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Another Drug Manufacturer Pursues Rebate Program as 340B Alternative

Client Alert
December 11, 2024

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.

Health LawHealthcareHRSA
Client Alert

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January 24, 2025The 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.Client Alert

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Will Student-Athlete Collectives Survive NIL Changes?

January 20, 2025By July 2025 the landscape of student-athlete funding will look nothing like the current landscape, so preparing now is a must. If you are a student-athlete, the parent of a student-athlete, a university/college, or “booster”, it behooves you to understand these evolving issues.Client Alert

Ohio's Recent Rule Changes to Administration of Immunizations, Outpatient Pharmacy Delivery, and Mobile Response Services

January 20, 2025The Ohio Board of Pharmacy (“BOP”) and Ohio Department of Mental Health and Addiction Services (“OMHAS”) recently posted notices of Ohio Administrative Code rule changes related to the administration of immunizations (BOP), outpatient pharmacy delivery services (BOP), and mobile response and stabilization services (OMHAS).Client Alert

HOA Construction Project Do’s and Don’ts

January 20, 2025Local regulators can approve new construction, but if a resident contacts their homeowners association there may be trouble. Fences, yard alterations, and backyard decks do not have to be such a hassle and a point of conflict. Find out general Do’s and Don’ts to help HOA residents avoid issues in this article by BMD Partner Scott Heasley.
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