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Another Drug Manufacturer Pursues Rebate Program as 340B Alternative

Client Alert

Some of the nation’s largest drug manufacturers are forging ahead to implement rebate programs for 340B drugs, even after the federal government has called these programs illegal.

In August 2024, Johnson & Johnson first announced its plan to implement a drug rebate program for 340B drugs whereby the manufacturer would charge buyers full price for drugs and offer a back-end rebate, instead of allowing safety net providers to purchase outpatient drugs at lower costs, as they have done since the program’s inception.

In response, the Health Resources and Services Administration (HRSA), the federal agency that oversees the 340B drug pricing program, deemed Johnson & Johnson’s rebate program illegal, prompting Johnson & Johnson to initially revoke the rebate plan. However, Johnson & Johnson had a change of heart and on November 12, 2024, filed a lawsuit to challenge HRSA’s decision.

Emboldened, other drug manufacturers have begun to implement drug rebate programs. On November 26, 2024, Bristol Myers Squibb filed a lawsuit against HRSA, asking the federal court to deem its rebate program legal and prevent U.S. Department of Health and Human Services from taking agency action to invalidated rebates.

While it is unclear how these federal courts will rule, these lawsuits signal a desire by drug makers to change how they offer 340B drug discounts to health care providers that operate using scarce federal resources, a move that could threaten the sustainability of safety net providers and the patients they serve.

If you have questions about these lawsuits, or the 340B program in general, please contact Member Daphne Kackloudis at dlkackloudis@bmdllc.com or Attorney Jordan Burdick at jaburdick@bmdllc.com.


Understanding the Seven Core Elements of an Effective Healthcare Compliance Program

The Affordable Care Act requires healthcare providers participating in Medicare, Medicaid, and CHIP to maintain an effective compliance program. Guidance from the Department of Health and Human Services and the Office of Inspector General outlines seven core elements that form the foundation of these programs, from written policies and compliance oversight to auditing, training, and corrective action. This alert highlights each element and explains how practices can tailor compliance programs to their size and risk profile while meeting federal expectations.

Preventing a Board Investigation

Healthcare professionals in Ohio are subject to licensing board investigations that can lead to disciplinary action. Staying compliant with regulations, documenting carefully, and operating within your professional scope can help prevent issues. If contacted by a board, working with an attorney is critical to protect your license and rights.

Ohio Board of Nursing Proposes Rule Changes for Nurses

On Monday, January 12, 2026, the Ohio Board of Nursing (“BON”) released a package of proposed changes to the Ohio Administrative Code. There are two proposed changes to continuing education requirements that Ohio nurses should be watching.

New Florida Law: Patient Overpayments Must Be Refunded Within 30 Days

Effective January 1, 2026, Florida Senate Bill 1808 requires health care facilities and practitioners to refund patient overpayments within 30 days after an overpayment is identified. The law applies to overpayments tied to claims submitted to government programs or private insurers and introduces fines and disciplinary consequences for noncompliance. Providers should review billing and payment practices now to prepare for the new requirements.

USCIS Policy Change Impacting Work Authorization: Advisory for Employers and Human Resources

USCIS has issued a policy memorandum pausing immigration benefit processing for individuals from 19 high-risk countries and requiring a re-review of certain previously approved cases. This change may affect work authorization, employment verification, and workforce stability. Employers and HR teams should review impacted employees and update compliance procedures.