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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.


Employee or Independent Contractor? New Guidance Issued by the Department of Labor

On January 9, 2024, the U.S. Department of Labor (DOL) issued its long-awaited final rule — effective March 11, 2024 — revising its prior interpretation of worker classifications under the federal Fair Labor Standards Act (FLSA). The new final rule rescinds the standard previously established in 2021, in turn, shifting the analysis of whether a worker is an employee (versus an independent contractor) of a business from a more streamlined “economic reality” test to a more complex “totality of the circumstances” standard.

Increased Medicaid Rates to Take Effect This Month for Ohio Providers

As required by House Bill 33, Ohio’s 2024-2025 operating budget bill, reimbursement rates paid by the Ohio Department of Medicaid will increase for a wide range of providers starting on January 1, 2024.

Corporate Transparency Act Update

The Corporate Transparency Act (“CTA”), with an effective date of January 1, 2024, is set to impose strict reporting guidelines on business owners throughout the country. The following provides a brief update on two aspects of the CTA ahead of its effectiveness next week.

The Second Wave of UnitedHealthcare's Prior Authorization Cuts Started in November

In August 2023, UnitedHealthcare released its plan to eliminate roughly one-fifth of its then-current prior authorization requirements. The first round of prior authorization cuts took effect on September 1, 2023. In that round, UnitedHealthcare eliminated the necessity for some prior authorizations for UnitedHealthcare Medicare Advantage, UnitedHealthcare commercial, UnitedHealthcare Oxford and UnitedHealthcare Individual Exchange plan members. The second and final round of prior authorization cuts began on November 1, 2023. The November 2023 Prior Authorization Cuts apply to the same plans as well as community plans (i.e., Medicaid managed care plans).

Legal Uncertainties Remain Following Passage of Issue 1 in Ohio

In the November 2023 General Election, Ohio voters passed Issue 1 which, among other things, “[e]stablish[es] in the Constitution of the State of Ohio an individual right to one’s own reproductive medical treatment, including but not limited to abortion”. Despite passage of Issue 1, questions persist about how its codification on December 7 affects previously passed legislation restricting abortion and related pending court cases.