Category: Breaking

Judge Rejects Government’s Contention that AstraZeneca’s 340B Lawsuit Is Moot

In Breaking, Federal, JudicialJuly 1, 2021871 Views

A federal judge yesterday, acting in a lawsuit filed by AstraZeneca, vacated HHS's December 2020 advisory opinion that the 340B statute compels drug manufacturers to offer 340B pricing when covered entities use contract pharmacies to dispense covered drugs to patients.

A federal district judge in Delaware yesterday rejected the U.S. Health and Human Services Department’s (HHS) position that its withdrawal of its December 2020 advisory opinion on 340B contract pharmacy rendered drug manufacturer AstraZeneca’s claims against the opinion moot.

…

BREAKING: HHS Withdraws 340B Contract Pharmacy Advisory Opinion, and Becerra Appoints 340B Dispute Resolution Board Members

In Breaking, Federal, Judicial, RegulatoryJune 19, 20211971 Views

Tom Mirga

HHS yesterday withdrew its ex-General Counsel Robert Charrow's legal advisory opinion that the 340B statute requires drug companies to offer 340B pricing when covered entities use contract pharmacies.

The U.S. Health and Human Services Department (HHS) yesterday withdrew its December 2020 legal advisory opinion on 340B contract pharmacy. Also, HHS Secretary Xavier Becerra appointed members to the 340B program administrative dispute resolution (ADR) board.

…

BREAKING: Novartis Sues HRSA in Defense of its 340B Contract Pharmacy Policy

In Breaking, Federal, JudicialJune 1, 20211168 Views

Tom Mirga

Novartis sued HRSA yesterday to stop it from enforcing its interpretation of the 340B statute's contract pharmacy requirements, and from imposing civil monetary penalties against Novartis for alleged violations. | Shutterstock

Novartis Pharmaceuticals has sued the U.S. Health Resources and Services Administration (HRSA) over the agency’s May 17 letter telling the company its restrictions on 340B pricing to covered entities that use contract pharmacies are illegal.

Please

…

HHS Wants to Audit 340B Providers to See How They Use 340B Net Income

In Breaking, Federal, RegulatoryMay 28, 20211824 Views

Tom Mirga

HRSA, headquartered in this suburban Washington office building, would be empowered to audit 340B covered entities to see how they use income from 340B drug purchases, under a Biden administration proposal issued today.

The Biden administration this afternoon proposed amending the 340B statute to let federal health officials audit 340B covered entities “to determine how net income from purchases under [340B] are used by the covered entity.”

Please Login

…

Late Breaking Developments in Lilly and AstraZeneca’s 340B Contract Pharmacy Lawsuits

In Breaking, Federal, JudicialMay 27, 20212271 Views

Tom Mirga

A federal district judge in Indianapolis late this afternoon declined to temporarily restrain federal health officials from requiring drug maker Eli Lilly, based on a May 17 enforcement letter, to provide 340B discounts on drugs dispensed by contract pharmacies. | Shutterstock

BREAKING: Developments in Multiple 340B Contract Pharmacy Lawsuits

In Breaking, Federal, JudicialMay 21, 20211689 Views

Tom Mirga

Eli Lilly and Sanofi yesterday filed court papers in response to HRSA's 340B contract cease and desist letters. Novo Nordisk is expected to follow suit. There could be a decision on AstraZeneca's motions as soon as tonight. | Shutterstock

Drug manufacturers Eli Lilly and Sanofi late yesterday asked federal judges for temporary protection from federal health agency orders to immediately resume offering 340B pricing on drugs shipped to contract pharmacies. Drug maker Novo Nordisk is expected to seek similar …

BREAKING: HRSA to Six Drug Makers—Your 340B Contract Pharmacy Policies Are Illegal, Resume Offering 340B Pricing Immediately

In Breaking, Federal, RegulatoryMay 17, 20212786 Views

Tom Mirga

HRSA Acting Administrator Diana Espinosa sent letters this morning to six drug manufacturers telling them their 340B contract pharmacy policies are illegal and must be stopped immediately.

U.S. Health Resources and Services Administration (HRSA) Acting Administrator Diana Espinosa this morning informed six pharmaceutical manufacturers that their restrictions on 340B program pricing to covered entities that dispense medications through contract pharmacies have resulted in overcharges and are in …

Breaking: Becerra, on 340B Pricing Denials, Tells House Panel, “Everyone Has to Follow the Law”

In Breaking, Federal, LegislativeMay 12, 20211686 Views

Tom Mirga

HHS Secretary Xavier Becerra told a House committee today "We are on this one" in reference to drug companies denying 340B pricing on their products.

U.S. Health and Human Services (HHS) Secretary Xavier Becerra told a member of Congress during a hearing this morning “We are on this one” when asked about six drug manufacturers’ denials of 340B drug discounts when covered entities use contract …

BREAKING: Judge Nixes Hospital Groups’ Participation in AstraZeneca’s 340B Contract Pharmacy Case

In Breaking, Federal, JudicialApril 26, 2021989 Views

Tom Mirga

Six hospital groups cannot participate as third parties in drug manufacturer AstraZeneca’s lawsuit against the government over its 340B contract pharmacy requirements, a judge ruled this morning in federal district court in Wilmington, Del. (pictured).

A federal district judge in Wilmington, Del., ruled this morning that six hospital groups cannot participate as third parties in drug manufacturer AstraZeneca’s lawsuit against the government over its 340B contract pharmacy requirements.

Please Login or

…

For-Profit Hospitals Make Major Pitch for Keeping Medicare’s 340B Hospital Cuts

In Breaking, Federal, Judicial, RegulatoryMarch 31, 202181 Views

Tom Mirga

United Therapeutics says that, starting May 13, entities must upload their 340B contract pharmacy claims data to its vendor 340B ESP twice monthly to "be eligible to place Bill To / Ship To replenishment orders for United Therapeutics products dispensed through a contract pharmacy.”

The association for U.S. for-profit hospitals submitted a brief to the U.S. Supreme Court and released a study today arguing against reversing the nearly 30 percent cut in what Medicare pays many public and private nonprofit hospitals for physician-administered, 340B-purchased …