Hospitals Face New 340B Requirements as Annual Recertification Begins

Hospital
The Health Resources and Services Administration's annual 340B hospital recertification process is taking place Aug. 10 through Sept. 9.
Hospitals beginning their annual 340B recertification process this week will face new federal requirements around drug shipping addresses and entity-owned [...]

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AbbVie Urges Court to Let 340B Patient Definition Suit Proceed

AbbVie
AbbVie filed a July 28 brief opposing HRSA's motion to dismiss the drugmaker's challenge to the agency's 340B patient definition.
Pharmaceutical giant AbbVie recently urged a federal court to reject HRSA’s attempt to dismiss its lawsuit challenging the agency’s longstanding [...]

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Attorneys: HRSA’s New Rebate Pilot Legally Stronger, Lawsuit Still Likely

340B rebate pilot notice
Attorneys told 340B Report that HRSA's new 340B rebate pilot appeared to be on stronger legal footing than the agency's previous attempt.
HRSA’s revised 340B rebate pilot unveiled last Friday appears more likely to withstand a legal challenge than the agency’s first [...]

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Genentech Unveils In-House Claims Data Reqs, Grantee CP Restrictions

Genentech logo
Genentech announced its new 340B “universal claims data submission” requirements on July 31.
A large California drugmaker recently announced it will soon require all covered entities to submit claims-level data for 340B purchases, [...]

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News Alert

340B Providers Slam, Drug Industry Praises HRSA’s New 340B Rebate Model Pilot

HRSA 340B rebate notice.
340B stakeholders offered competing reactions Friday to HRSA’s new 340B rebate model pilot.
340B stakeholders offered competing reactions Friday to HRSA’s new 340B rebate model pilot, with hospital and health center groups condemning [...]

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Breaking News

HRSA Releases New 340B Rebate Pilot with 2027 Start Date

HRSA rebate notice
The Health Resources and Services Administration on July 31 unveiled a new 340B rebate pilot set to begin in 2027.
HRSA on Friday released a new 340B rebate pilot set to take effect on Jan. 1, 2027, reviving its controversial [...]

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News Alert

OMB Clears Still-Unpublished 340B Rebate Pilot, Says ‘Economically Significant’

White House OMB notice
White House regulators recently cleared HRSA's latest 340B rebate pilot proposal, but the agency has not yet published the full policy.
White House regulators this week completed their review of HRSA’s latest 340B rebate pilot proposal after reclassifying it as “economically [...]

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Trump Admin. Looks to End Medicare Part D Premium Subsidies

CMS logo
CMS said in a July 28 release that it will conclude the 2025 Part D Premium Stabilization Demonstration at the end of the year.
The Trump administration on Tuesday announced plans to end subsidies that help lower Medicare drug premiums—a program which it argued [...]

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10th 340B ADR Panel Ruling Again Rejects Provider Petition

HRSA 340B ADR Decision Summaries page
HRSA recently published the summary of the 10th 340B ADR decision under the agency's revamped process.
The 10th decision under HRSA’s 340B Administrative Dispute Resolution (ADR) once again sided with a drugmaker, marking another loss for [...]

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White House Holds Last Scheduled Meeting on 340B Rebate Pilot

White House Office of Management and Budget
The White House Office of Management and Budget (OMB) recently held the last of 17 scheduled meetings on HRSA's pending 340B rebate notice.
White House officials on Wednesday held their last scheduled regulatory meeting on HRSA’s pending 340B rebate pilot guidance, potentially bringing [...]

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