Category: Regulatory

Minnesota Finalizes Expanded 340B Provider Reporting Requirements, Extends Submission Deadline to May 30

April 22, 2025 Bella Czajkowski, National Correspondent Views

The Minnesota Department of Health issued updated reporting guidance last week for 340B providers.

Minnesota covered entities will have additional 340B reporting requirements this year, but an extended deadline to submit that data, according [...]

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Leaked HHS Budget Document Details Plans to Move 340B Program to CMS

April 18, 2025 Shannon Young, Associate Editor/Senior Writer Views

The Trump administration appears to detail its plans to move the 340B program from HRSA to CMS in a reportedly leaked internal budget document.

President Donald Trump’s (R) preliminary budget appears to call for “new authority to regulate all aspects of the 340B program,” [...]

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Hospitals, Health Centers Criticize Trump’s Executive Order Over Controversial 340B Rule, Possible Medicare Payment Cuts

April 17, 2025 William Newton, Associate Editor/Senior Writer Views

President Donald Trump (R) issued a wide-ranging April 15 executive order on drug pricing policy.

Hospital and health center leaders are pushing back against President Donald Trump’s (R) new executive order, criticizing its controversial 340B [...]

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

April 16, 2025 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

April 15, 2025 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

April 15, 2025 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

April 10, 2025 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

April 10, 2025 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

April 8, 2025 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

April 3, 2025 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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Category: Regulatory

Minnesota Finalizes Expanded 340B Provider Reporting Requirements, Extends Submission Deadline to May 30

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News Alert

Leaked HHS Budget Document Details Plans to Move 340B Program to CMS

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Hospitals, Health Centers Criticize Trump’s Executive Order Over Controversial 340B Rule, Possible Medicare Payment Cuts

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News Alert

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

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

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SK Life Science Announces 340B Refunds for Epilepsy Treatment

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

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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

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

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

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