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 the 340B statute requires drug manufacturers to honor 340B purchases

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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.

Sanofi asked the judge for an emergency stay last week. The

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Drug Manufacturers May Seek Orphan Designations to Avoid Paying 340B Discounts, HHS OIG Concludes

The 340B orphan drug exclusion incentivizes manufacturers to get orphan designations for drugs approved to treat common diseases or conditions, a new government report says.

The ban on 340B discounts on orphan drugs for rural and free-standing cancer hospitals may give drug companies a powerful incentive “to seek orphan designation for drugs approved to treat common diseases or conditions,” the U.S. Health and Human Services

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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 to distribute the medicines.

“It seems

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Lifting of Title X Gag Rule Could Spur Hundreds of Clinics to Rejoin 340B

A September 2019 protest in Cleveland against the Trump administration rule barring Title X-funded family clinics from providing abortion referrals.

Hundreds of family planning clinics that lost their Title X federal grants and 340B eligibility because they opposed a Trump-era rule barring them from providing abortion referrals might return to Title X and 340B soon.

The U.S. Department of Health

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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.

U.S. Chief District Judge Freda Wolfson gave the U.S.

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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.

CMS last week Thursday sent its calendar year

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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.

Kalderos has created a service called 340B

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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.

Sanofi

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In Significant Development, HRSA Assigns Panels to Review 340B Dispute Resolution Claims Against Drug Companies

HRSA confirmed yesterday that 340B program administrative dispute resolution (ADR) panels have been assigned.

The U.S. Health Resources and Services Administration (HRSA) told 340B Report yesterday in response to an inquiry that 340B program administrative dispute resolution (ADR) panels have been assigned—signaling that an unknown number of proceedings might begin on ADR petitions by

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