News Alert

340B Dispute Resolution Final Rule Enters Last Stage of Regulatory Review

HHS signage and building
HRSA plans to host a webinar for federal grantees in the days leading up to the 2024 340B recertification period.
A final rule to implement the 340B administrative dispute resolution (ADR) process arrived this week at the last stage of [...]

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Five More Providers Owe Drugmakers 340B Repayment: Audits

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HRSA confirmed it will end a pandemic-era waiver program that allowed 340B drug use in certain offsite hospital locations.
A total of 16 covered entities (CEs) owe repayment to drugmakers, five more than reported a month ago, according to [...]

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Paper Warns on Duplicate Discounts from 340B Ceiling Price, Medicare Maximum Price

An Avalere study suggested 340B duplicate discounts could increase as a result of Medicare drug price negotiations.
Timelines for manufacturers to provide new Medicare “maximum fair prices” (MFPs) and 340B ceiling prices on drugs are misaligned, risking [...]

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Following Response Deadline, Next Steps in Senator’s 340B Probe Unclear

Bill Cassidy
Sen. Bill Cassidy, ranking Republican on the Senate HELP Committee, does not appear to have the authority to compel hospitals to respond to his inquiry on 340B revenue.
The deadline has passed for two health systems to respond to an influential senator’s probe into 340B revenue, and at [...]

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CMS Says 340B Lump Sum Payments Fueled Increase in Part B Premiums, Deductibles

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CMS said planned Medicare Part B premium increases are partly the result of the proposed lump sum payment for previous illegal 340B hospital cuts.
Federal regulators recently said planned out-of-pocket increases for Medicare beneficiaries are due, in part, to the proposed lump sum payment [...]

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HHS and HRSA Urge Judge to Reject Health Center’s Take on 340B Patient Definition

Genesis Health Care building and signage
Genesis Health Care's proposed 340B patient definition would remove all limits on dispensing 340B drugs, HHS and HRSA told a federal district judge.
Federal healthcare agencies recently told a federal district judge that backing a South Carolina health center’s interpretation of the 340B [...]

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HRSA Audit Finds Fourth Drugmaker Owes Refunds

Drugmaker RedHill Biopharma owes repayments to 340B covered entities, a finalized HRSA audit found.
A fourth drugmaker owes repayment to 340B covered entities, according to final audits posted this week by federal officials. RedHill [...]

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Hospital Fighting 340B Expulsion Gets Temporary Reprieve

Insight Hospital and Medical Center Chicago has an additional 31 days to fight its expulsion from the 340B program, a federal district judge ordered.
A federal district judge has granted a Chicago hospital an additional 31 days to fight its expulsion from the 340B [...]

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Hospital Advocates Meet with Regulators on Lump Sum Rule

Boris Bershteyn, an attorney representing AHA, will advocate for for changes in the 340B lump sum re-payment rule before federal regulators.
Two hospital advocacy groups are meeting with federal healthcare regulators to press their case for changes in the 340B lump [...]

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Drugmaker Overcharge Fines for 340B Drugs Reach Nearly $7,000

Drugmaker overcharge fines, which the Department of Health and Human Services assesses, recently increased to nearly $7,000.
The federal fine for each instance of drugmaker overcharges for 340B covered entities recently increased to nearly $7,000. The fine [...]

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