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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.


IRS Issues Guidance Relating to High Deductible Health Plans and Coronavirus Testing

In response to the Coronavirus/COVID-19 pandemic, the IRS has released guidance in Notice 2020-15 relating to the testing and treatment for individuals covered by a High Deductible Health Plan (HDHP).

OCR, HHS Issue 2020 HIPAA and Coronavirus Bulletin

The Office of Civil Rights and the U.S. Department of Health and Human Services has issued a bulletin on HIPAA Privacy and Novel Coronavirus, including important insights around sharing patient information if an outbreak of infectious disease or other emergency situation arises. Note that the protections of the Privacy Rule are not void during an emergency.

Nation’s First Conviction Under EKRA

Last month, the Department of Justice announced its first ever guilty plea under the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”).

Motor Carriers Beware - Lack of Written Independent Contractor Agreement Can Be Costly

Given recent changes in Ohio workers’ compensation law, “motor carriers” (as defined by Ohio law), operating in Ohio should carefully review their arrangements with independent contractor drivers and promptly implement changes to ensure compliance with statutory criteria.

Employers: Consider Important Deadlines for New H-1B Cap-Subject Foreign Worker Petitions

First-time new H-1B petitions or change of status petitions by employers can be filed for the upcoming U.S. Citizenship and Immigration Services (“USCIS”) fiscal year in April 2020 as long as the individual for whom the petition is being filed is in lawful status at the time of filing, and has not engaged in any unauthorized employment since his or her last lawful admission.