Articles by : William Newton, Associate Editor/Senior Writer

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HRSA to J&J: End 340B Rebate by Monday or Lose Access to Key Government Health Insurance Markets

September 27, 2024 William Newton, Associate Editor/Senior Writer Views

HHS and HRSA sent J&J a Sept. 27 letter that again threatened tough enforcement action against the drugmaker's 340B rebate proposal.

The federal agency overseeing the 340B program has doubled down on its threat to terminate Johnson & Johnson’s (J&J’s) access [...]

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High-Ranking HRSA Official Talks Genesis Decision, Drugmaker Audits During Rare Unscripted Q&A at Industry Conference

September 26, 2024 William Newton, Associate Editor/Senior Writer Views

Lisa Scholz interviewed HRSA's OPA Director Chantelle Britton at the MDRP Summit in Chicago.

A high-ranking federal regulator addressed the 340B patient definition and manufacturer audits during an unscripted Q&A session after a speech [...]

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Sanofi Imposes New 340B Contract Pharmacy Rule in Arkansas Following Legal Deal with State

September 26, 2024 William Newton, Associate Editor/Senior Writer Views

Sanofi implemented a new 340B contract pharmacy rule for certain Arkansas hospitals.

Sanofi is requiring Arkansas hospitals to prove they legally own 340B-priced drugs until they are dispensed at contract pharmacies after [...]

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CMS Publishes Final Rule on Medicaid Rebates with Significant 340B Implications

September 24, 2024 William Newton, Associate Editor/Senior Writer Views

CMS released a final rule for Medicaid rebates with new identifiers and definitions that impact the 340B program.

Federal regulators last Friday finalized a highly anticipated rule for the Medicaid Drug Rebate Program (MDRP) with new identifiers and [...]

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Delaware Enacts 340B-PBM Payment Law Without Contract Pharmacy Provisions from Original Version

September 24, 2024 William Newton, Associate Editor/Senior Writer Views

Delaware enacted a law prohibiting PBMs from limiting payments to healthcare providers based on their 340B status.

Delaware Gov. John Carney (D) late last week signed into law a bill to prohibit “discrimination against 340B entities by [...]

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PhRMA, HHS Seek Continued Pause on 340B ADR Lawsuit

September 24, 2024 William Newton, Associate Editor/Senior Writer Views

HHS and PhRMA will continue to pause a lawsuit challenging the government's 340B ADR process.

A major drug industry trade group and the federal government have asked a federal judge to continue to pause litigation [...]

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Senator Cassidy Extends 340B Inquiry to Two Major Pharmaceutical Manufacturers

September 23, 2024 William Newton, Associate Editor/Senior Writer Views

Sen. Bill Cassidy (R-La.) has extended an ongoing 340B probe to two major drug manufacturers.

An influential Republican senator this morning requested detailed information from Eli Lilly and Amgen on their 340B programs, including the [...]

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HRSA’s Enforcement Threats Against J&J’s 340B Rebate Proposal Could Face Drugmaker Challenge

September 19, 2024 William Newton, Associate Editor/Senior Writer Views

Attorneys are mixed on the strength of J&J's legal case if it chooses to challenge HRSA's opposition to its 340B rebate proposal in court.

The federal government’s recent threat to penalize Johnson & Johnson (J&J) for its unapproved 340B rebate model could spark a [...]

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Federal Judge Upholds Four Drugmakers’ 2021 Contract Pharmacy Restrictions—Without Addressing ‘40-Mile Radius’ Rule

September 19, 2024 William Newton, Associate Editor/Senior Writer Views

A federal district judge upheld four drugmakers' contract pharmacy restrictions as implemented in 2021.

A federal district judge ruled that four drugmakers’ 340B contract pharmacy restrictions—as implemented in 2021—do not violate the 340B statute, [...]

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HHS to J&J: End 340B Rebate Proposal Immediately or ‘Face Potential Consequences’—Including Termination from Federal Health Insurance Programs

September 17, 2024 William Newton, Associate Editor/Senior Writer Views

HHS sent J&J a Sept. 17 letter demanding the drugmaker "immediately" cease its plan to implement a 340B rebate model.

The federal agency that oversees the 340B program today formally warned Johnson & Johnson (J&J) that it must “cease implementation [...]

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