Articles by : Tom Mirga, Editor at Large

HRSA Tells Federal Court it Still Stands by its 340B Patient Definition in Closely Watched Case

August 1, 2023 Tom Mirga, Editor at Large Views

HRSA says it stands by its patient definition in Genesis' federal lawsuit seeking a far broader definition.

The U.S. Health Resources and Services Administration (HRSA) still stands by its 340B program patient definition, the agency said in [...]

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100+ Health Centers and Groups Sign Pro-340C Letter to Congress

July 27, 2023 Tom Mirga, Editor at Large Views

More than 100 health centers and groups have signed a letter to Congress supporting the 340C initiative.

More than 100 community health centers, state primary care associations, and national and local groups urged congressional leaders this week [...]

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HRSA Sends Previously Audited 340B Hospital a Second Follow-up Compliance Letter

July 27, 2023 Tom Mirga, Editor at Large Views

The Health Resources and Services Administration announced that the Office of Pharmacy Affairs will hold a June 11 webinar on the ADR final rule.

A hospital that the U.S. Health Resources and Services Administration audited for 340B program compliance and then was one of [...]

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340B Recertification for Hospitals Starts Aug. 14

July 27, 2023 Tom Mirga, Editor at Large Views

HRSA announced this year's 340B eligibility recertification period for hospitals will start Aug. 14 and end Sept. 11.

This year’s 340B eligibility recertification period for hospitals will start Aug. 14 and end Sept. 11, the U.S. Health Resources [...]

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Amgen, Vertex, and AstraZeneca Post 340B Refund and Replenishment Public Notices

July 27, 2023 Tom Mirga, Editor at Large Views

Aranesp is among the drugs listed on HRSA's latest manufacturer's notice posted on behalf of Amgen.

The U.S. Health Resources and Services Administration (HRSA) this week published notices from drug makers Amgen and Vertex about refunds [...]

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340B Report Publisher and CEO to Providers: New 340B Reporting Requirements are Inevitable

July 27, 2023 Tom Mirga, Editor at Large Views

Minnesota became the first state to impose 340B reporting requirements after Gov. Tim Walz (D) signed legislation in late May.

Health care providers almost certainly will have to accept new 340B reporting requirements in order to get unfettered access to [...]

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Large Drug Maker, Big Health System, and Influential Health Center Jointly Lobbying for Senate Bipartisan 340B Initiative

July 25, 2023 Tom Mirga, Editor at Large Views

340B Working Table 340B lobbying disclosure form

Under the name 340B Working Table, Genentech, Sanford Health, and Carolina Health Centers are jointly lobbying for a bipartisan U.S. Senate 340B reform initiative.

Biopharmaceutical manufacturer Genentech, South Dakota-based health system Sanford Health, and South Carolina federally qualified health center Carolina Health Centers are jointly lobbying members of Congress to back six U.S. senators’ bipartisan approach to federal 340B program reform, the three organizations

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NACHC Names Prominent Physician with Health Center and HRSA Experience as its Leader

July 20, 2023 Tom Mirga, Editor at Large Views

NACHC has chosen Dr. Kyu Rhee, now CVS Health senior vice president and Aetna chief medical officer, to be its new president and CEO.

The National Association of Community Health Centers (NACHC) announced yesterday that its board has chosen Dr. Kyu Rhee, now CVS [...]

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Generic Drugmaker Amring Providing Refunds for 340B Overcharges

July 20, 2023 Tom Mirga, Editor at Large Views

Generic drug manufacturer Amring Pharmaceuticals is giving 340B covered entities refunds for overcharges on 14 products between the first quarter [...]

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U.S. House Energy & Commerce Committee Drafting Drug Shortages Bill

July 18, 2023 Tom Mirga, Editor at Large Views

U.S. House Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) says the panel plans to circulate a draft drug shortage bill in the coming weeks.

The U.S. House Energy & Commerce Committee plans to circulate a draft drug shortage bill in the coming weeks, committee [...]

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