340B Guidance Overly Burdensome, Lawyers Say

The recently issued proposed guidance for the 340B drug discount program is overly burdensome and likely to result in a reduction in savings, speakers said Sept. 22 during a webinar sponsored by Foley & Lardner LLP.

Elizabeth S. Elson, of counsel at the law firm, said the definition of a 340B patient in the guidance would be more difficult to manage from a compliance perspective and would cost more. Covered entities, such as hospitals, will have to keep their 340B registration and databases updated to comply with the new definition, she said.

Anil Shankar, an associate at Foley & Lardner, ...