Feds and S.C. Health Center Spar Over Center’s Access to Government Info in its 340B Patient Definition Case

Genesis Health Care
Genesis Health Care and HHS are sparring over whether the health center should have access to more government information than it already has in its fight to clarify the 340B patient definition.

A South Carolina health center and the federal government are sparring over whether the center should have access to more information from the government than it already possesses in its fight to clarify the 340B patient definition.

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Breaking News

Appeals Court Questions Yet Again if it Has Jurisdiction Over Lilly’s 340B Contract Pharmacy Case

Frank Easterbrook
Federal appeals court Judge Frank Easterbrook is pictured during an appearance on C-SPAN in 2013. Easterbrook during a court hearing today questioned whether a closely watched 340B contract pharmacy case was ripe for appellate review.

A federal appeals court judge in Chicago expressed doubt during a hearing this morning that the court can review a lower court decision in drug manufacturer Eli Lilly’s 340B contract pharmacy lawsuit.

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

US Appeals Court Seventh Circuit
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 

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?

Gregory Katsas
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

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

Congressional Research Service
The Congressional Research Service issued a four-page backgrounder on litigation over the 340B contract pharmacy program and a two-pager on the entire drug discount program.

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.

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

Methodist Le Bonheur Healthcare
Methodist Le Bonheur Healthcare and the federal government are meeting with a mediator over the government's 340B-related False Claims Act suit against the system. Methodist says the claims are without merit.

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

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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
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

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Breaking News

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

Merck
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.

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

CMS
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%

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