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.
CMS Formally Rescinds Most Favored Nation Part B Drug Model
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would formally rescind its November 2020 Most Favored Nation model interim final rule (IFR).
DHCS Announces Medi-Cal Rx Will Go Live on Jan. 1, 2022
Given the ongoing challenges associated with the COVID-19 public health emergency, the Department of Health Care Services (DHCS) has decided to delay the full implementation of Medi-Cal Rx until April 1, 2021.
CHA Submits Concerns About White Bagging to Department of Consumer Affairs
CHA has submitted a letter of concern to the Department of Consumer Affairs about quality-of-care issues inherent in the payer practice known as white bagging.
Supreme Court Will Hear Case Challenging Medicare’s 340B Payment Cuts
On July 2, the Supreme Court agreed to hear American Hospital Association v. Becerra, a case that challenges Medicare’s 22.5% payment reduction to hospitals for certain separately payable outpatient drugs acquired under the 340B program.
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The Department of Health & Human Services (HHS) has withdrawn a December 2020 advisory opinion from the Health Resources and Services Administration requiring pharmaceutical manufacturers to sell covered entities 340B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.
HHS Proposes to Rescind Rule on Insulin, EpiPen Discounts for Community Health Centers
The Department of Health & Human Services (HHS) has issued a proposed rule to rescind a Trump-era final rule requiring federally qualified health centers to fully pass along discounts they received from the 340B drug discount program for insulin and EpiPens to low-income or uninsured patients.
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.