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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Health Care as a Human Right? Why Not?

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Let’s get this right out on the table: At Avita, we believe health care is a human right.

Polarizing politics aside, as an advanced, civilized society, we have an ethical obligation to care for the medical needs of every U.S. citizen compassionately and

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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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Arkansas Health System Asks State to Enforce its 340B Contract Pharmacy Law Against Novo Nordisk

Arkansas Insurance Department office sign
An Arkansas health system has asked state insurance officials to enforce the state's 340B contract pharmacy anti-discrimination law against Novo Nordisk.

An Arkansas health system is urging state officials to enforce the state’s novel 340B contract pharmacy anti-discrimination law against drug maker Novo Nordisk to end the company’s restrictions on 340B-priced drugs dispensed at multiple contract pharmacies. The lawsuit marks the

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Important Operational Insights for Covered Entities Choosing to Access 340B ESP

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Alas, after much deliberation, your covered entity has decided to submit data to 340B ESP. As you embark on this journey, you may be asking yourself: Now what?!?  

As someone who has operated a large 340B program at a DSH hospital and now has the privilege

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CMS Defends Delayed Fix for Illegal Medicare Drug Payment Cuts for 340B Hospitals

pill bottle and Medicare health insurance card
CMS defends its decision to wait until next year to decide how to remedy illegal past cuts in 340B hospitals Part B drug reimbursement.

Federal health officials last week defended their plan to wait until next year to say how they will reimburse 340B hospitals for illegal Medicare Part B drug payment cuts in place for the past five years after hospital groups told

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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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