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 Read the full article…
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 Read the full article…
Legal Update Compliance Program Check-Up: OIG’s Seven Elements of Compliance by Elizabeth “Issie” Karan For decades, the Office of the Inspector General (OIG) for the Department of Health and Human Read the full article…
Legal Update HHS Rescinds Advisory Opinion after Court Describes 340B Statute as Ambiguous as to Contract Pharmacies by Elizabeth “Issie” Karan Last week saw a new installment in the never-ending Read the full article…
Legal Update 340B Program Updates by Elizabeth “Issie” Karan On May 17, 2021, Health Resources and Services Administration (HRSA) Acting Administrator Diana Espinosa sent letters to six pharmaceutical manufacturers (AstraZeneca, Read the full article…
Legal Update Getting Out Your Message without Getting in Hot Water: HTC Marketing and the Grant Rules by Elizabeth (Issie) Karan Hemophilia Treatment Centers (HTCs) reach out to the Hemophilia Read the full article…
Legal Update State Laws Regulating Pharmacy Reimbursement, ERISA,and the Supreme Court – What Could Rutledge Mean for 340B Covered Entities? by Elizabeth (Issie) Karan On December 10, 2020, in Rutledge Read the full article…
In recent weeks, the Trump Administration released a long-awaited on the Alternative Dispute Resolution (ADR) process in the 340B Drug Discount Program (340B Program).
As part of the Department of Health and Human Services’ (HHS’) “Regulatory Sprint to Coordinated Care,” the Centers for Medicare & Medicaid Services (CMS) and the HHS Office of the Inspector General (OIG) both released final regulations on Friday, November 20, 2020.
HTCs often inquire with the Hemophilia Alliance regarding what is an appropriate “indirect cost rate.”
