On July 31, 2026, the Health Resources and Services Administration (HRSA) issued a new 340B Rebate Model Pilot Program notice implementing an updated pilot effective January 1, 2027. Under the pilot, qualifying drug manufacturers, with approval from the Department of Health and Human Services (HHS), will be allowed to use a post-dispense rebate model for select pharmaceuticals instead of the current 340B discount model. The new pilot comes on the heels of HRSA’s previous attempt at a 340B rebate model, which was finalized in fall 2025 but blocked by a federal court ruling.
Approved rebate models will apply to all covered entity types for the eligible drugs. HRSA will require participating manufacturers to allow covered entities to continue ordering selected drugs through existing distribution mechanisms, including 340B wholesaler accounts with wholesale acquisition cost (WAC) prices loaded, to preserve existing purchasing infrastructure. Covered entities will then need to submit standardized claims-level data to support a rebate equal to WAC minus the 340B ceiling price on the date of dispense.
Based on our estimates, at least 30% of a covered entity’s 340B drug purchasing may be subject to the rebate model. This will require a significant operational shift. This article explores the details of the 340B Rebate Model Pilot Program and how covered entities can prepare.
Which Drugs Will Be Included in the 340B Rebate Model Pilot?
The pilot is limited to the 11-digit National Drug Codes (NDCs) of active selected drugs included on CMS’ Medicare Selected Drugs and Negotiated Prices list for initial price applicability years (IPAYs) 2026 and 2027. HRSA states that the model applies regardless of payor or indication, but only during the selected drug’s effective dates for negotiated prices.
Medicare Drug Price Negotiation Selected Drugs Included in 340B Rebate Model Pilot Program Scope
| IPAY | Selected Drugs | Manufacturers |
|---|---|---|
| 20261 | Eliquis | Bristol Myers Squibb |
| Jardiance | Boehringer Ingelheim | |
| Xarelto | Janssen Pharms | |
| Januvia | Merck Sharp Dohme | |
| Farxiga | AstraZeneca AB | |
| Entresto | Novartis Pharms Corp | |
| Enbrel | Immunex Corporation | |
| Imbruvica | Pharmacyclics LLC | |
| Stelara | Janssen Biotech, Inc. | |
| NovoLog; Fiasp | Novo Nordisk Inc. | |
| 20272 | Ozempic; Rybelsus; Wegovy | Novo Nordisk Inc. |
| Trelegy Ellipta | GlaxoSmithKline Intellectual Property Development Ltd. England | |
| Xtandi | Astellas Pharma US, Inc. | |
| Pomalyst | Bristol Myers Squibb | |
| Ibrance | Pfizer Inc. | |
| Ofev | Boehringer Ingelheim | |
| Linzess | AbbVie Inc. | |
| Calquence | AstraZeneca UK Limited | |
| Austedo; Austedo XR | Teva Branded Pharmaceutical Products R&D LLC | |
| Breo Ellipta | GlaxoSmithKline Intellectual Property Development Ltd. England | |
| Tradjenta | Boehringer Ingelheim | |
| Xifaxan | Salix Pharmaceuticals Inc. | |
| Vraylar | AbbVie Inc. | |
| Janumet; Janumet XR | Merck Sharp Dohme | |
| Otezla; Otezla XR | Amgen Inc. |
What Are the Requirements for Drug Manufacturers in the 340B Rebate Model Pilot?
To participate, eligible manufacturers must submit a plan to implement a rebate model to HRSA/the Office of Public Affairs (OPA) by August 24, 2026. HRSA states it will approve manufacturers’ plans by September 24, 2026 for a January 1, 2027 effective date. Manufacturers may not implement a rebate plan without first receiving HHS approval.
Among other requirements, manufacturer plans must identify the IT platform that covered entities will use for data submission and ensure that all costs of that platform are borne by the manufacturer. The plan must provide covered entities and other affected stakeholders with at least 90 calendar days’ notice before implementation, including instructions for registering for applicable IT platforms.
Manufacturers also must demonstrate that their plans protect covered entity data. HRSA requires plans to include assurances that data collection will be limited to the elements necessary to provide 340B rebates and that IT platforms will protect protected health information (PHI) and other personally identifiable information consistent with applicable federal privacy and data security laws, including HIPAA.
Operationally, manufacturers must support real-time reconciliation reports, provide quarterly 340B price files for each relevant 11-digit NDC, submit periodic reports to HRSA/OPA, pay rebates at the unit level, and calculate the rebate as WAC minus the 340B ceiling price on the dispense date.
What Data Will Covered Entities Be Required to Submit to Receive 340B Rebates?
Similar to HRSA’s previous attempt at a 340B rebate model, the updated pilot will require providers to submit both pharmacy and medical claims data. The required elements from the notice are listed below.
| Pharmacy Claims Data3 | Medical Claims Data |
|---|---|
| Date of service | Date of service |
| Date prescribed | Claim line number |
| Rx number | Claim number |
| Fill number | Unit of measure |
| NDC-11 | NDC-11 |
| Quantity dispensed | Quantity |
| Prescriber ID | Rendering physician ID |
| Service provider ID | Service provider ID |
| 340B ID | 340B ID |
| Rx Bank Identification Number (BIN) | Health plan name |
| Rx Processor Control Number (PCN) | Health plan ID |
| Health plan ID qualifier (if available) |
The HRSA notice states that manufacturers must submit data definitions for each field with their plan for HRSA approval and make those definitions available to covered entities. To the extent that participating manufacturers are allowed to use a unique definition for each of these data elements, it will increase costs for covered entities and the risk of administrative denials for rebates.
What Are the Data Submission & Payment Time Frames for 340B Rebates?
Covered entities must be allowed at least 45 calendar days from the dispense date to submit required data, with allowances for extenuating circumstances and claim adjustments, including changes in 340B status.
Once a covered entity submits complete data, the manufacturer must either pay the rebate or issue a documented denial within 10 calendar days. If the submission is returned as incomplete, the 10-day payment clock restarts when all necessary data has been submitted.
It is unclear from the notice whether a documented denial restarts the 45-day submission clock or if the data must be resubmitted within 45 calendar days from the dispense date. Covered entities should consider designing their systems to submit a rebate request as soon as possible to allow for rework related to denials within the initial 45-day window.
How Will HRSA Monitor 340B Rebate Denials & Payment Delays?
HRSA’s previous attempt at a rebate model did not establish a formal appeals process for denied rebate requests. Instead, covered entities were instructed to report denials they believed were inappropriate to HRSA, which could remove a manufacturer from the pilot if it determined the manufacturer had improperly denied rebate requests.
In a change from the previous rebate model, HRSA requires manufacturers in the new pilot to document and report denied claims, including the basis for each denial and the status of any associated dispute. HRSA intends to use this information to monitor denial patterns, assess whether rebate determinations are applied consistently and appropriately across participating manufacturers, and remove manufacturers from the pilot when appropriate.
HRSA’s notice states that if covered entities report that a manufacturer consistently denies rebate payments without acceptable justification, HRSA could review a sample of affected transactions over a period, such as 10 calendar days. If a significant portion, such as 5% or more, were denied without acceptable justification, HRSA could initiate removal proceedings for noncompliance. The time frames and denial thresholds referenced in the notice are provided for illustrative purposes and are not intended by HRSA to be a statement of policy or procedure.
In addition, HRSA’s notice clarifies that manufacturers’ plans must ensure that rebates are not denied based on eligibility or compliance concerns with diversion or Medicaid duplicate discounts.
HRSA also intends to monitor payment delays. If covered entities report that a manufacturer consistently exceeds the 10-calendar-day payment threshold, HRSA could review a sample of affected transactions and initiate removal proceedings if a significant portion were delayed without justification.
HRSA will create a defined pathway for covered entities to challenge denied claims, including specified time frames for review and response. HRSA states that tools for reporting rebate denials will be made available within 30 calendar days of the pilot’s effective date, and unresolved disputes may proceed through the 340B Administrative Dispute Resolution process.
How Can Covered Entity Executives Prepare for the 340B Rebate Model Pilot Program?
The 340B rebate model pilot will require covered entities to create a “rebate cycle” for medical claims, similar to the revenue cycle. Covered entities will need to capture, validate, transmit, reconcile, and monitor claims-level data within compressed timelines. The 45-day submission window and 10-day manufacturer response requirement create a new operational cadence that will require coordination among pharmacy (both in-house and contract), finance, compliance, and IT teams. As a result, covered entities will incur operational costs associated with the staffing, technology, and compliance infrastructure necessary to manage the rebate cycle.
In addition to creating the work and data flows necessary to submit the required pharmacy and clinical claims data, covered entities will need to build the infrastructure to monitor timely processing, denial rates by claim count and dollar value, administrative expense, and rebate cycle key performance indicators (KPIs), and to share relevant experiences with HRSA and elected officials as HRSA evaluates whether to expand the model.
Covered entities should also anticipate cash flow issues related to having to pay WAC upfront and wait for the rebate. While HRSA’s notice downplays the risk of floating the upfront cost, our experience with similar rebate programs, such as Maximum Fair Price (MFP) rebates, suggests that denials and delays can extend the average time to payment well beyond established payment windows.
The pilot will shift some operational risk from acquisition to reimbursement. Covered entities that cannot reliably identify eligible dispenses, generate required data, submit timely claims, monitor denials, and escalate disputes may leave 340B savings unpaid or delayed. Organizations should begin designing a repeatable rebate cycle process before January 1, 2027, including data readiness testing, contract pharmacy coordination, denial management protocols, cash flow monitoring, and clear accountability for rebate performance.
How Forvis Mazars Can Help With 340B Performance
Our 340B professionals at Forvis Mazars are committed to helping healthcare organizations achieve regulatory excellence and financial discipline by understanding and adapting to the impact of evolving HRSA regulations on covered entities. If you have questions about how the 340B Rebate Model Pilot Program may affect your organization or how you can prepare, please reach out to our team today.
- 1“Medicare Drug Price Negotiation Program: Negotiated Prices for Initial Price Applicability Year 2026,” cms.gov, August 2024.
- 2“Medicare Drug Price Negotiation Program: Negotiated Prices for Initial Price Applicability Year 2027,” cms.gov, November 2025.
- 3HRSA also directs that BIN, PCN, and health plan fields for uninsured or cash-paying patients should allow submission as “CASH.”