Drug manufacturer Sanofi yesterday sent the U.S. Health Resources and Services Administration (HRSA) a 30-page defense of its requirement that 340B covered entities must submit their contract pharmacy claims data to a vendor to continue to be able to access
…Category: Federal
National hospital groups urged the U.S. Supreme Court last Friday to review and reverse a federal appellate decision upholding a steep cut in hospitals’ Medicare Part B reimbursement for 340B-purchased drugs.
The American Hospital Association (AHA), the Association of American
…Drug manufacturers Xellia Pharmaceuticals and Chartwell Rx have notified 340B covered entities about possible refunds for overcharges.
Xellia Pharmaceuticals
Xellia notified 340B covered entities about refunds for overcharges on 16 NDCs for its antibiotics vancomycin, daptomycin, and colistimethate.
Xellia posted
…Chiquita Brooks-LaSure last Thursday was formally sworn in as Administrator of the Centers for Medicare and Medicaid Services (CMS), setting in place another key Biden administration official with influence on the 340B program.
Although CMS does not control federal 340B
…Novartis Pharmaceuticals has sued the U.S. Health Resources and Services Administration (HRSA) over the agency’s May 17 letter telling the company its restrictions on 340B pricing to covered entities that use contract pharmacies are illegal.
Novartis told 340B Report late
…The Biden administration this afternoon proposed amending the 340B statute to let federal health officials audit 340B covered entities “to determine how net income from purchases under [340B] are used by the covered entity.”
The proposed legislation is included in
…A federal district judge in Indianapolis late this afternoon declined to temporarily restrain federal health officials from requiring drug maker Eli Lilly, based on a May 17 enforcement letter, to provide 340B discounts on drugs dispensed by contract pharmacies. Nonetheless,
…Drug makers Sanofi and Novo Nordisk and the federal government filed briefs Tuesday and Wednesday in federal district court in New Jersey in those two manufacturers’ separate challenges to the contract pharmacy requirements.
Sanofi and Novo Nordisk are seeking emergency
…Federal judges in Delaware and Indiana will hear arguments today in drug manufacturers’ AstraZeneca and Eli Lilly’s separate lawsuits challenging the 340B contract pharmacy requirements.
A judge in Wilmington, Del., earlier this week denied AstraZeneca’s motion for an emergency stay
…Robert Charrow—the U.S. Health and Human Services (HHS) general counsel who memorably opined that drug companies must offer their products at or below the 340B ceiling price “be it the lunar surface, low-earth orbit, or a neighborhood pharmacy”—has rejoined his
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