Exelixis Puts 45-Day Limit on Requests to Reclassify Past Sales as 340B Purchases

Exelixis
Exelixis says starting May 15 it will honor 340B covered entities' requests to replenish/reclassify prior purchases that were not made at the 340B ceiling price only within 45 days of the date that the drug was dispensed.

Starting May 15, biopharmaceutical manufacturer Exelixis will require 340B covered entities that want past drug purchases that were not made at the 340B ceiling price to be reclassified as 340B sales to do so within 45 days of the date

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Astellas Notifies 340B Entities for Second Time in 2023 About a Change in Drug’s NDC

Cresemba
Astellas says for 340B replenishment, the new and old NDCs of Cresemba’s 372mg intravenous formulation are interchangable.

Drug maker Astellas will let 340B covered entities count accumulations of an injectable form of its antifungal drug Cresemba under its old National Drug Code toward replenishment of equal quantities under the product’s corresponding new NDC, provided the entities use

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News Alert

Bayer Announces Tougher Limits on 340B Pricing for Hospitals

Bayer
Bayer today significantly tightened its limits on 340B pricing when hospitals contract with pharmacies to dispense drugs to patients.

Drug manufacturer Bayer this morning significantly tightened its limits on 340B pricing when hospital covered entities contract with pharmacies to dispense drugs to patients. Grantee entities remain exempt from Bayer’s restrictions.

Covered entities reported receiving letters from Bayer about

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Daiichi-Sankyo Offering Refunds for 340B Overcharges on Two Drugs

Enhertu
Daiichi-Sankyo is offering refunds for 340B overcharges on its breast cancer drug Enhertu and cholesterol drug Welchol for Oral Suspension.

Drug manufacturer Daiichi-Sankyo is offering 340B covered entities refunds for overcharges on metastatic breast cancer treatment Enhertu during Q1 2020 and on cholesterol medication Welchol for Oral Suspension during Q1 2022 and Q4 2022.

The U.S. Health Resources and Services

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Lilly Asks Covered Entity to Promptly Repay “Duplicate 340B/Medicaid Discounts”

Lilly
Eli Lilly is conducting government approved 340B provider audits that for the first time look for certain Medicaid health plan duplicate discounts.

Drug manufacturer Eli Lilly asked a 340B covered entity last week to promptly repay it for “duplicate 340B/Medicaid discounts” and evaluate all Lilly prescriptions that it or its contract pharmacies dispensed for the last three years.

Consultants and attorneys with

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HHS OIG and HRSA Are Mum About 340B Manufacturer Civil Monetary Penalties and Violation Notices

screenshot of HRSA correspondence to stakeholders web page
HRSA and OIG have no comment on the status of drug manufacturer civil monetary penalties and violation letters stemming from denials of 340B pricing to covered entities that use contract pharmacies.

The U.S. Department of Health and Human Services Office of Inspector General said yesterday it has no comment on the status of referrals from the U.S. Health Resources and Services Administration to fine eight drug manufacturers for failing to offer

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AHA Again Blasts PhRMA and NACHC’s Alliance to Remake 340B

screenshot of the AHA blog
The AHA slammed PhRMA and NACHC's 340B reform alliance again, this time in its blog and related talking points.

The American Hospital Association has again blasted the drug industry’s alliance with community health centers for 340B reform, calling it “another misguided attempt by drug companies to dismantle [340B] so that they can continue to pad their billion-dollar bottom lines.”

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Novartis to Appeals Court: Our New 340B Contract Pharmacy Policy Doesn’t Affect Our Case Before You

Novartis wordmark on a building
Drugmaker Novartis is offering refunds to 340B covered entities on certain purchases of two radiopharmaceuticals.

Drug maker Novartis told a federal appeals court in Washington, D.C. Tuesday its revised 340B contract pharmacy policy “does not impact the legal arguments at issue” in its 340B contract pharmacy case awaiting the court’s decision.

If the court disagrees,

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News Alert

Novartis Toughens its Conditions on 340B Pricing for Hospitals

Novartis wordmark on a building
Novartis announced today that it will let hospitals without an in-house pharmacy pick just one contract pharmacy location where Novartis will ship 340B discounted drugs.

Drug manufacturer Novartis this afternoon significantly beefed up its conditions on 340B pricing for hospitals.

Two others—GlaxoSmithKline and Pfizer—made similar moves on Friday. Novartis is the sixth to stiffen its 340B pricing policy since a federal appeals court ruled

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Breaking News

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

GlaxoSmithKline wordmark and GSK logo on a building
GlaxoSmithKline and Pfizer announced updates to their 340B contract pharmacy policies to comply with new state laws that will take effect in July.

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 the contract

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