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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.


Lessons Learned: Five Tips for Buying or Selling a Practice

If you are anticipating buying or selling a practice during the coming months, you are not alone. The healthcare industry is experiencing a wave of integration. In fact, it has been occurring for several years. Many transactional healthcare attorneys have negotiated and closed dozens of these transactions for clients. They have negotiated on behalf of the sellers in some cases and the buyers in others.

Ramping Up – A Quick Guide to Pressing COVID-19 Employment Law Issues

As the country continues to grapple with a global pandemic that now seems to be never-ending, businesses everywhere are waking up to realize that the calming of the COVID-19 employment issues over the summer has come to an end. As cases rise exponentially in all 50 states as we head into the winter months, the number of employment issues related to COVID-19 will also increase dramatically. For these reasons, it is important that we return to the employment law basics that were covered this prior spring, while highlighting the many lessons we have learned along the way. As COVID-19 matters and concerns continue to hinder the working environment of every business, it is important that you reference this review to guide you through these tough issues and questions.

Your Workplace Under Biden

This is my favorite recurring post – Predictions of How a New Administration Will Affect Your Workplace. Four years ago, we accurately called the emasculation of the 2016 proposed FLSA Overtime Rules (the salary exemption threshold was set at $35,568 in 2019, rather than $47,476 as proposed), we forecasted a conservative shift of the NLRB and its results (a roll-back of employee rights, social media policy evaluations, and joint employer rules), and we nailed the likelihood of multiple conservative appointments to the United States Supreme Court and its long-term effects (although I completely failed to predict that my ND classmate Amy Coney Barrett would fill the final vacancy during the Trump administration). This time, the L+E Practice of BMD has decided to make it a group effort at predicting what will happen, what probably happen, and what might happen under President Biden. As always, please save this in your important files and pull it out four (or eight) years from now to judge our accuracy.

HHS Provider Relief Funds Reporting Requirements: Important Updates Every Provider Should Know

HHS continues to revise its reporting requirements for the use of the Provider Relief Funds. Providers with more than $10,000 in Provider Relief Fund payments must report on the use of the funds through December 31, 2020. The reporting window will begin on January 15, 2021 and providers must complete reporting obligations for FY 2020 by February 15, 2021 through a portal designed by HHS. However, providers that have unexpended funds as of December 31, 2020, will have an additional 6 months to use the remaining funds through June 30, 2021. These providers must submit a second and final report no later than July 31, 2021.

Should I Apply for Phase 3 Funds? Important Considerations Every Provider Should Know

On October 1, 2020, the Department of Health and Human Services (“HHS”) announced an additional $20 billion in new funding for providers through a Phase 3 distribution. Importantly, providers that previously received HHS Provider Relief Funds or already received payments of approximately 2% of annual revenue from patient care are eligible to apply. Eligible providers have until November 6, 2020 to apply for these Phase 3 Funds. However, the question from providers continues to be: Should I Apply for Phase 3 Funds?