Biden Administration Wants to Scuttle Azar’s Rule to Automatically Snuff Out HHS Regulations

The Biden administration says it wants to withdraw or repeal ex-HHS Secretary Alex Azar’s final rule that will automatically extinguish all HHS regulations if HHS does not renew each regulation within a certain timeframe. | C-SPAN

The Biden administration last Friday, as widely expected, proposed withdrawing or repealing a Trump administration final rule that will automatically extinguish all U.S. Health and Human Services (HHS) regulations if HHS does not renew each regulation within a certain timeframe.

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340B INDUSTRY LEADER SPOTLIGHT

Kelly Kolker, President, 340B Solutions, CPS

Kelly Kolker

Q: Where did you grow up?

Born and raised in the great state of Iowa, and I still live here.  It is a fantastic place to raise a family.

Q: Where did you go to college/graduate school?

Clarke University for undergrad (Chemistry); The University of Iowa for Pharmacy School; University of Dubuque for MBA.

Q: What

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Breaking News

Breaking: Federal Judge Vacates HRSA’s May 17 Letter to Lilly on 340B Contract Pharmacies, Sends Matter Back to Agency

A federal district judge late this afternoon struck down, as arbitrary and capricious, HRSA's finding that Lilly's 340B contract pharmacy policies violate the 340B statute. However, the judge said that manufacturers should not be allowed to unilaterally impose conditions on the location and delivery of 340B drugs and sent the matter back to HRSA.

A federal district judge in Indianapolis late this afternoon set aside and vacated the federal government’s May 17 finding that drug manufacturer Eli Lilly’s denials of 340B ceiling prices when covered entities use contract pharmacies violate the 340B statute.

A

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340B Lobbying Intensifies on Capitol Hill and in Federal Agencies

2021 could be the runner up to 2018 in terms of 340B lobbying intensity, as measured by citations on lobbying disclosure forms.

2021 is on track to rival peak year 2018 in lobbying intensity on the 340B drug pricing program.

Attention on health care lobbying in Washington today focuses on the huge sums the drug industry is spending fighting Democratic drug price

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Both Sides in AstraZeneca’s 340B Contract Pharmacy Case Want a Quick Ruling, but It’s Unclear if They Will Get One

Both sides in AstraZeneca's 340B contract pharmacy lawsuit want an expedited decision, but for very different reasons.

Drug manufacturer Astra Zeneca and the federal government both want a federal district judge in Delaware to rule quickly in the drug company’s lawsuit over the government’s 340B contract pharmacy requirements.

The two sides, however, are miles apart on why

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D.C. Federal Judge Picks Up a Fourth 340B Contract Pharmacy Lawsuit

U.S. District Judge Dabney Friedrich is now in charge of four 340B contract pharmacy lawsuits.

U.S. District Judge Dabney Friedrich of the District of Columbia has been assigned to a fourth 340B contract pharmacy lawsuit.

Boehringer Ingelheim’s (BI) lawsuit in defense of its policy of denying hospitals 340B drug discounts when hospitals use contract pharmacies

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Federal Court Decision on Novel Arkansas 340B Contract Pharmacy Law Might Not Come Until 2023

A federal district judge in Little Rock might not rule on Arkansas’s 340B nondiscrimination law might until sometime in 2023.

A federal court ruling on the legality and constitutionality of Arkansas’s 340B nondiscrimination law might not come until sometime in 2023.

U.S. Senior District Judge Billy Roy Wilson on Monday issued an initial scheduling order in the drug industry lawsuit

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HRSA Orders Two Drug Makers to Repay 340B Entities After Audits Show Overcharges

HRSA has ordered Akorn Inc. and BioComp Pharma to repay 340B covered entities for overcharges following audits.

The U.S. Health Resources Services Administration (HRSA) has ordered two drug manufacturers that it audited—Akorn Inc. and BioComp Pharma—to repay 340B covered entities for overcharges.

HRSA updated its fiscal year 2021 audit results on its website last week.

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Updates on 340B Administrative Dispute Resolution Lawsuits and ADR Panel Hearings

There were several recent important developments involving HRSA's 340B administrative dispute resolution system. | Credit: "File:Massimo Busacca, Referee, Switzerland (10).jpg" by Steindy (talk) 11:44, 19 June 2011 (UTC) is licensed under CC BY-SA 3.0

The federal government and the two groups that sued it separately to force it to issue long delayed 340B administrative dispute resolution (ADR) regulations agreed last night to keep stays in place in both lawsuits until Jan. 3, 2022. Meanwhile,

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Virginia Health Center Joins 340B-Related Antitrust Suit Against Insulin and Diabetes Drug Makers

Central Virginia Health Services has joined an antitrust lawsuit against four insulin and diabetes drug manufacturers over the companies’ denials of 340B pricing when covered entities use contract pharmacies.

A central Virginia community health center has joined an upstate New York health center’s antitrust lawsuit against four insulin and diabetes drug manufacturers over the companies’ denials of 340B pricing when covered entities use contract pharmacies.

Central Virginia Health Services’

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