Category: Regulatory

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

September 28, 2023 Views

Congress is unlikely to pass a 340B program overhaul in 2024 unless there is unexpected pressure from appellate court decisions or a Senate "group of 6" breakthrough, attorneys and lobbyists said.

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

September 28, 2023 Views

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

September 26, 2023 Views

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

September 26, 2023 Views

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

September 26, 2023 Views

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

September 26, 2023 Views

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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One Quarter of HRSA Provider Audits Closed with No Adverse Findings

September 21, 2023 Views

Dept. of Health and Human Services sign and building

There were no adverse findings in nearly one quarter of provider audits conducted by HRSA, an agency within HHS.

Nearly one-quarter of the 200 provider audits planned for this year were closed by regulators with no adverse findings, they [...]

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GOP Scrutinizes Medicare Price Negotiations in House Subcommittee Hearing

September 21, 2023 Views

A 340B hearing next week called by Rep. Cathy McMorris Rodgers (R-Wash.), chair of the E&C Committee, will include as witnesses a policy researcher critical of 340B and a community health center leader.

Republicans and Democrats battled over Medicare price negotiation provisions under the Inflation Reduction Act (IRA) during a contentious Sept. 20 [...]

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AHF Files Appeal Over Its Claim That Apexus Did Not Obtain Sub-Ceiling Discounts

September 19, 2023 Views

AHF appealed a ruling to dismiss by U.S. District Judge Percy Anderson over AHF's claim that Apexus did not obtain sub-ceiling discounts..

The AIDS Healthcare Foundation (AHF) recently filed an appeal to an April district court dismissal of its case against Apexus, [...]

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Health Center Challenging 340B Patient Definition Responds to HRSA’s and Drug Companies’ Court Arguments

September 19, 2023 Views

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

There is no evidence to support federal allegations that a South Carolina community health center illegally diverts 340B-purchased drugs to [...]

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