Drug Makers May Be Getting Orphan Drug Designations to Exploit 340B Orphan Drug Exclusion, HHS OIG Tells Congress

The 340B orphan drug exclusion may give drug makers a strong incentive to get an orphan designation for their drugs prescribed primarily for common diseases or conditions, a federal watchdog agency reminded Congress this month.

The ban on 340B pricing on orphan drugs for over 1,000 hospitals may give companies that make drugs used primarily for common diseases or conditions a strong financial incentive to get an orphan designation for those drugs, a federal watchdog

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“Pharma Bro’s” ex-Company and ex-Partner Settling Claims Arising from Daraprim “Scheme,” FTC Says

“Pharma Bro” Martin Shkreli’s former company and former business partner agreed to settle legal claims arising from the company’s purchase of and 4,000% price increase on the drug Daraprim.

“Pharma Bro” Martin Shkreli’s former company and former business partner agreed Tuesday to settle legal claims brought against them by the U.S. and seven state governments arising from the company’s purchase of and 4,000% price increase on the drug Daraprim,

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340B Teaching Hospital Sues Over Medicare Part B Drug Payment Cut

The University of Kansas Medical Center sued last month over the continuation next year of a nearly 30% cut in Medicare Part B reimbursement for 340B purchased drugs.

The University of Kansas Medical Center (KUMC) has filed suit challenging the continuation in 2021 of a nearly 30% cut in Medicare Part B reimbursement for hospitals’ 340B-purchased physician-administered drugs.

KUMC filed the suit Nov. 24 in U.S. District Court

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Influential House Lawmaker and Rural Hospitals Upset About J&J’s 340B Orphan Drug Policy Change

Johnson & Johnson is ending voluntary 340B drug discounts on Remicade and other Janssen brand orphan drugs to rural and free-standing cancer hospitals.

Drug manufacturer Johnson & Johnson’s decision to end voluntary 340B drug discounts on orphan drugs to more than 1,000 rural hospitals at the end of this year “will make it even harder for patients to access drugs they desperately need,”

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House Panel Holding What Might be Last Hearing of its Drug Pricing Investigation

The U.S. House Oversight and Reform Committee is holding a hearing to review the findings of its investigation into drug industry pricing and business practices.

The Democratic-led U.S. House Oversight and Reform Committee is holding a hearing this Thursday to review the findings of its nearly three-year investigation into drug industry pricing and business practices.

The Dec. 9 hearing starts at 10:30 a.m. Eastern. It’s

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Feds Say They Need Time to Decide Whether to Appeal Ruling in Novartis and United Therapeutics 340B Cases

The federal government told U.S. District Judge Dabney Friedrich it needs more time to decide whether to appeal her joint ruling in Novartis and United Therapeutics’ 340B contract pharmacy lawsuits.

The federal government on Wednesday told the judge that ruled against it in drug makers Novartis and United Therapeutics’ (UT) 340B contract pharmacy lawsuits it needs more “time to decide whether to file appeals.”

The government’s Dec. 1 statement about

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HRSA Audit Finds Drug Maker and Subsidiary Overcharged 340B Providers

Generic drug manufacturer Precision Dose and its subsidiary Tagi Pharma overcharged 340B covered entities, a HRSA audit found.

Precision Dose, a maker of liquid generic drugs in unit-dose syringes and cups, and Tagi Pharma, a wholly owned subsidiary that makes generic oral and injectable drugs, will have to repay 340B covered entities for overcharges following an 340B program

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Lilly and Feds Disagree Over Whether 340B Case Is Ripe for Appeal

Drug maker Lilly and the federal government disagree over Lilly's 340B contract pharmacy appeal to U.S. Seventh Circuit Court of Appeals.

Drug manufacturer Lilly and the federal government disagree over whether a federal district judge’s recent decision in Lilly’s 340B contract pharmacy case is ripe for review.

Last month, the U.S. Seventh Circuit Court of Appeals questioned whether U.S. Senior

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Supreme Court May Upend Medicare DSH Calculation Formula, Which Would Impact 340B Stakeholders

Supreme Court Justices announced in a June 10 order that they’d review the U.S. Court of Appeals for the D.C. Circuit’s September 2023 decision in Advocate Christ Medical Center v. Becerra.

340B hospitals’ challenge to Medicare Part B drug reimbursement cuts was not the only case on the U.S. Supreme Court docket this week that could have a significant impact on the program.

On Monday, the justices heard the case of

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News Alert: U.S. Supreme Court Justices Question CMS’s Legal Basis for Slashing 340B Hospitals’ Drug Reimbursement

The U.S. Supreme Court heard arguments today about the legality of the nearly 30% Medicare Part B drug payment cut for 340B hospitals.

Several U.S. Supreme Court justices asked during a hearing today whether the Centers for Medicare & Medicaid Services (CMS) had statutory authority to single out 340B hospitals for a nearly 30% cut in Medicare Part B drug reimbursement beginning in

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