Pharmacy / 340B

In crucial areas such as compliance, transactions, advocacy, revenue optimization and reimbursement protection.

Feldesman has been at the forefront of 340B program advocacy since the drug discount program’s inception in 1992.  Representing a diverse range of 340B program stakeholders, our attorneys focus primarily on supporting covered entity grantees including federally qualified health centers, Ryan White HIV/AIDS Program providers, hemophilia treatment centers and family planning clinics, as well as eligible hospitals such as disproportionate share hospitals, children’s hospitals, critical access hospitals and other rural medical centers. We take pride in our commitment to staying at the forefront of innovative care delivery models, such as telemedicine, patient-centered medical care, chronic disease management and clinical pharmacy services.

Feldesman actively represents covered entities, and the pharmacies and administrators that support them before HRSA and its Office of Pharmacy Affairs, as well as state and federal lawmakers. We have played a pivotal role in developing and enacting 340B program protections at both the state and federal levels, including passing legislation in multiple states.

Our attorneys have a wealth of experience handling a myriad of transactional matters related to the 340B program. These include crafting contract pharmacy agreements, third-party administrator (TPA) agreements, independent audit engagements and fostering partnerships that serve the best interest of our clients.

In addition, we provide support to covered entities in resolving disputes with government agencies, vendors and drug manufacturers. Feldesman is recognized for its pioneering efforts in bringing dispute resolution claims before HRSA when drug manufacturers violate their program obligations.

Lastly, our attorneys believe strongly in compliance preparedness, offering multiple trainings and webinars throughout the year on 340B program compliance and management topics. The firm conducts audits of policies and procedures, and can perform compliance audits directly or engage experienced compliance reviewers on behalf of our clients.

If you have questions, please contact Michael B. Glomb at mglomb@feldesman.com or Steve Kuperberg at skuperberg@feldesman.com.