Category: Breaking

BREAKING: PhRMA Asks Court to Strike Down 340B Dispute Resolution Rule and Manufacturer Audit Guidelines

In Breaking, UncategorizedJanuary 26, 202162 Views

Pharmaceutical Research and Manufacturers of America (PhRMA) sued yesterday in federal district court in Maryland to strike down the federal final rule that established the new 340B program administrative dispute resolution (ADR) process. It also wants the court to declare …

BREAKING: HHS’s Top Lawyer Says Pharma’s 340B Contract Pharmacy Actions Are at Odds with the Law

In Breaking, Federal, Judicial, RegulatoryDecember 31, 2020115 Views

Tom Mirga

The U.S. Health and Human Services Department’s (HHS) top lawyer today rejected drug manufacturers’ legal arguments for either ending or imposing conditions on 340B pricing on covered outpatient drugs shipped to contract pharmacies.

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BREAKING: HHS Says 340B Discounts Apply to Contract Pharmacies

In Breaking, Federal, Judicial, RegulatoryDecember 30, 202025 Views

Tom Mirga

Drug manufacturers must deliver 340B drug discounts on covered outpatient drugs “when contract pharmacies are acting as agents of 340B covered entities,” the U.S. Health and Human Services Department (HHS) Office of General Counsel said today in an advisory opinion. …

BREAKING: 28 State AGs—Including HHS Nominee Becerra—Want Action on Pharma 340B Pricing Denials. Also, New GAO Report on HRSA 340B Oversight. (Updated)

In Breaking, Federal, Regulatory, Research/Reports, StateDecember 14, 202034 Views

Tom Mirga

28 State AGs—Including HHS Nominee Becerra—Want Action on Pharma 340B Pricing Denials. Also, New GAO Report on HRSA 340B Oversight. Twenty-eight state attorneys general—including California Attorney General Xavier Becerra (D), President-elect Biden’s nominee to be the next U.S. Health and …

BREAKING: Hospitals Sue HHS Over Drug Companies’ Denials of 340B Pricing

In Breaking, Federal, Judicial, Pharma Industry, Regulatory, Trade AssociationDecember 12, 202024 Views

Tom Mirga

Five hospital associations, the association of hospital pharmacists, and three hospitals last night sued the U.S. Health and Human Services Department and HHS Secretary Alex Azar “to take action against” drug manufacturers “refusing to offer 340B discounts for covered drugs …

BREAKING: 340B Dispute Resolution Final Rule Released

In Breaking, Federal, RegulatoryDecember 10, 202021 Views

Tom Mirga

The U.S. Health Resources and Services Administration (HRSA) has just released for public inspection a final rule that “sets forth the requirements and procedures for the 340B Program’s administrative dispute resolution (ADR) process.” It will be formally published in the …

BREAKING: Amgen Ending 340B-Like Price Reductions on Orphan Drugs on Jan. 1 (Updated)

In Breaking, Legislative, Pharma IndustryDecember 9, 202075 Views

Tom Mirga

Biopharmaceutical company Amgen is ending voluntary 340B pricing on orphan drugs for certain 340B hospital covered entities effective Jan. 1. | Source: Shutterstock

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BREAKING: Florida Medicaid Asks Rx Manufacturer to Suspend “Broad Brush” 340B Pricing Restrictions, Will Other States Follow?

In Breaking, Pharma Industry, Regulatory, StateDecember 3, 202010 Views

Tom Mirga

Florida Medicaid Asks Rx Manufacturer to Suspend “Broad Brush” 340B Pricing Restrictions, Will Other States Follow? Florida’s Medicaid director has asked drug manufacturer Eli Lilly and Co. and reportedly other manufacturers to suspend its restrictions on 340B pricing on its …

BREAKING: Novo Nordisk Will Cease 340B Pricing for Hospital Contract Pharmacies on Jan. 1

In Breaking, Federal, Pharma Industry, RegulatoryDecember 1, 202059 Views

Tom Mirga

Novo Nordisk today joined Eli Lilly and Co., AstraZeneca, Sanofi, Novartis, and United Therapeutics in imposing conditions on provision of 340B pricing on products dispensed by contract pharmacies. Today’s announcement means all three U.S. domestic suppliers of insulin (Lilly, Sanofi, …

BREAKING: Trump Issues Drug Pricing Rules That Impact 340B; Says 340B Health Center Final Rule Is Coming

In Breaking, Federal, RegulatoryNovember 20, 202015 Views

Tom Mirga

Medicare-participating 340B hospital outpatient departments will have to take part in the Trump administration’s “most favored nation” (MFN) payment test for Medicare Part B drugs, the U.S. Health and Human Services Department announced late today.

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