Category: News Alert

News Alert

Federal Appellate Judges Ask Lawyers, What is a Bona Fide Offer of 340B Pricing?

In Federal, Judicial, News AlertOctober 25, 2022977 Views

Judge Gregory Katsas is on a three-judge panel that will decide the legality of HRSA's 340B program violation letters to Novartis and United Therapeutics. He is shown here speaking at an October 2021 symposium on U.S. Supreme Court Justice Clarence Thomas, for whom he clerked. | C-SPAN

Two of three judges on a federal appeals court panel yesterday repeatedly asked lawyers during a highly anticipated hearing in Washington, D.C., what standard the court should use to decide whether drug manufacturers’ 340B contract pharmacy conditions are

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Feds Tell Court They Oppose Health Center’s Effort to Sink 340B Patient Definition

In Federal, Judicial, News AlertSeptember 23, 20221052 Views

Tom Mirga

Lawyers for HHS and HRSA told a federal district court yesterday the agencies oppose a health center’s efforts to have the longstanding 340B program definition of patient declared illegal.

Lawyers for federal healthcare officials told a federal district court yesterday that the government opposes a South Carolina health center’s efforts to have the longstanding 340B program definition of patient declared illegal.

In papers filed Sept. 22 in federal

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Becerra Says Legislation Is Needed to Strengthen HHS Authority to Address 340B Contract Pharmacy Pricing Denials

In Federal, Legislative, News Alert, Pharma Industry, RegulatorySeptember 3, 20221181 Views

Tom Mirga

Congress needs to give HHS more more regulatory power and money if its wants the department to do more about drug companies that curtail the use of 340B drugs in contract pharmacies, HHS Secretary Xavier Becerra told House members in a Sept. 1 letter.

U.S. Health and Human Services Secretary Xavier Becerra told members of Congress on Thursday that his department is doing all it can with the tools it has to address drug manufacturers’ denials of 340B pricing involving contract pharmacies.

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Boehringer Ingelheim Expands its 340B Drug Pricing Restrictions

In News Alert, Pharma IndustryAugust 8, 20221704 Views

Tom Mirga

Boehringer Ingelheim said on Friday that health centers will be subject to its limits on 340B pricing involving contract pharmacies starting Sept. 1.

Drug manufacturer Boehringer Ingelheim (BI) said on Friday that health centers will be subject to its limits on 340B pricing involving contract pharmacies starting Sept. 1. The restrictions previously applied to hospitals only. “At this time, for all

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New York State Sues CVS for Allegedly Forcing 340B Entities to Use Third Party Administrator Wellpartner

In Judicial, News Alert, StateJuly 28, 20221867 Views

Tom Mirga

New York State says in a lawsuit that CVS Health illegally forces 340B covered entities to use CVS's 340B TPA Wellpartner. CVS says the the state's claims lack merit and that it will defend itself.

New York State Attorney General Letitia James today sued CVS Health for allegedly forcing the state’s 340B covered entities to use CVS’s 340B third party administrator Wellpartner as a condition for letting the entities contract with CVS retail

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181 House Members Prod HHS to Start Fining Drug Makers for “Unlawful” 340B Overcharges Involving Contract Pharmacies

In Federal, Legislative, News AlertJuly 18, 2022944 Views

Tom Mirga

181 bipartisan U.S. House members on Friday urged HHS to quickly fine all drug manufacturers that deny 340B pricing when covered entities use contract pharmacies.

One hundred eighty-one U.S. House members—144 Democrats and 37 Republicans—urged the Biden administration on Friday to quickly impose civil monetary penalties against all drug manufacturers that restrict access to 340B pricing when covered entities use contract pharmacies.

“Manufacturers

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NACHC Asks HHS to Swiftly Punish Drug Makers for 340B Pricing Denials Involving Contract Pharmacies

In Federal, News Alert, Regulatory, Trade AssociationJune 17, 2022531 Views

Tom Mirga

NACHC urged HHS Secretary Xavier Becerra to hold drug manufacturers accountable for restricting shipments of 340B drugs to contract pharmacies.

The National Association of Community Health Centers (NACHC) strongly urged the U.S. Health and Human Services Secretary Xavier Becerra yesterday “to swiftly impose” fines on drug manufacturers that restrict shipments of 340B-purchased drugs to contract pharmacies and “hold

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New Study Finds 340B Contract Pharmacy Growth in Affluent and White Neighborhoods, Hospitals Criticize Research

In News Alert, Research/ReportsJune 17, 2022615 Views

Tom Mirga

340B contract pharmacy grew in affluent and White neighborhoods from 2011 to 2019 but declined in impoverished, Black, and Latino neighborhoods, a study published in JAMA Health Forum found. AHA strongly criticized the study.

340B contract pharmacy grew in affluent and White neighborhoods from 2011 to 2019 but declined in impoverished, Black, and Latino neighborhoods, raising questions about “the degree to which 340B program growth serves vulnerable communities,” according to research published

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Health Centers Ask Congress and Biden to Intervene to Protect 340B Savings from Pharma and PBM “Greed”

In News Alert, Research/Reports, Trade AssociationJune 13, 2022824 Views

Tom Mirga

An infographic NACHC released today in conjunction with a new survey of its members. The health center association wants Congress and the Biden administration to pass laws protecting centers from drug manufacturer and PBM policies that it says threaten centers' financial viability.

The National Association of Community Health Centers urged Congress and the Biden administration this afternoon to force drug companies to ship 340B drugs to contract pharmacies unconditionally and stop pharmacy benefit managers from siphoning off health centers’ 340B

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Exelixis, Maker of Expensive Cancer Drugs, Is Latest Manufacturer to Impose 340B Contract Pharmacy Conditions

In News Alert, Pharma IndustryJune 8, 20221174 Views

Tom Mirga

California-based biopharmaceutical company Exelixis is the 17th drug manufacturer to impose conditions on 340B pricing when hospitals use contract pharmacies.

Biopharmaceutical manufacturer Exelixis yesterday became the 17^th drug maker to impose conditions on 340B pricing when hospitals use contract pharmacies.

The company, a specialty manufacturer with two high-priced drug products on the market, announced its policy in email notices

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