The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more
8/5/2025
/ Comment Period ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
HRSA ,
Johnson & Johnson ,
Manufacturers ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
New Guidance ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Pilot Programs ,
Prescription Drugs ,
Regulatory Agenda ,
Section 340B
In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more
4/25/2024
/ Arbitration ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Healthcare ,
HRSA ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Section 340B
As the extensively covered Genesis Healthcare, Inc. v. Azar case continues to proceed, 340B covered entities expect to soon receive much-anticipated clarification on what can reasonably constitute a 340B eligible patient. In...more