Second of Three U.S. Appeals Court Hearings on 340B Contract Pharmacy Is Set for Monday

US Appeals Court Seventh Circuit court room
Oral arguments are scheduled for this Monday at the federal appeals court in Chicago over Lilly's 340B contract pharmacy restrictions.

Now that a federal appeals court in Washington, D.C., has heard arguments in Novartis and United Therapeutics’ 340B contract pharmacy lawsuits, the scene shifts to Chicago, where an appeals court will hear arguments Monday morning in Eli Lilly’s companion case.

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HRSA Cites Almaject for 340B Price Data Lapse, No Sanctions Imposed 

Screenshot of HRSA manufacturer audit results page
New Jersey-based generic manufacturer Almaject was cited for an infraction by HRSA during a recent audit. However, the company will not be sanctioned.

The U.S. Health Resources and Services Administration (HRSA) has cited Almaject, a New Jersey-based maker of generic injectables, with failing to submit quarterly pricing data into the 340B Office of Pharmacy Affairs Information System, although the agency did not impose

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News Alert

Federal Appellate Judges Ask Lawyers, What is a Bona Fide Offer of 340B Pricing?

Screenshot of Judge Gregory Katsas speaking on C-SPAN
Judge Gregory Katsas is on a three-judge panel that will decide the legality of HRSA's 340B program violation letters to Novartis and United Therapeutics. He is shown here speaking at an October 2021 symposium on U.S. Supreme Court Justice Clarence Thomas, for whom he clerked. | C-SPAN

Two of three judges on a federal appeals court panel yesterday repeatedly asked lawyers during a highly anticipated hearing in Washington, D.C., what standard the court should use to decide whether drug manufacturers’ 340B contract pharmacy conditions are legal.

The

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As Interest in Legislation Grows, Congressional Research Service Issues Back-to-Back Reports on 340B Program

Congressional Research Service wordmark and logo
The Congressional Research Service issued a summary of the range of policy actions affecting 340B contract pharmacy use in recent years

Congress’ nonpartisan research office has issued a four-page backgrounder on litigation over the 340B contract pharmacy program and a two-pager on the entire drug discount program. They could be a sign that 340B hearings and/or bills are coming.

The Congressional

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Feds in Mediation with Tenn. Health System that Allegedly Paid for Referrals to Boost 340B Profits

Methodist Le Bonheur Healthcare building
Methodist Le Bonheur Healthcare and the federal government have settled a 340B-related False Claims Act suit against the system.

The federal government and a Tennessee health system are meeting with a mediator in connection with a whistleblower lawsuit that alleges that the system paid Memphis-area cancer physicians for referrals that generated $50 million in profits in one year alone

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Breaking News

In Key Hearing, Appeals Court Panel Seems to Lean in Favor of Some Drug Manufacturer Conditions on 340B Pricing

CADC courtroom
A federal appeals court in Washington, D.C., heard arguments this morning in Novartis and United Therapeutics' consolidated 340B contract pharmacy cases.

Two of three judges on a federal appeals court panel strongly indicated this morning that they reject the federal government’s position that nothing in the 340B statute gives drug manufacturers the right to put any conditions on offers of 340B

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Breaking News

HRSA Refers Merck to HHS Inspector General Over its 340B Contract Pharmacy Policy

Merck flag with U.S. flag
Merck did not immediately comment on the governnment's referral yesterday to the HHS Inspector General for possible imposition of civil fines over the company's 340B contract pharmacy restrictions.

The U.S. Health Resources and Services Administration yesterday referred drug manufacturer Merck to the Department of Health and Human Services Office of Inspector General for possible imposition of civil fines over Merck’s 340B contract pharmacy restrictions.

Public Health Services Lt.

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CMS Says Steps to End Medicare Drug Payment Cut for 340B Hospitals Are in Progress

CMS building
CMS says it is making computer file changes to restore hospitals’ Part B payments for 340B-purchased drugs to average sales price plus 6% for the rest of 2022 after paying them almost 30% less since 2018.

The U.S. Centers for Medicare & Medicaid Services is making computer file changes to restore hospitals’ Part B payments for 340B-purchased drugs to average sales price plus 6% for the rest of 2022 after paying them almost 30% less since

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340B COVID-19 Flexibilities Will Continue Through Mid-January

Screenshot of HRSA COVID-19, 340B program resources page
HHS extended the COVID-19 public health emergency (PHE) to mid-January, which keeps in place 340B program flexibilities that started in March 2020.

The U.S. Department of Health and Human Services (HHS) late last week extended the COVID-19 public health emergency (PHE) to mid-January, giving some 340B-eligible entities more time for immediate enrollment in the program without having to wait for the next

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NACHC Seeks Meeting with Becerra About 340B Contract Pharmacy Restrictions After “Inexplicable” ADR Decision

NACHC wordmark
NACHC told HHS Secretary Becerra it has “little choice” but to turn to Congress after an HHS panel dismissed NACHC’s 340B overcharging claims against AstraZeneca and Sanofi.

The National Association of Community Health Centers is asking to meet with U.S. Health and Human Services Secretary Xavier Becerra to discuss drug companies’ “unlawful restrictions” on 340B drug shipments to contract pharmacies.

NACHC told Becerra in an Oct. 14

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