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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.


Board of Pharmacy Rule Changes

Board of Pharmacy made changes to rules effective on March 4, 2024

Counselor, Social Workers, and Marriage and Family Therapist (CSWMFT) Board Rule Changes

The Counselor, Social Workers, and Marriage and Family Therapist (CSWMFT) Board has proposed changes to the Ohio Administrative Code rules discussed below. The rules are scheduled for a public hearing on April 23, 2024, and public comments are due by this date. Please reach out to BMD Member Daphne Kackloudis for help preparing comments on these rules or for additional information.

Latest Batch of Ohio Chemical Dependency Professionals Board Rules: What Providers Should Know

The Ohio Chemical Dependency Professionals Board recently released several new rules and proposed amendments to existing rules over the past few months. A hearing for the new rules was held on February 16, 2024, but the Board has not yet finalized them.

Now in Effect: DOL Final Rule on Classification of Independent Contractors

Effective March 11, 2024, the U.S. Department of Labor (DOL) has adopted a new standard for the classification of employees versus independent contractors — a much anticipated update since the DOL issued its Final Rule on January 9, 2024, as previously discussed by BMD.  In brief, the Fair Labor Standards Act (FLSA) creates significant protections for workers related to minimum wage, overtime pay, and record-keeping requirements. That said, such protection only exists for employees. This can incentivize entities to classify workers as independent contractors; however, misclassification is risky and can be costly.

Florida's Recent Ruling on Arbitration Clauses

Florida’s recent ruling on arbitration clauses provides a crucial distinction in determining whether such clauses are void as against public policy and providers may have the opportunity to include arbitration clauses in their patient consent forms. On March 6, 2024, Florida’s Fourth District Court of Appeals reversed and remanded Florida’s Fifteenth Circuit Court ruling of Piero Palacios v. Sharnice Lawson. The Court of Appeals ruled that the parties’ arbitration agreement did not contradict the Legislature’s intent of Florida’s Medical Malpractice Act (the “MMA”), but rather reflects the parties’ choice to arbitrate claims entirely outside of the MMA’s framework. Therefore, the Court found that the agreement was not void as against public policy.