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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Eshoo and Castor Will Be Top Democrats on House E&C Subcommittees Involved in 340B

U.S. Rep. Anna Eshoo (D-CA) pictured at House Energy & Commerce committee meeting
U.S. House Energy & Commerce health subcommittee ranking Democrat Anna Eshoo (Calif.) spoke this morning during the full committee's initial organization meeting of the 118th Congress.

U.S. House Energy & Commerce Committee Democrats have announced their leaders and members of two subcommittees expected to act on 340B matters this session.

Republicans announced the subcommittees’ chairs and GOP members last week. The Republicans have a narrow

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340B Report Publisher and CEO Slafsky: Three 340B Observations for 2023

U.S. Capitol with U.S flag
Expect the 340B program to be get signficant attention at the federal and state level this year, 340B Report Publisher and CEO Ted Slafsky says.

In his inaugural column for Verity Solutions, 340B Report Publisher and CEO Ted Slafsky offers insights “on what to expect in Washington, D.C., and the states in 2023 when it comes to the 340B program.”

Slafsky in the column makes

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Breaking News

Third Circuit Court Rules for Drugmakers in 340B Contract Pharmacy Cases

Interior of Third Circuit Court courtroom
A federal appeals court ruled today that the 340B statute does not compel drug manufacturers to deliver 340B-purchased drugs "wherever and to whomever a buyer demands."

A federal appeals court in Philadelphia ruled 3-0 this morning that “Congress never said that drug makers must deliver discounted Section 340B drugs to an unlimited number of contract pharmacies.”

“By trying to enforce that supposed requirement, the government overstepped

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