult to submit claims promptly, monitor outstanding payments and determine whether every eligible rebate has been received.

Vitalyze has built a structured process to help automate that work. By bringing data aggregation, claim identification, submission, tracking and reconciliation together, EngineRx helps reduce the administrative burden while providing greater visibility into the financial impact of the rebate model.

Keep exploring

340B Performance → MFP Reconciliation → The EngineRx platform → Rebate Recovery →

January 1 is almost here.

Covered entities now have a limited window to prepare their data feeds, submission processes, financial workflows and reconciliation infrastructure. With an upfront 340B discount, the savings are immediate. With a rebate, the savings aren't realized until the money comes back. Vitalyze manages everything in between - from data aggregation and submission through payment tracking, reconciliation and resolution.

Prepare now for January 1, 2027