Category: Regulatory

Hospitals Defend 340B Compliance Amid Influential Senator’s Investigation

In Federal, Providers, RegulatoryOctober 3, 2023346 Views

Two health systems said they were compliant with the 340B program in response to an investigation from Sen. Bill Cassidy (R-La.).

The two hospital systems subject to a senator’s investigation into 340B program revenue have said they are fully compliant with [...]

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As Medicare Lump Sum Payment Regulation Heads to Finish Line, Critics Weigh In

In Regulatory, Trade AssociationOctober 3, 202380 Views

Rich Daly

Critics have weighed in on CMS' proposed lump sum payment regulation for illegal Medicare cuts as the deadline for finalizing the rule approaches.

The final rule to provide repayment to many 340B hospitals for five years of unlawful Medicare cuts entered the final [...]

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In Key 340B Patient Definition Case, Hospital Group Accuses Drugmakers of “Numerous Misstatements”

In Judicial, Providers, Regulatory, Trade AssociationOctober 3, 2023187 Views

Tom Mirga

Chief Judge R. Bryan Harwell of the U.S. District Court for the District of South Carolina has not yet decided on 340B Health's request to file an amicus brief in a key 340B patient definition case.

A national hospital group has asked a federal district court for permission “to correct numerous misstatements” that it says drug [...]

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Ranking GOP Senator on Key Committee Opens Investigation into 340B Hospital Revenue

In Federal, News Alert, Providers, RegulatorySeptember 29, 20231011 Views

William Newton

Sen. Bill Cassidy, ranking Republican on the Senate HELP Committee, sent letters to two health systems inquiring about their use of 340B savings.

The top Republican on an influential Senate committee has opened an investigation into how two major health systems use revenue [...]

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Looming Government Shutdown Poses 340B Program Uncertainty, Potential Legal Proceeding Slowdown

In Federal, Judicial, RegulatorySeptember 28, 2023592 Views

William Newton

An increasingly likely government shutdown could impact 340B regulation and pending litigation surrounding the program.

The government agency that oversees the 340B program will retain just over half of its staff in the event of [...]

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Lilly and Novo Post 340B Refund Notices, Amgen Posts 340B Replenishment Notice

In Pharma Industry, Providers, RegulatorySeptember 28, 2023243 Views

Tom Mirga

Lilly and Novo Nordisk are refunding 340B covered entities on some products due to 340B ceiling price adjustments.

Drugmakers Lilly and Novo Nordisk are giving covered entities refunds on some products due to 340B ceiling price adjustments, according [...]

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340B Drug Purchases Reached $53.7 Billion in 2022, HRSA Data Show

In Providers, Regulatory, Research/ReportsSeptember 26, 2023847 Views

Tom Mirga

Drug purchases under the 340B program totaled $53.7 billion in 2022, according to HRSA data obtained by Drug Channels.

Drug purchases under the 340B program totaled $53.7 billion in 2022, or 22.3% more than the $43.9 billion in 2021, [...]

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Providers Try a Range of Responses to Manufacturer 340B Contract Pharmacy Restrictions

In Pharma Industry, Providers, RegulatorySeptember 26, 2023918 Views

Rich Daly

Community health centers are attempting to mitigate the adverse financial effects of manufacturer 340B contract pharmacy restrictions on their organizations, said Colleen Meiman, national policy advisor for State & Regional Associations of Community Health Centers.

Amid an increasing number of drugmaker restrictions and requirements on the use of contract pharmacies, 340B providers are trying a [...]

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Expanding 340B Eligibility Could Double Program Size, Says Report

In Providers, Regulatory, Research/ReportsSeptember 26, 2023486 Views

William Newton

An analysis from pharmaceutical research and data firm IQVIA projected the 340B program could more than double in size if patient eligibility expands.

The 340B program could more than double in size if the 340B patient definition expands, according to a recent report [...]

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Senate Committee Rejects 340B Amendment to Bipartisan Health Bill

In Federal, Providers, Regulatory, Trade AssociationSeptember 26, 2023319 Views

William Newton

Sen. Bernie Sanders, chair of the Senate HELP committee, opposed an amendment that would implement 340B hospital verification requirements.

A Senate committee rejected an effort to add new 340B hospital verification requirements as part of a sweeping healthcare funding [...]

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