Q3 2026 340B News

A manufacturer notice can arrive in the pharmacy inbox while the information needed to respond sits in the medical billing system. That disconnect is a practical concern for 340B teams this September. Several policy letters now reach beyond contract pharmacy dispensing, making it important to check which transactions your reporting process actually captures.

This edition of the 340B Auditor monthly briefing covers selected developments through September 22, 2026. The immediate priorities are to review recently effective manufacturer policies, prepare for October changes in the 340B Office of Pharmacy Affairs Information System, and keep upcoming requirements separate from obligations already in effect.

Manufacturer changes to review now

Johnson & Johnson announced a claims data policy on September 4 with a September 15 effective date. Its stated scope includes eligible dispenses and administrations across dispensing locations and payer types. The letter provides a 45-day submission window, with 60 days for specifically listed products. It excludes the Ryan White Part B ADAP Rebate Option category and certain products, and says applicable state exemptions will be communicated separately. Those qualifications belong in any implementation review. ^[1]

Genentech's July 31 letter took effect August 31. It extends claims reporting across pharmacy and medical benefit utilization, brings federal grantees within its stated requirements, and includes contract pharmacy designation and distance conditions. HEMLIBRA and Evrysdi are excluded from the changes described in the letter. ^[2]

For a covered entity, the first useful question is whether the affected data already moves through an established reporting process. A contract pharmacy file may tell you little about medications administered in an outpatient clinic. Ask the people responsible for each channel to trace a recent applicable transaction from the original record through submission and any correction.

These are manufacturer-stated conditions. Their application requires review of the complete policy, relevant exceptions, and the entity's circumstances; a manufacturer letter should not be presented as a new HRSA rule.

Put the Amgen November date on the calendar

Amgen's August 26 revision announces a November 15, 2026 requirement for healthcare visit and service claims data associated with applicable 340B pharmacy and medical claims. The letter directs covered entities to 340B ESP for operational details. Its broader claims reporting policy had already taken effect June 1. ^[3]

That distinction changes the work plan. September is a reasonable time to identify the source systems and staff needed for the November requirement, while checking whether the existing reporting process is complete. Assign someone to obtain and review the current specifications as they become available. Do not assume that the file already sent by a vendor contains the additional information.

Prepare for the October OPAIS changes

HRSA's September 8 update announces OPAIS changes effective October 1. These include additional shipping-address information and new eligibility documentation for STD and TB covered entities. The notice also identifies family planning assistance-period information, Tribal Agreement numbers, and changes to hospital registration information. HRSA says these updates do not change underlying statutory eligibility requirements. ^[4]

Our recommendation is to make preparation specific to the entity. An STD clinic can identify the award or subrecipient documentation that supports its registration. A health system can review who maintains its addresses and registration records. The person preparing a change request should be able to find the required evidence without searching multiple inboxes at the last minute.

October 1 through 15 is also a regular contract pharmacy registration window. HRSA states that an approved pharmacy may begin dispensing 340B drugs on the first day of the following quarter. That makes January 1, 2027 the relevant prospective start date for an approved October registration. Existing active arrangements do not require a new registration merely because a window opens. ^[5]

Watch for rebate pilot decisions

HRSA announced a revised rebate model pilot on July 31, with a planned January 1, 2027 effective date for qualifying approved plans. The Federal Register notice identifies September 24 as the date by which approvals, if any, will be made. September 24 is still ahead of this edition's research cutoff. The announcement should not be read as confirmation that every manufacturer or drug will enter a rebate model. ^{[6] [7]}

Finance teams can prepare by identifying which purchasing and remittance records they would need to reconcile a rebate. A useful first exercise is to follow a purchase through payment and then identify where a later manufacturer payment would be recorded. Implementation decisions should use the actual approved terms and current program status.

This month at your 340B meeting

Use a short action list that produces evidence of completion:

• Identify which recently effective policies apply to your products, entity types, and dispensing channels.
• Test one applicable pharmacy transaction and one medical transaction where both channels are in scope. Record any missing fields or failed submissions.
• Confirm who receives manufacturer and platform notices, including a backup when the primary contact is away.
• Gather the OPAIS documentation relevant to your entity before the October changes.
• Assign an owner to review rebate pilot decisions and Amgen's November specifications when available.

A monthly briefing is most useful when it ends with an accountable next step. Record the owner, due date, and evidence needed to close each item. At the next meeting, ask whether the underlying process changed and whether a transaction test shows that the change worked.

For help reviewing manufacturer-policy exposure or testing the supporting records, contact 340B Auditor through our website.