News Alert

Merck Toughens Conditions on 340B Pricing for Hospitals and Health Centers Effective June 12

Merck
Drugmaker Merck today toughened its 340B pricing conditions for hospitals and community health centers.

Drug manufacturer Merck today stiffened its conditions on 340B pricing when hospitals and community health centers use contract pharmacies to dispense most Merck drugs to patients.

Merck told covered entities about the changes in a letter delivered by email

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Janssen to Pay Refunds for 340B Overcharges in Q2 2020

Janssen
Janssen Biotech is paying refunds for overcharges on certain 340B drugs purchased in the third quarter of 2020.

Drug manufacturer Janssen Pharmaceuticals said last week it would pay refunds for overcharges on 340B drugs purchased in the second quarter of 2020, including top-selling psoriasis drug Stelara.

Janssen, part of Johnson & Johnson, said it owes or may owe

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Lifestar, Chartwell Announce Refunds for Q4 2022 340B Overcharges

340B refund notices
HRSA recently posted notices on its website of refunds for 340B overcharges from two generic drug manufacturers.

Generic drug manufacturers Lifestar Pharma and Chartwell Pharmaceuticals may owe refunds to 340B covered entities for overcharges on drugs purchased from the companies in the fourth quarter of 2022, according to recent notices posted on the U.S. Health Resources and

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340B Sales Growth Rate Softened for Second Straight Year, Data Show

IQVIA
Prescription drug sales at 340B prices softened for the second consecutive year compared with sales growth from 2019 to 2020, data in a new IQVIA white paper show.

Prescription drug sales at 340B prices grew 12.2% year-on-year from 2021 to 2022, drug industry consulting and research firm IQVIA says in a new white paper. That is down 3.7 percentage points compared with 340B sales growth from 2020

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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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