HRSA revives 340B rebate pilot: up to 25 Medicare-negotiated drugs could shift to rebates Jan. 1, paid within 10 days

HRSA’s notice has a worked example tucked into its last page. A covered entity dispenses a drug from its neutral inventory on December 16, two weeks before the drug enters the rebate pilot, and has not yet accumulated enough units to reorder at the 340B price. Under the pilot, that entity can still claim a rebate for up to two such unreplenished packages, as long as it asks within 45 days of dispensing [1].

That transition rule only matters if the pilot happens. The last one never did.

What changed

HRSA published a revised 340B Rebate Model Pilot Program in the Federal Register on August 3, after HHS announced it July 31 [1, 2]. Drug manufacturers with selected drugs under the Medicare Drug Price Negotiation Program for 2026 and 2027 may apply to deliver the 340B ceiling price through a post-dispense rebate instead of an upfront discount, starting January 1, 2027 [1]. Plans are due August 24, HRSA says it will approve any by September 24, and participating manufacturers must commit to at least one year [1, 2].

The first pilot, announced August 1, 2025, was open to manufacturers of the 2026 negotiated drugs only. HRSA approved eight applications in October 2025 and a ninth later [1]. The American Hospital Association and the Maine Hospital Association sued [3], and on December 29, 2025, the U.S. District Court for the District of Maine issued a preliminary injunction that paused the pilot nationwide [1]. HHS dropped its appeal, and on February 10, 2026, the court vacated the 2025 notices and the manufacturer approvals [1]. HRSA then issued a request for information in February and reviewed 2,449 public comments, 1,170 of them identical letters from a single campaign [1].

The legal footing on the manufacturer side is now firmer. HRSA notes that on July 21, 2026, the D.C. Circuit affirmed that drugmakers may not impose rebate models on their own without HHS approval [1].

Who it affects

Every 340B covered entity that buys an included drug from an approved manufacturer. The pilot is voluntary for drugmakers, but HRSA says that once it approves a manufacturer’s plan, the rebate model “will become mandatory for 340B covered entities acquiring 340B drugs from that manufacturer” [1].

HRSA considered limiting the pilot to volunteer covered entities, to non-hospital entities or to entities with more operational capacity, and rejected all three, saying a narrow or self-selected group would introduce “substantial selection bias” [1]. It also declined to exclude physician-administered drugs or contract pharmacy arrangements [1].

The program is large. As of April 1, 2026, it counted 15,249 covered entities and 49,214 associated sites, with about $100 billion in purchases at 340B prices in 2025 [1]. Hospitals accounted for about 87% of 2024 purchases; federally qualified health centers and look-alikes made up about half of non-hospital purchases, roughly $5.2 billion [1].

Which drugs are in the 340B rebate pilot?

Only the NDC-11s on CMS’s selected drug lists for 2026 and 2027, and only while each drug’s negotiated price is in effect, but “regardless of payer or indication” [1]. That means a commercially insured patient’s fill counts the same as a Medicare patient’s.

The 2026 list has 10 drugs: Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Stelara, Imbruvica, and the Fiasp and NovoLog insulins [5]. The 2027 list has 15, led by Ozempic, Rybelsus and Wegovy, and includes Trelegy Ellipta, Xtandi, Pomalyst, Ofev, Ibrance, Linzess, Calquence, Austedo, Breo Ellipta, Xifaxan, Vraylar, Tradjenta, Janumet and Otezla [4]. Five of the 25, Xtandi, Pomalyst, Ibrance, Calquence and Imbruvica, treat cancers [4, 5].

Which of the 25 actually move depends on which manufacturers apply.

What it means for your practice

You pay list price first. Under an approved plan, your organization orders the drug through its existing wholesaler account at wholesale acquisition cost, then claims a rebate equal to WAC minus the 340B ceiling price on the day of dispensing [1]. For scale, CMS listed a 2024 WAC of $959 for a 30-day supply of Ozempic, Rybelsus or Wegovy [4]. The 340B ceiling price itself is not public.

The payment clock is short. Manufacturers must pay, or deny with documentation, within 10 calendar days of a complete submission, and rebates are paid per unit rather than per full package [1]. HRSA argues this means most rebates arrive before wholesaler invoices come due. It cites an IQVIA analysis that put interest costs for entity-owned pharmacies at 0.19% under a rebate model, no higher than physical replenishment, and under 1.2% even on unfavorable assumptions [1]. Covered entities argued the opposite in comments, warning of reliance on credit for rural and safety-net providers, and HRSA acknowledged that financing costs may fall harder on smaller entities that borrow at higher rates [1].

Data goes out by claim. You have at least 45 calendar days from dispensing to submit [1]. Manufacturers may ask only for a fixed list of fields. For pharmacy claims these include the Rx and fill numbers, NDC-11, quantity, prescriber ID, 340B ID, BIN and PCN; for medical claims they include claim and line numbers, units, the rendering physician ID and the health plan name and ID [1]. Purchasing and encounter data are off limits, uninsured fills can be marked “CASH,” and the manufacturer pays for the IT platform [1].

Some denials are off the table. Manufacturers may not deny rebates over eligibility, diversion or Medicaid duplicate discount concerns, or because they think you bought too little at WAC; those disputes go to HRSA, audits or administrative dispute resolution [1]. Denials are allowed for reasons such as the negotiated Medicare price already applying to the claim or another covered entity already receiving a rebate on it [1]. HRSA says it could start removal proceedings against a manufacturer if a sample showed, for example, 5% or more of transactions delayed or denied without justification [1].

Medicaid billing changes. Each participating manufacturer must post a quarterly 340B price file by NDC-11 so you can bill Medicaid at actual acquisition cost and set sliding-fee or cost-sharing amounts at the post-rebate price [1].

What to do now

1. Inventory your exposure. Pull a year of purchase and dispensing data for the 25 drugs, split by in-house pharmacy, contract pharmacy and clinic administration [1, 4, 5].
2. Talk to your TPA. HRSA’s notice cites a vendor saying 53 third-party administrators can already send data to its rebate platform and more than 10,000 covered entities have registered [1]. Confirm whether yours is one of them.
3. Line up cash terms. Compare your wholesaler payment window with the 10-day rebate deadline, and with the 45-day submission window you will actually use [1].
4. Watch late September. HRSA plans to post approved manufacturer plans, and each manufacturer must give 90 days’ notice with platform registration instructions before switching [1].
5. Prepare the year-end handoff. Note which packages of covered drugs are partly accumulated in December, since the grace period covers only up to two unreplenished packages [1].

The policy fight

The American Hospital Association, a plaintiff in the suit against the 2025 pilot, said it is “deeply concerned” and that the notice “dramatically understates the true costs of this program” [2, 3]. AHA President and CEO Rick Pollack said the AHA “is considering all available options to prevent this flawed program from going into effect” [2].

On the other side, Jen Laws, president and CEO of the advocacy group CANN, told AJMC the pilot is “a respite to the unfortunate realities of egregious program growth” and said the transparency that opponents assume under audits “is currently nonexistent” [3]. AJMC noted that HRSA puts 340B purchases at $53.7 billion in 2022 and more than $100 billion in 2025 [3].

HRSA’s own case rests on timing. Audits and disputes, it says, find duplicate discounts only after the fact, while a rebate requires validated claims data before the discount is paid [1]. Covered entities proposed claims modifiers, a clearinghouse or more audits instead; HRSA rejected each and noted that a clearinghouse is not explicitly authorized by the 340B statute [1].

HRSA says it will publish interim findings during the pilot and a first-year evaluation by April 30, 2028 [1].