Market Access Intelligence

340B 4th Circuit vacates Maryland's 340B contract pharmacy law, creating circuit split with 5th Circuit—Supreme Court petition now a question of when, not whether

340B Report reported (April 14) that a split 4th Circuit panel overturned a Maryland district court ruling that had allowed the state to enforce its 340B contract pharmacy access law. The appeals court cited its recent ruling that West Virginia's similar statute is likely preempted by federal law, extending the preemption logic to a second state within the same circuit. Law360 noted that the decision came just days after the 5th Circuit, on April 10, rejected two more manufacturer challenges to Mississippi's 340B contract pharmacy law—creating a direct split between the 4th and 5th Circuits on whether states can require manufacturers to honor 340B pricing at contract pharmacies. The AHA, 340B Health, the Maryland Hospital Association, and ASHP had filed amicus briefs supporting the state law.

340B 1,100+ identical comments flood HRSA's 340B rebate RFI, all linked to pharma-funded patient group—manufactured consensus in the public record

340B Report revealed that more than 1,100 identical public comments supporting 340B rebates were submitted to HRSA's Request for Information on the 340B rebate model, all traceable to a pharma-funded patient advocacy group. The comment flooding represents an attempt to manufacture the appearance of grassroots support for the rebate model that manufacturers prefer. HRSA's RFI, which has an April 20 deadline, seeks input on whether rebates can legally replace upfront discounts as the mechanism for effectuating 340B ceiling prices—a structural change that would fundamentally alter how covered entities capture 340B savings.

Policy Senate HELP hearing on drug pricing features two witnesses critical of 340B—Congressional scrutiny intensifies as courts splinter

340B Report noted (April 14) that the Senate HELP Committee scheduled a drug pricing hearing this week featuring two witnesses who have publicly criticized the 340B program. The hearing represents a shift in Congressional tone: earlier HELP hearings in 2025 focused primarily on PBM reform and manufacturer pricing behavior, while the 2026 hearing expands the lens to include the 340B program as a potential target for reform. The witness selection signals that the committee is exploring whether 340B hospital markups and contract pharmacy arrangements contribute to drug spending—a framing that aligns with PhRMA's longstanding advocacy position.

FORMULARY & BIOSIMILARS

• 340B AstraZeneca requires 340B in-house pharmacy data submissions from all covered entities (April 14) — AstraZeneca announced plans to require all 340B providers to submit claims data on 340B use at in-house pharmacies, joining Pfizer, Novo Nordisk, and others who have imposed similar attestation and data requirements. The escalating data demands create cumulative compliance burdens for covered entities that must now manage different submission formats, deadlines, and attestation requirements across multiple manufacturers simultaneously.
• Pricing Health Affairs: IRA Part D redesign producing lower premiums, higher deductibles, and smaller formularies (April 2026) — Analysis confirms the predicted tradeoff from the $2,000 out-of-pocket cap and restructured catastrophic coverage: plans are adjusting benefit design to absorb the new financial architecture. Watch which therapeutic categories face formulary contraction as plans optimize around the cap, particularly specialty drugs where per-claim costs push beneficiaries into the redesigned benefit phases faster.
• Policy PCMA: 100% rebate pass-through is now the market baseline — PCMA's analysis argues that both competitive pressure and the CAA 2026 have made full Part D rebate pass-through the standard operating model. The memo implicitly concedes that the pre-reform rebate retention model is dead while positioning PBMs as having led the transition voluntarily—a narrative that will be tested against the August 2028 delink compliance deadline and the House E&C reconciliation provisions targeting commercial spread pricing.

PRICING & REIMBURSEMENT

• Pricing Drug Channels: IRA list-price cuts deflating gross-to-net bubble—and 340B margins — DCI's analysis documents that six of the first 10 IRA-negotiated products have reduced their WAC by approximately half, with three more preemptive cuts for 2027–2028. The IRA's non-duplication provision further limits 340B by preventing manufacturers from providing both a 340B discount and a Maximum Fair Price on the same claim. Fein argues this resolves hospitals' main objection to the rebate model: once the WAC-to-340B gap shrinks, rebate financing burdens become trivial.
• Pricing Health Affairs: European view on MFN and value-based pricing (April 2026) — Analysis examines how U.S. MFN policies could cascade into European reference pricing systems as confidential net prices become visible through government programs. European HTA bodies may adjust benchmarks if U.S. MFN prices emerge as reference points, compressing global launch pricing corridors for manufacturers planning multi-market strategies.
• Policy PCMA calls on DOL to rescind commercial PBM transparency rule — PCMA argues the DOL's proposed rule requiring per-drug remuneration disclosure for self-insured employer plans is duplicative of CAA 2026 provisions and would harm PBM competitiveness. This defensive posture mirrors PCMA's March filing but comes as the House E&C reconciliation bill adds commercial spread pricing provisions—if both the DOL rule and reconciliation provisions advance, PBMs face transparency mandates across every market segment.

POLICY & REGULATORY

• 340B PhRMA files third lawsuit against Washington state's 340B contract pharmacy law (April 16) — PhRMA sued in Seattle federal court to block Washington's law prohibiting manufacturers from restricting contract pharmacy access, the third legal challenge to the statute. Washington's law was among the first enacted in the current wave of state contract pharmacy protections. Three separate lawsuits against a single state law—from PhRMA, individual manufacturers, and industry coalitions—reflect the intensity of the legal campaign against state-level 340B protections.
• 340B Circuit split deepens: 5th Circuit upholds Mississippi law (April 10) while 4th Circuit vacates Maryland law (April 14) — Within four days, two federal appeals courts reached opposite conclusions on the preemption question. The 5th Circuit rejected Novartis and PhRMA challenges to Mississippi's statute; the 4th Circuit overturned Maryland's. The split now encompasses multiple circuits: 4th Circuit (preemption), 5th Circuit (state law upheld), with the 8th Circuit (Minnesota) and Hawaii district court also upholding state laws. Supreme Court certiorari petition is the logical next step.
• Policy Senate HELP drug pricing hearing features 340B critics (April 14) — The committee's witness selection signals expanding Congressional scrutiny of 340B alongside PBM reform, creating potential legislative pathways for either strengthening or restricting the program. 340B Report noted that a separate Senate Committee witness called for replacing 340B entirely with a direct subsidy program—the most structurally radical proposal yet advanced in a Congressional forum.
• Policy RFK Jr. faces Congressional hearings on HHS budget, MAHA agenda, and drug pricing — STAT News reported that HHS Secretary Kennedy faces a marathon of hearings balancing the MAHA agenda with Trump administration priorities on drug pricing, including the MFN framework, TrumpRx expansion, and the proposed shift of 340B from HRSA to CMS oversight. The hearings come as the FY27 budget request maintains current OPA funding while proposing the structural transfer that would place 340B under the same agency administering Medicare drug negotiation.

WHAT TO WATCH NEXT

HRSA 340B rebate RFI comment deadline—April 20

The final days for substantive comment submission on HRSA's Request for Information on the 340B rebate model. With 1,100+ pharma-funded identical comments already in the record, individual substantive submissions from covered entities, patient advocates, and independent analysts carry disproportionate weight. HRSA's decisions on whether rebates can replace upfront discounts—and which drugs would be subject to a rebate model in 2026–2027—will be informed by this record. The RFI also signals that HRSA is considering expanding the rebate pilot to cover IRA-negotiated drugs, which would further compress 340B margins on the highest-spend products.

Supreme Court certiorari dynamics—4th/5th Circuit split

The circuit split on state contract pharmacy law preemption creates the strongest basis for Supreme Court review in the program's history. Either manufacturers (seeking national preemption) or covered entities/states (seeking to preserve state protections) could petition for certiorari. The timing of a petition depends on whether additional circuits weigh in first—the 8th Circuit's Minnesota ruling and pending actions in other circuits could deepen or narrow the split. A cert petition filed in late 2026 could produce a Supreme Court decision by mid-2027, creating either a national standard protecting state laws or a federal preemption ruling that unravels the entire state-level protection framework.

House E&C reconciliation markup—PBM spread pricing provisions

The Energy & Commerce Committee's reconciliation markup will test whether PBM spread pricing disclosure requirements can survive the Byrd rule's budget-relevance test. If spread pricing provisions remain, they create the first federal mandate for commercial PBM transparency, complementing the CAA 2026 Part D reforms. Combined with the DOL's proposed per-drug remuneration rule (which PCMA is fighting to rescind), successful reconciliation provisions would leave PBMs facing transparency mandates across Part D, commercial, and self-insured employer markets simultaneously.