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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.


Corporate Transparency Act Effective Again

The federal judiciary has issued multiple rulings on the enforceability of the Corporate Transparency Act (CTA), which took effect on January 1, 2024. Previously, enforcement was halted nationwide due to litigation in Smith v. U.S. Department of the Treasury. However, on February 18th, the court lifted the stay, reinstating the CTA’s reporting requirements. Non-exempt entities now have until March 21, 2025, to comply. Businesses should act promptly to avoid civil penalties of $591 per day and potential criminal liability.

Status Update: Physician Noncompete Agreements in Ohio

Noncompete agreements remain enforceable in Ohio if they meet specific legal requirements. While the AMA and FTC have challenged these restrictions, courts continue to uphold reasonable noncompete provisions for physicians. Recent cases, like MetroHealth System v. Khandelwal, highlight how courts may modify overly restrictive agreements to balance employer interests with patient care. With ongoing legal challenges to the FTC’s proposed ban, Ohio physicians should consult a healthcare attorney before signing or challenging a noncompete agreement.

Immigration Orders and Their Economic Impact on Small Business: Insights from Attorney and Former Immigration Judge Rob Ratliff

President Trump's recent executive orders, targeting immigration policies, could significantly impact small businesses in Ohio, particularly those owned by undocumented immigrants. With stricter visa vetting, halted refugee admissions, and potential deportations, these businesses face uncertainty, workforce disruption, and closures. Ohio's immigrant-owned businesses, especially in food services and transportation, contribute billions to the state economy, and any disruption could result in economic ripple effects.

Corporate Transparency Act Ruling from the U.S. Supreme Court

The U.S. Supreme Court recently ruled on the enforceability of the Corporate Transparency Act (CTA), lifting an injunction previously imposed by the Fifth Circuit. However, a separate nationwide injunction remains in effect, meaning businesses are still not required to comply with the CTA’s reporting requirements. FinCEN continues to accept voluntary reporting while enforcement remains paused.

Lead Paint Contamination and Resources for Ohio Landlords

Children are exposed to lead-based paint, which was used in most homes until it was banned in the US in 1978 and “can severely damage the brain and central nervous system causing coma, convulsions and even death.” Property owners and landlords should educate themselves on regulations and resources to mitigate their own liability.