DOJ and AstraZeneca Far Apart on How Company’s Lawsuit Should Proceed

AbbVie and AstraZeneca filed a pair of lawsuits to block Minnesota's law barring manufacturer 340B contract pharmacy restrictions.

Drug manufacturer AstraZeneca and the federal government are miles apart on what a federal judge should do next after ruling last week that the government had no basis for stating in December that the 340B statute unambiguously requires manufacturers to

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DOJ Asks Judge to Toss PhRMA Suit Against 340B Dispute Resolution System and Audit Guidelines

The federal government has asked a judge to dismiss PhRMA's legal challenge to the 340B administrative dispute resolution final rule and guidelines governing drug manufacturer audits of 340B covered entities.

The U.S. Justice Department (DOJ) has submitted a blistering motion asking that a lawsuit filed by Pharmaceutical Research and Manufacturers of America (PhRMA) to strike down the new 340B program administrative dispute resolution (ADR) process be tossed out of court.

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Government Notifies Drug Companies About 340B Contract Pharmacy Advisory Opinion’s Withdrawal

Federal district courts in Maryland and Mississippi saw various legal actions related to state 340B contract pharmacy access laws in the past week.

The federal government notified drug makers Lilly, Novo Nordisk, and Sanofi in court papers on Friday about its withdrawal of its 340B contract pharmacy legal advisory opinion, in connection with AstraZeneca’s contract pharmacy lawsuit. It said the withdrawal does not

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Biden Nominates Acting HHS Inspector General for the Job Full Time

President Biden nominated career civil servant Christi Grimm to be the next HHS Inspector General.

President Biden last Friday nominated career civil servant Christi Grimm to serve as Inspector General of the U.S. Health and Human Services Department (HHS).

The HHS Office of Inspector General (OIG) has issued numerous reports on the 340B program on

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Breaking News

BREAKING: HHS Withdraws 340B Contract Pharmacy Advisory Opinion, and Becerra Appoints 340B Dispute Resolution Board Members

HHS yesterday withdrew its ex-General Counsel Robert Charrow's legal advisory opinion that the 340B statute requires drug companies to offer 340B pricing when covered entities use contract pharmacies.

HHS Withdraws 340B Contract Pharmacy Advisory Opinion, Says May 17 Demand Letters Are Unaffected

The U.S. Health and Human Services Department (HHS) yesterday withdrew its December 2020 legal advisory opinion (AO) that the 340B statute unambiguously requires drug manufacturers to

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340B Entity Groups Accentuate Positives in 340B Contract Pharmacy Court Opinion

The 340B statute “is silent as to the role that contract pharmacies may play in connection with covered entities’ purchases of 340B drugs," a judge ruled Wednesday in a suit filed by AstraZeneca.

Groups representing 340B covered entities are emphasizing the positives in what they say was a federal judge’s otherwise disappointing opinion Wednesday on whether drug makers must offer 340B ceiling prices when covered entities use contract pharmacies.

The groups’ message is,

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Supreme Court Preserves ACA and, with it, the Health Care Reform Law’s 340B Provisions

340B hospital challenge to Medicare Part B reimbursement could reverse long-standing legal doctrine.

The U.S. Supreme Court ruled 7-2 this morning that Texas and a dozen other Republican-led states lacked standing to challenge the constitutionality of the Affordable Care Act.

In addition to expanding health insurance to 21 million Americans, the ACA included

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Congressman Asks Becerra to Commit to Pause 340B Hospitals’ DSH Percentage Requirement

Democratic Rep. Joe Morelle of New York (left) asked HHS Secretary Xavier Becerra (right) during a House Education and Labor Committee hearing yesterday if he would commit to temporarily waive an eligibility requirement for 340B hospitals during the COVID-19 pandemic.

A congressman from New York asked U.S. Health and Human Services Xavier Becerra during a hearing yesterday if he will use his existing authority to protect hospitals from losing eligibility for 340B drug discounts due to changes in patient mix

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BREAKING: Judge Hands HHS Major Setback in AstraZeneca’s 340B Contract Pharmacy Lawsuit

U.S. District Judge Leonard Stark today rejected HHS's conclusion that the 340B statute requires drug makers to offer 340B pricing when covered entities use contract pharmacies.

A federal district judge ruled today that the U.S. Health and Human Services Department’s (HHS) position that the 340B statute requires drug manufacturers that participate in the 340B program to offer discounts on drugs dispensed by contract pharmacies “is not

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Biden Administration Proposes to Rescind Trump’s 340B Health Center Insulin Rule

The Biden administration today moved to rescind the Trump administration final rule requiring health centers to pass along their 340B savings on insulin and epinephrine pens to low-income patients.

The Biden administration this morning formally announced plans to rescind the controversial Trump administration final rule requiring community health centers to pass along all 340B drug discount savings on insulin and injectable epinephrine to low-income patients, as a condition for

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