Starting January 1, 2027, the 340B landscape may shift following the Health Resources and Services Administration’s (HRSA) implementation of the revised 340B Rebate Model Pilot Program (“Pilot Program”).  According to HRSA, the revised Pilot Program was described and introduced to support transparency and program integrity, including efforts to reduce duplicate discounts which were program deficiencies previously cited by Congress and other governmental entities. For covered entities, the model would replace the traditional upfront 340B discount for selected drugs with a post-dispense rebate process, creating new administrative, data-submission, reconciliation, and cash-flow considerations.  

This revised Pilot Program follows HRSA’s earlier 2025 rebate pilot, which was paused before implementation after hospital and covered entity stakeholders successfully challenged the program in federal court. Following the litigation, HRSA sought additional stakeholder feedback through a Request for Information (RFI), and has now proposed a revised version intended to respond to comments it received.  The revised Pilot Program includes several important changes. 

This post covers the fundamentals of the 340B Rebate Model Pilot Program, including how the revised model is intended to operate, what has changed from the prior proposal, what remains unclear, and steps covered entities can take now to prepare. 

 

Background: The 340B Drug Pricing Program

The 340B Program was established in 1992 to help eligible safety-net providers stretch scarce federal resources and expand access to comprehensive services for vulnerable patient populations. Under the traditional model covered entities generally purchase eligible outpatient drugs at or below the 340B ceiling price through their existing wholesale purchasing channels  

The discounted prices allow covered entities to reinvest savings into patient care for the local populations they serve. The 340B Rebate Model Pilot Program changes how and when covered entities receive those savings. 

 

What is the HRSA 340B Rebate Pilot Program?

The HRSA 340B Rebate Pilot Program would change how covered entities access 340B savings for certain drugs selected under the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program. Instead of receiving the 340B price at the time of purchase covered entities would initially purchase selected drugs at the commercial Wholesale Acquisition Cost (WAC) through their 340B wholesaler accounts and later seek a rebate for the difference between WAC and the applicable 340B ceiling.   

After dispensing the selected drugs to eligible patients, covered entities would submit HRSA-specified claims data through the manufacturer’s identified IT platform. Under the proposed framework manufacturers would be required to pay a rebate or issue a documented denial with ten (10) calendar days after receiving a complete submission. HRSA has indicated that denial grounds would be limited, including situations involving the Medicare Drug Price Negotiation Program (MDPNP) maximum fair price, nonduplication, or where a 340B rebate has already been provided to another covered entity for the same claim. Manufacturers may not deny claims based on suspected instances of diversion or duplicate discounts. HRSA will publish a defined approach in early 2027 for covered entities to challenge any claims denials.  

It is anticipated the Pilot Program will run for one (1) year and because this is a pilot program, HRSA retains the authority to modify terms, extend timelines, add additional manufacturers and drugs, or discontinue the initiative entirely.

 

What Drugs Will Be Impacted by this Pilot?

The scope of the revised Pilot Program is expected   to focus on the 22 drugs subject to the IRA’s Medicare Drug Price Negotiation (MDPN) for 2026 and 2027, but inclusion remains dependent on manufacturer participation and HRSA approval. Covered entities should confirm the final approved drug list once HRSA publishes participating manufacturer plans.  

    • Austedo; Austedo XR (Teva)
    • Breo Ellipta (GlaxoSmithKline)
    • Calquence (AstraZeneca)
    • Eliquis (Bristol Myers Squibb)
    • Enbrel (Amgen)
    • Farxiga (AstraZeneca)
    • Ibrance (Pfizer)
    • Imbruvica (Pharmacyclics/AbbVie)
    • Janumet; Janumet XR (Merck)
    • Januvia (Merck)
    • Jardiance (Boehringer Ingelheim)
    • Linzess (AbbVie)
    • Novolog products, including Novolog FlexPen, Novolog PenFill, Fiasp, Fiasp FlexTouch, and Fiasp PenFill (Novo Nordisk)
    • Ofev (Boehringer Ingelheim)
    • Otezla; Otezla XR (Amgen)
    • Ozempic; Rybelsus; Wegovy (NovoNordisk)
    • Pomalyst (Bristol-Myers Squibb)
    • Tradjenta (Boehringer Ingelheim)
    • Trelegy Ellipta (GlaxoSmithKline)
    • Vraylar (AbbVie)
    • Xifaxan (Salix)
    • Xtandi (Astellas)

Entresto (Novartis), Stelara (Janssen), and Xarelto (Janssen) are not expected to be subject to the revised Pilot Program as of January 1, 2027, because they have been removed from the IRA Medicare Drug Price Negotiation Program due to new generic or biosimilar competition entering the market. 

 

How the New 340B Rebate Model Pilot Program Works

The rebate model shifts 340B savings from an upfront wholesaler discount to a post-dispense rebate.

Covered entities would purchase included drugs through their 340B wholesaler accounts at commercial WAC pricing, which will create higher upfront acquisition costs. After dispensing these medications to eligible patients, entities compile the required pharmacy and medical claims data, depending on the site of care, and submit this information through the IT platform identified in the applicable manufacturer plan.

The deadline for manufacturers to submit proposed participation plans to HRSA closed on August 24, 2026. HRSA is expected to announce approvals by September 24, 2026, and approved rebate models are scheduled to begin no earlier than, January 1, 2027. Manufacturers may not implement a rebate model without HRSA’s approval and must provide covered entities with at least 90 days’ advance notice of plan details.  Implementation dates may vary by manufacturer depending on when a plan is approved and when notice is issued.  

HRSA has established a detailed set of requirements that all manufacturer plans must meet. While the Pilot Program’s   design remains fundamentally similar to the original, HRSA’s revised Pilot Program’s framework includes new safeguards in response to over 2,000 comments from hospitals, manufacturers, pharmacies, and other interested stakeholders.

Under the Pilot Program’s revised framework, HRSA requires manufacturers seeking to participate in the pilot program to identify the IT platform used to process rebate submissions and to bear the associated costs. At this time, it is not known which IT platform(s) manufacturers will use to administer rebate submissions. Additional details are expected once HRSA approves participating manufacturers’ plans.

The Pilot Program’s revised framework also appears intended to preserve existing purchasing channels by allowing covered entities to continue purchasing drugs subject to the Pilot Program through their current 340B wholesaler accounts.

Lastly, manufacturers must issue or deny rebate payments within 10 days of receiving a complete and validated claim submission. A claim denied for incomplete data will restart the 10-day clock once missing data is submitted. 

HRSA also limits the data manufacturers may require from covered entities. Manufacturers may request only a defined set of standardized pharmacy and medical claims data fields and may not require purchasing records, encounter-level clinical data, or other patient-level information as part of the initial pilot. As previously highlighted, manufacturers may not deny rebate claims based on concerns with diversion or duplicate discounts, nor for perceived lack of WAC purchases. Those concerns must be addressed by manufacturers to HRSA or through existing 340B program mechanisms, such as audits or the administrative dispute resolution process. Manufacturers seeking to impose requirements beyond those established by HRSA must provide additional justification in their plan submissions, which could affect the timing of HRSA approval.

Although HRSA incorporated safeguards intended to mitigate financial and operational disruption, the real-world impact on covered entities will ultimately depend on the final approved manufacturer plans, the ease of data submission, denial rates, and the timing of rebate payments.  

 

340B Rebate Model Pilot Program Time Requirements for Claims

The revised 340B Rebate Model Pilot Program outlines two specific timelines for both covered entities submitting claims data and manufacturers processing rebates. Understanding these requirements plays an important role in evaluating how the rebate model could affect existing workflows, the reconciliation process, and cash flow.

The key timing requirements are:

    • Covered entity submission window: Covered entities must be given at least 45 calendar days from the date of dispense to submit the required claims-level data to the manufacturer’s rebate platform.

    • Manufacturer payment requirement: Manufacturers must pay the rebate or issue a documented denial within 10 calendar days from when a complete rebate submission is received.

HRSA has indicated that manufacturer plans should account for circumstances that may affect these timelines including extenuating circumstances land corrections when a claim’s 340B status changes after initial submission. These provisions may give covered entities some flexibility t but organizations should not assume every late or corrected claim will qualify for relief.

The 10-day manufacturer timeline works differently. If a covered entity submits incomplete information, the manufacturer is not required to process the rebate based on that insufficient submission. Instead, the 10-day period will restart once the covered entity provides the missing information to complete the submission.

These requirements reinforce the importance of having processes in place to track claim status, identify incomplete submissions, manage corrections, and reconcile rebate payments and denials.

Event  10-Day Clock Status 
Manufacturer receives a complete submission from the Covered Entity  Clock starts 
Manufacturer identifies missing required data  Payment not yet due 
Covered entity supplies missing information  10-Day clock restarts 
Complete submission now on file  Manufacturer pays or denies within 10 days  

 

Key Differences from the Existing 340B Program

The new 340B Rebate Model fundamentally changes how the 340B Program has worked since its inception in 1992.  It is essential that covered entities understand the key differences as they prepare for the January 1, 2027, transition.

 

Timing of Benefit

    • Longstanding 340B Upfront Discounts: Savings are realized upfront at the point of purchase, reducing drug acquisition costs.​

    • New 340B Rebate Model: Savings are realized after the drug has been dispensed to an eligible 340B patient via a rebate payment.  While entities will need to adjust cash flows, the 340B savings should ultimately remain the same.

 

Data and Administrative Requirements

The rebate model places greater emphasis on accurate claims data, timely submissions, and meticulous reconciliation. Covered entities comply with data submission requirements instead of simply purchasing 340B drugs using an upfront discount. For both approaches, covered entities must still purchase the drugs through their 340B wholesaler accounts.

 

Operational Touchpoints

The rebate model requires greater coordination between pharmacy operations, 340B program staff, IT and data teams, and finance departments to ensure accurate data flow and cash reconciliation.

Finance leaders will need to track manufacturer rebate receivables to confirm that payment are timely, complete, and properly reconciled. Effective reconciliation strategies will be an important key to maintaining visibility into true drug costs and avoiding margin degradation or unexpected budget variances.

 

How Covered Entities Can Prepare for the HRSA 340B Rebate Pilot

The following steps provide practical guidance for covered entities to prepare for the HRSA 340B Rebate Pilot launch. These recommendations are not exhaustive, and any actions taken should be under the counsel of your organization’s legal, compliance, and finance teams.

 

Understand Scope and Timelines

Confirm which of the selected pilot drugs are actively dispensed within your organization’s pharmacy program and calculate the financial impact based on recent utilization data.

Note key milestone dates, including September 24, 2026, the anticipated approval date for participating manufacturers, and January 1, 2027, the earliest intended effective date for approved rebate models. Covered entities should also monitor manufacturer-specific implementation guidance, transition provisions, and any purchasing or inventory considerations included in approved manufacturer plans.

 

Map Your Data and Systems

Identify where relevant pharmacy and medical claims data reside, including electronic health records (EHR), pharmacy management systems, TPAs, and billing platforms. Under the revised pilot, required pharmacy claims data include fields such as date of service, prescription and fill information, NDC-11, quantity dispensed, prescriber and service provider IDs, 340B ID, and Rx BIN and PCN. Medical claims require similar information, including date of service, claim and claim line numbers, NDC-11, quantity and unit of measure, provider and 340B IDs, and health plan information.

Ensure your organization can capture and transmit all required data fields for both pharmacy and medical claims, and test data extraction processes before the anticipated January 1, 2027, start date to avoid submission delays that could impact rebate payment timelines.

 

Clarify Roles and Responsibilities

Define clear ownership for critical functions, including data extraction and submission, rebate monitoring and reconciliation, and policy oversight and compliance. To start, confirm the role your 340B TPA or accumulator will play in the process. Some TPAs can submit claims data on behalf of a covered entity once authorized, while others may require the 340B team to extract and upload the data directly to a manufacturer’s vendor.

 

Engage with Trusted Resources

Monitor HRSA updates, 340B advocacy organizations like 340B Health, and other reputable educational resources to stay up to date on the latest on the rebate pilot.

 

340B Rebate Model Pilot Program: FAQs

 

Does the 340B Rebate Model Pilot replace the 340B program?

No, the 340B Rebate Model Pilot does not replace the 340B Drug Pricing Program. It is a limited, time-bound model that alters the mechanics of how covered entities access their 340B savings for certain drugs selected under the Medicare Drug Price Negotiation Program. All other 340B-eligible medications continue to operate under the traditional upfront discount model.

 

Do all drugs now move to a rebate model?

No, HRSA states that the pilot only applies to selected drugs under the IRA Medicare Price Negotiation Program for 2026 and 2027. Covered entities will continue purchasing all other 340B-eligible medications at upfront discounted ceiling prices through their existing wholesaler and contract pharmacy arrangements.

 

Is Beacon required for the revised pilot?

HRSA requires each manufacturer’s plan to identify the IT platform it will use for covered entity data submission but does not require a single platform or confirm that Beacon will be used for the revised pilot. Covered entities should wait for approved manufacturer plans, which are expected to be approved by September 24, before confirming whether Beacon or another platform will be utilized.

 

Where can we find official guidance and updates?

The primary source for official guidance is the HRSA 340B Rebate Model Pilot Program page, which includes approved manufacturer plans, program timelines, and policy updates. Additional industry analysis and advocacy perspectives are available through 340B Health and the American Hospital Association.

 

Moving Forward with Confidence

The value of 340B savings should presumably remain intact if claims requirements are met, but the mechanics of realizing those savings are changing for a defined subset of high-utilization drugs. While the rebate model introduces new administrative complexity, it also presents an opportunity for covered entities to strengthen data integrity, cross-functional coordination, and financial transparency across their 340B operations. Organizations that invest time now in mapping data flows, clarifying internal roles, and establishing robust reconciliation processes will be best positioned to navigate the transition without disruption.​

Connect with your internal 340B leaders, finance teams, and trusted advisors as soon as possible to ensure operational readiness before January 1, 2027. Stay engaged with official HRSA updates and industry resources to track evolving guidance as the pilot unfolds. For additional insights on optimizing specialty pharmacy operations and 340B strategy, explore our Outcomes Report for the latest trends and performance benchmarks.​