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Biogen Becomes 6th Drugmaker to Announce In-House Pharmacy Claims Data Requirements

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Biogen recently announced it's expanding its 340B claims data requirements to in-house pharmacy use, making it the sixth drugmaker to do so.
A Massachusetts pharmaceutical manufacturer recently announced plans to expand its 340B claims data requirements to in-house pharmacy use, making it [...]

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Three Operational Challenges as Medicare’s Maximum Fair Price Scales

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Medicare’s Maximum Fair Price (MFP) went into effect on January 1, introducing negotiated pricing for select Medicare Part D drugs under the Inflation Reduction Act (IRA). An additional 15 drugs are expected to follow in 2027 and beyond.

As a Third-Party

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HRSA Appeals Federal Court Ruling on 340B Child Site Registration Policy

HRSA recently appealed a ruling that vacated its 340B child site registration policy to the U.S. Court of Appeals for the District of Columbia.
The Health Resources and Services Administration (HRSA) recently appealed a federal court ruling that struck down its 340B hospital child [...]

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Maryland Officials Urge Appeals Court to Rehear State 340B Contract Pharmacy Case

U.S. 4th Circuit Court of Appeals
Maryland state officials recently asked the U.S. 4th Circuit Court of Appeals to rehear a case on the state's 340B contract pharmacy access law.
Maryland state officials recently urged a federal appeals court to reconsider a ruling against the state’s 340B contract pharmacy access [...]

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Gilead Latest Drugmaker to Move to Truzo, Kalderos’ Platform for 340B Contract Pharmacy Restrictions

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Gilead announced it will move its 340B contract pharmacy claims review and policy oversight duties from Second Sight Solutions’ 340B ESP to Kalderos’ Truzo as of June 15.
A California-based drugmaker recently announced that it will become the fourth drugmaker to utilize a new platform for its 340B [...]

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Bergman, Ruiz to Introduce Bipartisan Bill Exempting Additional Covered Entities From 340B Rebates

U.S. Reps. Jack Bergman (R-Mich.) and Raul Ruiz (D-Calif.) are expected to soon introduce legislation to exempt certain covered entities from a 340B rebate model.
An expected bipartisan-backed U.S. House bill would exempt a range of covered entities, but not major hospitals, from 340B rebates—building [...]

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Stemline Therapeutics 41st Drugmaker to Enact 340B Contract Pharmacy Restrictions

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Stemline Therapeutics announced its contract pharmacy restrictions for Orserdu will take effect May 18.
A New York-based drugmaker recently announced new contract pharmacy restrictions for covered entities looking to purchase a breast cancer treatment [...]

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Readiness Over Reaction

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Uncertainty has become a constant in the 340B landscape. Legal challenges, shifting manufacturer policies, and evolving oversight have made one thing clear: waiting for definitive answers before taking action is no longer a viable strategy.


For covered entity leaders, the

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Justice Department Tells Federal Judge Washington State’s 340B Contract Pharmacy Access Law is Unconstitutional

U.S. Justice Department builidng
The U.S. Department of Justice urged a federal judge to rule against Washington state's 340B contract pharmacy access law.
The U.S. Department of Justice (DOJ) recently urged a federal judge to strike down Washington state’s new 340B contract pharmacy [...]

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New Tennessee Law Strengthens Grant Requirements for Certain 340B Clinics Receiving In-Kind Funding

The Tennessee state legislature
Tennessee recently enacted a new law tightening oversight of certain 340B clinics that receive in-kind funding.
Tennessee Gov. Bill Lee (R) recently signed provider-backed legislation aimed at strengthening oversight of certain 340B clinics that receive in-kind [...]

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