Federal Appeals Court Schedules Arguments in Challenge to Arkansas Contract Pharmacy Law

340B state legislation map
Two states have laws protecting 340B contract pharmacy arrangements and two others have passed 340B reporting requirements.
A federal appeals court has scheduled oral arguments for September in a case challenging Arkansas’ protections for 340B providers’ contract [...]

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Drug Maker Owes 340B Providers Repayment, HRSA Pending Audit Finds

Nephron Pharmaceuticals
A HRSA fiscal year 2023 audit tentatively found that drug maker Nephron Pharmaceuticals owes 340B repayments to providers.
The first posted fiscal year 2023 audit of a drug maker tentatively found the company owes repayments to providers. The [...]

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340B Drugs Among Those at Tornado-Hit Facility Requiring Direct Purchase

Pfizer headquarters
Pfizer has limited multiple 340B-eligible drugs to direct purchase after a tornado damaged one of the drug maker's manufacturing facilities.
Federal officials confirmed that 340B-eligible drugs are among the 12 medications pharmaceutical manufacturer Pfizer has limited to direct purchase after [...]

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Three Terminations, 10 Paybacks to Manufacturers in HRSA’s 2023 Pending Provider Audits

HRSA provider audits
HRSA audits found terminations were required for a 340B provider site and a contract pharmacy and that another provider owed repayments to drugmakers.
Three provider organizations may have contract pharmacies terminated from the 340B program and 10 providers would owe repayments to drug [...]

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Share of Retail Pharmacies that Contract with ‘Core’ 340B Safety-Net Facilities Fell Over Time, Study Finds

JAMA contract pharmacy study
There has been a decline in the share of retail pharmacies that contract with 340B "core safety-net facilities," according to a JAMA Health Forum study.
The proportion of retail contract pharmacies in the 340B program that contract exclusively with “core safety-net” facilities fell from 95% [...]

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HHS Asks Court to Deny Injunction Against Medicare Drug Price Negotiations

Dayton v. Becerra
HHS asked the U.S. District Court in Dayton, Ohio to deny a preliminary injunction that would prevent Medicare drug price negotiations.
The U.S. Department of Health and Human Services (HHS) asked a federal court to deny a preliminary injunction sought by [...]

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Pfizer Changes Costly Cardiac Drugs’ Access Rules for 340B Providers

Pfizer headquarters
Pfizer has limited multiple 340B-eligible drugs to direct purchase after a tornado damaged one of the drug maker's manufacturing facilities.
Drug manufacturer Pfizer is changing how healthcare providers access 340B pricing on two expensive, related heart medicines, effective Nov. 1, [...]

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Two Drug Makers Post Manufacturer Notices for 340B Overcharges

Manufacturer notices
Meitheal Pharmaceuticals and Purdue Pharma are each sending 340B covered entities refunds for overcharges totaling $100 or more.
Two drug manufacturers are sending 340B covered entities refunds for overcharges totaling $100 or more, according to public filings posted [...]

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HRSA Allows Immediate 340B Enrollment in Hawaii Due to Wildfires

Hawaii wildfires
HRSA is allowing eligible covered entities in Hawaii to enroll in the 340B program immediately rather than having to wait for the next quarterly registration period.
Eligible covered entities in Hawaii may enroll in the 340B program immediately rather than having to wait for the next [...]

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340B Lobbying Activity Experiences Historic Surge

Capitol building
Lobbyists say Congress is unlikely to clear any major reform of the 340B in the remaining months of 2023 in the absence of a major court decision.
The hiring of lobbyists in the congressional legislative fight over 340B was dominated by pharmaceutical firms and provider-manufacturer alliances in [...]

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