Biden Moves to End Trump’s Limits on HHS Guidance Including for 340B

The Biden administration wants to repeal ex-President Trump's regulation that has helped to cast doubt on the authority of 340B program guidance.

The Biden administration yesterday formally announced that it wants to repeal a regulation issued during ex-President Trump’s last days in office that has helped to cast doubt on the authority of federal health care guidance, including for the 340B program.

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BMS Tells 340B Entities It Has Lifted Purchasing Limits on Leukemia Drug

BMS's Celgene subsidiary has lifted purchasing limits for 340B covered entities and non-340B buyers on its injectable acute myeloid leukemia (AML) drug Vidaza.

Bristol Myers Squibb’s Celgene subsidiary has removed purchasing limits due to demand-related supply constraints on its injectable acute myeloid leukemia (AML) drug Vidaza that have been in place since May 2020.

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In Important Development, HHS Close to Rescinding Trump-era Rule that Undercuts its Sub-Regulatory Power

HHS is poised to rescind Trump administration regulations that have added to doubt about the authority of HHS guidance documents, including for 340B.

The U.S. Health and Human Services Department (HHS) is poised to rescind Trump administration regulations that have added to doubt about the authority of HHS guidance documents, including those for the 340B program.

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Lifting of Title X Gag Rule Could Spur Hundreds of Clinics to Rejoin 340B

A September 2019 protest in Cleveland against the Trump administration rule barring Title X-funded family clinics from providing abortion referrals.

Hundreds of family planning clinics that lost their Title X federal grants and 340B eligibility because they opposed a Trump-era rule barring them from providing abortion referrals might return to Title X and 340B soon.

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CMS Rule that Will Set 340B Hospitals’ Part B Drug Reimbursement for 2022 Moves Closer to Release

The CMS final rule that will set Medicare reimbursement in 2022 to 340B hospitals for physician-administered drugs is another step closer to release.

The U.S. Centers for Medicare & Medicaid Services (CMS) final rule that will set what Medicare will pay 340B hospitals for physician-administered drugs next year is another step closer to release.

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In Significant Development, HRSA Assigns Panels to Review 340B Dispute Resolution Claims Against Drug Companies

HRSA confirmed yesterday that 340B program administrative dispute resolution (ADR) panels have been assigned.

The U.S. Health Resources and Services Administration (HRSA) told 340B Report yesterday in response to an inquiry that 340B program administrative dispute resolution (ADR) panels have been assigned—signaling that an unknown number of proceedings might begin on ADR petitions by

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Boehringer Ingelheim Defends its 340B Contract Pharmacy Policy After HRSA Finds it Is Unlawful

Boehringer Ingelheim disputes HRSA's Oct. 4 finding that BI’s denials of 340B discounts on its drugs when hospitals use contract pharmacies are illegal.

Drug manufacturer Boehringer Ingelheim on Tuesday disputed a federal health agency’s finding a day earlier that BI’s denials of 340B discounts on its drugs when hospitals use contract pharmacies are illegal.

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Breaking: HRSA Tells Boehringer Ingelheim its 340B Contract Pharmacy Restrictions Are Illegal

HRSA informed Boehringer Ingelheim today that its restrictions on 340B pricing when hospitals use contract pharmacies are illegal.

A senior federal health official informed drug manufacturer Boehringer Ingelheim (BI) today its restrictions on 340B pricing when hospitals use contract pharmacies are illegal and must end immediately, or BI could face civil monetary penalties.

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