In Important Development, HHS Close to Rescinding Trump-era Rule that Undercuts its Sub-Regulatory Power

HHS is poised to rescind Trump administration regulations that have added to doubt about the authority of HHS guidance documents, including for 340B.

The U.S. Health and Human Services Department (HHS) is poised to rescind Trump administration regulations that have added to doubt about the authority of HHS guidance documents, including those for the 340B program.

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A Closer Look at Critical Court Hearing on 340B Contract Pharmacy Legality

A federal district court in Washington, D.C., heard arguments this week in Novartis and United Therapeutics' 340B contract pharmacy lawsuits.

U.S. District Judge Dabney Friedrich all but told the federal government during a court hearing in Washington, D.C., on Tuesday she rejects its basic argument that the plain text of 340B statute requires drug manufacturers to honor 340B purchases by

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Feds Oppose Sanofi’s Request for Emergency Protection Against 340B ADR Proceedings

The federal government yesterday opposed Sanofi's request to a judge to grant it emergency protection from 340B dispute resolution proceedings.

The federal government yesterday asked a federal district judge to deny drug manufacturer Sanofi’s request for emergency protection from being brought before a 340B administrative dispute resolution panel.

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Judge Expresses Doubt About Government’s Position During Arguments in Novartis and United Therapeutics’ 340B Contract Pharmacy Lawsuits

U.S. District Judge Dabney Friedrich said today she agreed with another federal judge that the plain text of the 340B statute "doesn't speak" to contract pharmacy.

A federal district judge said today she “has a hard time following” the federal government’s argument that the 340B statute requires drug manufacturers to honor covered entities’ drug purchases no matter how entities choose the distribute the medicines.

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Feds Have Until Tomorrow to Oppose Sanofi’s Request for Stay Against 340B ADR Proceedings

U.S. Chief District Judge Freda Wolfson gave government lawyers until the end of the day tomorrow to weigh in on Sanofi’s request for emergency protection from 340B ADR proceedings.

A federal district judge has given government lawyers until Wednesday to weigh in on drug manufacturer Sanofi’s request for emergency protection from being brought before a 340B administrative dispute resolution panel.

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CMS Rule that Will Set 340B Hospitals’ Part B Drug Reimbursement for 2022 Moves Closer to Release

The CMS final rule that will set Medicare reimbursement in 2022 to 340B hospitals for physician-administered drugs is another step closer to release.

The U.S. Centers for Medicare & Medicaid Services (CMS) final rule that will set what Medicare will pay 340B hospitals for physician-administered drugs next year is another step closer to release.

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Managed Care Journal Article Gives 340B Hospitals Low Marks on Uncompensated Care

Researchers Sunita Desai (left) and J. Michael McWilliams, M.D., say they found no evidence that hospitals increased uncompensated care after entry into the 340B program any more than hospitals that never entered or had not yet entered the program.

Researchers who reported in 2018 that the 340B program leads to hospital-physician practice consolidation but probably not to better care or outcomes for low-income patients have released a new 340B study, this time on hospital provision of uncompensated care.

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Kalderos Sues HHS and HRSA, Says Ban on Drug Company Conditions on 340B Sales is Illegal

A mock-up of Request, one of the modules that make up Kalderos' 340B Pay service to enable drug manufacturers to provide 340B ceiling prices as rebates instead of as discounts.

Pharmaceutical industry vendor Kalderos has asked a federal court to vacate a federal health agency’s policy prohibiting drug manufacturers from conditioning 340B drug discounts on covered entities’ submission of drug claims data.

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Sanofi Seeks Emergency Stay Blocking 340B Dispute Resolution Proceedings

Drug manufacturer Sanofi yesterday asked a federal judge in New Jersey for an emergency stay against 340B administrative dispute resolution (ADR) proceedings against it brought by health centers.

Drug manufacturer Sanofi yesterday asked a federal judge in New Jersey to stay 340B administrative dispute resolution (ADR) proceedings against it brought by health centers seeking to overturn Sanofi’s restrictions on 340B pricing when covered entities use contract pharmacies.

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