340B Report Analysis: Federal 340B Law Gives States Room to Regulate their Own Drug Distribution Systems, Judge Rules in Arkansas Contract Pharmacy Case

U.S. District Court Little Rock, AR court room
A federal judge in Little Rock, Ark., held that the state's novel 340B anti-discrimination law is not preempted by federal laws.

As we reported on deadline on Tuesday, a federal district court ruled this week that Arkansas’ novel 340B antidiscrimination law is not preempted by federal laws governing the 340B program, a decision that strikes down one of two legal arguments

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117th Congress Nears End With No 340B Contract Pharmacy Fix Expected

U.S. Capitol building at sunrise
Five congressional Democrats signed on as co-sponsors to a bill that would bar drugmaker restrictions on 340B contract pharmacy arrangements.

The 117th Congress appears destined to end without further action on the 340B program.

The House and Senate are on track to finish all work for the year by no later than Friday, Dec. 23. According to news reports yesterday,

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340B Registration for First Quarter of 2023 Will Run from Jan. 1 to Jan. 17

Image of pen and clipboard with medical cross symbol
The first quarter 2023 registration period for covered entity enrollment in 340B will begin Jan. 1 and end Jan. 17.

The U.S. Health Resources and Services Administration has slightly adjusted the dates of the first of four periods in 2023 during which eligible entities may register themselves, their child sites, and their contract pharmacies to participate in the 340B program.

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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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