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The recent 340B Coalition Winter Conference brought together over 1700 program stakeholders in San Diego to take the pulse of a program at a critical crossroads. From federal policy shifts and litigation fallout to state-level contract pharmacy victories and operational pressures from overlapping pricing reforms, the 340B landscape in 2026 is as dynamic and consequential as ever.
Here’s what 340B covered entities (CEs) and industry partners need to know going into the rest of the year.
Rebate Model Pivot
The biggest policy headline of the conference was the administration’s withdrawal of its original controversial 340B Rebate Model Pilot Program. The pilot proposed a fundamental change in how CEs access 340B pricing by requiring drugs to be purchased at full market price upfront and reimbursed later through manufacturer rebates, rather than receiving the 340B discount at the point of sale. The model was expected to go into effect in January 2026 but was blocked by the courts after provider groups successfully argued that HHS did not follow the administrative procedures required to impose such a sweeping structural change. That legal setback ultimately influenced the administration’s decision to halt the appeals process and return to the drawing board to pursue a new rebate model through a more formal regulatory process.
While the courts’ decision forced a pause to the pilot as originally structured, it’s clear this is not the end of the rebate model conversation—only a reset. Just one day after formally withdrawing the pilot that had been blocked by federal courts, the U.S. Department of Health and Human Services (HHS) initiated regulatory review of a potential new 340B rebate rule. Just two days later, HHS published a Request for Information on a possible new pilot program. In other words, the litigation outcome likely did not eliminate the policy direction—it simply required HHS to slow down, follow a more formal path and attempt to build a stronger legal foundation for a rebate-based pricing structure.
In anticipation of this development, Capitol Hill is already moving to try to stop rebate implementation. A bipartisan House bill was introduced to protect community health centers and FQHCs from any forced participation in a 340B rebate model and another bill may be introduced to expand the protections to other CE types.
While limited in its current scope, this legislative effort reflects a growing congressional appetite to carve out protections for safety-net providers even if rebate rules advance.
Contract Pharmacy Access: Court Wins Keep Momentum Alive
One of the most uplifting themes for CEs was the continued momentum behind contract pharmacy access laws at the state level—and the federal courts upholding them.
Most recently, the U.S. Court of Appeals for the Fifth Circuit unanimously upheld Louisiana’s contract pharmacy access law, a significant judicial signal that state protections against manufacturer restrictions can survive legal scrutiny.
Across multiple sessions, speakers emphasized that state contract pharmacy protections have become one of the most effective levers to safeguard access in the face of restrictive manufacturer policies. In 2025 alone, 13 additional states passed 340B legislation with several more set to introduce new legislation this year, underscoring the appeal of state protections action as a powerful tool.
Manufacturer Data and Pricing Policies Are Evolving
Even as the federal rebate discussion pivots, manufacturers are increasingly shaping day-to-day 340B practice through claims-level data requirements and evolving access conditions. Conference discussions repeatedly pointed to Eli Lilly’s expansion of its 340B claims data policy, which now requires detailed claims submission tied to pricing access, including for in-house pharmacy dispenses—a move many stakeholders view as a significant operational escalation. Lilly’s new medical claims requirements mirror those requested as part of the now-abandoned rebate pilot – a source of confusion and a weighty application for entities to comply within a limited period.
Speakers noted that Lilly’s approach has not occurred in isolation. Exelixis has unveiled similar data demands with other manufacturers expected to follow suit, reinforcing a broader industry trend in which access to 340B pricing is increasingly conditioned on the submission of granular claims data. CEs warned these requirements create meaningful administrative burden, introduce new compliance risk, and complicate cash-flow management, particularly for entities operating in multiple pharmacy settings.
Layered on top of these manufacturer-driven changes are federal drug pricing reforms, including the Medicare Maximum Fair Price (MFP) provisions under the Inflation Reduction Act. Together, these developments mean CEs are now navigating multiple, overlapping pricing and reporting regimes at once, requiring substantial system, staffing, and workflow adjustments.
How far manufacturers continue to push claims-data requirements—and whether HRSA intervenes or provides clarity—will be central to 340B operations and compliance strategy throughout 2026.
OPPS Drug Acquisition Cost Survey Could Signal Payment Shifts
Another hot topic at the conference was CMS’s Outpatient Prospective Payment System (OPPS) drug acquisition cost survey, which many participants see as groundwork for potential reimbursement changes down the line.
CMS opened this survey with a March 31, 2026 deadline, asking hospitals to report drug acquisition costs. A recent pushback from hospital groups suggests fierce debate over whether survey participation is mandatory and what future reimbursement policy will look like.
Responses to this survey could underpin CMS’s efforts to recalibrate outpatient drug payments—possibly with implications for 340B hospital revenue streams.
Dual Price Reforms: 340B and Maximum Fair Price Must Be Aligned
Many sessions underscored the real-world friction between MFP pricing under the IRA and 340B ceilings. With both frameworks seeking to cap what is paid for drugs, CEs must carefully manage “lower of” pricing strategies while ensuring operational integrity and cash-flow balance. This will be consequential for CEs and community pharmacies alike, posing a threat to solvency of the latter, and once again, threatening upheaval of the delicate safety net existing today.
The industry is still learning how MFP refunds and 340B discounts intersect and what systems must change to handle these dual pricing constraints.
Final Thoughts
The coalition conference underscored a clear reality: the program is entering a period of accelerated change, driven as much by manufacturer policy as by federal regulation. While the rebate model pilot was halted by the courts, HHS’s rapid move to initiate regulatory review of a possible new rebate program signals the administration’s commitment to pursuing a rebate-based structure is likely far from over.
At the same time, manufacturers are escalating claims-level data requirements, adding new compliance and operational burdens. With federal policy still unsettled, state contract pharmacy protections and recent court wins remain one of the most significant sources of momentum—and one of the most closely watched battlegrounds heading into the rest of 2026.
Anne Marie Hunt is director of 340B Operations at Cervey. She can be reached at ahunt@cervey.com.
