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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.


FTC Continues to Target Noncompetes

The FTC is intensifying its focus on noncompete agreements in healthcare, urging employers to review contracts for compliance. While Ohio still generally enforces noncompetes, pending legislation could limit their use.

Medicare Updates: Prior Authorizations and Physician Fee Schedule

The Centers for Medicare & Medicaid Services (CMS) has announced two key updates effective January 1, 2026: a six-state prior authorization pilot program targeting high-risk services under the WISeR Model, and proposed revisions to the Physician Fee Schedule (PFS) that include increased payment rates, expanded telehealth coverage, and updated policies for chronic care, behavioral health, and rural providers.

USCIS Policy Updates: Implications for Business Immigration

In August 2025, USCIS issued three key policy updates enhancing vetting, good moral character (GMC) evaluations, and scrutiny of "anti-American" conduct in immigration adjudications. These policy memos will impact employers sponsoring foreign workers, including H-1B, L-1, EB visas, adjustments, and naturalization.

Ohio Passes Antidiscrimination Provision for CRNA Reimbursement

Ohio has passed House Bill 96, introducing a provider nondiscrimination provision that requires health plans to reimburse certified registered nurse anesthetists (CRNAs) at the same rate as physicians for the same services. The law aims to improve patient access to care by eliminating payment discrimination against CRNAs and will take effect on September 30, 2025.

Ohio Board of Pharmacy | Administrative Code Rule Changes

The Ohio Board of Pharmacy (“BOP”) recently posted notices of Ohio Administrative Code rule changes related to record keeping and the sale and distribution of certain ephedrine-containing products.