Breaking: Federal Law Doesn’t Preempt Arkansas’s Novel 340B Contract Pharmacy Law, Judge Rules

Arkansas Insurance Department office sign
The Arkansas Insurance Department will imminently enforce a state 340B contract pharmacy law following a key federal appeals court decision.

A federal district judge ruled yesterday that Arkansas’s novel 340B anti-discrimination law is not preempted by the 340B statute nor by the U.S. Food and Drug Administration’s Risk Evaluation and Mitigation Strategies requirements.

U.S. Senior District Judge Billy Roy Wilson’s

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340B’s Critics Often Misunderstand its Intent, Ex-House E&C Chair Waxman Says in Health Affairs Commentary

Henry Waxman headshot
Ex-U.S. Rep. Henry Waxman (D-Calif.) says in a Health Affairs commentary that criticism of the drug discount program often “reflect[s] a misunderstanding of Congress’ intent.”

Henry Waxman, a California Democrat who was one of the original sponsors of the 340B law when it was created in 1992, says in a commentary in Health Affairs that criticism of the drug discount program often “reflect[s] a misunderstanding

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340B Report Publisher and CEO Slafsky: Expect More Attention to 340B in New Congress

U.S. Capitol building East elevation
Be prepared for a lot more attention on the 340B program in the upcoming Congress, 340B Report Publisher and CEO Ted Slafsky predicts.

Be prepared for a lot more attention on the 340B program in the upcoming Congress, 340B Report Publisher and CEO Ted Slafsky says in his latest column for medication management solutions company Omnicell.

340B was a hot topic in Congress

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Novo Nordisk Announces Third Round of 340B Refunds This Year

Novo Nordisk wordmark on building facade
Novo Nordisk for the third time this year has announced refunds for 340B overcharges due to revisions of Medicaid pricing data.

Drug manufacturer Novo Nordisk for the third time this year has announced refunds for 340B overcharges due to revisions of Medicaid pricing data.

The U.S. Health Resources and Services Administration posted the company’s notice to covered entities on its website

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Provider of HIV/AIDS Care Refiles Suit Against 340B Prime Vendor

AHF
AIDS Healthcare Foundation (AHF) last week refiled its lawsuit against federally contracted 340B prime vendor Apexus

California-based AIDS Healthcare Foundation (AHF) last week refiled its lawsuit against Delaware-based federally contracted 340B prime vendor Apexus, setting forth facts that AHF argued gives a federal district court in California jurisdiction over the case.

AHF, based in Los Angeles,

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Senior U.S. House Democrat and Republican Say They’re Hopeful Congress Will Act on 340B; Hearings Expected in New Congress

Rep. Robin Kelly (D-IL) and Rep. Brett Guthrie (R-KY) headshots
U.S. Reps. Robin Kelly (D-Ill.) and Brett Guthrie (R-Ky.) each said during an event yesterday they were hopeful Congress would act on 340B—Kelly regarding covered entities' concerns and Guthrie regarding those of payers and manufacturers.

The Democratic vice chair of the U.S. House Energy & Commerce Committee said during a media event yesterday she hopes Congress will address healthcare providers’ concerns about the 340B program during its lame duck session scheduled to end Dec. 15.

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RWC-340B Assessing Dispute Resolution Proposed Rule’s Impact on Its Lawsuit and Current Dispute Resolution Petition

Ryan White Clinics-340B wordmark
RWC-340B is assessing how HRSA's proposed new 340B dispute resolution process would affect the group's ongoing dispute with AstraZeneca and ongoing lawsuit against HRSA and HHS.

Ryan White Clinics for 340B Access told a federal district judge last week it needs time to assess how proposed new 340B administrative dispute resolution regulations, if finalized, could affect the 340B overcharging claims it brought against AstraZeneca under the

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Mike Braun, Key U.S. Senator on 340B Matters, Won’t See Re-Election in 2024

Sen. Mike Braun (R-IN) headshot
U.S. Sen. Mike Braun (R-Ind.), a key voice on 340B matters, is running for governor of Indiana in 2024 instead of seeking re-election to Congress.

U.S. Sen. Mike Braun (R-Ind.), whom 340B covered entities have considered both a friend and foe, has decided to run for governor of Indiana in 2024 rather than seek reelection to the Senate.

A senator since 2019, Braun serves on

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340B Dispute Resolution Proposed Rule Would Eject CMS Staff and HHS Lawyers from Process and Put OPA in Charge

graphic image of people in business attire with one announced as the winner
The Biden administration wants major changes to the 340B program administrative dispute resolution process, including giving OPA the only votes on ADR panels.

As we were the first to report on Tuesday morning, the Biden administration has proposed major changes to the 340B program administrative dispute resolution process, including stripping the Centers for Medicare & Medicaid Services and the Department of Health and

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Provider Groups Cite Inaction on 340B Pricing Denials in Their Reactions to Dispute Resolution Proposal

Screenshot of HRSA ADR notice
HRSA posted a notice about its proposed rule to revamp the 340B administrative dispute resolution process on the Office of Pharmacy Affairs homepage.

Groups that represent 340B covered entities said they looked forward to studying the federal government’s proposal Tuesday to revamp the 340B administrative dispute process. But they expressed concern that drug manufacturers still are not being punished for denying 340B pricing

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