Articles by : Tom Mirga, Editor at Large

Senate Finance Committee Republicans Oppose CMS Plan to Redefine Medicaid Best Price

November 7, 2023 Tom Mirga, Editor at Large Views

A group of Republicans on the Senate Finance Committee have called on CMS to withdraw its plan to rewrite the definition of Medicaid best price.

A group of Senate Republicans recently urged federal regulators to withdraw a plan to change the definition of a drug’s [...]

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Federal Judge Rebukes HRSA on 340B Patient Definition

November 3, 2023 Tom Mirga, Editor at Large Views

Genesis Health Care successfully challenged HRSA's 340B patient definition in the U.S. District Court for the District of South Carolina.

A federal district judge in South Carolina late today struck down the 340B program’s patient definition, as federal regulators described [...]

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New York State Asks Court to Dismiss Challenge to Medicaid Drug Benefit Shift

November 2, 2023 Tom Mirga, Editor at Large Views

The New York State Department of Health asked a state trial court to dismiss two providers' challenge to a Medicaid drug benefit shift.

The New York State Department of Health recently told a state trial court in Manhattan that two community health centers [...]

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Sandoz Is 28th Drugmaker to Adopt 340B Contract Pharmacy Restrictions

November 1, 2023 Tom Mirga, Editor at Large Views

Drugmaker Sandoz, a Novartis spin-off, became the 28th pharmaceutical company to implement 340B contract pharmacy restrictions.

Generic and biosimilar drugmaker Sandoz today became the 28th pharmaceutical company to place conditions on 340B pricing involving drug shipments [...]

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340B Hospital Registration Waiver Withdrawal Could Draw Legal Challenge

October 31, 2023 Tom Mirga, Editor at Large Views

Dept. of Health and Human Services building and signage

Hospital advocates said HRSA's recent decision to end a 340B program waiver for hospitals could draw legal challenges.

The recent end of a 340B program waiver for hospitals is wrong, hurts hospitals and their patients, and is bound [...]

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HRSA To End Waiver for Some Offsite 340B Hospital Locations, Provides Grace Period

October 26, 2023 Tom Mirga, Editor at Large Views

HRSA confirmed it will end a pandemic-era waiver program that allowed 340B drug use in certain offsite hospital locations.

The Health Resources and Services Administration (HRSA) confirmed today it is ending a 340B program waiver issued early in the [...]

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340B Provider-Genentech Lobbying Group Boosts Spending, Adds Members

October 26, 2023 Tom Mirga, Editor at Large Views

More than 360 firms reported lobbying on the 340B program between July 1 and Sept. 30.

Genentech, Sanford Health, and Carolina Health Centers’ 340B reform group, 340B Working Table, spent $110,000 on lobbying and gained eight [...]

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Biocon Announces New NDC for its Lantus Biosimilar

October 26, 2023 Tom Mirga, Editor at Large Views

Biocon has added a new national drug code for its insulin biosimilar, the drugmaker recently notified 340B providers.

Indian biopharmaceutical manufacturer Biocon Biologics has notified 340B covered entities about a new national drug code (NDC) for insulin glargine-yfgn, [...]

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Genentech Asks Hospitals to Check 340B Split-Billing Software Settings

October 24, 2023 Tom Mirga, Editor at Large Views

Genentech gave advanced notice to 340B hospitals that the drugmaker would implement 340B contract pharmacy restrictions on May 1.

Drug manufacturer Genentech has asked health systems and hospitals about possible 340B program compliance violations involving split-billing software settings. Staff [...]

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CMS Seeks Input on Contractor to Prevent 340B, Medicare Maximum Price Duplication

October 24, 2023 Tom Mirga, Editor at Large Views

Kelsey Lang, a health policy principal at Avalere, said CMS's request for information affirms its interest in preventing 340B duplicate discounts.

Regulators are seeking input on a contractor to help it shield drug manufacturers from giving duplicate 340B discounts and new [...]

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Articles by : Tom Mirga, Editor at Large

Senate Finance Committee Republicans Oppose CMS Plan to Redefine Medicaid Best Price

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Federal Judge Rebukes HRSA on 340B Patient Definition

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New York State Asks Court to Dismiss Challenge to Medicaid Drug Benefit Shift

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Sandoz Is 28th Drugmaker to Adopt 340B Contract Pharmacy Restrictions

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340B Hospital Registration Waiver Withdrawal Could Draw Legal Challenge

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HRSA To End Waiver for Some Offsite 340B Hospital Locations, Provides Grace Period

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340B Provider-Genentech Lobbying Group Boosts Spending, Adds Members

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Biocon Announces New NDC for its Lantus Biosimilar

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Genentech Asks Hospitals to Check 340B Split-Billing Software Settings

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CMS Seeks Input on Contractor to Prevent 340B, Medicare Maximum Price Duplication

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