Parent Issue

FDA Announces Approval of Pfizer-BioNTech COVID-19 Vaccine

The Food and Drug Administration (FDA) today announced its full approval for the Pfizer-BioNTech COVID-19 vaccine — under the name Comirnaty — for individuals 16 and older, making it the first COVID-19 vaccine to go beyond emergency use authorization (EUA) in the U.S.  

CDC Announces COVID-19 Vaccine Boosters for All, CMS Updates Coding Guidance

The Centers for Disease Control and Prevention (CDC) announced plans to begin offering COVID-19 booster shots to all individuals beginning the week of Sept. 20 and starting eight months after an individual’s second dose, pending authorization from the Food and Drug Administration (FDA) and a review by the CDC’s vaccine advisory committee.

HHHS Withdraws Guidance Requiring Manufacturers to Provide 340B Discount at Contract Pharmacies

The Department of Health & Human Services (HHS) has withdrawn a December 2020 advisory opinion from the Health Resources and Services Administration requiring pharmaceutical manufacturers to sell covered entities 340B drugs at or below the ceiling price when those drugs are distributed through a contract pharmacy.  Earlier this year, AstraZeneca and other drugmakers sued the agency over the opinion. The withdrawal follows a federal judge denying HHS’ request to dismiss AstraZeneca’s challenge.  

White Bagging — Medication Distribution Payer Changes

How familiar are you with “white bagging?” Maybe you’ve heard of it but aren’t sure what it is or how it affects your facility. Here’s a quick explanation: white bagging means payers reimburse third-party pharmacies, which then distribute the medications to outpatient medical providers, removing your ability to make changes to the patients’ medication.

HRSA Orders Drug Companies to Resume Discounts to 340B Contract Pharmacies

The Health Resources & Services Administration (HRSA) ordered six pharmaceutical companies to resume payments to contract pharmacies participating in the 340B discount program, stating that their current policies have resulted in overcharges and are in direct violation of the 340B statute. The letters were sent to Eli Lilly, Sanofi, AstraZeneca, Novartis, United Therapeutics, and Novo Nordisk.