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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Bayer: 340B “Is Enriching Middlemen Versus Benefitting Patients”

Bayer wordmark on building
Bayer added a previously excluded drug to its list of products that face contract pharmacy restrictions.

While the 340B program “has merit when used as intended,” it has “strayed far from its original purpose, creating a profit stream that is enriching middlemen versus benefitting patients,” drug manufacturer Bayer told 340B Report yesterday.

Bayer gave the statement

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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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Breaking News

EMD Serono Is the Second Drug Maker Today to Impose Conditions on 340B Contract Pharmacy, and the 21st Overall

EMD Serono wordmark on building
Beginning Oct. 1, EMD Serono will extend its contract pharmacy restrictions to all 340B covered entities.

EMD Serono today became the 21st pharmaceutical manufacturer to impose conditions on 340B pricing involving drug shipments to contract pharmacies.

Bayer announced conditions on 340B sales involving contract pharmacies earlier today. The companies’ announcements came two days after

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Breaking News

Bayer Is the 20th Drug Maker to Impose Conditions on 340B Contract Pharmacy

Bayer wordmark on side of building
Bayer will no longer exempt federal grantees from its 340B contract pharmacy policy as of Oct. 1.

Bayer Healthcare Pharmaceuticals starting March 1 is imposing limits on hospitals’ replenishment orders of 340B-priced drugs shipped to contract pharmacies. It said it is voluntarily letting 340B grantee covered entities continue to use multiple contract pharmacies to dispense 340B drugs.

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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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Virginia House Subcommittee Defeats 340B Hospital Accountability Bill; Rev. Al Sharpton Says Program Direly Needs More Oversight

Screenshot of Virginia state legislature public testimony
Bon Secours Health System Vice President Rhodes Ritenour testified against proposed Virginia state legislation to require more accountability from 340B hospitals about how they use 340B program revenues. State House Del. Kathy Tran, the bill's sponsor, is seated behind him.

A Virginia House subcommittee last week voted 3-2 against a Democrat’s bill to require more accountability from 340B hospitals about how they use 340B program revenues.

In a reversal of their parties’ normal stances on 340B nationally, Democrats voted for

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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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