Novo Nordisk Joins Eli Lilly in 340B Data Demands, Sparking Hospital Backlash & AHA Plea to HRSA

The ongoing battle over the 340B drug discount program has escalated, with hospitals urging federal regulators to intervene as pharmaceutical companies implement new, data-intensive requirements for participation. The American Hospital Association (AHA) is raising concerns that these policies, recently adopted by both Eli Lilly and Novo Nordisk, place an undue burden on hospitals and could ultimately limit access to crucial medications for vulnerable patients. This latest development adds another layer of complexity to a program already fraught with legal challenges and political maneuvering.

The 340B program, established in 1992, requires drug manufacturers to provide outpatient drugs to eligible healthcare organizations – primarily hospitals serving low-income and uninsured populations – at significantly reduced prices. The program’s intent is to stretch scarce federal resources and allow providers to offer more affordable care. However, in recent years, pharmaceutical companies have increasingly scrutinized the program, alleging that hospitals are misusing the discounts and failing to pass savings on to patients. This has led to a series of disputes, lawsuits and proposed policy changes, creating considerable uncertainty for both hospitals and drugmakers.

Expanding Data Demands Spark Controversy

The current dispute centers around new requirements from Eli Lilly, announced in January, and now mirrored by Novo Nordisk, mandating that hospitals submit detailed claims data for all drugs purchased through the 340B program. According to a letter from the AHA to the Health Resources and Services Administration (HRSA) on March 3, 2026, these requirements are “onerous” and create significant administrative hurdles for hospitals. The AHA argues that the data collection process is complex, prone to errors, and will necessitate substantial investment in staff time and resources. The AHA further contends that the costs associated with compliance could effectively negate the discounts offered through the 340B program, undermining its core purpose.

Novo Nordisk confirmed its new policy in a notice released on Monday, stating that it requires providers to submit claims data for all 340B drugs dispensed, including those distributed through in-house and contract pharmacies, effective April 1, 2026. A spokesperson for Novo Nordisk clarified that the policy does not alter eligibility for 340B pricing or limit the quantity of drugs purchased, but rather seeks to obtain the same claims-level data already routinely submitted to third-party vendors. Details of the Novo Nordisk policy are available on the company’s website.

Drugmakers Cite Transparency and Fraud Prevention

Pharmaceutical companies defend the new data requirements as a necessary step to improve transparency within the 340B program and prevent fraud, abuse, and duplicate discounts. Eli Lilly, in a letter to HRSA, stated that the changes are consistent with decades of regulatory guidance allowing manufacturers to request information to ensure proper program utilization. Lilly’s full response to the AHA is available in a press release. The company argues that collecting this data does not impose new burdens on providers, as the information is already collected and submitted to insurers for billing purposes. However, the AHA disputes this claim, citing issues with the vendor used for data submission and the potential for costly errors.

A History of Legal Battles and Policy Shifts

The 340B program has been the subject of numerous legal challenges in recent years. In 2024, several drug manufacturers attempted to shift to an after-the-fact rebate model for 340B drugs, rather than providing upfront discounts. This move was met with resistance from hospitals and ultimately led to lawsuits against the HRSA when the agency blocked the manufacturers’ attempts. Sanofi’s lawsuit against the HRSA exemplifies this conflict.

The Trump administration too proposed a voluntary rebate program for 340B drugs, but this initiative was also challenged in court by hospitals. The HHS ultimately scrapped the pilot program in February 2026, following legal pressure from the AHA. The HHS decision to abandon the pilot program was reported by Healthcare Dive. These legal battles underscore the deep divisions surrounding the 340B program and the challenges of finding a sustainable path forward.

Impact on Safety-Net Hospitals and Patient Access

The AHA argues that the 340B program is a vital lifeline for safety-net hospitals, enabling them to provide affordable care to vulnerable populations. These hospitals often serve a disproportionate share of uninsured and low-income patients, and the 340B discounts allow them to offer free or reduced-cost medications. The AHA fears that the new data requirements, and the associated administrative costs, will jeopardize the financial stability of these hospitals and ultimately limit patient access to essential medications. The organization contends that the program’s benefits extend beyond hospitals, supporting comprehensive care services and community health initiatives.

Conversely, some argue that the 340B program has grown too large and that the discounts are not always reaching the intended beneficiaries. Concerns have been raised that some hospitals are using the 340B savings to increase profits rather than reinvesting them in patient care. This debate highlights the complex economic dynamics of the program and the need for greater oversight and accountability.

HRSA’s Role and Potential Remedies

The AHA is urging the HRSA to take immediate enforcement action against Eli Lilly and Novo Nordisk to halt their new policies, including the imposition of civil monetary penalties. The AHA argues that the policies are unlawful under the 340B statute, which requires drug manufacturers to provide covered medications at a discount. The organization also criticizes the HRSA for its silence on the matter, stating that its lack of response is “troubling.”

The HRSA, as the federal agency responsible for overseeing the 340B program, has the authority to investigate complaints, issue guidance, and enforce regulations. The agency’s response to the AHA’s concerns will be critical in determining the future of the program. Possible remedies could include issuing a clarifying rule, conducting an audit of the new data requirements, or pursuing legal action against the drug manufacturers.

As of press time, the HRSA had not responded to a request for comment on the AHA’s letter. The agency is expected to address the issue in the coming weeks, as the April 1, 2026, implementation date for Novo Nordisk’s policy approaches. Stakeholders are closely watching for any indication of the HRSA’s stance and potential next steps.

Key Takeaways

• Pharmaceutical companies Eli Lilly and Novo Nordisk are requiring hospitals to submit detailed claims data for 340B drugs.
• The American Hospital Association argues these requirements are overly burdensome and could jeopardize patient access to affordable medications.
• The 340B program has been the subject of numerous legal challenges and policy shifts in recent years.
• The HRSA is under pressure to intervene and address the concerns raised by the AHA.

The future of the 340B program remains uncertain. The ongoing dispute between hospitals and drugmakers underscores the need for a comprehensive review of the program’s policies and regulations. The HRSA’s response to the AHA’s concerns will be a key indicator of the agency’s commitment to protecting the program’s integrity and ensuring access to affordable medications for vulnerable populations. Further developments are expected as the April 1 implementation date for Novo Nordisk’s policy nears, and the industry awaits a response from the HRSA.

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