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

The federal government notified drug makers on Friday about its withdrawal of its 340B contract pharmacy legal advisory opinion. | Shutterstock

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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340B Sales Totaled $38 Billion Last Year, Industry Friendly Blog Reports

Prescription drug sales through the 340B program totaled $38 billion in calendar year 2020, says Adam Fein, writer of the Drug Channels blog.

Prescription drug sales through the 340B program totaled $38 billion in calendar year 2020, representing 7.2% of overall U.S. sales of $528 billion, Drug Channels blog reports.  Drug Channels is run by pharmaceutical manufacturer consultant Adam Fein, a leading critic

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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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AHA Wants Express Scripts to End 340B Claims ID Policy Immediately

The American Hospital Association asked Express Scripts this week to immediately withdraw its new 340B claims identification requirement for covered entities and their contract pharmacies.

The American Hospital Association (AHA) told pharmacy benefit manager Express Scripts (ESI) this week its new 340B claims identification requirement for covered entities and their contract pharmacies “is a major overreach” and should be withdrawn immediately.

An ESI spokesperson was

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340B Hospitals Concerned About New UnitedHealthcare Claims Reimbursement Policy

Starting Aug. 1, for commercial reimbursement, UnitedHealthcare will stop covering evaluation and management claims at hospital-owned outpatient facilities if the claim does not include an additional medical surgical service on the same date of service by the same provider. | Shutterstock

The nation’s largest health insurer is instituting a commercial claims reimbursement policy that that is raising alarms among 340B hospitals. 

Effective Aug. 1, UnitedHealthcare said it will no longer cover evaluation and management (E/M) claims at hospital-owned outpatient facilities

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