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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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 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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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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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
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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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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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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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