Breaking News

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

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.

Novartis told 340B Report late

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Breaking News

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

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.”

The proposed legislation is included in

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Breaking News

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

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

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. Nonetheless,

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Breaking News

BREAKING: Developments in Multiple 340B Contract Pharmacy Lawsuits

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

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Breaking News

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

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

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Breaking News

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

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

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Breaking News

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

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.

In a ruling delivered from the bench,

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Breaking News

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

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

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Breaking News

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

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

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Breaking News

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

“Certain manufacturers’ newfound and unilateral refusal to sell [340B] drugs through contract pharmacies is at odds with the structure and intended operation of the [340B] statute,” HHS General Counsel Robert Charrow said in an advisory opinion late today. | Source:
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