Allison Inserro

Biosimilar Medicare Part B Payment Boost Begins

October 03, 2022

Under the Inflation Reduction Act, there is a 5-year temporary increase in the add-on payment for qualifying biosimilars whose average sales price (ASP) is not more than the price of the reference product.

COA Says COVID-19 Policy Changes Put Patients at Risk

April 13, 2020

Cancer treatments can lead to unpredictable adverse events, so a COVID-19–related measure allowing home infusion jeopardizes patient health and safety, according to the Community Oncology Alliance (COA).

FDA Releases Q&A for Industry With Details About Insulin Transition

March 05, 2020

Looking to March 23, the FDA released a question-and-answer guidance document for industry about the upcoming transition for how certain products will now be approved under a biological pathway, including exceptions to the transition and how companies will receive notifications about their applications.