Not the Old, Not the New, but the Necessary: Legal Review of 2021
by Elizabeth “Issie” Karan, Legal Counsel

2021 brought new but also familiar opportunities and challenges in the hemophilia treatment center (HTC) compliance and legal world. While Hemophilia Alliance members always ask insightful questions amidst the larger healthcare landscape’s surprising turns, the pressures of operating a highly regulated grant program in a complex industry often return the legal team’s work to the same authorities and themes. Through both the known and novel, the Alliance legal team works to distill and translate the miasma into useful and actionable guidance for HTCs.

On new subjects, the legal team often collaborated with other members of the Alliance team. We assisted the policy and payer team in preparing for implementation of the Hemophilia SNF Access to Care Act. We advised the Alliance on issues related to DDAVP. We began to prepare for gene therapy by developing legal templates. We provided analysis of state pharmacy laws impacting HTCs’ operations. Additionally, we tracked litigation related to the 340B Program. Although many issues were different, the cooperation and camaraderie of the Alliance team remains.

On the familiar topics, the legal team fielded many members’ questions related to federal grants and the 340B Program. Among other things, in the grants arena, we provided technical assistance on the use of program income, reasonable indirect cost rates, and salary limitations. For 340B, we helped members with policies and procedures, audit protocols, and operationalizing the patient definition. Through it all, we encouraged HTCs to connect with their regional leadership when appropriate and educated members through presentation.

We know 2022 will bring both unexpected and known inquiries and look forward to helping guide the Alliance and its members to the right answers.