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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.


Supreme Court Clears Path for TPS Terminations: What Employers Need to Know

The U.S. Supreme Court's June 25, 2026 decision in Mullin v. Doe and Trump v. Miot removed legal obstacles that had delayed the termination of Temporary Protected Status (TPS) for Haiti and Syria. The ruling also reinforces the administration's authority to terminate other TPS designations currently under review. Employers should immediately identify workers whose employment authorization is tied to affected TPS programs, review Form I-9 records, and prepare for forthcoming USCIS guidance before taking any employment action.

The Risks of Outsourcing Medical Billing and the Importance of State-Law Compliance

Offshoring medical billing and other administrative functions can reduce costs, but it also raises significant compliance, operational, and contractual risks. Although HIPAA does not explicitly prohibit protected health information from being accessed or stored outside the United States, healthcare providers and their vendors remain responsible for safeguarding patient information and complying with state-specific restrictions that may limit or prohibit offshore subcontracting.

Risks of Using AI-Generated, Implied Celebrity Endorsements in Advertising

Businesses using AI-generated celebrity images, videos, or voice simulations in advertising may face significant legal risks if the content falsely implies an endorsement, affiliation, or sponsorship. This article discusses potential exposure under false advertising, right of publicity, consumer protection, and professional conduct laws, and explains why disclaimers may not be enough to avoid liability.

CMS Requires Providers to Use an Updated Advance Beneficiary Notice (ABN) Form by May 12, 2026

CMS has released an updated Advance Beneficiary Notice of Noncoverage (ABN), Form CMS-R-131, that all providers and suppliers must begin using by May 12, 2026. The revised form includes clearer language and formatting updates intended to improve patient understanding and compliance.

CMS and Ohio Ramp Up Fraud Enforcement in Home Health and Hospice

CMS and Ohio have launched sweeping new fraud prevention initiatives targeting home health and hospice providers, signaling a period of heightened scrutiny for enrollment, billing, documentation, and EVV compliance. While aimed at combating fraud, these measures also create significant operational and due process risks for compliant agencies, making proactive compliance programs, auditing, and governance more important than ever.