HRSA Sanctions Manufacturer for Not Issuing Refund for 340B Overcharges

KVK Tech office building
HRSA has ordered Pennsylvania-based generic drug manufacturer KVK Tech to repay 340B covered entities for program violations found during an audit.

The U.S. Health Resources and Services Administration has ordered Pennsylvania-based generic drug manufacturer KVK Tech to repay 340B covered entities for program violations found during an audit.

HRSA posted its audit findings Nov. 15. “KVK-Tech failed to refund covered entities for

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White House Gives HRSA Green Light to Publish Proposed New 340B Dispute Resolution Regulations

Screenshot of reginfo.gov 340B program ADR record
The White House yesterday authorized HRSA to publish a proposed rule to replace the 340B administrative dispute resolution final rule HRSA promulgated in late December 2020.

The White House yesterday unexpectedly gave the U.S. Health Resources and Services Administration permission to publish a proposed replacement for HRSA’s December 2020 340B administrative dispute resolution final rule.

The Office of Management and Budget announced on its website Nov.

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A Closer Look at Tuesday’s Arguments in Federal Appeals Court Over the Legality of the 340B Contract Pharmacy Program

Third Circuit Court building entrance
Today 340B Report takes a closer look at Tuesday's oral arguments in federal circuit court in Philadelphia in three 340B contract pharmacy lawsuits.

On Tuesday we reported about oral arguments before a federal appeals court in Philadelphia in AstraZeneca, Novo Nordisk, and Sanofi’s lawsuits challenging federal agency findings that the companies’ conditions on 340B covered entities’ use of contract pharmacies violate the 340B statute.

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With GOP Control of U.S. House, Expect Increased Oversight of 340B Providers

Screenshot of Twitter post by Kevin McCarthy
U.S. House GOP Leader Kevin McCarthy last night posted this tweet announcing his party will be the majority in the chamber for the next two years.

The Republican Party won control of the U.S. House last evening, securing the requisite 218th seat for majority status after the Associated Press declared Rep. Mike Garcia (R) the winner of a race in California.

Democrats on Nov. 12 won

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Breaking News

Two of Three Appeals Court Judges Question Government’s Stance That Drug Companies May Not Impose Conditions on 340B Sales

U.S. Third Circuit Court of Appeals court room
Two judges on a three-judge federal appeals court panel in Philadelphia today questioned whether the 340B statute forbids drug manufacturers from imposing distribution conditions on offers of 340B pricing.

Two judges on a three-judge federal appeals court panel this morning challenged a federal government lawyer’s stance that federal law forbids drug manufacturers from limiting how their drugs may be distributed when they offer to sell the drugs at reduced

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Appeals Court To Hear Arguments Today in AstraZeneca, Novo Nordisk, and Sanofi’s 340B Contract Pharmacy Suits

The seal of the U.S. Third Circuit Court of Appeals
A federal appeals court in Philadelphia is hearing arguments today in AstraZeneca, Novo Nordisk, and Sanofi’s 340B contract pharmacy lawsuits.

A federal appeals court in Philadelphia this morning is hearing arguments in AstraZeneca, Novo Nordisk, and Sanofi’s lawsuits challenging federal agency findings that the drug companies’ 340B contract pharmacy policies are illegal and must stop or the firms could be

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With Democrats Retaining Control of U.S. Senate, Expect New Leadership in Key Committee

Citizen holding I Voted election sticker
Missouri’s 340B contract pharmacy access law has become a hot topic in the state's primary races.

Democrats will still control the U.S. Senate for the next two years, it became clear over the weekend, but control of the House has not yet been decided one week after the Nov. 8 midterm elections.

As of early this

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340B Law Should Be Amended to Include Emergency-Use COVID-19 Drugs, Health Affairs Opinion Article Says

screenshot of Bebtelovimab product page
A screen shot from an HHS video about the monoclonal antibody betelovimab used to treat COVID-19 infection.

The 340B statute should be amended to extend discounts to emergency-use drugs to treat COVID-19 as a first step in rebuilding the COVID-19 safety net, an opinion piece published yesterday in the medical journal Health Affairs says.

The Nov.

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With Party Control of Congress Still Undecided, 340B Providers Lose Some Key Champions but Retain Some Heavy Hitters

Rep. Cathy McMorris Rodgers (R-WA) headshot
Legislation sponsored by Rep. Cathy McMorris Rodgers (R-Wash.) drew a partisan clash at a Sept. 14 hearing over changes it would implement for the 340B program.

Partisan control of Congress for the final two years of President Biden’s term in office was still undecided this morning, two days after Tuesday’s midterm elections.

Major national news organizations say Republicans are favored to take control of the House,

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MedPAC Is Expected to Make a Policy Recommendation That Could Prompt a Look at 340B Hospital Program Eligibility Criteria

MedPAC wordmark
MedPAC is on track to make a recommendation to Congress that could prompt debate or even action on the 340B program’s use of the Medicare disproportionate share (DSH) patient percentage to determine hospital eligibility.

Congressional Medicare advisers are moving toward recommending what they say is a better way to give extra Medicare funding to safety-net hospitals that disproportionately serve low-income and/or uninsured beneficiaries.

If Congress and the executive branch adopt the proposal, however, it

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