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  • D.C. Circuit Affirms HHS Authority Over 340B Rebate Models
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D.C. Circuit Affirms HHS Authority Over 340B Rebate Models

The D.C. Circuit stripped Eli Lilly, Novartis, Sanofi, Bristol Myers Squibb, and Kalderos of the power to impose 340B rebate models without HHS approval, handing the Secretary control of the program just as HRSA's own rebate framework nears publication.
pharminent July 24, 2026

Market Access Intelligence — July 24, 2026

The D.C. Circuit stripped Eli Lilly, Novartis, Sanofi, Bristol Myers Squibb, and Kalderos of the power to impose 340B rebate models without HHS approval, handing the Secretary control of the program just as HRSA’s own rebate framework nears publication and Drug Channels documents a net-pricing era taking hold across major manufacturers.

Today’s top developments:

  • D.C. Circuit affirms HHS authority to approve or block manufacturer 340B rebate models, rejecting the consolidated Lilly/Novartis/Sanofi/BMS/Kalderos appeal (Fierce Healthcare)
  • Drug Channels’ gross-to-net review of eight top drugmakers finds net prices fell at seven of eight — list prices up 3.7% but net prices down 1.8% (Drug Channels)
  • White House holds its “last scheduled” meeting on HRSA’s 340B rebate pilot, signaling an imminent rebate-framework publication (340B Report)
  • PCMA publishes its implementation framework for the enacted CAA 2026 PBM reforms, previewing the industry’s regulation-shaping playbook (PCMA)

What to Watch

  • HRSA rebate framework publication — With the D.C. Circuit ruling out unilateral manufacturer implementation and the White House concluding its stakeholder-meeting cycle, watch whether HRSA’s revised rebate framework arrives before Cassidy’s August 28 comment deadline, whether it incorporates the AHA’s burden critique of the earlier five-hour-per-week estimate, and how narrowly it scopes participation to limit litigation exposure.
  • Tampa General v. Lilly — The appellate precedent that manufacturers cannot enforce rebate models without HHS approval strengthens the hospital argument that Lilly’s wholesaler-block mechanism operates outside statutory authority; watch for an amended complaint, additional cut-off hospitals joining, or Lilly softening enforcement ahead of the first Middle District of Florida hearing.
  • CMS 2028 MFP draft guidance — The comment window on the Manufacturer Effectuation of Maximum Fair Price draft guidance is the next operational milestone in the Medicare Drug Price Negotiation cycle; manufacturer effectuation mechanics will set the template for how negotiated prices flow through the channel from 2028 onward.
  • Pre-recess legislative sprint — The July 15 House Ways and Means markup, advancing biosimilar bills, and price-transparency and prior-authorization measures are all compressed into the window before the August recess, framing how CAA 2026 implementation and competing 340B reform vehicles get reconciled this quarter.

This brief highlights the edition’s top stories. Read the full July 24, 2026 edition → for all stories and analysis — or browse the Market Access archive.

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