Legal Update, July 2021
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 Services (HHS) has provided its perspective on the most important elements to consider when developing and implementing an effective compliance program. Hospitals are required to […]
Legal Update, June 2021
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 saga of legal disputes related to the use of contract pharmacies in the 340B Discount Drug Pricing Program. On June 18, 2021, the Department of […]
Legal Update, May 2021
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, Lilly USA, Novartis, Novo Nordisk, Sanofi, and United Therapeutics). The letters may be found here (look for “HRSA Correspondence to Stakeholders 2021). The letters state […]
Legal Update, March 2021
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 Alliance with questions regarding marketing their programs. Often these questions result from tension between programmatic requirements for HTCS and the federal grant rules. However, the […]
Legal Update, February 2021
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 v. Pharmaceutical Care Management Association, the Supreme Court rejected a challenge to states’ authority to regulate pharmacy benefit managers (PBMs) and pharmacy reimbursements. In a […]
Legal Update, December 2020
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).
Legal Update, November 2020
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.
Legal Update, October 2020
HTCs often inquire with the Hemophilia Alliance regarding what is an appropriate “indirect cost rate.”
Legal Update, September 2020
Under the auspices of 340B Program compliance, manufacturers recently requested extensive data from covered entities related to drugs dispensed through contract pharmacies.
Legal Update, August 2020
Under the auspices of 340B Program compliance, manufacturers recently requested extensive data from covered entities related to drugs dispensed through contract pharmacies.