Legal Update, July 2022
Legal Update Genesis Healthcare Inc. v. Becerra: Reevaluating HRSA’s Regulatory Authority for the 340B Program by Elizabeth “Issie” Karan, Legal Counsel While lawsuits related to the 340B Discount Drug Program have become commonplace, there is a new important court ruling that jeopardizes the longstanding “patient” definition under the 340B Program. HTCs should expect this lawsuit […]
Legal Update, May/June 2022
Legal Update HTCs and Chapters: Partners in Education and Outreach by Elizabeth “Issie” Karan, Legal Counsel Hemophilia Treatment Centers (HTCs) ask the Hemophilia Alliance how they can support local chapters. As with all grants management questions, the way the support is structured matters. Below we review relevant guidance and provide suggestions for compliance. Education and […]
Legal Update, April 2022
Legal Update The Do’s and Don’ts of Contract Pharmacies in 340B Discount Drug Program for HTCs by Elizabeth “Issie” Karan, Legal Counsel The Office of Pharmacy Affairs (OPA) within the Health and Resources Services Administration (HRSA) oversees the 340B Discount Drug Program, and contract pharmacies operations. HRSA released guidance on contract pharmacy operations in 2010 […]
Legal Update, Spring 2022
Legal Update 340B Program Developments by Elizabeth “Issie” Karan, Legal Counsel On March 11, 2022, the U.S. District Court for the District of Delaware ruled that the Biden administration exceeded its legal authority when it used a letter to demand AstraZeneca honor discounts provided through the 340B program to contract pharmacies. The move marks a […]
Legal Update, February 2022
Legal Update Grants Management that Makes Sense by Elizabeth “Issie” Karan, Legal Counsel Hemophilia Treatment Centers (HTCs) often must grapple with grey areas when it comes to compliance with the rules for their federal funding. The Hemophilia Alliance team works to demystify these guardrails and steer HTCs towards effective operations. We want to highlight an […]
Legal Update, December 2021
Legal Update 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, […]
Legal Update, November 2021
Legal Update 340B Litigation Update: Once more unto the breach, dear friends, once more by Elizabeth “Issie” Karan and Mike Glomb Recently, three courts issued opinions related to ongoing 340B Program litigation. If you find yourself confused by headlines describing these outcomes, you are not alone. Before you devote significant brain power to dissecting the […]
Legal Update, October 2021
Legal Update Rebates Under the Uniform Grants Guidance: No Such Thing as a Free Lunch by Elizabeth “Issie” Karan & Michael B. Glomb Hemophilia Treatment Centers (HTCs) have asked whether rebates are considered “program income” under the Uniform Grants Guidance (UGG). Although rebates are excluded from the definition of program income, rebates constitute “applicable credits” […]
Legal Update, September 2021
Legal Update Reorganization of HRSA and Change in Office of Pharmacy Affairs Leadership by Elizabeth “Issie” Karan At the end of August, the Biden Administration released a notice in the Federal Register regarding the reorganization of the Health Resources and Services Administration (HRSA), including the 340B Program. The Office of Special Health Initiatives (OSHI) now […]
Legal Update, August 2021
Legal Update Uniform Grants Guidance Procurement Standards: More Than Just Finding a Good Bargain by Elizabeth “Issie” Karan When buying goods or materials, Hemophilia Treatment Centers (HTCs) may not first think to check federal regulations for grantees. However, the Uniform Grants Guidance (UGG) contains requirements for procurements conducted by federal grantees. These requirements were changed […]