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Category: Regulatory

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Trump Revives Controversial 340B Rule for Insulin, EpiPens in Sweeping Health Care Executive Order

William Newton, Associate Editor/Senior Writer Views
President Donald Trump issued an April 15 executive order on drug pricing with a controversial 340B requirement for community health centers.
President Donald Trump (R) last night issued a wide-ranging health care executive order that revives a controversial 340B policy from [...]

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HHS Briefs House E&C Committee Staff on Restructuring, Senate HELP Postpones Kennedy Hearing

Shannon Young, Associate Editor/Senior Writer Views
HHS Secretary Robert F. Kennedy Jr. was tentatively set to testify before the Senate HELP panel April 10 on his department's restructuring, a hearing which was ultimately postponed.
U.S. Department of Health and Human Services (HHS) officials last week briefed the Republican and Democratic staff of a key [...]

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SK Life Science Announces 340B Refunds for Epilepsy Treatment

Bella Czajkowski, National Correspondent Views
New Jersey-based SK Life Science announced refunds for 340B covered entities that purchased certain formulations of anti-seizure drug XCOPRI.
SK Life Science recently issued a refund notice for an epilepsy drug following a 340B price ceiling recalculation. The New [...]

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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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