Category: Regulatory

Federal Appellate Court Fast-Tracks Drugmakers’ Appeal of 340B Rebate Ruling

June 12, 2025 William Newton, Associate Editor/Senior Writer Views

A federal appellate court in Washington, D.C. will hear two drugmakers' appeal of a lower courts 340B rebate ruling on an expedited schedule.

A federal appellate court in Washington, D.C. is fast-tracking Novartis and Bristol Myers Squibb’s (BMS) appeal of a lower court [...]

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CMS Offers New Details on Medicare Drug Price Negotiations, 340B Advocates Raise Concerns About Impact on Program

June 12, 2025 Shannon Young, Associate Editor/Senior Writer Views

340B stakeholders raised concerns about May 12 draft guidance on the IRA Medicare Drug Price Negotiation Program's “manufacturer effectuation of the maximum fair price in 2026, 2027 and 2028,” among other things.

The Centers for Medicare and Medicaid Services (CMS) released new details this week to help stakeholders navigate the Inflation Reduction [...]

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Third Straight HRSA Audit Finds Drugmaker 340B Overcharges in 2025

June 10, 2025 Bella Czajkowski, National Correspondent Views

HRSA released its latest drugmaker audit findings, which resulted in sanctions against India-based Aurobindo Pharma.

For the third straight time in 2025, a federal audit has found a drug manufacturer overcharged covered entities for 340B [...]

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Premier Asks Court to Reject HRSA’s Defense of 340B Hospital Drug Purchasing Restrictions Policy, Requests Oral Arguments

June 5, 2025 Shannon Young, Associate Editor/Senior Writer Views

Premier again asked a Washington D.C. federal court to strike down a HRSA policy that restricts how certain 340B hospitals can purchase initial drug inventory.

A major group purchasing organization (GPO) recently urged a Washington D.C. federal court to reject the federal government’s defense of [...]

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SpecGx to Offer Covered Entities Refunds for a Record 30-Plus Years of 340B Overcharges

June 3, 2025 Bella Czajkowski, National Correspondent Views

Mallinckrodt's subsidiary, SpecGx, will offer refunds to covered entities for over 30 years of overcharges.

SpecGx, a generic subsidiary of Mallinckrodt Pharmaceuticals, will refund 340B covered entities that purchased addiction treatment medication Methadose for above [...]

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HHS Submits 340B Rebate Guidance for Review, But Publication Timeline Remains Unclear

June 2, 2025 William Newton, Associate Editor/Senior Writer Views

HHS submitted its 340B rebate guidance for regulatory review with OMB on June 1.

The Department of Health and Human Services (HHS) has submitted proposed 340B rebate guidance for regulatory review—but it is unclear [...]

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Trump’s Full 2026 Budget Request Would Shift 340B Program from HRSA to CMS, Maintain Current OPA Funding

May 30, 2025 William Newton, Associate Editor/Senior Writer Views

CMS would assume oversight of the 340B program under the White House’s full fiscal year 2026 budget proposal released May 30.

President Donald Trump’s fiscal year 2026 budget request released yesterday calls for moving control of the 340B program away from [...]

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First 340B Administrative Dispute Resolution Panel Decision Sides with Drug Industry

May 30, 2025 William Newton, Associate Editor/Senior Writer Views

The first decision was recently issued under HRSA's revised 340B Administrative Dispute Resolution process.

The first published decision under the revamped 340B Administrative Dispute Resolution (ADR) process sided with the drug industry, marking a [...]

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Novo Nordisk, Merck, GSK to Refund 340B Covered Entities for Overcharges

May 30, 2025 Bella Czajkowski, National Correspondent Views

Novo Nordisk, Merck and GSK announced they will refund covered entities following certain overcharges for 340B drugs.

Three drugmakers will refund covered entities that purchased certain 340B-priced medications following recent adjustments to their 340B drug ceiling prices. [...]

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HRSA Defends 340B Hospital Drug Purchasing Restrictions Policy, Asks Federal Court to Reject Premier’s Challenge

May 28, 2025 Shannon Young, Associate Editor/Senior Writer Views

HHS attorneys recently urged a Washington D.C. federal court to uphold a 2013 HRSA policy and reject Premier's claim that it unlawfully restricts how certain 340B hospitals can purchase initial drug inventory.

The Trump administration this month urged a Washington D.C. federal court to uphold a 2013 Health Resources and Services Administration [...]

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Category: Regulatory

Federal Appellate Court Fast-Tracks Drugmakers’ Appeal of 340B Rebate Ruling

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CMS Offers New Details on Medicare Drug Price Negotiations, 340B Advocates Raise Concerns About Impact on Program

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Third Straight HRSA Audit Finds Drugmaker 340B Overcharges in 2025

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Premier Asks Court to Reject HRSA’s Defense of 340B Hospital Drug Purchasing Restrictions Policy, Requests Oral Arguments

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SpecGx to Offer Covered Entities Refunds for a Record 30-Plus Years of 340B Overcharges

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HHS Submits 340B Rebate Guidance for Review, But Publication Timeline Remains Unclear

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Trump’s Full 2026 Budget Request Would Shift 340B Program from HRSA to CMS, Maintain Current OPA Funding

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First 340B Administrative Dispute Resolution Panel Decision Sides with Drug Industry

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Novo Nordisk, Merck, GSK to Refund 340B Covered Entities for Overcharges

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HRSA Defends 340B Hospital Drug Purchasing Restrictions Policy, Asks Federal Court to Reject Premier’s Challenge

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