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Ensuring Fair Access: SB 269 Protects Affordable Medication for Low-Income Patients

Client Alert
May 29, 2024

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.

340BDrug Discount ProgramHealthcareHealth LawDaphne Kackloudisjordan burdick
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March 29, 2023The Fair Labor Standards Act (FLSA) sets forth requirements for employers including, but not limited to, minimum wage, overtime pay, and recordkeeping for covered employees. These requirements are not as simple as they may appear on their face, which leads many employers to fall into compliance issues that they did not realize even existed.Client Alert

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Ohio Medical Board Releases New Telehealth Rules

February 23, 2023On Tuesday, February 21, 2023, the State Medical Board of Ohio released its final telehealth rules to implement Ohio’s telehealth statute (O.R.C. 4743.09) for physicians, physician assistants, dieticians, respiratory care professionals and genetic counselors. Ohio’s advanced practice registered nurses (“APRNs”) should also take note of these rules. While the Medical Board does not govern APRNs directly, those APRNs who are required to have a collaborating physician and standard care arrangement (namely nurse practitioners, certified nurse midwives, and clinical nurse specialists) are still affected by the rules. Generally, if an APRN’s collaborating physician is limited in their practice, then the APRN will also be limited.Client Alert

The End of the Public Health Emergency is (Finally) Here

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Multi-340B Contract Pharmacy Locations on the Brink? The Third Circuit’s Ruling Gives a Hint.

February 17, 2023The 340B drug discount program requires pharmaceutical manufacturers to offer to sell their products at significant discounts to safety net providers called “covered entities.” In 1996, the Health Resources and Services Administration (HRSA) issued guidance authorizing covered entities to enter into a contract pharmacy arrangement with a single third-party contract pharmacy, to which the manufacturer would ship 340B medications but bill the covered entity. In 2010, HRSA issued revised guidance permitting covered entities to enter into an unlimited number of contract pharmacy arrangements.
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