Novo Nordisk Updates 340B Contract Pharmacy Policy, Will Allow Claims Submission to 340B ESP

Novo Nordisk signage and building
Novo Nordisk has decided to let 340B hospitals buy its drugs at a reduced 340B price for shipment to an unlimited number of contract pharmacies if the hospitals submit their claims data to 340B ESP.

Novo Nordisk on Jan.1 will implement a policy to let 340B hospitals buy its drugs at a reduced 340B price for shipment to an unlimited number of contract pharmacies if the hospitals submit their claims data for such drugs to

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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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AIDS Healthcare Foundation Criticizes Idea of Creating a 340C Program for Non-Hospital Providers

graphic Image of 340B turned into 340C
AIDS Healthcare Foundation says taking non-hospital healthcare providers out of 340B and placing them in their own new 340C program is the wrong response to drug industry attacks on the existing program.

Separating the 340B drug discount program into one for hospitals and another for non-hospital healthcare providers would be the wrong response to drug company denials of 340B pricing when providers use contract pharmacies, AIDS Healthcare Foundation said yesterday.

“A new

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BREAKING: HRSA Proposes Streamlined, Less Trial-like 340B Dispute Resolution Process

Screenshot of HRSA, HHS 340B ADR document
HRSA this morning released its proposed replacement for its December 2020 340B administrative dispute resolution final rule.

The U.S. Health Resources and Services Administration this morning proposed a replacement for its two-year-old 340B administrative dispute resolution process. Comments are due Jan. 30.

“HRSA has encountered policy and operational challenges with implementation of the

2020 final rule,” the

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CSL Behring Confirms that First Gene Therapy for Hemophilia B Will Be Available at a 340B Price

CSL Behring wordmark on building
The FDA has approved CSL Behring's first-ever gene therapy to treat adults with hemophilia B.

The U.S. Food and Drug Administration (FDA) last week approved the first gene therapy to treat adults with hemophilia B, a genetic bleeding disorder resulting from missing or insufficient levels of a protein needed to make blood clot. About 15%

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340B Hospitals Use Biosimilars Less Than Others, PhRMA-Commissioned Study Finds

graphic image of biosimilar pills depicted equal on a scale
340B hospitals use biosimilar drugs less than other hospitals, a PhRMA-funded study found.

340B hospitals use biosimilar drugs less than other hospitals, which may expose patients to higher out-of-pocket costs, a drug industry funded study concludes.

Pharmaceutical Research and Manufacturers of America released the study last week. Healthcare consulting firm Milliman did the research for

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340B Prime Vendor Sued for Allegedly Not Negotiating Sub-Ceiling Pricing on HIV/AIDS Drugs

Screenshot of complaint AHF v. Apexus
AIDS Healthcare Foundation says in a lawsuit that Apexus, the 340B prime vendor, fails and refuses to negotiate sub-ceiling 340B discounts on HIV/AIDS medicines.

AIDS Healthcare Foundation sued Apexus, the federally contracted 340B prime vendor, on Friday for allegedly failing and refusing to negotiate sub-ceiling 340B discounts on HIV/AIDS prescription drugs pursuant to its agreement with the government.

An Apexus spokesperson yesterday said it

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