ACI Monthly – June 2026

This Month at a Glance

• State contract pharmacy protections remain volatile. Washington’s law took effect June 10, while manufacturers continued updating state exemptions in response to new laws, court rulings, and pending litigation.
• Manufacturer claims data requirements continue to expand. Eleven manufacturers have now implemented or announced claims-level data submission requirements, with GSK and Sobi being among the newest to join the trend.
• CVS lawsuits highlight contract pharmacy savings risk. Three major hospital systems allege CVS affiliates reduced reimbursement after claims were identified as 340B, raising new concerns around intermediary oversight.
• HRSA declines to appeal GPO purchasing policy ruling. The 2013 drug purchasing restrictions policy is no longer enforceable, creating potential flexibility for hospitals subject to the GPO prohibition.
• PhRMA and manufacturers continue multi-state challenges. Recent lawsuits and appeals show state 340B protections remain vulnerable even after enactment, with disputes now reaching both contract pharmacy access and reporting requirements.
• Rebate model moves back into focus. HRSA sent a proposed rebate model pilot to OMB for review, signaling the issue is active again even though scope, timing, and mechanics remain unknown.

State Contract Pharmacy Laws Enter a More Volatile Phase

State contract pharmacy protections continued to shift this period, with covered entities facing a mix of new state protections, manufacturer policy updates, and unresolved federal litigation. Washington’s contract pharmacy access law took effect June 10, while several manufacturers updated state exemptions in response to new laws and court rulings.

Washington Takes Effect

Washington’s new law prohibits manufacturers from restricting 340B contract pharmacy arrangements and bars certain data submission requirements. The law is also notable because it pairs contract pharmacy protections with reporting obligations for both covered entities and manufacturers.

Manufacturers have begun responding. GSK, Merck, and Novo Nordisk each announced Washington exemptions from certain contract pharmacy restrictions or claims data requirements. For Washington covered entities, the law may improve contract pharmacy access, but implementation should still be monitored closely because manufacturer lawsuits remain active.

Court Activity Remains Mixed

The broader legal landscape remains unsettled. Recent appellate losses in Maryland and West Virginia marked the first time federal appeals courts sided against state contract pharmacy access laws, though those decisions are being reconsidered. North Dakota’s law was also struck down at the district court level.

At the same time, courts have upheld similar laws in Arkansas, Louisiana, and Mississippi. This split means covered entities cannot assume state protections will be treated consistently across jurisdictions, and further appellate activity should be expected.

Manufacturer Exemptions Are Becoming More Fragmented

Manufacturer exemptions are becoming harder to track. Novo Nordisk expanded exemptions from its in-house and contract pharmacy claims data requirements to include several states. Bristol Myers Squibb added Missouri as a contract pharmacy exemption state, while Sobi revised its in-house pharmacy claims data exemptions after an earlier update appeared to include states without applicable protections.

These changes show how quickly manufacturer policies are shifting by state, manufacturer, pharmacy channel, and data requirement. A covered entity may be exempt from one manufacturer’s contract pharmacy restriction but still subject to another manufacturer’s in-house reporting requirement.

What This Means for CEs

Covered entities should review manufacturer policies by state, manufacturer, drug, and channel rather than relying only on whether their state has enacted a contract pharmacy law. Current contract pharmacy designations should be compared against the latest manufacturer notices, especially in states with recent litigation or newly effective laws.

CEs should also document any exemption they rely on and maintain copies of manufacturer policy notices in case access is later challenged. State protections remain important, but the operational burden now lies in monitoring how each manufacturer applies those protections in real time.

Manufacturer In-House Data Requirements Continue Expanding

Manufacturer claims data requirements tied to 340B purchases continue to expand. As discussed in our April update, this trend began with a smaller group of manufacturers but has accelerated quickly. As of June 2026, eleven manufacturers have now implemented or announced claims-level data submission requirements, including several that extend beyond contract pharmacy claims and into in-house pharmacy utilization.

Claims Data Timeline

The current manufacturer timeline now includes Exelixis, Eli Lilly, Novo Nordisk, AstraZeneca, Bristol Myers Squibb, Biogen, UCB, Amgen, Sanofi, GSK, and Sobi. Effective dates range from October 2025 through July 2026, with GSK and Sobi among the newest manufacturers to join the trend.

Covered entities should review each manufacturer’s policy directly to confirm current requirements, submission timing, state exemptions, and impacted products. Policy details continue to change quickly and should not be assumed consistent across manufacturers.

Why This Matters

For covered entities, these requirements create a growing operational and compliance burden. Submitting claims data may require coordination across TPAs, contract pharmacies, in-house pharmacies, billing systems, wholesalers, and compliance teams.

This becomes especially complex when requirements extend beyond traditional contract pharmacy claims and into mixed-use, in-house, or medical benefit workflows. Covered entities may need to determine where each required data element lives, who is responsible for preparing the submission, and how the organization will document decisions around data sharing.

Policy Details Remain Manufacturer-Specific

Although these policies are part of a larger trend, the details are not identical across manufacturers. Effective dates, required data fields, submission timelines, impacted products, and state exemptions may vary. Covered entities should avoid applying one manufacturer’s requirements across the board. Each policy should be reviewed separately, especially when determining whether a requirement applies to a specific covered entity, contract pharmacy arrangement, in-house pharmacy, or medical benefit workflow.

What Covered Entities Should Do Now

Covered entities should maintain a current tracking process for manufacturer requirements, including:

• Effective dates and first submission deadlines
• Impacted products and required data fields
• State exemptions and submission cadence
• Vendor responsibilities and internal documentation of data-sharing decisions

The continued expansion of claims data requirements shows this is becoming a broader manufacturer strategy, not a short-term exception.

For more information on these requirements, please see our April and June blog posts. The June update includes direct links to manufacturer policies for review. Manufacturer policies can also be accessed through the 340B ESP website.

CVS Lawsuits Highlight Contract Pharmacy Savings Risk

Manufacturer restrictions continue to dominate 340B headlines, but recent lawsuits against CVS Health and its affiliates highlight another major financial risk for covered entities: whether contract pharmacy savings are being retained as expected.

Three major hospital systems recently filed separate federal lawsuits accusing CVS Health, Caremark, Wellpartner, and CVS Specialty of reducing reimbursement on claims after they were identified as 340B eligible. The lawsuits allege these diverted savings that should have flowed back to the covered entities.

The allegations place contract pharmacy financial performance under a different kind of scrutiny. Even when a covered entity has access to contract pharmacy arrangements, the value of those arrangements depends on reimbursement mechanics, fee structures, adjudication behavior, and reconciliation accuracy.

Large Alleged Losses

The lawsuits allege substantial financial harm. The University of Michigan Hospitals and Health Centers estimated more than $66 million in losses, the University of Kansas Hospital Authority estimated more than $61 million, and the Mt. Sinai hospitals estimated more than $121 million in combined losses. CVS has not commented on the substance of the litigation, and the allegations have not been resolved.

A Broader Intermediary Risk

The 340B contract pharmacy model depends on multiple intermediaries, including pharmacies, PBMs, TPAs, wholesalers, and sometimes specialty pharmacy networks. Manufacturer restrictions may limit which pharmacies can be used, but reimbursement terms, pharmacy agreements, and reconciliation processes determine how much value is ultimately retained.

This issue is especially important as manufacturers increasingly point to PBMs, chain pharmacies, and vendors as evidence that 340B savings are not always reaching providers or patients. Provider-side lawsuits against intermediaries may complicate that narrative, but they also reinforce the need for covered entities to understand their own contract pharmacy economics in detail.

What CEs Should Review

Covered entities should review whether contract pharmacy savings are being calculated and remitted as expected. This includes monitoring reconciliation reports, reimbursement trends, pharmacy-level performance, fee structures, reversals, and any changes after claims are identified as 340B. CEs should also confirm contracts include clear audit rights and dispute mechanisms, especially for high-volume pharmacy partners.

What This Means for CEs

Contract pharmacy risk is not limited to manufacturer access. Covered entities should monitor both sides of the arrangement: whether drugs can be accessed at 340B pricing and whether the resulting savings are actually retained by the CE. Routine profitability review, claims-level reconciliation, and contract term review should be part of ongoing 340B program management, especially for high-volume pharmacies and specialty arrangements.

Hospital Purchasing Flexibility Expands After HRSA GPO Policy Ruling

Hospitals received a significant operational win this period after HRSA declined to appeal a federal court ruling that struck down the agency’s 2013 drug purchasing restrictions policy. The decision ends enforcement of a policy that many hospitals argued created unnecessary cost and administrative burden when purchasing initial outpatient drug inventory.

The underlying issue involves the 340B statute’s group purchasing organization, or GPO, prohibition. Certain 340B hospitals are prohibited from purchasing covered outpatient drugs through both the 340B program and a GPO at the same time. HRSA’s 2013 policy interpreted that prohibition in a way that often required hospitals to use higher-cost wholesale acquisition cost accounts before drugs were eligible for 340B replenishment.

What Changed

A Washington D.C. federal court struck down the 2013 policy in March. HRSA had until June 1 to appeal but did not do so, meaning the policy is no longer enforceable. This does not eliminate the statutory GPO prohibition. Hospitals subject to the prohibition must still ensure they are not purchasing covered outpatient drugs through a GPO in a way that violates the 340B statute. However, the ruling may create greater flexibility in how hospitals purchase initial outpatient drug inventory.

Operational Impact for Hospitals

The most immediate impact is financial. Hospitals may now have more flexibility to avoid purchasing certain initial inventory through higher-cost WAC accounts when another compliant purchasing path is available. For hospitals with significant outpatient drug spend, this could reduce costs tied to new drugs, new locations, or inventory setup. The decision may also reduce administrative burden by simplifying some purchasing workflows across 340B, GPO, and WAC accounts. However, changes should be made carefully and documented before workflows are updated.

Why Caution Is Still Needed

HRSA’s decision not to appeal does not mean the agency has abandoned oversight of GPO prohibition compliance. HRSA could still issue future guidance or pursue a new policy through a different process. Any changes to purchasing practices should be reviewed with legal counsel, pharmacy leadership, finance, and compliance. Internal policies should be updated before workflows change, and purchasing decisions should remain well documented.

What This Means for CEs

Hospitals subject to the GPO prohibition should review current WAC-first purchasing practices, split-billing logic, inventory workflows, and policies for new drug additions. The ruling may create meaningful flexibility, but it also places responsibility back on hospitals to ensure their interpretation of the statute is defensible. For hospitals managing tight pharmacy margins, this is an opportunity to reassess whether current purchasing practices are more restrictive than legally required while maintaining strong documentation and purchasing account controls.

PhRMA and Manufacturers Continue Challenges to 340B Laws

As more states enact 340B contract pharmacy protections, PhRMA and individual manufacturers continue using litigation as the primary tool to slow or block implementation. Recent activity includes lawsuits and appeals involving Washington, Maine, Rhode Island, Utah, and other states, with arguments focused on federal preemption, manufacturer pricing rights, and limits on state authority.

The strategy is no longer limited to challenging contract pharmacy access requirements. In Washington, PhRMA and manufacturers also challenged manufacturer reporting requirements, while the state’s law separately bars claims data submission requirements not mandated under federal law. That makes these lawsuits relevant not only for contract pharmacy access, but also for the expanding manufacturer claims data trend.

Covered entities should view state 340B laws as important but not final protection. Even when a law is enacted, litigation, appeals, enforcement delays, and manufacturer policy updates can affect whether protections are available in practice. CEs should continue monitoring manufacturer notices, state enforcement activity, and court developments before relying on a state law exemption or access pathway.

Current Status on State Bills and Laws That Prohibit Drugmaker 340B Contract Pharmacy Restrictions

*States in Bold are the newest updates.

Rebate Model Watch: HRSA Sends Proposal to OMB

The 340B rebate model debate moved forward again this period after HRSA sent a proposed rebate model pilot to the White House Office of Management and Budget for review. The proposal has not yet been released publicly, but the submission marks the first major step toward a new rebate model since stakeholder comments closed in April.

Hospitals successfully challenged the original pilot, with courts finding that HRSA had not adequately addressed administrative law requirements or potential financial harm.

HRSA has since attempted to build a stronger record, receiving more than 5,500 stakeholder comments in response to its rebate model request for information. The agency has also continued to reference a possible pilot tied to Medicare-negotiated drugs in 2026 and 2027.

Where Things Stand

A rebate model has not been finalized, and covered entities do not yet know the scope, timing, drug list, submission process, or reimbursement mechanics of any new pilot. However, OMB review signals the issue is active again and could move from policy debate back into implementation planning.

Even a limited pilot would create practical questions for covered entities, including how rebate claims would be submitted, how quickly reimbursement would occur, how disputes would be handled, and what documentation would be required to prove eligibility.

Claims Data and Rebate Policy Are Converging

The rebate model debate is not happening in isolation. Manufacturer claims data requirements are expanding at the same time, including into in-house pharmacy utilization. Kalderos’ Truzo platform, 340B ESP, and other vendor systems are becoming central to how manufacturers administer contract pharmacy restrictions, data submissions, and potential rebate models. This creates a broader trend toward more data-driven and manufacturer-monitored 340B activity. Covered entities are increasingly being asked to submit claims data not only for contract pharmacy dispenses, but also for owned pharmacy activity and potentially broader healthcare service information.

What This Means for CEs

Covered entities should begin preparing now by identifying exposure to Medicare-negotiated drugs, estimating cash flow impact under a purchase-now/rebate-later structure, and evaluating whether internal teams could handle additional claims submission and reconciliation requirements.

CEs should also assess data governance. Manufacturer data requirements and any federal rebate model will likely depend on claims-level information, so covered entities should know where that data lives, who validates it, which vendors touch it, and what controls exist before submission.

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