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
…Category: Regulatory
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
…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
…A Richmond, Va., citizen’s group is continuing the fight against a health system accused of 340B program misuse at a hospital in a low-income, majority Black neighborhood in the wake of the death of U.S. Rep. A. Donald McEachin (D-Va.),
…The U.S. Department of Health and Human Services (HHS) said last week it would apply $350 million in unused monies from the COVID-19 Provider Relief Fund to launch a new initiative aimed at increasing COVID-19 vaccinations in underserved communities.
HHS
…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
…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
…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
…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.
…The 340B statute should be amended to extend discounts to emergency-use drugs to treat COVID-19 as a first step in rebuilding the COVID-19 safety net, an opinion piece published yesterday in the medical journal Health Affairs says.
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