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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.


USCIS Policy Change Impacting Work Authorization: Advisory for Employers and Human Resources

USCIS has issued a policy memorandum pausing immigration benefit processing for individuals from 19 high-risk countries and requiring a re-review of certain previously approved cases. This change may affect work authorization, employment verification, and workforce stability. Employers and HR teams should review impacted employees and update compliance procedures.

CMS Releases CY 2026 Medicare Physician Fee Schedule Final Rule with Key Payment and Telehealth Updates

CMS issued the CY 2026 Medicare Physician Fee Schedule Final Rule on October 31, 2025, with changes effective January 1, 2026. The Final Rule includes increases to the conversion factor, a new efficiency adjustment, updates to practice expense methodology, permanent telehealth policy changes, revised payment for skin substitutes, expanded rules for Part B drugs and biologicals, enhanced policies for Rural Health Clinics and Federally Qualified Health Centers, and new care management and behavioral health services.

Ohio Department of Medicaid Updates: Key Changes to Physician Reimbursement Rates in Early Parenthood

The Ohio Department of Medicaid has proposed amending Ohio Administrative Code Rule related to covered Medicaid reimbursements for physicians. Beginning on January 1, 2026, they are proposing an increase to rates for prenatal care, childbirth, and infant care and provider visits.

Name, Image, and Likeness Agreements in Healthcare

For example, some healthcare providers have begun to utilize "Name, Image, and Likeness" agreements to promote the brand they have created through their healthcare practice.  We have seen the most healthcare NIL activity with longevity and wellness providers, as well as orthopedics.

Compounding GLP-1 Drugs - Recent Updates

Recent guidance from the Ohio Board of Pharmacy (“BOP”) indicates that providers should generally use the FDA approved GLP-1 drug, rather than a non-FDA approved compounded version of the medication. Importantly, if a GLP-1 drug is commercially available, it cannot be copied through compounding. Currently, compounded copies of Tirzepatide and Semaglutide are not permitted.