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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.


Banking and Cannabis: Is it Legal

Marijuana is still a Schedule 1 drug and is illegal under federal law. However, I am not aware of any federal banking law or regulation, or any other federal law or regulation, which explicitly makes it illegal for banks and other financial institutions to provide their traditional services to state legal cannabis businesses.

Protections Under Federal and Ohio Law for Bona Fide Prospective Purchasers of Contaminated Property

Most industrial/commercial property developers are generally aware of the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”), often also referred to as “Superfund”. CERCLA, a United Stated federal law administered by the U.S. Environmental Protection Agency, was created, in part, because the U.S. Environmental Protection Agency recognized that environmental cleanup could help promote reuse or redevelopment of contaminated, potentially contaminated, and formerly contaminated properties, helping revitalize communities that may have been adversely affected by the presence of the contaminated properties. Commercial property developers should be aware that CERCLA provides for some important liability limitations for landowners that own contaminated property impacted by materials hazardous to the environment. It can also assist with landowners concerned about the potential liabilities stemming from the presence of contamination to which they have not contributed. In particular, CERCLA provides important liability limitations for landowners that qualify as (1) bona fide prospective purchasers (BFPPS), (2) contiguous property owners, or (3) innocent landowners.

Puerto Rico Is Open For Business

Puerto Rico has the highest vaccination in the nation. More than 73% of the total population is fully vaccinated. The U.S. national average is just over 57%. The ports opened in June 2020 and San Juan held it first live concert this past summer. It is important to remember that Puerto Rico is a U.S. territory and there is no need for visas, the banking systems is almost identical to the mainland and the Island uses the U.S. postal service and U.S. dollar as its currency. There are thousands of flights from the U.S. to Puerto Rico daily and all main airlines fly to the Island.

Ohio Medical Board Changes Telemedicine Rules

A SCMS News Article by Scott Sandrock.

The Rising Threat from Insiders – Get Your House in Order

As its name implies, an ‘Insider Threat’ originates inside an organization. An ‘insider’ is any person who has or had authorized access to or knowledge of an organization’s resources, including personnel, facilities, information, equipment, networks, and systems. ‘Insider threat’ can manifest from malicious, complacent, negligent or unintentional acts that negatively affect the integrity, confidentiality, and availability of the organization, its data, personnel, or facilities. Certainly, ‘Insider Threat’ can be an activity by a bad actor employee, but can also arise from an inadvertent or unknowing action inside an organization (such as an employee who unintentionally opens a phishing email or clicks on a malicious link).