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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.


RNs and APRNs Take Note: Ohio Board of Nursing Mandates a New CE Reporting Period

Ohio’s Board of Nursing has updated the continuing education reporting period for RNs and APRNs. Beginning March 26, 2026, CE credits must be completed between July 1 and June 30 of odd-numbered years, replacing the previous November to October timeframe.

Ohio Med Spas: Peptide Do's and Do Not's

Recent guidance from the Ohio Board of Pharmacy outlines key compliance requirements for med spas using peptides. While some peptide drugs are FDA approved, others are not or cannot be compounded. Med spa operators should ensure they source medications from licensed suppliers, avoid non-approved or “research use only” products, and follow all compounding and storage regulations to maintain compliance and avoid enforcement actions.

Substance Use Disorder Providers: 42 CFR Part 2 Now Enforceable

Updates to 42 CFR Part 2 are now enforceable, bringing significant changes to how substance use disorder (SUD) records are handled. The Final Rule aligns Part 2 more closely with HIPAA, introduces updated penalties, allows a single patient consent for treatment, payment, and operations, and adds new requirements for Notices of Privacy Practices. It also creates a formal definition of SUD counseling notes and imposes strict consent requirements for their use and disclosure. Providers should review and update policies to ensure compliance.

AAA Introduces AI-Assisted Arbitrator for Certain Disputes

The American Arbitration Association has introduced an AI-assisted arbitration platform designed to streamline certain document-based disputes. While a human arbitrator still makes the final decision, the technology can improve efficiency, reduce costs, and accelerate case resolution. Companies should weigh these benefits against considerations such as transparency, risk, and contractual requirements before adopting AI-assisted arbitration.

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

Businesses 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.