340B Recertification for CDC Grantees Starts May 8

Recertification
Annual 340B recertification for CDC grantees will be May 8 through June 5.

This year’s annual 340B recertification period for U.S. Centers for Disease Prevention and Control grantees—Title X family planning, sexually transmitted disease, and tuberculosis clinics—will be May 8 through June 5, the U.S. Health Resources and Services Administration said Tuesday.

Recertification

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Daiichi-Sankyo Offering Refunds for 340B Overcharges on Two Drugs

Enhertu
Daiichi-Sankyo is offering refunds for 340B overcharges on its breast cancer drug Enhertu and cholesterol drug Welchol for Oral Suspension.

Drug manufacturer Daiichi-Sankyo is offering 340B covered entities refunds for overcharges on metastatic breast cancer treatment Enhertu during Q1 2020 and on cholesterol medication Welchol for Oral Suspension during Q1 2022 and Q4 2022.

The U.S. Health Resources and Services

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New 340B Transparency Bill to be Discussed Next Week in House Hearing, U.S. Senate Bills Introduced

Bucshon bill
Rep. Larry Bucshon (R-Ind.) has has written a bill to impose significant 340B program reporting requirements on disproportionate share hospitals and maybe other covered entities.

U.S. Rep. Larry Bucshon (R-Ind.), vice chair of the House Energy & Commerce health subcommittee, has written a bill to impose significant 340B program reporting requirements on disproportionate share hospitals and potentially other covered entities. Meanwhile, two bills have been

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HRSA Administrator Open to Congress’ Help Ensuring 340B Accountability and Transparency

Carole Johnson
HRSA Administrator Carole Johnson said during a House hearing yesterday she would welcome congressional help ensuring there is “accountability and transparency” in 340B.

U.S. Health Resources and Services Administration Administrator Carole Johnson said on Capitol Hill yesterday that HRSA would welcome congressional help ensuring there is “accountability and transparency” in the 340B program.

Johnson was answering questions from Rep. Morgan Griffith (R-Va.) during

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Hospitals Urge Fed. Appeals Court to Uphold Novel Ark. Law Protecting 340B Discounts in Contract Pharmacy Setting

Eighth Circuit Court
PhRMA filed a citation to notify the U.S. Eighth Circuit Court of Appeals in St. Louis that Arkansas is enforcing its 340B contract pharmacy law.

Three groups representing 340B hospitals late last week filed an amicus brief in federal circuit court in support of Arkansas’ novel contract pharmacy law, arguing the law doesn’t conflict with the 340B statute and in fact furthers the goals of

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Closed Pennsylvania 340B Hospital Sues CVS Health Over 340B TPA Policy

Brandywine Hospital
A closed Pennsylvania hospital has filed a federal antitrust class action against CVS over its 340B contract pharmacy policies.

A Philadelphia-area hospital that closed last year after its sale fell through has filed a federal antitrust class action against healthcare conglomerate CVS over its 340B contract pharmacy policies.

The same shuttered hospital has been challenging in state court its

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Feds Pass on Asking Full Appeals Court to Reconsider Adverse 340B Contract Pharmacy Ruling and Vacate Enforcement Letters to Three Manufacturers

Third Circuit Court
The federal government opted not to ask a federal appeals court to reconsider its opinion upholding three drug makers' restrictions on 340B pricing when their drugs are shipped to be dispensed by contract pharmacies.

The federal government yesterday decided not to ask all 14 judges on the U.S. Third Circuit Court of Appeals in Philadelphia to review a three-judge panel’s unanimous January opinion upholding AstraZeneca, Novo Nordisk, and Sanofi’s restrictions on 340B pricing when

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Lilly Asks Covered Entity to Promptly Repay “Duplicate 340B/Medicaid Discounts”

Lilly
Eli Lilly is conducting government approved 340B provider audits that for the first time look for certain Medicaid health plan duplicate discounts.

Drug manufacturer Eli Lilly asked a 340B covered entity last week to promptly repay it for “duplicate 340B/Medicaid discounts” and evaluate all Lilly prescriptions that it or its contract pharmacies dispensed for the last three years.

Consultants and attorneys with

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New Group 340B Truth Seeks Provider Consensus on Federal Legislation

340B Truth
A new group, 340B Truth, is seeking a covered entity consensus position on 340B reform to take to Congress for quick action.

About a dozen people who advise, help run, or work at 340B covered entities are launching a nonprofit group, 340B Truth, to try to hammer out a covered entity consensus position on 340B reform and urge Congress to pass it

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HHS OIG and HRSA Are Mum About 340B Manufacturer Civil Monetary Penalties and Violation Notices

screenshot of HRSA correspondence to stakeholders web page
HRSA and OIG have no comment on the status of drug manufacturer civil monetary penalties and violation letters stemming from denials of 340B pricing to covered entities that use contract pharmacies.

The U.S. Department of Health and Human Services Office of Inspector General said yesterday it has no comment on the status of referrals from the U.S. Health Resources and Services Administration to fine eight drug manufacturers for failing to offer

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