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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.


CLIENT ALERT: Class Action Waivers in Employment Contracts Upheld by Supreme Court

On May 21, 2018, in a 5-4 decision and a major win for employers, the United States Supreme Court upheld the legality of waivers in employment contracts that prohibit employees from grouping claims together in collective or class actions in favor of individual arbitration proceedings. See Epic Sys. Corp. v. Lewis, ___U.S.___ (2018).

CLIENT ALERT: Prohibition on Recoupment Prior to Exhaustion of Administrative Remedies

In April, the Fifth Circuit Court of Appeals, in Family Rehabilitation, Inc. v. Azar No. 17-11337 (5th Cir. 2018), held that district courts are authorized to enjoin the Centers of Medicare & Medicaid Services (“CMS”) and its contractors from recouping alleged overpayments prior to the completion of the administrative appeal process.

CLIENT ALERT: Low Volume Appeals Settlement for RAC Appeals

In April, the Centers for Medicare & Medicaid Services (“CMS”) issued a new settlement proposal to providers with outstanding appeals at the Office of Medicare Hearings and Appeals (“OMHA”) and the Medicare Appeals Council (“MAC”). Essentially, CMS is offering to pay up to 62% of the claim to the provider for qualifying claims that are currently in the appeal process. Interested providers may submit an Expression of Interest (“EOI”) to CMS by June 8, 2018. Providers should explore this settlement opportunity and submit an EOI to receive an offer of settlement. Providers may decline the offer after the EOI is submitted. Brennan, Manna & Diamond, LLC’s Provider Relations, Audit, and Appeals Unit, a division of its Healthcare Department, is able to assist providers with filing the EOI, analyzing the outstanding claims subject to the settlement, and reviewing the Administrative Agreement that is offered by CMS.

CLIENT ALERT: Ohio Managed Care Organization (MCO) Open Enrollment

Open Enrollment started April 30, and will continue through May 25, 2018, for your MCO (Managed Care Organization). Every State Fund Ohio employer can select their MCO for the coming policy year. The MCO is responsible for helping to manage Ohio Workers’ Compensation claim costs. All State Fund employers will begin to receive correspondence urging them to select that particular MCO, or urging them not to make a switch.

Medical Marijuana Rules and You

The Ohio Medical Board has adopted regulations in conjunction with the Ohio Pharmacy Board that would govern physicians who may elect to participate under the Ohio Medical Marijuana statutes.