HRSA's revised 340B Rebate Model Pilot is scheduled to start January 1, 2027. On October 1, 2026, HRSA approved 10 drug manufacturers to take part: AbbVie, Amgen, Astellas, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, GSK, Merck, Pfizer and Teva.
The American Hospital Association, the Maine Hospital Association and four safety-net hospitals sued in federal court in Maine on October 9, 2026 to block the pilot, so dates may change. Many covered entities are preparing as if the pilot will start on time while the case moves forward.
What changes for covered entities
For the drugs in the pilot, you no longer get the 340B price up front. Instead:
- You buy at WAC.You order the drugs on your 340B account, but you pay wholesale acquisition cost (WAC). Don't buy pilot drugs on your GPO or WAC (non-340B) accounts.
- You submit claims data.After the drug is dispensed or administered, you send the required claims data to the manufacturer's chosen platform. HRSA's notice says covered entities must be allowed at least 45 calendar days from the dispense date.
- The manufacturer pays or denies.The manufacturer has 10 calendar days after you submit complete data to pay the rebate (WAC minus the 340B ceiling price) or deny it with documentation. Manufacturers may also pay less than expected, so follow-up will be needed. If your data comes back incomplete, the 10-day clock starts over when you resubmit.
The pilot covers only drugs selected for the 2026 and 2027 Medicare negotiation years whose manufacturers have approved plans (currently 10 manufacturers, listed on HRSA's pilot page). It applies regardless of payer or indication.
Your readiness checklist
- Know which drugs are affected. List every pilot drug you buy, where it's dispensed or administered (contract pharmacy, owned pharmacy, clinic) and your monthly spend on each.
- Register on each manufacturer's platform. All 10 approved manufacturers use the Beacon platform, run by Second Sight Solutions. Beacon registration asks for your EIN, IRS letter CP 575, articles of incorporation and a W-9 (March 2024 revision) for each entity. Allow up to 5 business days for review. Under the approved plans, pilot claims go to Beacon starting January 1, 2027, so registering now means you're ready on day one.
- Set up banking. Each entity needs its account and routing numbers, a certified bank letter (dated within the last 180 days) and a small test deposit before any rebate can be paid. Don't leave this until December.
- Check your NPI list. Confirm every dispensing site is registered with HRSA on the dispense date and that its NPI is correct. Claims from unregistered or inactive sites can be flagged ineligible.
- Map your claims data. Confirm that your TPA, EHR and pharmacy systems can produce every required field, such as Rx number, fill number, NDC-11, prescriber NPI and pharmacy NPI, plus the medical-claim fields if you administer these drugs in clinics or other outpatient areas.
- Plan for cash flow. Estimate how much more you'll pay up front at WAC each month, and how long rebates may take to come back. Talk with finance now.
- Decide who reconciles. Someone needs to match every claim to its rebate payment, follow up on denials and track reversals. Across several manufacturers and sites, a spreadsheet gets complicated fast.
- Watch the 90-day notice. Approved manufacturers had to give 90 days' notice before a January 1 start, so notices should already be out. Check each manufacturer's approved plan on HRSA's pilot page and keep a calendar of its requirements.
- Know each manufacturer's MFP rule. When a 340B claim is also a Medicare MFP claim, the approved plans differ: Merck, Pfizer, Teva and Amgen pay the 340B rebate and adjust the pharmacy's MFP refund, while AbbVie, AstraZeneca and BMS may reject the 340B rebate when the MFP is lower than the 340B ceiling price. Build these rules into your reconciliation.
- Keep following the lawsuit. The case could delay or change the pilot. Recheck dates before you change purchasing.
How Secure340B can help
Secure340B's 340B Rebate Reconciliation service connects your claims, submission records and manufacturer payments, and follows up on exceptions. You can also take a tour of our 340B Reconciliation Demo portal or take a free 340B Rebate Readiness Quiz, which has 10 questions and provides instant results.
Information current as of October 31, 2026. This is general education, not legal advice. Sources: HRSA 340B Rebate Model Pilot Program; AHA News, Oct. 1, 2026; Beacon Channel Management support materials.