CMS Seeks Input on Excluding 340B Drugs from New Medicare Part D Inflation Rebates

Part D inflation rebate press release
CMS is seeking comment on how best to exclude 340B drugs from new Part D inflation rebate invoices.

The U.S. Centers for Medicare & Medicaid Services is seeking comments by March 11 on “the most reliable way to identify” 340B-purchased drugs dispensed to Medicare Part D beneficiaries so they can be excluded from new Part D inflation rebate

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Sanders, Asked About Abuse in 340B, Cites His Past Effort to End a Hospital’s Tax Exemption

Sen. Bernie Sanders speaking at a podium
Senate HELP chair Bernie Sanders (I-Vt.) talked about taking away hospitals' tax-exempt status when he was asked during an interview about alleged hospital abuse of 340B.

U.S. Sen. Bernie Sanders (I-Vt.), the new chair of the Senate committee that oversees the 340B program, recently answered a reporter’s question about alleged hospital abuse of 340B by noting that he tried to revoke a Burlington, Vt., hospital’s tax-exempt

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Inspector General Advises CMS to Monitor Non-Hospital 340B Entities’ Use of Modifiers on Part B Drug Claims

OIG challenge and solution chart
HHS OIG says CMS should monitor non-hospital covered entities' use of 340B modifiers when submitting Part B claims.

The U.S. Department of Health and Human Services Office of the Inspector General says the Centers for Medicare and Medicaid Services should monitor non-hospital 340B covered entities’ use of modifiers to identify 340B-priced drugs in Part B claims, as these

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340B Stakeholders Weigh in on HRSA’s Proposal to Replace 340B Dispute Resolution Process

Screenshot of regulations.gov 340B drug pricing program ADR document details.
340B contract pharmacy loomed large in stakeholders’ comments on HRSA's proposed revamp of the 340B program’s administrative dispute resolution system.

The fight over 340B contract pharmacy loomed large in stakeholders’ comments last week on a proposed federal regulation to revamp the 340B program’s administrative dispute resolution system.

Health care provider groups, citing manufacturers’ contract pharmacy policies, said they want the

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Bernie Sanders Officially Named Chair and Bill Cassidy Ranking Republican of Senate HELP Panel

Sen. Bernie Sanders and Sen. Bill Cassidy headshots
Sen. Bernie Sanders (I-Vt.) (left), is the new chair of the Senate HELP Committee and Sen. Bill Cassidy (R-La.) is its new ranking Republican.

The U.S. Senate committee with jurisdiction over 340B is officially under new leadership, with Bernie Sanders (I-Vt.) being seated as Health, Education, Labor, and Pensions chair last week and Bill Cassidy (R-La.) as ranking Republican.

The formal announcements had been

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GSK Announces Refunds for 340B Overcharges on Respiratory Drugs

GSK GlaxoSmithKline logo on office building
GlaxoSmithKline said last week it would pay refunds for 340B overcharges occurring in Q1 2021.

Pharmaceutical manufacturer GlaxoSmithKline said last week it would pay refunds for 340B overcharges occurring in the first quarter of 2021, including overcharges for blockbuster respiratory drugs Trelegy and Nucala.

The refund notice posted Feb. 2 on the U.S. Health

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Drugmakers Urge Appeals Courts to Follow Third Circuit Ruling and Uphold 340B Contract Pharmacy Restrictions

Digital rendering of a courtroom
Lilly, Novartis, and United Therapeutics want the appeals courts hearing their 340B contract pharmacy cases to follow the lead of the appeals court in AstraZeneca, Sanofi, and Novo Nordisk’s cases and uphold their 340B policies.

Drugmakers Lilly, Novartis, and United Therapeutics this week urged federal appeals courts in Chicago and Washington, D.C., to follow the lead of the appeals court in Philadelphia and uphold their restrictions on 340B providers’ use of contract pharmacies.   

Lilly on

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Upcoming End of COVID-19 Emergency Could Prompt HRSA to End or Scale Back 340B Flexibilities

COVID-19 PHE sign with beach in background
The Biden administration plans to end the nationwide COVID-19 public health emergency on May 11.

The Biden administration said on Monday that it plans to end the nationwide COVID-19 public health emergency on May 11. When the PHE ends, COVID-related 340B program flexibilities announced in March 2020 could end too.

The U.S. Health Resources and

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AHA Seeks Meeting with HHS About Repaying 340B Hospitals for Illegal Medicare Drug Reimbursement Cuts

AHA seal on office wall
The AHA wants to meet with HHS to hear how the government will repay 340B hospitals for five years’ worth of illegal Medicare Part B drug reimbursement cuts.

The American Hospital Association yesterday asked to meet with the team of federal officials that will decide how the government will repay 340B hospitals for five years’ worth of illegal Medicare Part B drug reimbursement cuts. The amount of refunds

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The Day After: Stakeholders Take Stock of Third Circuit Court’s 340B Contract Pharmacy Opinion

United States Third Circuit Court building entrance
Drug makers "need not help [covered entities] maximize their 340B profits," a federal appeals court in Philadelphia said yesterday in holding that three manufacturers' restrictions on delivery to contract pharmacies do not violate the 340B statute.

Covered entities may still use the 340B program under drug manufacturers’ conditions on the use of contract pharmacies, and while they “cannot squeeze as much revenue out of it as they once could, drug makers need not help them maximize

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