Category: Regulatory

AstraZeneca Announces Change to Cancer Drug Replenishment After Discontinuing Certain Dosage

October 29, 2024 Bella Czajkowski, National Correspondent Views

AstraZeneca recently posted an NDC notice to 340B covered entities regarding replenishment of a cancer medication.

AstraZeneca will discontinue a certain bottle dosage of its breast cancer drug Truqap (capiversatib) by the end of the year, [...]

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Fifth Hospital Sues HRSA for Authorizing ‘Unlawful’ J&J 340B Audits

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

University of Washington Medical Center sued HRSA for authorizing an allegedly unlawful 340B program audit of the hospital.

A Washington state hospital on Tuesday became the fifth provider to sue the federal government for authorizing Johnson & Johnson [...]

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Growth in 340B Purchases Driven by Pharma Price Increases, Broader Healthcare Trends, Providers Say

October 22, 2024 William Newton, Associate Editor/Senior Writer Views

Providers say drugmaker price increases and broader healthcare trends drove last year's increase in total 340B purchases.

The growth in total 340B purchases last year was largely a result of drugmaker price increases and broader healthcare trends, [...]

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Total 340B Drug Purchases Reached $66 Billion in 2023

October 18, 2024 William Newton, Associate Editor/Senior Writer Views

Total 340B purchases reached $66.3 billion in 2023, according to new HRSA data released Oct. 18.

Drug purchases under the 340B program reached $66.3 billion in 2023, marking a 24% increase over the $54 billion in [...]

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PhRMA Pans Government’s Response to J&J’s 340B Rebate Proposal in Letter to HRSA Administrator

October 16, 2024 William Newton, Associate Editor/Senior Writer Views

PhRMA sent an Oct. 11 letter to HRSA criticizing the agency's opposition to J&J's 340B rebate proposal.

Pharmaceutical Research and Manufacturers of America (PhRMA) expressed “serious concerns” with the federal government’s opposition to Johnson & Johnson’s (J&J’s) [...]

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CMS Inaction on IRA-340B Conflicts May Drive ‘Manufacturer-Friendly’ Compliance Models

October 10, 2024 William Newton, Associate Editor/Senior Writer Views

CMS has not assumed responsibility for “deduplicating” discounts that arise between the 340B program and the IRA's Medicare drug price negotiations.

Federal regulators’ inaction on the 340B program’s interactions with Medicare drug price negotiations will likely lead drugmakers to pursue “manufacturer-friendly” [...]

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CMS’ MDRP Final Rule May Impact 340B Covered Drugs, Attorneys Say

October 8, 2024 William Newton, Associate Editor/Senior Writer Views

CMS' recently-released MDRP final rule may affect 340B covered drugs and draw litigation.

A new federal regulation updating the definition of a covered outpatient drug could change the number of drugs covered under [...]

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Arkansas Begins Enforcement Against AstraZeneca for Allegedly Violating Contract Pharmacy Access Law

October 3, 2024 William Newton, Associate Editor/Senior Writer Views

The Arkansas Insurance Department held a preliminary hearing with attorneys for AstraZeneca on Oct. 1.

Arkansas officials initiated enforcement proceedings earlier this week against AstraZeneca for allegedly violating a state law that prohibits drugmaker 340B [...]

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CMS Finalizes Next Medicare Drug Negotiation Guidance Without Resolving Key Concerns of 340B Stakeholders

October 3, 2024 William Newton, Associate Editor/Senior Writer Views

The AHA raised concerns that October 2024 federal guidance on Medicare drug price negotiations may allow drugmakers to “wrongly justify fundamental changes to the 340B program.”

Federal regulators issued final guidance for the next round of Medicare drug price negotiations yesterday but did not propose remedies [...]

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340B Provider Groups, Key Federal Lawmaker Praise HRSA for Pressuring J&J to Drop 340B Rebate Proposal

October 1, 2024 William Newton, Associate Editor/Senior Writer Views

U.S. Rep. Abigail Spanberger (D-Va.) and multiple 340B provider groups applauded HRSA for its response on J&J's 340B rebate proposal.

Multiple 340B provider groups have applauded the federal government for threatening “strong” enforcement actions that led Johnson & Johnson (J&J) [...]

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