Drugmakers face Thursday deadline to opt into 340B rebate model
Jul 17, 2026 – Aug 23, 2026
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AHA disputes HRSA burden estimate for new 340B rebate pilot program
The American Hospital Association filed comments disputing HRSA's estimate of the administrative burden that its proposed 340B Rebate Model Pilot Program would place on hospitals.
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HRSA expands 340B rebate pilot to 25 drugs as court curbs drugmaker rebate models
HRSA's revised 340B Rebate Model Pilot Program grew from about 10 drugs and eight manufacturers to as many as 25 products from 13 companies, days after a federal appeals court ruled Novartis, Johnson and Johnson Health Care Systems, Bristol Myers Squibb and Eli Lilly cannot run their own rebate models without HHS approval.
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HRSA revives 340B rebate pilot with August 24 opt-in deadline for drugmakers
HRSA's second attempt at a 340B rebate model, after a 2025 version was withdrawn following a hospital lawsuit, requires manufacturers of drugs in Medicare's price negotiation program to file rebate plans by August 24 for approvals expected by September 24 and an effective date of January 1, 2027.
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Bipartisan Senate bill would terminate HRSA's 340B rebate pilot within a year
Six senators introduced the SUSTAIN 340B Act on August 5, 2026, which would kill HRSA's rebate-based 340B overhaul within one year of enactment and replace it with an independent data clearinghouse, threatening the pilot's August 24 manufacturer opt-in deadline.
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HRSA revives 340B rebate pilot, sets manufacturer deadline
HRSA republished its 340B Rebate Model Pilot Program in the Federal Register, giving drug manufacturers until August 24, 2026 to opt in ahead of a January 1, 2027 launch, with no exemption this time for critical access or children's hospitals.
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Drugmakers face Thursday deadline to opt into 340B rebate model
HRSA's revived 340B Rebate Model Pilot Program requires manufacturers of drugs in the Medicare Drug Price Negotiation Program to submit participation plans by August 24, with approved switches to after-sale rebates taking effect January 1, 2027.
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