340B Drug Pricing Program

Offering a 360-degree view of the pharmacy and 340B universe.

Husch Blackwell has saved clients hundreds of millions of dollars through annual external audits and the ongoing guidance of our 340B team. We take a holistic approach to 340B compliance—integrating program optimization, complex regulatory strategies, and audit risk mitigation, among other concerns—to help our clients unlock greater corporate value.

Our team tracks and monitors 340B and related regulations, including patient eligibility determinations, contract pharmacy requirements, manufacturer actions, Medicaid duplicative discount compliance, shared savings programs, and grant limitations on use of savings. Husch Blackwell’s deep 340B and pharmacy bench also provides clients with our unique perspective of working in-house with pharmacy benefit managers and pharmacies alike, offering an unmatched depth of market and operational insight.

We have guided hundreds of 340B-covered entities at every phase of compliance and program optimization, from design and development to handling audits, where our team has assisted clients with more than 100 Health Resources and Services Administration (HRSA) and drug manufacturer audits, inquiries, and appeals. We have been extensively involved in the 340B Program for more than 10 years and have experience with essentially all areas of the 340B Program, including but not limited to comprehensive 340B external audits, assistance with HRSA audits, drafting of 340B Policies and Procedures, operational and financial strategies to maximize efficiencies and 340B savings, drug procurement strategies, TPA contract negotiations, TPA implementation assistance, OPAIS registrations, contract pharmacy PSA drafting and negotiations, billing and reimbursement guidance, in-house training and onboarding, etc.  As attorneys, we combine both our legal/regulatory knowledge and expertise with our operational and strategic experience to provide a dual-pronged approach to both navigate the legal complexities of the 340B program while also providing practical solutions to ensure all covered entities are making the most of their 340B programs.