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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

Chemical Dependency Professionals Board Rule Changes: Part 2

April 1, 2024New rule changes for Certification of Chemical Dependency Counselor Assistants (CDCA)Client Alert

Board of Pharmacy Rule Changes

April 1, 2024Board of Pharmacy made changes to rules effective on March 4, 2024Client Alert

Counselor, Social Workers, and Marriage and Family Therapist (CSWMFT) Board Rule Changes

March 29, 2024The Counselor, Social Workers, and Marriage and Family Therapist (CSWMFT) Board has proposed changes to the Ohio Administrative Code rules discussed below. The rules are scheduled for a public hearing on April 23, 2024, and public comments are due by this date. Please reach out to BMD Member Daphne Kackloudis for help preparing comments on these rules or for additional information.Client Alert

Latest Batch of Ohio Chemical Dependency Professionals Board Rules: What Providers Should Know

March 25, 2024The Ohio Chemical Dependency Professionals Board recently released several new rules and proposed amendments to existing rules over the past few months. A hearing for the new rules was held on February 16, 2024, but the Board has not yet finalized them.Client Alert

Now in Effect: DOL Final Rule on Classification of Independent Contractors

March 21, 2024Effective March 11, 2024, the U.S. Department of Labor (DOL) has adopted a new standard for the classification of employees versus independent contractors — a much anticipated update since the DOL issued its Final Rule on January 9, 2024, as previously discussed by BMD.  In brief, the Fair Labor Standards Act (FLSA) creates significant protections for workers related to minimum wage, overtime pay, and record-keeping requirements. That said, such protection only exists for employees. This can incentivize entities to classify workers as independent contractors; however, misclassification is risky and can be costly.
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