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HHS Issues Opinion Regarding Illegal Attempts by Drug Manufacturers to Deny 340B Discounts under Contract Pharmacy Arrangements

The federal 340B discount drug program is a safety net for many federally qualified health centers, disproportionate share hospitals, and other covered entities. This program allows these providers to obtain discount pricing on drugs which in turn allows the providers to better serve their patient populations and provide their patients with access to vital health care services. Over the years, the 340B program has faced intense scrutiny, particularly by drug manufacturers who are required by federal law to provide the discounted pricing.

Ongoing struggles between covered entities and drug manufacturers continued in 2020 when six manufacturers unilaterally decided to deny 340B discount drug pricing to covered entities utilizing contract pharmacy arrangements. This led to lawsuits filed by the American Hospital Association and a national network of HIV/AIDS clinics in the Fall of 2020. The battle between the covered entities and drug manufacturers took a unique twist on December 30, 2020 when the U.S. Department of Health and Human Services issued Advisory Opinion 20-06, which instructed that drug manufacturers were not legally permitted to deny the discounted 340B pricing to contract pharmacy arrangements. 

The HHS Advisory Opinion made three key conclusions:

  1. The plain language of the 340B Statute requires manufacturers to provide the 340B discounted pricing to covered entities independent of whether the covered entity chooses to utilize a third-party contract pharmacy to dispense the drugs.
  1. The purpose and history of the 340B program indicate that contract pharmacies have always been an integral part of the 340B program and HHS’s longstanding interpretation of the 340B statute and regulations has recognized the legitimate use of contract pharmacies.
  1. Manufacturers are inappropriately attempting to circumvent the 340B program’s standing procedures for resolving disputes between manufacturers and covered entities by unilaterally excluding contract pharmacy arrangements from their 340B discount drug pricing.

While the HHS Advisory Opinion does not have the binding effect of law, it should be noted that HHS, through its Health Resources and Services Administration (“HRSA”), oversees the 340B program. Only time will tell if the Advisory Opinion will persuade drug manufacturers to resume 340B pricing to covered entities utilizing contract pharmacy relationships. Stay tuned for future developments.

If you are interested in learning more about the 340B discount drug program or collaborative strategies to enhance patient care opportunities for 340B covered entities, please contact BMD Healthcare and Hospital Law Member Jeana M. Singleton at jmsingleton@bmdllc.com or 330-253-2001, or any member of the BMD Healthcare and Hospital Law group

For an update on actions the state of Ohio is taking to reduce predatory practices of PBMs, see BMD Healthcare and Hospital Law Member Daphne Kackloudis' article, SB 263 Protects 340B Covered Entities from Predatory Practices in Ohio.

Surprise! A Cautionary Tale for Out-Of-Network Billing: The No Surprises Act and the Impact on Healthcare Providers

SURPRISE! Congress passed The No Surprises Act at the end of 2020. Providers, particularly those billing as out-of-network providers, should start thinking about strategies to comply with this new law, set to take effect on January 1, 2022. In its most basic sense, the new law prohibits providers from billing patients for more than the in-network cost-sharing amount in most situations where surprise bills happen. It specifically applies to non-government payers and the amounts will be set through a process described in the new law. In particular, the established in-network cost-sharing amount must be billed for the following services:

Ohio Enacts Substantial Changes to Employment Discrimination Laws

In January, Governor Mike DeWine signed into law the Employment Law Uniformity Act, amending the employment protections in the Ohio Civil Rights Act in several significant ways. Such changes to the state’s anti-discrimination and anti-harassment laws have been considered and debated for years and finally made their way into Ohio law. What has changed for employment claims under the amended Ohio Civil Rights Act?

OHIO ADOPTS THE SERIES LLC: Implementation of Ohio’s Revised Limited Liability Company Act is Coming

On January 7, 2021, Ohio adopted S.B. 276. The new legislation establishes the Ohio Revised Limited Liability Company Act (“ORLLCA”) which effectively replaces the current Ohio LLC Act. ORLLCA will be fully effective as of January 2022. While the new law contains numerous changes to the existing LLC landscape, below is an overview of some of the key differences under the ORLLCA.

Will Federal Legislation Open Cannabis Acquisition Floodgate?

Are potential buyers quietly lobbying at federal and state levels to kick open the door to launch a new round of strategic acquisitions? Will presently pending federal legislation, the SAFE and MORE Acts, providing safe harbor for banks and re- or de-scheduling marijuana, be sufficient to mobilize into action major non-cannabis companies that previously shunned the cannabis industry due to the unknown implications of owning businesses whose activities are illegal under federal law?

The Future of the Families First Coronavirus Response Act

Over the last year we all have had to adjust to the new normal ushered in by the coronavirus pandemic. Schools and daycares closed, businesses transitioned from in-office work to work from home, bars and restaurants have closed their doors...all to slow the spread and try to prevent this pandemic from spiraling out of control. The start of the pandemic was utter pandemonium. Working parents trying to balance both caring for their now at-home children and their livelihood. Businesses trying to decide how to implement leave policies with limited information. Employees determining if they could financially afford to take time off. We were all flying by the seat of our pants trying to adjust to our new normal.