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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.


CARES Act Offers Additional Funds to Healthcare Providers Offering Care, Diagnoses, or Testing Related to COVID-19

In order to help prevent, prepare for, and respond to the COVID-19 pandemic, a $100 billion fund, run through the Public Health and Social Services Emergency Fund (PHSSEF), has been made available to cover non-reimbursable costs attributable to COVID-19 under the CARES Act. This fund has been designed to get money into the health care system as quickly as possible. As such, applications will be reviewed, and payments will be made, on a rolling basis. HHS has been given significant flexibility in determining how the funds are to be allocated, as opposed to operating under a mandated formula or process for awarding the funds. While the Secretary of HHS has not yet released guidance on the application process, this is expected in the near future. BMD will provide updates as soon as this information becomes available.

COVID-19 Small Business Loan Relief Guidance - Updated April 8, 2020

Economic Action Plan for Clients Our legal and business crisis response team has collaborated with lending institutions in Ohio and Florida to advise small businesses with regard to the loans available due to the COVID-19 health and economic crisis. There are several loan options that may work for you, and we have also added a section for Frequently Asked Questions. For more information, please contact your primary BMD attorney and they would be happy to assist you in developing an Economic Relief Action plan for your business.

Paid Leave for Coronavirus: Department of Labor Issues Its Temporary FFCRA Rule

The Department of Labor issued its Temporary Rules under the Families First Coronavirus Response Act (FFCRA) pertaining to the Emergency Paid Sick Leave Act (EPSLA) and the Emergency Family and Medical Leave Expansion Act (EFMLEA). The rule became operational on April 1, 2020 and was officially published on April 6, 2020.

Florida’s “Stay-at-Home” Order and What it Means for Businesses

On April 1, 2020, in response to the State’s ongoing efforts to fight the spread of COVID-19, Governor Ron DeSantis issued Executive Order 20-91, which is State-wide “Stay-at-Home” Order. The Order goes into effect Friday, April 3, 2020 at 12:01 a.m., and expires on April 30, 2020, unless extended by subsequent order (the full text of the order is available here).

CMS Offers New Stark Waivers and More Flexibility to Health Care Providers Due to COVID-19

On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued several temporary regulatory waivers to further enable the American healthcare system to respond to the COVID-19 pandemic with more efficiency and flexibility. The official publication can be found here: Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19.