Resources

Client Alerts, News Articles, Blog Posts, & Multimedia

Everything you need to know about BMD and the industry.

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.


BMD Named to the 2024 U.S. News – Best Lawyers® “Best Law Firms”

Brennan Manna & Diamond (BMD) is recognized among the leading law firms in the nation according to the 2024 Edition of U.S. News – Best Lawyers®  "Best Law Firms." The firm has ranked in in 13 practice areas and has earned “National Tier 1” rankings in Health Care Law and Litigation-Trusts & Estates.

Friendly Physician Models: The Basics Through 5 Frequently Asked Questions

During the past several years, many health law practices have noticed a dramatic increase in the number of telehealth businesses and private equity backed health care providers. Both of these trends often rely heavily on corporate structures commonly referred to as “friendly physician,” “captive PC” or “MSO” models. Although friendly physician models are used by non-physician health care providers (e.g., physical therapists, psychologists, and dentists), this article focuses on physicians and how the model is used in connection with the provision of professional medical services.

The DOL and EEOC Enter a Partnership to Strengthen Federal Employment Law Enforcement

On September 13, the U.S. Department of Labor’s (DOL) Wage and Hour Division and the Equal Employment Opportunity Commission (EEOC) entered into a Memorandum of Understanding (MOU) agreeing to work together in enforcing federal employment laws. The MOU forms a partnership between the two agencies to encourage coordination through information sharing, joint investigations, training, and outreach.

Proposed Laboratory Arrangement Draws Heightened Scrutiny from the OIG

On September 25, 2023, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO). The Opinion involved a proposed arrangement between an independent laboratory and other physician laboratories for the purchase of the technical component of anatomic pathology services. The OIG ultimately concluded that the arrangement at issue, if it was entered into with the requisite intent, would implicate the Federal Anti-Kickback Statute (AKS) and constitute grounds for sanctions.

SMALL BUSINESS ALERT: January 1, 2024 - Beneficial Ownership Information Reporting

Beginning on January 1, 2024, many small businesses across the United States will have to report personal information about their owners, beneficial owners, and others who own or exercise control over the company. The information will have to be reported to, and maintained by, the Financial Crimes Enforcement Network (“FinCEN”) as part of the Beneficial Ownership Information Rule. FinCEN is a bureau of the U.S. Department of the Treasury.