Resources

Client Alerts, News Articles, Blog Posts, & Multimedia

Everything you need to know about BMD and the industry.

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

Quiet Hours Texts and TCPA Claims: Consent Remains King as Courts Divide on Text Messages

March 31, 2026Businesses face increasing TCPA lawsuits over off-hours marketing texts, but recent court decisions highlight strong defenses. Clear consumer consent and updated terms and conditions can defeat many claims, while a growing number of courts are finding that text messages are not “telephone calls” under the statute. Proactive compliance measures, including clickwrap agreements and forum-selection clauses, are critical to reducing risk.Client Alert

New Ohio Reporting Requirements for Non-Residential Contractors

March 18, 2026Ohio’s E-Verify Workforce Integrity Act, effective March 19, 2026, requires all nonresidential construction companies, subcontractors, and labor brokers to use E-Verify to confirm employee work eligibility on projects across the state. The law applies regardless of company size and carries financial penalties and potential restrictions on future state contracts for noncompliance. Some uncertainty remains around requirements for existing employees, making early compliance planning important.Client Alert

DOT Non-Domiciled CDL Rule

March 11, 2026A new rule from the Federal Motor Carrier Safety Administration (FMCSA) will significantly narrow eligibility for non-domiciled Commercial Driver’s Licenses (CDLs) beginning March 16, 2026. The rule limits eligibility to holders of H-2A, H-2B, and E-2 visas and eliminates Employment Authorization Documents (EADs) as qualifying proof of work authorization. As a result, many lawfully present and work-authorized immigrants, including refugees, asylees, DACA recipients, and Temporary Protected Status holders, will no longer be able to obtain or renew a non-domiciled CDL. The change is expected to affect roughly 194,000 drivers nationwide and has prompted multiple legal challenges, including a pending emergency stay request before the United States Court of Appeals for the District of Columbia Circuit.Client Alert

FinCEN Residential Real Estate Reporting Rule Now in Effect

March 6, 2026FinCEN’s new Residential Real Estate Reporting Rule, effective March 1, 2026, requires certain real estate transfers to be reported to combat financial crimes. Transfers of residential property to entities or trusts without financing may require a Real Estate Report.Client Alert

Department of Education Proposes Redefinition of “Professional Degree,” Excluding Nursing and Limiting Graduate Loan Borrowing

February 20, 2026The U.S. Department of Education has issued a Notice of Proposed Rulemaking that would redefine “professional degree” programs under the One Big Beautiful Bill Act. The proposal excludes nursing from the recognized list and would impose new borrowing limits for graduate students while eliminating the Grad PLUS program. Public comments are due by March 2, 2026.
Older posts