340B Guidance Documents Removed from HHS Public Database

It is not known when the majority of the 340B guidance documents disappeared from the HHS Guidance Portal, who took them down, or why.

Nearly all 340B-related program guidance documents have been taken down from an online database that the Trump administration launched last summer to underscore its position that federal government guidance documents are non-binding.

The U.S. Health Resources and Services Administration’s (HRSA)

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AHA Asks CMS to Withdraw Trump’s Most Favored Nation Drug Pricing Rule

During an October 2018 event at HHS, former President Trump promised to end "global freeloading" that caused Americans to pay higher drug prices. | Source: C-SPAN

The American Hospital Association (AHA) asked the Biden administration this week to immediately withdraw the Trump administration’s “most favored nation” (MFN) drug pricing interim final rule, in part, because of the damage it will do to 340B hospitals and “critical

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Generic Liquid Drug Manufacturer Providing Refunds for 340B Overcharges

The U.S. Health Resources and Services Administration (HRSA) is requiring Pharmaceutical Associates, Inc. (PAI), a South Carolina-based generic liquid drug manufacturer, to repay 340B covered entities for charges on its products above the 340B ceiling price discovered during a fiscal

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Drug Company Eton Posts 340B Limited Distribution Notice

Illinois-based Eton Pharmaceuticals is making its Alkindi Sprinkle hydrocortisone product available through a sole specialty distributor “to ensure that patients…receive appropriate drug and clinical counseling and to support therapeutic adherence,” the company informed 340B covered entities in a Jan. 12

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340B COVID-19 Flexibilities Expected to Run Through the End of 2021

The announcement Friday that the COVID-19 national public health emergency probably will last all year probably means COVID-related 340B program flexibilities will last all year, too.

The acting head of the U.S. Health and Human Services Department (HHS) told state governors on Friday that the national COVID-19 public health emergency (PHE) is expected to last through the end of the year. That likely means 340B program

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Conservative News Sites Cast Shade on Biden’s Freeze on 340B Insulin Rule

Health center advocates are responding to social media posts that suggest that, by freezing a Trump administration rule regarding health centers' 340B pricing on insulin, the Biden administration raised insulin's price.

Health center advocates are trying to stamp out fast-spreading claims on social media that the Biden administration, in freezing a Trump administration rule, raised the price of insulin.

Facebook and Twitter have been filled with posts and counter-posts about the

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Biden Administration Withdraws Azar’s Notice of Appointments to 340B Dispute Resolution Board

There are questions about the legal and practical effects of the administration's action yesterday regarding ex-HHS Secretary Azar's appointments to the new 340B dispute resolution board. | Shutterstock

The Biden administration yesterday withdrew former U.S. Health and Human Services (HHS) Secretary Alex Azar’s Jan. 20 public notice of his appointment of six voting and two ex-officio non-voting members to a new 340B program administrative dispute resolution (ADR)

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Biden Team Freezes 340B Insulin Rule, to Health Centers’ Relief

Health center leaders worried that the Biden's administration's regulatory freeze memo didn't guarantee that a Trump administration rule regarding the 340B program and insulin that they opposed would definitely be delayed. | Source: Shutterstock

Health centers leaders are applauding the Biden administration’s decision yesterday to push back, from today until March 22, the effective date of the Trump administration’s controversial final rule to require health centers to provide insulin and injectable epinephrine to low-income

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In Surprise Move, 340B Dispute Resolution Board Members Appointed

In one of his last acts as HHS Secretary, Alex Azar appointed the six voting and two ex-officio non-voting members of the 340B program’s new administrative dispute resolution (ADR) board.

Alex Azar, at 8:45 a.m. Eastern yesterday in one of his last acts as U.S. Health and Human Services (HHS) secretary, appointed the six voting and two ex-officio non-voting members of the 340B program’s new administrative dispute resolution (ADR) board.

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Pedley’s Promotion May Presage Hiring of a New 340B Program Director

Rear Adm. Krista Pedley’s promotion, and OPA’s new place within the HRSA administrator’s office, are symbolic of the 340B program’s growing importance in prescription drug pricing policy, and reflects how highly regarded Pedley is in HRSA and HHS.

U.S. Public Health Service (PHS) Rear Adm. Krista Pedley, who has led the federal 340B drug pricing program for more than a decade, has been promoted within the U.S. Health Resources and Services Administration (HRSA) in conjunction with a major

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