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

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.


New Ohio Recovery Housing Rules Take Effect January 1, 2025

Ohio’s new recovery housing rules, effective January 1, 2025, require certified community behavioral health providers to refer clients only to accredited recovery housing residences listed on the statewide registry.

SCOTUS to Weigh In on Medicaid Beneficiaries’ Right to Choose their Provider

The U.S. Supreme Court will hear arguments this spring on whether Medicaid beneficiaries have an enforceable right to choose their healthcare providers without state interference, as outlined in Section 1902(a)(23) of the Social Security Act. This case stems from a South Carolina petition challenging a Fourth Circuit ruling that blocked the state from terminating Planned Parenthood’s Medicaid provider agreement.

I Went to Bed and the Rules Changed: the Corporate Transparency Act is Back on Hold

The United States Court of Appeals for the Fifth Circuit ordered on December 26, 2024 that in an effort to “preserve the constitutional status quo” while it considered the Federal Government’s appeal, it vacated the prior order for a stay of the nationwide injunction pending appeal entered on December 23, 2024, and reinstated the preliminary injunction enjoining enforcement of the CTA and its corresponding Reporting Rule.

Telemedicine Flexibilities Extended to March 31, 2025

The American Relief Act of 2025 extends key telehealth flexibilities through March 31, 2025, originally enacted during the COVID-19 Public Health Emergency (PHE). These flexibilities remove geographic and originating site restrictions for Medicare patients, expand the list of qualified practitioners, and allow for audio-only services and telehealth mental health care without in-person requirements. Although this extension is temporary, it provides continued access to essential healthcare services. Congress will need to pass permanent legislation to solidify these changes beyond March 2025.

Corporate Transparency Act Is Back in Effect: Are You Ready?

On December 23, 2024, the Fifth Circuit Court of Appeals reinstated the filing requirements under the Corporate Transparency Act (CTA), overturning a prior injunction. Businesses now have updated deadlines to file initial beneficial ownership information reports with the Financial Crimes Enforcement Network (FinCEN), based on their registration date. Affected companies must comply with these new deadlines, which vary depending on when the company was created or registered.