Legal Update, January 2024
Legal Update Legal Team Update: Beware! Scammers Steal Funds from Department of Health and Human Services (HHS) Grant Recipients by Elizabeth “Issie” Karan, Karan Legal Group, Hemophilia Alliance Legal Counsel Last week, news outlets reported that hackers gained access to the Payment Management Services (PMS) system utilized by HHS to process civilian grant payments and, […]
Legal Update, November 2023
Legal Update Genesis Healthcare Inc. v. Becerra: District Court Invalidates HRSA’s Patient Definition and Implementation in 340B Program by Elizabeth “Issie” Karan, Karan Legal Group, Hemophilia Alliance Legal Counsel On November 3, 2023, the US District Court for the District of South Carolina Florence Division ruled in favor of Genesis Healthcare Inc., a federally qualified […]
Legal Update, August 2023
Legal Update Detrimental Impact of Medicaid Unwinding by Elizabeth “Issie” Karan, Hemophilia Alliance Legal Counsel As a reminder, as part of the COVID-19 public health emergency (PHE), state Medicaid programs were not allowed to conduct the typical, annual re-determination process for beneficiaries (i.e., state Medicaid programs could not remove anyone from their rolls). Now and […]
Legal Update, July 2023
Legal Update Lawsuits on Implementation of Medicare Drug Pricing Negotiation by Elizabeth “Issie” Karan, Hemophilia Alliance Legal Counsel In recent weeks, pharmaceutical manufacturers, including Merk, Bristol-Myers Squibb, and PhRMA, and the Chamber of Commerce have filed a slew of lawsuits challenging the Medicare Drug Price Negotiation Program authorized by the Inflation Reduction Act. Merck argued […]
Legal Update, April 2023
Legal Update 340B Contract Pharmacy Services Agreement: Some Rules and Many Pitfalls by Elizabeth “Issie” Karan, Legal Counsel Controversy abounds in use of contract pharmacies in the 340B Discount Drug Pricing Program with 22 manufacturers restricting their use and/or requiring extensive data reporting from most covered entities. Luckily, and with some hard work from the […]
Legal Update, February 2023
Legal Update A New Era of Conundrums: Contracting with Related Pharmacies to Prepare for Gene Therapy by Elizabeth (Issie) Karan and Michael B. Glomb, Legal Counsels With the dawn of gene therapy, the Hemophilia Alliance is fielding more questions from member Hemophilia Treatment Centers (HTCs) about options for collaborating with in-house and/or institution pharmacies. More […]
Legal Update, January 2023
Legal Update 340B Compliance Spotlight: The Importance of Self-Audits by Issie Karan, Legal Counsel Hemophilia Treatment Centers (HTCs), which participate in the 340B Discount Drug Pricing Program as Covered Entities, must dedicate resources to appropriate oversight of their program. The hallmarks of 340B compliance include strong policies and procedures, processes, internal controls and a leadership […]
Legal Update, October 2022
Legal Update How to Compliantly Increase Visibility of HTCs and the Comprehensive Care Model by Elizabeth “Issie” Karan, Legal Counsel Recently, several Hemophilia Treatment Centers (HTCs) have inquired about the rules and any limitations on marketing their programs. As described further below, these activities can be vital to HTC operations and have support in programmatic […]
Legal Update, September 2022
Legal Update Really, Truly: Only Eligible Patients Can Receive 340B Drugs by Elizabeth “Issie” Karan, Legal Counsel The 340B Discount Drug Program grants eligibility to many types of federal grantees and specially designated hospitals, along with Hemophilia Treatment Centers (HTCs). Sometimes these entities may be part of the same health system and/or corporate structure. However, […]
Legal Update, August 2022
Legal Update Proving the Absence of a Requirement: Use of Funds Derived from the 340B Program for Indigent Care by Elizabeth “Issie” Karan Recently, the Hemophilia Alliance team was asked to prove that funds generated from a HTC’s 340B Program are not required to be used exclusively to support charity care. Although this is not […]