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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News Alert: Boehringer Ingelheim Sues HRSA in Defense of its 340B Contract Pharmacy Policy

Boehringer Ingelheim sued the federal government this afternoon in defense of its policy of denying hospitals 340B drug discounts when hospitals use contract pharmacies.

Drug manufacturer Boehringer Ingelheim (BI) sued the federal government this afternoon in federal district court in Washington, D.C., in defense of its policy of denying hospitals 340B drug discounts when hospitals use contract pharmacies.

BI is the seventh manufacturer to

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Senate Panel Backs Penalizing Drugmakers for their 340B Contract Pharmacy Actions

The Democratic-controlled Senate Appropriations Committee says it's pleased with HRSA's response to six drug manufacturers’ denials of 340B drug discounts involving contract pharmacy.

U.S. Senate appropriators say they’re happy with the federal government’s response to six drug manufacturers’ denials of 340B drug discounts involving contract pharmacy.

The Democratic-controlled Senate Appropriations Committee praised the U.S. Health Resources and Services Administration (HRSA) for its actions

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Biden Moves to End Trump’s Limits on HHS Guidance Including for 340B

The Biden administration wants to repeal ex-President Trump's regulation that has helped to cast doubt on the authority of 340B program guidance.

The Biden administration yesterday formally announced that it wants to repeal a regulation issued during ex-President Trump’s last days in office that has helped to cast doubt on the authority of federal health care guidance, including for the 340B program.

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Appeals Court Affirms Dismissal of Privacy Lawsuit Involving 340B Contract Pharmacy

A federal appeals court affirmed the legality of Walgreens' handling of customers' personal identifying information for 340B purposes.

A federal appeals court has affirmed a lower court’s dismissal of a lawsuit alleging that Walgreens’ internal transfer of pharmacy customers’ personal identifying information (PII) for 340B drug discount drug purposes violates South Carolina and federal privacy laws.

The U.S.

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BMS Tells 340B Entities It Has Lifted Purchasing Limits on Leukemia Drug

BMS's Celgene subsidiary has lifted purchasing limits for 340B covered entities and non-340B buyers on its injectable acute myeloid leukemia (AML) drug Vidaza.

Bristol Myers Squibb’s Celgene subsidiary has removed purchasing limits due to demand-related supply constraints on its injectable acute myeloid leukemia (AML) drug Vidaza that have been in place since May 2020.

BMS announced the switch back to normal sales in

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During Crucial Oral Arguments in AstraZeneca 340B Suit, Feds Urge Judge to Take a Fresh Look at Their Case

A federal district judge in Delaware heard arguments yesterday in AstraZeneca's 340B contract pharmacy lawsuit against the government.

A federal government lawyer told a judge during a hearing yesterday that the government’s case against AstraZeneca and other drug companies that deny 340B drug discounts when covered entities use contract pharmacies is “in a very different posture” than it

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340B ADR Rule Is Fundamentally Defective, PhRMA Tells Federal Court

PhRMA told a federal court in Baltimore, Md., that none of the federal government's legal arguments "can hide the fundamental defects" in the 340B ADR rule.

Pharmaceutical Research and Manufacturers of America told a federal district judge last week that the federal government has failed to refute PhRMA’s contention that the regulation establishing the 340B administrative dispute resolution (ADR) process “is unconstitutional, procedurally defective, and relies

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