Denial
Step 1
- Documented rationale required
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The FQHC Operator · Issue 2 · Late November 2026
340B rebates start January 1. Your cash timing changes on the same day.
The short answer: from January 1, 2027, ten manufacturers stop discounting selected drugs up front and instead pay a rebate equal to WAC minus the 340B ceiling price per unit. You buy at WAC, submit claim data within 45 calendar days, and the manufacturer must pay or deny within 10 calendar days.
Jan 1, 2027 · pilot start45 days · to submit10 days · to pay or denyWAC minus ceiling · the rebate
Edition
Issue 2 · Nov 2026
Focus
340B rebate pilot
Audience
FQHC pharmacy · finance
Effective date
Jan 1, 2027
Metric
Under 1.2% modeled cost
Length
4 min read
What starts on January 1: the rebate mechanism in one line
HRSA published the revised notice on August 3, 2026, after a court enjoined the first version in December 2025 [2]. Scope: the CMS selected drug list for 2026 and 2027, regardless of payer [1].
- 1Order at WAC340B wholesaler account only
- 2DispenseUnit level
- 3Submit dataWithin 45 calendar days of dispense
- 4RebateWAC minus the 340B ceiling price per unit
- 5Paid or deniedWithin 10 calendar days of a complete submission
- 6If lateManufacturer first, then HRSA; repeat misses can remove a manufacturer
Your cash
You carry the drug at WAC until the rebate lands
Grace at start
15-day grace for up to two unreplenished packages
Platform
One IT platform, paid for by the manufacturer; real-time rebate status per claim
Working capital outTransition graceManufacturer platform
Approved plans listed by HRSA, all starting January 1, 2027
| Manufacturer | Selected drugs in the pilot |
|---|---|
| AbbVie | Imbruvica, Linzess, Vraylar |
| Amgen | Enbrel, Otezla, Otezla XR |
| Astellas | Xtandi |
| AstraZeneca | Farxiga |
| Bristol Myers Squibb | Eliquis, Pomalyst |
| Boehringer Ingelheim | Jardiance, Ofev, Tradjenta |
| GSK | Breo Ellipta, Trelegy Ellipta |
| Merck | Januvia, Janumet, Janumet XR |
| Pfizer | Ibrance |
| Teva | Austedo, Austedo XR |
The cash clock, and what HRSA modeled it costs
Modeled interest cost of a rebate model as a share of purchases, as cited by HRSA in the notice
HRSA says it designed the pilot so rebates arrive before wholesaler terms fall due [2].
Unfavorable assumptions, ceilingHRSA model
under 1.2%worst case
Entity-owned pharmacyHRSA model
0.19%16% of the ceiling
Contract pharmacyHRSA model
0.03%3% of the ceiling
0%0.4%0.8%1.2%
Ceiling under unfavorable assumptionsModeled by pharmacy type
Twelve pharmacy fields, eleven medical fields, three things a manufacturer cannot deny for
HRSA limits the data a manufacturer may request and bars purchasing and encounter-level data; manufacturers must publish a quarterly ceiling price file by NDC-11 for Medicaid acquisition-cost billing and sliding fee math [1].
| Topic | Rule in the notice and on the HRSA page |
|---|---|
| 12 pharmacy fields | Date of service and date prescribed, Rx and fill number, NDC-11, quantity, prescriber and provider IDs, 340B ID, BIN, PCN, plan ID qualifier |
| 11 medical fields | Date of service, claim and line number, unit of measure, NDC-11, quantity, rendering and provider IDs, 340B ID, plan name and ID |
| Denials not allowed | Eligibility, diversion, duplicate discount concerns, or perceived lack of WAC purchases |
| Denials allowed | Only with documented rationale, such as a Maximum Fair Price refund on the same claim |
| Data use | Pilot data may not be aggregated, shared or licensed beyond the pilot |
Manufacturer
Step 2
- Good-faith contact first
HRSA tool
Step 3
- Denial-reporting tools within 30 days of the start date
340B ADR
Step 4
- Statutory fallback
Takeaway
Walk one pilot drug from the shelf to the rebate, then write down 45 days of that drug at WAC. That is the working capital question for the board.
The 30-minute trace, in order
Pick one selected drugThe one your diabetes program dispenses most.
Find the accountWhich wholesaler line it is ordered on.
Test the 12 fieldsCan the pharmacy system produce them per fill?
Name the price-file ownerWho loads the quarterly ceiling price file; what Medicaid acquisition-cost billing uses after January 1.
Write down the float45 days of that drug at WAC; evaluation after year one is due April 30, 2028 [1].
Read this month's toolsFQHC KPI scorecard, wrap denials fix list, FQHC billing services, FQHC RCM toolkit.
Frequently asked questions
Which drugs are in the 340B rebate pilot?
Only active selected drugs for price applicability years 2026 and 2027 on the CMS Medicare Drug Price Negotiation Selected Drug List, regardless of payer or indication. HRSA's approved-plan table lists ten manufacturers, all starting January 1, 2027.
How fast must the rebate be paid?
Within 10 calendar days of a completed data submission, paid or denied with documentation. An incomplete return restarts the clock. Covered entities have up to 45 calendar days from dispense to submit.
Can a manufacturer deny a rebate for a suspected duplicate discount?
No. Rebates may not be denied for eligibility, diversion or Medicaid duplicate discount concerns, or for a perceived lack of WAC purchases. Those go to HRSA, audits or administrative dispute resolution.
Does the pilot apply to contract pharmacy dispenses?
The pilot covers listed drugs in any setting, including clinic-administered drugs, and each manufacturer may include all covered entity types or carve out exceptions in its approved plan. Read each plan on the HRSA page.
- HRSA Office of Pharmacy Affairs: 340B Rebate Model Pilot Program (approved manufacturer plans, how the pilot works, FAQs; last reviewed October 2026)
- Federal Register: Notice Regarding 340B Rebate Model Pilot Program, 91 FR 48883 (August 3, 2026)
Checked October 25, 2026. Proposed rules are not final until published; confirm against the source before relying on a number.
Need the 340B feed and the billing path checked before January?
We trace your pilot drugs from wholesaler account to rebate claim, confirm the data fields and the Medicaid acquisition-cost logic, and give the board the working-capital number.