Tom Mirga
Editor at Large
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
… Tom Mirga
Editor at Large
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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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
… Tom Mirga
Editor at Large
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
… Tom Mirga
Editor at Large
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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Laura Gilcrest
Editor at Large
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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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,
… Laura Gilcrest
Editor at Large
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
… Tom Mirga
Editor at Large
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
… Tom Mirga
Editor at Large
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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