340B “Overdue for Reform,” Industry Trade Group BIO Says in Blog

Screenshot of bionews.com 340B drug discount program story
The 340B program “is buckling under its own weight and overdue for reform,” BIO says in its blog.

The 340B program “is buckling under its own weight and overdue for reform,” biotechnology industry trade group BIO said last week in its blog.

BIO, which is marking its 30th anniversary in 2023, has experienced inner turmoil in recent

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CMS Plans in April to Address Potential Remedies for Illegal Drug Payment Cuts for 340B Hospitals

Screenshot of CMS meeting agenda
CMS plans to issue a proposed rule in April regarding “potential remedies” for illegal Part B drug payment cuts for 340B hospitals from 2018 through late September 2022.

Federal Medicare officials plan to issue a proposed rule in April regarding “potential remedies” for illegal Part B drug payment cuts for 340B hospitals from 2018 through late September 2022.

The Centers for Medicare & Medicaid Services revealed April as

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340B Provider Ally Stabenow Will Not Seek Re-Election to U.S. Senate in 2024

Sen. Debbie Stabenow (D-MI) headshot
U.S. Sen. Debbie Stabenow (D-Mich.) will not seek re-election in 2024, depriving 340B covered entities of a reliable ally.

U.S. Sen. Debbie Stabenow (D-Mich.) will not seek re-election in 2024, a decision that will deprive 340B covered entities of a reliable ally in Congress.

Stabenow issued a statement yesterday announcing her decision. She was one of six senators—three

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Janssen Providing Refunds for 340B Overcharges During Q1 2020

Janssen building signage
Janssen Pharmaceuticals is providing refunds to 340B covered entities for overcharges on 14 NDCs during Q1 2020.

Johnson & Johnson’s Janssen Pharmaceuticals division is providing refunds to 340B covered entities for overcharges on 14 NDCs during Q1 2020.

The U.S. Health Resources and Services Administration (HRSA) posted J&J’s refund notice yesterday. The company said the 340B

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Lilly Says 340B Entities Can’t Designate Central Fill Pharmacies as Contract Pharmacies

Lilly wordmark on top of building
Pharmaceutical giant Eli Lilly has significantly escalated its restrictions on access to 340B pricing in the contract pharmacy setting, the company announced June 19 on the drug industry vendor site 340B ESP.

Drug manufacturer Eli Lilly late last month again updated its conditions on 340B pricing when covered entities use contract pharmacies.

Lilly was the first company to impose such conditions, starting with one drug in July 2020 then expanding to

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PhRMA Takes its Fight Against Arkansas 340B Law to Federal Appeals Court

U.S. Eighth Circuit Court of Appeals building
PhRMA has asked the federal appeals court in St. Louis to overturn a lower court's ruling that federal law does not preempt Arkansas’s novel 340B anti-discrimination law.

Brand drug manufacturers have asked a federal appeals court to overturn a judge’s ruling last month that Arkansas’s novel 340B anti-discrimination law is not preempted by the 340B statute nor by the U.S. Food and Drug Administration’s Risk Evaluation and

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Alcon Providing Refunds for 340B Overcharges on 22 Products

Alcon wordmark on a building
Alcon is providing refunds for charges above 340B ceiling prices on 22 NDCs for varying sales periods from Q3 2019 through Q3 2022.

Swiss eye care drug manufacturer Alcon is providing refunds for charges above 340B ceiling prices on 22 NDCs for varying sales periods from Q3 2019 through Q3 2022.

The U.S. Health Resources and Services Administration posted Alcon’s public notice about

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House GOP Leadership Spat Stymies All Action, Including Any on 340B

Rep. Kevin McCarthy (R-CA) pictured at the entrance to the West Wing of the White House
The split among House Republicans about whether to pick Rep. Kevin McCarthy (Calif.) to be House Speaker has ground the chamber to a halt.

The U.S. House was frozen stuck this morning after the new Republican majority splintered yesterday, the first day of the 118th Congress, over who should be the next House speaker.

Representatives cannot be sworn in and the House cannot begin

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Office of Pharmacy Affairs Get Slight Funding Bump

HRSA building and signage
HRSA plans to host a webinar for federal grantees in the days leading up to the 2024 340B recertification period.

President Biden on Dec. 29 signed a $1.7 trillion omnibus appropriations bill for fiscal year 2023 that gave the 340B drug pricing program a slight funding boost.

The U.S. Health Resources and Services Administration’s Office of Pharmacy Affairs will get

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CMS Requiring All 340B Entities to Use Claims Modifiers When Billing Part B for 340B Drugs

Screenshot of CMS Part B inflation rebate guidance
CMS is requiring all 340B covered entities by Jan. 1, 2024, to use claims modifiers to identify drugs as having been purchased through 340B when they bill for separately payable Medicare Part B drugs.

The U.S. Centers for Medicare & Medicaid Services starting Jan. 1, 2024, will require all 340B covered entities—hospital and grantee—to use claims modifiers to identify drugs as having been purchased through 340B when they bill for separately payable Medicare Part

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