Sanofi and Novartis Fight HRSA’s 340B Contract Pharmacy Demand Letters

Sanofi yesterday sent HRSA a long letter defending its limits on 340B contract pharmacy. | Shutterstock

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

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340B Hospitals Ask Supreme Court Again to End Steep Medicare Drug Payment Cut

The U.S. Supreme Court this morning agreed to take up a case regarding Medicare Part B cuts to 340B hospitals. | Shutterstock

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

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Two Drug Makers Providing Refunds for 340B Overcharges

Drug manufacturers Xellia and Chartwell have notified 340B covered entities about possible refunds for overcharges. | Shutterstock

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

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Brooks-LaSure Sworn in as CMS Administrator

HHS Secretary Xavier Becerra (left) administers the oath of office to new CMS Administrator Chiquita Brooks-LaSure as her husband, Allyn Brooks-LaSure looks on.

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

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Breaking News

BREAKING: Novartis Sues HRSA in Defense of its 340B Contract Pharmacy Policy

Novartis sued HRSA yesterday to stop it from enforcing its interpretation of the 340B statute's contract pharmacy requirements, and from imposing civil monetary penalties against Novartis for alleged violations. | Shutterstock

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

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Breaking News

HHS Wants to Audit 340B Providers to See How They Use 340B Net Income

HRSA, headquartered in this suburban Washington office building, would be empowered to audit 340B covered entities to see how they use income from 340B drug purchases, under a Biden administration proposal issued today.

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

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Breaking News

Late Breaking Developments in Lilly and AstraZeneca’s 340B Contract Pharmacy Lawsuits

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. | Shutterstock

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,

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As June 1 Deadline Looms, Drug Manufacturers and Feds Make Their Case in New Jersey Federal Court

Drug makers Novo Nordisk and Sanofi and the federal government filed briefs Tuesday and Wednesday in federal district court in New Jersey in the two manufacturers’ separate challenges to the contract pharmacy requirements.

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

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Key Hearings Today in AstraZeneca and Lilly’s 340B Contract Pharmacy Lawsuits

AstraZeneca and Eli Lilly will be before federal district judges today seeking to stop enforcement of 340B contract pharmacy requirements they oppose.

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

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Vermont Places 340B-Related Strictures on PBMs and Adds Protections to Contract Pharmacies

Vermont’s legislature has voted to bar pharmacy benefit managers (PBMs) from requiring claims modifiers on 340B-purchased drugs, except for claims paid directly or indirectly by Medicaid. | Tony Fischer https://www.flickr.com/photos/tonythemisfit/

Vermont’s legislature has voted to bar pharmacy benefit managers (PBMs) from requiring claims modifiers on 340B-purchased drugs, except for claims paid directly or indirectly by Medicaid.

PBMs also would be unable to restrict 340B contract pharmacies’ access to pharmacy networks

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