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Ensuring Fair Access: SB 269 Protects Affordable Medication for Low-Income Patients

Client Alert

Senate Bill 269 (SB 269), introduced on May 14, 2024, will ensure that 340B covered entities, including Federally Qualified Health Centers, Ryan White Clinics, disproportionate share hospitals, and Title X clinics, can acquire 340B drugs without facing undue restrictions or discriminatory practices from drug manufacturers and distributors. This protection is crucial for 340B covered entities to continue to provide affordable medications and comprehensive services to low-income patients.

What is the Federal 340B Drug Pricing Program?
Under the 340B Program, Federal law permits covered entities to buy outpatient prescription drugs from drug manufacturers at a discount. In exchange for committing to serve historically marginalized and underserved patients, payors reimburse covered entities at retail rates, allowing the covered entity to realize a savings. Covered entities reinvest that savings into their services and programs; the savings covered entities achieve through the 340B Program helps them stretch scarce federal resources. Without the 340B Program, covered entities will not be able to provide care to vulnerable populations.

What Does SB 269 Do?
Prohibits Restrictive Practices: SB 269 prohibits drug manufacturers, re-packagers, third-party logistics providers, and wholesale distributors (and their agents or affiliates) from denying, prohibiting, restricting, discriminating against, or otherwise limiting the acquisition or delivery of 340B drugs to covered entities, unless required by Federal law. The law would prohibit drug manufacturers and others from limiting covered entities’ use of contract pharmacies, a practice that interferes with the ability of patients who rely on covered entities to access needed health care services and affordable prescription drugs. Under the bill, these parties also cannot require 340B covered entities to submit claims or utilization data as a condition for acquiring or delivering 340B drugs, unless such data sharing is mandated by Federal law.

Enforcement and Penalties: Under the bill, violations of these provisions may result in a civil penalty of $50,000 per violation, as well as referral to the Ohio Board of Pharmacy for further action.

Please contact BMD Healthcare Member Daphne Kackloudis at dlkackloudis@bmdllc.com or Attorney Jordan Burdick at jaburdick@bmdllc.com with any questions about SB 269 or the 340B drug pricing program, or to weigh in with your lawmaker about the bill.


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.