Sanofi Pauses Rebate Model; Files Lawsuit Against HRSA
On December 16, Sanofi informed HRSA that it will pause the implementation of its rebate model, termed a “340B credit model.” The same day, Sanofi filed a lawsuit in the…
HRSA Warns Sanofi Over Proposed Rebate Model; Alludes to Possible Termination of Pharmaceutical Pricing Agreement (PPA)
On December 13th, the Health Resources and Services Administration (HRSA) issued a letter to Sanofi calling for the manufacturer to cease implementation of its rebate model, which Sanofi terms a…
Bristol-Myers Squibb Sues To Implement Rebate Model; AbbVie Adds Grantees To Its Contract Pharmacy Policy
Bristol-Myers Squibb Sues HHS To Implement 340B Rebate Model On November 26, 2024, Bristol-Myers Squibb (BMS) filed a lawsuit against HRSA in the D.C. District Court to defend its proposed…
Third Lawsuit Is Filed Against HRSA for Blocking the Rebate Model
11/19/2024 – Third Lawsuit Is Filed Against HRSA for Blocking the Rebate Model On November 14, 2024, Eli Lilly and Company (Lilly) filed a lawsuit against HHS and HRSA in…
J&J Sues HHS and HRSA Over HRSA’s Opposition to J&J’s Proposed Rebate Model
11/14/2024 – J&J Sues HHS and HRSA Over HRSA’s Opposition to J&J’s Proposed Rebate Model On November 12, 2024, Johnson and Johnson Health Care System Inc. (J&J) filed a lawsuit…
J&J Pauses Rebate Model After HRSA Warning
Yesterday, Johnson & Johnson Health Care System Inc. (J&J) stated in a letter to HRSA that it will halt implementation of its proposed rebate model, which was set to take…
Two Covered Entity Hospitals Sue HRSA Over Johnson & Johnson Request for Audit
On July 24, 2024, two hospital-covered entities sued the Health Resources and Services Administration (“HRSA”), arguing that HRSA’s approval of J&J’s 340B audit request against them was unlawful and premature. The…
HHS Issues Revised ADR Regulations
Today, HHS published revised 340B administrative dispute resolution regulations (ADR Rule) that will replace existing ADR regulations effective June 18. Most notably, the ADR Rule does not include a proposal…
RWC-340B Sends Letters to Gilead, HHS Secretary, and OPA Director.
A growing number of pharmaceutical manufacturers have recently posed restrictions affecting Ryan White Clinics and other Safety Net Providers. RWC-340B has taken action to address these challenges head-on. On…
New AbbVie and Lilly Contract Pharmacy Policies
AbbVie is the 11th Manufacturer to Restrict Access to 340B Prices at Contract Pharmacies By letter dated December 29, 2021, AbbVie announced that, effective February 1, 2022, it will implement…