Our team has extensive experience guiding clients through the complex world of the 340B drug pricing program. Our experience extends to representing nearly every category of stakeholder involved in the 340B program, including hospital covered entities, grantee covered entities, contract pharmacies, third party administrators (TPA), manufacturers, pharmacy benefit managers (PBM) and drug wholesalers. This well-rounded experience informs the holistic and practical nature of our 340B advice, ensuring that any proposed actions or procedural changes are made with the full picture in mind. More specifically, we routinely assist covered entities in complying with their reporting, enrollment, audit and other regulatory obligations related to the 340B program, ranging from general compliance with federal 340B requirements to more granular compliance with state-level Medicaid billing and general board of pharmacy regulations. We also assist covered entities in developing creative, compliant strategies for 340B program optimization to ensure the maximum available 340B benefit for their patient population, including coordinating with TPA partners to determine the most beneficial eligibility configuration settings to maximize compliant capture of 340B claims.
On the pharmacy side, we frequently work with contract pharmacies to negotiate 340B contract pharmacy agreements that enable both covered entities and the contract pharmacies to obtain 340B program benefits and maintain program compliance. We also work with PBMs as they expand their pharmacy network and pharmacy services agreements to include the provision of 340B pharmacy services and navigate state-level restrictions on 340B program reimbursement. In addition to our experience with the 340B program specifically, our team has a deep bench of experienced pharmacy lawyers who can ably identify and resolve pharmacy issues adjacent to the 340B program.
Brenda Maloney ShaferEmail
Brenda is a member of Quarles & Brady’s Health Law Practice Group. Her practice focuses primarily in health law and, in particular, health care regulatory and transactional work. Along with her law degree, she holds a Master’s of Law in Health Law. A particular area of focus is counseling clients regarding compliance with the 340B Drug Pricing Program.
Richie has extensive experience with the 340B Program and has worked with both contract pharmacies and covered entities to develop and optimize their program participation. His practice also focuses on a wide variety of pharmacy regulatory issues, including controlled substances and state licensure compliance.
Mike has unique experience in the 340B Program, utilizing his former 340B consulting background to blend legal analysis with operational and financial considerations. Mike has assisted an extensive list of 340B stakeholders optimize available 340B benefit while ensuring compliance with the 340B Program’s complex regulatory structure.
Madison has growing experience in the 340B Program, and has assisted with providing updates to stakeholders in the ever-changing landscape of 340B.