CMS’ MDRP Final Rule May Impact 340B Covered Drugs, Attorneys Say

CMS' recently-released MDRP final rule may affect 340B covered drugs and draw litigation.
A new federal regulation updating the definition of a covered outpatient drug could change the number of drugs covered under [...]

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CMS Finalizes Next Medicare Drug Negotiation Guidance Without Resolving Key Concerns of 340B Stakeholders

The AHA raised concerns that October 2024 federal guidance on Medicare drug price negotiations may allow drugmakers to “wrongly justify fundamental changes to the 340B program.”
Federal regulators issued final guidance for the next round of Medicare drug price negotiations yesterday but did not propose remedies [...]

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340B Provider Groups, Key Federal Lawmaker Praise HRSA for Pressuring J&J to Drop 340B Rebate Proposal

U.S. Rep. Abigail Spanberger (D-Va.) and multiple 340B provider groups applauded HRSA for its response on J&J's 340B rebate proposal.
Multiple 340B provider groups have applauded the federal government for threatening “strong” enforcement actions that led Johnson & Johnson (J&J) [...]

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Kalderos Launches New Drug Discount Platform with 340B Rebate Capabilities as Lawsuit with HHS Remains Paused

Kalderos announced a new drug discount platform that supports 340B rebate capabilities.
Drug industry vendor Kalderos last week launched a new drug discount platform with 340B rebate capabilities as its prior lawsuit [...]

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Breaking News

J&J Abandons 340B Rebate Due to HRSA’s Enforcement Threats But Defends Model in Letter to Agency

J&J announced it will "forgo implementation" of its 340B rebate proposal due to enforcement threats from HRSA.
Johnson & Johnson (J&J) notified the Health Resources and Services Administration (HRSA) this morning that it will drop its 340B [...]

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Sanofi Imposes New 340B Contract Pharmacy Rule in Arkansas Following Legal Deal with State

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Sanofi implemented a new 340B contract pharmacy rule for certain Arkansas hospitals.
Sanofi is requiring Arkansas hospitals to prove they legally own 340B-priced drugs until they are dispensed at contract pharmacies after [...]

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CMS Publishes Final Rule on Medicaid Rebates with Significant 340B Implications

CMS released a final rule for Medicaid rebates with new identifiers and definitions that impact the 340B program.
Federal regulators last Friday finalized a highly anticipated rule for the Medicaid Drug Rebate Program (MDRP) with new identifiers and [...]

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AHA Op-Ed Takes Aim at ‘Big Pharma’s’ 340B Program Growth Rhetoric 

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AHA officials penned a Medical Economics op-ed on “the truth behind growth of the 340B prescription drug program.”
A major hospital group recently hit back against the drug industry’s claims that hospital behavior has helped drive “out of [...]

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Breaking News

Senator Cassidy Extends 340B Inquiry to Two Major Pharmaceutical Manufacturers

Sen. Bill Cassidy (R-La.) has extended an ongoing 340B probe to two major drug manufacturers.
An influential Republican senator this morning requested detailed information from Eli Lilly and Amgen on their 340B programs, including the [...]

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HRSA’s Enforcement Threats Against J&J’s 340B Rebate Proposal Could Face Drugmaker Challenge

Attorneys are mixed on the strength of J&J's legal case if it chooses to challenge HRSA's opposition to its 340B rebate proposal in court.
The federal government’s recent threat to penalize Johnson & Johnson (J&J) for its unapproved 340B rebate model could spark a [...]

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