Amgen and GSK Announce Refunds for 340B Overcharges

Nucala
GlaxoSmithKline is providing refunds for overcharges during Q2 2021 on sales of two NDCs of its severe asthma medicine Nucala.

Drug manufacturers Amgen and GlaxoSmithKline have notified 340B covered entities about refunds for overcharges, Amgen for sales in 2020 and GSK for sales in 2021.

The U.S. Health Resources and Services Administration posted both companies’ notices on its website yesterday.

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New Evidence that HRSA in 2020 Declared Permanent a 340B Policy it Abruptly Ended Last Week

Correspondence
In a May 18, 2020, email exchange, a 340B prime vendor executive (bottom excerpt) confirmed to a lawyer representing a 340B hospital (top excerpt) that HRSA's policy about using 340B drugs in hospital sites not on the hospital's most recently filed cost report was "applicable regardless of COVID-19."

Correspondence in April and May 2020 between the 340B prime vendor and a law firm sheds more light on the start of a policy that the federal government ended abruptly last week that let hospitals start using 340B drugs at

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Breaking News

HRSA and Prime Vendor Yank FAQs About 340B Use in Hospital Child Sites, and GAO Issues a New 340B Study

FAQ excerpt
Excerpts from 340B FAQs that HRSA (top) and the 340B prime vendor Apexus (bottom) have removed from their websites.

The U.S. Health Resources and Services Administration midday yesterday and the 340B prime vendor Apexus this morning, in connection with the end of the COVID-19 public health emergency late last night, withdrew mostly identical 340B program FAQs about use of

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Janssen to Pay Refunds for 340B Overcharges in Q2 2020

Janssen
Janssen Biotech is paying refunds for overcharges on certain 340B drugs purchased in the third quarter of 2020.

Drug manufacturer Janssen Pharmaceuticals said last week it would pay refunds for overcharges on 340B drugs purchased in the second quarter of 2020, including top-selling psoriasis drug Stelara.

Janssen, part of Johnson & Johnson, said it owes or may owe

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“This Is Bananas”: Hospitals Irate About HRSA’s Snap Decision to End 340B Patient Eligibility Clarification

Hospital outpatient location
340B hospitals expressed shock at HRSA's decision to cease a policy that has let patients receive 340B drugs at offsite outpatient locations that are sill going through the 340B registration process.

Editor’s note: New information from HRSA and Apexus obtained as we were going to press appears at the end of this article.

Hospital representatives said they were floored to learn yesterday that a June 2020 federal 340B patient eligibility policy

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Lifestar, Chartwell Announce Refunds for Q4 2022 340B Overcharges

340B refund notices
HRSA recently posted notices on its website of refunds for 340B overcharges from two generic drug manufacturers.

Generic drug manufacturers Lifestar Pharma and Chartwell Pharmaceuticals may owe refunds to 340B covered entities for overcharges on drugs purchased from the companies in the fourth quarter of 2022, according to recent notices posted on the U.S. Health Resources and

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Exclusive

HRSA Says COVID Flexibility About Dispensing 340B Drugs in Unregistered Hospital Offsite Locations Will End Thursday

COVID-19 flexibility
HRSA has reversed course and will end a 340B COVID-19 flexibility that it previously said was permanent that lets hospitals under certain conditions start using 340B drugs at offsite outpatient locations sooner than HRSA would normally allow.

The U.S. Health Resources and Services Administration said late Friday that when the COVID-19 public health emergency ends on Thursday, so too will a nearly three-year-old policy clarification that lets hospitals under certain conditions dispense 340B drugs at offsite outpatient

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340B COVID-19 Flexibilities Will End May 11 as Public Health Emergency Expires

HRSA
340B program flexibilities allowed under the COVID-19 public health emergency will expire May 11, HRSA said Monday.

Certain flexibilities to the 340B program allowed under the COVID-19 public health emergency will expire May 11 alongside the PHE, the U.S. Health Resources and Services Administration announced Monday.

The update, which HRSA posted prominently on the Office of Pharmacy

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Astellas Notifies 340B Entities for Second Time in 2023 About a Change in Drug’s NDC

Cresemba
Astellas says for 340B replenishment, the new and old NDCs of Cresemba’s 372mg intravenous formulation are interchangable.

Drug maker Astellas will let 340B covered entities count accumulations of an injectable form of its antifungal drug Cresemba under its old National Drug Code toward replenishment of equal quantities under the product’s corresponding new NDC, provided the entities use

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340B Recertification for CDC Grantees Starts May 8

Recertification
Annual 340B recertification for CDC grantees will be May 8 through June 5.

This year’s annual 340B recertification period for U.S. Centers for Disease Prevention and Control grantees—Title X family planning, sexually transmitted disease, and tuberculosis clinics—will be May 8 through June 5, the U.S. Health Resources and Services Administration said Tuesday.

Recertification

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