Category: Regulatory

Expanding 340B Eligibility Could Double Program Size, Says Report

September 26, 2023 William Newton, Associate Editor/Senior Writer Views

An IQVIA analysis looked at the 340B program’s growth under the Affordable Care Act.

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 William Newton, Associate Editor/Senior Writer 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 Rich Daly, Editor in Chief 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 William Newton, Associate Editor/Senior Writer 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 Rich Daly, Editor in Chief 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 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.

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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Uncertain Outlook for GOP Drug Shortages Bill with 340B Provisions

September 19, 2023 William Newton, Associate Editor/Senior Writer Views

Rep. Anna Eshoo, ranking member of the E&C Health Subcommittee, was one of multiple Democrats opposed to a Republican drug shortages bill.

The future of a Republican drug shortages bill with 340B provisions remains unclear after it was examined in a contentious [...]

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AHIP Objects to Hospital Efforts to Target Medicare Advantage 340B ‘Windfall’

September 19, 2023 Rich Daly, Editor in Chief Views

Matthew Eyles, president and CEO of AHIP, objected to hospital-sought rules that target the Medicaid Advantage 340B "windfall."

The largest health insurer advocacy organization urged federal regulators to reject hospital-sought rules to limit the ability of Medicare Advantage [...]

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340B Health Centers Appeal Loss in California Medicaid Lawsuit

September 14, 2023 Rich Daly, Editor in Chief Views

Michelle Baass, director of the California Department of Health Care Services, was the defendant in a California Medicaid lawsuit by health centers.

California health centers that participate in the 340B program recently appealed a federal district judge’s dismissal of a suit to reverse [...]

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Two More Drugmakers Owe 340B Provider Repayments, HRSA Audits Find

September 14, 2023 Rich Daly, Editor in Chief 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.

Two drugmakers owe repayment to 340B covered entities, according to final audits posted this week by federal officials. American Health [...]

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