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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

DHS Ends All Employment Authorization Auto-Extensions

October 29, 2025Effective October 30, 2025, DHS ends all automatic work authorization renewals. The 540-day extension applies only to renewals filed before this date, and there is no grace period for expired EADs filed on or after October 30. Employers must audit EADs, train staff, ensure I-9 compliance, and plan for work authorization gaps. Penalties for noncompliance can be severe.Client Alert

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Expanding Access to Care: Ohio’s Effort to Modernize APRN Practice Through Ohio SB 258 and HB 508

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Cleveland Joins the Pay Transparency Movement: What Employers Need to Know

October 21, 2025Beginning October 27, 2025, all Cleveland employers with 15 or more employees will be prohibited from asking applicants about their pay history and will be required to include reasonable pay ranges in all job postings where the position will be performed, solicited, considered, or processed in Cleveland. The ordinance is intended to help close the gender wage gap and promote greater pay equity across the city.Client Alert

New $100,000 Fee on H-1B Petitions – Legal Immigration

September 23, 2025President Trump issued an Executive Order (EO) imposing a $100,000 payment to accompany any new H-1B visa petitions submitted after 12:01 a.m. eastern time on September 21, 2025 and will remain in place for 12 months (unless extended).
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