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Category: Regulatory

HRSA Allows One Sagebrush Site to Remain in 340B, but Other Sites’ Eligibility Still in Dispute

William Newton, Associate Editor/Senior Writer Views
HRSA reversed its position to allow one Sagebrush site to remain 340B eligible, but the agency is continuing to contest the eligibility of the STD clinic's other sites.
Sagebrush Health, a Nevada-based STD clinic, notched a partial legal victory on Monday when the Health Resources and Services Administration [...]

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Drugmakers Ask Court to Rule in Favor of 340B Rebate Model, Reject Hospitals’ Arguments; Kalderos Opposes 340B Health’s Amicus Brief

Shannon Young, Associate Editor/Senior Writer Views
Drug manufacturers and a drug industry vendor recently urged a Washington D.C. federal court in various lawsuit filings to reject hospitals and the government’s arguments against implementing a 340B rebate model.
Four major drug manufacturers and a drug industry vendor recently urged a Washington D.C. federal court to reject the government [...]

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HHS Layoffs, Restructuring Don’t Appear to Have Affected 340B Yet, But Sources Say Program Could Move to CMS

Shannon Young, Associate Editor/Senior Writer Views
The recent HHS restructuring has not had much of an impact on the 340B program, but that could change if the agency moves oversight of the program to CMS, sources said this week.
The Trump administration’s recent efforts to restructure the Department of Health and Human Services (HHS)—including division consolidations and the elimination [...]

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AstraZeneca Lifts 340B Contract Pharmacy Restrictions in Arkansas Following State Order

William Newton, Associate Editor/Senior Writer Views
AstraZeneca announced it will exempt Arkansas-based covered entities from its 340B contract pharmacy restrictions.
AstraZeneca announced today that it will exempt Arkansas 340B providers from its contract pharmacy restrictions, two days after a state [...]

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Senate HELP Committee Asks RFK Jr. to Testify on HHS Reorganization Amid Mass Layoffs Including Up to One Third of HRSA Workforce

Shannon Young, Associate Editor/Senior Writer Views
The Senate HELP Committee this week invited HHS Secretary Robert F. Kennedy Jr. to speak at an upcoming hearing on major restructuring at the Department of Health and Human Services, which included reportedly up to 600 layoffs at HRSA.
The leaders of a Senate panel that oversees several key federal health agencies this week invited Health and Human Services [...]

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News Alert

Arkansas Orders AstraZeneca to Restore 340B Drug Access at Contract Pharmacies

William Newton, Associate Editor/Senior Writer Views
Arkansas Insurance Department Commissioner Alan McClain ordered AstraZeneca to “restore access to 340B drugs at all contract pharmacy delivery locations for Arkansas covered entities.”
An Arkansas state official yesterday ordered AstraZeneca to restore access to 340B drugs at all contract pharmacy locations, marking the [...]

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In Apparent About-Face, HRSA Confirms Sagebrush’s 340B Eligibility During Federal Court Hearing

William Newton, Associate Editor/Senior Writer Views
Sagebrush Health had sought emergency relief against the government to keep its clinic sites in the 340B program.
A federal judge yesterday delayed ruling on Sagebrush Health’s request for emergency relief after the government apparently reversed course and [...]

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Trump Administration Creates New Agency Overseeing HRSA Amid Major HHS Staffing Cuts

William Newton, Associate Editor/Senior Writer Views
HHS announced significant staffing cuts and restructuring that will merge HRSA with four other HHS divisions.
In a sweeping overhaul of the nation’s top government health agencies, the U.S. Department of Health and Human Services (HHS) [...]

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Trump-Aligned Think Tank Proposes Lowering U.S. Drug Prices Through IRA and Other Policies, Doesn’t Weigh In on 340B Program

Shannon Young, Associate Editor/Senior Writer Views
America First Policy Institute released a March 21 brief detailing how policymakers “could accelerate drug development and enhance patient health by implementing reforms that discourage other countries from freeloading off American drug innovation.”
A conservative think tank, which officials who served in President Donald Trump’s (R) first administration founded to advance his priorities, [...]

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Trump’s HHS Continues to Oppose Unilateral Drugmaker 340B Rebates in Kalderos Lawsuit

Bella Czajkowski, National Correspondent Views
HHS filed a motion for summary judgement against Kalderos, the drug industry vendor behind Eli Lilly’s rebate proposal.
The Trump administration this week continued to oppose drug industry attempts to unilaterally convert 340B discounts to a rebate model, [...]

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