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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.


Hurry Up, STOP. . .Has CTA Been Struck Down By Courts?

Following a recent case in Texas, uncertainty has arisen regarding whether clients should file "beneficial owners" reports. This is a result of the Federal Government enjoined from enforcing the CTA. Contact your BMD Member Blake Gerney to find out how this affects you.

DEA and HHS Issue its Third Extension of Telemedicine Flexibilities through 2025

The DEA and U.S. Department of Health and Human Services (HHS) have extended telemedicine flexibilities for prescribing controlled medications through December 31, 2025. This extension builds on temporary exceptions made in 2020 due to COVID-19, allowing providers to prescribe Schedule II-V controlled substances based on a telemedicine evaluation alone. The extension ensures continued patient access to necessary prescriptions and provides time for providers to comply with future regulations.

Medicare Making Changes to Improve Behavioral Health Care Access

The Centers for Medicare & Medicaid Services (CMS) has introduced changes to Medicare’s behavioral health coverage, including allowing Marriage and Family Therapists and Mental Health Counselors to enroll independently, increasing reimbursements for crisis psychotherapy and substance use treatment, and expanding services via community health workers. These updates address gaps in care and improve access to mental health services for Medicare beneficiaries.

The Ohio Department of Medicaid Announces Four Next Generation MyCare Plans

On November 1, 2024, the Ohio Department of Medicaid (ODM) announced four managed care organizations that will become ODM’s Next Generation MyCare plans starting January 2026. MyCare Ohio is a managed care program that supports Ohioans across 29 counties enrolled in both Medicare and Medicaid.

Corporate Transparency Act Reporting Deadline: December 31

The Corporate Transparency Act (“CTA”), which became effective January 1, 2024, imposes strict reporting guidelines on small business owners throughout the country.  The deadline for non-exempt businesses to submit reporting is December 31, 2024.