Category: Regulatory

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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Medicare to Continue ASP Plus 6% for 340B Drugs in 2024

November 3, 2023

Rich Daly Editor in Chief Views

CMS will continue its 2023 policy to pay for 340B products at the statutory default rate.

Medicare Part B will continue to pay hospitals for 340B drugs at the rate of average sales price (ASP) plus [...]

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CMS Finalizes 340B Lump Sum Payment, Retains Offsetting Cuts Starting in 2026

November 2, 2023

Rich Daly Editor in Chief Views

CMS issued the final rule to implement a $9 billion lump sum payment to 340B hospitals for previous illegal cuts between 2018 and 2021.

Medicare issued a final rule today to implement a $9 billion lump sum payment to 340B hospitals and to cut [...]

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Health Systems Sue to Reverse Elimination of Hospital Registration Waiver

November 2, 2023

Rich Daly Editor in Chief Views

U.S. District Court of the District of Columbia

More than 40 hospitals and health systems challenged federal healthcare agencies over their recent decision to end a 340B COVID-related registration flexibility in the U.S. District Court of the District of Columbia.

Forty-four health systems and hospitals sued federal healthcare agencies over their recent decision to end a 340B COVID-related registration flexibility [...]

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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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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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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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Congressional Witnesses Urge Medicare 340B Cuts

October 24, 2023

William Newton Washington Correspondent Views

Dr. Debra Patt, executive vice president at Texas Oncology, testified during a House subcommittee hearing that the 340B program was "broken."

Witnesses recently told a U.S. House subcommittee that Congress should cut Medicare payments for 340B drugs. The House Energy and [...]

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340B Dispute Resolution Final Rule Enters Last Stage of Regulatory Review

October 19, 2023

Rich Daly Editor in Chief Views

A coming final rule would implement HRSA's administrative dispute resolution process to handle 340B program disputes between providers and drug manufacturers.

A final rule to implement the 340B administrative dispute resolution (ADR) process arrived this week at the last stage of [...]

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Category: Regulatory

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

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News Alert

Medicare to Continue ASP Plus 6% for 340B Drugs in 2024

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News Alert

CMS Finalizes 340B Lump Sum Payment, Retains Offsetting Cuts Starting in 2026

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Health Systems Sue to Reverse Elimination of Hospital Registration Waiver

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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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Biocon Announces New NDC for its Lantus Biosimilar

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

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Congressional Witnesses Urge Medicare 340B Cuts

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News Alert

340B Dispute Resolution Final Rule Enters Last Stage of Regulatory Review

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