HRSA Sends 340B Rebate Model Prerule to White House for Review

6/3/2026 – HRSA Sends 340B Rebate Model Prerule to White House for Review Overview Last week, HRSA sent a prerule document titled “Notice Regarding 340B Rebate Model Pilot Program” to the White…

Legal Fight Over HRSA’s Hospital Child Site Policy Continues, as Agency Appeals Court Decision

5/13/2026 – Legal Fight Over HRSA’s Hospital Child Site Policy Continues, as Agency Appeals Court Decision Overview HRSA has appealed a federal district court’s decision that vacated the agency’s eligibility and registration requirements for…

Gilead and Amphastar Start Using Truzo to Implement Contract Pharmacy Restrictions

5/11/2026 – Gilead and Amphastar Start Using Truzo to Implement Contract Pharmacy Restrictions Gilead and Amphastar recently became the fourth and fifth manufacturers to announce use of the Truzo platform operated by Kalderos…

AstraZeneca and BMS Jump on 340B Claims Data Submission Bandwagon For Entity-Owned Pharmacies

4/21/2026 – AstraZeneca and BMS Jump on 340B Claims Data Submission Bandwagon For Entity-Owned Pharmacies AstraZeneca and Bristol Myers Squibb (BMS) became the most recent manufacturers to require covered entities to submit data…

Drug Manufacturer AbbVie Sues HRSA Over the 340B Patient Definition

4/17/2026 – Drug Manufacturer AbbVie Sues HRSA Over the 340B Patient Definition Last week, the drug manufacturer AbbVie filed a federal lawsuit challenging HRSA’s long-standing definition of a 340B patient.…

Federal Court Strikes Down HRSA’s 2013 GPO Prohibition Policy

4/8/2026 – Federal Court Strikes Down HRSA’s 2013 GPO Prohibition Policy A federal court struck down the Health Resources and Services Administration’s (HRSA) 2013 policy requiring certain 340B hospitals to make their initial purchases…

Fourth Circuit Upholds Preliminary Injunction Blocking West Virginia’s Contract Pharmacy Protection Law

4/6/2026 – Fourth Circuit Upholds Preliminary Injunction Blocking West Virginia’s Contract Pharmacy Protection Law In a 2–1 decision, the  Fourth Circuit upheld a lower court’s preliminary injunction blocking West Virginia from…

Ninth Circuit Lays the Groundwork for Potential False Claims Act Liability of Manufacturers for 340B Overcharges

4/3/2026 – Ninth Circuit Lays the Groundwork for Potential False Claims Act Liability of Manufacturers for 340B Overcharges In a pivotal decision upholding False Claims Act (FCA) litigation against drug…

RWC-340B Letter to Novo Nordisk CEO Objecting to Policy Requiring Covered Entities to Submit Claims-level Data

03/30/2026 – RWC-340B Letter to Novo Nordisk CEO Objecting to Policy Requiring Covered Entities to Submit Claims-Level Data RWC-340B sent a letter to Novo Nordisk’s CEO on March 26, 2026,…

RWC-340B Objects to Eli Lilly’s Claims Submission Mandate as Unprecedented, Violation of Federal Law

03/09/2026 – RWC-340B Objects to Eli Lilly’s Claims Submission Mandate as Unprecedented, Violation of Federal Law RWC-340B sent a letter to Eli Lilly’s CEO on February 18, 2026, objecting to…