340B

Quarles has significant experience assisting health care clients in navigating the complex world of the 340B drug pricing program. At one time or another, we have represented every type of player involved in interacting with the 340B program. For example, we have assisted covered entities in negotiating agreements with contract pharmacies and in complying with their reporting, audit, and other regulatory obligations. We have helped pharmacies draft contract pharmacy agreements to enter into the 340B realm using the ship to/bill to protocol. We have worked with Pharmacy Benefits Managers (PBMs) as they expanded their pharmacy network and pharmacy services agreements to include the provision of 340B pharmacy services.

Our experience includes defending a 340B pharmacy services provider in a protracted dispute with a covered entity. The key issues involved whether drugs purchased through the 340B program were dispensed to ineligible patients and whether the Group Purchasing Organization (GPO) exclusion provisions were violated. As part of this dispute, Quarles examined the 340B drug delivery system in detail, including the order, purchase, delivery, dispensing, tracking, and reporting of eligible 340B drugs. We also have advised a federally qualified health center lookalike on use of the 340B program. We have guided a covered entity client through a government investigation of its pricing and claims filing for 340B drugs provided to Title XIX patients. This project involved developing an understanding of how the state Medicaid agency was managing its exclusion file.

In addition to our significant experience drafting and negotiating contract pharmacy agreements from several client perspectives, Quarles has tremendous operational knowledge of the specialty pharmacy industry and the opportunities available to specialty pharmacy providers. The March 2010 HRSA guidance allows covered entities to contract with more than one pharmacy which maximizes medication therapy outcomes for the specialty pharmacy patient population.

The Quarles & Brady 340B team includes two partners who started their professional careers as pharmacists, one of whom was the owner of an independent pharmacy. The entire team has considerable 340B drafting, negotiating, and advisement experience. This combination of real life, relevant experience from pharmacist and pharmacy owner perspectives, coupled with our legal expertise, enables us to provide unparalleled advice to clients.