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.


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.

#CancelRent – What’s Next for Landlords?

Across the country, residential tenants, small businesses, and even national retailers such as Cheesecake Factory, Subway, and Mattress Firm have declared war on their landlords by refusing to pay rent on account of the Covid-19 pandemic (“COVID-19”). This has sent shockwaves through the real-estate industry. As of April 1st, residential tenants owe an estimated $40 Billion in rent. Estimates for the commercial sector are not far off. So far, federal, state, and local measures have focused on providing relief to residential and commercial tenants and even to some commercial landlords.

Record Keeping Requirements to Receive FFCRA IRS Tax Credit

On April 1, 2020, the IRS and Department of Labor issued temporary regulations to provide clarity regarding the documents required by employees requesting leave under the Families First Coronavirus Response Act (FFCRA) and the documentation that employers need to maintain.