2026 will reshape how drugs launch, grow, and defend value in the US. Policy stacking across Medicare, Medicaid, and 340B, plus new data and enforcement infrastructure, means concessions, unit definitions, and channel moves will travel farther and faster. We map six intersections tightening the system and what manufacturers should pressure-test now to protect their launch, lifecycle, and gross-to-net decisions to avoid downstream rebate, ceiling, and reimbursement surprises.
Drug pricing has always been interconnected across the economics of Medicare, Medicaid, and 340B, but manufacturers could still plan as if channels were semi-separate. That era is over. Not because any single rule overhauls pricing, but because 2026 kicks off a period when multiple effective dates converge, and policymakers are building the infrastructure to observe and enforce the interactions with more precision.
Medicare negotiation (with the first negotiated prices effective in 2026 and Initial Price Applicability (IPAY) 2028 underway representing the first year for Part B negotiated drugs), Inflation Reduction Act (IRA) inflation-adjusted rebates, Part D redesign, 340B policy shifts, and new payment model tests are landing close enough together that they will start interacting in practice, turning Medicaid from a downstream consequence into a pressure multiplier as other programs begin to anchor net price.
In that environment, every decision matters. Unit definitions can reshape rebate math; rebate structure can expand Best Price exposure and tighten downstream ceilings; acquisition-cost visibility is already influencing reimbursement design; and benchmarking plus model tests are resetting net-price expectations across public programs. The result: a system that is more tightly coupled and more observable.
The six intersections doing the most to tighten the coupling
1. Concession topology, where the discount lives.
The first inflection point isn’t whether a product is “in” or “out” of Medicaid, it’s how value is delivered, and whether it’s structured to spill over across programs. The GENEROUS Model (GENErating cost Reductions for US Medicaid) highlights this shift by using CMS-led negotiation and supplemental rebates to participating states, aligning Medicaid net prices with international benchmarks for covered outpatient drugs.
Because rebates paid to State Medicaid agencies under the Medicaid Drug Rebate Program (MDRP), including CMS-authorized supplemental rebate agreements under section 1927, are excluded from Best Price, GENEROUS can deliver MFN-aligned net price moves via supplemental rebates without automatically resetting Best Price.
2. Best Price and ASP risk concentrate in commercial leakage.
If GENEROUS creates a more insulated lane for Medicaid-specific net-price moves, it also sharpens the contrast with the real risk center: commercial constructs that leak unintended price signals. In a more observable system, Best Price is less likely to be tripped by a headline discount than by sloppy mechanics, chargebacks that behave like concessions, specialty pharmacy “service” payments that blur into price, or patient affordability designs that aren’t cleanly segregated.
And the spillover isn’t just Medicaid: CMS’s CY 2026 Medicare Physician Fee Schedule (MPFS) final rule tightens the standard for excluding bona fide service fees from Part B Average Sales Price (ASP), increasing the odds that loosely governed service payments get treated as price concessions.
3. Unit-level truth arrives in Part D.
Starting January 1, 2026, 340B units must be excluded from Medicare Part D inflation rebate calculations, reducing inflation-rebate exposure but forcing end-to-end traceability that links 340B status to Part D claims. This is an area that has historically been operationally difficult for manufacturers.
The requirement is bigger than a compliance task alone. It moves the system toward unit-level reconciliation. When “what happened” is defined at the unit-by-unit level, strategies that rely on ambiguity no longer hold up.
4. 340B shifts from front-end discounting toward settlement.
Health Resources and Services Administration’s (HRSA) 340B Rebate Model Pilot (announced as voluntary for 2026-selected drugs but currently paused due to litigation) is another signal of direction. The economics of 340B increasingly hinge on segregation, settlement, and auditability.
In rebate settlement, the manufacturer's problem is less “how much” and more “how clean”, what gets tagged, what gets reconciled, and what disputes (or unintended erosion) appear outside the intended channel.
5. Acquisition cost becomes an input, not an argument.
By collecting NDC-level, net-of-rebates outpatient drug acquisition costs via the Outpatient Prospective Payment System (OPPS) Drug Acquisition Cost Survey (due March 31, 2026), CMS is turning “spread” from anecdote into a measurable dataset that can be modeled. This is a quiet turning point that shifts payment, contracting, and channel strategy accordingly.
6. MFN-style benchmarking and next-gen models move into Medicare’s baseline.
Proposed models like Global Benchmark for Efficient Drug Pricing (GLOBE) Model (Part B) and Guarding US Medicare Against Rising Drug Costs (GUARD) Model (Part D) would assess rebates when US prices exceed those in economically comparable countries, importing Most Favored Nation (MFN)-style pressure into Medicare lanes over multi-year time horizons.
Beyond benchmarking, CMS and Center for Medicare & Medicaid Innovation (CMMI) have long been signaling additional model concepts in high-spend categories, including the newly-named, BALANCE, a GLP-1 access model, and long advancing other innovation models, such as the Cell & Gene Therapy (CGT) Access Model and total-cost of-care approaches in areas like oncology (EOM), cardiology (ASM), and other areas that can pressure drug economics indirectly through utilization, site-of-care, and pathway design, even when framed as “pilots.”
The way forward
The implication for manufacturers is clear: US drug pricing strategy can’t be optimized one program at a time. Launch sequencing, discount architecture, NDC strategy, and channel contracting now reverberate across a system built to reconcile the whole picture. The “so what” is practical: you need to design and test concessions, units, and channels for how they travel across programs before they show up as higher rebates, tighter ceilings, or distorted reimbursement.
We invite you to connect with us and our team at Simon-Kucher to map the relevant policy stack to your product and channel strategy, stress-test your pricing and contracting plans, and quantify cross-program exposure through scenario modeling so you can move from policy fluency to precision-driven actions at launch or in-market.
This is an opening installment of a short series. Next, we’ll go deeper on (1) concession topology and commercial leakage, (2) unit-level truth and 340B settlement mechanics, and (3) measurement and models: how acquisition-cost datasets and benchmarking change the operating system for pricing strategy.
