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Month: November 2022

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

In Federal, Regulatory813 Views Tom Mirga
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

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

In Federal, Pharma Industry556 Views Tom Mirga
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.

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Health Care as a Human Right? Why Not?

In Sponsored Content502 Views Sponsored Content
multiracial hands embraced
Introducing Avita’s Dr. Joel Rosenstock & Our Commitment to Health Equity

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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 equitably, regardless of their race, gender, sexual identity, or ability to

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

In Pharma Industry, Research/Reports324 Views Tom Mirga
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

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

In Federal, Judicial847 Views Tom Mirga
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

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

In Regulatory, State382 Views Laura Gilcrest
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

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

In Sponsored Content2436 Views Sponsored Content
Key Considerations for Streamlining 340B ESP Use

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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 to consult many covered entities as they tackle 340B challenges, I

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

In Federal, Judicial197 Views Laura Gilcrest
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

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HRSA Sanctions Manufacturer for Not Issuing Refund for 340B Overcharges

In Federal, Pharma Industry, Regulatory214 Views Tom Mirga
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

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

In Federal, Regulatory676 Views Tom Mirga
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

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