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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.


Update on Temporary Protected Status (TPS) for Haiti and Related Countries

USCIS has temporarily extended Employment Authorization Documents (EADs) for certain Temporary Protected Status (TPS) beneficiaries from Haiti and several other countries following recent court action. Employers and TPS recipients should review EAD expiration dates, monitor ongoing developments, and ensure compliance with Form I-9 and E-Verify requirements.

HHS Accessibility Requirements for Medical Diagnostic Equipment: What Health Care Providers Need to Know

Health care providers that receive federal financial assistance are now subject to updated HHS accessibility requirements for medical diagnostic equipment under Section 504 of the Rehabilitation Act. With the July 8, 2026, compliance deadline in effect, covered providers should ensure they have the required accessible equipment, train staff, and review operational practices to reduce compliance risk and provide accessible care for patients with disabilities.

Florida Super Lawyers® Recognizes Brennan Manna Diamond Attorneys to the 2026 Lists

BRENNAN, MANNA & DIAMOND is proud to announce that three of our attorneys have been designated to the 2026 Florida Super Lawyers® and Florida Rising Stars® lists. Super Lawyers is based on multiple categories of independent research and peer evaluation to identify outstanding lawyers.

Supreme Court Clears Path for TPS Terminations: What Employers Need to Know

The U.S. Supreme Court's June 25, 2026 decision in Mullin v. Doe and Trump v. Miot removed legal obstacles that had delayed the termination of Temporary Protected Status (TPS) for Haiti and Syria. The ruling also reinforces the administration's authority to terminate other TPS designations currently under review. Employers should immediately identify workers whose employment authorization is tied to affected TPS programs, review Form I-9 records, and prepare for forthcoming USCIS guidance before taking any employment action.

The Risks of Outsourcing Medical Billing and the Importance of State-Law Compliance

Offshoring medical billing and other administrative functions can reduce costs, but it also raises significant compliance, operational, and contractual risks. Although HIPAA does not explicitly prohibit protected health information from being accessed or stored outside the United States, healthcare providers and their vendors remain responsible for safeguarding patient information and complying with state-specific restrictions that may limit or prohibit offshore subcontracting.