CMS Taps Massachusetts Medicaid Director to Run Key Post Impacting 340B Program

Massachusetts Medicaid director Daniel Tsai has been named Director of CMS’s Center for Medicaid and CHIP Services.

The U.S. Centers for Medicare & Medicaid Services (CMS) announced on Monday that Massachusetts’ Medicaid director Daniel Tsai has been named Deputy Administrator of CMS and Director of CMS’s Center for Medicaid and CHIP Services (CMCS). A record 80 million

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NEWS ANALYSIS: Top Job at HRSA Remains Unfilled as Biden Presidency Enters its Sixth Month

HRSA recently held a webinar for hospitals ahead of their annual 340B recertification period.

Today is President Biden’s 155th day in office, and he has yet to pick someone to run the U.S. Health Resources and Services Administration (HRSA), the federal agency responsible for the 340B drug pricing program.

This normally might be a

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News Alert: Becerra Puts His Imprint On Long-Awaited 340B Dispute Resolution Board

HHS Secretary Xavier Becerra made appointments today to the 340B administrative dispute resolution board. | Shutterstock

U.S. Health and Human Services (HHS) Secretary Xavier Becerra this morning announced his six appointees to the long-awaited 340B administrative dispute resolution (ADR) board.

The move will be welcomed by the 340B provider community, which has pushed for the creation

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Pharma’s 340B Contract Pharmacy Limits Are Costing Providers $3.2 Billion a Year, DOJ Tells Court

Covered entities' monthly 340B savings on Sanofi products dropped from $54.2 million just before the company limited discounts on drugs shipped to contract pharmacies to about $5 million within two months, federal lawyers told a judge last week.

Hospitals, health centers, and clinics are losing a projected $3.2 billion a year in 340B program savings due to six drug manufacturers’ denials of 340B pricing on drugs shipped to contract pharmacies, the federal government said in a court filing

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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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