Genesis Ruling Creates Legal, Regulatory Uncertainty for 340B, Says Attorney Panel

Maureen Testoni, president and CEO of 340B Health, Jason Reddish, a principal at Powers Law, and Ross Margulies, a partner at Foley Hoag, discussed the looming uncertainty in 340B following a key federal district court ruling during the 340B Coalition Winter Conference.
A recent federal district court ruling on the 340B patient definition created a “gray area” for 340B providers and drugmakers, [...]

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Potential Senate Flip May Increase 340B Scrutiny, But Congressional 340B Action Unlikely in 2024, Say 340B Advocate, Drug Industry Analyst

Michael McCaughan, co-founder of Provision Policy, spoke about drug pricing policy at the 340B Coalition Winter Conference.
Congress is unlikely to act on 340B in 2024, but a potential flip of the U.S. Senate could lead to [...]

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Tennessee Bills Introduced to Regulate 340B Funding for Certain STD Clinics

Companion bills recently introduced in the Tennessee state house and senate would add regulations for 340B in-kind funding.
Tennessee state lawmakers have introduced companion bills that would require sexually transmitted disease (STD) clinics to enter into a contract [...]

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News Alert

Senior HRSA Official Doubles Down on Agency’s 340B Patient Definition in Wake of Genesis Ruling

Rear Admiral Krista Pedley saluting
Rear Adm. Krista Pedley, director of HRSA's Office of Special Health Initiatives, addressed the 340B patient definition at a conference Tuesday.
A high-ranking Health Resources & Services Administration (HRSA) official this morning told 340B stakeholders that the agency would continue to [...]

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Health Systems, HRSA Spar in Federal Court Over 340B Registration Policy Reversal

U.S. District Court of the District of Columbia
A hospital association asked the U.S. District Court of the District of Columbia to side with more than 40 health systems that sued federal regulators over a hospital registration policy change.
Forty-four health systems have asked a federal district court to decide, without a full trial, on their lawsuit against federal [...]

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Amid Possible Coming Enforcement, PhRMA Again Asks Court to Block Louisiana’s 340B Contract Pharmacy Law

In a recent federal court filing, Louisiana Attorney General Liz Murrill's office said it had not moved to enforce a state 340B contract pharmacy law.
After Louisiana signaled plans to possibly enforce its state 340B contract pharmacy law, a powerful drug industry trade group has [...]

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Arizona State Senators Introduce Latest 340B Contract Pharmacy Bill

Two influential Arizona state senators recently introduced a bill that would prohibit drugmaker restrictions on 340B contract pharmacy use.
Two high-ranking Republican Arizona state senators have introduced a bill that would bar drug manufacturer restrictions on 340B contract pharmacy [...]

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HIV/AIDS Group Continues Legal Fight with Apexus Over 340B Prime Vendor Contract

AHF has asked a federal appeals court to reverse an earlier court's decision to dismiss a case against Apexus over its provision of 340B sub-ceiling price discounts on drugs.
The AIDS Healthcare Foundation (AHF) recently urged a federal appeals court to reverse a lower court’s decision to dismiss its [...]

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High-Ranking GOP Lawmakers Introduce Bills to Quantify 340B Use Among ‘Noncitizens’

Sen. Bill Cassidy (R-La.) and other influential Republican lawmakers introduced companion bills calling for a government report on 340B use among people living in the country without legal permission.
Influential Republican lawmakers have introduced companion bills in the U.S. House and Senate that call for a government report on [...]

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New Medicaid Policy Change Could Reduce 340B Savings, Cause Drug Discontinuations, Warn Stakeholders

A Medicaid drug rebate policy change that recently took effect could lead to reduced 340B savings and drug discontinuations.
A Medicaid policy change that took effect at the start of 2024 could indirectly lead to lower 340B savings and [...]

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