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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.


Protecting Your Image in the Age of AI-Generated “Deepfakes”

The rapid evolution of artificial intelligence (AI) has transformed how we create and consume digital content, but it also poses significant risks. Among the most troubling developments in AI is the proliferation of AI-generated fraudulent content, often called “deepfakes”.

Tariffs, Market Downturn, and Employment Considerations for Employers

As tariffs continue to impact various industries, employers must prepare for the ripple effects these economic pressures can have on workforce management. The economic impact can dramatically impact companies’ bottom lines, and companies look to improve finances and save for the future and many will choose to reduce employee count/wages.

Corporate Transparency Act Overhauled: U.S. Entities No Longer Required to Report

The Department of Treasury has issued an interim final rule significantly altering the Corporate Transparency Act (CTA). As of March 21, 2025, all U.S.-created entities and their beneficial owners are exempt from reporting requirements. Only non-U.S. entities registered to do business in the U.S. must still report, but they are not required to disclose U.S. citizen owners. Business owners should stay informed on these changes and consult legal counsel for compliance guidance.

ODM to Implement Medicaid Work Requirements: What Providers and Medicaid Expansion Recipients Need to Know

The Ohio Department of Medicaid (ODM) has submitted a waiver to impose work requirements for Medicaid expansion recipients. If approved, the new eligibility criteria will take effect on January 1, 2026. A federal public comment period is open until April 7, 2025.

Ohio Appellate Court Rules in Favor of Gender-Affirming Care

On March 18, 2025, the 10th District Court of Appeals in Franklin County ruled that Ohio’s House Bill (HB) 68, which restricts puberty blockers and hormone therapy for minors seeking gender-affirming care, violates the Health Care Freedom Amendment and is therefore unenforceable. The court found that the law unlawfully interferes with parental rights and medical decision-making. The case, Moe v. Yost, has been remanded, and Ohio Attorney General Dave Yost intends to appeal.