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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 Federal Medical Conscience Rule and Its Implications

The Department of Health and Human Services Office for Civil Rights issued a Final Rule to clarify protections for healthcare providers who refuse services based on religious or moral beliefs. This includes protection against discrimination for refusing procedures like assisted suicide or abortion. The OCR can receive complaints, conduct investigations, and enforce these protections. Entities are encouraged to update policies accordingly and display a model notice provided by the OCR.

Marijuana Reclassification and APRN/PA Prescribing

Marijuana is expected to be reclassified by the Drug Enforcement Administration (DEA) from a Schedule I controlled substance to a Schedule III controlled substance as a result of efforts by the Biden administration.

Federal Trade Commission Voids Non-Compete Agreements Nationwide

On April 23, 2024, the U.S. Federal Trade Commission (“FTC”) issued its Final Rule containing regulations impacting non-compete agreements across the country for all employees. The Final Rule implements some of the most impactful changes to employment law during this century. The Final Rule will take effect 120 days from its publication in the Federal Register, which we expect to occur within the next few weeks.

Department of Labor Finalizes Rule with Substantial Salary Increases for White-Collar Overtime Exemptions

On April 23, 2024, the U.S. Department of Labor (DOL) announced a final rule that will significantly impact overtime eligibility for white-collar employees under the Fair Labor Standards Act (FLSA). This rule implements a dramatic increase in the minimum salary level required for an employee to be exempt under the FLSA’s administrative, executive, and professional exemptions (the so-called “white collar exemptions”) as well as the FLSA’s highly compensated employee exemption.

Chemical Dependency Professionals Board Rule Changes: Part 2

New rule changes for Certification of Chemical Dependency Counselor Assistants (CDCA)