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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.


RNs and APRNs Take Note: Ohio Board of Nursing Mandates a New CE Reporting Period

Ohio’s Board of Nursing has updated the continuing education reporting period for RNs and APRNs. Beginning March 26, 2026, CE credits must be completed between July 1 and June 30 of odd-numbered years, replacing the previous November to October timeframe.

Ohio Med Spas: Peptide Do's and Do Not's

Recent guidance from the Ohio Board of Pharmacy outlines key compliance requirements for med spas using peptides. While some peptide drugs are FDA approved, others are not or cannot be compounded. Med spa operators should ensure they source medications from licensed suppliers, avoid non-approved or “research use only” products, and follow all compounding and storage regulations to maintain compliance and avoid enforcement actions.

Substance Use Disorder Providers: 42 CFR Part 2 Now Enforceable

Updates to 42 CFR Part 2 are now enforceable, bringing significant changes to how substance use disorder (SUD) records are handled. The Final Rule aligns Part 2 more closely with HIPAA, introduces updated penalties, allows a single patient consent for treatment, payment, and operations, and adds new requirements for Notices of Privacy Practices. It also creates a formal definition of SUD counseling notes and imposes strict consent requirements for their use and disclosure. Providers should review and update policies to ensure compliance.

AAA Introduces AI-Assisted Arbitrator for Certain Disputes

The American Arbitration Association has introduced an AI-assisted arbitration platform designed to streamline certain document-based disputes. While a human arbitrator still makes the final decision, the technology can improve efficiency, reduce costs, and accelerate case resolution. Companies should weigh these benefits against considerations such as transparency, risk, and contractual requirements before adopting AI-assisted arbitration.

Quiet Hours Texts and TCPA Claims: Consent Remains King as Courts Divide on Text Messages

Businesses face increasing TCPA lawsuits over off-hours marketing texts, but recent court decisions highlight strong defenses. Clear consumer consent and updated terms and conditions can defeat many claims, while a growing number of courts are finding that text messages are not “telephone calls” under the statute. Proactive compliance measures, including clickwrap agreements and forum-selection clauses, are critical to reducing risk.