Category: Breaking

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GSK Extends 340B Pricing Conditions to all Covered Entities and all Products

In Breaking, Pharma IndustryMarch 31, 20231457 Views

GSK today extened its conditions on 340B pricing to all covered entities and all of its products.

UPDATE Friday, March 31, 2023, 6:45 p.m. EDT—Story updated with comment from the National Association of Community Health Centers.

Drug manufacturer GlaxoSmithKline this afternoon announced a major expansion of its conditions on 340B pricing in

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Major Drug Industry and Health Center Groups Unite to Reform 340B for Patients and “True” Safety-Net Providers

In Breaking, Federal, Legislative, Pharma Industry, ProvidersMarch 9, 20233602 Views

Tom Mirga

PhRMA, NACHC, and and the National Hispanic Medical Association created a new group, ASAP 340B, and issued a 10-point plan to ensure that the 340B program “benefits patients and true safety-net providers, including rural hospitals.”

Pharmaceutical Research and Manufacturers of America, the National Association of Community Health Centers, and the National Hispanic Medical Association this morning jointly issued a 10-point plan and created a nonprofit group to ensure that the 340B program “benefits

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EMD Serono Is the Second Drug Maker Today to Impose Conditions on 340B Contract Pharmacy, and the 21st Overall

In Breaking, Pharma IndustryFebruary 1, 20231829 Views

Tom Mirga

EMD Serono was the second drug maker today to announce conditions on 340B drug sales to hospitals.

EMD Serono today became the 21st pharmaceutical manufacturer to impose conditions on 340B pricing involving drug shipments to contract pharmacies.

Bayer announced conditions on 340B sales involving contract pharmacies earlier today. The companies’ announcements came two

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Bayer Is the 20th Drug Maker to Impose Conditions on 340B Contract Pharmacy

In Breaking, Pharma IndustryFebruary 1, 20231572 Views

Tom Mirga

Bayer's limits on 340B drug sales involving shipments to contract pharmacies apply to hospitals only, the company said.

Bayer Healthcare Pharmaceuticals starting March 1 is imposing limits on hospitals’ replenishment orders of 340B-priced drugs shipped to contract pharmacies. It said it is voluntarily letting 340B grantee covered entities continue to use multiple contract pharmacies to dispense

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Third Circuit Court Rules for Drugmakers in 340B Contract Pharmacy Cases

In Breaking, Federal, JudicialJanuary 30, 20234609 Views

Tom Mirga

A federal appeals court ruled today that the 340B statute does not compel drug manufacturers to deliver 340B-purchased drugs "wherever and to whomever a buyer demands."

A federal appeals court in Philadelphia ruled 3-0 this morning that “Congress never said that drug makers must deliver discounted Section 340B drugs to an unlimited number of contract pharmacies.”

“By trying to enforce that supposed requirement, the

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Wall Street Journal Says Its Investigation of 340B Hospitals Raises Questions about Program’s Growth and Purpose

In Breaking, Research/ReportsDecember 20, 20221415 Views

Tom Mirga

The Wall Street Journal's long article today about hospital participation in 340B comes three months after a similar lengthy critique by The New York Times.

A growing number of hospitals that do not qualify for 340B drug discounts as disproportionate share hospitals are enrolling instead under less demanding criteria for rural referral centers—including nationally prominent urban hospitals in metro Boston, Chicago, and Cleveland,

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Two of Three Appeals Court Judges Question Government’s Stance That Drug Companies May Not Impose Conditions on 340B Sales

In Breaking, Federal, JudicialNovember 15, 20221221 Views

Tom Mirga

Two judges on a three-judge federal appeals court panel in Philadelphia today questioned whether the 340B statute forbids drug manufacturers from imposing distribution conditions on offers of 340B pricing.

Two judges on a three-judge federal appeals court panel this morning challenged a federal government lawyer’s stance that federal law forbids drug manufacturers from limiting how their drugs may be distributed when they offer to sell the drugs

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CMS Says It Will Announce Sometime Next Year How it Will Repay 340B Hospitals for Five Years of Illegal Drug Reimbursement Cuts

In Breaking, Federal, Judicial, RegulatoryNovember 1, 2022923 Views

Tom Mirga

CMS said late this afternoon it will put off until next year its decision on how it will comply with a U.S. Supreme Court decision striking down five years of drug reimbursement cuts for 340B hospitals.

The U.S. Centers for Medicare & Medicaid Services said late this afternoon that it will address how it will remedy five years of illegal Medicare Part B underpayments to hospitals for 340B purchased drugs “in future rulemaking,” rather

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Appeals Court Questions Yet Again if it Has Jurisdiction Over Lilly’s 340B Contract Pharmacy Case

In Breaking, Federal, JudicialOctober 31, 2022906 Views

Tom Mirga

Federal appeals court Judge Frank Easterbrook is pictured during an appearance on C-SPAN in 2013. Easterbrook during a court hearing today questioned whether a closely watched 340B contract pharmacy case was ripe for appellate review.

A federal appeals court judge in Chicago expressed doubt during a hearing this morning that the court can review a lower court decision in drug manufacturer Eli Lilly’s 340B contract pharmacy lawsuit.

Judge Frank Easterbrook, the senior judge

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In Key Hearing, Appeals Court Panel Seems to Lean in Favor of Some Drug Manufacturer Conditions on 340B Pricing

In Breaking, Federal, JudicialOctober 24, 20221218 Views

Tom Mirga

A federal appeals court in Washington, D.C., heard arguments this morning in Novartis and United Therapeutics' consolidated 340B contract pharmacy cases.

Two of three judges on a federal appeals court panel strongly indicated this morning that they reject the federal government’s position that nothing in the 340B statute gives drug manufacturers the right to put any conditions on offers

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