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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.


Wrongful Death Lawsuits in the Wake of COVID-19

Several major “essential business” employers, including Walmart and Tyson, have been served with wrongful death lawsuits in relation to COVID-19. As many Ohio employees begin to return to work, employers should be prudent in following workplace safety practices.

We are Working in a Virtual, Video-Conferencing World – But What About Wiretapping?

Businesses and other organizations often have a need or desire to record telephone conversations related to their business interests and customer dealings; however, this practice is not always permissible as federal and state laws vary on this issue. Knowing and understanding your jurisdiction’s rules and regulations on this practice is essential to remaining in compliance with the law.

President Trump Signs Executive Orders that Enable Access to Affordable Meds

On Friday, July 24, 2020, President Trump signed four Executive Orders concerning prescription drug pricing which collectively direct the Secretary of the Department of Health and Human Services (HHS) to take following actions: 1. Increase Patient Access to Insulin and Injectable Epinephrine 2. Facilitate the Importation of Certain Prescription Drugs 3. Remove the Anti-Kickback Safe Harbor Protection for Prescription Rebates 4. Implement the “Most Favored Nation” Order to Lower Medicare Part B Drug Cost

Guidance for Employers Receiving HHS Funding During COVID-19 on Civil Rights Protections

On July 20, 2020, HHS OCR issued guidance to help employers receiving federal financial assistance understand their requirements to comply with applicable federal civil rights laws and regulations that prohibit discrimination on the basis of race, color, and national origin in HHS-funded programs during COVID-19; specifically, Title VI of the Civil Rights Act of 1964 (“Title VI”). Title VI states that “[n]o person in the United States shall, on the ground of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.”

Ohio Businesses Required to Post Exceptions to State-wide Mask Mandate at all Entrances

On July 22, 2020, in conjunction with the state-wide mask mandate instituted by Governor Mike DeWine, Lance D. Himes, Interim Director of the Ohio Department of Health, issued an order requiring Ohio businesses to post any permitted exceptions they provide to customers, patrons, visitors, contractors, vendors and similar individuals to use facial coverings at all business entrances.